A Phase 3, Multi-Center, Randomized, Double-Blind, Vehicle- Controlled, 2-Arm, Parallel Group Comparison Study Comparing the Efficacy and Safety of IDP-121 and IDP-121 Vehicle Lotion in the Treatment of Acne Vulgaris
Phase: PHASE3
Conditions: Acne
Sponsor: Bausch Health Americas, Inc.

C LI NI C A L S T U D Y P R O T O C O L 
I D P-1 2 1  
Pr ot oc ol V 0 1 -1 2 1 A -3 0 1  
A P hase 3, M ulti -C e nter, Ra n d o miz e d, D o u ble -Bli n d, Ve hicle - 
C o ntr olle d, 2 -Ar m, Parallel Gr o u p C o m paris o n St u d y C o m pari n g t he 
Efficac y a n d Safet y of I D P -1 2 1 a n d I D P -1 2 1 Ve hicle L oti o n i n t he 
Treat me nt of Ac ne V ul garis  
De vel o p me nt  P h ase:  
3 
St u d y  Desi g n:  
M ulti -ce nter, ra n d o mize d, d o u ble- bli n d, ve hicle -c o ntr olle d 
efficac y a n d s afet y st u d y  
D ate:  
0 4 J u ne 2 0 1 5 
S p o ns or:  
D o w P har mace utical Sci e nces, a Di visi o n of Valea nt 
P har mace uticals N ort h A merica,  L L C  
1 3 3 0 Re d w o o d Wa y  
Petal u ma, C A  9 4 9 5 4 
C O N FI D E N TI A L  
N ot hi n g herei n is t o be discl ose d wit h o ut pri or a p pr o v al of t he s p o ns or.  
N C T #: N C T 0 2 9 3 2 3 0 6 

Pr ot oc ol  V 0l -1 2 1 A -3 0 1,  I D P-1 2 1  
V ulc n nt Researc h & De vel o p me nt  
 
Pr ot oc ol R e vie w a n d A p pr o vals  
 
A P h as e 3, M ulti -C e nte r, R a n d o miz e d, D o u ble -Bli n d, V e hicle -C o ntr olle d, 2 -A r m, 
P a r allel G r o u p C o m p a ris o n St u d y C o m p a ri n g t h e Effic a c y a n d S afet y of I D P -1 2 1 a n d 
I D P-1 2 1 V e hicle L oti o n i n t h e T r e at m e nt of A c n e V ul g a ris  
 
Re vie we d a n d a p pr o ve d:  
 
 
 
 
V alea nt P ha n nace uticals N ort h A merica, L L C  
 
 
 
 
 
Valea nt P ha n nace uticals N ort h A merica, L L C  
 
 
 
 
Valea nt  P har mace uticals  N ort h  A merica,  L L C  
 
ztl r..,,_,/-i w.J 
Da te 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Versi o n  1,  0 4  J u ne 2 0 1 5  
C O N FI D E N TI A L  
2  

Protocol V01-121A-301, IDP-121 
Valeant Research & Development 
Version 1, 04 June 2015 
CONFIDENTIAL 
3 
 
 
Personnel Responsible for Conducting the Study 
 
A Phase 3, Multi-Center, Randomized, Double-Blind, Vehicle-Controlled, 2-Arm, 
Parallel Group Comparison Study Comparing the Efficacy and Safety of IDP-121 and 
IDP-121 Vehicle Lotion in the Treatment of Acne Vulgaris 
 
Contract Research Organization 
 
Medical Monitor 
 
TKL Research, Inc. 
365 W. Passaic Street, Suite 550 
Rochelle Park, NJ 07662 
 
 
 
 
 
 
 
 
Sr. Project Manager 
 
TKL Research, Inc. 
365 W. Passaic Street, Suite 550 
Rochelle Park, NJ 07662 
 
 
 

Pr ot oc ol V 0 1 -1 2 1 A -3 0 1, I D P -1 2 1  
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Versi o n 1, 0 4 J u ne 2 0 1 5  
C O N FI D E N TI A L  
4  
 
 
 
I a gree: 
Pri nci p al I n vesti g at or Pr ot oc ol A gree me nt P a ge  
•  T o ass u me res p o nsi bilit y f or t he pr o per c o n d u ct of t his cli nical st u d y at t his site a n d t o 
c o n d uct t he st u d y i n c o m plia nce wit h t his pr ot oc ol, a n y f ut ure a me n d me nts, a n d wit h 
a n y ot h er st u d y c o n d uct pr oce d ures pr o vi de d b y t he  s p o ns or. 
•  T hat I a m a w are of, a n d will c o m pl y wit h, t he i nter nati o nall y rec o g nize d c o de of G o o d 
Cli nical Practices ( G C P) a n d all ot her a p plica ble re g ul at or y re q uire me nts t o o btai n 
writte n a n d date d a p pr o v al fr o m t he I nstit uti o nal Re vie w B o ar d (I R B) or I n de pe n de nt 
Et hics C o m mittee (I E C) f or t he st u d y pr ot oc ol, writte n i nf or me d c o nse nt, c o nse nt  f or m 
u p dates, s u bject -r ecr uit m e nt pr oce d ures (e. g., a d v ertise me nts), a n d a ny ot her writte n 
i nf or mati o n t o be pr o vi de d t o t he s u bjects, bef ore i nitiati n g t his cli nical st u d y. 
•  N ot t o i m ple me nt a n y c h a n ges t o, or de viati o ns fr o m t he pr ot oc ol wit h o ut pri or 
a gree m e nt fr o m t he s p o ns or a n d re vie w a n d d o c u me nte d a p pr o val fr o m t he I R B/I E C , 
e x ce pt t o eli mi nate a n i m me diate hazar d t o t he st u d y s u bjects, or w he n c ha n ge(s) 
i n v ol ves o nl y l o gistical or a d mi nistrati ve as pects of t he cli nical st u d y. 
•  T o per mit direct m o nit ori n g a n d a u diti n g b y t he s p o ns or or s p o ns or’s  re pres e ntati ves 
a n d i ns pecti o n  b y t h e a p pr o priate re g ulat or y  a ut h orit y(ies).  
•  T hat I a m t h or o u g hl y fa miliar wit h t he a p pr o priate use of t he i n vesti gati o nal 
pr o d ucts(s), as d escri be d i n t his pr ot oc ol, a n d a n y ot her i nf or mati o n pr o vi d e d b y t h e 
s p o ns or or desi g nee, i n cl u di n g, b ut n ot li mite d t o, t he c urre nt I n vesti gat or Br oc h ure or 
e q ui vale nt d oc u me nt a n d a p pr o ve d pr o d u ct la bel (if  a p plica ble).  
•  T o pr o vi de s ufficie nt ti m e, a n d a d e q uate n u m bers of q ualifie d staff a n d facilities f or t he 
f oresee n d urati o n of t he cli nical st u d y t o c o n d uct t he st u d y pr o p erl y, et hicall y, a n d 
safel y. 
•  T o e ns ure t hat all pers o ns assisti n g i n t his st u d y are a de q u atel y i nf or me d a b o ut t he 
pr ot oc ol, i n vesti gati o nal pr o d uct(s), a n d t h eir cli nical st u d y -relat e d d uties a n d 
f u ncti o ns. 
 
 
 
 
Pri nci pal I n v esti gat or ( pri nt na me) 
 
 
Pri nci pal  I n vesti gat or (si g nat ur e) 
Date  

Pr ot oc ol V 0 1 -1 2 1 A -3 0 1, I D P -1 2 1  
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2  S y n o psis  
 
N a me of S p o ns or/ C o m p a n y: D o w P h ar m ace utic al Scie nc es, a di visi o n of Valea nt P har mace uticals 
N ort h A merica, L L C  
N a me of I n vesti g ati o n al Pr o d uct: I D P-1 2 1 L oti o n  
N a me of Acti ve I n gre die nts: Treti n oi n 0. 0 5 % l oti o n  
Title of St u d y: A P hase 3, M ulti -Ce nter, Ra n d o mize d, D o u ble -Bli n d, Ve hicle -C o ntr olle d, 2 -Ar m, P arallel 
Gr o u p C o m paris o n St u d y C o m pari n g t he Efficac y a n d Safet y of I D P -1 2 1 L oti o n a n d I D P -1 2 1 Ve hicle 
L oti o n  i n t he Treat me nt of Ac ne V ul garis 
N u m ber of cli nic al ce nters: M ultice nter, a p pr o xi matel y 3 2 -5 0 i n vesti gati o nal ce nters i n N ort h A merica  
O bjecti ve:  
T he pri mar y o bj ecti ve of t his st u d y is t o c o m pare t he efficac y, safet y a n d t olera bilit y of I D P -1 2 1 L oti o n 
a n d ve hicle i n t he treat me nt of s u bj ects wit h ac ne v ul garis.  
M et h o d ol o g y:  
T his is a m ultice nter, ra n d o mi ze d, d o u ble -bli n d, parallel gr o u p, ve hicle -c o ntr olle d, 1 2 -wee k st u d y t o 
e val uate relati ve c ha n ges i n i nfla m mat or y a n d n o n -i nfla m mat or y lesi o n c o u nts, as well as treat me nt 
s uccess usi n g a n E val uat or’s Gl o bal Se verit y Scale ( E G S S) i n s u bj ects wit h m o derate t o s e vere ac ne. 
S u bj ects m ust be at least 9 years of a ge a n d ol der wit h m o der ate t o se vere ac ne v ul garis (a s c ore of 3 or 4 
[ m o derate t o se vere] o n t he E G S S scale), prese nti n g wit h 2 0-4 0 i nfla m mat or y facial lesi o ns ( pa p ules, 
p ust ules, a n d n o d ules), 2 0 -1 0 0 n o n -i nfla m mat or y facial lesi o ns ( o pe n a n d cl ose d c o me d o nes), a n d <  2 
facial n o d ules.  
A p pr o xi matel y ei g ht h u n dre d ( 8 0 0) s u bj ects will be ra n d o mi ze d t o t he f oll o wi n g treat me nt gr o u ps: 
•  
4 0 0 S u bj ects t o I D P -1 2 1 L oti o n, o nce -dail y  a p plicati o n  
•  
4 0 0 S u bj ects t o I D P -1 2 1 Ve hicle L oti o n, o nce -dail y  a p plicati o n 
All s u bj ects will recei ve o nce dail y, t o picall y -a p plie d treat me nt t o t he face f or 1 2 wee ks. S u bj ect visits 
i ncl u de Scree ni n g, B aseli ne, W ee k 4, W ee k 8, a n d W ee k 1 2, at w hic h safet y a n d efficac y assess me nts will 
be c o n d ucte d.  
N u m ber of s u bjects pl a n ne d:  
A p pr o xi matel y 8 0 0 s u bj ects will be ra n d o mize d t o t he f oll o wi n g treat me nt gr o u ps: 
•  
4 0 0 S u bj ects t o I D P -1 2 1 L oti o n, o nce -dail y  a p plicati o n  
•  
4 0 0 S u bj ects t o I D P -1 2 1 Ve hicle L oti o n, o nce -dail y  a p plicati o n 
I ncl usi o n criteri a: 
1.  Male or fe male at least 9 years of a ge a n d ol der;  
2.  Writte n a n d ver bal i nf or me d c o nse nt m ust be o btai ne d. S u bj ects less t ha n a ge of c o nse nt m ust si g n a n 
asse nt f or t he st u d y a n d a pare nt or a le gal g uar dia n m ust si g n t he i nf or me d c o nse nt (if s u bj ect reac hes 
a ge of c o nse nt d uri n g t he st u d y t he y s h o ul d be re -c o nse nte d at t he ne xt st u d y visit);  
3.  S u bj ect  m ust  ha ve  a sc ore of  3  ( m o derate) or  4  (se vere) o n  t he E val uat or’s  Gl o bal  Se verit y  assess me nt 
at t he scree ni n g a n d baseli ne  visit;  
4.  S u bj ects wit h facial ac ne i nfla m mat or y lesi o n ( pa p ules, p ust ules, a n d n o d ules) c o u nt n o less t ha n 2 0 
b ut n o m ore t ha n  4 0;  
5.  S u bj ects wit h facial ac ne n o n -i nfla m mat or y lesi o n ( o pe n a n d cl ose d c o me d o nes) c o u nt n o less t ha n 2 0 
b ut n o m ore t ha n  1 0 0;  
6.  S u bj ects wit h t w o or fe wer facial  n o d ules;  

Protocol V01-121A-301, IDP-121 
Valeant Research & Development 
Version 1, 04 June 2015 
CONFIDENTIAL 
6 
 
 
 
7. Women of childbearing potential and females that are pre-menses must be willing to practice 
effective contraception for the duration of the study. (Effective contraception is defined as stabilized 
on oral contraceptive for at least 3 months, IUD, condom with spermicidal, diaphragm with 
spermicidal, implant, Nuvaring, injection, transdermal patch or abstinence.) Females on birth control 
pills must have taken the same type pill for at least three months prior to entering the study and must 
not change type during the study. Those who have used birth control pills in the past must have 
discontinued usage at least three months prior to the start of the study. Women who use birth control 
for acne control only should be excluded. 
8. Pre-menses females and women of childbearing potential must have a negative urine pregnancy test at 
the screening and baseline visits; 
9. Subjects must be willing to comply with study instructions and return to the clinic for required visits. 
Subjects under the age of consent must be accompanied by the parent or legal guardian at the time of 
assent/consent signing; 
10. If a cleanser, moisturizer or sunscreen is needed during the study, Subjects must be willing to use only 
allowed cleansers, moisturizers, sunscreens, or moisturizer/sunscreen combination products (see 
Appendix 2). If the subject wears makeup they must agree to use non-comedogenic makeup. 
Exclusion criteria: 
1. Use of an investigational drug or device within 30 days of enrollment or participation in a research 
study concurrent with this study; 
2. 
Any dermatological conditions on the face that could interfere with clinical evaluations such as acne 
conglobata, acne fulminans, secondary acne, perioral dermatitis, clinically significant rosacea, gram- 
negative folliculitis; 
3. 
Any underlying disease(s) or some other dermatological condition of the face that requires the use of 
interfering topical or systemic therapy or makes evaluations and lesion count inconclusive; 
4. 
Subjects with a facial beard or mustache that could interfere with the study assessments; 
5. 
Subjects with more than two (2) facial nodules; 
6. 
Evidence or history of cosmetic-related acne; 
7. 
Subject has a history of experiencing significant burning or stinging when applying any facial 
treatment (eg, make-up, soap, masks, washes, sunscreens, etc) to their face; 
8. 
Female subjects who are pregnant, nursing mothers, planning a pregnancy during the course of the 
trial, or become pregnant during the study; 
9. 
Use of estrogens (eg, Depogen, Depo-Testadiol, Gynogen, Valergen, etc) for less than 12 weeks 
immediately preceding study entry; Subjects treated with estrogens 12 or more consecutive weeks 
immediately prior to study entry need not be excluded unless the Subject expects to change dose, drug 
or discontinue estrogen use during the study; 
10. If female, subject has a history of hirsutism, polycystic ovarian disease or clinically significant 
menstrual irregularities; 
11. Treatment of any type of cancer within the last 6 months; 
12. Subject uses medications and/or vitamins during the study which are reported to exacerbate acne 
(azothiaprim, haloperidol, Vitamin D, Vitamin B12, halogens such as iodides or bromides, lithium, 
systemic or mid-to super-high potency corticosteroids, phenytoin and phenobarbital); Daily vitamins 
at the prescribed amounts are acceptable; 
13. History of hypersensitivity or allergic reactions to any of the study preparations as described in the 
Investigator’s Brochure, including known sensitivities to any dosage form of tretinoin; 
14. Concomitant use of potentially irritating over-the-counter products that contain ingredients such as 
benzoyl peroxide, alpha-hydroxy acid, salicylic acid, retinol or glycolic acids; 

Protocol V01-121A-301, IDP-121 
Valeant Research & Development 
Version 1, 04 June 2015 
CONFIDENTIAL 
7 
 
 
 
15. Subjects that have not undergone the specified washout period(s) for the following topical 
preparations used on the face or subjects who require the concurrent use of any of the following 
topical agents in the treatment area: 
Topical astringents and abrasives on face 
1 week 
Antibiotics on the facial area 
2 weeks 
Non-allowed moisturizers or sunscreens on face 
2 weeks 
Other topical anti-acne drugs on face 
2 weeks 
Soaps containing antimicrobials on the face 
2 weeks 
Anti-inflammatory agents and corticosteroids on the facial area 4 weeks 
Retinoids, including retinol on the face 
4 weeks 
If the subject requires topical treatment for acne on areas other than the face (e.g., chest and/or back), the 
investigator may prescribe a product that does not contain tretinoin and must be noted in source 
documents and eCRF. 
16. Subjects that have not undergone the specified washout period(s) for the following systemic 
medications or subjects who require the concurrent use of any of the following systemic medications: 
Corticosteroids (including intramuscular injections) 
(inhaled corticosteroids allowed) 
4 weeks 
Antiobiotics 
4 weeks 
Other systemic acne treatments 
4 weeks 
Systemic retinoids 
6 months 
17. Subject intends to use a tanning booth or sunbathe during the study. 
18. Subjects who are unable to communicate or cooperate with the Investigator due to language problems, 
poor mental development, or impaired cerebral function. 
19. Subjects with any underlying disease that the Investigator deems uncontrolled, and poses a concern 
for the subjects safety while participating in the study. 
Investigational product, dosage and mode of administration: 
Investigational Product: IDP-121 (tretinoin 0.05%) Lotion, applied topically to the face, once daily for 12 
weeks. 
Comparator Product: IDP-121 Vehicle Lotion, applied topically to the face, once daily for 12 weeks. 
Duration of treatment: 
12 weeks for all subjects. 
Reference therapy, dosage and mode of administration: 
See comparator product above. 
Criteria for evaluation: 
Co-Primary efficacy: 
IDP-121 Lotion versus IDP-121 Vehicle Lotion 
Co-primary endpoints are: 
(1) Superiority in absolute change from Baseline to Week 12 in mean inflammatory lesion counts 
(2) Superiority in absolute change from Baseline to Week 12 in mean non-inflammatory lesion counts, 
and, 
(3) Percent of subjects who achieve at least a two-grade reduction from baseline and are Clear -or Almost 
Clear at Week 12 in the Evaluator’s Global Severity Score. 
Secondary efficacy variables: 
Mean percent change in inflammatory and non-inflammatory lesion counts from baseline as well as 
proportion of subjects with at least a two grade improvement in the Evaluator’s Global Severity Score 
from baseline will be evaluated at Weeks 4, 8 and 12. 

Protocol V01-121A-301, IDP-121 
Valeant Research & Development 
Version 1, 04 June 2015 
CONFIDENTIAL 
8 
 
 
Efficacy Measurements: 
Lesion Counts 
At each visit the Evaluator will count the total number of inflammatory lesions (papules, pustules, and 
nodules) on the subject’s face. Nodules will be counted separately but will be included in the total 
inflammatory lesion count. At baseline, eligible subjects may have no more than two nodules. Nodules 
will be included in the statistical analysis of inflammatory lesion counts. All inflammatory lesions will be 
counted at the same time rather than counting papules and pustules separately. The Evaluator will also 
count the total number of non-inflammatory lesions (open and closed comedones). The same blinded 
evaluator should perform the lesion counts and EGSS evaluations at all visits from baseline to week 12 for 
the same subject. 
Inflammatory lesions are defined as follows: 
Papule – a small, solid elevation less than 5 mm in diameter. Most of the lesion is above the surface of the 
skin. 
Pustule – a small, circumscribed elevation less than 5 mm in diameter that contains yellow-white exudate. 
Nodule – a subcutaneous lesion greater than or equal to 5 mm in diameter 
Non-inflammatory lesions are defined as follows: 
Open comedones (black head) - a lesion in which the follicle opening is widely dilated with the contents 
protruding out onto the surface of the skin. 
Closed comedones (white head)– a lesion in which the follicle opening is closed, but the sebaceous gland 
is enlarged by the pressure of the sebum build up, which in turn causes the skin around the follicle to thin 
and become elevated with a white appearance. 
Evaluator’s Global Severity Score (EGSS) 
At each visit the severity will be determined based on evaluator-blinded evaluations of the signs and 
symptoms of acne vulgaris. Evaluations will be scored on a scale of 0-4, with 0 being clear and 4 being 
severe. Please see the table below for complete definitions. 
Score 
Grade 
Description 
0 
Clear 
Normal, clear skin with no evidence of acne vulgaris 
1 
Almost clear 
Rare non-inflammatory lesions present, with rare non-inflamed papules (papules must 
be resolving and may be hyperpigmented, though not pink-red) 
2 
Mild 
Some non-inflammatory lesions are present, with few inflammatory lesions 
(papules/pustules only; no nodulo-cystic lesions) 
3 
Moderate 
Non-inflammatory lesions predominate, with multiple inflammatory lesions evident: 
several to many comedones and papules/pustules, and there may or may not be one 
nodulo-cystic lesion 
4 
Severe 
Inflammatory lesions are more apparent, many comedones and papules/pustules, there 
may or may not be up to 2 nodulo-cystic lesions 
 
Cutaneous safety and tolerability will be evaluated by tabulations of adverse events and Cutaneous Safety 
and Tolerability Evaluation scores (scaling, erythema, itching, burning, and stinging) to be assessed at 
each study visit. Itching, burning and stinging (Cutaneous tolerability) will be reviewed with the subject at 
each study visit as an average over the period since the previous visit. Scaling and erythema (Cutaneous 
Safety) will be assessed by the evaluator at each visit. 
Cutaneous tolerability signs and symptoms that result in the subject requiring a concomitant therapy, 
interruption of treatment, or discontinuation from the study will be reported as an AE. 
At selected sites, standardized photography of the face will be performed. 

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St atistic al met h o ds:  
All statistical pr ocessi n g will be perf or me d usi n g S A S ®  versi o n 9. 3 or later u nless ot her wise state d. 
Statistical si g nifica nce will be base d o n t w o -taile d tests of t he n ull h y p ot hesis res ulti n g i n p-val ues of 0. 0 5 
or less. T ests of lesi o n c o u nt s u peri orit y will be base d o n a n A N C O V A wit h fact ors of treat me nt a n d 
a nal ysis ce nter a n d t he res pecti ve B aseli ne lesi o n c o u nt as a c o variate or o n ra n ke d data s u b mitte d t o a n 
A N C O V A wit h fact ors of treat me nt a n d a nal ysis ce nter a n d t he res pecti ve B aseli ne lesi o n c o u nt as a 
c o variate. T he pri mar y met h o d of ha n dli n g missi n g efficac y data will be base d o n esti mati o n usi n g t he 
met h o d of Mar k o v C hai n M o nte Carl o ( M C M C) i m p utati o n. A d diti o nall y, a m o del -base d m ulti ple 
i m p utati o n pr ocess will be use d as a se nsiti vit y a nal ysis t o t he M C M C i m p utati o n. Fi nall y, t he a bs ol ute 
c ha n ge i n lesi o n c o u nt will be a nal yze d usi n g a re peate d meas ures A N C O V A f or lesi o n c o u nt data or a 
re peate d meas ures l o gistic re gressi o n m o del ( ge neralize d esti mati n g e q uati o ns) f or t he dic h ot o mize d 
E G S S.  
T he c o -pri mar y a nal ysis of t he dic h ot o mize d E G S S will be base d o n t he l o gistic re gressi o n test stratifie d 
b y a nal ysis ce nter.  
P o p ul ati o ns A n alyze d a n d Tre at me nt Gr o u ps:  
I nfla m mat or y a n d n o n-i nfla m mat or y lesi o n c o u nts will be rec or de d f or eac h S u bj ect at B aseli ne a n d at 
W ee ks 4, 8, a n d 1 2. T he a bs ol ute a n d perce n t c ha n ge fr o m B aseli ne i n i nfla m mat or y a n d n o n- 
i nfla m mat or y lesi o ns will be deri ve d f or eac h S u bj ect at W ee ks 4, 8, a n d 1 2. 
T he E G S S will be rec or de d f or eac h S u bj ect. T he E G S S will be dic h ot o mize d i nt o “s uccess” a n d “fail ure” 
wit h a S u bj ect c o nsi dere d a s uccess if t he E val uat or’s Gl o bal Se verit y Sc ore at W ee k 4, 8, a n d 1 2 is at 
least 2 gra des less t ha n baseli ne a n d Clear or Al m ost Clear. 
A n i nte nt -t o-treat (I T T) a nal ysis will be c o n d ucte d o n all st u d y s u bj ects. T he I T T p o p ulati o n will c o nsist 
of all ra n d o mize d s u bj ects w h o recei ve d st u d y me dicati o n.  
T he safet y p o p ulati o n will be c o m prise d of all ra n d o mize d s u bj ects w h o are pres u me d t o ha ve use d t he 
st u d y me dicati o n at least o nce a n d w h o pr o vi de at least o ne p ost-baseli ne e val uati o n. A per -pr ot oc ol ( P P) 
a nal ysis will als o be c o n d ucte d. S u bj ects will be eli gi ble f or t he P P a nal ysis if t he y c o m pl ete t he 1 2-wee k 
e val uati o n wit h o ut n ote w ort h y st u d y pr ot oc ol vi olati o ns (i.e., a n y S u bj ect or i n vesti gat or acti vit y t hat 
c o ul d ha ve p ossi bl y i nterfere d wit h t he t hera p e utic a d mi nistrati o n of t he treat me nt or t he precise 
e val uati o n of treat me nt efficac y). T he P P p o p ulati o n will i ncl u de s u bj ects i n t he I T T p o p ulati o n w h o d o 
n ot meet a n y of t he f oll o wi n g criteria:  
•  Faile d a n y of t he i ncl usi o n/e xcl usi o n  criteria;  
•  Ha ve ta ke n a n y i nterferi n g c o nc o mita nt me dicati o ns;  
•  Di d n ot atte n d t he W ee k 1 2 visit, wit h t he e xce pti o n of a dis c o nti n uati o n fr o m t he st u d y 
d ue  t o a n a d verse  e ve nt relate d t o st u d y treat me nt or  d oc u me nte d  lac k of  treat me nt effect;  
•  Misse d b ot h t he wee k 4 a n d wee k 8  visits;  
•  Ha ve n ot bee n c o m plia nt wit h t he d osi n g re gi me n (i.e. S u bj ects ma y n ot miss m ore t ha n 
fi ve c o nsec uti ve  da ys  of  d osi n g  a n d m ust ta ke 8 0 -1 2 0 %  of  e x pecte d  d oses.  T he  n u m ber  of 
e x pecte d d oses will be deter mi ne d f or eac h s u bj ects base d o n t he le n gt h of t heir 
partici pati o n i n t he  st u d y); 
•  O ut of visit wi n d o w at t he 1 2 -wee k  visit  
Pri or t o brea ki n g t he bli n d, ot her a d diti o nal criteria ma y be a d de d t o t he list t o acc o m m o d ate f or 
u nf oresee n e ve nts t hat occ urre d d uri n g t he c o n d uct of t he tri al t hat res ul t i n n ote w ort h y st u d y pr ot oc ol 
vi olati o ns.  
A p pr o xi matel y ei g ht h u n dre d ( 8 0 0) s u bj ects will be ra n d o mi ze d t o t he f oll o wi n g treat me nt gr o u ps:  
•  
4 0 0 S u bj ects t o I D P -1 2 1 L oti o n, o nce -dail y  a p plicati o n  
•  
4 0 0 S u bj ects t o I D P -1 2 1 Ve hicle L oti o n, o nce -dail y  a p plicati o n 

Protocol V01-121A-301, IDP-121 
Valeant Research & Development 
Version 1, 04 June 2015 
CONFIDENTIAL 
10 
 
 
 
Efficacy: 
Primary: 
Co-primary efficacy analyses of the absolute change in inflammatory and in non-inflammatory lesions 
will be conducted on the ITT population. The pre-specified time point will be Week 12. Descriptive 
statistics will be presented by treatment group for inflammatory and for non-inflammatory lesions as well 
as the absolute change in inflammatory and in non-inflammatory lesions. All of the testing relating to the 
analysis of inflammatory and non-inflammatory lesions will use the methods introduced in Section 12. 
The co-primary analysis of the dichotomized EGSS (success being at least a 2 grade improvement and 
achieving Clear or Almost Clear) for the ITT population will be based on the logistic regression test 
stratified by analysis center. 
Secondary: 
Mean percent change in inflammatory and non-inflammatory lesion counts from baseline, as well as 
proportion of subjects with at least a two grade improvement in the Evaluator’s Global Severity Score 
from baseline, will be evaluated at Weeks 4, 8 and 12. 
Safety Evaluation: 
All subjects who receive medication and provide at least one post-baseline evaluation will constitute the 
safety population. 
Safety will be evaluated by tabulations of adverse events (AEs), Cutaneous Tolerability Evaluations. 
Cutaneous Safety Evaluation scores (erythema and scaling) and Tolerability (itching, burning, and 
stinging) will be presented with descriptive statistics at Baseline and at Weeks 4, 8, and 12 for each 
treatment group. Frequencies and percentages for each outcome category will be included in these 
statistics. Mean values will be presented graphically by week and treatment group. 
Vital signs and an abbreviated physical exam will be conducted on all subjects at specified visits. For 
females of child-bearing potential (FOCBP), urine pregnancy testing and serum pregnancy testing will 
occur at specified visits. 
All adverse events occurring during the study will be recorded and classified on the basis of MedDRA 
terminology. Descriptions of AEs will include the date of onset, the date the AE ended, the severity of the 
AE, the relationship to study medication, the action taken regarding study medication usage, the action 
taken regarding to treat the AE, and the outcome. 
Adverse events will be summarized by treatment group and severity. Each subject will be counted only 
once within a system organ class or a preferred term by using the adverse events with the highest severity 
within each category. 
Adverse events will be summarized by treatment group and relationship to study medication. Each 
subject will be counted only once within a system organ class or a preferred term by using the adverse 
events with the greatest relationship within each category. 
Comparisons among treatment groups will be made by tabulating the frequency of subjects with one or 
more AEs (classified into MedDRA terms) during the study. The Fisher’s Exact test will be used to 
compare the proportion of subjects in each treatment group who report any adverse event at a significance 
level of 0.05. The specific system organ classes and preferred terms analyzed will be those that are 
reported by at least one percent of the subjects in any treatment group. 
All information pertaining to AEs noted during the study will be listed by subject, detailing verbatim 
given by the investigator, preferred term, system organ class, start date, stop date, severity, actions taken, 
and drug relatedness. The AE onset will also be shown relative (in number of days) to the day of initial 
dose of the randomized study medication. 
Serious adverse events (SAEs) will be tabulated by subject within treatment groups. 
In addition, a list of subjects who discontinued from the study and a list of subjects who experienced 
SAEs will also be provided. 

Protocol V01-121A-301, IDP-121 
Valeant Research & Development 
Version 1, 04 June 2015 
CONFIDENTIAL 
11 
 
 
 
Subject Self-Assessments 
An exploratory patient self assessment questionnaire and satisfaction survey will also be administered 
during the study. 
Subjects will be asked to complete three questionnaires during the study: the Subject Self Assessment 
scale, the Patient Satisfaction Survey and the Acne-Specific Quality of Life Questionnaire. The 
Investigator assessments (EGSS, lesion counts) will be conducted independently of these subject self 
assessments. The EGSS should always be completed prior to the lesion counts. Inferential statistical 
analysis will not be performed on these questionnaires; the subjective responses will be compared between 
treatment groups for trends. 
 
This study will be performed in compliance with GCP including the archiving of essential study 
documents. This protocol follows guidelines outlined by the International Conference on Harmonization 
(ICH). All data furnished to the investigator and his/her staff, and all data obtained through this stud, will 
be regarded as confidential and proprietary in nature and will not be disclosed to any third party, except 
for the United States Food and Drug Administration or other regulatory body, without written consent 
from the sponsor. 

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3  T a ble of  C o nte nts  
1  
TI T L E  P A G E  ...........................................................................................................1  
2  
S Y N O P SI S  ...............................................................................................................5 #  
3  
T A B L E  O F  C O N T E N T S  .......................................................................................1 2 #  
4  
LI S T O F A B B R E VI A TI O N S A N D D E FI NI TI O N S  O F  T E R M S  ........................1 5 #  
5  
I N T R O D U C TI O N .................................................................................................1 6 #  
6  
S T U D Y O BJ E C TI V E S  A N D  P U R P O S E  ............................................................. 1 7 #  
7  
I N V E S TI G A TI O N A L P L A N  ............................................................................... 1 7 #  
7. 1  
O verall St u d y Desi g n a n d  Pla n:  Descri pti o n  ............................................. 1 7 #  
8  
S E L E C TI O N A N D WI T H D R A W A L  O F  S U BJ E C T S  ........................................ 2 1 #  
8. 1  
S u bject  I n cl usi o n Criteri a .......................................................................... 2 1 #  
8. 2  
S u bject  E x cl usi o n  Criteria  ........................................................................ 2 2 #  
8. 3  
S u bject  Wit h dra wal  Criteria  .......................................................................2 3 #  
9  
T R E A T M E N T  P L A N  ............................................................................................2 5 #  
9. 1  
Met h o ds of Assi g ni n g S u bjects t o  Treat me nt  Gr o u ps  ...............................2 5 #  
9. 2  
Ra n d o mizati o n  a n d Bli n di n g  .....................................................................2 5 #  
9. 3  
U n -bli n di n g  ............................................................................................... 2 5 #  
9. 4  
Pri or a n d Pr o hi bite d C o nc o mita nt Me dicati o n  or  T hera p y  ........................2 6 #  
9. 5  
Treat me nt  C o m plia nce  ...............................................................................2 7 #  
9. 6  
Pr ot oc ol De viati o ns  a n d Vi olati o ns  .......................................................... 2 7 #  
1 0  
S T U D Y D R U G M A T E RI A L S  A N D  M A N A G E M E N T  ...................................... 2 8 #  
1 0. 1  
I D P-1 2 1 L oti o n a n d I D P -1 2 1  Ve hicle  L oti o n  ........................................... 2 8 #  
1 0. 1. 1  Pac ka gi n g  a n d La b eli n g  .................................................................2 8 #  
1 0. 1. 2  St ora ge, Ha n dli n g, a n d Dis p osal of  St u d y  Dr u g  ........................... 2 9 #  
1 0. 1. 3  A d mi nistrati o n  .............................................................................. 2 9 #  
1 0. 2  
St u d y  Dr u g  Acc o u nta bilit y  ........................................................................3 0 #  
1 1  
S T U D Y P R O C E D U R E S  A N D  E V A L U A TI O N S ................................................ 3 1 #  
1 1. 1  
Sc he d ule of E val u ati o ns  a n d Pr oce d ures  .................................................. 3 1 #  
1 1. 1. 1  Visit 1:  Scree ni n g  Visit  ................................................................. 3 1 #  
1 1. 1. 2  Visit 2: Baseli ne Visit  ( D a y 0)  .......................................................3 2 #  
1 1. 1. 3  Visit 3 a n d 4: Wee k 4 ( Da y 2 8 ± 3 Da ys) a n d Wee k 8 ( Da y  5 6  
± 3  Da ys)  Visits ............................................................................. 3 3 #  
1 1. 1. 4  Visit 5: Wee k 1 2 ( Da y 8 4  -3/ + 5  Da ys)  Visit  –   E n d  of  St u d y 
Visit  ............................................................................................... 3 4 #  
1 1. 2  
E val uati o n of  Efficac y  ...............................................................................3 4 #  
1 1. 2. 1  E val uat or’s Gl o bal Se v erit y  Sc ore ( E G S S) ....................................3 5 #  

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1 1. 2. 2  Lesi o n  C o u nts  ................................................................................3 5 #  
1 1. 2. 3  Ot her  Ass ess me nts  ........................................................................ 3 6 #  
1 1. 3  
E val uati o n of  Safet y  ...................................................................................3 6 #  
1 1. 3. 1  C uta ne o us  Safet y  E val u ati o ns  ........................................................3 6 #  
1 1. 3. 2  T olera bilit y  E val uati o ns  ................................................................. 3 7 #  
1 1. 3. 3  Me dical Hist or y a n d A b bre viate d  P h ysical  E x a mi nati o n  .............. 3 7 #  
1 1. 3. 4  Pre g n a nc y  T ests  .............................................................................3 8 #  
1 1. 4  
A d verse  E ve nts  ......................................................................................... 3 8 #  
1 1. 4. 1  Defi niti o n of  A d vers e  E v e nt  ......................................................... 3 8 #  
1 1. 4. 2  D oc u me nti n g  A d vers e  E x perie nces  ...............................................3 8 #  
1 1. 4. 3  Seri o us  A d vers e  E ve nts  ................................................................ 3 9 #  
1 1. 4. 4  Assess me nt  of  Se verit y  ................................................................. 4 0 #  
1 1. 4. 5  Assess me nt  of  Ca usalit y  ................................................................4 0 #  
1 1. 4. 6  Re p orti n g of Seri o us  A d verse  E ve nts  ............................................4 0 #  
1 1. 4. 7  E x pe dite d Seri o us A d verse  E ve nt  Re p orts .....................................4 1 #  
1 1. 4. 8  Pre g n a nc y  ...................................................................................... 4 2 #  
1 2  
S T A TI S TI C S  ........................................................................................................ 4 3 #  
1 2. 1  
Assess me nt  of  Efficac y  ..............................................................................4 3 #  
1 2. 1. 1  Pri mar y  Effi cac y  ........................................................................... 4 4 #  
1 2. 1. 2  Sec o n dar y  Efficac y  ....................................................................... 4 4 #  
1 2. 1. 3  Test of S u peri orit y f or Lesi o n  C o u nt  Varia bles  ............................ 4 4 #  
1 2. 1. 4  Statistical H y p ot hesis Testi n g a n d C o ntr ol  of M ulti plicit y  ...........4 5 #  
1 2. 1. 5  Descri pti ve  Statistics  ..................................................................... 4 6 #  
1 2. 1. 6  P o oli n g  A nal ysis  ........................................................................... 4 6 #  
1 2. 1. 7  Missi n g Efficac y  Dat a  I m p utati o ns ................................................4 8 #  
1 2. 1. 8  Se nsiti vit y  Efficac y  A n al ys es ........................................................ 4 9 #  
1 2. 1. 9  S u b gr o u p  A nal ys es  ....................................................................... 5 0 #  
1 2. 2  
Assess me nt  of  Safet y  .................................................................................5 0 #  
1 2. 2. 1  A d verse  E ve nts  ............................................................................. 5 1 #  
1 2. 2. 2  Vital  Si g n  Meas ure me nts  ...............................................................5 1 #  
1 2. 2. 3  C o nc o mita nt  Me dicati o ns  ............................................................. 5 2 #  
1 2. 2. 4  S u bject  Self -Assess me nts  ............................................................. 5 2 #  
1 2. 3  
S u bject  Dis p ositi o n  ....................................................................................5 2 #  
1 2. 4  
De m o gra p hics a n d  Baseli ne  C haracteristics  ..............................................5 2 #  
1 2. 5  
Pr ot oc ol  De viati o ns  ................................................................................... 5 2 #  
1 2. 6  
C o m plia nce  ................................................................................................5 2 #  
1 2. 7  
I nteri m A nal yses  ....................................................................................... 5 2 #  
1 2. 8  
A d diti o nal  Statistical  C o nsi derati o ns  ........................................................ 5 2 #  
1 2. 8. 1  A nal ysis  P o p ulati o ns  ..................................................................... 5 2 #  

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1 2. 8. 2  Sa m ple  Size  Deter mi nati o n.  .......................................................... 5 3 #  
1 2. 8. 3  Ha n dli n g of  Missi n g  Dat a  ..............................................................5 4 #  
1 2. 8. 4  M ultice nter  Iss ues ......................................................................... 5 4 #  
1 2. 8. 5  M ulti plicit y  Iss ues ..........................................................................5 4 #  
1 2. 8. 6  Wi n d o wi n g  R ules.  ..........................................................................5 5 #  
1 3  
Q U A LI T Y C O N T R O L A N D  Q U A LI T Y  A S S U R A N C E  .....................................5 5 #  
1 3. 1  
St u d y  M o nit ori n g  .......................................................................................5 5 #  
1 3. 2  
A u dits  a n d I ns pecti o ns  ...............................................................................5 5 #  
1 3. 3  
Data  Q u alit y  Ass ura nce  .............................................................................5 6 #  
1 4  
E T HI C S A N D  A D MI NI S T R A TI V E I S S U E S  ..................................................... 5 6 #  
1 4. 1  
Et hical C o n d uct of  t he St u d y .....................................................................5 6 #  
1 4. 2  
Et hics Re vie w  ............................................................................................5 6 #  
1 4. 3  
Writte n  I nf or me d C o nse nt  .........................................................................5 6 #  
1 4. 4  
S u bject  Data  Pr otecti o n  ............................................................................. 5 7 #  
1 4. 5  
Data  M o nit ori n g  C o m mittee  ......................................................................5 7 #  
1 4. 6  
Fi na ncial  Discl os ur e  ...................................................................................5 7 #  
1 4. 7  
I n v esti gat or O bli gati o ns  ............................................................................ 5 8 #  
1 4. 8  
C ha n ges t o  t he Pr ot oc ol  .............................................................................5 8 #  
1 4. 9  
C o nfi de ntialit y/ P u blicati o n of  t he St u d y ....................................................5 8 #  
1 5  
D A T A H A N D LI N G A N D  R E C O R D  K E E PI N G  .................................................5 8 #  
1 5. 1  
I ns p ecti o n of  Rec or ds  ............................................................................... 5 8 #  
1 5. 2  
Rete nti o n  of  Rec or ds  ..................................................................................5 9 #  
1 6  
R E F E R E N C E S  ......................................................................................................6 0 #  
1 7  
A P P E N DI C E S  .......................................................................................................6 1 #  
1 7. 1  
S u bject  I nstr u cti o n S heet  ...........................................................................6 1 #  
1 7. 2  
Clea nsers, M oist urizers a n d S u nscree n  Use  G ui deli nes  ........................... 6 3 #  
1 7. 3  
S u bject Self Assess me nt  Sc ori n g  Scal e  .....................................................6 4 #  
1 7. 4  
Patie nt Satisfacti o n  S ur ve y  ( P S S) ..............................................................6 5 #  
1 7. 5  
Ac ne -S pecific Q u alit y of Life  Q uesti o n naire  ( Ac n e-Q o L)  ........................6 6 #  
 
LI S T O F T A B L E S  
Ta ble  1.  
St u d y Desi g n a n d Sc h e d ule  of  Assess me nts  ...................................................2 0  
Ta ble  2.  
Dr u g  S u bsta nces  I d e ntificati o n ….................................................................. 2 8  
Ta ble  3.  
Test Pr o d uct  I d e ntificati o n … ........................................................................ 2 8  
Ta ble  4.  
E val uat or’s Gl o bal  Se verit y  S c ore …  ............................................................. 3 5  

Protocol V01-121A-301, IDP-121 
Valeant Research & Development 
Version 1, 04 June 2015 
CONFIDENTIAL 
15 
 
 
4 List of Abbreviations and Definitions of Terms 
 
Abbreviation or Specialist Term 
Definition or Explanation 
 
AE 
Adverse event 
CRA 
Clinical Research Associate 
CRF 
Case Report Form 
CRO 
Contract Research Organization 
cGCP 
Current Good Clinical Pratice 
EGSS 
Evaluator’s Global Severity Score 
ET 
Early termination 
FDA 
FOCBP 
United States Food and Drug Administration 
Female of Childbearing Potential 
g 
Gram 
GCP 
Good Clinical Practice 
IATL 
Investigator’s Assessment of Total Lesions 
ICH 
International Conference on Harmonization 
IEC 
Independent Ethics Committee 
IRB 
Institutional Review Board 
ITT 
Intent-to-treat 
IWRS 
Interactive Web Response System 
LOCF 
Last observation carried forward 
MedDRA 
Medical Dictionary for Regulatory Affairs 
mL 
Milliliter 
OTC 
Over-the-counter 
PP 
Per protocol 
PSS 
Patient Satisfaction Survey 
QoL 
Quality of Life 
SAE 
Serious adverse event 
SSA 
Subject Self Assessment 
UPT 
Urine Pregnancy Test 
WHO 
World Health Organization 
 
In this protocol, “sponsor duties” refer to responsibilities that will be performed by the 
sponsor, the sponsor’s designee, or the sponsor’s designated contract research organization. 
In this protocol, “investigator” refers to the principal investigator or his/her designee, who is 
responsible for performing the study procedures and assessments. 

Pr ot oc ol V 0 1 -1 2 1 A -3 0 1, I D P -1 2 1  
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5  I ntr o d ucti o n 
Ac ne is a ver y c o m m o n dis or der of se b ace o us f ollicles t hat us uall y be gi ns at t he ti me of t he 
s har p i ncrease i n a n dr o ge n pr o d ucti o n occ urri n g i n a d olesce n ce [1 ]. T he disease is m ost 
pre vale nt a m o n gst tee na gers, b ut it d oes occ ur l ater i n life, partic ularl y i n t h e t hir d a n d f o urt h 
deca d e. T he pat h o ge nesis is c o m ple x a n d i n v ol ves a n a n dr o ge n -sti m ulate d i ncreas e i n se b u m 
pr o d ucti o n, ass ociate d wit h f ollic ular h y p er kerati nizati o n a n d o bstr ucti o n of t he se bace o us 
f ollicles. T his res ults i n a b n or mal des q ua mati o n of t he f ollic ular e pit heli u m, a n d is ass ociate d 
wit h bacterial pr olif erati o n (es peci all y Pr o pi o ni b a cteri u m ac nes ( P. ac nes) ) a n d c hr o nic 
i nfla m mati o n ass ociated wit h ac ne. T hes e c h a n ges i n ac ne s u bjects res ult i n e nlar ge d 
se bace o us gl a n ds; o bstr ucti o n of t he f ollic ular ca n al wit h ass ociate d se b u m rete nti o n a n d 
diste nti o n of t he f ollicle b y ti g htl y p ac ke d h or n y cells t hat lea d t o t he f or mati o n cli nical 
i nfla m mat or y l esi o ns i ncl u di n g s u perficial p ust ules s uc h as c o me d o n es ( p o p ularl y k n o w n as 
“ blac k hea ds” or “ w hite h ea ds”); a n d m ore dee pl y l ocate d pa p ules, n o d ules a n d c ysts [ 1 ]. T he 
areas m ost affecte d b y t h e disease i ncl u d e t he pil ose b ace o us f ollicles of t he hea d a n d u p p er 
tr u n k, w here t h e se bace o us gla n ds are p artic ularl y acti ve [2 ]. 
C urre ntl y, t hera p e utic treat me nt of ac n e is directe d a gai nst 3 pri nci pal pat h o ge ni c fact ors of 
t he disease, i ncl u di n g t he bacterial c ol o nizati o n of f ollicles, t he h y p ersecreti o n of t he 
se bace o us gl a n d, a n d i ntr af ollic ular h y perc or nifi cati o n t hat i n d uces f ollic ular o bstr ucti o n. 
Effecti ve treat me nt dir ect e d a gai nst t he c ol o nizati o n of bacteria ( P. a c nes ) i n f ollicles has 
ma de us e of a nti-i nfecti v es s uc h as t o pical be nz o yl per o xi de ( 2. 5 %-1 0 %), cli n da m yci n, a n d 
er yt hr o m yci n a n d s yste mic tetrac ycli n es; h o we ver, k n o w n disa d va nta ges t o t his treat me nt 
m o dalit y i ncl u de irritati o n a n d li mite d use d ue t o pat h o ge n resista nce [ 2 -5 ]. Effecti ve 
treat me nt direct e d t o war ds i n hi biti n g se bace o us gla n d acti vit y h as i ncl u de d oral 
c ortic oster oi ds, s pir o n olact o ne, a n d is otreti n oi n i n a d diti o n t o a nti -a n dr o ge ns  
(e g, c y pr ot er o ne acet ate). K n o w n disa d va nta ges t o t his treat me nt m o dalit y i ncl u de bei n g 
li mite d t o use i n fe males (a nti-a n dr o ge ns), a n d li mite d t o s h ort ter m use f or safet y ( oral 
c ortic oster oi ds). Fi nall y, effecti ve treat me nt direct e d a gai nst i ntraf ollic ular 
h y perc or nifi cati o n has m a de use of reti n oi ds s uc h as oral is otreti n oi n a n d t o pical treti n oi n or 
is otreti n oi n t o re g ulate t h e i ntraf ollic ular k erati nizati o n pr ocess, i n hi biti n g f ollic ular 
h y per ker ati nizati o n a n d f ollic ular o bstr ucti o n [ 6 ]. I n ge neral, t he k n o w n us ef ul ness of oral 
reti n oi ds (ie, oral is otreti n oi n) is li mite d b y t heir si de effects, w hic h ra n ge fr o m relati vel y 
mi n or effects (e g, dr y n ess of m uc osa a n d s ki n, s ki n irritati o n, a n d s ki n scali n g) t o maj or 
t o xicit y s y n dr o mes (r e versi ble hair l oss, b o ne t o xicit y a n d t erat o ge ni cit y) a n d ma y i ncl u d e 
var yi n g d e gr ees of s y m pt o ms ass ociate d wit h h y p er vita mi n osis A s y n dr o m e [ 2 , 7 , 8 ]. 
Li ke wis e, t he efficac y of t o pical reti n oi ds s uc h as treti n oi n or is otreti n oi n ma y b e li mite d b y 
t he k n o w n si de effects, w hic h i ncl u de si g nifi ca nt er yt he m a, dr y ness, p eeli n g, scali n g, a n d 
irritati o n [9 ]. 

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Treti n oi n (all -tra ns-reti n oic-aci d) is a m e m ber of t he reti n oi d fa mil y of c o m p o u n ds a n d is a 
meta b olite of Vita mi n A t h at occ urs nat urall y i n a ni mal a n d h u ma n tiss ues. W hile oral 
reti n oi ds (e g, is otreti n oi n) are reser ve d f or treat me nt of se vere n o d ular ac ne or se vere ac n e 
resista nt t o oral a nti bi otics, t o pical reti n oi ds (e g, treti n oi n or is otreti n oi n) a p plie d dail y are 
use d t o i n hi bit t he f or mati o n of c o me d o nes a n d us uall y cl ear e ve n se v ere c o me d o nal ac n e 
wit hi n a fe w m o nt hs [ 6 ]. T o pical f or mati o ns of treti n oi n ha ve bee n use d t o treat ac n e i n t he 
U nite d States ( U S) a n d t he E ur o pea n U ni o n f or m ore t ha n 2 5 years.  
Treti n oi n bi n ds wit h hi g h affi nit y t o s pecific reti n oic aci d rece pt ors l ocate d i n b ot h t he 
c yt os ol a n d n u cle us, b ut c uta ne o us le vels of treti n oi n i n e x cess of p h ysi ol o gic c o nce ntrati o ns 
occ ur f oll o wi n g a p plicati o n of a treti n oi n -c o ntai ni n g t o pical dr u g pr o d uct. Treti n oi n acti vates 
3 me m bers of t he r eti n oi d aci d ( R A R) n uclear rece pt ors ( R A R α, R A R β, a n d R A Rγ) w hic h 
act t o m o dif y ge ne e x pressi o n, s u bse q ue nt pr otei n s y nt hesis, a n d e pit helial cell gr o wt h a n d 
differe ntiati o n; h o we v er, it has n o t bee n esta blis he d w het her t he cli nical effects of treti n oi n 
are me diat e d t hr o u g h acti vati o n of reti n oic aci d rece pt ors, ot her mec ha nis ms, or b ot h.  
Alt h o u g h t he e x act m o de of acti o n of treti n oi n is u n k n o w n, c urre nt e vi de nce s u g gests t hat 
t o pical treti n oi n decreases c o hesi ve ness of f ollic ular e pit helial cells wit h decreas e d 
micr oc o me d o f or m ati o n. A d diti o nall y, treti n oi n sti m ulates mit otic acti vit y a n d i ncreas e d 
t ur n o ver of f ollic ular e pit helial cells ca usi n g e xtr usi o n of t he c o me d o nes. 
I D P-1 2 1 is a l oti o n c o ntai ni n g 0. 0 5 % treti n oi n f or t he t o pical treat me nt of ac ne. T his 
pr o p ose d pr o d uct is t he first l oti o n f or m ulati o n de vel o pe d f or treti n oi n a n d will be e val uate d 
f or effecti ve n ess i n treati n g ac ne v ul garis. 
 
6  St u d y O bjecti ves a n d  P ur p ose  
T he o bjecti ve of t h e st u d y is t o e val uat e t he efficac y, s afet y a n d t olera bilit y of a o nce-dail y 
t o pical a p plicati o n of I D P-1 2 1 L oti o n c o m pare d t o its ve hicle (I D P -1 2 1 V e hicle L oti o n) i n 
s u bjects wit h m o derate t o se vere ac n e v ul garis (a sc ore of 3 or 4 [ m o derate t o se vere] o n t he 
E G S S scale).  
 
7  I n vesti g ati o n al pl a n  
7. 1  
O ver all St u d y Desi g n a n d Pl a n:  Descri pti o n  
T his is a m ultice nter, ra n d o mize d, d o u ble -bli n d, parallel -gr o u p st u d y d esi g ne d t o assess t he 
safet y, efficac y a n d t oler a bilit y of I D P-1 2 1 L oti o n i n c o m paris o n wit h its ve hicle. T o be 
eli gi ble f or t he st u d y, s u bjects m ust be at least 9 years of a ge a n d ol der a n d ha ve a cli nical 
dia g n osis of m o derate t o se vere ac n e v ul garis (a s c ore of 3 or 4 [ m o derate t o se vere] o n t he 
E G S S scale).  
A p pr o xi matel y 8 0 0 s u bj ects will be e nr ol le d i nt o t his st u d y a n d ra n d o mize d i nt o o ne ( 1) of 
t w o ( 2) treat me nt gr o u ps: 4 0 0 s u bjects i n t he I D P-1 2 1 L oti o n, o nce d ail y a p plicati o n gr o u p,  

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18 
 
 
and 400 subjects in the IDP-121 Lotion Vehicle, once daily application group. Subjects will 
be enrolled at a minimum of 32 and maximum of 50 independent study centers. The duration 
of treatment will be 12 weeks. Subjects will be evaluated at Screening, Baseline and at 
subsequent follow-up visits (Weeks 4, 8, and 12). 
An interactive web based response system (IWRS) will be employed to facilitate 
randomization of study patients. Treatment assignments and study drug kit numbers will be 
generated centrally by the IWR system. At each clinical site, subject numbers will be 
assigned consecutively at the screening visit starting with 001. 
The assigned study drug will be applied topically to the face once daily for 12 weeks. The 
initial application will be made at the investigational center as per instruction from the study 
coordinator or designee. The subjects will be instructed to avoid exposure to direct sunlight 
to prevent sunburn. Subjects will apply their daily treatments at home as explained by the 
study coordinator or designee at each investigational center. During post-baseline study visits 
(Weeks 4, 8 and 12) the subjects will be asked to return their used tubes of study drug and 
will be dispensed new tubes of study drug (only Weeks 4 and 8; Week 12 will be final visit). 
During the study, each subject will only be permitted to use approved non-medicated 
cleansers, moisturizers and sunscreens. 
Subjects will be asked to complete three questionnaires during the study: the Subject Self 
Assessment scale (SSA, Appendix 17.3), the Patient Satisfaction Survey (PSS, Appendix 
17.4) and the Acne-Specific Quality of Life Questionnaire (Acne-QoL, Appendix 17.5). The 
Investigator assessments (EGSS, lesion counts) will be conducted independently of these 
subject self assessments. The EGSS should be completed prior to the lesion counts. Subjects 
will assess the severity of their acne at the baseline visit and at Weeks 2 (at home), 4, 8, and 
12 by completing the SSA. The Week 2 SSA form will be dispensed to the subject at the 
baseline visit with instructions to complete it two weeks later and return it the Week 4 visit; 
sites should call the Subject at Week 2 to remind them to complete the SSA. Subjects will 
complete the PSS related to prior therapy at baseline, and at Week 12 will complete the PSS 
related to current study medication. The Acne-QOL will be completed at baseline and Week 
12. Inferential statistical analysis will not be performed on these questionnaires; the 
subjective responses will be compared between treatment groups for trends. 
Information on reported and observed adverse events (AEs) will be obtained at each visit. An 
abbreviated physical examination will be performed at Baseline and Week 12 (end of 
treatment, final visit) for all subjects. 
For all female subjects of childbearing potential, urine pregnancy testing will be performed at 
Screening and confirmed at Baseline with a urine pregnancy test prior to randomization, and 
at Weeks 4, 8 and 12. Serum pregnancy tests will also be conducted at Screening and Week 
12. 

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Subjects who terminate study participation early will be asked to complete all Week 12 
assessments, as appropriate. Subjects who discontinue from the study during the treatment 
period will not be replaced. 

 
Protocol V01-121A-301, IDP-121 
Valeant Research & Development 
 
Table 1. 
Study Design and Schedule of Assessments 
 
PROCEDURES 
VISIT 11 
Screening 
Visit 
VISIT 22 
Baseline 
Day 0 
VISIT 32 
Week 4 
(Day 28 ±3 days) 
VISIT 42 
Week 8 
(Day 56 ± 3 days) 
VISIT 52,3 
Week  12 
(Day 84 -3/+5 days) 
Informed consent/Assent 
X 
Obtain Subject Number from IWRS 
X 
Demographics 
X 
Medical history 
X 
X 
Inclusion/Exclusion criteria 
X 
X 
Previous therapies 
X 
PSS & Acne-QoL 
X 
X 
SSA4 
X 
X 
X 
X 
Urine Pregnancy Test (UPT) (FOCBP) 
X 
X 
X 
X 
X 
Serum Pregnancy Test (FOCBP) 
X 
X 
Abbreviated physical examination 
X 
X 
Oily/shiny skin assessment 
X 
X 
Lesion Counts 
X 
X 
X 
X 
X 
EGSS 
X 
X 
X 
X 
X 
Photographs (select sites only) 
X 
X 
Cutaneous Safety Evaluation 
X 
X 
X 
X 
Tolerability Evaluation 
X 
X 
X 
X 
Randomization in IWRS (obtain kit #) 
X 
X 
X 
Administer Subject Instructions (Appendix 17.1) 
X 
Dispense Study Drug5 
X 
X 
X 
Weigh Study Drug 
X 
X 
X 
X 
Study Drug applied at investigational center 
X 
Study Drug Collected 
X 
X 
X 
Subject Diary Calendar dispensed 
X 
X 
X 
Subject Compliance Reviewed / Diary 
X 
X 
X 
Adverse Events 
X 
X 
X 
X 
X 
Concomitant Therapy and Prohibited Therapies Review 
X 
X 
X 
X 
X 
End of Study 
X 
1 If no washout is needed, Visits 1 and 2 may occur on the same day. If a washout is needed, Visit 2 must occur after the appropriate washout period. 
2 All visit dates are in reference to baseline, e.g., Visit 4 occurs 8 weeks +/- 3 days after baseline visit. 
3 All Week 12 procedures should be completed for all subjects who terminate early. 
4 The Week 2 SSA will be sent home with the subject during the baseline visit (Visit 2) with instructions to complete it at two weeks and return it at 
the Week 4 visit. The site should call the subject at Week 2 to remind them to take the Week 2 SSA. 
5 Dispense one tube of test material at the Baseline, Week 4 and Week 8 visits. 
 
Version 1, 04 June 2015 
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8 Selection and Withdrawal of Subjects 
8.1 
Subject Inclusion Criteria 
Subjects meeting all of the following criteria will be eligible for study entry: 
1. Male or female at least 9 years of age and older; 
2. Written and verbal informed consent must be obtained. Subjects less than age of 
consent must sign an assent for the study and a parent or a legal guardian must sign 
the informed consent (if subject reaches age of consent during the study they should 
be re-consented at the next study visit); 
3. Subject must have a score of 3 (moderate) or 4 (severe) on the Evaluator’s Global 
Severity assessment at the screening and baseline visit; 
4. Subjects with facial acne inflammatory lesion (papules, pustules, and nodules) count 
no less than 20 but no more than 40; 
5. Subjects with facial acne non-inflammatory lesion (open and closed comedones) 
count no less than 20 but no more than 100; 
6. Subjects with two or fewer facial nodules; 
7. Females of childbearing potential1 and females that are pre-menses must be willing to 
practice effective contraception for the duration of the study. (Effective contraception 
is defined as stabilized on oral contraceptive for at least 3 months, IUD, condom with 
spermicidal, diaphragm with spermicidal, implant, Nuvaring, injection, transdermal 
patch or abstinence.) Females on birth control pills must have taken the same type pill 
for at least three months prior to entering the study and must not change type during 
the study. Those who have used birth control pills in the past must have discontinued 
usage at least three months prior to the start of the study. Women who use birth 
control for acne control only should be excluded. 
8. Pre-menses females and females of childbearing potential must have a negative urine 
pregnancy test2 at the screening and baseline visits; 
9. Subjects must be willing to comply with study instructions and return to the clinic for 
required visits. Subjects under the age of consent must be accompanied by the parent 
or legal guardian at the time of assent/consent signing; 
10. If a cleanser, moisturizer or sunscreen is needed during the study, Subjects must be 
willing to use only allowed cleansers, moisturizers, sunscreens, or 
 
 
1 Pre-menses females and Females of Child Bearing Potential (FOCBP) include any female who has not undergone 
successful surgical sterilization (hysterectomy, bilateral tubal ligation or bilateral oophorectomy) or is not 
postmenopausal [defined as amenorrhea >12 consecutive months; or women on hormone replacement therapy 
(HRT) with documented plasma follicle-stimulating hormone (FSH) level >35mLU/mL]. Even women who are 
using oral, implanted or, injectable contraceptive hormones, an intrauterine device (IUD), barrier methods 
(diaphragm, condoms, spermicidal) to prevent pregnancy, practicing abstinence or where partner is sterile (e.g., 
vasectomy), should be considered to be of child bearing potential. 
2 Urine pregnancy tests must have a minimum sensitivity of 25mIU -HCG/mL of urine and must be performed 
within 72 hours prior to the start of study medication. Kits will be provided by the CRO. 

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moisturizer/sunscreen combination products (see Appendix 2). If the subject wears 
makeup they must agree to use non-comedogenic makeup. 
 
8.2 
Subject Exclusion Criteria 
Subjects meeting any of the following criteria will be excluded from the study: 
1. Use of an investigational drug or device within 30 days of enrollment or participation 
in a research study concurrent with this study; 
2. Any dermatological conditions on the face that could interfere with clinical 
evaluations such as acne conglobata, acne fulminans, secondary acne, perioral 
dermatitis, clinically significant rosacea, gram-negative folliculitis; 
3. Any underlying disease(s) or some other dermatological condition of the face that 
requires the use of interfering topical or systemic therapy or makes evaluations and 
lesion count inconclusive; 
4. Subjects with a facial beard or mustache that could interfere with the study 
assessments; 
5. Subjects with more than two (2) facial nodules; 
6. Evidence or history of cosmetic-related acne; 
7. Subject has a history of experiencing significant burning or stinging when applying 
any facial treatment (eg, make-up, soap, masks, washes, sunscreens, etc) to their face; 
8. Female subjects who are pregnant, nursing mothers, planning a pregnancy during the 
course of the trial, or become pregnant during the study; 
9. Use of estrogens (eg, Depogen, Depo-Testadiol, Gynogen, Valergen, etc) for less than 
12 weeks immediately preceding study entry; Subjects treated with estrogens 12 or 
more consecutive weeks immediately prior to study entry need not be excluded unless 
the Subject expects to change dose, drug or discontinue estrogen use during the study; 
10. If female, subject has a history of hirsutism, polycystic ovarian disease or clinically 
significant menstrual irregularities; 
11. Treatment of any type of cancer within the last 6 months; 
12. Subject uses medications and/or vitamins during the study which are reported to 
exacerbate acne (azothiaprim, haloperidol, Vitamin D, Vitamin B12, halogens such as 
iodides or bromides, lithium, systemic or mid-to super-high potency corticosteroids, 
phenytoin and phenobarbital); Daily vitamins are acceptable; 
13. History of hypersensitivity or allergic reactions to any of the study preparations as 
described in the Investigator’s Brochure, including known sensitivities to any dosage 
form of tretinoin; 
14. Concomitant use of potentially irritating over-the-counter products that contain 
ingredients such as benzoyl peroxide, alpha-hydroxy acid, salicylic acid, retinol or 
glycolic acids; 

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1 5.  S u bjects t hat ha ve n ot u n der g o ne t he s pecifi e d was h o ut peri o d(s) f or t he f oll o wi n g 
t o pical pre p arati o ns us e d o n t he face or s u bjects w h o re q uire t he c o n c urre nt use of 
a n y of t he f oll o wi n g t o pical a ge nts i n t he treat me nt area  : 
 
T o pical astri n ge nts a n d a brasi ves  o n  face 
1  wee k  
A nti bi otics o n t he  facial area  
2 wee ks 
N o n -all o we d m oist urizers or s u nscree ns  o n  face 
2 wee ks 
Ot her t o pical a nti -ac ne dr u gs  o n  face 
2 wee ks 
S oa ps c o ntai ni n g a nti micr o bials o n  t he face 
2 wee ks 
A nti -i nfla m mat or y a ge nts a n d c ortic oster oi ds o n t he 
facial ar ea  
4  wee ks  
Reti n oi ds, i ncl u di n g reti n ol o n  t he face 
4  wee ks  
 
If t he s u bject re q uires t o pical treat me nt f or ac ne o n areas ot her t ha n t he face (e. g., 
c hest a n d/ or b ac k), t h e i n vesti gat or m a y pres cri be a pr o d uct t hat d o es n ot c o ntai n 
treti n oi n a n d m ust be n ote d i n s o urce d o c u me nts a n d e C R F. 
 
1 6.  S u bjects t hat ha ve n ot u n der g o ne t he s p ecifie d w as h o ut peri o d(s) f or t h e f oll o wi n g 
s yste mic me dicati o ns or s u bjects w h o re q uire t he c o nc urre nt use of a n y of t he 
f oll o wi n g s ystemic  me di cati o ns:  
 
C ortic oster oi ds (i ncl u di n g i ntra m usc ul ar i njecti o ns)  
(i n hale d c ortic oster oi ds are all o we d)  
4  wee ks  
A nti bi otics  
4  wee ks  
Ot her s yste mic  ac n e treat me nts 
4  wee ks  
S yste mic  r eti n oi ds 
6 m o nt hs  
 
1 7.  S u bject i nte n ds t o use a ta n ni n g b o ot h or s u n b at he d uri n g t he st u d y. 
1 8.  S u bjects w h o are u n a ble t o c o m m u nicate or c o o p erate wit h t he I n v esti gat or d ue t o 
la n g u a ge pr o ble ms, p o or me ntal de vel o p me nt, or i m paire d cere bral f u ncti o n. 
1 9.  S u bjects wit h a n y u n derl yi n g diseas e t hat t he I n vesti gat or dee ms u nc o ntr o ll e d, a n d 
p oses a c o ncer n f or t he s u bjects safet y w hile p arti ci pati n g i n t he  st u d y. 
 
8. 3  
S u bject Wit h dr a w al  Criteri a  
Reas o ns f or wit h dra wal ma y i ncl u d e, b ut are n ot li mite d t o, t he f oll o wi n g:  
•  Ac ne  flare, as deter mi ne d  b y  t he i n vesti gat or, w hic h  re q uires treat me nt wit h  a 
disall o we d  t hera p y. 
•  Eit her at t he i n vesti gat or's re q uest, f or t olera bilit y reas o ns (e g, se vere  a d verse 
reacti o ns), or at t he s u bject’s re q u est. 
•  W he n t he re q uire me nts of t he pr ot oc ol are n ot  f oll o we d. 
•  W he n a c o nc o mita nt t her a p y li kel y t o i nterfere wit h t he res ults of t he st u d y is 
re p orte d, or re q uir e d b y t he s u bject (t he i n vesti gat ors will re p ort all s uc h i nf or mati o n 

Pr ot oc ol V 0 1 -1 2 1 A -3 0 1, I D P -1 2 1  
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o n t he s o urce d o c u me nts/case re p ort f or ms ( C R Fs) a n d deci de, i n acc or da nce wit h t he 
s p o ns or, w het her t he s u bj ect is t o be wit h dra w n). 
•  W he n a s u bject is l ost t o f oll o w -u p. T he i n vesti gat ors will tr y t wice t o reac h t he 
s u bject b y tel e p h o ne a n d will se n d a f oll o w-u p letter b y certifie d mail bef ore 
c o nsi deri n g t hat t he s u bject is l ost t o f oll o w-u p.  T hese  acti o ns will  be  re p orte d o n  t he 
E n d of St u d y C R F a n d a c o p y of t he f oll o w -u p lett er mai ntai ne d i n t he i n vesti gat or's 
file. 
All pre mat ure disc o nti n u ati o ns a n d t heir reas o ns m ust be caref ull y d o c u me nte d b y t he 
i n vesti gat or o n t he fi nal C R F, a n d, if nee d b e, o n t he A E f or m. I n a n y cas e, n o s u bject w h o has 
bee n i ncl u de d a n d has a st u d y n u m ber assi g n e d ca n be re place d b y a n ot h er if t he y disc o nti n ue 
pre mat urel y f or w hat e ver reas o n. All data gat here d o n t he s u bject pri or t o ter mi nati o n will be 
ma de a vaila ble t o t he s p o ns or.  
Reas o ns f or st u d y c o m pl eti o n/ disc o nti n uati o n as liste d o n t he fi nal re p ort f or m are d efi ne d as 
f oll o ws: 
N or m al St u d y C o m pleti o n –  S u bject c o m pletes t he st u d y as pla n ne d i n t h e pr ot oc ol.  
A d verse E ve nt –  C o m plete A E f or m.  
De at h –  C o m plete  S A E f or m.  
S u bject Re q uest –  C o nse nt wit h dra wal, s u bject m o ve d, sc he d ule c o nflicts. 
Pr ot oc ol Vi ol ati o n –  C o ntact t he S p o ns or or desi g nee bef ore ma ki n g d ecisi o n. 
L ost t o F oll o w -U p –  D o c u me nt wit h 2 p h o ne calls a n d a certifie d letter.  
Pre g n a nc y –  S u bject wil l disc o nti n ue st u d y dr u g i m me diatel y, b ut will be f oll o we d t o ter m. 
C o m plete pre g na nc y f or m.  
W orse ni n g C o n diti o n –  S u bject re q uires alter nate treat me nt f or ac ne b ef ore t he e n d of t he 
st u d y a n d t he i n vesti gat or deter mi nes it is n ot d ue t o lac k of efficac y.  
L ac k of Effic ac y –  S u bject re q uir es alter n ate treat me nt f or ac n e after at least 2 wee ks of 
st u d y dr u g tr eat me nt a n d t he ris k of c o nti n ui n g t he s u bject i n t he st u d y o ut wei g hs t h e be nefit 
as deter mi ne d b y t he i n v esti gat or.  
Wit h dr a w al b y P are nt/ G u ar di a n –  A n i n dicati o n t hat t he st u d y partici pa nt has bee n 
re m o ve d fr o m t he st u d y b y t he p are nt or l e gal g uar dia n. C o nse nt wit h dra w al, s u bject m o ve d, 
sc he d ule c o nflicts. 
St u d y Ter mi n ate d b y S p o ns or –  A n i n dicati o n t hat a cli nical st u d y was st o p pe d b y its 
S p o ns or.  
Ot her –  S pecif y i n c o m me nts secti o n of fi nal C R F.  
S u bjects w h o ter mi nate treat me nt earl y will be as ke d t o c o m plete all Wee k 1 2 assess me nts a n d 
pr oce d ur es pri or t o c o m me nce me nt of a n y alter n ati ve t hera p y f or ac ne (if p ossi ble). S u bjects 
w h o disc o nti n u e fr o m t he st u d y d uri n g t he treat m e nt peri o d will n ot be re place d.  

Protocol V01-121A-301, IDP-121 
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25 
 
 
 
 
All subjects are free to withdraw from participating in this study at any time and for whatever 
reason, specified or unspecified, and without prejudice. No constraints will be placed on ordinary 
subject management, and subjects, when appropriate, will be placed on other conventional 
therapy upon request or whenever clinically necessary as determined by their physician. 
 
9 Treatment Plan 
9.1 
Methods of Assigning Subjects to Treatment Groups 
This is a double-blinded study, in which the identity of the study drug will be unknown to 
investigator/evaluator and subjects, as well as all individuals closely associated with the study. 
Subjects will be randomized to 1 of the 2 study drug groups in a ratio of 1:1 (IDP-121 [tretinoin 
0.05%] Lotion : IDP-121 Vehicle Lotion). Each screened subject will be assigned a unique 6- 
digit study subject number assigned by the investigational center, which will consist of the 3- 
digit investigational center/site number (pre-assigned by sponsor/designee) and the 3 digit 
chronological screening order number, starting with 001 (eg, 101001, 101002). The study drug 
kit will be assigned to subjects based on a randomization code and kit will be dispensed to the 
subjects at Baseline by the IRW system, and at Week 4 and Week 8 visits. A study drug log will 
document the inventory and dispensing of study drug at each investigational center. 
 
9.2 
Randomization and Blinding 
The study drugs will be packaged and labeled identically, and the study drug kits will be 
numbered sequentially and dispensed randomly to the subjects entering the study within each 
investigational center. Study drug supplies will be distributed to the investigational centers to 
maintain the randomization ratio within each investigational center. 
As a double-blinded study, the investigators, the site staff, the sponsor, and the clinical monitors 
will not be aware of the treatment assigned to the individual study subjects. Delegated staff 
members at each investigational center will dispense the study drugs and will collect all used and 
unused study drug tubes as scheduled. 
 
9.3 
Un-blinding 
The treatment assignments for all enrolled subjects will be unblinded only after the conclusion of 
the study. Specifically, the blind will be broken only after all data are verified, entered into the 
database, and validated; subject evaluability assessments are performed and entered into the 
database; and the database is locked. 
In the case of a medical emergency, the investigator can break the blind for the subject involved 
preferably by first discussing the situation with the medical monitor and the sponsor (or 
designee) immediately. After confirmation, the investigator will be contacted with unblinding 

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information by a sponsor representative. The investigator will record the code break in the 
subject’s source documents. 
 
9.4 
Prior and Prohibited Concomitant Medication or Therapy 
Any concomitant therapy stopped for washout as indicated below is to be recorded. As noted in 
the exclusion criteria, there are mandatory washout periods and restrictions during the study for 
the following topical treatments on the face that have a known beneficial effect for acne vulgaris: 
Topical astringents and abrasives on the face 
1 week 
Antibiotics on the facial area 
2 weeks 
Non-allowed moisturizers or sunscreens on the face 
2 weeks 
Other topical anti-acne drugs on the face 
2 weeks 
Soaps containing antimicrobials on the face 
2 weeks 
Anti-inflammatory agents and corticosteroids on 
the facial area 
4 weeks 
Retinoids, including retinol on the face 
4 weeks 
 
If the subject requires topical treatment for acne on areas other than the face (eg, chest or back), 
the investigator may prescribe a product that does not contain tretinoin and noted in source 
documents and eCRF. 
In addition there is a mandatory wash out period and restrictions during the study for the 
following systemic drugs: 
Corticosteroids (including intramuscular injections, 
inhaled corticosteroids are allowed) 
4 weeks 
Antibiotics 
4 weeks 
Other systemic acne treatments 
4 weeks 
Systemic retinoids 
6 months 
 
Subjects using concomitant therapies during the course of the study that could interfere with the 
interpretation of the study results (including but not limited to those listed above) should not be 
withdrawn, but the use of the concomitant product should be discontinued. No other topical 
treatment (except as noted above) other than the study drug will be permitted for acne. 
Information on concomitant therapies will be recorded in the Prior and Concomitant Medication 
or Therapy source document and eCRF. Any therapy used by the subject will be considered 
concomitant therapy (eg, aspirin, Tylenol, birth control pills, vitamins, moisturizers, sunscreens). 
Every attempt should be made to keep concomitant therapy dosing constant during the study. 
Any change to concomitant therapy should be noted on the Concomitant Therapy source 
document and eCRF. 

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All cleansers and moisturizers and other topical products used on the treatment area that are not 
prescription products will be captured on the Other Skin Care Products source document and 
eCRF. Subjects must use Investigator approved cleansers and moisturizers. 
Subjects should avoid excessive UV exposure by such activities as sun bathing or tanning 
booths. 
 
9.5 
Treatment Compliance 
Each subject will be instructed on the importance of returning his or her study drug at each 
applicable study visit. If a subject does not return his or her study drug, he or she will be 
instructed to return it as soon as possible. The subjects will bring the tubes dispensed at each 
treatment visit to the next subsequent study visit. Each tube will be weighed by a study 
coordinator or designee prior to dispensation and after collection. The subject will also be asked 
to complete a diary calendar and questioned regarding the study drug use since the previous visit 
in order to judge the subject’s compliance with applying the study drug. A subject who deviates 
significantly from the prescribed application amount will be counseled. Any missed applications 
of study drug will be noted by the subject on the diary, which will be collected and placed in the 
appropriate source document. Missed applications will be documented in the CRF. The subject 
will also be sent home with a Subject Self Assessment (SSA) survey at the Baseline visit, with 
instructions to complete it at home at two (2) weeks after their baseline visit, and return it at the 
Week 4 study visit. 
 
9.6 
Protocol Deviations and Violations 
The investigators must read the protocol thoroughly and must follow the instructions exactly. 
A deviation from the protocol is an unintended and/or unanticipated departure from the 
procedures and/or processes approved by the sponsor and the IRB/IEC and agreed to by the 
investigator. Deviations usually have an impact on individual patients or a small group of 
patients and do not involve inclusion/exclusion or primary endpoint criteria. 
A protocol violation occurs when there is nonadherence to the protocol that results in a 
significant, additional risk to the patient, when the patient or investigator has failed to adhere to 
significant protocol requirements (inclusion/exclusion criteria) and the patient was enrolled 
without prior sponsor approval, or when there is nonadherence to FDA regulations and/or ICH 
GCP guideline. 
The investigator or designee must document and explain in the patients’ source documentation 
any deviation from the approved protocol. The investigator may implement a deviation from, or 
a change of, the protocol to eliminate an immediate hazard to study patients without prior 
IRB/IEC approval. As soon as possible after such an occurrence, the implemented deviation or 
change, the reasons for it, and any proposed protocol amendment(s) should be submitted to the 

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IRB/IEC for review and approval, to the sponsor for agreement, and to the regulatory authorities, 
if required. 
 
10 Study Drug Materials and Management 
The study drug will be dispensed by an appropriately qualified member of the study staff 
assigned by the investigator to this task. 
 
10.1 IDP-121 Lotion and IDP-121 Vehicle Lotion 
Chemical structure and formula for the active ingredients in IDP-121 Lotion and vehicle are 
listed in the tables below: 
Table 2. 
Drug Substances Identification 
 
Active Ingredient 
Tretinoin 0.05% 
Chemical Name 
(2E,4E,6E,8E)-3,7-dimethyl-9-(2,6,6-trimethylcyclohexen-1-yl)nona- 
2,4,6,8-tetraenoic acid 
Chemical Class 
Retinoid 
Molecular Formula 
C20H28O2 
CAS Registry Number 
302-79-4 
 
Table 3. 
Test Product Identification 
 
Investigational Product 
Vehicle 
Name of Active Ingredient 
Tretinoin, EP / USP 
N/A 
Drug Name/Formulation/ 
Concentration 
IDP-121 Lotion [Tretinoin 0.05%] 
IDP-121 Vehicle Lotion 
Manufacturer 
Valeant Pharmaceuticals International, Inc. 
2150 St. Elzear Boulevard West 
Laval (Quebec), Canada H7L 4A8 
Packaging 
45 g tube 
45 g tube 
Storage Requirements 
Store at 20°C to 25°C (68°F to 
77°F) 
Store at 20°C to 25°C (68°F 
to 77°F) 
Appearance 
Opaque pale yellow lotion 
Opaque pale yellow lotion 
Dosing Schedule 
Once daily x 12 weeks 
Once daily x 12 weeks 
Route of Administration 
Topical Application 
Topical Application 
 
10.1.1 Packaging and Labeling 
IDP-121 Lotion and its vehicle will be supplied in subject kits. Instructions will be provided to 
the study drug technician responsible at the clinical sites. When a subject is randomized into the 
study, the IWRS specific kit number will be assigned to be used for that randomized subject by 
the IWR system. Each subject kit will contain one tube, which has 45 grams of study material. A 
new subject kit will be assigned to a subject at each visit: Baseline, Week 4 and Week 8. The 
subjects will be dispensed one kit at Baseline as assigned in the IWR system. The tube will be 

Pr ot oc ol V 0 1 -1 2 1 A -3 0 1, I D P -1 2 1  
Valea nt Researc h & De vel o p me nt  
Versi o n 1, 0 4 J u ne 2 0 1 5  
C O N FI D E N TI A L  
2 9  
 
 
 
 
wei g h e d pri or t o dis pe nsi n g. T he s u bj ect will bri n g t he t u be t o t he n e x t st u d y visit ( Wee k 4), 
w here it will be c ollecte d a n d wei g he d; o ne n e w t u be will be dis pe nse d a gai n b y t he I W R s yste m 
at Wee k 4, wei g he d a n d pr o vi de d t o t he s u bject. T he sa me will occ ur at t h e Wee k 8 visit.. If t h e 
s u bject l oses a t u be (l ost or da ma ge d t ube), a n ot her kit will be dis pe nse d via I W R S. Eac h t u be 
dis pe nsi n g will be d oc u me nte d o n t he dr u g acc o u nta bilit y l o g.  
Eac h s u bject kit (a n d t u b e) will ha ve a si n gle p a nel la bel. La bels will c o ntai n t he f oll o wi n g 
i nf or mati o n: 
•  Pr ot oc ol  N u m ber  
•  Kit N u m ber  
•  C o nte nts  
•  S pace f or e ntr y of t he s u bject  i nitials 
•  S pace f or e ntr y of d ate  dis pe nse d  
•  T he s p o ns or na me, D o w P har mace utical Scie nces, a di visi o n of  Valea nt 
P har mace uticals N. A.,  L L C  
•  T he q ua ntit y of pr o d uct ( 4 5  gra ms)  
•  A state me nt rea di n g, “ F or e xter nal use o nl y . A v oi d c o ntact wit h e yes a n d li ps” 
•  A state me nt rea di n g, “ St ore at c o ntr olle d r o o m te m perat ure 2 0° C t o 2 5° C ( 6 8° F t o 
7 7° F) wit h e x c ursi o ns per mitte d bet wee n 1 5° C t o 3 0° C ( 5 9° F t o 8 6° F) .” 
•  A state me nt rea di n g, “ Ca uti o n: Ne w Dr u g Li mite d b y Fe deral La w t o  I n vesti gati o nal 
Use”  
•  A state me nt rea di n g, “ Ret ur n t his pr o d uct t o y o ur i n vesti gati o nal site at y o ur ne xt 
visit.”  
1 0. 1. 2  St or a ge, H a n dli n g, a n d Dis p os al of St u d y  Dr u g  
T he st u d y dr u g s h o ul d be st ore d at c o ntr olle d r o o m te m perat ure 2 0° C t o 2 5° C ( 6 8° F t o 7 7° F) wit h 
e xc ursi o ns per mitte d bet wee n 1 5° C t o 3 0° C ( 5 9° F t o 8 6° F) , a n d s h o ul d n ot be refri gerate d. All 
u n use d st u d y dr u g will be se nt bac k t o t he S p o ns or or S p o ns or desi g nee u p o n st u d y c o m pleti o n 
f or d oc u me nte d dis p osal. 
1 0. 1. 3  A d mi nistr ati o n  
Test material will be a p plie d  t o picall y t o t he face o nce a d a y f or a peri o d of 1 2 wee ks. Test 
material will be a p plie d as a t hi n c oati n g (a da b t h e size of a lar ge p ea) t hat is ge ntl y r u b be d i n t o 
t he s ki n. T he test material use s h o ul d be li mite d t o t he face. 
T he I n vesti gat or a n d/ or t rai ne d i n vesti gati o nal ce nter staff me m b er will i nstr uct t he s u bject o n 
t he pr o per a p plicati o n pr oce d ure of t he st u d y dr u g t o t he treat me nt area at t he Bas eli ne visit (see 
A p pe n di x 1 7. 1). All s u bjects will be i nstr ucte d t o a p pl y t he t est material at a p pr o x i matel y t he 

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same time every day for 12 weeks after cleansing. On study visit days subjects should be 
instructed to wait until after their study visit to apply study medication. No time interval between 
dosing and meals or any other activity is specified. Subjects will be instructed to gently wash 
their face with a Sponsor approved cleanser and warm (not hot) water. After washing, the 
subjects will be asked to thoroughly rinse and gently pat their face dry. The subjects should use 
the tube to dispense a pea-sized amount of study drug to their fingertip. This dose should then be 
dotted on to 6 areas (chin, left cheek, right cheek, nose, left forehead, right forehead) on the face. 
After distributing the dose in this manner the subject should gently rub the lotion into the skin. 
This amount of drug should be sufficient to cover the entire face excluding the mouth, eyes, 
inside the nose, and lips. It is important for the subject to treat their entire face (excluding the 
mouth, eyes and lips) and they should be instructed NOT to treat only specific lesions. They 
should gently smooth the test material over the face evenly. The test material should become 
invisible almost immediately following application with gentle rubbing. If this does not happen, 
the Investigator should instruct the subject on the use of a smaller dosage. The subject should 
wash his/her hands after applying the investigational product to the face. 
The subjects will be instructed to continue using the same Sponsor approved facial cleanser and 
moisturizer and not to change products during the study. At each visit, subjects are to be asked if 
they have changed their cleansing routine. Facial makeup may be applied according to the 
subject’s normal daily routine; however, subjects should be instructed not to wear make-up 
during study visits as it may interfere with the evaluator’s assessments. Subjects must also agree 
to use non-comedogenic makeup during the study if they use makeup. No other products should 
be used on the face. 
Subjects should be instructed to store the test material at room temperature. 
 
10.2 Study Drug Accountability 
Upon receipt of the study drug, the Investigator is responsible for ensuring that the designated 
investigational center staff member will conduct a complete inventory of study materials and 
assume responsibility for their storage and dispensing. In accordance with federal regulations, 
the investigators must agree to keep all study materials in a secure location with restricted access. 
The Investigator will keep a record of the inventory and dispensing of all study drug. This record 
will be made available to the sponsor’s monitor for the purpose of accounting for all clinical 
supplies. Any significant discrepancy and/or deficiency must be recorded with an explanation. 
All supplies sent to the Investigators will be accounted for and, in no case, used in any 
unauthorized situation. Tubes will be weighed (with the cap on) before dispensing to and upon 
return by the subjects, and weights will be recorded on the pharmacy log and appropriate CRF. 
All used and unused supplies will be returned to sponsor/designee for destruction at the 
conclusion of the study. 

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11 Study Procedures and Evaluations 
All subject information and data obtained during the study visits will be recorded in the source 
documents, applicable study logs, and eCRFs. 
Evaluators must have appropriate, documented experience and training, or obtain approval from 
the sponsor based on experience (or through additional training organized by the sponsor). 
At each study visit, every attempt should be made to ensure that the same investigator / evaluator 
assesses the same subject. 
 
11.1 Schedule of Evaluations and Procedures 
11.1.1 Visit 1: Screening Visit 
The following procedures will be conducted at this visit: 
1. Obtain written informed consent prior to performing any study procedures. Subjects less 
than 18 years of age must sign an assent form and the parent or legal guardian must sign 
the informed consent form. 
2. Assign the subject a 6-digit subject number by accessing IWRS, which will consist of the 
3-digit site number (pre-assigned to your site) and the 3-digit chronological order 
screening number, assigned by the IWR system and starting with 101 (eg, 101 001, 101 
002, etc; in this example site number is 101). 
3. Record the subject’s demographic information. 
4. Record the subject’s medical history. 
5. Record all previous medications (including acne medications) for the past 4 weeks (past 6 
months for systemic retinoids). Record any therapies that will be used concomitantly 
during the study. 
6. Perform Evaluator’s Global Assessment followed by inflammatory lesion count and non- 
inflammatory lesion count to determine eligibility. 
7. Perform a Urine Pregnancy Test and Serum Pregnancy Test for all females that are pre- 
menses and females of childbearing potential. The urine pregnancy tests will be supplied 
by the CRO. 
8. Discuss allowed moisturizers and sunscreens and record any cleanser, moisturizer and 
sunscreen use. (Appendix 17.2). 
9. If subject wears makeup, remind the subject not to wear make-up during any future visits. 
10. Verify that the subject meets the applicable inclusion/exclusion criteria as outlined in 
Sections 8.1 and 8.2. 
11. Remind subject to not apply test medication on day of next study visit prior to the clinic 
visit. 

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12. If the subject requires a washout, schedule the Baseline visit to occur after the washout is 
complete. If no washout is required, the Screening and Baseline visits may occur on the 
same day. 
13. Schedule subject to return for the Baseline/Day 0 visit. If the subject requires a washout, 
schedule the Baseline/Day 0 visit to occur after the washout is complete. 
NOTE: At the Screening and Week 12 visits, serum pregnancy testing is mandatory for all 
females of childbearing potential. In addition, a urine pregnancy test must be completed at 
Screening and at the Baseline visit prior to randomization, and at Weeks 4, 8 and 12. The 
decision may be made by the investigator to do additional pregnancy tests during the course of 
the study. 
11.1.2 Visit 2: Baseline Visit (Day 0) 
If a washout is not needed, this visit may occur on the same day as the Screening Visit (Visit 1). 
If a washout is needed, Visit 2 must occur after the appropriate washout period based on the 
criteria provided in Section 8.2. 
The following procedures will be conducted at this visit: 
1. The baseline Subject Self Assessment (SSA), Patient Satisfaction Survey (PSS) and the 
Acne-Specific Quality of Life Questionnaire (Acne-QoL) will be completed by the 
subject and collected prior to any other study-related procedures. The Week 2 SSA will 
be sent home with the subject with instructions to complete it at two weeks and return it 
at the Week 4 visit. 
2. Verify that the subject continues to meet the applicable inclusion/exclusion criteria as 
outlined in Sections 8.1 and 8.2. 
3. Record changes in any concomitant medications since the previous visit under Prior and 
Concomitant Medications or Therapies. Check for prior and concomitant therapies as per 
Section 9.4. 
4. Perform a Urine Pregnancy Test for all females that are pre-menses and females of 
childbearing potential. The urine pregnancy tests will be supplied by the CRO. 
5. Perform an abbreviated physical exam, including measurements of height and weight, 
and vital signs. Any abnormal physical exam findings will be recorded. 
6. The Evaluator will query the subject regarding how oily/shiny their facial skin has been 
in the past week. 
7. The Evaluator will perform Baseline efficacy evaluations including the Evaluator’s 
Global Severity Score (EGSS), inflammatory lesion counts and non-inflammatory lesion 
counts. The EGSS is performed prior to the lesion counting. Every effort should be made 
for the same qualified, validated Evaluator to perform the efficacy evaluations at all visits 
from Baseline to Week 12 for the same subject. 
8. The Evaluator will perform Cutaneous Safety and Tolerability Evaluations. 

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9. Assign the subject the presented kit number (this number will be generated from the 
Interactive Web Response system, (IWRS)). 
10. The study coordinator or designee will weigh the tube within the assigned kit and 
dispense to the subject. A study diary calendar will also be dispensed and the subject will 
be instructed to bring it in for their subsequent visits. 
11. The study coordinator or designee will instruct the subject on the proper application 
procedure for the study drug per Section 10.1.3, and will provide written subject use 
instructions to the subject (Appendix 17.1). For the first application, the subject will 
apply the study drug at the investigational center under the direction of the study 
coordinator or designee. The study drug should be applied after all clinical assessments. 
The study coordinator or designee will instruct the subjects to apply the study drug once 
daily at home. 
12. Record any AEs or changes in AEs since the screening visit and/or reported 
spontaneously by the subject. 
13. Selected Sites only - Obtain representative photographs of the face. 
14. Schedule the next study visit at Week 4 (Day 28 ± 3 days). Remind the subject to not 
apply test medication on day of next study visit, prior to the clinic visit. 
11.1.3 Visit 3 and 4: Week 4 (Day 28 ± 3 Days) and Week 8 (Day 56 ± 3 Days) Visits 
The following procedures will be conducted at this visit (if a subject terminates early, all final 
visit (Week 12/Final Visit) procedures must be performed): 
1. The take-home Week 2 SSA will be collected during the Week 4 study visit. 
2. The Week 4 or Week 8 SSA will be conducted and collected. 
3. The Evaluator will perform the efficacy evaluations including the Evaluator’s Global 
Severity Score (EGSS), inflammatory lesion counts and non-inflammatory lesion counts. 
The EGSS is performed prior to the lesion counting. Every effort should be made for the 
same qualified and validated evaluator to perform the efficacy evaluations at all visits 
from Baseline to Week 12 for the same subject. 
4. The Evaluator will perform Cutaneous Safety and Tolerability Evaluations. 
5. Record changes in any concomitant medications since the previous visit under Prior and 
Concomitant Medications or Therapies. Check for prior and concomitant therapies as per 
Section 9.4. 
6. Record any new AEs reported spontaneously by the subject or changes in any ongoing 
AEs. 
7. Perform a Urine Pregnancy Test for all females that are pre-menses and females of 
childbearing potential. The urine pregnancy tests will be supplied by the CRO. 
8. The study drug technician will retrieve and weigh the used test material tube and assign 
the subject another kit number (this number will be generated from the Interactive Web 
Response system, (IWRS) and dispense a new subject kit of test material. The tube will 
be weighed on a calibrated scale. Record the weight to the nearest 0.1 gram. 

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9. The study diary calendar will be collected and reviewed for compliance. Any missed 
doses or deviations should be reported. A new study diary calendar will be dispensed. 
10. Schedule the subsequent study visit, as applicable. Remind the subject to not apply test 
medication on the day of the next study visit, prior to the clinic visit. 
11.1.4 Visit 5: Week 12 (Day 84 -3/+5 Days) Visit – End of Study Visit 
The following procedures will be conducted at this visit: 
1. The Week 12 SSA, PSS and Acne-QoL will be completed by the subject and collected 
prior to any other study-related procedures. 
2. Perform an abbreviated physical exam, including measurements of height and weight, 
and vital signs. Any abnormal physical exam findings will be recorded. 
3. The Evaluator will query the subject regarding how oily/shiny their facial skin has been 
in the past week. 
4. The Evaluator will perform the efficacy evaluations including the Evaluator’s Global 
Severity Score (EGSS), inflammatory lesion counts and non-inflammatory lesion counts. 
The EGSS is performed prior to the lesion counting. Every effort should be made for the 
same qualified and validated Evaluator to perform the efficacy evaluations at all visits 
from Baseline to Week 12 for the same subject. 
5. The Evaluator will perform Cutaneous Safety and Tolerability Evaluations. 
6. Record changes in any concomitant medications since the previous visit under Prior and 
Concomitant Medications or Therapies. Check for prior and concomitant therapies as per 
Section 9.4. 
7. Record any new AEs reported spontaneously by the subject or changes in any ongoing 
AEs. 
8. The study diary calendar will be collected and reviewed for compliance. Any missed 
doses or deviations should be reported. 
9. The study drug technician will retrieve all test material tubes from the subject and weigh 
the tubes on a calibrated scale and record the weight to the nearest 0.1 gram. 
10. For women of child bearing potential, collect a blood sample for a serum pregnancy test 
and perform a final Urine Pregnancy Test for all females that are pre-menses and females 
of childbearing potential. The urine pregnancy tests will be supplied by the CRO. 
11. Selected Sites only - Obtain representative photographs of the face. 
12. Exit the subject from the study and complete the end of study CRFs. 
 
11.2 Evaluation of Efficacy 
The determination of efficacy will be based on evaluator-blinded assessments of the signs and 
symptoms of acne vulgaris. Evaluators must be a board-certified/board-eligible dermatologist or 
have appropriate documented experience and training, and be present for formal study training 

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and validation at the Investigator Meeting (and/or Site Initiation Visit), or obtain a waiver from 
the Sponsor based on experience (or through additional training organized by the Sponsor). 
The EGSS scores and lesion counts will be performed at each study visit. The EGSS scores will 
be collected before the Lesion Counts. All Subject assessments will be performed by a trained 
and validated Evaluator. Every effort should be made to have the same evaluator assess the same 
Subject at each visit. If this is not possible, the same Evaluator must assess the Subject at both 
the baseline and Week 12 visits. 
11.2.1 Evaluator’s Global Severity Score (EGSS) 
The Evaluator’s Global Severity Score will be a static assessment that is independent of the 
baseline score. The investigator will make the assessment without referring to the baseline value. 
Every effort should be made for the same evaluator to perform each study assessment for the 
same study subject, for consistency in evaluations. 
Subjects are eligible if they have acne with a global severity of a 3 (moderate) or a 4 (severe) on 
the EGSS at the baseline visit. The following scores will be used to describe the severity grade 
and subsequent score: 
Table 4. Evaluator’s Global Severity Score 
Score 
Grade 
Description 
0 
Clear 
Normal, clear skin with no evidence of acne vulgaris 
1 
Almost 
Clear 
Rare non-inflammatory lesions present, with rare non-inflamed papules (papules must 
be resolving and may be hyperpigmented, though not pink-red 
2 
Mild 
Some non-inflammatory lesions are present, with few inflammatory lesions 
(papules/pustules only; no nodulocystic lesions) 
3 
Moderate 
Non-inflammatory lesions predominate, with multiple inflammatory lesions evident: 
several to many comedones and papules/pustules, and there may or may not be one 
nodulocystic lesion 
4 
Severe 
Inflammatory lesions are more apparent, many comedones and papules/pustules, there 
may or may not be up to 2 nodulocystic lesions 
 
11.2.2 Lesion Counts 
The facial area lesion counts will be taken from the subject’s face. The lesion count groups will 
be inflammatory and non-inflammatory. Facial inflammatory lesions (pustules, papules, and 
nodules) will be counted as follows: pustules and papules will be counted and recorded together, 
not separately; nodular lesions will be counted and recorded separately. Non-inflammatory 
lesions (open and closed comedones) will be counted and recorded together. The lesions counts 
will be collected at each visit and/or upon discontinuation. The following are definitions of each 
lesion type counted: 

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Inflammatory lesions are defined as follows: 
 
Papule – a solid, elevated lesion less than 5 mm 
Pustule – an elevated lesion containing pus less than 5 mm 
Nodule – palpable subcutaneous lesion greater than 5 mm; has depth, not necessarily elevated 
Non-inflammatory lesions are defined as follows: 
 
Open comedones (blackhead) – plugged hair follicle with dilated/open orifice; black in color 
Closed comedones (whitehead) – plugged hair follicle: small opening at skin surface 
 
11.2.3 Other Assessments 
Oily/Shiny Face Assessment 
The subject will be asked at Baseline and Week 12 to assess how oily their skin has been in the 
past week by the scale below: 
Oily/Shiny skin assessment 
0 – None 
No oily or shiny skin on face  
1 – Mild 
Mild oily or shiny skin on face 
2 – Moderate Definite oily or shiny skin on face 
3 – Severe 
Extremely oily or shiny skin on face 
If subject answers 1, 2 or 3 to the above they will also be asked how often the oily skin made 
them feel bothered during the past week with scale below: 
0 – Not bothered at all 
1 – A little bothered 
2 – Moderately bothered 
3 – Very bothered 
4 – Extremely bothered 
Photography 
At select sites, photographs of the face will be taken at Baseline and Week 12, at a minimum. 
Only subjects who provide written photographic consent for facial photographs will be included 
in photography. 
 
11.3 Evaluation of Safety 
Safety assessments will be conducted at baseline and each subsequent visit. 
 
11.3.1 Cutaneous Safety Evaluations 
Cutaneous tolerability will be evaluated through assessment of selected local signs and 
symptoms at the drug-application site: itching, burning and stinging at the time of the visit. 
Cutaneous tolerability signs and symptoms that result in the subject’s requiring a concomitant 
therapy, interruption of treatment, or discontinuation from the study, will be reported as an AE. 

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(Note: To be assessed by the evaluator at the time of the study visit.) 
Scaling: 
0 – None 
No scaling 
1 – Mild 
Barely perceptible, fine scales present on limited areas of the face 
2 – Moderate Fine scale generalized to all areas of the face 
3 – Severe 
Scaling and peeling of skin over all areas of the face 
 
Erythema: 
0 – None 
No evidence of erythema present 
1 – Mild 
Slight pink coloration 
2 – Moderate Definite redness 
3 – Severe 
Marked erythema, bright red to dusky dark red in color 
 
11.3.2 Tolerability Evaluations 
To be reviewed with the subject at the study visit as average over the period since the previous 
visit. 
Itching: 
0 – None 
No itching 
1-  Mild 
Slight itching, not really bothersome 
2 – Moderate Definite itching that is somewhat bothersome 
3 – Severe 
Intense itching that may interrupt daily activities and/or sleep 
 
Burning: 
0 – None 
No burning 
1 – Mild 
Slight burning sensation; not really bothersome 
2 – Moderate Definite warm, burning sensation that is somewhat bothersome 
3 – Severe 
Hot burning sensation that causes definite discomfort and may 
interrupt daily activities and/or sleep 
 
Stinging: 
0 – None 
No stinging 
1 – Mild 
Slight stinging sensation, not really bothersome 
2 – Moderate Definite stinging sensation that is somewhat bothersome 
3 – Severe 
Stinging sensation that causes definite discomfort and may interrupt daily 
activities and/or sleep 
11.3.3 Medical History and Abbreviated Physical Examination 
A medical history will be taken at Screening, and confirmed and revised if needed, at Baseline. 
Medical histories having resolved two or more years before Baseline need not be collected unless 
considered relevant by the investigator. 
An abbreviated physical examination including measurements of height and weight, and vital 
signs (blood pressure, heart rate, respiration rate, and oral temperature) will be performed at 

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Baseli ne a n d Wee k 1 2 ( e n d of treat me nt/st u d y). A n y a b n or mal p h ysical e x a m fi n di n gs will be 
rec or d e d. 
1 1. 3. 4  Pre g n a nc y  Tests  
All fe male s u bjects of c hil d beari n g p ot e ntial will u n der g o ser u m pre g na n c y testi n g at Scree ni n g 
a n d Wee k 1 2. I n a d diti o n, uri ne pre g n a nc y testi n g will b e perf or me d at Scree ni n g a n d pri or t o 
ra n d o mizati o n at Baseli n e, a n d at Wee k 4, 8 a n d Wee k 1 2. T he uri ne pre g na nc y tests will be 
s u p plie d b y t he C R O. 
 
1 1. 4  A d verse  E ve nts  
1 1. 4. 1  Defi niti o n of A d verse  E ve nt  
A n A E is a n y u nt o war d me dical occ urre n ce i n a patie nt or cli ni cal i n vesti gati o n s u bject 
a d mi nistere d a me dici nal pr o d uct a n d w hic h d o es n ot necessaril y ha v e a ca usal relati o ns hi p wit h 
t he st u d y dr u g. A Es i ncl u de a n y u nfa v ora ble a n d u ni nte n de d ill ness, si g n, s y m pt o m, cli nicall y 
si g nifica nt la b orat or y test a b n or malit y, or disease t e m p orall y ass ociate d wit h t he use of a 
me dici nal pr o d uct t hat has a p pear e d or w orse ne d d uri n g t he c o urse of t he cli nical trial, re gar dless 
of ca usal r elati o ns hi p t o t he st u d y dr u g(s) u n der st u d y. A Es i ncl u d e a n y ill ness, si g n, s y m pt o m, 
or o ut -of -r a n ge a n d cli nicall y si g nifica nt la b orat or y fi n di n g t hat h as a p peare d or w ors e ne d d uri n g 
t he c o urse of t h e cli nical trial, re gar dl ess of ca usal relati o ns hi p t o t he st u d y. T he c ollecti o n of 
n o n -seri o us A Es a n d s eri o us a d verse e ve nts ( S A Es) will be gi n f oll o wi n g t h e s u bject's 
c o m pleti o n of t he c o nse nt pr ocess t o partici pat e i n t he  st u d y. 
1 1. 4. 2  D oc u me nti n g A d verse  E x perie nces  
It is t he r es p o nsi bilit y of t he i n vesti gat or t o d o c u me nt all A Es t hat occ ur d uri n g t he c o urse of t he 
st u d y. T he A Es s h o ul d be d oc u me nte d as a si n gle me dical dia g n osis. W he n t his is n ot p ossi ble, 
t he A E s h o ul d be d oc u m e nte d i n ter ms of si g ns a n d/ or s y m pt o ms o bser ve d b y t he i n vesti gat or or 
re p orte d b y t he s u bject at eac h st u d y visit. Eac h A E w hic h a p pears t o be i n de pe n de nt of a n y pri or 
e ve nt wil l be re p orte d se paratel y. 
All A Es occ urri n g after t he s u bject si g ns t he i nf or me d c o nse nt t hr o u g h t he last st u d y visit m ust 
be re p ort e d, re gar dless of w het her or n ot t he A Es are c o nsi dere d dr u g -relat e d. All A Es, w het her 
i n res p o nse t o a q uer y, o bser ve d b y the st u d y site pers o n nel, or re p orte d s p o nta ne o usl y b y t he 
s u bject, will be rec or de d. 
At eac h visit d uri n g t he st u d y, t he s u bject will be assesse d f or t h e occ urre n ce of ne w a n d o n g oi n g 
A Es. C uta ne o us t olera bilit y si g ns a n d s y m pt o ms t hat res ult i n t he s u bjec t’s re q uiri n g a 
c o nc o mita nt t hera p y or disc o nti n uati o n fr o m t he st u d y will be re p orte d as a n A E. T he f oll o wi n g 
data will be c ollecte d o n all A Es a n d rec or de d o n t he a p pr o pri ate C R F:  
•  E ve nt na me ( dia g n osis pr eferre d, if u n k n o w n, rec or d t he  si g ns/s y m pt o ms) 

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•  O nset date a n d e n d  date  
•  Ma xi m u m i nte nsit y  (se v erit y) 
•  Seri o us ness  
•  Acti o n ta ke n re gar di n g st u d y  dr u g  
•  C orrecti ve tr eat me nt, if  gi ve n  
•  O utc o me  
I n a d diti o n, t he i n vesti gat or’s assess me nt of ca usalit y will be rec or de d. 
Vital si g n a b n or m alities are t o be rec or de d as A Es o nl y if t he y are cli nicall y si g nifica nt (f or 
e x a m ple: are s y m pt o mati c, re q uiri n g c orrecti ve treat me nt, lea di n g t o disc o nti n uati o n or f ulfilli n g 
a seri o us ness criteri o n).  
1 1. 4. 3  Seri o us A d verse  E ve nts  
All A Es will be assesse d as eit her seri o us or n o n -s eri o us. 
A n S A E or seri o us a d v erse e ve nt is defi ne d as a n y u nt o war d me dical o cc urre nce t h at at a n y 
d ose:  
•  Res ults i n  deat h  
•  Is i m me diatel y life t hr eat e ni n g, (t h e ter m "life t hreate ni n g" i n t he d efi niti o n of 
"seri o us" r efers t o a n e v e nt i n w hic h t he s u bject is at ris k of deat h at t he ti m e of t he 
e ve nt; it d oes n ot refer t o a n e ve nt w hic h h y p ot h eticall y mi g ht ha ve ca use d deat h if it 
were m or e  se vere) 
•  Re q uires i n patie nt h os pitalizati o n or pr ol o n gati o n of e xisti n g h os pitalizati o n 
( h os pitalizati o n f or electi ve s ur ger y f or a  bas eli ne  c o n diti o n is n ot  c o nsi dere d  a n A E)  
•  Res ults i n persiste nt or si g nifica nt disa bilit y/i n ca p acit y ( per m a ne nt or s u bst a ntial 
disr u pti o n of a pers o n’s a bilit y t o c o n d u ct n or mal life  f u ncti o ns) 
•  Is a c o n ge nital a n o mal y/ birt h defect 
•  Is a me dicall y i m p orta nt e ve nt t hat ma y n ot be i m me diatel y life t hreat e ni n g or res ult 
i n deat h or h os pitalizati o n, b ut ma y je o p ar dize t he s u bject a n d ma y re q uire me dical or 
s ur gical i nter ve nti o n t o pre ve nt o ne of t he a b o v e liste d o utc o mes. E x a m ples of s uc h 
e ve nts i ncl u de, b ut ar e n ot li mite d t o, aller gic br o nc h os pas m re q uiri n g i nte nsi ve 
treat me nt i n a n e mer ge nc y r o o m or at h o me; bl o o d d yscrasias or c o n v ulsi o ns t hat d o 
n ot res ult i n i n patie nt  h os pitalizati o n.  
N ote: A s p o nta ne o us a b orti o n will be c o nsi dere d a n S A E, a n d m ust be re p orte d per Re p orti n g of 
S A Es u n der Secti o n 1 1. 4. 6.  

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1 1. 4. 4  Assess me nt of  Se verit y  
T he se verit y assi g ne d t o a n A E s h o ul d be deter mi ne d b y t h e ma xi m u m se verit y of t he A E. T h e 
cate g ories d escri b e d bel o w s h o ul d be use d t o esti mate t he se verit y of A Es: 
•  Mil d: Tra nsie nt or mil d disc o mf ort; n o li mitati o n i n acti vit y; n o  me di cal 
i nter ve nti o n/t hera p y re q uire d 
•  M o derate: Mil d t o m o der ate li mitati o n i n acti vit y; s o me assista nce ma y b e nee de d; n o 
or mi ni mal me dical i nter ve nti o n/t hera p y re q uire d 
•  Se vere: Mar k e d li mitati o n i n acti vit y; s o me assista nce us uall y re q uire d; m e dical 
i nter ve nti o n/t hera p y r e q uire d; h os pitalizati o n or pr ol o n gati o n of c urre nt 
h os pitalizati o n p ossi ble; ma y b e i nca p acitati n g or life  t hreate ni n g 
1 1. 4. 5  Ass ess me nt of  C a us alit y 
T he i n vesti gat or s h o ul d assess t he relati o ns hi p of t he A E, if a n y, t o t he st u d y dr u g as eit her 
“ Relate d” or “ N ot Relate d”. T he f oll o wi n g s h o ul d be ta ke n i nt o acc o u nt w he n assessi n g S A E 
ca usalit y:  
Relate d: T here is at least a reas o n a ble  p ossi bilit y t hat t he A E/ S A E is relate d t o t he st u d y dr u g. 
Reas o na ble p ossi bilit y m ea ns t hat t her e is e vi de nce t o s u g gest a ca us al relati o ns hi p bet wee n t he 
dr u g a n d t he A E. 
 
N ot Relate d: T here is little or n o reas o na ble p ossi bilit y t hat t he A E/ S A E is relate d t o t he st u d y 
dr u g. T his assess me nt i m plies t hat t he A E/ S A E has little or n o te m p oral relati o ns hi p t o t he st u d y 
dr u g a n d/ or a m or e li kel y or cert ai n alter nati ve eti ol o g y e xists. 
 
1 1. 4. 6  Re p orti n g of Seri o us A d verse  E ve nts  
A d verse e ve nts classifie d as “seri o us” re q uire e x pe diti o us ha n dli n g a n d re p orti n g t o s p o ns or or 
desi g nee wit hi n 2 4 h o urs of i n vesti gati o nal ce nter n otificati o n t o c o m pl y wit h re g ul at or y 
re q uire me nts. 
All S A Es, w het her rel ate d or u nrelate d t o st u d y dr u g, m ust be i m me diatel y re p orte d t o t he 
me dical m o nit or wit hi n 2 4 h o urs of t he i n vesti gat or’s a w are n ess of t he e v e nt. All S A Es m ust be 
re p orte d via c o nfir me d facsi mile a n d e mail tra ns missi o n a n d m ust be s u b mitte d o n a writte n S A E 
re p ort f or m si g ne d b y t he i n vesti gat or wit hi n 2 4 h o urs of t he i n vesti gat or’s a ware ness of t he 
e ve nt.  
T he c o ntact(s) f or re p orti n g a n S A E are:  
 
 Me dical M o nit or 
 
 
 

Protocol V01-121A-301, IDP-121 
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41 
 
 
 
 
& 
 
 Program Manager [TKL Research, Inc.] 
 
 
Investigators should not wait to receive additional information to fully document the event 
before notifying Medical Monitor and Sponsor of an SAE. If only limited information is initially 
available, follow-up reports are required. Additional relevant information such as hospital 
records and autopsy reports should be provided to the Sponsor as soon as they are available. 
Should the investigator become aware of an SAE (regardless of its relationship to investigational 
product) that occurs within 30 days after stopping the study drug, the SAE must be reported in 
accordance with procedures specified in this protocol. 
All deaths of subjects, regardless of cause, and which are known to the Investigator will be 
reported on the appropriate CRF for up to 30 days after the administration of study drug, 
regardless of the Investigator's opinion regarding drug relationship. Documentation of the 
subject’s cause of death and a copy of the autopsy or hospital report will also be provided. The 
Medical Monitor must be notified within 24 hours of knowledge of the event by telephone 
(and/or facsimile/email) of all subject deaths. Written follow-up must be received by the medical 
monitor and the Institutional Review Board within five (5) calendar days of initial notification. 
 
The investigator should take all appropriate measures to ensure the safety of the subjects, notably 
he/she should follow a subject with an SAE until the event has resolved or the condition has 
stabilized. This may imply that follow-up will continue after the subject has left the study, and 
that additional investigations may be requested by the Sponsor, and that additional investigations 
may be requested by the Sponsor. When a SAE persists at the end of the study, the Investigator 
will conduct follow-up contacts with the subject until the Investigator/Sponsor agree the event is 
satisfactorily resolved and/or stabilized. If at any time after 30 days after administration of study 
drug, the investigator becomes aware of an SAE which he/she feels is related to study drug or 
procedure, this must also be reported immediately (within 24 hours of knowledge of occurrence) 
by telephone and confirmed facsimile transmission/email to the Medical Monitor and Sponsor 
11.4.7 Expedited Serious Adverse Event Reports 
An AE, whether serious or non-serious, is designated unexpected (unlabeled) if it is not reported 
in the clinical safety section of the Investigator Brochure or if the event is of greater frequency, 
specificity or severity. 
Expedited SAE reports are those that are both unexpected based on the reference document 
(Investigator Brochure or Package Insert) and are related (ie, the relationship cannot be ruled 
out) to the study drug. These expedited reports are subject to reporting timelines of 7 and/or 15 

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cale n dar da ys t o t he r e g ulat or y re p orti n g a ge nc y(i es). T he S p o ns or will n otif y re g ulat or y 
a ut h orities of t hese A Es a n d all partici pati n g i n vesti gati o nal ce nt ers i n writi n g f or s u b missi o n b y 
t he i n vesti gat or t o t he I R B/I E C. T his n otificati o n will be i n t he f or m of a S afet y U p dat e t o t he 
I n v esti gat or Br oc h ur e (ie, “ 1 5-da y letter”).  
U p o n recei vi n g s u c h n otices, t he i n vesti gat or m ust re vie w a n d retai n t he n otice wit h t he 
I n v esti gat or Br oc h ur e a n d i m me diatel y s u b mit a c o p y of t his i nf or mati o n t o t he res p o nsi ble 
I R B/I E C acc or di n g t o l ocal re g ulati o ns. T he i n v esti gat or a n d I R B/I E C will deter mi ne if t he 
i nf or me d c o nse nt r e q uires re visi o n. T he i n vesti gat or s h o ul d als o c o m pl y wit h t he I R B/I E C 
pr oce d ur es f or re p orti n g a n y ot h er saf et y i nf or mati o n.  
1 1. 4. 8  Pre g n a nc y  
All fe male s u bjects of c hil d beari n g p ot e ntial m ust use a n effecti ve m et h o d of birt h c o ntr ol d uri n g 
t he c o urse of t h e st u d y, i n a ma n ner s u c h t hat ris k of c o ntrace pti ve fail ure is mi ni mize d. 
A bsti ne nce is all o we d as a birt h c o ntr ol met h o d.  
Bef ore e nr olli n g a fe mal e s u bject of c hil d beari n g p ote ntial i n t his cli nical trial, t he i n vesti gat or 
m ust re vie w t he f oll o wi n g i nf or m ati o n a b o ut st u d y partici pati o n:  
•  I nf or me d c o ns e nt re q uir e me nts 
•  C o ntrace pti ves i n c urre nt use  
F oll o wi n g re vie w of t his i nf or mati o n a n d a p pr o priate s u bje ct c o u ns eli n g, t h e i n vesti gat or or 
desi g nee a n d t he s u bj ect m ust si g n t he i nf or me d c o nse nt bef ore st u d y e nr oll me nt.  
D uri n g t h e st u d y, all fe m ale s u bjects of c hil d beari n g p ote ntial s h o ul d be i nstr ucte d t o c o ntact t he 
i n vesti gat or i m me diatel y if t he y s us p ect t he y mi g ht be pre g na nt (e g, misse d or late me nstr ual 
peri o d).  
If a s u bject or i n vesti gat or s us pects t hat t he s u bject ma y b e pre g n a nt pri or t o st u d y e nr oll me nt, 
t he st u d y dr u g m ust be wit h hel d u ntil t he res ults of la b orat or y pre g na n c y testi n g are a vaila ble. If 
pre g na nc y is c o nfir me d, t he s u bject m ust n ot recei ve st u d y dr u g a n d m ust n ot be e nr olle d i n t he 
st u d y. If pre g na n c y is s us pecte d w hile t he s u bject is recei vi n g st u d y treat me nt, t he st u d y dr u g 
m ust i m me diatel y b e wit h hel d u ntil t he res ult of p re g na nc y t esti n g is k n o w n. If pre g n a nc y is 
c o nfir me d, t he st u d y dr u g will be per ma ne ntl y dis c o nti n ue d a n d t he s u bject will be f oll o we d 
u ntil t he pre g n a nc y c o m es t o ter m. A Pre g na nc y R e p ort f or m will be s u b mitte d t o t he s p o ns or, 
i nitiall y a n d at t he e n d of t he pre g na n c y, w hic h i n cl u des t he o utc o me of t h e pre g na n c y a n d a n y 
c o m plicati o ns occ urri n g d uri n g t he pre g na n c y or t he deli ver y.  
All c o nfir me d pre g n a nci es m ust be i m me diatel y re p orte d t o t he me dical m o nit or wit hi n 2 4 h o urs 
of t he i n vesti gat or’s a war e ness o f t he pre g n a nc y. All c o nfir me d pre g na nci es m ust be re p orte d via 
c o nfir me d f acsi mile/e mail tra ns missi o n a n d m ust be s u b mitte d o n a S A E f or m wit hi n 2 4 h o urs of  

Protocol V01-121A-301, IDP-121 
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the investigator’s awareness of the pregnancy using the same reporting as procedure for an SAE 
under Section 11.4.6. 
 
12 Statistics 
All statistical processing will be performed using SAS® version 9.3 or later unless otherwise 
stated. Statistical significance will be based on two-tailed tests of the null hypothesis resulting in 
p-values of 0.05 or less. 
The primary method of handling missing efficacy data will be based on estimation using the 
method of Markov Chain Monte Carlo (MCMC) imputation. This method provides robust 
estimation when the pattern of missingness is arbitrary. Additionally, the estimation will be done 
for each treatment group separately so that the pattern of missingness for one group does not 
influence the estimation of missing data for another group. Groups of complete datasets 
following the estimation will be concatenated to form analysis datasets for the comparative 
analyses and subsequent imputation result inference with SAS PROC MIANALYZE. 
Descriptive statistics will also be derived from the multiply imputed datasets. 
Additionally, a model-based multiple imputation process will be used as a sensitivity analysis to 
the MCMC imputation. Finally, the absolute change in lesion count will be analyzed using a 
repeated measures ANCOVA for lesion count data or a repeated measures logistic regression 
model (generalized estimating equations) for the dichotomized EGSS. 
 
 
A statistical analysis plan (SAP), describing all statistical analyses will be provided as a separate 
document. The SAP will be finalized prior to unblinding of the study treatments. 
Evaluations and Analyses 
Inflammatory lesions and non-inflammatory lesions will be recorded for each subject at Baseline 
and at Weeks 4, 8, and 12. The absolute and percent change from baseline of inflammatory 
lesions and non-inflammatory lesions will be derived for each subject at Weeks 4, 8, and 12. 
The EGSS will be recorded for each Subject. The EGSS will be dichotomized into “success” and 
“failure” at Week 4, 8 and 12 with a subject considered a success for those visits if the Global 
Severity Score is at least 2 grades less than baseline and are Clear or Almost Clear. An additional 
assessment of subjects who have achieved 2 grade improvement will be also be conducted as a 
secondary efficacy variable. 
The subject will be asked at Baseline and Week 12 to assess how oily their skin has been in the 
past week. 
All assessments will be conducted for both ITT and PP. 
 
12.1 Assessment of Efficacy 

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All efficac y a n al ys es will be c o n d ucte d o n t h e I T T ( pri mar y) a n d P P (s u p p orti ve) p o p ulati o ns.  
 
1 2. 1. 1  Pri m ar y  Effic ac y  
T here are t hr ee c o -pri mar y efficac y e n d p oi nts:  
•  A bs ol ute c ha n ge i n i nfla m mat or y lesi o n c o u nt fr o m baseli ne t o Wee k  1 2  
•  A bs ol ute c ha n ge i n n o n -i nfla m mat or y lesi o n c o u nt fr o m baseli ne t o Wee k 1 2  
•  Pr o p orti o n of s u bjects w h o ha ve a least a 2 gra de re d ucti o n at Wee k 1 2 fr o m baseli ne 
i n t he E val uat or's Gl o bal Se verit y Sc ore a n d were Clear or Al m ost Clear  
1 2. 1. 2  Sec o n d ar y  Effic ac y  
T here are t hr ee Wee k 1 2 sec o n dar y effi cac y e n d p oi nts:  
•  Perce nt c h a n ge i n i nfla m mat or y lesi o n c o u nt fr o m baseli ne t o Wee k  1 2  
•  Perce nt c h a n ge i n n o n -i nfla m mat or y lesi o n c o u nt fr o m baseli ne t o Wee k 1 2  
•  Pr o p orti o n of s u bjects w h o ha ve a least a 2 gra de r e d ucti o n at Wee k 1 2 fr o m baseli ne 
i n t he E val uat or's Gl o bal Se verit y S c ore  
T here are t hr ee Wee k 8 s ec o n dar y effi cac y e n d p oi nts:  
•  Perce nt c h a n ge i n i nfla m mat or y lesi o n c o u nt fr o m baseli ne t o Wee k  8  
•  Perce nt c h a n ge i n n o n -i nfla m mat or y lesi o n c o u nt fr o m baseli ne t o Wee k 8  
•  Pr o p orti o n of s u bjects w h o ha ve a least a 2 gra de re d ucti o n at Wee k 8 fr o m baseli ne 
i n t he E val uat or's Gl o bal Se verit y S c ore  
T here are t hr ee Wee k 4 s ec o n dar y effi cac y e n d p oi nts:  
•  Perce nt c h a n ge i n i nfla m mat or y lesi o n c o u nt fr o m baseli ne t o Wee k  4  
•  Perce nt c h a n ge i n n o n -i nfla m mat or y lesi o n c o u nt fr o m baseli ne t o Wee k 4  
•  Pr o p orti o n of s u bjects w h o ha ve a least a 2 gra de re d ucti o n at Wee k 4 fr o m baseli ne 
i n t he E val uat or's Gl o bal Se verit y S c ore  
1 2. 1. 3  Test of S u peri orit y f or Lesi o n C o u nt  V ari a bles  
T his secti o n pr o vi des t he basic m o del a n d statistical a p pr oac h w hic h is use d i n c o m bi nati o n wit h 
t he m ulti ple i m p utati o n pr oce d ur es descri be d i n Secti o n 1 2. 1. 7. Tests of s u peri orit y f or t he 
a bs ol ute c ha n ge fr o m Baseli ne i n i nfla m mat or y a n d n o n -i nfla m mat or y lesio ns will be base d o n 
eit her par a metric or n o n -para metri c met h o ds c o nsiste nt wit h t he statistical ass u m pti o ns re q uire d 
t o s u p p ort t he a nal ys es. S pecificall y, t he tests of s u peri orit y will be base d o n a n A N C O V A wit h 
fact ors of tr eat me nt a n d a nal ysis ce nter an d t h e res pecti ve Baseli ne lesi o n c o u nt as a c o variate or 
o n ra n ke d dat a s u b mitte d t o a n A N C O V A wit h fact ors of treat me nt a n d a n al ysis ce nter a n d t h e 
res pecti ve Bas eli ne lesi o n c o u nt as a c o v ariate. If t he treat me nt-b y -a nal ysis ce nter i nteracti o n 
effect is  si g nifica nt at a n al p ha less t ha n 0. 1 0, t he n t he effect will be i ncl u de d i n t he m o del; 
ot her wise it will be re m o ve d.  

Pr ot oc ol V 0 1 -1 2 1 A -3 0 1, I D P -1 2 1  
Valea nt Researc h & De vel o p me nt  
Versi o n 1, 0 4 J u ne 2 0 1 5  
C O N FI D E N TI A L  
4 5  
 
 
 
 
A s ke w ness test, bas e d o n t he met h o ds prese nte d b y J. H. Zar ( 1 9 8 4) [ 1 0 ], will be a p plie d t o t he 
resi d uals res ulti n g fr o m an A N C O V A. A t w o -si de d p-val ue f or t h e s ke w n ess test si g nifica nt at  
0. 0 1 will i m pl y t he use of t he n o n -par a metric m et h o d. If a para metri c a nal ysis is i n dicate d, t he 
res ults of t he par a metric a nal ysis will be c o nsi dere d t he pri mar y a nal ysis. S h o ul d a n o n- 
pa ra metri c a nal ysis be i n dicate d, t he a bs ol ute or p erce nt c ha n ges i n i nfla m mat or y a n d n o n- 
i nfla m mat or y l esi o ns will be ra n k tra nsf or me d pri or t o s u b mitti n g t he m t o t he A N C O V A. 
Res ults of t he ra n k -tra nsf or me d a nal yses t he n will be c o nsi dere d t he pri mar y a n alysis; h o w e ver, 
res ults of t he n o n-r a n ke d tra nsf or me d a nal yses will als o be prese nte d. 
1 2. 1. 4  St atistic al H y p ot hesis Testi n g a n d C o ntr ol of  M ulti plicit y  
Statistical h y p ot h esis testi n g f or l esi o n c o u nt a nal yses will use t he statistical m o del i ntr o d uce d i n 
Secti o n 1 2. 1. 3 a n d e m pl o ys t he met h o ds of Secti o n re gar di n g missi n g v al u es. T he a n al ysis of t he 
dic h ot o mize d E val uat or's Gl o bal Se verit y Sc ore will be base d o n t he l o gisti c re gressi o n test 
stratifie d b y a nal ysis ce nt er a n d e m pl o ys t he met h o ds of Secti o n 1 2. 1. 7 re gar di n g missi n g val ues. 
T he o ver all T y p e I err or will be c o ntr olle d b y re q uiri n g t he c o -pri mar y effi cac y e n d p oi nts of 
eac h gr o u p t o b e statisticall y si g nifica nt. S pecificall y, fail ure of a n y o n e of t he pri mar y efficac y 
e n d p oi nts will i n vali date t he statistical si g nifica n ce of t he sec o n dar y efficac y e n d p oi nts. 
T he f oll o wi n g ste p wise pr ocess will be c o n d u cte d f or testi n g t he s ec o n d ar y efficac y e n d p oi nts i n 
or der t o c o ntr ol f or m ulti plicit y. T hese t ests will be perf or me d f or o nl y t he I T T p o p ul ati o n. T he 
testi n g pr ocess will ter mi nate w he n e ver a statistical test f or a ste p is n ot si g nifica nt. All 
s u bse q ue nt tests f or t he r e mai ni n g ste ps will be c o nsi dere d n ot si g nifi ca nt. T he or der of testi n g 
is: 
 
Ste p  
N u m ber  
Sec o n d ar y E n d p oi nt  
1  
Perce nt c h a n ge i n n o n -i nfla m mat or y lesi o n c o u nt fr o m baseli ne t o Wee k 1 2 
2  
Perce nt c h a n ge i n i nfla m mat or y lesi o n c o u nt fr o m baseli ne t o Wee k 1 2  
3  
Perce nt c h a n ge i n n o n -i nfla m mat or y lesi o n c o u nt fr o m baseli ne t o Wee k 8 
4  
Perce nt c h a n ge i n i nfla m mat or y le si o n c o u nt fr o m baseli ne t o Wee k 8 
5  
Perce nt c h a n ge i n n o n -i nfla m mat or y lesi o n c o u nt fr o m baseli ne t o Wee k 4 
6  
Perce nt c h a n ge i n i nfla m mat or y lesi o n c o u nt fr o m baseli ne t o Wee k 4  
7  
Pr o p orti o n of s u bjects w h o ha ve a least a 2 gra de re d ucti o n at Wee k 1 2 fr o m 
baseli ne i n t he E val uat or's Gl o bal Se verit y Sc ore  
8  
Pr o p orti o n of s u bjects w h o ha ve a least a 2 gra de re d ucti o n at Wee k 8 fr o m  
baseli ne i n t he E val uat or's Gl o bal Se verit y Sc ore  
9  
Pr o p orti o n of s u bjects w h o ha ve a least a 2 gra de re d ucti o n at Wee k 4 fr o m  
baseli ne i n t he E val uat or's Gl o bal Se verit y Sc ore  

Pr ot oc ol V 0 1 -1 2 1 A -3 0 1, I D P -1 2 1  
Valea nt Researc h & De vel o p me nt  
Versi o n 1, 0 4 J u ne 2 0 1 5  
C O N FI D E N TI A L  
4 6  
 
 
 
 
1 2. 1. 5  Descri pti ve  St atistics  
Descri pti ve statistics will be prese nt e d f or t he f oll o wi n g para meters b y treat me nt gr o u p f or b ot h 
t he I T T a n d P P p o p ulati o ns: 
•  Fre q u e nc y a n d per ce nt distri b uti o ns of t he E val uat or’s Gl o bal Se verit y Sc ore at 
Baseli ne a n d Wee ks 4, 8, a n d  1 2.  
•  Fre q u e nc y a n d per ce nt distri b uti o ns of t he dic h ot o mize d E val uat or’s Gl o bal Se verit y 
Sc ore at Baseli ne a n d Wee ks 4, 8, a n d  1 2.  
•  Descri pti ve statistics i ncl u di n g mea n, me dia n, sta n dar d de viati o n, mi ni m u m, a n d 
ma xi m u m will be use d t o s u m marize i nfla m mat or y a n d n o n -i nfla m mat or y lesi o n 
c o u nts at baseli ne a n d wee ks 4, 8, a n d  1 2.  
•  Descri pti ve statistics i ncl u di n g mea n, m e dia n, sta n dar d de viati o n, mi ni m u m, a n d 
m a xi m u m will be use d t o s u m marize t he a bs ol ute a n d perce nt c ha n ge i n 
i nfla m mat or y a n d n o n-i nfla m mat or y lesi o n c o u nts at Wee ks 4, 8, a n d 1 2.  
•  Fre q u e nc y a n d per ce nt distri b uti o ns f or t he Oil y/ S hi n y assess me nts at Wee k  1 2  
Mea ns, sta n dar d d e viati o ns a n d fre q u e nc y c o u nts (r o u n de d t o t he nearest w h ole n u m ber) will be 
c o m p ute d fr o m t he m ulti pl y i m p ute d M C M C data f or t he vari a ble.  
1 2. 1. 6  P o oli n g  A n al ysis  
T he cli nical st u d y will be c o n d ucte d u n der a c o m m o n pr ot oc ol f or eac h i n vesti gati o nal site wit h 
t he i nte nti o n of p o oli n g t he data f or a nal ysis. E ver y eff ort will be ma d e t o pr o m ote c o nsiste nc y 
i n st u d y e x ec uti o n at eac h i n vesti gati o nal site. T h e st u d y is i nte n de d t o be c o n d ucte d i n a ma n n er 
s uc h t hat a mi ni m u m of 5 s u bjects will be e nr olle d i n eac h treat me nt ar m f or a n y i n vesti gat or. I n 
t he e ve nt t hat t her e ar e t o o fe w s u bjects i n a treat me nt ar m f or a n i n v esti gat or, t he n t his 
i n vesti gat or's dat a will be c o m bi ne d t o ac hie v e t he desire d sa m ple size mi ni m u m per ar m. T he 
c o m bi ni n g of i n vesti gat or's d ata will be acc o m plis he d b y t a ki n g t h e i n vesti gat or wit h t he 
s mallest e nr oll me nt a n d c o m bi ni n g it wit h t he i n vesti gat or wit h t he lar gest. If t here is a f urt her 
nee d t o c o m bi ne dat a, t he n t he data of t h e i n vesti gat or wit h t he sec o n d s m allest e nr oll me nt will 
be c o m bi ne d wit h t he  i n v esti gat or's d ata w hic h h a d t he sec o n d lar gest e nr oll me nt, a n d s o o n.  
T his pr ocess will c o nti n ue f or all i n vesti gat ors w h o di d n ot ha ve a mi ni m u m of 5 s u bjects per 
acti ve treat me nt ar m. T h e pr ocess of c o m bi ni n g i n vesti gat or d ata t hat ha v e i ns ufficie nt s u bjects 
per treat me nt ar m will res ult i n re defi ni n g t he gr o u ps of i n vesti gat ors f or t he p ur p oses of 
statistical a nal ys es. T hes e c o m bi ne d gr o u ps will b e referre d t o as "a nal ysis ce nters" i n t he 
statistical a nal ys es base d o n A N C O V A a n d stratifie d l o gistic testi n g. 
Pri or t o i n vesti gati n g t h e treat me nt effect wit hi n t h e a nal ysis ce nt ers, t he ma g nit u de of t he site 
mail effect will be i n vesti gat e d t o deter mi ne if t he mai n site -t o-site varia bilit y is s uc h t hat it 
c o ul d mas k t he a nal ysis ce nter effects. T h us, if c o m p utati o nall y p ossi ble, a o ne -wa y A N C O V A 
(f or lesi o n c o u nt varia bles) or a l o gistic re gressi o n a nal ysis (f or E G S S) wit h a fact or of site will 
be c o n d ucte d pri or t o p o oli n g. If t he d ata str uct ure i nterferes wit h t he l o gistic re gressi o n, a  

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descriptive analysis of the site effect will be undertaken. Conclusions appropriate to the findings 
of this step will be presented. 
The consistency of treatment response will be investigated across the analysis centers subsequent 
to combining the data as described above. Statistical tests will be conducted to identify if there 
are extreme analysis centers that could affect the interpretation of common statistical and clinical 
conclusions. An analysis center by treatment interaction will be included in the primary and 
secondary variable analyses to test for parallel treatment effect at an alpha level of 0.10. Change 
from baseline in inflammatory lesions and non-inflammatory lesions will be analyzed with an 
ANCOVA (unranked or ranked) with factors of treatment, analysis center, and treatment by 
analysis center interaction and the respective baseline lesion count variable as a covariate. For 
the purpose of testing consistency of treatment response, the dichotomized EGSS will be 
analyzed with a logistic regression procedure. Further examination will follow for any variables 
that have a significant ANCOVA or logistic regression interaction term. In the event that the 
ANCOVA or logistic regression interaction (referred to henceforth as the "appropriate test") p- 
value is less than or equal to 0.10, a sensitivity analysis that excludes analysis centers with the 
extreme efficacy result will be performed to determine the robustness of the treatment effect. On 
the other hand, if the outcome of the appropriate test has a p-value greater than 0.10, then the 
conclusions from the pooled data will be considered to be free of the impact of extreme analysis 
centers. 
The first step in conducting a sensitivity analysis is to identify the extreme analysis center or 
centers that contribute to the statistical significance of the appropriate test. The process involves 
submitting subsets of analysis centers to the appropriate test and observing the appropriate test p- 
value for the subset. Subsets with p-values greater than 0.10 for the appropriate test are 
considered homogeneous. 
The search for an extreme analysis center begins by analyzing all subsets that can be created by 
excluding one analysis center. If one or more of the subsets result in an appropriate test p-value 
greater than or equal to 0.10, then the analysis center excluded from the subset with the largest p- 
value for the appropriate test is deemed to be the extreme analysis center. 
If all appropriate test subset p-values are less than or equal to 0.10, then the process will analyze 
the appropriate test for all subsets that can be created by excluding two analysis centers.  If one 
or more of these subsets generate appropriate test p-values larger than 0.10, then the analysis 
centers excluded from the subset with the largest appropriate test p-value are deemed the extreme 
analysis centers. 
Thus, the process of identifying the extreme analysis centers will continue in a stepwise manner 
by first excluding one, then two, then three, etc., analysis centers until the appropriate test p- 
value exceeds 0.10. 

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Once the extreme analysis center or centers have been identified, then the treatment p-values of 
the remaining analysis centers will be computed. Inferences will be drawn from the treatment p- 
value, as well as any pertinent observations regarding the extreme analysis center or centers. 
Additionally, it is noted that this process excludes subjects from the analysis in a non-random 
manner and has an unpredictable impact on the power of the treatment effect test. In the event 
that the treatment effect of the remaining subset is not statistically significant, due consideration 
of the post-hoc aspects of the process will be given when the results are interpreted. Conclusions 
will be presented by the sponsor as appropriate to the findings of the sensitivity analysis. 
12.1.7 Missing Efficacy Data Imputations 
Lesion Count Variable Missing Data Imputation 
Missing 12 week data will be estimated by multiple imputation and subsequently analyzed. 
Missing lesion count data will be derived for the analysis using the method of Markov Chain 
Monte Carlo (MCMC) multiple imputation which does not rely on the assumption of data 
missing at random. Additionally, the pattern of missing observations in each treatment group 
cannot influence the missing value estimation in the other because the imputation is being 
conducted independently for each treatment group. 
Multiple imputation and subsequent analysis will involve 4 distinct phases with these principal 
tasks: 
 
1. Calculated the number of missing values to be estimated by MCMC (nmiss) for 12 week 
value. 
2. Create a data set of subjects, one for each treatment group, with observed values and 
those needing estimation by MCMC. The missing lesion count values in each data set 
will be filled in using the MCMC method ‘5 x nmiss’ times to generate ‘5 x nmiss’ data 
sets. The resulting data sets for each treatment arm will be combined into one complete 
data set for each imputation. 
3. For each complete data set, the absolute change in lesion counts for baseline minus the 12 
week value will be computed. Each complete data set will be analyzed as specified for 
the particular analysis. 
4. The results from these analyses will be combined into a single inference using SAS 
PROC MIANALYZE. 
EGSS Missing Data Imputation 
A similar procedure will be used for the analyses based on proportion of EGSS successes 
wherein the ANCOVA analysis is replaced with a logistic regression analysis. Specifically, 
missing 12 week EGSS values from which the dichotomized EGSS is derived will be estimated 
by (MCMC) which does not rely on the assumption of data missing at random. Additionally, the 

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pattern of missing observations in each treatment group cannot influence the missing value 
estimation in the other because the imputation is being conducted independently for each 
treatment group. 
The missing 12 week EGSS values will be derived for the analysis using the method of Markov 
Chain Monte Carlo (MCMC) multiple imputation. Multiple imputation and subsequent analysis 
will involve 4 principal tasks: 
1. Calculate the number of missing values to be estimated by MCMC (nmiss) for 12 week 
value. 
2. Create a data set, one for each treatment group, of subjects with observed values and 
those needing estimation by MCMC. The missing EGSS values in each data set will be 
filled in using the MCMC method ‘5 x nmiss’ times to generate ‘5 x nmiss’ data sets. The 
resulting data sets for each treatment arm will be combined into one complete data set by 
imputation. 
3. For each complete data set, the dichotomous success rate (clear or almost clear with a 2- 
point change from baseline) will be computed. The 12-week estimated global values will 
be rounded to the nearest integer value prior to evaluating the success rate. Each 
complete data set will be analyzed with a logistic regression with factors of treatment 
group and analysis center. 
4. The results from these analyses will be combined into a single inference using SAS 
PROC MIANALYZE. 
12.1.8 Sensitivity Efficacy Analyses 
Sensitivity analyses for absolute change in lesion count 
The first sensitivity analysis for absolute change in lesion count use a repeated measures 
ANCOVA, with treatment, analysis center, and visit (ie, Week 4, Week 8) as independent factors 
and a covariate of baseline lesion count.  In this analysis, data from all post-baseline visits will 
be included with no imputation for missing data. 
The second sensitivity analysis will use the model based multiple imputation method to impute 
missing data for the absolute change in lesion counts at Week 12. Multiple imputation will 
involve 4 principal tasks: 
1. Calculate the number of missing values (nmiss) for absolute change in lesion count. 
2. Missing values will be filled in ‘5 x nmiss’ times to generate ‘5 x nmiss’ complete data 
sets. The imputation model used will be an ANCOVA with factors of treatment group 
and analysis center, and a covariate of baseline lesion count (ie, the imputation model 
will be the same as the analysis model). Appropriate modifications will be made should 
the analysis be based on a non-parameteric method. 

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3. Each complete data set will be analyzed with an ANCOVA with factors of treatment 
group, and analysis center, and a covariate of baseline lesion count. 
4. Results from these analyses will be combined into a single inference. 
Sensitivity analyses for EGSS 
The first sensitivity analysis for the dichotomized EGSS success will use a repeated measures 
logistic regression model (generalized estimating equations), with dichotomized EGSS success 
as the dependent variable and treatment, analysis center, and visit (ie, Week 4, Week 8) as 
independent factors. In this analysis, data from all post-baseline visits will be included with no 
imputation for missing data. 
The second sensitivity analysis will use the model based multiple imputation method to impute 
missing data for the dichotomized EGSS data. Multiple imputation will involve 4 principal 
tasks: 
1. Calculate the number of missing values (nmiss) for absolute change in lesion count. 
2. Missing values will be filled in ‘5 x nmiss’ times to generate ‘5 x nmiss’ complete data 
sets. The imputation model used logistic regression with factors of treatment group and 
analysis center (ie, the imputation model will be the same as the analysis model). 
3. Each complete data set will be analyzed with a logistic regression a factors of treatment 
group and analysis center. 
4. Results from these analyses will be combined into a single inference. 
 
12.1.9 Subgroup Analyses 
Subset analyses will be conducted for the ITT populations for the subgroups baseline global 
severity, gender, age, ethnicity and race. Age will be dichotomized to less than the median age of 
subjects and greater than or equal to the median age of subjects. An additional analysis will be 
include with categories of less than 18, 18 to less than the median age and greater than or equal 
to the median age. Subset analyses will be conducted on the variables absolute change from 
baseline in inflammatory lesions and non-inflammatory lesions at Week 12 as well as the 
dichotomized global severity score at Week 12. These analyses will contain only descriptive 
statistics. 
 
12.2 Assessment of Safety 
Safety will be evaluated by tabulations of adverse events (AEs), Cutaneous Safety Evaluation, 
and Tolerability Evaluations. Cutaneous Safety Evaluation scores (erythema and scaling) and 
Tolerability (itching, burning, and stinging) will be presented with descriptive statistics at 
Baseline and at Weeks 4, 8, and 12 for each treatment group. Frequencies and percentages for 

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each outcome category will be included in these statistics. Mean values will be presented 
graphically by week and treatment group. 
12.2.1 Adverse Events 
All adverse events occurring during the study will be recorded and classified on the basis of 
MedDRA terminology. Descriptions of AEs will include the date of onset, the date the AE 
ended, the severity of the AE, the relationship to study medication, the action taken regarding 
study medication usage, the action taken regarding to treat the AE, and the outcome. All reported 
treatment-emergent AEs (TEAEs) will be summarized by the number of Subjects reporting AEs, 
system organ class, severity, seriousness, and relationship to study medication. TEAEs are those 
AEs with an onset on or after the date of the first study drug application. 
Adverse events will be summarized by treatment group and severity. Each subject will be 
counted only once within a system organ class or a preferred term by using the adverse events 
with the highest severity within each category. 
Adverse events will be summarized by treatment group and relationship to study medication. 
Each subject will be counted only once within a system organ class or a preferred term by using 
the adverse events with the greatest relationship within each category. 
Comparisons among treatment groups will be made by tabulating the frequency of subjects with 
one or more AEs (classified into MedDRA terms) during the study. The Fisher’s Exact test will 
be used to compare the proportion of subjects in each treatment group who report any adverse 
event at a significance level of 0.05. The specific system organ classes and preferred terms 
analyzed will be those that are reported by at least one percent of the subjects in any treatment 
group. 
All information pertaining to AEs noted during the study will be listed by subject, detailing 
verbatim given by the investigator, preferred term, system organ class, start date, stop date, 
severity, actions taken, and drug relatedness. The AE onset will also be shown relative (in 
number of days) to the day of initial dose of the randomized study medication. 
Serious adverse events (SAEs) will be tabulated by subject within treatment groups. 
In addition, a list of subjects who discontinued from the study and a list of subjects who 
experienced SAEs will also be provided. 
12.2.2 Vital Sign Measurements 
Changes from Baseline in vital sign measurements will be summarized with descriptive statistics 
for each treatment group at all applicable study visits. 

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12.2.3 Concomitant Medications 
All previous therapies and concomitant medications will be classified based on terminology from 
the WHO Drug Dictionary. Previous therapies and concomitant medications data will be 
presented in data listings. 
12.2.4 Subject Self-Assessments 
Subjects will be asked to complete three questionnaires during the study: the Subject Self 
Assessment scale, the Patient Satisfaction Survey and the Acne-Specific Quality of Life 
Questionnaire (Appendices 17.3, 17.4 and 17.5). Descriptive statistics will be used to summarize 
the data reported for each questionnaire. No Inferential analyses will be conducted. 
 
12.3 Subject Disposition 
A tabulation of subject disposition will be provided. The tabulation will include the numbers of 
subjects who enter the study, complete the study, and discontinue the study. The reasons for 
discontinuation will be included. 
 
12.4 Demographics and Baseline Characteristics 
Subject demographic and baseline characteristics will be summarized by treatment group for 
both the ITT population and the PP population. For continuous variables (e.g. age) comparisons 
among the two treatment groups will be conducted using a two-way analysis of variance 
(ANOVA) with factors of treatment group and analysis center. Ethnicity and race will be 
analyzed with a Cochran-Mantel-Haenszel test stratified by analysis center. Past and current 
medical conditions, as well as history of disease will not be compared statistically. 
 
12.5 Protocol Deviations 
All protocol deviations will be reported to the sponsor and recorded throughout the study. A 
tabulation of protocol deviations will be included in the final study report. 
 
12.6 Compliance 
No formal evaluations of compliance are planned. 
 
12.7 Interim Analyses 
No interim analyses are planned. 
 
12.8 Additional Statistical Considerations 
12.8.1 Analysis Populations 
Approximately 800 subjects at least 9 years of age and older with moderate or severe acne (a 
score of 3 or 4 [moderate to severe] on the EGSS scale) will be enrolled and randomized in the 
study. With a 1:1 randomization ratio, it is anticipated that: 

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•  4 0 0 s u bjects will be ra n d o mize d t o recei ve I D P -1 2 1 L oti o n, o nce d ail y  a p plicati o n 
•  4 0 0 s u bjects will be ra n d o mize d t o recei ve I D P -1 2 1 Ve hicle L oti o n, o nce dail y 
a p plicati o n 
T he I T T p o p ulati o n will c o nsist of all ra n d o mize d s u bjects w h o recei ve d st u d y me dicati o n. T he 
safet y p o p ulati o n will be c o m prise d of all ra n d o mize d s u bjects w h o are pres u me d t o ha ve use d 
t he st u d y me dicati o n at least o nce a n d w h o pr o vi d e at least o ne p ost-b aseli ne e val uati o n.  
A n i nte nt -t o-treat (I T T) a nal ysis will be c o n d u cte d o n all st u d y s u bjects. A per-pr ot oc ol ( P P) 
a nal ysis will als o be c o n d ucte d. S u bjects will be eli gi ble f or t he P P a nal ysis if t he y c o m plet e t he 
1 2 -wee k e val uati o n wit h o ut n ote w ort h y st u d y pr ot oc ol vi olati o ns ( i.e., a n y s u bject or 
i n vesti gat or acti vit y t hat c o ul d ha ve p ossi bl y i nterfere d wit h t he t hera p e utic a d mi nistrati o n of t he 
treat me nt or t he pr ecise e val uati o n of treat me nt efficac y). T h e P P p o p ulati o n will i ncl u de 
s u bjects i n t he safet y p o p ulati o n w h o d o n ot meet a n y of t he f oll o wi n g criteria: 
•  Faile d a n y of t he i ncl usi o n/e x cl usi o n  criteria; 
•  Ha ve ta k e n a n y i nterferi n g c o n c o mita nt  me dicati o ns;  
•  Di d n ot atte n d t he Wee k 1 2 visit, wit h t he e x ce pti o n of a disc o nti n uati o n fr o m t he st u d y 
d ue t o a n a d verse e v e nt r elate d t o st u d y treat me nt or d oc u me nte d lac k of treat me nt 
effect; 
•  Misse d b ot h t he wee k 4 a n d wee k 8  visits;  
•  Ha ve n ot bee n c o m plia nt wit h t he d osi n g re gi me n (i.e. S u bjects ma y n ot miss m ore 
t ha n fi ve c o nsec uti ve da ys of d osi n g a n d m ust ta ke 8 0-1 2 0 % of e x pe cte d d oses. T he 
n u m ber  of  e x pecte d  d oses  will  be  deter mi ne d  f or eac h s u bject b ase d  o n  t he le n gt h of 
t heir partici pati o n i n t he st u d y); 
•  O ut of visit wi n d o w at t he 1 2 -wee k  visit.  
Pri or t o brea ki n g t he bli n d, ot her a d diti o nal criteri a ma y be a d d e d t o t he list  t o acc o m m o date f or 
u nf oresee n e ve nts t hat o cc urre d d uri n g t h e c o n d uct of t he trial t hat res ult i n n ote w ort h y st u d y 
pr ot oc ol vi olati o ns.  
T he safet y p o p ulati o n will be c o m prise d of all ra n d o mize d s u bjects w h o are pres u me d t o ha v e 
use d t he st u d y me di cati o n a t least o nce a n d w h o pr o vi de at least o ne p ost-b aseli ne e val u ati o n.  
1 2. 8. 2  S a m ple Size  Deter mi n ati o n  
T hese  p o w er  calc ulati o ns  are base d  pri maril y  o n  t h e o bser ve d  Wee k  1 2  res ults of  t he St u d y  2  i n 
Atrali n ™ (treti n oi n) Gel, 0. 0 5 % N D A 0 2 2 0 7 0 a p plicati o n. T his st u d y was a t w o-ar m trial of 
Atrali n ™ vers us its ve hicle a n d is felt t o be a rele v a nt st u d y i n N D A 0 2 2 0 7 0 f or p o weri n g t h e 
c urre nt st u d y. T he n e xt t hree p o w er calc ulati o ns are c o nstr uct e d fr o m t he res ult s of St u d y 2.  
A sa m ple size of 4 0 0 per treat me nt ar m has at least 9 6 % p o wer t o det ect a st atisticall y si g nifica nt 
differe n ce wit h a si g nifica nce le v el of 0. 0 5. T he esti mate d a bs ol ute c ha n ge fr o m baseli ne  i n 

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treatment means were 6.5 and 3.5 for Atralin™ versus its vehicle, respectively, with a standard 
deviation of 11.3. 
A sample size of 400 per treatment arm has greater than 99% power to detect a statistically 
significant difference with a significance level of 0.05 using the estimated absolute change from 
baseline in treatment means of 17.8 and 9.9 for Atralin™ versus its vehicle, respectively, with a 
standard deviation of 24.7. 
The sample size estimates for the dichotomized EGSS require a substantially larger enrollment in 
order to achieve a power of at least 90%. The success rates observed in the second Atralin™ 
study was 23% for Atralin™ and 14% for its vehicle which is a difference of 9%. Approximately 
90% power is achieved with sample sizes of 400 per treatment group, respectively, using a 1:1 
randomization. 
It is noted that the same differential in success rates was observed in Study 1 (Atralin™ 
(tretinoin) Gel, 0.05% NDA 022070 application). The success rates observed in the first 
Atralin™ study was 13% for Atralin™ and 4% for its vehicle which is also a difference of 9%. 
Using these estimates, more than 99% percent power is achieved with sample sizes of 400 per 
treatment group. 
The clinical study will be conducted under a common protocol at each investigational site and 
every effort will be made to promote consistency in study execution at each investigational site 
as well as uniform evaluation of the EGSS evaluation for subjects at the various study visits. The 
experience in clinical trial execution gained during the execution of several acne studies 
conducted under the guidance of the Sponsor raises the expectation that the differential between 
the success rates of the two arms will be greater than 9%. Thus, the power of the EGSS is 
expected to be at least 95% for sample sizes of 400 subjects in each arm. 
Individually and collectively the considerations lead to a choice of randomizing 400 subjects per 
treatment group. 
12.8.3 Handling of Missing Data 
The method of multiple imputation will be used (see Section 12.1.7). 
 
12.8.4 Multicenter Issues 
The study will be conducted at multiple investigational centers in North America with the 
intention of pooling the results for analysis. 
12.8.5 Multiplicity Issues 
Not applicable. 

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12.8.6 Windowing Rules 
The timing of all study visits is relative to Baseline (Day 0). The Week 4 and Week 8 visits 
should occur within ± 3 days of the scheduled times, the Week 12 visit should occur within -3 / 
+5 days of the scheduled time. 
 
13 Quality Control and Quality Assurance 
13.1 Study Monitoring 
An Investigator Meeting and/or an initiation visit will be conducted with the principal 
investigator and study coordinators by sponsor and/or its designee. During this meeting, an 
extensive review and discussion of the protocol, the role of the study technician, all study 
procedures, source documents, and eCRFs will be conducted. Evaluation scales will be reviewed 
extensively and documentation of training will be recorded for training of sponsor-approved 
evaluators. 
The study monitors/clinical research associates will be trained prior to study initiation. Following 
this training, an overview of the study disease and study material background will be understood. 
Specific monitoring guidelines and procedures to be followed during monitoring visits will also 
be utilized. During the course of the study, all data will be 100% source document verified by the 
monitors. All subject source records must be made available to the monitors. 
The conduct of the study will be closely monitored by the sponsor following GCP guidelines. 
The reports of these verifications will also be archived with the study report. In addition, 
inspections or on site audits may be carried out by local authorities or by the sponsor's Quality 
Assurance Department. The investigators will allow the sponsor's representatives and any 
regulatory agency to examine all study records, corresponding subject medical records, clinical 
dispensing records and storage area, and any other documents considered source documentation. 
The investigators agree to assist the representative, if required. 
 
13.2 Audits and Inspections 
The study will be conducted under the sponsorship of Valeant in conformation with all 
appropriate local and federal regulations, as well as ICH guidelines. Interim and end of study 
audits of raw data, study files, and final report may be conducted by Valeant’s Quality Assurance 
Department or designee. 
The sponsor is responsible for implementing and maintaining quality assurance and quality 
control systems to ensure that studies are conducted and data are generated, documented, and 
reported in compliance with the protocol, GCP, and applicable regulatory requirements. In 
addition, the sponsor will be responsible for securing agreement from all involved parties to 
ensure direct access to all study related investigational centers, source data/documents, CRFs, 

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and reports for the purpose of monitoring and auditing by the sponsor, and inspection by 
domestic and foreign regulatory authorities. 
 
13.3 Data Quality Assurance 
All assessments performed will be accurately documented in the subject’s source documents and 
CRFs. The investigator or designee will enter the information required by the protocol into the 
source documents and CRFs provided by the sponsor or designee. Subjects will be identified in 
the CRFs by their assigned subject number and initials only. 
The investigators must read the protocol thoroughly and must follow the instructions exactly. 
Any deviations should be agreed to by prior discussion between the sponsor and the investigator, 
with appropriate written protocol amendments made prior to implementing the agreed changes. 
Any amendment containing major modifications (particularly if it may involve an increased risk 
to the subjects) will be approved by the IRB before it may be implemented. No change in the 
conduct of the study can be instituted without written approval from the sponsor. 
 
14 Ethics and Administrative Issues 
14.1 Ethical Conduct of the Study 
This study will be conducted in accordance with the ethical principles originating from the 
Declaration of Helsinki, ICH guidelines, GCP, and in compliance with local regulatory 
requirements. The investigator agrees, when signing the protocol, to adhere to the instructions 
and procedures described in it and thereby to adhere to the principles of GCP. 
 
14.2 Ethics Review 
This protocol, proposed informed consent form and other information to subjects, and all 
appropriate amendments will be properly reviewed and approved by an Institutional Review 
Board (IRB) or Independent Ethics Committee (IEC). A signed and dated notification of the 
IRB/IEC approval will be provided to the sponsor and investigator prior to study initiation. The 
name and occupation of the chairman and members of the IRB/IEC will be supplied to the 
sponsor. The investigator will provide required progress reports and report all SAEs to the 
IRB/IEC as required by the IRB/IEC. 
 
14.3 Written Informed Consent 
Written informed consent/assent, in accordance with local clinical investigation regulations, must 
be obtained prior to participation in the study. The investigator or designee will discuss the 
purpose of the study with each subject, and provide a description of the study drug (including 
any potential and possible side effects) and the study procedures. Information must be given both 
in oral and written form. Subject information will be provided in a language understandable to 
the subject and may not include any language that appears to waive any of the subject‘s legal 

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rights or appears to release the investigator, the sponsor or the institution from liability or 
negligence. 
The investigator will provide the prospective subject sufficient time to consider whether or not to 
participate, minimizing the possibility of coercion or undue influence and will discuss any 
questions the subject may have. The investigator will explain to the subject that participation in 
the study is voluntary and that withdrawal from the study is possible at any time without 
detriment to care. The consent must include acknowledgment that medical records and medical 
data derived from the study may be forwarded to the sponsor or to responsible local or federal 
authorities. 
No subject can enter the study or have any study related procedures performed before his/her 
written informed consent has been obtained. The original signed and dated informed consent 
form will be retained with the study records, and a copy of the signed form will be given to the 
subject. 
An informed consent template will be supplied by the sponsor. Any changes to the informed 
consent form must be agreed to by the sponsor or designee prior to submission to the IRB/IEC, 
and a copy of the approved version must be provided to the sponsor or designee after IRB/IEC 
approval. 
 
14.4 Subject Data Protection 
Subject data will be protected by ensuring that no captured data contain subject names, 
addresses, telephone numbers, email addresses, or other direct personally identifying 
information. It is acknowledged that subject initials, demographics (including birthdates), 
medical histories, and prior concomitant medication uses, along with the name and address of the 
enrolling investigator may allow for personal identification of study participants. Other than 
where necessary to meet regulatory requirements, all data collected in this study will be 
presented in tabulated (ie, aggregate) form and listings containing information that could be used 
to identify an individual subject will not be included in any public disclosures of the study data 
or the study results. 
 
14.5 Data Monitoring Committee 
Not applicable. 
 
14.6 Financial Disclosure 
Financial disclosures will be obtained from all investigators in order to document any potential 
conflicts of interest. 

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1 4. 7  I n vesti g at or O bli g ati o ns  
T he i n vesti gat or a gr ees, w he n si g ni n g t he pr ot oc ol, t o a d here t o t he i nstr ucti o ns a n d pr oce d ures 
descri be d i n it a n d t her e b y t o a d h ere t o t he pri nci ples of G o o d Cli nical Practice ( G C P).  
 
1 4. 8  C h a n ges t o t he  Pr ot oc ol  
T he i n vesti gat ors m ust rea d t he pr ot oc ol t h or o u g hl y a n d m ust f oll o w t he i nstr ucti o ns e x actl y. 
W he ne ver p ossi ble, a n y pla n ne d de viati o ns s h o ul d be a gree d t o b y pri or disc ussi o n bet wee n t he 
s p o ns or a n d t he i n vesti gat or, wit h a p pr o priate d o c u me ntati o n of s p o ns or a p pr o val pri or t o 
effecti n g t h e c ha n ges a gr ee d u p o n. A n y a m e n d me nt t o t he pr ot oc ol c o ntai ni n g maj or 
m o dificati o ns ( partic ularl y if it ma y i n v ol ve a n i ncrease d ris k t o t he s u bjects) will be a p pr o ve d 
b y t he I R B bef ore it ma y be i m ple me nte d. N o c h a n ge i n t he c o n d uct of t he st u d y ca n be 
i nstit ute d wit h o ut writte n a p pr o val fr o m t he s p o ns or. 
 
1 4. 9  C o nfi de nti alit y/ P u blic ati o n of t he  St u d y  
All t he data f ur nis he d t o t he i n vesti gat or a n d his/ her staff a n d all data o bt ai ne d t hr o u g h t his 
pr ot oc ol will be re gar de d as c o nfi de ntial a n d pr o prietar y i n nat ure a n d will n ot be discl ose d t o 
a n y t hir d p art y, e x ce pt f or t he F D A or ot her re g ulat or y b o d y, wit h o ut writte n c o nse nt fr o m t he 
s p o ns or. 
 
1 5  D at a H a n dli n g a n d Rec or d  Kee pi n g  
1 5. 1  I ns pecti o n of Rec or ds 
I n v esti gat ors m ust mai ntai n detaile d rec or ds o n all st u d y s u bjects w h o are e nr olle d i n t he st u d y 
or u n der g o scree ni n g. D ata will be rec or de d i n t he s u bject’s s o urce d oc u me nts a n d i n a p plica ble 
st u d y l o gs pr o vi de d b y t h e s p o ns or. S o urce d o c u me nts i ncl u de s u bject me di cal rec or ds, h os pital 
c harts, cli nic c h arts, i n vesti gat or s u bject st u d y files, as well as t he res ults o f dia g n ostic tests 
(e g, la b or at or y tests). All re q uire d d ata s h o ul d be rec or de d i n t he st u d y d o c u me ntati o n 
c o m pletel y f or pr o m pt data re vie w. U p o n st u d y c o m pleti o n or at a n y ot h er ti me s pecifie d b y t he 
s p o ns or or desi g nee, t h e a p pr o priate st u d y d oc u m e nts must be s u b mitte d.  
T he i n vesti gat or m ust kee p acc urate s e parate rec or ds (s o urce d oc u me ntati o n) of all s u bject visits, 
bei n g s ur e t o i ncl u de all perti ne nt st u d y relate d i nf or mati o n. At a mi ni m u m, t his i ncl u des t he 
f oll o wi n g i nf or mati o n: 
•  A state me nt i n dicati n g t h at t he s u bject has bee n e nr olle d i n t he st u d y a n d t h e s u bject 
n u m ber  
•  Date t hat i nf or me d c o nse nt was  o btai ne d  
•  E vi de nce t hat t he s u bject meets st u d y eli gi bilit y re q uire me nts (e g, me dical hist or y, 
scree ni n g e v al uati o ns)  

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•  Dates  of  all st u d y r elate d visits  a n d res ults of  a n y e val uati o ns/ pr oce d ures  perf or me d, 
i ncl u di n g w h o perf or me d eac h assess me nt at eac h visit  
•  Use of a n y c o nc urre nt m e dicati o ns d uri n g t he  st u d y 
•  D oc u me ntati o n of st u d y dr u g  acc o u nta bilit y 
•  A n y a n d all si de effects a n d A Es m ust be t h or o u g hl y d oc u me nt e d t o  c o ncl usi o n  
•  Res ults of a n y dia g n ostic tests c o n d ucte d d uri n g t he  st u d y 
•  T he date t he s u bject e xite d t he st u d y a n d a state me nt i n dicati n g t hat t he s u bj ect 
c o m plete d t he st u d y or w as disc o nti n ue d earl y, i ncl u di n g t he reas o n f or 
disc o nti n uati o n  
N otes descri bi n g tele p h o ne c o n vers ati o ns a n d all electr o nic mail wit h t he s u bject or t he s p o ns or 
(s p o ns or’s desi g nee) c o n cer ni n g t he st u d y m ust be rec or de d or k e pt o n file. All s o urce 
d oc u me nts m ust be ma de a vaila ble t o t he s p o ns or a n d t he s p o ns or’s desi g n ate d m o nit or u p o n 
re q uest. 
 
1 5. 2  Rete nti o n of Rec or ds  
T he i n vesti gat or s h o ul d pr o perl y st ore a n d mai ntai n all st u d y rec or ds i n acc or da nce wit h s p o ns or 
directi ves. All rec or ds r elati n g t o t he c o n d u ct of t his st u d y are t o be ret ai ne d b y  t he i n vesti gat or 
u ntil n otifie d b y t h e s p o ns or i n writi n g t hat t he rec or ds ma y b e destr o ye d.  
T he i n vesti gat or will all o w re pr ese ntati ves of t he s p o ns or’s m o nit ori n g tea m, t he g o ver ni n g 
I R B/I E C, t he F D A, a n d ot her a p plica ble re g ulat or y a ge ncies t o i ns pect all st u d y rec or ds, C R Fs, 
a n d c orr es p o n di n g p orti o ns of t he s u bject’s cli nic a n d/ or h os pital me dical rec or ds at re g ular 
i nter vals t hr o u g h o ut t he st u d y. T hes e i ns pecti o ns are f or t he p ur p ose of v erif yi n g a d h ere nce t o 
t he pr ot oc ol, c o m plete ness a n d acc urac y of t he data bei n g e ntere d o nt o t he C R F, a n d c o m plia nce 
wit h F D A or ot her re g ul at or y a ge nc y re g ulati o ns.  

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16 References 
1. 
Leyden JJ, Shalita AR. Rational therapy for acne vulgaris: an update on topical treatment. 
J Am Acad Dermatol. 1986;15(4 Pt 2):907-15. 
 
2. 
Webster GF. Acne vulgaris. BMJ. 2002;325(7362):475-9. 
 
3. 
Eady EA. Bacterial resistance in acne. Dermatology. 1998;196(1):59-66. 
 
4. 
Eady EA, Farmery MR, Ross JI, Cove JH, Cunliffe WJ. Effects of benzoyl peroxide and 
erythromycin alone and in combination against antibiotic-sensitive and -resistant skin 
bacteria from acne patients. Br J Dermatol. 1994;131(3):331-6. 
 
5. 
Leyden JJ, McGinley KJ, Cavalieri S, Webster GF, Mills OH, Kligman AM. 
Propionibacterium acnes resistance to antibiotics in acne patients. J Am Acad Dermatol. 
1983;8(1):41-5. 
 
6. 
Shalita A. The integral role of topical and oral retinoids in the early treatment of acne. J 
Eur Acad Dermatol Venereol. 2001;15 Suppl 3:43-9. 
 
7. 
McLane J. Analysis of common side effects of isotretinoin. J Am Acad Dermatol. 
2001;45(5):S188-94. 
 
8. 
Orfanos CE, Ehlert R, Gollnick H. The retinoids. A review of their clinical pharmacology 
and therapeutic use. Drugs. 1987;34(4):459-503. 
 
9. 
Lucky AW, Cullen SI, Funicella T, Jarratt MT, Jones T, Reddick ME. Double-blind, 
vehicle-controlled, multicenter comparison of two 0.025% tretinoin creams in patients 
with acne vulgaris. J Am Acad Dermatol. 1998;38(4):S24-30. 
 
10. 
Zar, JH. Biostatistical analysis. 2nd Edition. Englewood Cliffs, NJ: Prentice-Hall. P. 118- 
119. 1984. 

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17 Appendices 
17.1 Subject Instruction Sheet 
 
Wash your face gently with a mild cleanser approved by your study doctor and warm (not hot) 
water. Rinse thoroughly and gently pat dry with a cotton towel. Wait until skin is completely dry 
before applying the test material. 
 
A thin coating of test material should be applied once daily (about the same time every day) to 
the entire face for twelve weeks. Use the tube to dispense a pea-sized amount of study drug to 
your fingertip. 
 
This dose should then be dotted on to 6 areas (chin, left cheek, right cheek, nose, left forehead, 
right forehead) on the face. After distributing the dose in this manner, gently rub the lotion into 
the skin. This amount should be used to evenly cover the entire face excluding the mouth, eyes 
and lips. It is important to treat your entire face. 
 
Do NOT treat only specific lesions. DO NOT APPLY MORE THAN THE PRESCRIBED 
AMOUNT. 
Be sure to wash your hands after you apply the product. 
Reminders: 
- 
On study visit days please wait until after your study visit to apply the study medication. 
- 
Avoid contact with the eyes, inside the nose, mouth and all mucous membranes. 
- 
Do not cover the affected areas with any type of dressing, such as gauze. 
- 
THE TEST MATERIAL SHOULD BE USED ONLY BY THE PERSON FOR WHOM IT 
WAS PRESCRIBED and it should be kept out of the reach of others of limited capacity to 
read or understand. 
- 
Store at controlled room temperature 20°C to 25°C (68°F to 77°F) with excursions permitted 
between 15°C to 30°C (59°F to 86°F). Do not freeze. Avoid excessive heat or cold. 
- 
Tubes of test material must be returned to the study facility, even if they are empty. 
- 
If you miss any doses, at your next visit inform the study doctor of the date(s) of the missed 
dose(s). 
- 
Continue to use the same, study doctor approved, cleanser, moisturizer and sunscreen 
throughout the study. 
- 
You must not use any other treatment for your facial acne while you are participating in this 
study. 
- 
Avoid unnecessary sun exposure and tanning booths. 

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- 
It is important that you inform the study site about any medications (i.e., prescriptions, over- 
the-counter medications, street drugs, or herbal medications) that you have taken during the 
study. 
 
If you have any questions or have a potential research-related side effect or injury you may 
contact  
at  
. 

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17.2 Cleansers, Moisturizers and Sunscreen Use Guidelines 
Subjects may use the following products. The Investigator may use their discretion on what 
products each subject may use in the treatment area during the study. Subjects may only use 
Investigator approved products on the treatment area. Information regarding products used 
should be captured in the source document and recorded on the facial skin care section of the 
eCRF. 
 
Approved Cleansers: · 
CeraVe cleanser 
· 
Cetaphil daily cleaner and gentle cleansing bar 
· 
Purpose gentle cleansing wash 
Approved Moisturizers: 
· 
CeraVe Cream or Lotion 
· 
Moisturel cream or lotion 
· 
Nutraderm 
· 
Cetaphil lotion or cream 
· 
DML 
· 
Eucerin lotion or cream 
· 
Purpose 
Approved Moisturizer/Sunscreen Combination Products: 
· 
CeraVe Lotion A.M. 
· 
Olay Complete (SPF 15) 
· 
Neutrogena Health Defense Daily Moisturizer (SPF 30) 
· 
Cetaphil Daily Facial Moisturizer (SPF 15) 
Approved Sunscreens: 
· 
Banana Boat Sport Sunblock Lotion (SPF 15, 30+ or 50) 
· 
Neutrogena UVA/UVB (SPF 30 or 45) 
· 
Neutrogena Sensitive Skin Sunblock Lotion (SPF 17) 
· 
Neutrogena Healthy Defense Oil-Free Sunblock Lotion (SPF 30 or 45) 
· 
Coppertone Water Babies UVA/UVB Sunblock Lotion (SPF 45) 

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1 7. 3  S u bject Self Assess me nt Sc ori n g  Sc ale  
 
 
B aseli ne S u bject Q uesti o n  
H o w w o ul d rate t h e c urre nt se verit y of y o ur facial ac ne c o n diti o n o n a scale of 1 -7?  
( C hec k o nl y o ne b o x) 
1, Clear or al m ost clear s ki n ( > 9 0 %);  
2, M o deratel y cl ear s ki n ( > 8 0 % b ut ≤ 9 0 %);  
3, Fairl y clear s ki n ( > 7 0 % b ut ≤ 8 0 %); 
4, Ac ne c o v ere d a b o ut 5 0 % of t he face;  
5, Fairl y se v ere ac ne ( > 7 0 % b ut ≤ 8 0 % c o vera ge);  
6, M o deratel y se v ere ac n e ( > 8 0 % b ut ≤ 9 0 % c o vera ge); 
7, Se vere ac ne, wit h al m ost t otal c o vera ge ( > 9 0 %).  
 
Wee k 2 ( at -h o me), 4, 8, a n d 1 2 S u bject Q uesti o n  
H o w w o ul d rate t h e c urre nt se verit y of y o ur facial ac ne c o n diti o n o n a scale of 1 -7?  
( C hec k o nl y o ne b o x) 
1, clear ( 1 0 0 %);  
2, al m ost clear  ( 9 0 % t o < 1 0 0 %); 
3, mar ke d i m pr o ve me nt ( 7 5 % t o < 9 0 %);  
4, m o derate i m pr o ve m e nt ( 5 0 % t o < 7 5 %);  
5, fair i m pr o ve me nt ( 2 5 % t o < 5 0 %);  
6, n o c ha n ge;  
7, w orse  

Protocol V01-121A-301, IDP-121 
Valeant Research & Development 
Version 1, 04 June 2015 
CONFIDENTIAL 
65 
 
 
 
 
17.4 Patient Satisfaction Survey (PSS) 
 
 
Baseline Question 
 
On a scale of 1-10 with 1 being the least satisfied and 10 being the most satisfied please rate your 
level of satisfaction with your prior facial acne therapy. 
 
 
 
 
Week 12 Question 
 
On a scale of 1-10 with 1 being the least satisfied and 10 being the most satisfied please rate your 
level of satisfaction with your current facial acne study treatment. 
 
 
 

Pr ot oc ol V 0 1 -1 2 1 A -3 0 1, I D P -1 2 1  
Valea nt Researc h & De vel o p me nt  
Versi o n 1, 0 4 J u ne 2 0 1 5  
C O N FI D E N TI A L  
6 6  
 
 
 
 
1 7. 5  Ac ne -S pecific Q u alit y of Lif e Q uesti o n n aire  ( A c ne-Q o L)  
 
1.  I n t he p ast W E E K, h o w u nattracti ve di d y o u feel beca use of y o ur facial ac ne?  
 e xtre mel y  ver y  m uc h  q uite  a bit 
a g o o d bit  
s o me w hat a little bit n ot at  all 
2.  I n t he p ast W E E K, h o w e m barrasse d di d y o u feel beca use of y o ur facial ac ne?  
 e xtre mel y  ver y  m uc h  q uite  a bit 
a g o o d bit  
s o me w hat a little bit n ot at  all 
3.  I n t he p ast W E E K, h o w s elf -c o nsci o us ( u neas y a b o ut o neself) di d y o u feel a b o ut y o ur facial 
ac ne?  
 e xtre mel y  ver y  m uc h  q uite  a bit 
a g o o d bit  
s o me w hat a little bit n ot at  all 
4.  I n t he p ast W E E K, h o w u pset were y o u a b o ut ha vi n g facial ac ne?  
 e xtre mel y  ver y  m uc h  q uite  a bit 
a g o o d bit  
s o me w hat a little bit n ot at  all 
5.  I n t he p ast W E E K, h o w a n n o ye d di d y o u feel at h a vi n g t o s pe n d ti me e ver y da y clea ni n g a n d 
treati n g y o ur face b eca us e of y o ur facial ac ne? 
 e xtre mel y  ver y  m uc h  q uite  a bit 
a g o o d bit  
s o me w hat a little bit n ot at  all 
6.  I n t he p ast W E E K, h o w dissatisfie d wit h y o ur self-a p peara n ce di d y o u feel beca use of y o ur 
facial ac n e?  
 e xtre mel y  ver y  m uc h  q uite  a bit 
a g o o d bit  
s o me w hat a little bit n ot at  all 
7.  I n t he p ast W E E K, h o w c o ncer ne d or w orrie d were y o u a b o ut n ot l o o ki n g y o ur b est beca use 
of y o ur facial  ac ne?  
 e xtre mel y  ver y  m uc h  q uite  a bit 
a g o o d bit  
s o me w hat a little bit n ot at  all 
8.  I n t he p ast W E E K, h o w c o ncer ne d or w orrie d were y o u t h at y o ur ac n e me dicati o n pr o d ucts 
were w or ki n g fast e n o u g h i n cleari n g u p t he ac ne o n y o ur  face? 
 e xtre mel y  ver y  m uc h  q uite  a bit 
a g o o d bit  
s o me w hat a little bit n ot at  all 
9.  I n t he p ast W E E K, h o w b ot here d di d y o u feel a b o ut t he nee d t o al wa ys h a v e me dicati o n or 
c o ver-u p a vaila ble f or t h e ac n e o n y o ur face?  
 e xtre mel y  ver y  m uc h  q uite  a bit 
a g o o d bit  
s o me w hat a little bit n ot at  all 
1 0.  I n t he p ast  W E E K,  h o w  m uc h  was y o ur  self-c o nfi de nce (s ure of  y o urs elf)  n e gati vel y  affecte d 
beca use of y o ur f acial  ac ne?  
 e xtre mel y  ver y  m uc h  q uite  a bit  
a g o o d bit  
s o me w hat a little bit n ot at  all 
1 1.  I n t he past  W E E K,  h o w  c o ncer ne d  or  w orrie d  were  y o u  a b o ut meeti n g  n e w  pe o ple  beca us e 
of y o ur facial  ac ne?  
 e xtre mel y  ver y  m uc h  q uite  a bit 
a g o o d bit  
s o me w hat a little bit n ot at  all 
1 2.  I n t he p ast W E E K, h o w c o ncer ne d or w orrie d were y o u a b o ut g oi n g o ut i n p u blic beca use of 
y o ur faci al ac n e?  
 e xtre mel y  ver y  m uc h  q uite  a bit 
a g o o d bit  
s o me w hat a little bit n ot at  all 

Pr ot oc ol V 0 1 -1 2 1 A -3 0 1, I D P -1 2 1  
Valea nt Researc h & De vel o p me nt  
Versi o n 1, 0 4 J u ne 2 0 1 5  
C O N FI D E N TI A L  
6 7  
 
 
 
 
1 3.  I n t he p ast W E E K, h o w m uc h was s ocializi n g wit h pe o ple a pr o ble m f or y o u beca use of y o ur 
facial ac n e?  
 e xtre mel y  ver y  m uc h  q uite  a bit 
a g o o d bit  
s o me w hat a little bit n ot at  all 
1 4.  I n t he past  W E E K,  h o w  m uc h  was  i nteracti n g wit h  t he o p p osite  se x ( or sa me se x if ga y  or 
les bia n) a pr o ble m f or y o u beca use of y o ur facial  ac ne?  
 e xtre mel y  ver y  m uc h  q uite  a bit 
a g o o d bit  
s o me w hat a little bit n ot at  all 
1 5.  I n t he p ast W E E K, h o w ma n y b u m ps di d y o u ha v e o n y o ur face? 
 E xte nsi ve   A  w h ole  l ot A  l ot A  m o derate  a m o u nt  S o me Ver y fe w  N o ne  
1 6.  I n t he p ast W E E K, h o w ma n y b u m ps f ull of p us di d y o u ha v e o n y o ur  face? 
 E xte nsi ve   A  w h ole  l ot A  l ot A  m o derate  a m o u nt  S o me Ver y fe w  N o ne  
1 7.  I n t he p ast W E E K, h o w m uc h sca b bi n g fr o m y o ur faci al ac n e di d y o u ha v e?  
 E xte nsi ve   A  w h ole  l ot A  l ot A  m o derate  a m o u nt  S o me Ver y fe w  N o ne  
1 8.  I n t he p ast W E E K, h o w c o ncer ne d or w orrie d were y o u a b o ut scarri n g fr o m y o ur facial ac ne?  
 e xtre mel y  ver y  m uc h  q uite  a bit 
a g o o d bit  
s o me w hat a little bit n ot at  all 
1 9.  I n t he p ast W E E K, h o w oil y was y o ur facial s ki n ? 
 e xtre mel y  ver y  m uc h  q uite  a bit 
a g o o d bit  
s o me w hat a little bit n ot at  all 
 
 
 
 
C o p yri g ht © 1 9 9 7 Merc k & C o., I nc.  
W hite h o use Stati o n, NJ, U S A 
Use d wit h P er missi o n  

Pr ot oc ol V 0 1 -1 2 1 A -3 0 1, I D P -1 2 1  
Valea nt Researc h & De vel o p me nt  
Versi o n 1, 0 4 J u ne 2 0 1 5  
C O N FI D E N TI A L  
6 8  
 
 
1. D ura nte la S E M A N A pasa da, ¿ q ué ta n p oc o atr acti v o( a) t e se ntiste de bi d o al ac né d e la 
cara?  
2. D ura nte la S E M A N A pasa da, ¿ q ué ta n a ver g o nz a d o( a) te se ntiste de bi d o al ac né d e la cara? 
3. D ura nte la S E M A N A pasa da, ¿ q ué ta n ac o m pl ej a d o( a), [i nc ó m o d o(a) c o nti g o mis m o(a)], te 
se ntiste de bi d o al ac n é de la car a? 
4. D ura nte la S E M A N A pasa da, ¿ q ué ta n dis g ust a d o( a) te se ntiste p or te n er ac n é de la cara? 
5. D ura nte la S E M A N A pasa da, ¿ q ué ta n m ol est o( a) te se ntiste p or t o mar t a nt o tie m p o 
diaria me nte li m piá n d ote y trat á n d ote la cara, d e bi d o al ac né d e la cara?  
6. D ura nte la S E M A N A pasa da, ¿ q ué ta n i ns atisfec h o( a) te se ntiste c o n t u as pect o pers o nal, 
de bi d o al ac n é de la car a?  
7. D ura nte la S E M A N A pasa da, ¿ q ué ta n i ntr a n q uil o( a) o pre oc u p a d o( a) est u viste de n o verte 
l o mej or p osi ble, de bi d o al ac né d e la cara? 
 
 
Fec h a:   
 
 
C uesti o n ari o s o bre l a c ali d a d de vi d a, es pecífic o al ac né  
 
  
N o. de  I de ntific aci ó n: 
 
 
( F av or de m arc ar u n a c asill a p ar a c a d a pre g u nt a) 
 
 
de masia d o  
m uc h o  
m u y  
basta nte  
al g o 
u n p oc o  
na da  
 
 
 
 
 
 
 
 
 
de masia d o  
m uc h o  
m u y  
basta nte  
al g o 
u n p oc o  
na da  
 
 
 
 
 
 
 
 
 
de masia d o  
m uc h o  
m u y  
basta nte  
al g o 
u n p oc o  
na da  
 
 
 
 
 
 
 
 
 
de masia d o  
m uc h o  
m u y  
basta nte  
al g o 
u n p oc o  
na da  
 
 
 
 
 
 
 
 
 
de masia d o  
m uc h o  
m u y  
basta nte  
al g o 
u n p oc o  
na da  
 
 
 
 
 
 
 
 
 
de masia d o  
m uc h o  
m u y  
basta nte  
al g o 
u n p oc o  
na da  
 
 
 
 
 
 
 
 
 
de masia d o  
m uc h o  
m u y  
basta nte  
al g o 
u n p oc o  
na da  
 
 
 
 
 
 
 

Pr ot oc ol V 0 1 -1 2 1 A -3 0 1, I D P -1 2 1  
Valea nt Researc h & De vel o p me nt  
Versi o n 1, 0 4 J u ne 2 0 1 5  
C O N FI D E N TI A L  
6 9  
 
 
8. D ura nte la S E M A N A pasa da, ¿ q ué ta n i ntr a n q uil o( a) o pre oc u p a d o( a) est u viste de q ue l os 
me dica me nt os y pr o d uct os para el ac né est u viese n f u nci o na n d o l o s uficie nte me nte rá pi d o 
para eli mi nar el ac n é de l a car a?  
9. D ura nte la S E M A N A pasa da, ¿ q ué ta n m ol est o( a) te se ntiste p or la n ecesi da d de te ner 
sie m pre dis p o ni bles me dica me nt os o cre mas para c u brir el ac né d e la cara?  
1 0. D ura nte la S E M A N A pasa da, ¿ q ué ta n ne g ati v o f ue el efect o d el ac né e n t u c o nfia nza e n ti 
mis m o(a)?  
1 1. D ura nte la S E M A N A pasa da, ¿ q ué ta n i ntr a n q uil o( a) o pre oc u p a d o( a) te se ntiste al 
c o n ocer a n ue v as pers o n as, de bi d o al ac n é de la cara?  
 
 
( F av or de m arc ar u n a c asill a p ar a c a d a pre g u nt a)  
 
 
de masia d o  
m uc h o  
m u y  
basta nte  
al g o 
u n p oc o  
na da  
 
 
 
 
 
 
 
 
 
de masia d o  
m uc h o  
m u y  
basta nte  
al g o 
u n p oc o  
na da  
 
 
 
 
 
 
 
 
 
de masia d o  
m uc h o  
m u y  
basta nte  
al g o 
u n p oc o  
na da  
 
 
 
 
 
 
 
 
 
de masia d o  
m uc h o  
m u y  
basta nte  
al g o 
u n p oc o  
na da  
 
 
 
 
 
 
 
 
 
de masia d o  
m uc h o  
m u y  
basta nte  
al g o 
u n p oc o  
na da  
 
 
 
 
 
 
 
 
 
de masia d o  
m uc h o  
m u y  
basta nte  
al g o 
u n p oc o  
na da  
 
 
 
 
 
 
 
 
 
 
de masia d o  
m uc h o  
m u y  
basta nte  
al g o 
u n p oc o  
na da  
 
 
 
 
 
 
 
1 2. D ura nte la S E M A N A pasa da, ¿ q ué ta n i ntr a n q uil o( a) o pre oc u p a d o( a) te se ntiste al salir y 
estar e ntr e la ge nte, d e bi d o al ac né d e la cara?  
1 3. D ura nte la S E M A N A pasa da, ¿ q ué t a n pr o ble m átic o f ue p ar a ti s oci aliz ar c o n l as 
pers o n as, de bi d o al ac né de la cara?  
1 4. D ura nte la S E M A N A pasa da, ¿ q ué t a n pr o ble m átic o f ue p ar a ti rel aci o n arte c o n 
pers o n as del se x o o p uest o ( o del mis m o se x o, para h o m ose x uales), de bi d o al ac né d e la 
cara?  

Pr ot oc ol V 0 1 -1 2 1 A -3 0 1, I D P -1 2 1  
Valea nt Researc h & De vel o p me nt  
Versi o n 1, 0 4 J u ne 2 0 1 5  
C O N FI D E N TI A L  
7 0  
 
 
 
 
( F av or de m arc ar u n a c asill a p ar a c a d a pre g u nt a)  
 
 
 
a b u n da ntes 
u na  gra n  
ca nti da d 
 
m uc h os  
u na ca nti da d  
m o dera da  
 
al g u n os 
m u y  
p oc os  
 
ni n g u n o  
 
 
 
 
 
 
 
 
u na  gra n  
a b u n da ntes 
ca nti da d 
 
 
 
 
 
a b u n da ntes 
u na  gra n  
ca nti da d 
 
m uc has  
u na ca nti da d  
m o dera da  
 
al g u nas 
m u y  
p ocas  
 
ni n g u na  
 
 
 
 
 
 
 
 
 
de masia d o  
m uc h o  
m u y  
basta nte  
al g o 
u n p oc o  
na da  
 
 
 
 
 
 
 
 
 
de masia d o  
m uc h o  
m u y  
basta nte  
al g o 
u n p oc o  
na da  
 
 
 
 
 
 
 
1 5. D ura nte la S E M A N A pasa da, ¿c uá nt os gr a n os te nías e n la cara? 
1 6. D ura nte la S E M A N A pasa da, ¿c uá nt os gr a n os i nfect a d os te nías e n la cara? 
1 7. D ura nte la S E M A N A pasa da, ¿c uá ntas c ostr as o p ostill as (es pi nill as sec as) te nías, de bi d o al 
ac né d e la cara?  
1 8. D ura nte la S E M A N A pasa da, ¿ q ué ta n i ntr a n q uil o( a) o pre oc u p a d o( a) est u viste p or las 
marcas y o cicatrices, q u e q ue dar o n d el ac n é de la cara?  
1 9. D ura nte la S E M A N A pasa da, ¿ q ué ta n gr as os o esta ba el c utis?  
 
m uc h os  
u na ca nti da d  
m o dera da  
 
al g u n os 
m u y  
p oc os  
 
ni n g u n o  
 
 
 
 
 
 

S O C, A m 1, 2 0 A u g ust 2 0 1 5  
P a ge 1 of 1  
 
 
 
 
S U M M A R Y O F C H A N G E S  
Pr ot oc ol V 0 1 -1 2 1 A -3 0 1 
A me n d me nt 1, 2 0 A u g ust 2 0 1 5  
A d diti o ns mar ke d i n b ol d , deleti o ns mar ke d i n stri ket hr o u g h. 
Secti o n  
P a ge  
Descri pti o n of C h a n ge or Cl arific ati o n  
R ati o n ale  
As  
a p plica ble 
As  
a p plica ble 
U p date t o re visi o n c hr o n ol o g y, f o oters  
A d mi nistrati ve c ha n ges  
2  
1 0  
Delete d “ a n d ser u m pre g na nc y testi n g ” 
Re m o val of re q uire me nt f or 
ser u m pre g na nc y testi n g * 
7. 1  
1 8, 2 0  
Delete d “ Ser u m pre g na nc y tests will als o be  
c o n d ucte d at Scree ni n g a n d Wee k 1 2 ”; 
Delete d “ Ser u m Pre g na nc y T est ( F O C B P) ” 
li ne ite m i n Sc he d ule of Assess me nts. 
Re m o val of re q uire me nt f or 
ser u m pre g na nc y testi n g *  
1 1. 1. 1  
3 1, 3 2  
Delete d “ a n d Ser u m Pre g na nc y T est ”. 
Delete d “ At t he Scree ni n g a n d Wee k 1 2  
visits, ser u m pre g na nc y testi n g is ma n dat or y  
f or all fe males of c hil d beari n g p ote ntial. I n 
a d diti o n, a” 
Re m o val of re q uire me nt f or 
ser u m pre g na nc y testi n g *  
1 1. 1. 4  
3 4  
Delete d “ c ollect a bl o o d sa m ple f or a ser u m 
pre g na nc y test a n d ”. 
Re m o val of re q uire me nt f or 
ser u m pre g na nc y testi n g * 
1 1. 3. 4  
3 8  
Delete d “ ser u m pre g na nc y testi n g at 
Scree ni n g a n d Wee k 1 2. I n a d diti o n, ”. 
Re m o val of re q uire me nt f or 
ser u m pre g na nc y testi n g * 
* Detaile d rati o nale f or re m o val of ser u m pre g na nc y testi n g:  
- I nitial pr ot oc ol (s u b mitte d t o F D A as part of pI N D mt g) di d n ot i ncl u de ser u m pre g na nc y testi n g ( o nl y U P T)  
- S p o ns or s u bse q ue ntl y a d de d i n ser u m testi n g ( B aseli ne a n d W ee k 1 2), t o be c o nser vati ve i n t he a p pr oac h wit h 
re gar d t o reti n oi ds –  t his versi o n  of  pr ot oc ol  ( V 0 1-1 2 1 A -3 0 1)  was  s u b mitte d i n t he I N D p ac ka ge  o n  2 4 -J ul y-1 5  
- S u bse q ue nt re vie w of w h ole pr ot oc ol, a n d I n vesti gat or fee d bac k c o nsi dere d t he f oll o wi n g p oi nts t o all o w f or 
re m o val of t he ser u m pre g na nc y testi n g re q uire me nt: 
o  
U P Ts all o w f or se nsiti vit y of  ~ 9 9. 6 %  
o  
U P Ts will be perf or me d at all st u d y visits ( Scree ni n g, B aseli ne, W ee k 4, W ee k 8 a n d W ee k 1 2). T he 
c ha nce  f or m ulti ple false ne gati ves  is l o w. If at a n y p oi nt  d uri n g  t he st u d y a s u bj ect bec o mes  pre g na nt,  t he 
s u bj ect m ust disc o nti n ue use of t he st u d y dr u g.  
o  
T here  are n o  safet y la bs bei n g  c o n d ucte d  i n t his st u d y, s o t his bl o o d  sa m ple w o ul d be  t he o nl y  dra w  f or t he 
st u d y. T his ma y precl u de fe male s u bj ects fr o m e nteri n g t he st u d y ( partic ularl y  i n t he 1 0-1 4 a ge ra n ge).  
- T he st u d y dr u g is a t o pical reti n oi d (treti n oi n, 0. 0 5 %), c o nsi dere d Cate g or y  C.  
P R O T O C O L V 0 1 -1 2 1 A -3 0 1  
I D P-1 2 1 L oti o n  
Pr ot oc ol V 0 1 -1 2 1 A -3 0 1 (I D P -1 2 1)  
A P hase 3, M ulti -Ce nter, Ra n d o mize d, D o u ble -Bli n d, Ve hicle -C o ntr olle d, 2 - 
Ar m, Parallel Gr o u p C o m paris o n St u d y C o m pari n g t he Efficac y a n d Safet y 
of I D P -1 2 1 a n d I D P -1 2 1 Ve hicle L oti o n i n t he Treat me nt of Ac ne V ul garis  
S p o ns or:  
D o w P h ar m ace utic al Scie nces, a di visi o n of V ale a nt P h ar m ace utic als,  
1 3 3 0 Re d w o o d  W a y  
Pet al u m a, C A  9 4 9 5 4  

P R O T O C O L V 0 1 -1 2 1 A -3 0 1  
I D P-1 2 1 L oti o n  
P a ge 1  of 3  
 
 
 
 
 
 
S U M M A R Y O F C H A N G E S  
Pr ot oc ol V 0 1 -1 2 1 A -3 0 1 
A me n d me nt 2, 2 8 Se pte m ber 2 0 1 5  
A d diti o ns mar ke d i n b ol d , deleti o ns mar ke d i n stri ket hr o u g h. 
Secti o n  
P a ge  
Descri pti o n of C h a n ge or Cl arific ati o n  
R ati o n ale 
As  
a p plica ble 
As  
a p plica ble 
U p date t o re visi o n c hr o n ol o g y, f o oters  
A d mi nistrati ve c ha n ges  
1  
1 1. 4. 6  
3  
4 2  
A d de d Office p h o ne n u m ber f or me dical m o nit or,  
“ Office: 
 
A d diti o nal i nf or mati o n f or  
me dical m o nit or c o ntact  
2  
5, 6, 7, 8,  
9 
A d de d “ Bl o o d s a m ples will be c ollecte d fr o m 
s u bjects f or s afet y m o nit ori n g at B aseli ne a n d Wee k 
1 2. ”  
Re place d refere nce t o A p pe n di x 2 wit h A p pe n di x 
1 7. 2.  
Re vise d sec o n dar y efficac y varia bles t o i ncl u de:  
( 1) P erce nt c ha n ge i n i nfla m mat or y lesi o n c o u nt fr o m 
B aseli ne t o W ee k  1 2  
( 2) P erce nt c ha n ge i n n o n -i nfla m mat or y lesi o n c o u nt 
fr o m B aseli ne t o W ee k 1 2  
A n d a d de d S u p p orti ve Efficac y t o i ncl u de:  
•  Pr o p orti o n of s u bj ects w h o ha ve at least a 2 gra de 
re d ucti o n at W ee k 1 2 fr o m B aseli ne i n t he E val uat or’s 
Gl o bal Se verit y  Sc ore  
•  P erce nt c ha n ge i n i nfla m mat or y lesi o n c o u nt fr o m 
B aseli ne t o W ee k  8 
•  P erce nt c ha n ge i n n o n -i nfla m mat or y lesi o n c o u nt fr o m 
B aseli ne t o W ee k  8 
•  Pr o p orti o n of s u bj ects w h o ha ve at least a 2 gra de 
re d ucti o n at W ee k 8 fr o m B as eli ne i n t he E val uat or’s 
Gl o bal Se verit y  Sc or e 
•  P erce nt c ha n ge i n i nfla m mat or y lesi o n c o u nt fr o m 
B aseli ne t o W ee k  4 
•  P erce nt c ha n ge i n n o n -i nfla m mat or y lesi o n c o u nt fr o m 
B aseli ne t o W ee k  4 
•  Pr o p orti o n of s u bj ects w h o ha ve at least a 2 gra de 
re d ucti o n at W ee k 4 fr o m B as eli ne i n t he E val uat or’s 
Gl o bal Se v erit y Sc ore  
Re q ueste d rec o m me n dati o n fr o m 
a ge nc y i n St u d y Ma y Pr ocee d 
letter ( date d 1 0-Se p - 1 5); 
T y p o fi x; 
Re visi o n per re q ueste d 
rec o m me n dati o n fr o m a ge nc y i n 
St u d y Ma y Pr ocee d letter ( date d 
1 0- Se p - 1 5) 
Pr ot oc ol V 0 1 -1 2 1 A -3 0 1 (I D P -1 2 1)  
A P hase 3, M ulti -Ce nter, Ra n d o mize d, D o u ble -Bli n d, Ve hicle -C o ntr olle d, 2 - 
Ar m, Parallel Gr o u p C o m paris o n St u d y C o m pari n g t he Efficac y a n d Safet y 
of I D P -1 2 1 a n d I D P -1 2 1 Ve hicle L oti o n i n t he Treat me nt of Ac ne V ul garis  
S p o ns or: 
D o w  P h ar m a ce utic al  Scie nces,  a di visi o n  of V ale a nt P h ar m a ce utic als,  N A 
1 3 3 0 Re d w o o d W a y 
Pet al u m a, C A 9 4 9 5 4 

PROTOCOL V01-121A-301 
IDP-121 Lotion 
Page 2 of 3 
 
 
 
Added hypo/hyper-pigmentation to cutaneous safety 
assessments; 
Added Changes from baseline in all safety laboratory 
values will be summarized using descriptive statistics 
by treatment group. 
Added: Additional supportive efficacy endpoints 
(including mean percent change in inflammatory and 
non-inflammatory lesions counts from baseline at 
Weeks 4 and 8, as well as proportion of subjects with 
at least a two grade improvement in the Evaluator’s 
Global Severity Score from baseline at Weeks 4, 8 
and 12) will be conducted, as noted above. 
Added Changes from baseline in safety laboratory 
values and vital sign measurements will be 
summarized with descriptive statistics for each 
treatment group at all applicable study visits. Shift 
tables will be presented for changes in safety 
laboratory values to summarize laboratory test 
results collected at Baseline and Week 12. Normal 
ranges established by the central laboratory will be 
used to determine the shifts. A listing of all out-of- 
range laboratory test results at Week 12 will also be 
provided. Determination of clinical significance for 
all out-of-range laboratory values will be made by 
each investigator and included in the listing. In 
addition, a listing of all clinically significant 
laboratory test results will be provided. 
Revision per requested 
recommendation from agency in 
Study May Proceed letter (dated 
10-Sep-15) 
7.1 
19, 21 
Added and safety labs 
Added line item for “Safety labs (hematology, 
CBC/diff, urinalysis)” 
Revision per recommendation 
from agency in Study May 
Proceed letter dated 10-Sep-15 
8.2 
23 
Added “at the prescribed amounts” for exclusion 
criteria #12 
Typo updated for consistency 
with synopsis section 
9.4 
28 
Added “non-medicated” and “and, sunscreens” 
To clarify that skin care product 
use must be nonmedicated 
11.1.1 
32 
Added “cleansers” 
Clarification of allowed skin care 
products 
11.1.2 
11.1.4 
33 
35 
Added “blood pressure, heart rate, respiration rate, 
and oral temperature” 
Added line item for: Collect blood samples for 
routine laboratory analysis (CBC/Diff, serum 
chemistry and urinalysis) 
Clarification of vital signs; 
Revision per recommendation 
from agency in Study May 
Proceed letter dated 10-Sep-15 
11.3.1 
37, 38 
Added Cutaneous safety will be evaluated through 
assessment of scaling, erythema, hypo-pigmentation 
and hyper-pigmentation at the drug-application site 
at the time of the visit. 
Added Hypopigmentation and Hyperpigmentation 
scale. 
Clarification of cutaneous safety 
assessments and recommendation 
from agency in Study May 
Proceed letter dated 10-Sep-15 
11.3.4 
39 
Added Section for Laboratory Tests 
Revision per recommendation 
from agency in Study May 
Proceed letter dated 10-Sep-15 
11.4.2 
40 
Added “Any AEs deemed related to treatment 
reported or observed at the final study/treatment 
visit will be followed until stabilization or resolution 
Revision per recommendation 
from agency in Study May 
Proceed letter dated 10-Sep-15 

PROTOCOL V01-121A-301 
IDP-121 Lotion 
Page 3 of 3 
 
 
 
(or up to 30 days after final study visit).” 
12.1.2 
45 
Deleted bullet point “Proportion of subjects who 
have at least a 2 grade reduction at Week 12 from 
baseline in the Evaluator’s Global Severity Score” 
from Secondary Efficacy and added it to Section 
12.1.3 Supportive Efficacy endpoints 
Revision per recommendation 
from agency in Study May 
Proceed letter dated 10-Sep-15 
12.1.5 
47 
Edited Secondary Endpoint table to remove step 
numbers 3-9, and added to a new Secondary 
Supportive Endpoint table; also added: The 
following stepwise process will be conducted for 
testing the supportive efficacy endpoints in order to 
control for multiplicity. These tests will be 
performed for only the ITT population. In order to 
control for multiplicity failure of any one of the 
secondary efficacy endpoints will invalidate the 
statistical significance of the supportive efficacy 
endpoints. The testing process will terminate 
whenever a statistical test for a step is not significant. 
All subsequent tests for the remaining steps will be 
considered not significant. The order of testing is: 
Revision per recommendation 
from agency in Study May 
Proceed letter dated 10-Sep-15 
12.1.8 
50, 51, 52 
Added Syntax code; 
Added: A total of 4 random seeds will be needed to 
impute inflammatory lesion counts from non- 
inflammatory lesion counts for the two treatment 
groups. Those 4 random seeds have been pre- 
specified by using a random number generator: 
• Inflammatory Lesion Counts; IDP-121 Lotion: 
Seed= 1028933764 
• Inflammatory Lesion Counts; IDP-121 Vehicle: 
Seed= 356782065 
• Non-Inflammatory Lesion Counts; IDP-121 
Lotion: Seed= 1307444541 
• Non-Inflammatory Lesion Counts; IDP-121 
Vehicle: Seed= 436373460 
Added: A total of 2 random seeds will be needed to 
impute EGSS for the two treatment groups. Those 2 
random seeds have been pre-specified by using a 
random number generator: 
• EGSS; IDP-121 Lotion: Seed= 1210644108 
• EGSS; IDP-121 Vehicle: Seed= 763715437 
Revision per recommendation 
from agency in Study May 
Proceed letter dated 10-Sep-15 
12.1.9 
52, 53 
Added: Although the full details will be presented in 
the Statistical Analysis Plan (SAP), the multiple” 
Revision per recommendation 
from agency in Study May 
Proceed letter dated 10-Sep-15 
12.2 
53 
Added “and hypo/hyper-pigmentation” 
Revision per recommendation 
from agency in Study May 
Proceed letter dated 10-Sep-15 
12.2.2 
54 
Added Section for Safety Laboratory Tests 
Revision per recommendation 
from agency in Study May 
Proceed letter dated 10-Sep-15 
App 17.2 
66 
Deleted “only”; Added “as examples of approved 
products”, “the below set of examples or other”, 
“non-medicated” 
Revision per recommendation 
from agency in Study May 
Proceed letter dated 10-Sep-15 

P R O T O C O L V 0 1 -1 2 1 A -3 0 1  
I D P-1 2 1 L oti o n  
P a ge 1  of 3  
 
 
 
 
 
 
S U M M A R Y O F C H A N G E S  
Pr ot oc ol V 0 1 -1 2 1 A -3 0 1 
A me n d me nt 3, 7 Oct o ber 2 0 1 6  
A d diti o ns mar ke d i n b ol d , deleti o ns mar ke d i n stri ket hr o u g h. 
Secti o n  
P a ge  
Descri pti o n of C h a n ge or Cl arific ati o n 
R ati o n ale 
As  
a p plica ble 
As  
a p plica ble 
U p date t o re visi o n c hr o n ol o g y, f o oters  
A d mi nistrati ve c ha n ges  
1, 1 1. 4. 6  
3, 4 3  
U p date t o m o bile p h o ne n u m ber f or me dical 
m o nit or, fr o m 
t o 
 
 
U p date d c o ntact i nf or mati o n f or 
me dical m o nit or  
1; 1 1. 4. 6  
3, 4 3  
Re place d C R O Pr oject Ma na ger na me a n d c o ntact 
fr o m 
 
Sr. Pr oject Ma na ger  
 
 
T o  
 
P r oject  M a n a ger  
 
F a x n u m ber:  N/ A  
 
C ha n ge i n C R O Pr oject Ma na ger  
2, 1 2. 8. 4  
5, 5 8  
A d de d “ a n d L ati n A meric a ”  
A d de d Lati n A merica sites t o t he  
st u d y 
2, 7. 1,  
1 0. 1. 3 
5, 1 9, 3 1  
A d de d Gl o ball y  
1 2 wee ks “ ( u p t o wee k 1 2 visit). ” 
A d de d f or m ore clarificati o n  
2, 1 1. 3. 4,  
1 1. 3. 5  
5, 4 0  
A d de d Gl o ball y  
wee k 1 2 “ visits ”  
A d de d f or m ore clarificati o n  
2  
7  
Re place d A nti o bi otics t o A nti bi otics  
C orrecti o n of s pelli n g  
2, 9. 5,  
1 0. 1. 1, 
1 0. 2, 
1 1. 1. 2,  
2 1, 2 8, 3 0,  
3 2, 3 4, 3 5 
A d de d Gl o ball y  
“( wit h t he c a p o n) t o t he ne arest 0. 1 gr a m ”  
A d de d f or m ore clarificati o n a n d 
c o nsiste nc y 
Pr ot oc ol V 0 1 -1 2 1 A -3 0 1 (I D P -1 2 1)  
A P hase 3, M ulti -Ce nter, Ra n d o mize d, D o u ble -Bli n d, Ve hicle -C o ntr olle d, 2 - 
Ar m, Parallel Gr o u p C o m paris o n St u d y C o m pari n g t he Efficac y a n d Safet y 
of I D P -1 2 1 a n d I D P -1 2 1 Ve hicle L oti o n i n t he Treat me nt of Ac ne V ul garis  
S p o ns or: 
D o w  P h ar m a ce utic al  Scie nces,  a di visi o n  of V ale a nt P h ar m a ce utic als,  N A 
1 3 3 0 Re d w o o d W a y 
Pet al u m a, C A 9 4 9 5 4 

PROTOCOL V01-121A-301 
IDP-121 Lotion 
Page 2 of 3 
 
 
 
11.1.3, 
11.1.4 
8.3 
25 
Added 
Pregnancy – Subject will discontinue study drug 
immediately, but will be followed to term. 
Complete pregnancy and SAE forms. 
Added for more clarification for 
pregnancy reporting 
9.4 
27-28 
Updated 
Any concomitant medication or therapy stopped 
for washout as indicated below is to be recorded. 
Subjects using concomitant medications or 
therapies during the course of the study that could 
interfere with the interpretation of the study results 
(including but not limited to those listed above) 
should not be withdrawn, but the use of the 
concomitant product should be discontinued. 
Information on concomitant medications or 
therapies will be recorded in the Prior and 
Concomitant Medication or Therapy source 
document and eCRF. Any therapy used by the 
subject will be considered concomitant therapy 
(e.g., Facial procedures, surgical procedures, 
investigations and operations) and any 
medication both over the counter (OTC) or 
prescription used by the subject will be 
considered concomitant medication (eg, aspirin, 
Tylenol, birth control pills, vitamins, moisturizers, 
sunscreens). Every attempt should be made to keep 
concomitant medication and therapy dosing 
constant during the study. Any change to 
concomitant medication or therapy should be 
noted on the Concomitant Medication or Therapy 
source document and eCRF. 
All cleansers and moisturizers and other topical 
products used on the treatment area that are not 
prescription products will be captured on the Other 
Skin Care Products Concomitant Medication 
source document and eCRF 
Updated section to add 
clarification and to be consistent 
with the eCRF guidelines and 
how this information should be 
captured 
11.4.8 
45 
Added 
All confirmed pregnancies must be reported via 
confirmed facsimile/email transmission and must 
be submitted on a SAE and pregnancy report 
forms within 24 hours of the investigator’s 
awareness of the pregnancy using the same 
reporting as procedure for an SAE under Section 
11.4.6. 
Added for more clarification for 
pregnancy reporting 
12.1.10 
54 
Updated 
Subset analyses will be conducted for the ITT 
populations for the subgroups baseline global 
severity, gender, age, ethnicity, and race, and 
geographic location. Age will be dichotomized to 
less than the median age of subjects and greater 
than or equal to the median age of subjects. An 
Addition of outside US 
Geographic region due to addition 
of Latin America sites. 

PROTOCOL V01-121A-301 
IDP-121 Lotion 
Page 3 of 3 
 
 
 
additional analysis will be include with categories 
of less than 18, 18 to less than the median age and 
greater than or equal to the median age. 
Geographic region will be dichotomized to US 
and outside US (OUS). 
12.5 
56 
Replaced 
A tabulation of protocol deviations will be included 
in the final study report. 
With 
A listing of protocol deviations will be included in 
the final study report 
Correction on format of protocol 
deviations in the study report 

 
C LI NI C A L S T U D Y P R O T O C O L 
I D P-1 2 1  
Pr ot oc ol V 0 1 -1 2 1 A -3 0 1  
 
A P hase 3, M ulti -Ce nter, Ra n d o miz e d, D o u ble -Bli n d, Ve hicle - 
C o ntr olle d, 2 -Ar m, Parallel Gr o u p C o m paris o n St u d y C o m pari n g  t he 
Efficac y a n d Safet y of I D P -1 2 1 a n d I D P -1 2 1 Ve hicle L oti o n i n t he 
Treat me nt of Ac ne  V ul garis 
 
 
De vel o p me nt  P h ase:  
3 
 
St u d y  Desi g n:  
M ulti -ce nter, ra n d o mize d, d o u ble- bli n d, ve hicle -c o ntr olle d 
efficac y a n d s afet y st u d y  
 
D ate:  
0 7 Oct o ber 2 0 1 6 ( A me n d me nt 3) 
 
S p o ns or:  
D o w P har mace utical Sci e nces, a Di visi o n of Valea nt 
P har mace uticals N ort h A merica, L L C  
1 3 3 0 Re d w o o d Wa y 
Petal u ma, C A  9 4 9 5 4 
 
 
 
 
C O N FI D E N TI A L  
N ot hi n g herei n is t o be discl ose d wit h o ut pri or a p pr o v al of t he s p o ns or.  
 
 
 
 
 
 
 
 
 
 
 

 
Pr ot oc ol  V OJ -1 2 1 A -3 0l, l D P -1 2 1  
Val e a nt Researc h &  De vel o p me nt  
 
 
Pr ot o c ol Re vie w a n d A p pr o v als  
 
A P h as e 3, M ulti -C e nt e r, R a n d o mi z e d, D o u bl e -Bli n d, V e hi cl e -C o nt r oll e d, 2 -A r m, 
P a r all el  G r o u p  C o m p a ris o n  St u d y  C o m p a ri n g  t h e Effi c a c y  a n d  S af et y  ofl D P -1 2 1  a n d 
I D P-1 2 1 V e hi cl e L oti o n i n t h e T r e at m e nt of A c n e V ul g a ris  
 
R e vi e w e d a n d a p p r o v e d:  
 
 
 
 
V al ea nt P h ar ma c e uti c als N ort h A m eri c a, L L C  
\1 (  t \ Z. 0 1(, o  
D at e  
 
 
 
 
 
V a 1 e a nt P h ar m ac e utic als N ort h A m eri c a, L L C  
 
 
 
, 2 g.O c _J.. t 2 &:. 1(.. 
D at e  
 
 
 
 
u/ s J 1 I wt &  
 
 
V al ea nt P h ar ma c e uti c als N ort h A m eri c a, L L C  
' Dat e  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
V ersi o n 4,  7  O ct o b er  2 0 1 6  
C O N FI D E N TI A L  
2  

Protocol V01-121A-301, IDP-121 
Valeant Research & Development 
Version 4, 7 October 2016 
CONFIDENTIAL 
3 
 
 
 
 
Personnel Responsible for Conducting the Study 
 
A Phase 3, Multi-Center, Randomized, Double-Blind, Vehicle-Controlled, 2-Arm, 
Parallel Group Comparison Study Comparing the Efficacy and Safety of IDP-121 and 
IDP-121 Vehicle Lotion in the Treatment of Acne Vulgaris 
 
Contract Research Organization 
 
 
Medical Monitor 
TKL Research, Inc. 
365 W. Passaic Street, Suite 550 
Rochelle Park, NJ 07662 
 
 
 
 
 
 
Project Manager 
Fax number: N/A 
TKL Research, Inc. 
 
365 W. Passaic Street, Suite 550 
Rochelle Park, NJ 07662 

Pr ot oc ol V 0 1 -1 2 1 A -3 0 1, I D P -1 2 1  
Valea nt Researc h & De vel o p me nt  
Versi o n 4, 7 Oct o ber 2 0 1 6  
C O N FI D E N TI A L  
4  
 
 
 
 
 
I a gree: 
Pri nci p al I n vesti g at or Pr ot oc ol A gree me nt P a ge  
•  T o ass u me res p o nsi bilit y f or t he pr o per c o n d u ct of t his cli nical st u d y at t his site a n d  t o 
c o n d uct t he st u d y i n c o m plia nce wit h t his pr ot oc ol, a n y f ut ure a me n d me nts, a n d wit h 
a n y ot h er st u d y c o n d uct pr oce d ures pr o vi de d b y t he  s p o ns or. 
•  T hat I a m a w are of, a n d will c o m pl y wit h, t he i nter nati o nall y rec o g nize d c o de of G o o d 
Cli nical Practices ( G C P) a n d all ot her a p plica ble re g ul at or y re q uire me nts t o o btai n 
writte n a n d date d a p pr o v al fr o m t he I nstit uti o nal Re vie w B o ar d (I R B) or I n de pe n de nt 
Et hics C o m mittee (I E C) f or t he st u d y pr ot oc ol, writte n i nf or me d c o nse nt, c o nse nt  f or m 
u p dates, s u bject -r ecr uit m e nt pr oce d ures (e. g., a d v ertise me nts), a n d a n y ot her writte n 
i nf or mati o n t o be pr o vi de d t o t he s u bjects, bef ore i nitiati n g t his cli nical st u d y. 
•  N ot t o i m ple me nt a n y c h a n ges t o, or de viati o ns fr o m t he pr ot oc ol wit h o ut pri or 
a gree m e nt fr o m t he s p o ns or a n d re vie w a n d d o c u me nte d a p pr o val fr o m t he  I R B/I E C, 
e x ce pt t o eli mi nate a n i m me diate hazar d t o t he st u d y s u bjects, or w he n c ha n ge(s) 
i n v ol ves o nl y l o gistical or a d mi nistrati ve as pects of t he cli nical st u d y. 
•  T o per mit direct m o nit ori n g a n d a u diti n g b y t he s p o ns or o r s p o ns or’s re pres e ntati ves 
a n d i ns pecti o n b y t h e a p pr o priate re g ulat or y  a ut h orit y(ies).  
•  T hat I a m t h or o u g hl y fa miliar wit h t he a p pr o priate use of t he i n vesti gati o nal 
pr o d ucts(s), as d escri be d i n t his pr ot oc ol, a n d a n y ot her i nf or mati o n pr o vi d e d b y t h e 
s p ons or or desi g nee, i n cl u di n g, b ut n ot li mite d t o, t he c urre nt I n vesti gat or Br oc h ure  or 
e q ui vale nt d oc u me nt a n d a p pr o ve d pr o d u ct la bel (if  a p plica ble).  
•  T o pr o vi de s ufficie nt ti m e, a n d a d e q uate n u m bers of q ualifie d staff a n d facilities f or t he 
f oresee n d uratio n of t he cli nical st u d y t o c o n d uct t he st u d y pr o p erl y, et hicall y, a n d 
safel y. 
•  T o e ns ure t hat all pers o ns assisti n g i n t his st u d y are a de q u atel y i nf or me d a b o ut t he 
pr ot oc ol, i n vesti gati o nal pr o d uct(s), a n d t h eir cli nical st u d y -relat e d d uties a n d 
f u ncti o ns. 
 
 
 
 
Pri nci pal I n v esti gat or ( pri nt na me)  
 
 
Pri nci pal I n v esti gat or (si g nat ur e)  
 
Date  

Pr ot oc ol V 0 1 -1 2 1 A -3 0 1, I D P -1 2 1  
Valea nt Researc h & De vel o p me nt  
Versi o n 4, 7 Oct o ber 2 0 1 6  
C O N FI D E N TI A L  
5  
 
 
 
 
2  S y n o psis  
 
N a me of S p o ns or/ C o m p a n y: D o w P h ar m ace utic al Scie nc es, a di visi o n of Valea nt P har mace uticals 
N ort h A merica, L L C  
N a me of I n vesti g ati o n al Pr o d uct: I D P-1 2 1 L oti o n  
N a me of Acti ve I n gre die nts: Treti n oi n 0. 0 5 % l oti o n  
Title of St u d y: A P hase 3, M ulti -Ce nter, Ra n d o mize d, D o u ble -Bli n d, Ve hicle -C o ntr olle d, 2 -Ar m, P arallel 
Gr o u p C o m paris o n St u d y C o m pari n g t he Efficac y a n d Sa fet y of I D P-1 2 1 L oti o n a n d I D P -1 2 1 Ve hicle 
L oti o n i n t he Treat me nt of Ac ne V ul garis  
N u m ber of cli nic al ce nters: M ultice nter, a p pr o xi matel y 3 2 -5 0 i n vesti gati o nal ce nters i n N ort h A merica 
a n d Lati n A merica  
O bjecti ve:  
T he pri mar y o bj ecti ve of t his st u d y is t o c o m pare t he efficac y, safet y a n d t olera bilit y of I D P-1 2 1 L oti o n 
a n d ve hicle i n t he treat me nt of s u bj ects wit h ac ne v ul garis.  
M et h o d ol o g y:  
T his is a m ultice nter, ra n d o mi ze d, d o u ble -bli n d, parallel gr o u p, ve hicle -c o ntr olle d, 1 2 -wee k st u d y t o 
e val uate relati ve c ha n ges i n i nfla m mat or y a n d n o n -i nfla m mat or y lesi o n c o u nts, as well as treat me nt 
s uccess usi n g a n E val uat or’s Gl o bal Se verit y Scale ( E G S S) i n s u bj ects wit h m o derate t o s e vere ac ne. 
S u bj ects m ust be at least 9 years of a ge a n d ol der wit h m o der ate t o se vere ac ne v ul garis (a s c ore of 3 or  4 
[ m o derate t o se vere] o n t he E G S S scale), prese nti n g wit h 2 0-4 0 i nfla m mat or y facial lesi o ns ( pa p ules, 
p ust ules, a n d n o d ules), 2 0 -1 0 0 n o n -i nfla m mat or y facial lesi o ns ( o pe n a n d cl ose d c o me d o nes), a n d <  2 
facial n o d ules.  
A p pr o xi matel y ei g ht h u n dre d ( 8 0 0) s u bj ects will be ra n d o mi ze d t o t he f oll o wi n g treat me nt gr o u ps:  
•  
4 0 0 S u bj ects t o I D P -1 2 1 L oti o n, o nce -dail y a p plicati o n  
•  
4 0 0 S u bj ects t o I D P -1 2 1 Ve hicle L oti o n, o nce -dail y  a p plicati o n 
All s u bj ects will recei ve o nc e dail y, t o picall y-a p plie d treat me nt t o t he face f or 1 2 wee ks ( u p t o wee k 1 2 
visit). S u bj ect visits i ncl u de S cree ni n g, B aseli ne, W ee k 4, W ee k 8, a n d W ee k 1 2, at w hic h safet y a n d 
efficac y assess me nts will be c o n d ucte d. Bl o o d sa m ples will be c ollecte d fr o m s u bj ects f or safet y 
m o nit ori n g at B aseli ne a n d W ee k 1 2 visits.  
N u m ber of s u bjects pl a n ne d:  
A p pr o xi matel y 8 0 0 s u bj ects will be ra n d o mize d t o t he f oll o wi n g treat me nt gr o u ps:  
•  
4 0 0 S u bj ects t o I D P -1 2 1 L oti o n, o nce -dail y a p plicati o n  
•  
4 0 0 S u bj ects t o I D P-1 2 1 Ve hicle L oti o n, o nce -dail y  a p plicati o n 
I ncl usi o n criteri a: 
1.  Male or fe male at least 9 years of a ge a n d  ol der;  
2.  Writte n a n d ver bal i nf or me d c o nse nt m ust be o btai ne d. S u bj ects less t ha n a ge of c o nse nt m ust si g n a n 
asse nt f or t he st u d y a n d a pare nt or a le gal g uar dia n m ust si g n t he i nf or me d c o nse nt (if s u bj ect  reac hes 
a ge of c o nse nt d uri n g t he st u d y t he y s h o ul d be re -c o nse nte d at t he ne xt st u d y  visit);  
3.  S u bj ect m ust ha ve a sc ore of 3 ( m o derate) or 4 (se vere) o n t he E val uat or’s Gl o bal Se verit y  assess me nt 
at t he scree ni n g a n d baseli ne  visit;  
4.  S u bj ects wit h facial ac ne i nfla m mat or y lesi o n ( pa p ules, p ust ules, a n d n o d ules) c o u nt n o less t ha n  2 0 
b ut n o m ore t ha n 4 0;  
5.  S u bj ects wit h facial ac ne n o n -i nfla m mat or y lesi o n ( o pe n a n d cl ose d c o me d o nes) c o u nt n o less t ha n 2 0 
b ut n o m ore t ha n 1 0 0;  
6.  S u bj ects wit h t w o or fe wer facial  n o d ules;  

Protocol V01-121A-301, IDP-121 
Valeant Research & Development 
Version 4, 7 October 2016 
CONFIDENTIAL 
6 
 
 
 
 
7. Women of childbearing potential and females that are pre-menses must be willing to practice 
effective contraception for the duration of the study. (Effective contraception is defined as stabilized 
on oral contraceptive for at least 3 months, IUD, condom with spermicidal, diaphragm with 
spermicidal, implant, Nuvaring, injection, transdermal patch or abstinence.) Females on birth control 
pills must have taken the same type pill for at least three months prior to entering the study and must 
not change type during the study. Those who have used birth control pills in the past must have 
discontinued usage at least three months prior to the start of the study. Women who use birth control 
for acne control only should be excluded. 
8. Pre-menses females and women of childbearing potential must have a negative urine pregnancy test at 
the screening and baseline visits; 
9. Subjects must be willing to comply with study instructions and return to the clinic for required visits. 
Subjects under the age of consent must be accompanied by the parent or legal guardian at the time of 
assent/consent signing; 
10. If a cleanser, moisturizer or sunscreen is needed during the study, Subjects must be willing to use only 
allowed cleansers, moisturizers, sunscreens, or moisturizer/sunscreen combination products (see 
Appendix 17.2). If the subject wears makeup they must agree to use non-comedogenic makeup. 
Exclusion criteria: 
1. Use of an investigational drug or device within 30 days of enrollment or participation in a research 
study concurrent with this study; 
2. 
Any dermatological conditions on the face that could interfere with clinical evaluations such as acne 
conglobata, acne fulminans, secondary acne, perioral dermatitis, clinically significant rosacea, gram- 
negative folliculitis; 
3. 
Any underlying disease(s) or some other dermatological condition of the face that requires the use of 
interfering topical or systemic therapy or makes evaluations and lesion count inconclusive; 
4. 
Subjects with a facial beard or mustache that could interfere with the study assessments; 
5. 
Subjects with more than two (2) facial nodules; 
6. 
Evidence or history of cosmetic-related acne; 
7. 
Subject has a history of experiencing significant burning or stinging when applying any facial 
treatment (eg, make-up, soap, masks, washes, sunscreens, etc) to their face; 
8. 
Female subjects who are pregnant, nursing mothers, planning a pregnancy during the course of the 
trial, or become pregnant during the study; 
9. 
Use of estrogens (eg, Depogen, Depo-Testadiol, Gynogen, Valergen, etc) for less than 12 weeks 
immediately preceding study entry; Subjects treated with estrogens 12 or more consecutive weeks 
immediately prior to study entry need not be excluded unless the Subject expects to change dose, drug 
or discontinue estrogen use during the study; 
10. If female, subject has a history of hirsutism, polycystic ovarian disease or clinically significant 
menstrual irregularities; 
11. Treatment of any type of cancer within the last 6 months; 
12. Subject uses medications and/or vitamins during the study which are reported to exacerbate acne 
(azothiaprim, haloperidol, Vitamin D, Vitamin B12, halogens such as iodides or bromides, lithium, 
systemic or mid-to super-high potency corticosteroids, phenytoin and phenobarbital); Daily vitamins 
at the prescribed amounts are acceptable; 
13. History of hypersensitivity or allergic reactions to any of the study preparations as described in the 
Investigator’s Brochure, including known sensitivities to any dosage form of tretinoin; 
14. Concomitant use of potentially irritating over-the-counter products that contain ingredients such as 
benzoyl peroxide, alpha-hydroxy acid, salicylic acid, retinol or glycolic acids; 

Protocol V01-121A-301, IDP-121 
Valeant Research & Development 
Version 4, 7 October 2016 
CONFIDENTIAL 
7 
 
 
 
 
15. Subjects that have not undergone the specified washout period(s) for the following topical 
preparations used on the face or subjects who require the concurrent use of any of the following 
topical agents in the treatment area: 
Topical astringents and abrasives on face 
1 week 
Antibiotics on the facial area 
2 weeks 
Non-allowed moisturizers or sunscreens on face 
2 weeks 
Other topical anti-acne drugs on face 
2 weeks 
Soaps containing antimicrobials on the face 
2 weeks 
Anti-inflammatory agents and corticosteroids on the facial area 4 weeks 
Retinoids, including retinol on the face 
4 weeks 
If the subject requires topical treatment for acne on areas other than the face (e.g., chest and/or back), the 
investigator may prescribe a product that does not contain tretinoin and must be noted in source 
documents and eCRF. 
16. Subjects that have not undergone the specified washout period(s) for the following systemic 
medications or subjects who require the concurrent use of any of the following systemic medications: 
Corticosteroids (including intramuscular injections) 
(inhaled corticosteroids allowed) 
4 weeks 
Antibiotics 
4 weeks 
Other systemic acne treatments 
4 weeks 
Systemic retinoids 
6 months 
17. Subject intends to use a tanning booth or sunbathe during the study. 
18. Subjects who are unable to communicate or cooperate with the Investigator due to language problems, 
poor mental development, or impaired cerebral function. 
19. Subjects with any underlying disease that the Investigator deems uncontrolled, and poses a concern 
for the subjects safety while participating in the study. 
Investigational product, dosage and mode of administration: 
Investigational Product: IDP-121 (tretinoin 0.05%) Lotion, applied topically to the face, once daily for 12 
weeks. 
Comparator Product: IDP-121 Vehicle Lotion, applied topically to the face, once daily for 12 weeks. 
Duration of treatment: 
12 weeks for all subjects. 
Reference therapy, dosage and mode of administration: 
See comparator product above. 
Criteria for evaluation: 
Co-Primary efficacy: 
IDP-121 Lotion versus IDP-121 Vehicle Lotion 
Co-primary endpoints are: 
(1) Superiority in absolute change from Baseline to Week 12 in mean inflammatory lesion counts 
(2) Superiority in absolute change from Baseline to Week 12 in mean non-inflammatory lesion counts, 
and, 
(3) Percent of subjects who achieve at least a two-grade reduction from baseline and are Clear -or Almost 
Clear at Week 12 in the Evaluator’s Global Severity Score. 
Secondary efficacy: 
(1) Percent change in inflammatory lesion count from Baseline to Week 12 
(2) Percent change in non-inflammatory lesion count from Baseline to Week 12 

Pr ot oc ol V 0 1 -1 2 1 A -3 0 1, I D P -1 2 1  
Valea nt Researc h & De vel o p me nt  
Versi o n 4, 7 Oct o ber 2 0 1 6  
C O N FI D E N TI A L  
8  
 
 
 
 
S u p p orti ve Effic ac y:  
•  
Pr o p orti o n of s u bj ects w h o ha ve at least a 2 gra de re d ucti o n at W ee k 1 2 fr o m B aseli ne i n  t he 
E val uat or’s Gl o bal Se verit y  S c ore  
•  
P erce nt c ha n ge i n i nfla m mat or y lesi o n c o u nt fr o m B aseli ne t o W ee k  8  
•  
P erce nt c ha n ge i n n o n -i nfla m mat or y lesi o n c o u nt fr o m B as eli ne t o W ee k 8  
•  
Pr o p orti o n of s u bj ects w h o ha ve at least a 2 gra de re d ucti o n at W ee k 8 fr o m B aseli ne i n  t he 
E val uat or’s Gl o bal Se verit y  S c ore  
•  
P erce nt c ha n ge i n i nfla m mat or y lesi o n c o u nt fr o m B aseli ne t o W ee k  4  
•  
P erce nt c ha n ge i n n o n -i nfla m mat or y lesi o n c o u nt fr o m B as eli ne t o W ee k 4  
•  
Pr o p orti o n of s u bj ects w h o ha ve at least a 2 gra de re d ucti o n at W e e k 4 fr o m B aseli ne i n t he 
E val uat or’s Gl o bal Se verit y  S c ore  
Effic ac y M e as ure me nts:  
Lesi o n C o u nts  
At eac h visit t he E val uat or will c o u nt t he t otal n u m ber of i nfl a m mat or y lesi o ns ( pa p ules, p ust ules, a n d 
n o d ules) o n t he s u bj ect’s face. N o d ules will be c o u nte d  se paratel y b ut will be i ncl u de d i n t he t otal 
i nfla m mat or y lesi o n c o u nt. At baseli ne, eli gi ble s u bj ects ma y ha ve n o m ore t ha n t w o n o d ules. N o d ules 
will be i ncl u de d i n t he statistic al a nal ysis of i nfla m mat or y lesi o n c o u nts. All i nfla m mat or y lesi o ns will be 
c o u nte d at t he sa me ti me rat her t ha n c o u nti n g pa p ules a n d p ust ules se paratel y. T he E val uat or will als o 
c o u nt t he t otal n u m ber of n o n -i nfla m mat or y lesi o ns ( o pe n a n d cl ose d c o me d o nes). T he sa me bli n de d 
e val uat or s h o ul d perf or m t he l esi o n c o u nts a n d E G S S e val uati o ns at all visits fr o m baseli ne t o wee k 1 2 f or 
t he sa me s u bj ect. 
I nfl a m m at ory lesi o ns are defi ne d as f oll o ws:  
P a p ule –  a s mall, s oli d ele vati o n less t ha n 5 m m i n dia meter. M ost of t he lesi o n is a b o ve t he s urface of t he 
s ki n. 
P ust ule –  a s mall, circ u ms c ri be d ele vati o n less t ha n 5 m m i n dia meter t hat c o ntai ns yell o w-w hite e x u date. 
N o d ule –  a s u bc uta ne o us lesi o n greater t ha n or e q ual t o 5 m m i n dia meter  
N o n -i nfl a m m at ory lesi o ns are defi ne d as f oll o ws:  
O pe n c o me d o nes ( blac k hea d) - a lesi o n i n w hic h t he f ol licle o pe ni n g is wi del y dilate d wit h t he c o nte nts 
pr otr u di n g o ut o nt o t he s urfac e of t he s ki n.  
Cl ose d c o me d o nes ( w hite hea d) –  a lesi o n i n w hic h t he f ollicle o pe ni n g is cl ose d, b ut t he se bace o us  gla n d 
is e nlar ge d  b y  t he press ure  of  t he se b u m b uil d u p, w hic h  i n t ur n ca uses t he s ki n ar o u n d  t he f ollicle t o t hi n 
a n d bec o me ele vate d wit h a w hite  a p peara nce.  
Ev al u at or’s Gl o b al Severity Sc ore ( E G S S)  
At eac h visit t he se verit y will be deter mi ne d base d o n e val uat or -bli n de d e val uati o ns of t he si g ns a n d 
s y m pt o ms of ac ne v ul garis. E val uati o ns will be sc ore d o n a scale of 0-4, wit h 0 bei n g clear a n d 4 bei n g 
se vere. Please see t he ta ble bel o w f or c o m plete defi niti o ns. 
Sc ore  
Gra d e  
Descri pti o n  
0  
Clear  
N or mal, clear s ki n wit h n o e vi d e nce of ac n e v ul garis  
1  
 
Al m ost clear  
Rare n o n -i nfla m mat or y lesi o ns prese nt, wit h rare n o n-i nfla me d p a p ules ( p a p ules m ust 
b e res ol vi n g a n d ma y b e h y p er pi g me nte d, t h o u g h n ot pi n k -re d) 
2  
 
Mil d  
S o me n o n -i nfla m mat or y lesi o ns are prese nt, wit h fe w i nfla m mat or y lesi o ns 
( p a p ules/ p ust ules o nl y; n o n o d ul o-c ystic lesi o ns)  
 
3  
 
M o d erate  
N o n -i nfla m mat or y lesi o ns pre d o mi n ate, wit h m ulti ple i nfla m mat or y lesi o ns e vi d e nt: 
se ver al t o ma n y c o me d o n es a n d pa p ules/ p ust ules, a n d t h ere ma y or ma y n ot b e o n e 
n o d ul o -c ystic lesi o n  
4  
 
Se vere  
I nfla m mat or y lesi o ns are m ore a p p are nt, ma n y c o me d o n es a n d p a p ules/ p ust ules, t h ere 
ma y or ma y n ot b e u p t o 2 n o d ul o -c ystic lesi o ns 

Pr ot oc ol V 0 1 -1 2 1 A -3 0 1, I D P -1 2 1  
Valea nt Researc h & De vel o p me nt  
9  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
A L  
C uta ne o us safet y a n d t olera bilit y will be e val uate d b y ta b ulati o ns of a d verse e ve nts a n d C uta ne o us Safet y 
a n d T olera bilit y E val uati o n sc ores (scali n g, er yt he ma, h y p o/ h y per -pi g me ntati o n, itc hi n g, b ur ni n g, a n d 
sti n gi n g) t o be assesse d at eac h st u d y visit. Itc hi n g, b ur ni n g a n d sti n gi n g ( C uta ne o us t olera bilit y) will be 
re vie we d wit h t he s u bj ect at eac h st u d y visit as a n a vera ge o ver t he peri o d si nce t he pre vi o us visit.  
Scali n g, er yt he ma a n d h y p o/ h y per -pi g me ntati o n ( C uta ne o us Safet y) will be assesse d b y t he e val uat or at 
eac h visit. C ha n ges fr o m baseli ne i n all safet y la b orat or y val ues will be s u m mar ize d usi n g descri pti ve 
statistics b y treat me nt gr o u p. 
C uta ne o us t olera bilit y si g ns a n d s y m pt o ms t hat res ult i n t he s u bj ect re q uiri n g c o nc o mita nt t hera p y, 
i nterr u pti o n of treat me nt, or disc o nti n uati o n fr o m t he st u d y will be re p orte d as a n A E. At selecte d sites, 
sta n dar dize d p h ot o gra p h y of t he face will be perf or me d. 
St atistic al met h o ds:  
All statistical pr ocessi n g will be perf or me d usi n g S A S ®  versi o n 9. 3 or later u nless ot her wise state d. 
Statistical si g nifica nce will be base d o n t w o -taile d tests of t he n ull h y p ot hesis res ulti n g i n p-val ues of 0. 0 5 
or less. T ests of lesi o n c o u nt s u peri orit y will be base d o n a n A N C O V A wit h fact ors of treat me nt a n d 
a nal ysis ce nter a n d t he res pecti ve B aseli ne lesi o n c o u nt as a c o variate or o n ra n ke d data s u b mitte d t o a n  
A N C O V A wit h fact ors of treat me nt a n d a nal ysis ce nter a n d t he res pecti ve B aseli ne lesi o n c o u nt as a 
c o variate. T he pri mar y met h o d of ha n dli n g missi n g efficac y data will be base d o n esti mati o n usi n g t he 
met h o d of Mar k o v C hai n M o nte Carl o ( M C M C) i m p utati o n. A d diti o nall y, a m o del -base d m ulti ple 
i m p utati o n pr ocess will be use d as a se nsiti vit y a nal ysis t o t he M C M C i m p utati o n. Fi nall y, t he a bs ol ute 
c ha n ge i n lesi o n c o u nt will be a nal yze d usi n g a re peate d meas ures A N C O V A f or lesi o n c o u nt data or a 
re peate d meas ures l o gistic re gressi o n m o del ( ge neralize d esti mati n g e q uati o ns) f or t he dic h ot o mize d 
E G S S.  
T he c o -pri mar y a nal ysis of t he dic h ot o mize d E G S S will be base d o n t he l o gistic re gressi o n test stratifie d 
b y a nal ysis ce nter.  
P o p ul ati o ns A n alyze d a n d Tre at me nt Gr o u ps:  
I nfla m mat or y a n d n o n-i nfla m mat or y lesi o n c o u nts will be rec or de d f or eac h S u bj ect at B aseli ne a n d at 
W ee ks 4, 8, a n d 1 2. T he a bs ol ute a n d perce nt c ha n ge fr o m B aseli ne i n i nfla m mat or y a n d n o n - 
i nfla m mat or y lesi o ns will be deri ve d f or eac h S u bj ect at W eeks 4, 8, a n d 1 2.  
T he E G S S will be rec or de d f or eac h S u bj ect. T he E G S S will be dic h ot o mize d i nt o “s uccess” a n d “fail ure” 
wit h a S u bj ect c o nsi dere d a s uccess if t he E val uat or’s Gl o bal Se verit y Sc ore at W ee k 4, 8, a n d 1 2 is at 
least 2 gra des less t ha n baseli ne a n d Clear or Al m ost Clear.  
A n i nte nt -t o-treat (I T T) a nal ysis will be c o n d ucte d o n all st u d y s u bj ects. T he I T T p o p ulati o n will c o nsist 
of all ra n d o mize d s u bj ects w h o recei ve d st u d y me dicati o n.  
T he safet y p o p ulati o n will be c o m prise d of all ra n d o mize d s u bj ects w h o are pres u me d t o ha ve use d t he 
st u d y me dicati o n at least o nce a n d w h o pr o vi de at least o ne p ost-baseli ne e val uati o n. A per -pr ot oc ol ( P P) 
a nal ysis will als o be c o n d ucte d. S u bj ects will be eli gi ble f or t he P P a nal ysis if t he y c o m pl ete t he 1 2-wee k 
e val uati o n wit h o ut n ote w ort h y st u d y pr ot oc ol vi olati o ns (i.e., a n y S u bj ect or i n vesti gat or acti vit y t hat 
c o ul d ha ve p ossi bl y i nterfere d wit h t he t hera pe utic a d mi nistrati o n of t he treat me nt or t he precise 
e val uati o n of treat me nt efficac y). T he P P p o p ulati o n will i ncl u de s u bj ects i n t he I T T p o p ulati o n w h o d o 
n ot meet a n y of t he f oll o wi n g criteria:  
•  Faile d a n y of t he i ncl usi o n/e xcl usi o n  criteria;  
•  Ha ve ta ke n a n y i nterferi n g c o nc o mita nt  me dicati o ns;  
•  Di d n ot atte n d t he W ee k 1 2 visit, wit h t he e xce pti o n  of a dis c o nti n uati o n fr o m t he st u d y 
d ue t o a n a d verse e ve nt relate d t o st u d y treat me nt or d oc u me nte d lac k of treat me nt  effect;  
•  Misse d b ot h t he wee k 4 a n d wee k 8  visits;  
•  Ha ve n ot bee n c o m plia nt wit h t he d osi n g re gi me n (i.e. S u bj ects ma y n ot miss m ore t ha n 
fi ve c o nsec uti ve da ys of d osi n g a n d m ust ta ke 8 0-1 2 0 % of e x pecte d d oses. T he n u m ber  of 
e x pecte d d oses will be deter mi ne d f or eac h s u bj ects base d o n t he le n gt h of t heir 
partici pati o n i n t he  st u d y); 
•  O ut of visit wi n d o w at t he 1 2 -wee k  visit  
Versi o n 4, 7  Oct o ber  2 0 1 6  
C O N FI D E N TI  
 

Pr ot oc ol V 0 1 -1 2 1 A -3 0 1, I D P -1 2 1  
Valea nt Researc h & De vel o p me nt  
Ve rsi o n 4, 7 Oct o ber 2 0 1 6 
C O N FI D E N TI A L  
1 0  
 
 
 
 
Pri or t o brea ki n g t he bli n d, ot her a d diti o nal criteria ma y be a d de d t o t he list t o acc o m m o d ate f or 
u nf oresee n e ve nts t hat occ urre d d uri n g t he c o n d uct of t he tri al t hat res ult i n n ote w ort h y st u d y pr ot oc ol 
vi olati o ns.  
A p pr o xi matel y ei g ht h u n dre d ( 8 0 0) s u bj ects will be ra n d o mi ze d t o t he f oll o wi n g treat me nt gr o u ps:  
•  
4 0 0 S u bj ects t o I D P -1 2 1 L oti o n, o nce -dail y a p plicati o n  
•  
4 0 0 S u bj ects t o I D P -1 2 1 Ve hicle L oti o n, o nce -dail y  a p plicati o n 
Effic ac y:  
Pri m ary:  
C o -pri mar y efficac y a nal yses of t he a bs ol ute c ha n ge i n i nfla m mat or y a n d i n n o n -i nfla m mat or y lesi o ns 
will be c o n d ucte d o n t he I T T p o p ulati o n. T he pre -s pecifie d ti me p oi nt will be W ee k 1 2. Descri pti ve 
statistics will be prese nte d b y treat me nt gr o u p f or i nfla m mat or y a n d f or n o n-i nfla m mat or y lesi o ns as well 
as t he a bs ol ute c ha n ge i n i nfla m mat or y a n d i n n o n -i nfla m mat or y lesi o ns. All of t he testi n g relati n g t o t he 
a nal ysis of i nfla m mat or y a n d n o n -i nfla m mat or y lesi o ns will use t he met h o ds i ntr o d uce d i n Secti o n 1 2. 
T he c o -pri mar y a nal ysis of t he dic h ot o mize d E G S S (s uccess bei n g at least a 2 gra de i m pr o ve me nt a n d 
ac hie vi n g Clear or Al m ost Cle ar) f or t he I T T p o p ulati o n will be base d o n t he l o gistic re gressi o n test 
stratifie d b y a nal ysis ce nter. 
Sec o n d ary:  
Mea n perce nt c ha n ge i n i nfla m mat or y a n d n o n -i nfla m mat or y lesi o n c o u nts fr o m baseli ne t o W ee k 1 2. 
S u p p ortive:  
A d diti o nal s u p p orti ve efficac y e n d p oi nts (i ncl u di n g mea n perce nt c ha n ge i n i nfla m mat or y a n d n o n - 
i nfla m mat or y lesi o ns c o u nts fr o m baseli ne at W ee ks 4 a n d 8, as well as pr o p orti o n of s u bj ects wit h at least 
a t w o gra de i m pr o ve me nt i n t he E val uat or’s Gl o bal Se verit y Sc ore fr o m baseli ne at W ee ks 4, 8 a n d 1 2) 
will be c o n d ucte d, as n ote d a b o ve.  
S afet y E v al u ati o n:  
All s u bj ects w h o recei ve me di cati o n a n d pr o vi de at least o ne p ost -baseli ne e val uati o n will c o nstit ute t he 
safet y p o p ulati o n. 
Safet y will be e val uate d b y ta b ulati o ns of a d verse e ve nts  ( A Es), C uta ne o us T olera bilit y E val uati o ns. 
C uta ne o us Safet y E val uati o n s c ores (er yt he ma, scali n g, a n d h y p o/ h y per -pi g me ntati o n) a n d T olera bilit y 
(itc hi n g, b ur ni n g, a n d sti n gi n g) will be prese nte d wit h descri pti ve statistics at B aseli ne a n d at W ee ks 4, 8, 
an d 1 2 f or eac h treat me nt gr o u p. Fre q ue ncies a n d perce nta ges f or eac h o utc o me cate g or y will be i ncl u de d 
i n t hese statistics. Mea n val ues will be prese nte d gra p hicall y b y wee k a n d treat me nt gr o u p. 
Vital si g ns a n d a n a b bre viate d p h ysical e xa m, a n d safet y la bs  will be c o n d ucte d o n all s u bj ects at s pecifie d 
visits. F or fe males of c hil d -be ari n g p ote ntial ( F O C B P), uri ne pre g na nc y testi n g will occ ur at s pecifie d 
visits. C ha n ges fr o m baseli ne i n safet y la b orat or y val ues a n d vital si g n meas ure me nts will be s u m marize d  
wit h descri pti ve statistics f or eac h treat me nt gr o u p at all a p plica ble st u d y visits. S hift ta bles will be 
prese nte d f or c ha n ges i n safet y la b orat or y val ues t o s u m marize la b orat or y test res ults c olle cte d at B aseli ne 
a n d W ee k 1 2. N or mal ra n ges esta blis he d b y t he ce ntral la b orat or y will be use d t o deter mi ne t he s hifts. A 
listi n g of all o ut-of -ra n ge la b orat or y test res ults at W ee k 1 2 will als o be pr o vi de d. Deter mi nati o n of 
cli nical si g nifica nce f or all o ut -of -ra n ge la b orat or y val ues will be ma de b y eac h i n vesti gat or a n d i ncl u de d 
i n t he listi n g. I n a d diti o n, a listi n g of all cli nicall y si g nifica nt la b orat or y test res ults will be pr o vi de d.  
All a d verse e ve nts occ urri n g d uri n g t he st u d y will be rec or de d a n d classifie d o n t he basis of Me d D R A 
ter mi n ol o g y. Descri pti o ns of A Es will i ncl u de t he date of o nset, t he date t he A E e n de d, t he se verit y of t he 
A E, t he relati o ns hi p t o st u d y me dicati o n, t he acti o n ta ke n re gar di n g st u d y me dicati o n usa ge, t he acti o n 
ta ke n re gar di n g t o treat t he A E, a n d t he o utc o me. 

Protocol V01-121A-301, IDP-121 
Valeant Research & Development 
Version 4, 7 October 2016 
CONFIDENTIAL 
11 
 
 
 
 
Adverse events will be summarized by treatment group and severity. Each subject will be counted only 
once within a system organ class or a preferred term by using the adverse events with the highest severity 
within each category. 
Adverse events will be summarized by treatment group and relationship to study medication. Each 
subject will be counted only once within a system organ class or a preferred term by using the adverse 
events with the greatest relationship within each category. 
Comparisons among treatment groups will be made by tabulating the frequency of subjects with one or 
more AEs (classified into MedDRA terms) during the study. The Fisher’s Exact test will be used to 
compare the proportion of subjects in each treatment group who report any adverse event at a significance 
level of 0.05. The specific system organ classes and preferred terms analyzed will be those that are 
reported by at least one percent of the subjects in any treatment group. 
All information pertaining to AEs noted during the study will be listed by subject, detailing verbatim 
given by the investigator, preferred term, system organ class, start date, stop date, severity, actions taken, 
and drug relatedness. The AE onset will also be shown relative (in number of days) to the day of initial 
dose of the randomized study medication. 
Serious adverse events (SAEs) will be tabulated by subject within treatment groups. 
In addition, a list of subjects who discontinued from the study and a list of subjects who experienced 
SAEs will also be provided. 
Subject Self-Assessments 
An exploratory patient self assessment questionnaire and satisfaction survey will also be administered 
during the study. 
Subjects will be asked to complete three questionnaires during the study: the Subject Self Assessment 
scale, the Patient Satisfaction Survey and the Acne-Specific Quality of Life Questionnaire. The 
Investigator assessments (EGSS, lesion counts) will be conducted independently of these subject self 
assessments. The EGSS should always be completed prior to the lesion counts. Inferential statistical 
analysis will not be performed on these questionnaires; the subjective responses will be compared between 
treatment groups for trends. 
This study will be performed in compliance with GCP including the archiving of essential study 
documents. This protocol follows guidelines outlined by the International Conference on Harmonization 
(ICH). All data furnished to the investigator and his/her staff, and all data obtained through this stud, will 
be regarded as confidential and proprietary in nature and will not be disclosed to any third party, except 
for the United States Food and Drug Administration or other regulatory body, without written consent 
from the sponsor. 

Pr ot oc ol V 0 1 -1 2 1 A -3 0 1, I D P -1 2 1  
Valea nt Researc h & De vel o p me nt  
Ve rsi o n 4, 7 Oct o ber 2 0 1 6 
C O N FI D E N TI A L  
1 2  
 
 
 
 
 
3  T a ble of  C o nte nts  
1  
TI T L E  P A G E  ...........................................................................................................1  
2  
S Y N O P SI S  ...............................................................................................................5  
3  
T A B L E  O F  C O N T E N T S  .......................................................................................1 2  
4  
LI S T O F A B B R E VI A TI O N S A N D D E FI NI TI O N S  O F  T E R M S  ........................1 6  
5  
I N T R O D U C TI O N .................................................................................................1 7  
6  
S T U D Y O BJ E C TI V E S  A N D  P U R P O S E  .............................................................1 8  
7  
I N V E S TI G A TI O N A L P L A N  ................................................................................1 8  
7. 1  
O verall St u d y Desi g n a n d  Pla n:  Descri pti o n  .............................................1 8  
8  
S E L E C TI O N A N D WI T H D R A W A L  O F  S U BJ E C T S  .........................................2 2  
8. 1  
S u bject I n cl usi o n  Criteria  ..........................................................................2 2  
8. 2  
S u bject  E x cl usi o n  Criteria  .........................................................................2 3  
8. 3  
S u bject  Wit h dra wal  Criteria .......................................................................2 4  
9  
T R E A T M E N T  P L A N  ............................................................................................2 6  
9. 1  
Met h o ds of Assi g ni n g S u bjects t o  Treat me nt Gr o u ps  ...............................2 6  
9. 2  
Ra n d o mizati o n  a n d Bli n di n g  .....................................................................2 6  
9. 3  
U n -bli n di n g  ................................................................................................2 6  
9. 4  
Pri or a n d Pr o hi bite d C o nc o mita nt Me dicati o n  or T hera p y  ........................2 7  
9. 5  
Treat me nt  C o m plia nce  ...............................................................................2 8  
9. 6  
Pr ot oc ol De viati o ns  a n d Vi olati o ns  ...........................................................2 8  
1 0  
S T U D Y D R U G M A T E R I A L S A N D  M A N A G E M E N T  ......................................2 9  
1 0. 1  
I D P-1 2 1 L oti o n a n d I D P -1 2 1  Ve hicle  L oti o n  ...........................................2 9  
1 0. 1. 1  Pac ka gi n g  a n d La beli n g  .................................................................3 0  
1 0. 1. 2  St ora ge, Ha n dli n g, a n d Dis p osal of  St u d y  Dr u g  ............................3 0  
1 0. 1. 3  A d mi nistrati o n  ...............................................................................3 1  
1 0. 2  
St u d y  Dr u g  Acc o u nta bilit y  ........................................................................3 1  
1 1  
S T U D Y P R O C E D U R E S  A N D  E V A L U A TI O N S  ................................................3 2  
1 1. 1  
Sc he d ule of E val u ati o ns  a n d Pr oce d ures  ...................................................3 2  
1 1. 1. 1  Visit 1:  Scree ni n g  Visit  ..................................................................3 2  
1 1. 1. 2  Visit 2: Baseli ne Visit  ( D a y 0)  .......................................................3 3  
1 1. 1. 3  Visit 3 a n d 4: Wee k 4 ( Da y 2 8 ± 3 Da ys) a n d Wee k 8 ( Da y  5 6  
± 3  Da ys)  Visits  .............................................................................3 4  
1 1. 1. 4  Visit 5: Wee k 1 2 ( Da y 8 4 -3/ + 5 Da ys) Visit  –   E n d  of  St u d y  
Visit  ................................................................................................3 5  
1 1. 2  
E val uati o n  of Efficac y  ...............................................................................3 6  

Pr ot oc ol V 0 1 -1 2 1 A -3 0 1, I D P -1 2 1  
Valea nt Researc h & De vel o p me nt  
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C O N FI D E N TI A L  
1 3  
 
 
1 1. 2. 1  E val uat or’s Gl o bal Se v erit y  Sc ore  ( E G S S) ...................................3 6  
1 1. 2. 2  Lesi o n  C o u nts  ................................................................................3 7  
1 1. 2. 3  Ot her  Assess me nts  .........................................................................3 7  
1 1. 3  
E val uati o n of Safet y  ...................................................................................3 8  
1 1. 3. 1  C uta ne o us  Safet y  E v al uati o ns  ........................................................3 8  
1 1. 3. 2  T olera bilit y  E v al uati o ns  .................................................................3 8  
1 1. 3. 3  Me dical Hist or y a n d A b bre viate d  P h ysical E x a mi nati o n  ..............3 9  
1 1. 3. 4  La b orat or y  T ests  ............................................................................3 9  
1 1. 3. 5  Pre g n a nc y  Tests  .............................................................................3 9  
1 1. 4  
A d verse  E ve nts  ..........................................................................................4 0  
1 1. 4. 1  Defi niti o n of  A d vers e  E ve nt  ..........................................................4 0  
1 1. 4. 2  D oc u me nti n g  A d v erse  E x perie nces  ...............................................4 0  
1 1. 4. 3  Seri o us  A d verse  E ve nts  .................................................................4 1  
1 1. 4. 4  Assess me nt of Se verit y  ..................................................................4 1  
1 1. 4. 5  Assess me nt  of Ca usalit y  ................................................................4 2  
1 1. 4. 6  Re p orti n g of Seri o us  A d verse  E v e nts  ............................................4 2  
1 1. 4. 7  E x pe dite d Seri o us A d verse  E ve nt Re p orts  ....................................4 3  
1 1. 4. 8  Pre g n a nc y  .......................................................................................4 4  
1 2  
S T A TI S TI C S  .........................................................................................................4 5  
1 2. 1  
Assess me nt  of Efficac y  ..............................................................................4 5  
1 2. 1. 1  Pr i mar y Efficac y  ............................................................................4 5  
1 2. 1. 2  Sec o n dar y  Efficac y  ........................................................................4 6  
1 2. 1. 3  S u p p orti ve  Efficac y  .......................................................................4 6  
1 2. 1. 4  Test of S u peri orit y f or Lesi o n  C o u nt Varia bles  .............................4 6  
1 2. 1. 5  Statistical H y p ot hesis Testi n g a n d C o ntr ol  of  M ulti plicit y  ...........4 7  
1 2. 1. 6  Descri pti ve  Statistics  ......................................................................4 8  
1 2. 1. 7  P o oli n g  A nal ysis  ............................................................................4 8  
1 2. 1. 8  Missi n g Efficac y  Data  I m p utati o ns ................................................5 0  
1 2. 1. 9  Se nsiti vit y  Efficac y  A n al ys es  ........................................................5 2  
1 2. 1. 1 0  S u b gr o u p  A n al ys es  ........................................................................5 3  
1 2. 2  
Assess me nt of Safet y  .................................................................................5 3  
1 2. 2. 1  A d verse  E ve nts  ..............................................................................5 3  
1 2. 2. 2  Safet y  La b orat or y  Tests  .................................................................5 4  
1 2. 2. 3  Vital  Si g n Meas ure me nts  ...............................................................5 4  
1 2. 2. 4  C o nc o mita nt  Me dicati o ns  ..............................................................5 5  
1 2. 2. 5  S u bject  Self -Assess me nts  ..............................................................5 5  
1 2. 3  
S u bject  Dis p ositi o n  ....................................................................................5 5  
1 2. 4  
De m o gra p hics a n d Baseli ne C haract eristics  ..............................................5 5  

Pr ot oc ol V 0 1 -1 2 1 A -3 0 1, I D P -1 2 1  
Valea nt Researc h & De vel o p me nt  
Ve rsi o n 4, 7 Oct o ber 2 0 1 6 
C O N FI D E N TI A L  
1 4  
 
 
1 2. 5  
Pr ot oc ol  De viati o ns  ....................................................................................5 5  
1 2. 6  
C o m plia nce  ................................................................................................5 5  
1 2. 7  
I nteri m A nal ys es  ........................................................................................5 5  
1 2. 8  
A d diti o nal  Statistical C o nsi derati o ns  .........................................................5 5  
1 2. 8. 1  A nal ysis  P o p ulati o ns  ......................................................................5 5  
1 2. 8. 2  Sa m ple  Size  Deter mi nati o n  ............................................................5 6  
1 2. 8. 3  Ha n dli n g of  Missi n g  Dat a  ..............................................................5 7  
1 2. 8. 4  M ultice nter  Iss u es ..........................................................................5 7  
1 2. 8. 5  M ulti plicit y  Iss ues ..........................................................................5 7  
1 2. 8. 6  Wi n d o wi n g  R ules  ...........................................................................5 8  
1 3  
Q U A LI T Y C O N T R O L A N D  Q U A LI T Y A S S U R A N C E  .....................................5 8  
1 3. 1  
St u d y  M o nit ori n g  .......................................................................................5 8  
1 3. 2  
A u dits  a n d I ns pecti o ns ...............................................................................5 8  
1 3. 3  
Data Q ualit y  Ass ura n ce  .............................................................................5 9  
1 4  
E T HI C S A N D  A D MI NI S T R A TI V E  I S S U E S ......................................................5 9  
1 4. 1  
Et hical C o n d uct of  t he St u d y  .....................................................................5 9  
1 4. 2  
Et hics  Re vie w  ............................................................................................5 9  
1 4. 3  
Writte n  I nf or me d C o nse nt .........................................................................5 9  
1 4. 4  
S u bject  Data Pr otecti o n  ..............................................................................6 0  
1 4. 5  
Data  M o nit ori n g  C o m mittee  ......................................................................6 0  
1 4. 6  
Fi na ncial  Discl os ure  ...................................................................................6 0  
1 4. 7  
I n v esti gat or O bli gati o ns  .............................................................................6 1  
1 4. 8  
C ha n ges t o  t he Pr ot oc ol  .............................................................................6 1  
1 4. 9  
C o nfi de ntialit y/ P u blicati o n of  t he St u d y ...................................................6 1  
1 5  
D A T A H A N D LI N G A N D R E C O R D K E E PI N G  .................................................6 1  
1 5. 1  
I ns p ecti o n of  Rec or ds  ................................................................................6 1  
1 5. 2  
Rete nti o n  of Rec or ds  ..................................................................................6 2  
1 6  
R E F E R E N C E S  ......................................................................................................6 3  
1 7  
A P P E N DI C E S  .......................................................................................................6 4  
1 7. 1  
S u bject  I nstr ucti o n S heet ...........................................................................6 4  
1 7. 2  
Clea nsers, M oist urizers a n d S u nscree n  Use  G ui deli nes  ............................6 6  
1 7. 3  
S u bject Self Assess me nt  Sc ori n g  Scale  .....................................................6 7  
1 7. 4  
Patie nt Satisfacti o n  S ur ve y  ( P S S) ..............................................................6 8  
1 7. 5  
Ac ne -S pecific Q u alit y of Life  Q uesti o n naire  ( A c n e-Q o L)  ........................6 9  

Pr ot oc ol V 0 1 -1 2 1 A -3 0 1, I D P -1 2 1  
Valea nt Researc h & De vel o p me nt  
Ve rsi o n 4, 7 Oct o ber 2 0 1 6 
C O N FI D E N TI A L  
1 5  
 
 
 
LI S T O F T A B L E S  
Ta ble  1.  
St u d y Desi g n a n d Sc h e d ule  of  Assess me nts  ...................................................2 1  
Ta ble  2.  
Dr u g  S u bsta nces I d e ntificati o n  ...................................................................... 2 9  
Ta ble  3.  
Test  Pr o d uct  I de ntificati o n … ........................................................................ 2 9  
Ta ble  4.  
E val uat or’s Gl o bal  Se verit y  S c ore  ................................................................. 3 6  

Protocol V01-121A-301, IDP-121 
Valeant Research & Development 
Version 4, 7 October 2016 
CONFIDENTIAL 
16 
 
 
 
 
 
4 List of Abbreviations and Definitions of Terms 
 
Abbreviation or Specialist Term 
Definition or Explanation 
AE 
Adverse event 
CRA 
Clinical Research Associate 
CRF 
Case Report Form 
CRO 
Contract Research Organization 
cGCP 
Current Good Clinical Pratice 
EGSS 
Evaluator’s Global Severity Score 
ET 
Early termination 
FDA 
FOCBP 
United States Food and Drug Administration 
Female of Childbearing Potential 
G 
Gram 
GCP 
Good Clinical Practice 
IATL 
Investigator’s Assessment of Total Lesions 
ICH 
International Conference on Harmonization 
IEC 
Independent Ethics Committee 
IRB 
Institutional Review Board 
ITT 
Intent-to-treat 
IWRS 
Interactive Web Response System 
LOCF 
Last observation carried forward 
MedDRA 
Medical Dictionary for Regulatory Affairs 
mL 
Milliliter 
OTC 
Over-the-counter 
PP 
Per protocol 
PSS 
Patient Satisfaction Survey 
QoL 
Quality of Life 
SAE 
Serious adverse event 
SSA 
Subject Self Assessment 
UPT 
Urine Pregnancy Test 
WHO 
World Health Organization 
 
In this protocol, “sponsor duties” refer to responsibilities that will be performed by the 
sponsor, the sponsor’s designee, or the sponsor’s designated contract research organization. 
In this protocol, “investigator” refers to the principal investigator or his/her designee, who is 
responsible for performing the study procedures and assessments. 

Pr ot oc ol V 0 1 -1 2 1 A -3 0 1, I D P -1 2 1  
Valea nt Researc h & De vel o p me nt  
Ve rsi o n 4, 7 Oct o ber 2 0 1 6 
C O N FI D E N TI A L  
1 7  
 
 
 
 
5  I ntr o d ucti o n 
Ac ne is a ver y c o m m o n dis or der of se b ace o us f ollicles t hat us uall y be gi ns at t he ti me of t he 
s har p i ncrease i n a n dr o ge n pr o d ucti o n occ urri n g i n a d olesce n ce [1 ]. T he disease is m ost 
pre vale nt a m o n gst tee na gers, b ut it d oes oc c ur l ater i n life, partic ularl y i n t h e t hir d a n d f o urt h 
deca d e. T he pat h o ge nesis is c o m ple x a n d i n v ol ves a n a n dr o ge n -sti m ulate d i ncreas e i n se b u m 
pr o d ucti o n, ass ociate d wit h f ollic ular h y p er kerati nizati o n a n d o bstr ucti o n of t he se bace o us 
f ollicles. T his res ults i n a b n or mal des q ua mati o n of t he f ollic ular e pit heli u m, a n d is ass ociate d 
wit h bacterial pr olif erati o n (es peci all y Pr o pi o ni b a cteri u m ac nes ( P. ac nes) ) a n d c hr o nic 
i nfla m mati o n ass ociate d wit h ac ne. T hes e c h a n ges i n ac ne s u bjects res ult i n e nlar ge d 
se bace o us gl a n ds; o bstr ucti o n of t he f ollic ular ca n al wit h ass ociate d se b u m rete nti o n a n d 
diste nti o n of t he f ollicle b y ti g htl y p ac ke d h or n y cells t hat lea d t o t he f or mati o n cli nical 
i nfla m mat or y l esi o ns i ncl u di n g s u perficial p ust ules s uc h as c o me d o n es ( p o p ularl y k n o w n as 
“ blac k hea ds” or “ w hite h ea ds”); a n d m ore dee pl y l ocate d pa p ules, n o d ules a n d c ysts [1 ]. T he 
areas m ost affecte d b y t h e disease i ncl u d e t he pil ose bace o us f ollicles of t he hea d a n d u p p er 
tr u n k, w here t h e se bace o us gla n ds are p artic ularl y acti ve [2 ]. 
C urre ntl y, t hera p e utic treat me nt of ac n e is directe d a gai nst 3 pri nci pal pat h o ge ni c fact ors of 
t he disease, i ncl u di n g t he bacterial c ol o nizati o n of f ollicles, t he h y p ersecreti o n of t he 
se bace o us gl a n d, a n d i ntr af ollic ular h y perc or nifi cati o n t hat i n d uces f ollic ular o bstr ucti o n. 
Effecti ve treat me nt dir ect e d a gai nst t he c ol o nizati o n of bacteria ( P. a c nes ) i n f ollicles has 
ma de use of a nti -i nfecti v es s uc h as t o pical be nz o yl per o xi de ( 2. 5 % -1 0 %), cli n da m yci n, a n d 
er yt hr o m yci n a n d s yste mic tetrac ycli n es; h o we ver, k n o w n disa d va nta ges t o t his treat me nt 
m o dalit y i ncl u de irritati o n a n d li mite d use d ue t o pat h o ge n resista nce [2 -5 ]. Effecti ve 
treatme nt direct e d t o war ds i n hi biti n g se bace o us gla n d acti vit y h as i ncl u de d oral 
c ortic oster oi ds, s pir o n olact o ne, a n d is otreti n oi n i n a d diti o n t o a nti -a n dr o ge ns  
(e g, c y pr ot er o ne acet ate). K n o w n disa d va nta ges t o t his treat me nt m o dalit y i ncl u de bei n g 
li mite d t o use i n fe males (a nti-a n dr o ge ns), a n d li mite d t o s h ort ter m use f or safet y ( oral 
c ortic oster oi ds). Fi nall y, effecti ve treat me nt direct e d a gai nst i ntraf ollic ular 
h y perc or nifi cati o n has m a de use of reti n oi ds s uc h as oral is otreti n oi n a n d t o pical treti n oi n or 
is otreti n oi n t o re g ulate t h e i ntraf ollic ular k erati nizati o n pr ocess, i n hi biti n g f ollic ular 
h y per ker ati nizati o n a n d f ollic ular o bstr ucti o n [6 ]. I n ge neral, t he k n o w n us ef ul ness of oral 
reti n oi ds (ie, oral is otreti n oi n) is li mite d b y t heir si de effects, w hic h ra n ge fr o m relati vel y 
mi n or effects (e g, dr y n ess of m uc osa a n d s ki n, s ki n irritati o n, a n d s ki n scali n g) t o maj or 
t o xicit y s y n dr o mes (r e versi ble hair l oss, b o ne t o xicit y a n d t erat o ge ni cit y) a n d ma y i ncl u d e 
var yi n g d e gr ees of  s y m pt o ms ass ociate d wit h h y p er vita mi n osis A s y n dr o m e [2 , 7 , 8 ]. 
Li ke wis e, t he efficac y of t o pical reti n oi ds s uc h as treti n oi n or is otreti n oi n ma y b e li mite d b y  
t he k n o w n si de effects, w hic h i ncl u de si g nifi ca nt er yt he m a, dr y ness, p eeli n g, scali n g, a n d 
irritati o n [9 ]. 

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C O N FI D E N TI A L  
1 8  
 
 
 
 
Treti n oi n (all -tra ns-reti n oic-aci d) is a m e m ber of t he reti n oi d fa mil y of c o m p o u n ds a n d is a 
meta b ol ite of Vita mi n A t hat occ urs nat urall y i n a ni mal a n d h u ma n tiss ues. W hile oral 
reti n oi ds (e g, is otreti n oi n) are reser ve d f or treat me nt of se vere n o d ular ac ne or se vere ac n e 
resista nt t o oral a nti bi otics, t o pical reti n oi ds (e g, treti n oi n or is otreti n oi n) a pplie d dail y are 
use d t o i n hi bit t he f or mati o n of c o me d o nes a n d us uall y cl ear e ve n se v ere c o me d o nal ac n e 
wit hi n a fe w m o nt hs [6 ]. T o pical f or mati o ns of treti n oi n ha ve bee n use d t o treat ac n e i n t he 
U nite d States ( U S) a n d t he E ur o pea n U ni o n f or m ore t ha n 2 5 years.  
Treti n oi n bi n ds wit h hi g h affi nit y t o s pecific reti n oic aci d rece pt ors l ocate d i n b ot h t he 
c yt os ol a n d n u cle us, b ut c uta ne o us le vels of treti n oi n i n e x cess of p h ysi ol o gic c o nce ntrati o ns 
occ ur f oll o wi n g a p plicati o n of a treti n oi n-c o ntai ni n g t o pical dr u g pr o d uct. Treti n oi n acti vates 
3 me m bers of t he r eti n oi d aci d ( R A R) n uclear rece pt ors ( R A R α, R A R β, a n d R A Rγ) w hic h 
act t o m o dif y ge ne e x pressi o n, s u bse q ue nt pr otei n s y nt hesis, a n d e pit helial cell gr o wt h a n d 
differe ntiati o n ; h o we v er, it has n ot bee n esta blis he d w het her t he cli nical effects of treti n oi n 
are me diat e d t hr o u g h acti vati o n of reti n oic aci d rece pt ors, ot her mec ha nis ms, or b ot h.  
Alt h o u g h t he e x act m o de of acti o n of treti n oi n is u n k n o w n, c urre nt e vi de nce s u g gests t ha t 
t o pical treti n oi n decreases c o hesi ve ness of f ollic ular e pit helial cells wit h decreas e d 
micr oc o me d o f or m ati o n. A d diti o nall y, treti n oi n sti m ulates mit otic acti vit y a n d i ncreas e d 
t ur n o ver of f ollic ular e pit helial cells ca usi n g e xtr usi o n of t he c o me d o nes. 
I DP -1 2 1 is a l oti o n c o ntai ni n g 0. 0 5 % treti n oi n f or t he t o pical treat me nt of ac ne. T his 
pr o p ose d pr o d uct is t he first l oti o n f or m ulati o n de vel o pe d f or treti n oi n a n d will be e val uate d 
f or effecti ve n ess i n treati n g ac ne v ul garis. 
 
6  St u d y O bjecti ves a n d  P ur p ose  
T he o bjecti ve of t h e st u d y is t o e val uat e t he efficac y, s afet y a n d t olera bilit y of a o nce -dail y 
t o pical a p plicati o n of I D P-1 2 1 L oti o n c o m pare d t o its ve hicle (I D P -1 2 1 V e hicle L oti o n) i n 
s u bjects wit h m o derate t o se vere ac n e v ul garis (a sc ore of 3 or 4 [ m o derate t o se vere] o n t he 
E G S S scale).  
 
7  I n vesti g ati o n al pl a n 
7. 1  
O ver all St u d y Desi g n a n d Pl a n: Descri pti o n  
T his is a m ultice nter, ra n d o mize d, d o u ble -bli n d, parallel -gr o u p st u d y d esi g ne d t o assess t he 
safet y, efficac y a n d t oler a bilit y of I D P-1 2 1 L oti o n i n c o m paris o n wit h its ve hicle. T o be 
eli gi ble f or t he st u d y, s u bjects m ust be at least 9 years of a ge a n d ol der a n d ha ve a cli nical 
dia g n osis of m o derate t o se vere ac n e v ul garis (a s c ore of 3 or 4 [ m o derate t o se vere] o n t he 
E G S S scale).  
A p pr o xi matel y 8 0 0 s u bj ects will be e nr olle d i nt o t his st u d y a n d ra n d o mize d i nt o o ne ( 1) of 
t w o ( 2) treat me nt gr o u ps: 4 0 0 s u bjects i n t he I D P-1 2 1 L oti o n, o nce d ail y a p plicati o n gr o u p,  

Protocol V01-121A-301, IDP-121 
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19 
 
 
 
 
and 400 subjects in the IDP-121 Lotion Vehicle, once daily application group. Subjects will 
be enrolled at a minimum of 32 and maximum of 50 independent study centers. The duration 
of treatment will be 12 weeks. Subjects will be evaluated at Screening, Baseline and at 
subsequent follow-up visits (Weeks 4, 8, and 12). 
An interactive web based response system (IWRS) will be employed to facilitate 
randomization of study patients. Treatment assignments and study drug kit numbers will be 
generated centrally by the IWR system. At each clinical site, subject numbers will be 
assigned consecutively at the screening visit starting with 001. 
The assigned study drug will be applied topically to the face once daily for 12 weeks (up to 
week 12 visit). The initial application will be made at the investigational center as per 
instruction from the study coordinator or designee. The subjects will be instructed to avoid 
exposure to direct sunlight to prevent sunburn. Subjects will apply their daily treatments at 
home as explained by the study coordinator or designee at each investigational center. During 
post-baseline study visits (Weeks 4, 8 and 12) the subjects will be asked to return their used 
tubes of study drug and will be dispensed new tubes of study drug (only Weeks 4 and 8; 
Week 12 will be final visit). During the study, each subject will only be permitted to use 
approved non-medicated cleansers, moisturizers and sunscreens. 
Subjects will be asked to complete three questionnaires during the study: the Subject Self 
Assessment scale (SSA, Appendix 17.3), the Patient Satisfaction Survey (PSS, Appendix 
17.4) and the Acne-Specific Quality of Life Questionnaire (Acne-QoL, Appendix 17.5). The 
Investigator assessments (EGSS, lesion counts) will be conducted independently of these 
subject self assessments. The EGSS should be completed prior to the lesion counts. Subjects 
will assess the severity of their acne at the baseline visit and at Weeks 2 (at home), 4, 8, and 
12 by completing the SSA. The Week 2 SSA form will be dispensed to the subject at the 
baseline visit with instructions to complete it two weeks later and return it the Week 4 visit; 
sites should call the Subject at Week 2 to remind them to complete the SSA. Subjects will 
complete the PSS related to prior therapy at baseline, and at Week 12 will complete the PSS 
related to current study medication. The Acne-QOL will be completed at baseline and Week 
12. Inferential statistical analysis will not be performed on these questionnaires; the 
subjective responses will be compared between treatment groups for trends. 
Information on reported and observed adverse events (AEs) will be obtained at each visit. An 
abbreviated physical examination and safety labs will be performed at Baseline and Week 12 
(end of treatment, final visit) for all subjects. 
For all female subjects of childbearing potential, urine pregnancy testing will be performed at 
Screening and confirmed at Baseline with a urine pregnancy test prior to randomization, and 
at Weeks 4, 8 and 12. 

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Subjects who terminate study participation early will be asked to complete all Week 12 
assessments, as appropriate. Subjects who discontinue from the study during the treatment 
period will not be replaced. 

Version 4, 07 October 2016 
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21 
 
 
Protocol V01-121A-301, IDP-121 
Valeant Research & Development 
 
Table 1. 
Study Design and Schedule of Assessments 
 
PROCEDURES 
VISIT 11 
Screening 
Visit 
VISIT 22 
Baseline 
Day 0 
VISIT 32 
Week 4 
(Day 28 ±3 days) 
VISIT 42 
Week 8 
(Day 56 ± 3 days) 
VISIT 52,3 
Week  12 
(Day 84 -3/+5 days) 
Informed consent/Assent 
X 
Obtain Subject Number from IWRS 
X 
Demographics 
X 
Medical history 
X 
X 
Inclusion/Exclusion criteria 
X 
X 
Previous therapies 
X 
PSS & Acne-QoL 
X 
X 
SSA4 
X 
X 
X 
X 
Urine Pregnancy Test (UPT) (FOCBP) 
X 
X 
X 
X 
X 
Abbreviated physical examination and vital signs 
X 
X 
Safety labs (hematology, CBC/diff, urinalysis) 
X 
X 
Oily/shiny skin assessment 
X 
X 
Lesion Counts 
X 
X 
X 
X 
X 
EGSS 
X 
X 
X 
X 
X 
Photographs (select sites only) 
X 
X 
Cutaneous Safety Evaluation 
X 
X 
X 
X 
Tolerability Evaluation 
X 
X 
X 
X 
Randomization in IWRS (obtain kit #) 
X 
X 
X 
Administer Subject Instructions (Appendix 17.1) 
X 
Dispense Study Drug5 
X 
X 
X 
Weigh Study Drug to the nearest 0.1gram 
X 
X 
X 
X 
Study Drug applied at investigational center 
X 
Study Drug Collected 
X 
X 
X 
Subject Diary Calendar dispensed 
X 
X 
X 
Subject Compliance Reviewed / Diary 
X 
X 
X 
Adverse Events 
X 
X 
X 
X 
X 
Concomitant Therapy and Prohibited Therapies Review 
X 
X 
X 
X 
X 
End of Study 
X 
1 If no washout is needed, Visits 1 and 2 may occur on the same day. If a washout is needed, Visit 2 must occur after the appropriate washout period. 
2 All visit dates are in reference to baseline, e.g., Visit 4 occurs 8 weeks +/- 3 days after baseline visit. 
3 All Week 12 procedures should be completed for all subjects who terminate early. 
4 The Week 2 SSA will be sent home with the subject during the baseline visit (Visit 2) with instructions to complete it at two weeks and return it at 
the Week 4 visit. The site should call the subject at Week 2 to remind them to take the Week 2 SSA. 
5 Dispense one tube of test material at the Baseline, Week 4 and Week 8 visits. 

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8 Selection and Withdrawal of Subjects 
8.1 
Subject Inclusion Criteria 
Subjects meeting all of the following criteria will be eligible for study entry: 
1. Male or female at least 9 years of age and older; 
2. Written and verbal informed consent must be obtained. Subjects less than age of 
consent must sign an assent for the study and a parent or a legal guardian must sign 
the informed consent (if subject reaches age of consent during the study they should 
be re-consented at the next study visit); 
3. Subject must have a score of 3 (moderate) or 4 (severe) on the Evaluator’s Global 
Severity assessment at the screening and baseline visit; 
4. Subjects with facial acne inflammatory lesion (papules, pustules, and nodules) count 
no less than 20 but no more than 40; 
5. Subjects with facial acne non-inflammatory lesion (open and closed comedones) 
count no less than 20 but no more than 100; 
6. Subjects with two or fewer facial nodules; 
7. Females of childbearing potential1 and females that are pre-menses must be willing to 
practice effective contraception for the duration of the study. (Effective contraception 
is defined as stabilized on oral contraceptive for at least 3 months, IUD, condom with 
spermicidal, diaphragm with spermicidal, implant, Nuvaring, injection, transdermal 
patch or abstinence.) Females on birth control pills must have taken the same type pill 
for at least three months prior to entering the study and must not change type during 
the study. Those who have used birth control pills in the past must have discontinued 
usage at least three months prior to the start of the study. Women who use birth 
control for acne control only should be excluded. 
8. Pre-menses females and females of childbearing potential must have a negative urine 
pregnancy test2 at the screening and baseline visits; 
9. Subjects must be willing to comply with study instructions and return to the clinic for 
required visits. Subjects under the age of consent must be accompanied by the parent 
or legal guardian at the time of assent/consent signing; 
10. If a cleanser, moisturizer or sunscreen is needed during the study, Subjects must be 
willing to use only allowed cleansers, moisturizers, sunscreens, or 
 
 
1 Pre-menses females and Females of Child Bearing Potential (FOCBP) include any female who has not undergone 
successful surgical sterilization (hysterectomy, bilateral tubal ligation or bilateral oophorectomy) or is not 
postmenopausal [defined as amenorrhea >12 consecutive months; or women on hormone replacement therapy 
(HRT) with documented plasma follicle-stimulating hormone (FSH) level >35mLU/mL]. Even women who are 
using oral, implanted or, injectable contraceptive hormones, an intrauterine device (IUD), barrier methods 
(diaphragm, condoms, spermicidal) to prevent pregnancy, practicing abstinence or where partner is sterile (e.g., 
vasectomy), should be considered to be of child bearing potential. 
2 Urine pregnancy tests must have a minimum sensitivity of 25mIU -HCG/mL of urine and must be performed 
within 72 hours prior to the start of study medication. Kits will be provided by the CRO. 

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moisturizer/sunscreen combination products (see Appendix 17.2). If the subject wears 
makeup they must agree to use non-comedogenic makeup. 
 
8.2 
Subject Exclusion Criteria 
Subjects meeting any of the following criteria will be excluded from the study: 
1. Use of an investigational drug or device within 30 days of enrollment or participation 
in a research study concurrent with this study; 
2. Any dermatological conditions on the face that could interfere with clinical 
evaluations such as acne conglobata, acne fulminans, secondary acne, perioral 
dermatitis, clinically significant rosacea, gram-negative folliculitis; 
3. Any underlying disease(s) or some other dermatological condition of the face that 
requires the use of interfering topical or systemic therapy or makes evaluations and 
lesion count inconclusive; 
4. Subjects with a facial beard or mustache that could interfere with the study 
assessments; 
5. Subjects with more than two (2) facial nodules; 
6. Evidence or history of cosmetic-related acne; 
7. Subject has a history of experiencing significant burning or stinging when applying 
any facial treatment (eg, make-up, soap, masks, washes, sunscreens, etc) to their face; 
8. Female subjects who are pregnant, nursing mothers, planning a pregnancy during the 
course of the trial, or become pregnant during the study; 
9. Use of estrogens (eg, Depogen, Depo-Testadiol, Gynogen, Valergen, etc) for less than 
12 weeks immediately preceding study entry; Subjects treated with estrogens 12 or 
more consecutive weeks immediately prior to study entry need not be excluded unless 
the Subject expects to change dose, drug or discontinue estrogen use during the study; 
10. If female, subject has a history of hirsutism, polycystic ovarian disease or clinically 
significant menstrual irregularities; 
11. Treatment of any type of cancer within the last 6 months; 
12. Subject uses medications and/or vitamins during the study which are reported to 
exacerbate acne (azothiaprim, haloperidol, Vitamin D, Vitamin B12, halogens such as 
iodides or bromides, lithium, systemic or mid-to super-high potency corticosteroids, 
phenytoin and phenobarbital); Daily vitamins at the prescribed amounts are 
acceptable; 
13. History of hypersensitivity or allergic reactions to any of the study preparations as 
described in the Investigator’s Brochure, including known sensitivities to any dosage 
form of tretinoin; 
14. Concomitant use of potentially irritating over-the-counter products that contain 
ingredients such as benzoyl peroxide, alpha-hydroxy acid, salicylic acid, retinol or 
glycolic acids; 

Pr ot oc ol V 0 1 -1 2 1 A -3 0 2, I D P -1 2 1  
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C O N FI D E N TI A L  
2 4  
 
 
1 5.  S u bjects t hat ha ve n ot u n der g o ne t h e s pecifie d w as h o ut peri o d(s) f or t he  f oll o wi n g 
t o pical pre p arati o ns use d o n t he face or s u bjects w h o re q uire t he c o nc urre nt use of 
a n y of t he f oll o wi n g t o pical a ge nts i n  t he treat me nt area : 
 
T o pical astri n ge nts a n d a brasi ves o n face  
1 wee k  
A nti bi otics o n t he facial area  
2 wee ks  
N o n -all o we d m oist urizers or s u nscree ns o n face  
2 wee ks  
Ot her t o pical a nti -ac ne dr u gs o n face  
2 wee ks  
S oa ps c o ntai ni n g a nti micr o bials o n t he face  
2 wee ks  
A nti -i nfla m mat or y a ge nts a n d c ortic oster oi ds o n t he 
facial area 
 
4 wee ks  
Reti n oi ds, i ncl u di n g reti n ol o n t he face  
4 wee ks  
 
If t he s u bject re q uires t o pical treat me nt f or ac ne o n areas ot her t ha n t he face (e. g., 
c hest a n d/ or bac k), t he i n vesti gat or ma y prescri b e a pr o d uct t hat d oes n ot c o ntai n 
treti n oi n a n d m ust be n ote d i n s o urce d o c u me nts a n d e C R F. 
 
1 6.  S u bjects t hat ha ve n ot u n der g o ne t he s p ecifie d w as h o ut peri o d(s) f or t h e f oll o wi n g 
s yste mic me dicati o ns or s u bjects w h o re q uire t he c o nc urre nt use of a n y of t he 
f oll o wi n g s yste mic me di cati o ns:  
 
C ortic oster oi ds (i ncl u di n g i ntra m usc ul ar i njecti o ns)  
(i n hale d c ortic oster oi ds are all o we d) 
 
4 wee ks  
A nti bi otics  
4 wee ks  
Ot her s yste mic ac n e treat me nts  
4 wee ks  
S yste mic reti n oi ds  
6 m o nt hs  
 
1 7.  S u bject i nte n ds t o use a ta n ni n g b o ot h or s u n b at he d uri n g t he  st u d y. 
1 8.  S u bjects w h o are u n a ble t o c o m m u nicate or c o o p erate wit h t he I n v esti gat or d ue t o 
la n g u a ge pr o ble ms, p o or me ntal de vel o p me nt, or i m paire d cere bral f u ncti o n. 
1 9.  S u bjects wit h a n y u n derl yi n g diseas e t hat t he I n vesti gat or dee ms u nc o ntr oll e d,  a n d 
p oses a c o ncer n f or t he s u bjects safet y w hile p arti ci pati n g i n t he  st u d y. 
 
8. 3  
S u bject Wit h dr a w al  Criteri a  
Reas o ns f or wit h dra wal ma y i ncl u d e, b ut are n ot li mite d t o, t he f oll o wi n g: 
•  Ac ne flare, as deter mi ne d b y t he i n vesti gat or, w hic h re q uires treat me nt wit h  a 
disall o we d  t hera p y. 
•  Eit her at t he i n vesti gat or's re q uest, f or t olera bilit y reas o ns (e g, se vere  a d v erse 
reacti o ns), or at t he s u bject’s re q u est. 
•  W he n t he re q uire me nts of t he pr ot oc ol are n ot  f oll o we d. 
•  W he n a c o nc o mita nt t her a p y li kel y t o i nterfere wit h t he res ults of t he st u d y is 
re p orte d, or re q uir e d b y t he s u bject (t he i n vesti gat ors will re p ort all s uc h i nf or mati o n 

Pr ot oc ol V 0 1 -1 2 1 A -3 0 2, I D P -1 2 1  
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2 5  
 
 
o n t he s o urce d o c u me nts /case re p ort f or ms ( C R Fs) a n d deci de, i n acc or da nce wit h t he 
s p o ns or, w het her t he s u bj ect is t o be wit h dra w n). 
•  W he n a s u bject is l ost t o f oll o w -u p. T he i n vesti gat ors will tr y t wice t o reac h t he 
s u bject b y tel e p h o ne a n d will se n d a f oll o w-u p letter b y certi fie d mail bef ore 
c o nsi deri n g t hat t he s u bject is l ost t o f oll o w -u p. T hese acti o ns will be re p orte d o n  t he 
E n d of St u d y C R F a n d a c o p y of t he f oll o w -u p lett er mai ntai ne d i n t he i n vesti gat or's 
file. 
All pre mat ure disc o nti n u ati o ns a n d t heir reas o ns m ust be ca ref ull y d o c u me nte d b y t he 
i n vesti gat or o n t he fi nal C R F, a n d, if nee d b e, o n t he A E f or m. I n a n y cas e, n o s u bject w h o has 
bee n i ncl u de d a n d has a st u d y n u m ber assi g n e d ca n be re place d b y a n ot h er if t he y disc o nti n ue 
pre mat urel y f or w hat e ver reas o n. All data  gat here d o n t he s u bject pri or t o ter mi nati o n will be 
ma de a vaila ble t o t he s p o ns or.  
Reas o ns f or st u d y c o m pl eti o n/ disc o nti n uati o n as liste d o n t he fi nal re p ort f or m are d efi ne d as 
f oll o ws: 
N or m al St u d y C o m pleti o n –  S u bject c o m pletes t he st u d y as pla n ne d i n t h e pr ot oc ol.  
A d verse E ve nt –  C o m plete A E f or m.  
De at h –  C o m plete S A E f or m.  
S u bject Re q uest –  C o nse nt wit h dra wal, s u bject m o ve d, sc he d ule c o nflicts. 
Pr ot oc ol Vi ol ati o n –  C o ntact t he S p o ns or or desi g nee bef ore ma ki n g d ecisi o n. 
L ost t o F oll o w -U p –  D o c u me nt wit h 2 p h o ne calls a n d a certifie d letter.  
Pre g n a nc y –  S u bject will disc o nti n ue st u d y dr u g i m me diatel y, b ut will be f oll o we d t o ter m. 
C o m plete pre g na nc y a n d S A E f or ms.  
W orse ni n g C o n diti o n –  S u bject re q uires alter nate treat me nt f or ac ne b ef ore t he e n d of t he 
st u d y a n d t he i n vesti gat or deter mi nes it is n ot d ue t o lac k of efficac y. 
L ac k of Effic ac y –  S u bject re q uir es alter n ate treat me nt f or ac n e after at least 2 wee ks of 
st ud y dr u g tr eat me nt a n d t he ris k of c o nti n ui n g t he s u bject i n t he st u d y o ut wei g hs t h e be nefit 
as deter mi ne d b y t he i n v esti gat or.  
Wit h dr a w al b y P are nt/ G u ar di a n –  A n i n dicati o n t hat t he st u d y partici pa nt has bee n 
re m o ve d fr o m t he st u d y b y t he p are nt or l e gal guar dia n. C o nse nt wit h dra w al, s u bject m o ve d, 
sc he d ule c o nflicts. 
St u d y Ter mi n ate d b y S p o ns or –  A n i n dicati o n t hat a cli nical st u d y was st o p pe d b y its 
S p o ns or.  
Ot her –  S pecif y i n c o m me nts secti o n of fi nal C R F.  
S u bjects w h o ter mi nate treat me nt earl y will be a s ke d t o c o m plete all Wee k 1 2 assess me nts a n d 
pr oce d ur es pri or t o c o m me nce me nt of a n y alter n ati ve t hera p y f or ac ne (if p ossi ble). S u bjects 
w h o disc o nti n ue fr o m t he st u d y d uri n g t he treat m e nt peri o d will n ot be re place d.  

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CONFIDENTIAL 
26 
 
 
All subjects are free to withdraw from participating in this study at any time and for whatever 
reason, specified or unspecified, and without prejudice. No constraints will be placed on ordinary 
subject management, and subjects, when appropriate, will be placed on other conventional 
therapy upon request or whenever clinically necessary as determined by their physician. 
 
9 Treatment Plan 
9.1 
Methods of Assigning Subjects to Treatment Groups 
This is a double-blinded study, in which the identity of the study drug will be unknown to 
investigator/evaluator and subjects, as well as all individuals closely associated with the study. 
Subjects will be randomized to 1 of the 2 study drug groups in a ratio of 1:1 (IDP-121 [tretinoin 
0.05%] Lotion : IDP-121 Vehicle Lotion). Each screened subject will be assigned a unique 6- 
digit study subject number assigned by the investigational center, which will consist of the 3- 
digit investigational center/site number (pre-assigned by sponsor/designee) and the 3 digit 
chronological screening order number, starting with 001 (eg, 101001, 101002). The study drug 
kit will be assigned to subjects based on a randomization code and kit will be dispensed to the 
subjects at Baseline by the IRW system, and at Week 4 and Week 8 visits. A study drug log will 
document the inventory and dispensing of study drug at each investigational center. 
 
9.2 
Randomization and Blinding 
The study drugs will be packaged and labeled identically, and the study drug kits will be 
numbered sequentially and dispensed randomly to the subjects entering the study within each 
investigational center. Study drug supplies will be distributed to the investigational centers to 
maintain the randomization ratio within each investigational center. 
As a double-blinded study, the investigators, the site staff, the sponsor, and the clinical monitors 
will not be aware of the treatment assigned to the individual study subjects. Delegated staff 
members at each investigational center will dispense the study drugs and will collect all used and 
unused study drug tubes as scheduled. 
 
9.3 
Un-blinding 
The treatment assignments for all enrolled subjects will be unblinded only after the conclusion of 
the study. Specifically, the blind will be broken only after all data are verified, entered into the 
database, and validated; subject evaluability assessments are performed and entered into the 
database; and the database is locked. 
In the case of a medical emergency, the investigator can break the blind for the subject involved 
preferably by first discussing the situation with the medical monitor and the sponsor (or 
designee) immediately. After confirmation, the investigator will be contacted with unblinding 

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information by a sponsor representative. The investigator will record the code break in the 
subject’s source documents. 
 
9.4 
Prior and Prohibited Concomitant Medication or Therapy 
Any concomitant medication or therapy stopped for washout as indicated below is to be 
recorded. As noted in the exclusion criteria, there are mandatory washout periods and restrictions 
during the study for the following topical treatments on the face that have a known beneficial 
effect for acne vulgaris: 
 
Topical astringents and abrasives on the face 
1 week 
Antibiotics on the facial area 
2 weeks 
Non-allowed moisturizers or sunscreens on the face 2 weeks 
Other topical anti-acne drugs on the face 
2 weeks 
Soaps containing antimicrobials on the face 
2 weeks 
Anti-inflammatory agents and corticosteroids on 
the facial area 
4 weeks 
Retinoids, including retinol on the face 
4 weeks 
 
If the subject requires topical treatment for acne on areas other than the face (eg, chest or back), 
the investigator may prescribe a product that does not contain tretinoin and noted in source 
documents and eCRF. 
In addition there is a mandatory wash out period and restrictions during the study for the 
following systemic drugs: 
 
Corticosteroids (including intramuscular injections, 
inhaled corticosteroids are allowed) 
4 weeks 
Antibiotics 
4 weeks 
Other systemic acne treatments 
4 weeks 
Systemic retinoids 
6 months 
 
Subjects using concomitant medications or therapies during the course of the study that could 
interfere with the interpretation of the study results (including but not limited to those listed 
above) should not be withdrawn, but the use of the concomitant product should be discontinued. 
No other topical treatment (except as noted above) other than the study drug will be permitted for 
acne. 
Information on concomitant medications or therapies will be recorded in the Prior and 
Concomitant Medication or Therapy source document and eCRF. Any therapy used by the 
subject will be considered concomitant therapy (e.g., Facial procedures, surgical procedures, 
investigations and operations) and any medication both over the counter (OTC) or prescription 
used by the subject will be considered concomitant medication (eg, aspirin, Tylenol, birth control 
pills, vitamins, moisturizers, sunscreens). Every attempt should be made to keep concomitant 

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medication and therapy dosing constant during the study. Any change to concomitant medication 
or therapy should be noted on the Concomitant Medication or Therapy source document and 
eCRF. 
All cleansers and moisturizers and other topical products used on the treatment area that are not 
prescription products will be captured on the Concomitant Medication source document and 
eCRF. Subjects must use Investigator approved non-medicated cleansers, moisturizers, and 
sunscreens. 
Subjects should avoid excessive UV exposure by such activities as sun bathing or tanning 
booths. 
 
9.5 
Treatment Compliance 
Each subject will be instructed on the importance of returning his or her study drug at each 
applicable study visit. If a subject does not return his or her study drug, he or she will be 
instructed to return it as soon as possible. The subjects will bring the tubes dispensed at each 
treatment visit to the next subsequent study visit. Each tube will be weighed (with the cap on) to 
the nearest 0.1 gram by a study coordinator or designee prior to dispensation and after collection. 
The subject will also be asked to complete a diary calendar and questioned regarding the study 
drug use since the previous visit in order to judge the subject’s compliance with applying the 
study drug. A subject who deviates significantly from the prescribed application amount will be 
counseled. Any missed applications of study drug will be noted by the subject on the diary, 
which will be collected and placed in the appropriate source document. Missed applications will 
be documented in the eCRF. The subject will also be sent home with a Subject Self Assessment 
(SSA) survey at the Baseline visit, with instructions to complete it at home at two (2) weeks after 
their baseline visit, and return it at the Week 4 study visit. 
 
9.6 
Protocol Deviations and Violations 
The investigators must read the protocol thoroughly and must follow the instructions exactly. 
A deviation from the protocol is an unintended and/or unanticipated departure from the 
procedures and/or processes approved by the sponsor and the IRB/IEC and agreed to by the 
investigator. Deviations usually have an impact on individual patients or a small group of 
patients and do not involve inclusion/exclusion or primary endpoint criteria. 
A protocol violation occurs when there is nonadherence to the protocol that results in a 
significant, additional risk to the patient, when the patient or investigator has failed to adhere to 
significant protocol requirements (inclusion/exclusion criteria) and the patient was enrolled 
without prior sponsor approval, or when there is nonadherence to FDA regulations and/or ICH 
GCP guideline. 

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The investigator or designee must document and explain in the patients’ source documentation 
any deviation from the approved protocol. The investigator may implement a deviation from, or 
a change of, the protocol to eliminate an immediate hazard to study patients without prior 
IRB/IEC approval. As soon as possible after such an occurrence, the implemented deviation or 
change, the reasons for it, and any proposed protocol amendment(s) should be submitted to the 
IRB/IEC for review and approval, to the sponsor for agreement, and to the regulatory authorities, 
if required. 
 
10 Study Drug Materials and Management 
The study drug will be dispensed by an appropriately qualified member of the study staff 
assigned by the investigator to this task. 
 
10.1 IDP-121 Lotion and IDP-121 Vehicle Lotion 
Chemical structure and formula for the active ingredients in IDP-121 Lotion and vehicle are 
listed in the tables below: 
Table 2. 
Drug Substances Identification 
 
Active Ingredient 
Tretinoin 0.05% 
Chemical Name 
(2E,4E,6E,8E)-3,7-dimethyl-9-(2,6,6-trimethylcyclohexen-1-yl)nona- 
2,4,6,8-tetraenoic acid 
Chemical Class 
Retinoid 
Molecular Formula 
C20H28O2 
CAS Registry Number 
302-79-4 
 
Table 3. 
Test Product Identification 
 
Investigational Product 
Vehicle 
Name of Active Ingredient 
Tretinoin, EP / USP 
N/A 
Drug Name/Formulation/ 
Concentration 
IDP-121 Lotion [Tretinoin 0.05%] 
IDP-121 Vehicle Lotion 
Manufacturer 
Valeant Pharmaceuticals International, Inc. 
2150 St. Elzear Boulevard West 
Laval (Quebec), Canada H7L 4A8 
Packaging 
45 g tube 
45 g tube 
Storage Requirements 
Store at 20°C to 25°C (68°F to 
77°F) 
Store at 20°C to 25°C (68°F 
to 77°F) 
Appearance 
Opaque pale yellow lotion 
Opaque pale yellow lotion 
Dosing Schedule 
Once daily x 12 weeks 
Once daily x 12 weeks 
Route of Administration 
Topical Application 
Topical Application 

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1 0. 1. 1  P ac k a gi n g a n d  L a beli n g  
I D P-1 2 1 L oti o n a n d its ve hicle will be s u p plie d i n s u bject kits. I nstr ucti o ns will be pr o vi de d t o 
t he st u d y dr u g tec h nicia n res p o nsi ble at t he cli nical sites. W he n a s u bject is ra n d o mize d i nt o t he 
st u d y, t he I W R S s pecific kit n u m ber will be assi g ne d t o be use d f or t hat ra n d o mize d s u bject b y 
t he I W R s yst e m. Eac h s ubject kit will c o ntai n o ne t u be, w hic h has 4 5 gra ms of st u d y material. A 
ne w s u bject kit will be assi g ne d t o a s u bject at eac h visit: Baseli ne, Wee k 4 a n d Wee k 8. T he 
s u bjects will be dis pe nse d o ne kit at Bas eli ne as assi g ne d i n t he I W R s yste m. T he t u be will be 
wei g h e d ( wit h t he ca p o n) t o t he near est 0. 1 gra m pri or t o dis pe nsi n g. T he s u bject will bri n g t he 
t u be t o t he ne xt st u d y visit ( Wee k 4), w here it will be c ollecte d a n d wei g h e d ( wit h t he ca p o n) t o 
t he near est 0. 1 gra m; o ne ne w t u be will be dis pe ns e d a gai n b y t he I W R s yst e m at Wee k 4, 
wei g h e d ( wit h t he ca p o n) t o t he near est 0. 1 gra m a n d pr o vi de d t o t he s u bject. T he sa me will 
occ ur at t he Wee k 8 visit. If t he s u bject l oses a t u b e (l ost or da ma ge d t u b e), a n ot her kit will be 
dis pe nse d via I W R S. Eac h t u be  dis pe nsi n g will be d oc u me nte d o n t he dr u g acc o u nta bilit y l o g.  
Eac h s u bject kit (a n d t u b e) will ha ve a si n gle p a nel la bel. La bels will c o ntai n t he f oll o wi n g 
i nf or mati o n: 
•  Pr ot oc ol  N u m ber  
•  Kit N u m ber  
•  C o nte nts  
•  S pace f or e ntr y of t he s u bject  i nitials 
•  S pace f or e ntr y of d ate dis pe nse d  
•  T he s p o ns or na me, D o w P har mace utical Scie nces, a di visi o n of  Valea nt 
P har mace uticals N. A., L L C  
•  T he q ua ntit y of pr o d uct ( 4 5  gra ms)  
•  A state me nt rea di n g, “ F or e xter nal use o nl y. A v oi d c o ntact wit h e yes a n d  li ps” 
•  A state me nt rea di n g , “ St ore at c o ntr olle d r o o m te m perat ure 2 0° C t o 2 5° C ( 6 8° F t o 
7 7° F) wit h e x c ursi o ns per mitte d bet wee n 1 5° C t o 3 0° C ( 5 9° F t o 8 6° F) .” 
•  A state me nt rea di n g, “ Ca uti o n: Ne w Dr u g Li mite d b y Fe deral La w t o  I n vesti gati o nal 
Use”  
•  A state me nt rea di n g, “ Ret ur n t his pr o d uct t o y o ur i n vesti gati o nal site at y o ur ne xt 
visit.”  
1 0. 1. 2  St or a ge, H a n dli n g, a n d Dis p os al of St u d y  Dr u g  
T he st u d y dr u g s h o ul d be st ore d at c o ntr olle d r o o m te m perat ure 2 0° C t o 2 5° C ( 6 8° F t o 7 7° F) wit h 
e xc ursi o ns per mitte d bet wee n 1 5° C t o 3 0° C ( 5 9° F t o 8 6° F) , a n d s h o ul d n ot be refri gerate d. All 
u n use d st u d y dr u g will be se nt bac k t o t he S p o ns or or S p o ns or desi g nee u p o n st u d y c o m pleti o n 
f or d oc u me nte d dis p osal. 

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10.1.3 Administration 
Test material will be applied topically to the face once a day for a period of 12 weeks. Test 
material will be applied as a thin coating (a dab the size of a large pea) that is gently rubbed in to 
the skin. The test material use should be limited to the face. 
The Investigator and/or trained investigational center staff member will instruct the subject on 
the proper application procedure of the study drug to the treatment area at the Baseline visit (see 
Appendix 17.1). All subjects will be instructed to apply the test material at approximately the 
same time every day for 12 weeks (up to week 12 visit) after cleansing. On study visit days 
subjects should be instructed to wait until after their study visit to apply study medication. No 
time interval between dosing and meals or any other activity is specified. Subjects will be 
instructed to gently wash their face with a Sponsor approved cleanser and warm (not hot) water. 
After washing, the subjects will be asked to thoroughly rinse and gently pat their face dry. The 
subjects should use the tube to dispense a pea-sized amount of study drug to their fingertip. This 
dose should then be dotted on to 6 areas (chin, left cheek, right cheek, nose, left forehead, right 
forehead) on the face. After distributing the dose in this manner the subject should gently rub the 
lotion into the skin. This amount of drug should be sufficient to cover the entire face excluding 
the mouth, eyes, inside the nose, and lips. It is important for the subject to treat their entire face 
(excluding the mouth, eyes and lips) and they should be instructed NOT to treat only specific 
lesions. They should gently smooth the test material over the face evenly. The test material 
should become invisible almost immediately following application with gentle rubbing. If this 
does not happen, the Investigator should instruct the subject on the use of a smaller dosage. The 
subject should wash his/her hands after applying the investigational product to the face. 
The subjects will be instructed to continue using the same Sponsor approved facial cleanser, 
moisturizer, and sunscreen, and not to change products during the study. At each visit, subjects 
are to be asked if they have changed their cleansing routine. Facial makeup may be applied 
according to the subject’s normal daily routine; however, subjects should be instructed not to 
wear make-up during study visits as it may interfere with the evaluator’s assessments. Subjects 
must also agree to use non-comedogenic makeup during the study if they use makeup. No other 
products should be used on the face. 
Subjects should be instructed to store the test material at room temperature. 
 
10.2 Study Drug Accountability 
Upon receipt of the study drug, the Investigator is responsible for ensuring that the designated 
investigational center staff member will conduct a complete inventory of study materials and 
assume responsibility for their storage and dispensing. In accordance with federal regulations, 
the investigators must agree to keep all study materials in a secure location with restricted access. 
The Investigator will keep a record of the inventory and dispensing of all study drug. This record 

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will be made available to the sponsor’s monitor for the purpose of accounting for all clinical 
supplies. Any significant discrepancy and/or deficiency must be recorded with an explanation. 
All supplies sent to the Investigators will be accounted for and, in no case, used in any 
unauthorized situation. Tubes will be weighed (with the cap on) to the nearest 0.1 gram before 
dispensing to and upon return by the subjects, and weights to the nearest 0.1 gram will be 
recorded on the pharmacy log and appropriate CRF. All used and unused supplies will be 
returned to sponsor/designee for destruction at the conclusion of the study. 
 
11 Study Procedures and Evaluations 
All subject information and data obtained during the study visits will be recorded in the source 
documents, applicable study logs, and eCRFs. 
Evaluators must have appropriate, documented experience and training, or obtain approval from 
the sponsor based on experience (or through additional training organized by the sponsor). 
At each study visit, every attempt should be made to ensure that the same investigator / evaluator 
assesses the same subject. 
 
11.1 Schedule of Evaluations and Procedures 
11.1.1 Visit 1: Screening Visit 
The following procedures will be conducted at this visit: 
1. Obtain written informed consent prior to performing any study procedures. Subjects less 
than 18 years of age must sign an assent form and the parent or legal guardian must sign 
the informed consent form. 
2. Assign the subject a 6-digit subject number by accessing IWRS, which will consist of the 
3-digit site number (pre-assigned to your site) and the 3-digit chronological order 
screening number, assigned by the IWR system and starting with 101 (eg, 101 001, 101 
002, etc; in this example site number is 101). 
3. Record the subject’s demographic information. 
4. Record the subject’s medical history. 
5. Record all previous medications (including acne medications) for the past 4 weeks (past 6 
months for systemic retinoids). Record any therapies that will be used concomitantly 
during the study. 
6. Perform Evaluator’s Global Assessment followed by inflammatory lesion count and non- 
inflammatory lesion count to determine eligibility. 
7. Perform a Urine Pregnancy Test for all females that are pre-menses and females of 
childbearing potential. The urine pregnancy tests will be supplied by the CRO. 
8. Discuss allowed cleansers, moisturizers and sunscreens and record any cleanser, 
moisturizer and sunscreen use. (Appendix 17.2). 

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9.  If s u bject wears ma k e u p, re mi n d t he s u bject n ot t o wear ma k e -u p d uri n g a n y f ut ure  visits.  
1 0.  Verif y t hat t he s u bject meets t he a p plica bl e i ncl usi o n/e x cl usi o n criteria as o utli ne d  i n 
Secti o ns 8. 1  a n d 8. 2 . 
1 1.  Re mi n d s u bject t o n ot a p pl y test me dicati o n o n da y of n e xt st u d y visit pri or t o t he  cli nic 
visit.  
1 2.  If t he s u bject r e q uires a was h o ut, sc he d ule t he Baseli ne visit t o occ ur after t he was h o ut is 
c o m plete. If n o w as h o ut is re q uire d, t he Scree ni n g a n d Bas eli ne v isits ma y o cc ur o n t he 
sa me da y.  
1 3.  Sc he d ule s u bject t o ret ur n f or t he Baseli ne/ D a y 0 visit. If t he s u bject re q uires a was h o ut, 
sc he d ule t he Baseli ne/ D a y 0 visit t o occ ur after t h e was h o ut is c o m plete.  
N O T E : A uri ne pre g n a n c y t est m ust be c o m plete d at Scree ni n g a n d at t he Baseli ne visit pri or t o 
ra n d o mizati o n, a n d at Wee ks 4, 8 a n d 1 2. T h e decisi o n ma y be ma d e b y t he i n vesti gat or t o d o 
a d diti o nal pre g na nc y t ests d uri n g t he c o urse of t he st u d y.  
1 1. 1. 2  Visit 2: B aseli ne Visit ( D a y  0)  
If a w as h o ut is n ot nee de d, t his visit ma y occ ur o n t he sa me da y as t h e Scree ni n g Visit ( Visit 1). 
If a w as h o ut is nee de d, Visit 2 m ust occ ur after t he a p pr o priate was h o ut peri o d base d o n t he 
criteria pr o vi d e d i n Secti o n 8. 2 . 
T he f oll o wi n g pr oce d ures wi ll be c o n d ucte d at t his visit: 
1.  T he baseli ne S u bject Self Assess me nt ( S S A), Patie nt Satisfacti o n S ur ve y ( P S S) a n d t he 
Ac ne -S pecific Q u alit y of Lif e Q uesti o n naire ( Ac n e -Q o L) will be c o m plete d b y t he 
s u bject a n d c ollect e d pri or t o a n y ot her st u d y-relate d pr oce d ures. T he Wee k 2 S S A will 
be se nt h o me wit h t he s u bject wit h i nstr ucti o ns t o c o m plete it at t w o wee ks a n d ret ur n it 
at t he Wee k 4  visit.  
2.  Verif y t hat t he s u bject c o nti n ues t o meet t he a p plica ble i ncl usi o n/e x cl usi o n criteria  as 
o utli ne d i n Secti o ns 8. 1  a n d 8. 2 . 
3.  Rec or d c h a n ges i n a n y c o nc o mita nt me dicati o ns si nce t he pre vi o us visit u n der Pri or a n d 
C o nc o mita nt Me dicati o ns or T hera pi es. C hec k f or pri or a n d c o n c o mita nt t hera pies as  per 
Secti o n  9. 4 . 
4.  Perf or m a Uri ne Pre g n a n c y T est f or all fe males t h at are pre -me ns es a n d fe males of 
c hil d beari n g p ote ntial. T he uri ne pre g na nc y t ests will be s u p plie d b y t he  C R O.  
5.  Perf or m a n a b br e viate d p h ysical e x a m, i ncl u di n g meas ure me nts of hei g ht a n d  wei g ht, 
a n d vital si g ns ( bl o o d press ure, heart rate, res pirati o n rate, a n d oral te m perat ure). A n y 
a b n or mal p h ysical e x a m fi n di n gs will be rec or d e d.  
6.  C ollect bl o o d sa m ples f or r o uti ne la b orat or y a nal ysis ( C B C/ Diff, ser u m c h e mistr y  a n d 
uri nal ysis).  
7.  T he E val uat or will q uer y t he s u bject re gar di n g h o w oil y/s hi n y t heir facial s ki n has  bee n 
i n t he past wee k.  

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8.  T he E val uat or will perf or m Baseli ne efficac y e v al uati o ns i ncl u di n g t he E val uat or’s 
Gl o bal Se verit y Sc ore ( E G S S), i nfla m mat or y lesi o n c o u nts a n d n o n -i nfla m mat or y lesi o n 
c o u nts. T he E G S S is perf or me d pri or t o t he lesi o n c o u nti n g. E ver y eff ort s h o ul d be ma de 
f or t he sa me q u alifie d, vali date d E val uat or t o perf or m t he efficac y e val uati o ns at all visits 
fr o m Bas eli ne t o Wee k 1 2 f or t he sa me s u bject. 
9.  T he E val uat or will perf or m C uta ne o us Safet y a n d T olera bilit y  E val uati o ns.  
1 0.  Assi g n t he s u bject t he pr ese nte d kit n u m ber (t his n u m ber will be ge nerate d fr o m t he 
I nteracti ve We b Res p o nse s yste m, (I W R S)). 
1 1.  T he st u d y c o or di nat or or desi g nee  will wei g h t h e t u be ( wit h t he ca p o n) t o t he nearest  0. 1 
gr a m wit hi n t he assi g ne d kit a n d dis pe nse t o t h e s u bject. A st u d y diar y cale n dar will als o 
be dis pe nse d a n d t he s u bj ect will be i nstr ucte d t o bri n g it i n f or t heir s u bs e q ue nt  visits.  
1 2.  T he st u d y c o or d i nat or or desi g nee will i nstr uct t he s u bject o n t he pr o per a p plicati o n 
pr oce d ur e f or t h e st u d y dr u g p er Secti o n 1 0. 1. 3, a n d will pr o vi de writte n s u bject use 
i nstr ucti o ns t o t he s u bject ( A p pe n di x 1 7. 1). F or t h e first a p plicati o n, t he s u bject will 
a p pl y t he st u d y dr u g at t he i n vesti gati o nal ce nter u n der t he directi o n of t he st u d y 
c o or di nat or or d esi g n ee. T he st u d y dr u g s h o ul d be a p plie d after  all cli nical assess me nts. 
T he st u d y c o or di nat or or desi g nee will i nstr uct t he s u bjects t o a p pl y t he st u d y dr u g o n ce 
da il y at h o me.  
1 3.  Rec or d a n y A Es or c h a n ges i n A Es si nce t he scree ni n g visit a n d/ or re p orte d 
s p o nta ne o usl y b y t he s u bject. 
1 4.  Selecte d Sites o nly - O btai n re prese nt ati ve p h ot o gra p hs of t he  face. 
1 5.  Sc he d ule t he ne xt st u d y visit at Wee k 4 ( Da y 2 8 ± 3 da ys). Re mi n d t he s u bject t o n ot 
a p pl y test me dicati o n o n da y of ne xt st u d y visit, pri or t o t he cli nic  visit.  
1 1. 1. 3  Visit 3 a n d 4: Wee k 4 ( D a y 2 8 ± 3 D a ys) a n d Wee k 8 ( D a y 5 6 ± 3 D a ys)  Visits  
T he f oll o wi n g pr oce d ures will be c o n d ucte d at t his visit (if a s u bject ter mi nates earl y, all fi nal 
visit ( Wee k 1 2/ Fi nal Visit) pr oce d ur es m ust be perf or me d):  
1.  T he ta ke -h o m e Wee k 2 S S A will be c ollecte d d uri n g t he Wee k 4 st u d y  visit.  
2.  T he Wee k 4 or Wee k 8 S S A will be c o n d ucte d a n d  c ollecte d.  
3.  T he E val uat or will perf or m t he effica c y e v al uati o ns i ncl u di n g t he E val u at or’s Gl o bal 
Se verit y Sc ore ( E G S S), i nfla m mat or y lesi o n c o u nts a n d n o n -i nfla m mat or y lesi o n c o u nts. 
T he E G S S is perf or me d pri or t o t he lesi o n c o u nti n g. E ver y eff ort s h o ul d b e ma de f or t he 
sa me q ualifie d a n d v ali date d e val uat or t o perf or m t he efficac y e val uati o ns at all visits 
fr o m Bas eli ne t o Wee k 1 2 f or t he sa me s u bject. 
4.  T he E val uat or will perf or m C uta ne o us Safet y a n d T olera bilit y  E val u ati o ns.  
5.  Rec or d c h a n ges i n a n y c o nc o mita nt me dicati o ns si nce t he pre vi o us visit u n der Pri or a n d 
C o nc o mita nt Me dicati o ns or T hera pi es. C hec k f or pri or a n d c o n c o mita nt t hera pies as  per 
Secti o n  9. 4 . 
6.  Rec or d a n y n e w A Es r e p orte d s p o nta ne o usl y b y t he s u bject or c h a n ges i n a n y  o n g oi n g 
A Es.  

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7.  Perf or m a Uri ne Pre g n a n c y T est f or all fe males t h at are pre -me ns es a n d fe males of 
c hil d beari n g p ote ntial. T he uri ne pre g na nc y t ests will be s u p plie d b y t he  C R O.  
8.  T he st u d y dr u g tec h nicia n will retrie ve a n d wei g h t he use d test m aterial t u be a n d  assi g n 
t he s u bject a n other kit n u m ber (t his n u m ber will be ge n erate d fr o m t he I nteracti ve We b 
Res p o nse s yste m, (I W R S) a n d dis pe nse a n e w s u bject kit of t est materi al. T he t u be will 
be wei g he d o n a cali br ate d scale. Rec or d t he wei g ht ( wit h t he ca p o n) t o t he nearest 0. 1 
gr a m.  
9.  T he  st u d y diar y cal e n dar will be c ollecte d a n d re vi e we d f or c o m plia nce. A n y misse d 
d oses or de viati o ns s h o ul d be re p ort e d. A ne w st u d y diar y cale n d ar will be  dis pe nse d.  
1 0.  Sc he d ule t he s u bse q ue nt st u d y visit, as a p plica ble. Re mi n d t he s u bject t o n ot a p pl y  test 
m e dicati o n o n t he da y of t he ne xt st u d y visit, pri or t o t he cli nic  visit.  
1 1. 1. 4  Visit 5: Wee k 1 2 ( D a y 8 4 -3/ + 5 D a ys) Visit –  E n d of St u d y  Visit  
T he f oll o wi n g pr oce d ures will be c o n d ucte d at t his visit:  
1.  T he Wee k 1 2 S S A, P S S a n d Ac ne -Q o L will be c o m plete d b y t he s u bject a n d  c ollecte d 
pri or t o a n y ot her st u d y -r elate d pr o ce d ures.  
2.  Perf or m a n a b bre viate d p h ysical e x a m, i ncl u di n g meas ure me nts of hei g ht a n d  wei g ht, 
a n d vital si g ns ( bl o o d press ure, heart rate, res pirati o n rate, a n d oral te m perat ure). A n y 
a b n or mal p h ysical e x a m fi n di n gs will be rec or d e d.  
3.  C ollect bl o o d sa m ples f or r o uti ne la b orat or y a nal ysis ( C B C/ Diff, ser u m c h e mistr y  a n d 
uri nal ysis).  
4.  T he E val uat or will q uer y t he s u bject re gar di n g h o w oil y/s hi n y t heir facial s ki n has  bee n 
i n t he past wee k.  
5.  T he E val uat or will perf or m t he efficac y e v al uati o ns i ncl u di n g t he E val u at or’s Gl o bal 
Se verit y Sc ore ( E G S S), i nfla m mat or y lesi o n c o u nts a n d n o n -i nfla m mat or y lesi o n c o u nts. 
T he E G S S is perf or me d pri or t o t he lesi o n c o u nti n g. E ver y eff ort s h o ul d b e ma de f or t he 
sa me q ualifie d a n d v ali date d E val uat or t o p erf or m t he efficac y e v al uati o ns at all visits 
fr o m Bas eli ne t o Wee k 1 2 f or t he sa me s u bject. 
6.  T he E val uat or will perf or m C uta ne o us Safet y a n d T olera bilit y  E val uati o ns.  
7.  Rec or d c h a n ges i n a n y c o nc o mita nt me dicati o ns s i nce t he pre vi o us visit u n der Pri or a n d 
C o nc o mita nt Me dicati o ns or T hera pi es. C hec k f or pri or a n d c o n c o mita nt t hera pies as per 
Secti o n  9. 4 . 
8.  Rec or d a n y n e w A Es r e p orte d s p o nta ne o usl y b y t he s u bject or c h a n ges i n a n y  o n g oi n g 
A E s. 
9.  T he st u d y diar y cal e n dar will be c ollecte d a n d re vi e we d f or c o m plia nce. A n y  misse d 
d oses or de viati o ns s h o ul d be  re p orte d. 
1 0.  T he st u d y dr u g tec h nicia n will retrie ve all test material t u bes fr o m t he s u bj ect a n d  wei g h 
t he t u bes o n a cali br ate d scale a n d recor d t he wei g ht ( wit h t he ca p o n) t o t h e nearest 0. 1 
gr a m.  

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11. For women of child bearing potential, perform a final Urine Pregnancy Test for all 
females that are pre-menses and females of childbearing potential. The urine pregnancy 
tests will be supplied by the CRO. 
12. Selected Sites only - Obtain representative photographs of the face. 
13. Exit the subject from the study and complete the end of study CRFs. 
 
11.2 Evaluation of Efficacy 
The determination of efficacy will be based on evaluator-blinded assessments of the signs and 
symptoms of acne vulgaris. Evaluators must be a board-certified/board-eligible dermatologist or 
have appropriate documented experience and training, and be present for formal study training 
and validation at the Investigator Meeting (and/or Site Initiation Visit), or obtain a waiver from 
the Sponsor based on experience (or through additional training organized by the Sponsor). 
The EGSS scores and lesion counts will be performed at each study visit. The EGSS scores will 
be collected before the Lesion Counts. All Subject assessments will be performed by a trained 
and validated Evaluator. Every effort should be made to have the same evaluator assess the same 
Subject at each visit. If this is not possible, the same Evaluator must assess the Subject at both 
the baseline and Week 12 visits. 
11.2.1 Evaluator’s Global Severity Score (EGSS) 
The Evaluator’s Global Severity Score will be a static assessment that is independent of the 
baseline score. The investigator will make the assessment without referring to the baseline value. 
Every effort should be made for the same evaluator to perform each study assessment for the 
same study subject, for consistency in evaluations. 
Subjects are eligible if they have acne with a global severity of a 3 (moderate) or a 4 (severe) on 
the EGSS at the baseline visit. The following scores will be used to describe the severity grade 
and subsequent score: 
Table 4. Evaluator’s Global Severity Score 
Score 
Grade 
Description 
0 
Clear 
Normal, clear skin with no evidence of acne vulgaris 
1 
Almost 
Clear 
Rare non-inflammatory lesions present, with rare non-inflamed papules (papules must 
be resolving and may be hyperpigmented, though not pink-red 
2 
Mild 
Some non-inflammatory lesions are present, with few inflammatory lesions 
(papules/pustules only; no nodulocystic lesions) 
3 
Moderate 
Non-inflammatory lesions predominate, with multiple inflammatory lesions evident: 
several to many comedones and papules/pustules, and there may or may not be one 
nodulocystic lesion 
4 
Severe 
Inflammatory lesions are more apparent, many comedones and papules/pustules, there 
may or may not be up to 2 nodulocystic lesions 

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11.2.2 Lesion Counts 
The facial area lesion counts will be taken from the subject’s face. The lesion count groups will 
be inflammatory and non-inflammatory. Facial inflammatory lesions (pustules, papules, and 
nodules) will be counted as follows: pustules and papules will be counted and recorded together, 
not separately; nodular lesions will be counted and recorded separately. Non-inflammatory 
lesions (open and closed comedones) will be counted and recorded together. The lesions counts 
will be collected at each visit and/or upon discontinuation. The following are definitions of each 
lesion type counted: 
Inflammatory lesions are defined as follows: 
 
Papule – a solid, elevated lesion less than 5 mm 
Pustule – an elevated lesion containing pus less than 5 mm 
Nodule – palpable subcutaneous lesion greater than 5 mm; has depth, not necessarily elevated 
Non-inflammatory lesions are defined as follows: 
 
Open comedones (blackhead) – plugged hair follicle with dilated/open orifice; black in color 
Closed comedones (whitehead) – plugged hair follicle: small opening at skin surface 
 
11.2.3 Other Assessments 
Oily/Shiny Face Assessment 
The subject will be asked at Baseline and Week 12 to assess how oily their skin has been in the 
past week by the scale below: 
Oily/Shiny skin assessment 
0 – None 
No oily or shiny skin on face 
1 – Mild 
Mild oily or shiny skin on face 
2 – Moderate Definite oily or shiny skin on face 
3 – Severe 
Extremely oily or shiny skin on face 
If subject answers 1, 2 or 3 to the above they will also be asked how often the oily skin made 
them feel bothered during the past week with scale below: 
0 – Not bothered at all 
1 – A little bothered 
2 – Moderately bothered 
3 – Very bothered 
4 – Extremely bothered 
Photography 
At select sites, photographs of the face will be taken at Baseline and Week 12, at a minimum. 
Only subjects who provide written photographic consent for facial photographs will be included 
in photography. 

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11.3 Evaluation of Safety 
Safety assessments will be conducted at baseline and each subsequent visit. 
 
11.3.1 Cutaneous Safety Evaluations 
Cutaneous safety will be evaluated through assessment of scaling, erythema, hypo-pigmentation 
and hyper-pigmentation at the drug-application site at the time of the visit. Cutaneous tolerability 
will be evaluated through assessment of selected local signs and symptoms at the drug- 
application site: itching, burning and stinging at the time of the visit. 
Cutaneous tolerability signs and symptoms that result in the subject’s requiring a concomitant 
therapy, interruption of treatment, or discontinuation from the study, will be reported as an AE. 
(Note: To be assessed by the evaluator at the time of the study visit.) 
Scaling: 
0 – None 
No scaling 
1 – Mild 
Barely perceptible, fine scales present on limited areas of the face 
2 – Moderate Fine scale generalized to all areas of the face 
3 – Severe 
Scaling and peeling of skin over all areas of the face 
 
 
Erythema: 
0 – None 
No evidence of erythema present 
1 – Mild 
Slight pink coloration 
2 – Moderate Definite redness 
3 – Severe 
Marked erythema, bright red to dusky dark red in color 
 
Hypo-pigmentation: 
0 – None 
No evidence 
1 – Mild 
Slight, barely perceptible 
2 – Moderate Definite, evident 
3 – Severe 
Marked, prominent 
 
Hyper-pigmentation: 
0 – None 
No evidence 
1 – Mild 
Slight, barely perceptible 
2 – Moderate Definite, evident 
3 – Severe 
Marked, prominent 
 
11.3.2 Tolerability Evaluations 
To be reviewed with the subject at the study visit as average over the period since the previous 
visit. 

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Itching: 
0 – None 
No itching 
1-  Mild 
Slight itching, not really bothersome 
2 – Moderate Definite itching that is somewhat bothersome 
3 – Severe 
Intense itching that may interrupt daily activities and/or sleep 
 
Burning: 
0 – None 
No burning 
1 – Mild 
Slight burning sensation; not really bothersome 
2 – Moderate Definite warm, burning sensation that is somewhat bothersome 
3 – Severe 
Hot burning sensation that causes definite discomfort and may 
interrupt daily activities and/or sleep 
 
Stinging: 
0 – None 
No stinging 
1 – Mild 
Slight stinging sensation, not really bothersome 
2 – Moderate Definite stinging sensation that is somewhat bothersome 
3 – Severe 
Stinging sensation that causes definite discomfort and may interrupt daily 
activities and/or sleep 
11.3.3 Medical History and Abbreviated Physical Examination 
A medical history will be taken at Screening, and confirmed and revised if needed, at Baseline. 
Medical histories having resolved two or more years before Baseline need not be collected unless 
considered relevant by the investigator. 
An abbreviated physical examination will consist of measurements of height and weight, and 
vital signs (blood pressure, heart rate, respiration rate, and oral temperature) and will be 
performed at Baseline and Week 12 (end of treatment/study). Any abnormal physical exam 
findings will be recorded. 
11.3.4 Laboratory Tests 
Clinical laboratory analyses (CBC/Diff, serum chemistry, and urinalysis) will be conducted on 
blood samples collected from subjects at Baseline and Week 12 visits. All results will be 
reported, including results that are abnormal. Clinically significant results, in the opinion of the 
investigator, should be reported as AEs. If an AE should require laboratory testing, the results of 
the test must be obtained by the investigative site and filed in the subject’s documentation. 
11.3.5 Pregnancy Tests 
All female subjects of childbearing potential will undergo urine pregnancy testing at Screening 
and prior to randomization at Baseline, and at Week 4, 8 and Week 12 visits. The urine 
pregnancy tests will be supplied by the CRO. 

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1 1. 4  A d verse  E ve nts  
1 1. 4. 1  Defi niti o n of A d verse  E ve nt  
A n A E is a n y u nt o war d me dical occ urre n ce i n a patie nt or cli nical i n vesti gati o n s u bject 
a d mi nistere d a me dici nal pr o d uct a n d w hic h d o es n ot necessaril y ha v e a ca usal relati o ns hi p wit h 
t he st u d y dr u g. A Es i ncl u de a n y u nfa v ora ble a n d u ni nte n de d ill ness, si g n, s y m pt o m, cli nicall y 
si g nifica nt la b orat or y test a b n or malit y, or disease t e m p orall y ass ociate d wit h t he use of a 
me dici nal pr o d uct t hat has a p pear e d or w orse ne d d uri n g t he c o urse of t he cli nical trial,  re gar dl ess 
of ca usal r elati o ns hi p t o t he st u d y dr u g(s) u n der st u d y. A Es i ncl u d e a n y ill ness, si g n, s y m pt o m, 
or o ut -of -r a n ge a n d cli nicall y si g nifica nt la b orat or y fi n di n g t hat h as a p peare d or w ors e ne d d uri n g 
t he c o urse of t h e cli nical trial, re gar dl ess of ca usal relati o ns hi p t o t he st u d y. T he c ollecti o n of 
n o n -seri o us A Es a n d s eri o us a d verse e ve nts ( S A Es) will be gi n f oll o wi n g t h e s u bject's 
c o m pleti o n of t he c o nse nt pr ocess t o partici pat e i n t he  st u d y. 
1 1. 4. 2  D oc u me nti n g A d verse  E x perie nces  
It is t he r es p o nsi bilit y of t he i n vesti gat or t o d o c u me nt all A Es t hat occ ur d uri n g t he c o urse of t he 
st u d y. T he A Es s h o ul d be d oc u me nte d as a si n gle me dical dia g n osis. W he n t his is n ot p ossi ble, 
t he A E s h o ul d be d oc u m e nte d i n ter ms of si g ns a n d/ or s y m pt o ms o bser ve d b y t he i n vesti gat or or 
re p orte d b y t he s u bject at eac h st u d y visit. Eac h A E w hic h a p pears t o be i n de pe n de nt of a n y pri or 
e ve nt will be re p orte d se paratel y.  
All A Es occ urri n g after t he s u bject si g ns t he i nf or me d c o nse nt t hr o u g h t he last st u d y visit m ust 
be re p ort e d, re gar dless of w het her or n ot t he A Es are c o nsi dere d dr u g -relat e d. All A Es, w het her 
i n res p o nse t o a q uer y, o bser ve d b y t he st u d y site pers o n nel, or re p orte d s p o nta ne o usl y b y t he 
s u bject, will be rec or de d. A n y A Es dee me d relate d t o treat me nt re p ort e d or o bser ve d at t he fi nal 
st u d y/treat me nt visit will be f oll o we d u ntil sta bilizati o n or res ol uti o n ( or u p t o 3 0 da ys after fi nal 
st u d y visit). 
At eac h visit d uri n g t he st u d y, t he s u bject will be assesse d f or t h e occ urre n ce of ne w a n d o n g oi n g 
A Es. C uta ne o us t olera bilit y si g ns a n d s y m pt o ms t hat res ult i n t he s u bject’s re q uiri n g a 
c o nc o mita nt t hera p y or disc o nti n uati o n fr o m t he st u d y will be re p orte d as a n A E. T he f oll o wi n g 
data will be c ollecte d o n all A Es a n d rec or de d o n t he a p pr o pri ate C R F:  
•  E ve nt na me ( dia g n osis pr eferre d, if u n k n o w n, rec or d t he  si g ns/s ym pt o ms)  
•  O nset date a n d e n d date  
•  Ma xi m u m i nte nsit y  (s e verit y) 
•  Seri o us ness  
•  Acti o n ta ke n re gar di n g st u d y  dr u g  
•  C orrecti ve tr eat me nt, if  gi ve n  

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•  O utc o me  
I n a d diti o n, t he i n vesti gat or’s assess me nt of ca usalit y will be rec or de d. 
Vital si g n a b n or m alities are t o be rec or de d as A Es o nl y if t he y are cli nicall y si g nifica nt (f or 
e x a m ple: are s y m pt o mati c, re q uiri n g c orrecti ve treat me nt, lea di n g t o disc o nti n uati o n or f ulfilli n g 
a seri o us ness criteri o n).  
1 1. 4. 3  Seri o us A d verse  E ve nts  
All A Es will be assesse d as eit her seri o us or n o n -s eri o us. 
A n S A E or seri o us a d v erse e ve nt is defi ne d as a n y u nt o war d me dical o cc urre nce t h at at a n y 
d ose:  
•  Res ults i n  deat h  
•  Is i m me diatel y life t hr eat e ni n g, (t h e ter m "life t hreate ni n g" i n t he d efi niti o n of 
"seri o us" r efers t o a n e v e nt i n w hic h t he s u bject is at ris k of deat h at t he ti m e of t he 
e ve nt; it d oes n ot refer t o a n e ve nt w hic h h y p ot h eticall y mi g ht ha ve ca use d deat h if  it 
were m or e  se v er e) 
•  Re q uires i n patie nt h os pitalizati o n or pr ol o n gati o n of e xisti n g h os pitalizati o n 
( h os pitalizati o n f or electi ve s ur ger y f or a b aseli ne c o n diti o n is n ot c o nsi dere d a n A E)  
•  Res ults i n persiste nt or si g nifica nt disa bilit y/i n ca p acit y ( per m a ne nt or  s u bst a ntial 
disr u pti o n of a pers o n’s a bilit y t o c o n d u ct n or mal life  f u ncti o ns) 
•  Is a c o n ge nital a n o mal y/ birt h defect  
•  Is a me dicall y i m p orta nt e ve nt t hat ma y n ot be i m me diatel y life t hreat e ni n g or res ult 
i n deat h or h os pitalizati o n, b ut ma y je o p ar dize t he s u bject a n d ma y re q uire me dical or 
s ur gical i nter ve nti o n t o pre ve nt o ne of t he a b o v e liste d o utc o mes. E x a m ples of s uc h 
e ve nts i ncl u de, b ut ar e n ot li mite d t o, aller gic br o nc h os pas m re q uiri n g i nte nsi ve 
treat me nt i n a n e mer ge nc y r o o m or at h o me; bl o o d d yscrasias or c o n v ulsi o ns t hat d o 
n ot res ult i n i n patie nt  h os pitalizati o n.  
N ote: A s p o nta ne o us a b orti o n will be c o nsi dere d a n S A E, a n d m ust be re p orte d per Re p orti n g of 
S A Es u n der Secti o n 1 1. 4. 6 . 
1 1. 4. 4  Assess me nt of  Se verit y  
T he se verit y assi g ne d t o a n A E s h o ul d be deter mi ne d b y t h e ma xi m u m se verit y of t he A E. T h e 
cate g ories d escri b e d bel o w s h o ul d be use d t o esti mate t he se verit y of A Es:  
•  Mil d: Tra nsie nt or mil d disc o mf ort; n o li mitati o n i n acti vit y; n o  me dical 
i nter ve nti o n/t hera p y re q uire d 

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•  M o derate: Mil d t o m o der ate li mitati o n i n acti vit y; s o me assista nce ma y b e nee de d;  n o 
or mi ni mal me dical i nter ve nti o n/t hera p y  re q uire d 
•  Se vere: Mar k e d li mitati o n i n acti vit y; s o me assista nce us uall y re q uire d;  me dical 
i nter ve nti o n/t hera p y r e q uire d; h os pitalizati o n or pr ol o n gati o n of c urre nt 
h os pit alizati o n p ossi ble; ma y b e i nca p acitati n g or life  t hreate ni n g 
1 1. 4. 5  Assess me nt of  C a us alit y 
T he i n vesti gat or s h o ul d assess t he relati o ns hi p of t he A E, if a n y, t o t he st u d y dr u g as eit her 
“ Relate d” or “ N ot Relate d”. T he f oll o wi n g s h o ul d be ta ke n i nt o acc o u nt w he n assessi n g S A E 
ca usalit y:  
Relate d: T here is at least a reas o n a ble p ossi bilit y t hat t he A E/ S A E is relate d t o t he st u d y dr u g. 
Reas o na ble p ossi bilit y m ea ns t hat t her e is e vi de nce t o s u g gest a ca us al relati o ns hi p bet wee n t he 
dr u g a n d t he A E. 
 
N ot Relate d: T here is little or n o reas o na ble p ossi bilit y t hat t he A E/ S A E is relate d t o t he st u d y 
dr u g. T his assess me nt i m plies t hat t he A E/ S A E has little or n o te m p oral relati o ns hi p t o t he st u d y 
dr u g a n d/ or a m or e li kel y or cert ai n alter nati ve eti ol o g y e xists . 
 
1 1. 4. 6  Re p orti n g of Seri o us A d verse E ve nts  
A d verse e ve nts classifie d as “seri o us” re q uire e x pe diti o us ha n dli n g a n d re p orti n g t o s p o ns or or 
desi g nee wit hi n 2 4 h o urs of i n vesti gati o nal ce nter n otificati o n t o c o m pl y wit h re g ul at or y 
re q uire me nts. 
All S A Es, w het her  rel ate d or u nrelate d t o st u d y dr u g, m ust be i m me diatel y re p orte d t o t he 
me dical m o nit or wit hi n 2 4 h o urs of t he i n vesti gat or’s a w are n ess of t he e v e nt. All S A Es m ust be 
re p orte d via c o nfir me d facsi mile a n d e mail tra ns missi o n a n d m ust be s u b mitte d o n a writte n S A E 
re p ort f or m si g ne d b y t he i n vesti gat or wit hi n 2 4 h o urs of t he i n vesti gat or’s a ware ness of t he 
e ve nt.  
T he c o ntact(s) f or re p orti n g a n S A E are: 
 Me dical M o nit or 
 
 
 
 
& 
 
 Pr oject Ma na ger [ T K L Res earc h, I n c.] 
 
Fa x:  
N/ A  

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Investigators should not wait to receive additional information to fully document the event 
before notifying Medical Monitor and Sponsor of an SAE. If only limited information is initially 
available, follow-up reports are required. Additional relevant information such as hospital 
records and autopsy reports should be provided to the Sponsor as soon as they are available. 
Should the investigator become aware of an SAE (regardless of its relationship to investigational 
product) that occurs within 30 days after stopping the study drug, the SAE must be reported in 
accordance with procedures specified in this protocol. 
All deaths of subjects, regardless of cause, and which are known to the Investigator will be 
reported on the appropriate CRF for up to 30 days after the administration of study drug, 
regardless of the Investigator's opinion regarding drug relationship. Documentation of the 
subject’s cause of death and a copy of the autopsy or hospital report will also be provided. The 
Medical Monitor must be notified within 24 hours of knowledge of the event by telephone 
(and/or facsimile/email) of all subject deaths. Written follow-up must be received by the medical 
monitor and the Institutional Review Board within five (5) calendar days of initial notification. 
 
The investigator should take all appropriate measures to ensure the safety of the subjects, notably 
he/she should follow a subject with an SAE until the event has resolved or the condition has 
stabilized. This may imply that follow-up will continue after the subject has left the study, and 
that additional investigations may be requested by the Sponsor, and that additional investigations 
may be requested by the Sponsor. When a SAE persists at the end of the study, the Investigator 
will conduct follow-up contacts with the subject until the Investigator/Sponsor agree the event is 
satisfactorily resolved and/or stabilized. If at any time after 30 days after administration of study 
drug, the investigator becomes aware of an SAE which he/she feels is related to study drug or 
procedure, this must also be reported immediately (within 24 hours of knowledge of occurrence) 
by telephone and confirmed facsimile transmission/email to the Medical Monitor and Sponsor. 
11.4.7 Expedited Serious Adverse Event Reports 
An AE, whether serious or non-serious, is designated unexpected (unlabeled) if it is not reported 
in the clinical safety section of the Investigator Brochure or if the event is of greater frequency, 
specificity or severity. 
Expedited SAE reports are those that are both unexpected based on the reference document 
(Investigator Brochure or Package Insert) and are related (ie, the relationship cannot be ruled 
out) to the study drug. These expedited reports are subject to reporting timelines of 7 and/or 15 
calendar days to the regulatory reporting agency(ies). The Sponsor will notify regulatory 
authorities of these AEs and all participating investigational centers in writing for submission by 
the investigator to the IRB/IEC. This notification will be in the form of a Safety Update to the 
Investigator Brochure (ie, “15-day letter”). 

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U p o n recei vi n g s u c h n otices, t he i n vesti gat or m ust re vie w a n d retai n t he n otice wit h t he 
I n v esti gat or Br oc h ur e a n d i m me diatel y s u b mit a c o p y of t his i nf or mati o n t o t he res p o nsi ble 
I R B/I E C acc or di n g t o l ocal re g ulati o ns. T he i n v esti gat or a n d I R B/I E C will deter mi ne if t he 
i nf or me d c o nse nt r e q uires re visi o n. T he i n vesti gat or s h o ul d als o c o m pl y wit h t he I R B/I E C 
pr oce d ur es f or re p orti n g a n y ot h er saf et y i nf or mati o n.  
1 1. 4. 8  Pre g n a nc y  
All fe male s u bjects of c hil d beari n g p ot e ntial m ust use a n effecti ve m et h o d of birt h c o ntr ol d uri n g 
t he c o urse of t h e st u d y, i n a ma n ner s u c h t hat ris k of c o ntrace pti ve fail ure is mi ni mize d. 
A bsti ne nce is all o we d as a birt h c o ntr ol met h o d.  
Bef ore e nr olli n g a fe mal e s u bject of c hil d beari n g p ote ntial i n t his cli nical trial, t he i n vesti gat or 
m ust re vie w t he f oll o wi n g i nf or m ati o n a b o ut st u d y partici pati o n:  
•  I nf or me d c o ns e nt re q uire me nts 
•  C o ntrace pti ves i n c urre nt  use  
F oll o wi n g re vie w of t his i nf or mati o n a n d a p pr o priate s u bject c o u ns eli n g, t h e i n vesti gat or or 
desi g nee a n d t he s u bj ect m ust si g n t he i nf or me d c o nse nt bef ore st u d y e nr oll me nt.  
D uri n g t h e st u d y, all fe m ale s u bjects of c hil d beari n g p ote ntial s h o ul d be i nstr ucte d t o c o ntact t he 
i n vesti gat or i m me diatel y if t he y s us p ect t he y mi g ht be pre g na nt (e g, misse d or late me nstr ual 
peri o d).  
If a s u bject or i n vesti gat or s us pects t hat t he s u bject ma y b e pre g n a nt pri or t o st u d y e nr oll me nt, 
t he st u d y dr u g m ust be wit h hel d u ntil t he res ults of la b orat or y pre g na n c y testi n g are a vaila ble. If 
pre g na nc y is c o nfir me d, t he s u bject m ust n ot recei ve st u d y dr u g a n d m ust n ot be e nr olle d i n t he 
st u d y. If pre g na n c y is s us pecte d w hile t he s u bject is recei vi n g st u d y treat me nt, t he st u d y dr u g 
m ust i m me diatel y b e wit h hel d  u ntil t he res ult of pre g na nc y t esti n g is k n o w n. If pre g n a nc y is 
c o nfir me d, t he st u d y dr u g will be per ma ne ntl y dis c o nti n ue d a n d t he s u bject will be f oll o we d 
u ntil t he pre g n a nc y c o m es t o ter m. A Pre g na nc y R e p ort f or m will be s u b mitte d t o t he s p o ns or, 
i nitiall y a n d at t he e n d of t he pre g na n c y, w hic h i n cl u des t he o utc o me of t h e pre g na n c y a n d a n y 
c o m plicati o ns occ urri n g d uri n g t he pre g na n c y or t he deli ver y.  
All c o nfir me d pre g n a nci es m ust be i m me diatel y re p orte d t o t he me dical m o nit or wit hi n 2 4 h o urs 
of t he i n ve sti gat or’s a w ar e ness of t he pre g na n c y. All c o nfir me d pre g n a nci es m ust be re p orte d vi a 
c o nfir me d f acsi mile/e mail tra ns missi o n a n d m ust be s u b mitte d o n a S A E a n d pre g na nc y re p ort 
f or ms wit hi n 2 4 h o urs of t he i n vesti gat or’s a w are n ess of t he pre g n a nc y usi n g t he sa m e re p orti n g 
as pr oce d ure f or a n S A E u n der Secti o n 1 1. 4. 6.  

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12 Statistics 
All statistical processing will be performed using SAS® version 9.3 or later unless otherwise 
stated. Statistical significance will be based on two-tailed tests of the null hypothesis resulting in 
p-values of 0.05 or less. 
The primary method of handling missing efficacy data will be based on estimation using the 
method of Markov Chain Monte Carlo (MCMC) imputation. This method provides robust 
estimation when the pattern of missingness is arbitrary. Additionally, the estimation will be done 
for each treatment group separately so that the pattern of missingness for one group does not 
influence the estimation of missing data for another group. Groups of complete datasets 
following the estimation will be concatenated to form analysis datasets for the comparative 
analyses and subsequent imputation result inference with SAS PROC MIANALYZE. 
Descriptive statistics will also be derived from the multiply imputed datasets. 
Additionally, a model-based multiple imputation process will be used as a sensitivity analysis to 
the MCMC imputation. Finally, the absolute change in lesion count will be analyzed using a 
repeated measures ANCOVA for lesion count data or a repeated measures logistic regression 
model (generalized estimating equations) for the dichotomized EGSS. 
A statistical analysis plan (SAP), describing all statistical analyses will be provided as a separate 
document. The SAP will be finalized prior to unblinding of the study treatments. 
Evaluations and Analyses 
Inflammatory lesions and non-inflammatory lesions will be recorded for each subject at Baseline 
and at Weeks 4, 8, and 12. The absolute and percent change from baseline of inflammatory 
lesions and non-inflammatory lesions will be derived for each subject at Weeks 4, 8, and 12. 
The EGSS will be recorded for each Subject. The EGSS will be dichotomized into “success” and 
“failure” at Week 4, 8 and 12 with a subject considered a success for those visits if the Global 
Severity Score is at least 2 grades less than baseline and are Clear or Almost Clear. An additional 
assessment of subjects who have achieved 2 grade improvement will be also be conducted as a 
secondary efficacy variable. 
The subject will be asked at Baseline and Week 12 to assess how oily their skin has been in the 
past week. 
All assessments will be conducted for both ITT and PP. 
 
12.1 Assessment of Efficacy 
All efficacy analyses will be conducted on the ITT (primary) and PP (supportive) populations. 
 
12.1.1 Primary Efficacy 
There are three co-primary efficacy endpoints: 

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•  A bs ol ute c ha n ge i n i nfla m mat or y lesi o n c o u nt fr o m baseli ne t o Wee k  1 2  
•  A bs ol ute c ha n ge i n n o n -i nfla m mat or y lesi o n c o u nt fr o m baseli ne t o Wee k 1 2  
•  Pr o p orti o n of s u bjects w h o ha ve a least a 2 gra de re d ucti o n at Wee k 1 2 fr o m baseli ne 
i n t he E val uat or's Gl o bal Se verit y Sc ore a n d were Clear or Al m ost Clear  
1 2. 1. 2  Sec o n d ar y  Effic ac y  
T here are t w o Wee k 1 2 s ec o n dar y effi cac y e n d p oi nts:  
•  Perce nt c h a n ge i n i nfla m mat or y lesi o n c o u nt fr o m baseli ne t o Wee k  1 2  
•  Perce nt c h a n ge i n n o n -i nfla m mat or y lesi o n c o u nt fr o m baseli ne t o Wee k 1 2  
1 2. 1. 3  S u p p orti ve  Effic ac y  
T here is o ne Wee k 1 2 s u p p orti ve efficac y e n d p oi nt:  
•  Pr o p orti o n of s u bjects w h o ha ve at least a 2 gra d e re d ucti o n at Wee k 1 2 fr o m baseli ne 
i n t he E val uat or's Gl o bal Se verit y Sc ore  
T here are t hr ee Wee k 8 s u p p orti ve efficac y e n d p oi nts:  
•  Perce nt c h a n ge i n i nfla m mat or y lesi o n c o u nt fr o m baseli ne t o Wee k  8  
•  Perce nt c h a n ge i n n o n -i nfla m mat or y lesi o n c o u nt fr o m baseli ne t o Wee k 8  
•  Pr o p orti o n of s u bjects w h o ha ve at least a 2 gra d e re d ucti o n at Wee k 8 fr o m baseli ne 
i n t he E val uat or's Gl o bal Se verit y S c ore  
T here are t hr ee Wee k 4 s u p p orti ve efficac y e n d p oi nts:  
•  P erce nt c h a n ge i n i nfla m mat or y lesi o n c o u nt fr o m baseli ne t o Wee k  4  
•  Perce nt c h a n ge i n n o n -i nfla m mat or y lesi o n c o u nt fr o m baseli ne t o Wee k 4  
•  Pr o p orti o n of s u bjects w h o ha ve at least a 2 gra d e re d ucti o n at Wee k 4 fr o m baseli ne 
i n t he E val uat or's Gl o bal Se verit y  Sc ore  
1 2. 1. 4  Test of S u peri orit y f or Lesi o n C o u nt  V ari a bles  
T his secti o n pr o vi des t he basic m o del a n d statistical a p pr oac h w hic h is use d i n c o m bi nati o n wit h 
t he m ulti ple i m p utati o n pr oce d ur es descri be d i n Secti o n 1 2. 1. 7. Tests of s u peri orit y f or t he 
a bs ol ute c ha n ge fr o m Baseli ne i n i nfla m mat or y a n d n o n-i nfla m mat or y lesi o ns will be base d o n 
eit her par a metric or n o n -para metri c met h o ds c o nsiste nt wit h t he statistical ass u m pti o ns re q uire d 
t o s u p p ort t he a nal ys es. S pecificall y, t he tests of s u peri orit y will be base d o n a n A N C O V A wit h 
fact ors of tr eat me nt a n d a nal ysis ce nter a n d t h e res pecti ve Baseli ne lesi o n c o u nt as a c o variate or 
o n ra n ke d dat a s u b mitte d t o a n A N C O V A wit h fact ors of treat me nt a n d a n al ysis ce nter a n d t h e 
res pecti ve Bas eli ne lesi o n c o u nt as a co v ariate. If t he treat me nt -b y -a nal ysis ce nter i nteracti o n 
effect is si g nifica nt at a n al p ha less t ha n 0. 1 0, t he n t he effect will be i ncl u de d i n t he m o del; 
ot her wise it will be re m o ve d.  
A s ke w ness test, bas e d o n t he met h o ds prese nte d b y J. H. Zar ( 1 9 8 4) [1 0 ], will be a p plie d t o t he 
resi d uals res ulti n g fr o m a n A N C O V A. A t w o-si de d p-val ue f or t h e s ke w n ess test si g nifica nt at  

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0.01 will imply the use of the non-parametric method. If a parametric analysis is indicated, the 
results of the parametric analysis will be considered the primary analysis. Should a non- 
parametric analysis be indicated, the absolute or percent changes in inflammatory and non- 
inflammatory lesions will be rank transformed prior to submitting them to the ANCOVA. 
Results of the rank-transformed analyses then will be considered the primary analysis; however, 
results of the non-ranked transformed analyses will also be presented. 
12.1.5 Statistical Hypothesis Testing and Control of Multiplicity 
Statistical hypothesis testing for lesion count analyses will use the statistical model introduced in 
Section 12.1.3 and employs the methods of Section regarding missing values. The analysis of the 
dichotomized Evaluator's Global Severity Score will be based on the logistic regression test 
stratified by analysis center and employs the methods of Section 12.1.7 regarding missing 
values. 
The overall Type I error will be controlled by requiring the co-primary efficacy endpoints of 
each group to be statistically significant. Specifically, failure of any one of the primary efficacy 
endpoints will invalidate the statistical significance of the secondary efficacy endpoints. 
The following stepwise process will be conducted for testing the secondary efficacy endpoints in 
order to control for multiplicity. These tests will be performed for only the ITT population. The 
testing process will terminate whenever a statistical test for a step is not significant. All 
subsequent tests for the remaining steps will be considered not significant. The order of testing 
is: 
 
Step Number Secondary Endpoint 
1 
Percent change in non-inflammatory lesion count from baseline to Week 12 
2 
Percent change in inflammatory lesion count from baseline to Week 12 
 
The following stepwise process will be conducted for testing the supportive efficacy endpoints in 
order to control for multiplicity. These tests will be performed for only the ITT population. In 
order to control for multiplicity failure of any one of the secondary efficacy endpoints will 
invalidate the statistical significance of the supportive efficacy endpoints. The testing process 
will terminate whenever a statistical test for a step is not significant. All subsequent tests for the 
remaining steps will be considered not significant. The order of testing is: 
 
Step 
Number 
Supportive Endpoint 
1 
Percent change in non-inflammatory lesion count from baseline to Week 8 
2 
Percent change in inflammatory lesion count from baseline to Week 8 
3 
Percent change in non-inflammatory lesion count from baseline to Week 4 
4 
Percent change in inflammatory lesion count from baseline to Week 4 
5 
Proportion of subjects who have at least a 2 grade reduction at Week 12 from 

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baseli ne i n t he E val uat or's Gl o bal Se verit y Sc ore  
6  
Pr o p orti o n of s u bjects w h o ha ve at least a 2 gra d e re d ucti o n at Wee k 8 fr o m  
baseli ne i n t he E val uat or's Gl o bal Se verit y Sc ore  
7  
Pr o p orti o n of s u bjects w h o ha ve at least a 2 gra d e re d ucti o n at Wee k 4 fr o m  
baseli ne i n t he E val uat or's Gl o bal Se verit y Sc ore  
 
 
1 2. 1. 6  Descri pti ve  St atistics  
Descri pti ve statistics will be prese nt e d f or t he f oll o wi n g para meters b y treat me nt gr o u p f or b ot h 
t he I T T a n d P P p o p ulati o ns: 
•  Fre q u e nc y a n d per ce nt distri b uti o ns of t he E val uat or’s Gl o bal Se verit y Sc ore at 
Baseli ne a n d Wee ks 4, 8, a n d  1 2.  
•  Fre q u e nc y a n d per ce nt distri b uti o ns of t he dic h ot o mize d E val uat or’s Gl o bal Se verit y 
Sc ore at Baseli ne a n d Wee ks 4, 8, a n d 1 2.  
•  Descri pti ve statistics i ncl u di n g mea n, me dia n, sta n dar d de vi ati o n, mi ni m u m, a n d 
ma xi m u m will be use d t o s u m marize i nfla m mat or y a n d n o n -i nfla m mat or y lesi o n 
c o u nts at baseli ne a n d wee ks 4, 8, a n d 1 2.  
•  Descri pti ve statistics i ncl u di n g mea n, m e dia n, sta n dar d de viati o n, mi ni m u m,  a n d 
ma xi m u m will be use d t o s u m marize t he a bs ol ute a n d perce nt c ha n ge i n 
i nfla m mat or y a n d n o n-i nfla m mat or y lesi o n c o u nts at Wee ks 4, 8, a n d 1 2.  
•  Fre q u e nc y a n d per ce nt distri b uti o ns f or t he Oil y/ S hi n y assess me nts at Wee k  1 2  
Mea ns, sta n dar d d e viati o ns a n d fre q u e nc y c o u nts (r o u n de d t o t he nearest w h ol e n u m ber) will be 
c o m p ute d fr o m t he m ulti pl y i m p ute d M C M C data f or t he vari a ble.  
1 2. 1. 7  P o oli n g  A n al ysis  
T he cli nical st u d y will be c o n d ucte d u n der a c o m m o n pr ot oc ol f or eac h i n vesti gati o nal site wit h 
t he i nte nti o n of p o oli n g t he data f or a nal ysis. E ver y eff ort will be ma d e t o pr o m ote c o nsiste nc y 
i n st u d y e x ec uti o n at eac h i n vesti gati o nal site. T h e st u d y is i nte n de d t o be c o n d ucte d i n a ma n n er 
s uc h t hat a mi ni m u m of 5 s u bjects will be e nr olle d i n eac h treat me nt ar m f or a n y i n vesti gat or. I n 
t he e ve nt t hat ther e ar e t o o fe w s u bjects i n a treat me nt ar m f or a n i n v esti gat or, t he n t his 
i n vesti gat or's dat a will be c o m bi ne d t o ac hie v e t he desire d sa m ple size mi ni m u m per ar m. T he 
c o m bi ni n g of i n vesti gat or's d ata will be acc o m plis he d b y t a ki n g t h e i n vesti gat or wit h t he 
s mallest e nr oll me nt a n d c o m bi ni n g it wit h t he i n vesti gat or wit h t he lar gest. If t here is a f urt her 
nee d t o c o m bi ne dat a, t he n t he data of t h e i n vesti gat or wit h t he sec o n d s m allest e nr oll me nt will 
be c o m bi ne d wit h t he i n v esti gat or's d ata w hic h h a d t he se c o n d lar gest e nr oll me nt, a n d s o  o n.  
T his pr ocess will c o nti n ue f or all i n vesti gat ors w h o di d n ot ha ve a mi ni m u m of 5 s u bjects per 
acti ve treat me nt ar m. T h e pr ocess of c o m bi ni n g i n vesti gat or d ata t hat ha v e i ns ufficie nt s u bjects 
per treat me nt ar m will res ult  i n re defi ni n g t he gr o u ps of i n vesti gat ors f or t he p ur p oses of 

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statistical analyses. These combined groups will be referred to as "analysis centers" in the 
statistical analyses based on ANCOVA and stratified logistic testing. 
Prior to investigating the treatment effect within the analysis centers, the magnitude of the site 
mail effect will be investigated to determine if the main site-to-site variability is such that it 
could mask the analysis center effects. Thus, if computationally possible, a one-way ANCOVA 
(for lesion count variables) or a logistic regression analysis (for EGSS) with a factor of site will 
be conducted prior to pooling. If the data structure interferes with the logistic regression, a 
descriptive analysis of the site effect will be undertaken. Conclusions appropriate to the findings 
of this step will be presented. 
The consistency of treatment response will be investigated across the analysis centers subsequent 
to combining the data as described above. Statistical tests will be conducted to identify if there 
are extreme analysis centers that could affect the interpretation of common statistical and clinical 
conclusions. An analysis center by treatment interaction will be included in the primary and 
secondary variable analyses to test for parallel treatment effect at an alpha level of 0.10. Change 
from baseline in inflammatory lesions and non-inflammatory lesions will be analyzed with an 
ANCOVA (unranked or ranked) with factors of treatment, analysis center, and treatment by 
analysis center interaction and the respective baseline lesion count variable as a covariate. For 
the purpose of testing consistency of treatment response, the dichotomized EGSS will be 
analyzed with a logistic regression procedure. Further examination will follow for any variables 
that have a significant ANCOVA or logistic regression interaction term. In the event that the 
ANCOVA or logistic regression interaction (referred to henceforth as the "appropriate test") p- 
value is less than or equal to 0.10, a sensitivity analysis that excludes analysis centers with the 
extreme efficacy result will be performed to determine the robustness of the treatment effect. On 
the other hand, if the outcome of the appropriate test has a p-value greater than 0.10, then the 
conclusions from the pooled data will be considered to be free of the impact of extreme analysis 
centers. 
The first step in conducting a sensitivity analysis is to identify the extreme analysis center or 
centers that contribute to the statistical significance of the appropriate test. The process involves 
submitting subsets of analysis centers to the appropriate test and observing the appropriate test p- 
value for the subset. Subsets with p-values greater than 0.10 for the appropriate test are 
considered homogeneous. 
The search for an extreme analysis center begins by analyzing all subsets that can be created by 
excluding one analysis center. If one or more of the subsets result in an appropriate test p-value 
greater than or equal to 0.10, then the analysis center excluded from the subset with the largest p- 
value for the appropriate test is deemed to be the extreme analysis center. 
If all appropriate test subset p-values are less than or equal to 0.10, then the process will analyze 
the appropriate test for all subsets that can be created by excluding two analysis centers. If one 

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or more of these subsets generate appropriate test p-values larger than 0.10, then the analysis 
centers excluded from the subset with the largest appropriate test p-value are deemed the extreme 
analysis centers. 
Thus, the process of identifying the extreme analysis centers will continue in a stepwise manner 
by first excluding one, then two, then three, etc., analysis centers until the appropriate test p- 
value exceeds 0.10. 
Once the extreme analysis center or centers have been identified, then the treatment p-values of 
the remaining analysis centers will be computed. Inferences will be drawn from the treatment p- 
value, as well as any pertinent observations regarding the extreme analysis center or centers. 
Additionally, it is noted that this process excludes subjects from the analysis in a non-random 
manner and has an unpredictable impact on the power of the treatment effect test. In the event 
that the treatment effect of the remaining subset is not statistically significant, due consideration 
of the post-hoc aspects of the process will be given when the results are interpreted. Conclusions 
will be presented by the sponsor as appropriate to the findings of the sensitivity analysis. 
12.1.8 Missing Efficacy Data Imputations 
Lesion Count Variable Missing Data Imputation 
Missing 12 week data will be estimated by multiple imputation and subsequently analyzed. 
Missing lesion count data will be derived for the analysis using the method of Markov Chain 
Monte Carlo (MCMC) multiple imputation which does not rely on the assumption of data 
missing at random. Additionally, the pattern of missing observations in each treatment group 
cannot influence the missing value estimation in the other because the imputation is being 
conducted independently for each treatment group. 
Multiple imputation and subsequent analysis will involve 4 distinct phases with these principal 
tasks: 
 
1. Calculated the number of missing values to be estimated by MCMC (nmiss) for 12 week 
value. 
2. Create a data set of subjects, one for each treatment group, with observed values and 
those needing estimation by MCMC. The missing lesion count values in each data set 
will be filled in using the MCMC method ‘5 x nmiss’ times to generate ‘5 x nmiss’ data 
sets. The resulting data sets for each treatment arm will be combined into one complete 
data set for each imputation. 
Syntax: 
proc mi data=datain out=dataout seed=&seed. nimpute=5xnmiss <options>; 
where trtpn=(1, or 2); 
mcmc chain=multiple; 
var baseline week4 week8 week12; 
run; 

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3. For each complete data set, the absolute change in lesion counts for baseline minus the 12 
week value will be computed. Each complete data set will be analyzed as specified for 
the particular analysis. 
4. The results from these analyses will be combined into a single inference using SAS 
PROC MIANALYZE. 
 
A total of 4 random seeds will be needed to impute inflammatory lesion counts from non- 
inflammatory lesion counts for the two treatment groups. Those 4 random seeds have been pre- 
specified by using a random number generator: 
• 
Inflammatory Lesion Counts; IDP-121 Lotion: Seed= 1028933764 
• 
Inflammatory Lesion Counts; IDP-121 Vehicle: Seed= 356782065 
• 
Non-Inflammatory Lesion Counts; IDP-121 Lotion: Seed= 1307444541 
• 
Non-Inflammatory Lesion Counts; IDP-121 Vehicle: Seed= 436373460 
EGSS Missing Data Imputation 
A similar procedure will be used for the analyses based on proportion of EGSS successes 
wherein the ANCOVA analysis is replaced with a logistic regression analysis. Specifically, 
missing 12 week EGSS values from which the dichotomized EGSS is derived will be estimated 
by (MCMC) which does not rely on the assumption of data missing at random. Additionally, the 
pattern of missing observations in each treatment group cannot influence the missing value 
estimation in the other because the imputation is being conducted independently for each 
treatment group. 
The missing 12 week EGSS values will be derived for the analysis using the method of Markov 
Chain Monte Carlo (MCMC) multiple imputation. Multiple imputation and subsequent analysis 
will involve 4 principal tasks: 
1. Calculate the number of missing values to be estimated by MCMC (nmiss) for 12 week 
value. 
2. Create a data set, one for each treatment group, of subjects with observed values and 
those needing estimation by MCMC. The missing EGSS values in each data set will be 
filled in using the MCMC method ‘5 x nmiss’ times to generate ‘5 x nmiss’ data sets. The 
resulting data sets for each treatment arm will be combined into one complete data set by 
imputation. 
Syntax: 
proc mi data=datain out=dataout seed=&seed. nimpute=5xnmiss <options>; 
where trtpn=(1, or 2); 
mcmc chain=multiple; 
var baseline week4 week8 week12; 

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run; 
 
3. For each complete data set, the dichotomous success rate (clear or almost clear with a 2- 
point change from baseline) will be computed. The 12-week estimated global values will 
be rounded to the nearest integer value prior to evaluating the success rate. Each 
complete data set will be analyzed with a logistic regression with factors of treatment 
group and analysis center. 
4. The results from these analyses will be combined into a single inference using SAS 
PROC MIANALYZE. 
A total of 2 random seeds will be needed to impute EGSS for the two treatment groups. Those 2 
random seeds have been pre-specified by using a random number generator: 
• 
EGSS; IDP-121 Lotion: Seed= 1210644108 
• 
EGSS; IDP-121 Vehicle: Seed= 763715437 
 
12.1.9 Sensitivity Efficacy Analyses 
Sensitivity analyses for absolute change in lesion count 
The first sensitivity analysis for absolute change in lesion count use a repeated measures 
ANCOVA, with treatment, analysis center, and visit (ie, Week 4, Week 8) as independent factors 
and a covariate of baseline lesion count.  In this analysis, data from all post-baseline visits will 
be included with no imputation for missing data. 
The second sensitivity analysis will use the model based multiple imputation method to impute 
missing data for the absolute change in lesion counts at Week 12. Although the full details will 
be presented in the Statistical Analysis Plan (SAP), the multiple imputation will involve 4 
principal tasks: 
1. Calculate the number of missing values (nmiss) for absolute change in lesion count. 
2. Missing values will be filled in ‘5 x nmiss’ times to generate ‘5 x nmiss’ complete data 
sets. The imputation model used will be an ANCOVA with factors of treatment group 
and analysis center, and a covariate of baseline lesion count (ie, the imputation model 
will be the same as the analysis model). Appropriate modifications will be made should 
the analysis be based on a non-parameteric method. 
3. Each complete data set will be analyzed with an ANCOVA with factors of treatment 
group, and analysis center, and a covariate of baseline lesion count. 
4. Results from these analyses will be combined into a single inference. 
Sensitivity analyses for EGSS 

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The first sensitivity analysis for the dichotomized EGSS success will use a repeated measures 
logistic regression model (generalized estimating equations), with dichotomized EGSS success 
as the dependent variable and treatment, analysis center, and visit (ie, Week 4, Week 8) as 
independent factors. In this analysis, data from all post-baseline visits will be included with no 
imputation for missing data. 
The second sensitivity analysis will use the model based multiple imputation method to impute 
missing data for the dichotomized EGSS data. Although the full details will be presented in the 
SAP, the multiple imputation will involve 4 principal tasks: 
1. Calculate the number of missing values (nmiss) for absolute change in lesion count. 
2. Missing values will be filled in ‘5 x nmiss’ times to generate ‘5 x nmiss’ complete data 
sets. The imputation model used logistic regression with factors of treatment group and 
analysis center (ie, the imputation model will be the same as the analysis model). 
3. Each complete data set will be analyzed with a logistic regression a factors of treatment 
group and analysis center. 
4. Results from these analyses will be combined into a single inference. 
 
12.1.10 Subgroup Analyses 
Subset analyses will be conducted for the ITT populations for the subgroups baseline global 
severity, gender, age, ethnicity, race, and geographic location. Age will be dichotomized to less 
than the median age of subjects and greater than or equal to the median age of subjects. An 
additional analysis will be include with categories of less than 18, 18 to less than the median age 
and greater than or equal to the median age. Geographic region will be dichotomized to US and 
outside US (OUS). Subset analyses will be conducted on the variables absolute change from 
baseline in inflammatory lesions and non-inflammatory lesions at Week 12 as well as the 
dichotomized global severity score at Week 12. These analyses will contain only descriptive 
statistics. 
 
12.2 
Assessment of Safety 
Safety will be evaluated by tabulations of adverse events (AEs), Cutaneous Safety Evaluation, 
and Tolerability Evaluations. Cutaneous Safety Evaluation scores (erythema, scaling, and 
hypo/hyper-pigmentation) and Tolerability (itching, burning, and stinging) will be presented with 
descriptive statistics at Baseline and at Weeks 4, 8, and 12 for each treatment group. Frequencies 
and percentages for each outcome category will be included in these statistics. Mean values will 
be presented graphically by week and treatment group. 
12.2.1 Adverse Events 
All adverse events occurring during the study will be recorded and classified on the basis of 
MedDRA terminology. Descriptions of AEs will include the date of onset, the date the AE 

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ended, the severity of the AE, the relationship to study medication, the action taken regarding 
study medication usage, the action taken regarding to treat the AE, and the outcome. All reported 
treatment-emergent AEs (TEAEs) will be summarized by the number of Subjects reporting AEs, 
system organ class, severity, seriousness, and relationship to study medication. TEAEs are those 
AEs with an onset on or after the date of the first study drug application. 
Adverse events will be summarized by treatment group and severity. Each subject will be 
counted only once within a system organ class or a preferred term by using the adverse events 
with the highest severity within each category. 
Adverse events will be summarized by treatment group and relationship to study medication. 
Each subject will be counted only once within a system organ class or a preferred term by using 
the adverse events with the greatest relationship within each category. 
Comparisons among treatment groups will be made by tabulating the frequency of subjects with 
one or more AEs (classified into MedDRA terms) during the study. The Fisher’s Exact test will 
be used to compare the proportion of subjects in each treatment group who report any adverse 
event at a significance level of 0.05. The specific system organ classes and preferred terms 
analyzed will be those that are reported by at least one percent of the subjects in any treatment 
group. 
All information pertaining to AEs noted during the study will be listed by subject, detailing 
verbatim given by the investigator, preferred term, system organ class, start date, stop date, 
severity, actions taken, and drug relatedness. The AE onset will also be shown relative (in 
number of days) to the day of initial dose of the randomized study medication. 
Serious adverse events (SAEs) will be tabulated by subject within treatment groups. 
In addition, a list of subjects who discontinued from the study and a list of subjects who 
experienced SAEs will also be provided. 
12.2.2 Safety Laboratory Tests 
Changes from baseline in safety laboratory values will be summarized with descriptive statistics 
at Week 12. Shift tables will be presented for changes in safety laboratory values. Normal ranges 
established by the central laboratory will be used to determine the shifts. A listing of all out-of- 
range laboratory test results at any assessment time point will also be provided. Determination of 
clinical significance for all out-of-range laboratory values will be made by each investigator and 
included in the listing. In addition, a listing of all clinically significant laboratory test results will 
be provided. 
12.2.3 Vital Sign Measurements 
Changes from Baseline in vital sign measurements will be summarized with descriptive statistics 
for each treatment group at all applicable study visits. 

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12.2.4 Concomitant Medications 
All previous therapies and concomitant medications will be classified based on terminology from 
the WHO Drug Dictionary. Previous therapies and concomitant medications data will be 
presented in data listings. 
12.2.5 Subject Self-Assessments 
Subjects will be asked to complete three questionnaires during the study: the Subject Self 
Assessment scale, the Patient Satisfaction Survey and the Acne-Specific Quality of Life 
Questionnaire (Appendices 17.3, 17.4 and 17.5). Descriptive statistics will be used to summarize 
the data reported for each questionnaire. No Inferential analyses will be conducted. 
 
12.3 
Subject Disposition 
A tabulation of subject disposition will be provided. The tabulation will include the numbers of 
subjects who enter the study, complete the study, and discontinue the study. The reasons for 
discontinuation will be included. 
 
12.4 
Demographics and Baseline Characteristics 
Subject demographic and baseline characteristics will be summarized by treatment group for 
both the ITT population and the PP population. For continuous variables (e.g. age) comparisons 
among the two treatment groups will be conducted using a two-way analysis of variance 
(ANOVA) with factors of treatment group and analysis center. Ethnicity and race will be 
analyzed with a Cochran-Mantel-Haenszel test stratified by analysis center. Past and current 
medical conditions, as well as history of disease will not be compared statistically. 
 
12.5 
Protocol Deviations 
All protocol deviations will be reported to the sponsor and recorded throughout the study. A 
listing of protocol deviations will be included in the final study report. 
 
12.6 
Compliance 
No formal evaluations of compliance are planned. 
 
12.7 
Interim Analyses 
No interim analyses are planned. 
 
12.8 
Additional Statistical Considerations 
12.8.1 Analysis Populations 
Approximately 800 subjects at least 9 years of age and older with moderate or severe acne (a 
score of 3 or 4 [moderate to severe] on the EGSS scale) will be enrolled and randomized in the 
study. With a 1:1 randomization ratio, it is anticipated that: 

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•  4 0 0 s u bjects will be ra n d o mize d t o recei ve I D P -1 2 1 L oti o n, o nce d ail y  a p plicati o n 
•  4 0 0 s u bjects will be ra n d o mize d t o recei ve I D P -1 2 1 Ve hicle L oti o n, o nce dail y 
a p plicati o n 
T he I T T p o p ulati o n will c o nsist of all ra n d o mize d s u bjects w h o recei ve d st u d y me dicati o n. T he 
safet y p o p ulati o n will be c o m prise d of all ra n d o mize d s u bjects w h o are pres u me d t o ha ve use d 
t he st u d y me dicati o n at least o nce a n d w h o pr o vi d e at least o ne p ost-b aseli ne e val uati o n.  
A n i nte nt -t o-treat (I T T) a nal ysis will be c o n d u cte d o n all st u d y s u bjects. A per-pr ot oc ol ( P P) 
a nal ysis will als o be c o n d ucte d. S u bjects will be eli gi ble f or t he P P a nal ysis if t he y c o m plet e t he 
1 2 -wee k e val uati o n wit h o ut n ote w ort h y st u d y pr ot oc ol vi olati o ns (i.e., a n y s u bject or 
i n vesti gat or acti vit y t hat c o ul d ha ve p ossi bl y i nterfere d wit h t he t hera p e utic a d mi nistrati o n of t he 
treat me nt or t he pr ecise e val uati o n of treat me nt efficac y). T h e P P p o p ulati o n will i ncl u de 
s u bjects i n t he safet y p o p ulati o n w h o d o n ot meet a n y of t he f oll o wi n g criteria: 
•  Faile d a n y of t he i ncl usi o n/e x cl usi o n  criteria; 
•  Ha ve ta k e n a n y i nterferi n g c o n c o mita nt  me dicati o ns;  
•  Di d n ot atte n d t he Wee k 1 2 visit, wit h t he e x ce pti o n of a disc o nti n uati o n fr o m t he st u d y 
d ue t o a n a d verse e v e nt r elate d t o st u d y treat me nt or d o c u me nte d lac k of treat me nt 
effect; 
•  Misse d b ot h t he wee k 4 a n d wee k 8  visits;  
•  Ha ve n ot bee n c o m plia nt wit h t he d osi n g re gi me n (i.e. S u bjects ma y n ot miss m ore 
t ha n fi ve c o nsec uti ve da ys of d osi n g a n d m ust ta ke 8 0-1 2 0 % of e x pecte d d oses. T he 
n u m ber of e x pecte d d oses will be deter mi ne d f or eac h s u bject base d o n t he le n gt h  of 
t heir partici pati o n i n t he st u d y); 
•  O ut of visit wi n d o w at t he 1 2 -wee k  visit.  
Pri or t o brea ki n g t he bli n d, ot her a d diti o nal criteri a ma y be a d d e d t o t he list t o acc o m m o date f or 
u nf ore see n e ve nts t hat o cc urre d d uri n g t h e c o n d uct of t he trial t hat res ult i n n ote w ort h y st u d y 
pr ot oc ol vi olati o ns.  
T he safet y p o p ulati o n will be c o m prise d of all ra n d o mize d s u bjects w h o are pres u me d t o ha v e 
use d t he st u d y me di cati o n at least o nce a n d w h o pr o vi de at least o ne p ost -b aseli ne e val u ati o n.  
1 2. 8. 2  S a m ple Size  D eter mi n ati o n  
T hese p o wer cal c ulati o ns are bas e d pri maril y o n t he o bser ve d Wee k 1 2 res ults of t he St u d y 2  i n 
Atrali n ™ (treti n oi n) Gel, 0. 0 5 % N D A 0 2 2 0 7 0 a p plicati o n. T his st u d y was a t w o-ar m trial of 
Atrali n ™ vers us its ve hicle a n d is felt t o be a rele v a nt st u d y i n N D A 0 2 2 0 7 0 f or p o weri n g t h e 
c urre nt st u d y. T he n e xt t hree p o w er calc ulati o ns are c o nstr uct e d fr o m t he res ults of St u d y  2.  
A sa m ple size of 4 0 0 per treat me nt ar m has at least 9 6 % p o wer t o d et ect a st atisticall y si g nifica nt 
differe n ce wit h a si g nifica nce le v el of 0. 0 5. T he esti mate d a bs ol ute c ha n ge fr o m baseli ne  i n 

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treatment means were 6.5 and 3.5 for Atralin™ versus its vehicle, respectively, with a standard 
deviation of 11.3. 
A sample size of 400 per treatment arm has greater than 99% power to detect a statistically 
significant difference with a significance level of 0.05 using the estimated absolute change from 
baseline in treatment means of 17.8 and 9.9 for Atralin™ versus its vehicle, respectively, with a 
standard deviation of 24.7. 
The sample size estimates for the dichotomized EGSS require a substantially larger enrollment in 
order to achieve a power of at least 90%. The success rates observed in the second Atralin™ 
study was 23% for Atralin™ and 14% for its vehicle which is a difference of 9%. Approximately 
90% power is achieved with sample sizes of 400 per treatment group, respectively, using a 1:1 
randomization. 
It is noted that the same differential in success rates was observed in Study 1 (Atralin™ 
(tretinoin) Gel, 0.05% NDA 022070 application). The success rates observed in the first 
Atralin™ study was 13% for Atralin™ and 4% for its vehicle which is also a difference of 9%. 
Using these estimates, more than 99% percent power is achieved with sample sizes of 400 per 
treatment group. 
The clinical study will be conducted under a common protocol at each investigational site and 
every effort will be made to promote consistency in study execution at each investigational site 
as well as uniform evaluation of the EGSS evaluation for subjects at the various study visits. The 
experience in clinical trial execution gained during the execution of several acne studies 
conducted under the guidance of the Sponsor raises the expectation that the differential between 
the success rates of the two arms will be greater than 9%. Thus, the power of the EGSS is 
expected to be at least 95% for sample sizes of 400 subjects in each arm. 
Individually and collectively the considerations lead to a choice of randomizing 400 subjects per 
treatment group. 
12.8.3 Handling of Missing Data 
The method of multiple imputation will be used (see Section 12.1.8). 
 
12.8.4 Multicenter Issues 
The study will be conducted at multiple investigational centers in North America and Latin 
America with the intention of pooling the results for analysis. 
12.8.5 Multiplicity Issues 
Not applicable. 

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12.8.6 Windowing Rules 
The timing of all study visits is relative to Baseline (Day 0). The Week 4 and Week 8 visits 
should occur within ± 3 days of the scheduled times, the Week 12 visit should occur within -3 / 
+5 days of the scheduled time. 
 
13 Quality Control and Quality Assurance 
13.1 
Study Monitoring 
An Investigator Meeting and/or an initiation visit will be conducted with the principal 
investigator and study coordinators by sponsor and/or its designee. During this meeting, an 
extensive review and discussion of the protocol, the role of the study technician, all study 
procedures, source documents, and eCRFs will be conducted. Evaluation scales will be reviewed 
extensively and documentation of training will be recorded for training of sponsor-approved 
evaluators. 
The study monitors/clinical research associates will be trained prior to study initiation. Following 
this training, an overview of the study disease and study material background will be understood. 
Specific monitoring guidelines and procedures to be followed during monitoring visits will also 
be utilized. During the course of the study, all data will be 100% source document verified by the 
monitors. All subject source records must be made available to the monitors. 
The conduct of the study will be closely monitored by the sponsor following GCP guidelines. 
The reports of these verifications will also be archived with the study report. In addition, 
inspections or on site audits may be carried out by local authorities or by the sponsor's Quality 
Assurance Department. The investigators will allow the sponsor's representatives and any 
regulatory agency to examine all study records, corresponding subject medical records, clinical 
dispensing records and storage area, and any other documents considered source documentation. 
The investigators agree to assist the representative, if required. 
 
13.2 
Audits and Inspections 
The study will be conducted under the sponsorship of Valeant in conformation with all 
appropriate local and federal regulations, as well as ICH guidelines. Interim and end of study 
audits of raw data, study files, and final report may be conducted by Valeant’s Quality Assurance 
Department or designee. 
The sponsor is responsible for implementing and maintaining quality assurance and quality 
control systems to ensure that studies are conducted and data are generated, documented, and 
reported in compliance with the protocol, GCP, and applicable regulatory requirements. In 
addition, the sponsor will be responsible for securing agreement from all involved parties to 
ensure direct access to all study related investigational centers, source data/documents, CRFs, 

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and reports for the purpose of monitoring and auditing by the sponsor, and inspection by 
domestic and foreign regulatory authorities. 
 
13.3 
Data Quality Assurance 
All assessments performed will be accurately documented in the subject’s source documents and 
CRFs. The investigator or designee will enter the information required by the protocol into the 
source documents and CRFs provided by the sponsor or designee. Subjects will be identified in 
the CRFs by their assigned subject number and initials only. 
The investigators must read the protocol thoroughly and must follow the instructions exactly. 
Any deviations should be agreed to by prior discussion between the sponsor and the investigator, 
with appropriate written protocol amendments made prior to implementing the agreed changes. 
Any amendment containing major modifications (particularly if it may involve an increased risk 
to the subjects) will be approved by the IRB before it may be implemented. No change in the 
conduct of the study can be instituted without written approval from the sponsor. 
 
14 Ethics and Administrative Issues 
14.1 
Ethical Conduct of the Study 
This study will be conducted in accordance with the ethical principles originating from the 
Declaration of Helsinki, ICH guidelines, GCP, and in compliance with local regulatory 
requirements. The investigator agrees, when signing the protocol, to adhere to the instructions 
and procedures described in it and thereby to adhere to the principles of GCP. 
 
14.2 
Ethics Review 
This protocol, proposed informed consent form and other information to subjects, and all 
appropriate amendments will be properly reviewed and approved by an Institutional Review 
Board (IRB) or Independent Ethics Committee (IEC). A signed and dated notification of the 
IRB/IEC approval will be provided to the sponsor and investigator prior to study initiation. The 
name and occupation of the chairman and members of the IRB/IEC will be supplied to the 
sponsor. The investigator will provide required progress reports and report all SAEs to the 
IRB/IEC as required by the IRB/IEC. 
 
14.3 
Written Informed Consent 
Written informed consent/assent, in accordance with local clinical investigation regulations, must 
be obtained prior to participation in the study. The investigator or designee will discuss the 
purpose of the study with each subject, and provide a description of the study drug (including 
any potential and possible side effects) and the study procedures. Information must be given both 
in oral and written form. Subject information will be provided in a language understandable to 
the subject and may not include any language that appears to waive any of the subject‘s legal 

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rights or appears to release the investigator, the sponsor or the institution from liability or 
negligence. 
The investigator will provide the prospective subject sufficient time to consider whether or not to 
participate, minimizing the possibility of coercion or undue influence and will discuss any 
questions the subject may have. The investigator will explain to the subject that participation in 
the study is voluntary and that withdrawal from the study is possible at any time without 
detriment to care. The consent must include acknowledgment that medical records and medical 
data derived from the study may be forwarded to the sponsor or to responsible local or federal 
authorities. 
No subject can enter the study or have any study related procedures performed before his/her 
written informed consent has been obtained. The original signed and dated informed consent 
form will be retained with the study records, and a copy of the signed form will be given to the 
subject. 
An informed consent template will be supplied by the sponsor. Any changes to the informed 
consent form must be agreed to by the sponsor or designee prior to submission to the IRB/IEC, 
and a copy of the approved version must be provided to the sponsor or designee after IRB/IEC 
approval. 
 
14.4 
Subject Data Protection 
Subject data will be protected by ensuring that no captured data contain subject names, 
addresses, telephone numbers, email addresses, or other direct personally identifying 
information. It is acknowledged that subject initials, demographics (including birthdates), 
medical histories, and prior concomitant medication uses, along with the name and address of the 
enrolling investigator may allow for personal identification of study participants. Other than 
where necessary to meet regulatory requirements, all data collected in this study will be 
presented in tabulated (ie, aggregate) form and listings containing information that could be used 
to identify an individual subject will not be included in any public disclosures of the study data 
or the study results. 
 
14.5 
Data Monitoring Committee 
Not applicable. 
 
14.6 
Financial Disclosure 
Financial disclosures will be obtained from all investigators in order to document any potential 
conflicts of interest. 

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14.7 I n vesti g at or O bli g ati o ns  
T he i n vesti gat or a gr ees, w he n si g ni n g t he pr ot oc ol, t o a d here t o t he i nstr ucti o ns a n d pr oce d ures 
descri be d i n it a n d t her e b y t o  a d h ere t o t he pri nci ples of G o o d Cli nical Practice ( G C P).  
 
14.8 C h a n ges t o t he  Pr ot o c ol  
T he i n vesti gat ors m ust rea d t he pr ot oc ol t h or o u g hl y a n d m ust f oll o w t he i nstr ucti o ns e x actl y. 
W he ne ver p ossi ble, a n y pla n ne d de viati o ns s h o ul d be a gree d t o b y pri or disc uss i o n bet wee n t he 
s p o ns or a n d t he i n vesti gat or, wit h a p pr o priate d o c u me ntati o n of s p o ns or a p pr o val pri or t o 
effecti n g t h e c ha n ges a gr ee d u p o n. A n y a m e n d me nt t o t he pr ot oc ol c o ntai ni n g maj or 
m o dificati o ns ( partic ularl y if it ma y i n v ol ve a n i ncrease d ris k t o t he s u bjects) will be a p pr o ve d 
b y t he I R B bef ore it ma y be i m ple me nte d. N o c h a n ge i n t he c o n d uct of t he st u d y ca n be 
i nstit ute d wit h o ut writte n a p pr o val fr o m t he s p o ns or. 
 
14.9 C o nfi de nti alit y/ P u blic ati o n of t he St u d y  
All t he data f ur nis he d t o t he i n vesti gat or a n d his/ her staff a n d all data o bt ai ne d t hr o u g h t his 
pr ot oc ol will be re gar de d as c o nfi de ntial a n d pr o prietar y i n nat ure a n d will n ot be discl ose d t o 
a n y t hir d p art y, e x ce pt f or t he F D A or ot her re g ulat or y b o d y, wit h o ut writte n c o nse nt fr o m t he 
s p o ns or. 
 
1 5  D a t a H a n dli n g a n d Rec or d Kee pi n g  
15.1 I ns pecti o n of Rec or ds 
I n v esti gat ors m ust mai ntai n detaile d rec or ds o n all st u d y s u bjects w h o are e nr olle d i n t he st u d y 
or u n der g o scree ni n g. D ata will be rec or de d i n t he s u bject’s s o urce d oc u me nts a n d i n a p plica ble 
st u d y l o gs pr o vi de d b y t h e s p o ns or. S o urce d o c u me nts i ncl u de s u bject me di cal rec or ds, h os pital 
c harts, cli nic c h arts, i n vesti gat or s u bject st u d y files, as well as t he res ults of dia g n ostic tests  
(e g, la b or at or y tests). All re q uire d d ata s h o ul d be rec or de d i n t he st u d y d o c u me ntati o n 
c o m pletel y f or pr o m pt data re vie w. U p o n st u d y c o m pleti o n or at a n y ot h er ti me s pecifie d b y t he 
s p o ns or or desi g nee, t h e a p pr o priate st u d y d oc u m e nts m ust be s u b mitte d. 
T he i n vesti gat or m ust kee p acc urate s e parate rec or ds (s o urce d oc u me nt ati o n) of all s u bject visits, 
bei n g s ur e t o i ncl u de all perti ne nt st u d y relate d i nf or mati o n. At a mi ni m u m, t his i ncl u des t he 
f oll o wi n g i nf or mati o n: 
•  A state me nt i n dicati n g t h at t he s u bject has bee n e nr olle d i n t he st u d y a n d t h e  s u bject 
n u m ber  
•  Date t hat i nf o r me d c o nse nt was o btai ne d 
•  E vi de nce t hat t he s u bject meets st u d y eli gi bilit y re q uire me nts (e g, me dical hist or y, 
scree ni n g e val uati o ns)  

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C O N FI D E N TI A L  
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•  Dates of all st u d y rel ate d visits a n d res ults of a n y e val uati o ns/ pr oce d ures  p erf or me d, 
i ncl u di n g w h o perf or me d eac h assess me nt at eac h  visit  
•  Use of a n y c o nc urre nt m e dicati o ns d uri n g t he  st u d y 
•  D oc u me ntati o n of st u d y dr u g  acc o u nt a bilit y 
•  A n y a n d all si de effects a n d A Es m ust be t h or o u g hl y d oc u me nt e d t o  c o ncl usi o n  
•  Res ults of a n y dia g n ostic tests c o n d ucte d d ur i n g t he st u d y 
•  T he date t he s u bject e xite d t he st u d y a n d a state me nt i n dicati n g t hat t he  s u bj ect 
c o m plete d t he st u d y or w as disc o nti n ue d earl y, i ncl u di n g t he reas o n f or 
disc o nti n uati o n  
N otes descri bi n g tele p h o ne c o n vers ati o ns a n d all electr o nic mail wit h t he s u bject or t he s p o ns or 
(s p o ns or’s desi g nee) c o n cer ni n g t he st u d y m ust be rec or de d or k e pt o n file. All s o urce 
d oc u me nts m ust be ma de a vaila ble t o t he s p o ns or a n d t he s p o ns or’s desi g n ate d m o nit or u p o n 
re q uest. 
 
15.2 Rete nti o n of Rec or ds  
T he i n vesti gat or  s h o ul d pr o perl y st ore a n d mai ntai n all st u d y rec or ds i n acc or da nce wit h s p o ns or 
directi ves. All rec or ds r elati n g t o t he c o n d u ct of t his st u d y are t o be ret ai ne d b y t he i n vesti gat or 
u ntil n otifie d b y t h e s p o ns or i n writi n g t hat t he rec or ds ma y b e destr o ye d . 
T he i n vesti gat or will all o w re pr ese ntati ves of t he s p o ns or’s m o nit ori n g tea m, t he g o ver ni n g 
I R B/I E C, t he F D A, a n d ot her a p plica ble re g ulat or y a ge ncies t o i ns pect all st u d y rec or ds, C R Fs, 
a n d c orr es p o n di n g p orti o ns of t he s u bject’s cli nic a n d/ or h os pital me dical rec or ds at re g ular 
i nter vals t hr o u g h o ut t he st u d y. T hes e i ns pecti o ns are f or t he p ur p ose of v erif yi n g a d h ere nce t o 
t he pr ot oc ol, c o m plete ness a n d acc urac y of t he data bei n g e ntere d o nt o t he C R F, a n d c o m plia nce 
wit h F D A or ot her re g ul at or y a ge nc y re g ulati o ns.  

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Version 4, 7 October 2016 
CONFIDENTIAL 
63 
 
 
16 References 
1. 
Leyden JJ, Shalita AR. Rational therapy for acne vulgaris: an update on topical treatment. 
J Am Acad Dermatol. 1986;15(4 Pt 2):907-15. 
 
2. 
Webster GF. Acne vulgaris. BMJ. 2002;325(7362):475-9. 
 
3. 
Eady EA. Bacterial resistance in acne. Dermatology. 1998;196(1):59-66. 
 
4. 
Eady EA, Farmery MR, Ross JI, Cove JH, Cunliffe WJ. Effects of benzoyl peroxide and 
erythromycin alone and in combination against antibiotic-sensitive and -resistant skin 
bacteria from acne patients. Br J Dermatol. 1994;131(3):331-6. 
 
5. 
Leyden JJ, McGinley KJ, Cavalieri S, Webster GF, Mills OH, Kligman AM. 
Propionibacterium acnes resistance to antibiotics in acne patients. J Am Acad Dermatol. 
1983;8(1):41-5. 
 
6. 
Shalita A. The integral role of topical and oral retinoids in the early treatment of acne. J 
Eur Acad Dermatol Venereol. 2001;15 Suppl 3:43-9. 
 
7. 
McLane J. Analysis of common side effects of isotretinoin. J Am Acad Dermatol. 
2001;45(5):S188-94. 
 
8. 
Orfanos CE, Ehlert R, Gollnick H. The retinoids. A review of their clinical pharmacology 
and therapeutic use. Drugs. 1987;34(4):459-503. 
 
9. 
Lucky AW, Cullen SI, Funicella T, Jarratt MT, Jones T, Reddick ME. Double-blind, 
vehicle-controlled, multicenter comparison of two 0.025% tretinoin creams in patients 
with acne vulgaris. J Am Acad Dermatol. 1998;38(4):S24-30. 
 
10. 
Zar, JH. Biostatistical analysis. 2nd Edition. Englewood Cliffs, NJ: Prentice-Hall. P. 118- 
119. 1984. 

Protocol V01-121A-302, IDP-121 
Valeant Research & Development 
Version 4, 7 October 2016 
CONFIDENTIAL 
64 
 
 
17 Appendices 
17.1 Subject Instruction Sheet 
 
Wash your face gently with a mild cleanser approved by your study doctor and warm (not hot) 
water. Rinse thoroughly and gently pat dry with a cotton towel. Wait until skin is completely dry 
before applying the test material. 
 
A thin coating of test material should be applied once daily (about the same time every day) to 
the entire face for twelve weeks. Use the tube to dispense a pea-sized amount of study drug to 
your fingertip. 
 
This dose should then be dotted on to 6 areas (chin, left cheek, right cheek, nose, left forehead, 
right forehead) on the face. After distributing the dose in this manner, gently rub the lotion into 
the skin. This amount should be used to evenly cover the entire face excluding the mouth, eyes 
and lips. It is important to treat your entire face. 
 
Do NOT treat only specific lesions. DO NOT APPLY MORE THAN THE PRESCRIBED 
AMOUNT. 
Be sure to wash your hands after you apply the product. 
Reminders: 
- 
On study visit days please wait until after your study visit to apply the study medication. 
- 
Avoid contact with the eyes, inside the nose, mouth and all mucous membranes. 
- 
Do not cover the affected areas with any type of dressing, such as gauze. 
- 
THE TEST MATERIAL SHOULD BE USED ONLY BY THE PERSON FOR WHOM IT 
WAS PRESCRIBED and it should be kept out of the reach of others of limited capacity to 
read or understand. 
- 
Store at controlled room temperature 20°C to 25°C (68°F to 77°F) with excursions permitted 
between 15°C to 30°C (59°F to 86°F). Do not freeze. Avoid excessive heat or cold. 
- 
Tubes of test material must be returned to the study facility, even if they are empty. 
- 
If you miss any doses, at your next visit inform the study doctor of the date(s) of the missed 
dose(s). 
- 
Continue to use the same, study doctor approved, cleanser, moisturizer and sunscreen 
throughout the study. 
- 
You must not use any other treatment for your facial acne while you are participating in this 
study. 
- 
Avoid unnecessary sun exposure and tanning booths. 

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CONFIDENTIAL 
65 
 
 
- 
It is important that you inform the study site about any medications (i.e., prescriptions, over- 
the-counter medications, street drugs, or herbal medications) that you have taken during the 
study. 
 
If you have any questions or have a potential research-related side effect or injury you may 
contact  
at  
. 

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17.2 Cle a nsers, M oist urizers a n d S u nscree n Use  G ui deli nes  
S u bjects ma y use t h e f oll o wi n g pr o d u cts as e x a m ples of a p pr o ve d pr o d ucts. T he I n vesti gat or 
ma y use t h eir discr eti o n o n w hat pr o d ucts eac h s u bject ma y use i n t he treat me nt area d uri n g t he 
st u d y. S u bjects ma y use t he bel o w set of e x a m ples or ot her I n vesti gat or a p pr o ve d n o n - 
me dicate d pr o d u cts o n t he treat me nt area. I nf or m ati o n re gar di n g pr o d ucts use d s h o ul d be 
ca pt ure d i n t he s o ur ce d o c u me nt a n d rec or d e d o n t he faci al s ki n care secti o n of t he e C R F.  
 
A p pr o ve d Clea ns er E x a m ples:  
Cera Ve clea ns er  
Ceta p hil dail y clea ner a n d ge ntle clea nsi n g bar 
P ur p ose ge ntle clea nsi n g was h  
 
A p pr o ve d M oist urizer  E x a m ples:  
Cera Ve Crea m or L oti o n 
M oist urel crea m or l oti o n 
N utra der m  
Ceta p hil l oti o n or crea m 
D M L  
E uceri n l oti o n or cr ea m 
P ur p ose  
 
A p pr o ve d M oist urizer/ S u nscree n C o m bi nati o n Pr o d uct E x a m ples: 
Cera Ve L oti o n A. M.  
Ola y C o m plete ( S P F 1 5)  
Ne utr o ge na Healt h D efe nse Dail y M oist urizer ( S P F 3 0) 
Ceta p hil Dail y Faci al M oist urizer ( S P F 1 5)  
 
A p pr o ve d S u nscr ee n E x a m ples:  
Ba na n a B oat S p ort S u n bl oc k L oti o n ( S P F 1 5, 3 0 + or 5 0) 
Ne utr o ge na U V A/ U V B ( S P F 3 0 or 4 5)  
Ne utr o ge na S e nsiti ve S ki n S u n bl oc k L oti o n ( S P F 1 7)  
Ne utr o ge na Healt h y D efe nse Oil -Free S u n bl oc k L oti o n ( S P F 3 0 or 4 5) 
C o p pert o ne Water Ba bies U V A/ U V B S u n bl oc k L oti o n ( S P F 4 5)  

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17.3 S u bject Self Assess me nt Sc ori n g  Sc ale  
 
 
B aseli ne S u bject Q uesti o n  
H o w w o ul d rate t h e c urre nt se verit y of y o ur facial ac ne c o n diti o n o n a scale of 1 -7?  
( C hec k o nl y o ne b o x) 
1, Clear or al m ost clear s ki n ( > 9 0 %);  
2, M o deratel y cl ear s ki n ( > 8 0 % b ut ≤ 9 0 %);  
3, Fairl y clear s ki n ( > 7 0 % b ut ≤ 8 0 %); 
4, Ac ne c o v ere d a b o ut 5 0 % of t he face;  
5, Fairl y se v ere ac ne ( > 7 0 % b ut ≤ 8 0 % c o vera ge);  
6, M o deratel y se v ere ac n e ( > 8 0 % b ut ≤ 9 0 % c o vera ge); 
7, Se vere ac ne, wit h al m ost t otal c o vera ge ( > 9 0 %).  
 
Wee k 2 ( at -h o me), 4, 8, a n d 1 2 S u bject Q uesti o n  
H o w w o ul d rate t h e c urre nt se verit y of y o ur facial ac ne c o n diti o n o n a scale of 1 -7?  
( C hec k o nl y o ne b o x) 
1, clear ( 1 0 0 %);  
2, al m ost clear  ( 9 0 % t o < 1 0 0 %); 
3, mar ke d i m pr o ve me nt ( 7 5 % t o < 9 0 %);  
4, m o derate i m pr o ve m e nt ( 5 0 % t o < 7 5 %);  
5, fair i m pr o ve me nt ( 2 5 % t o < 5 0 %);  
6, n o c ha n ge;  
7, w orse  

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Version 4, 7 October 2016 
CONFIDENTIAL 
68 
 
 
17.4 
Patient Satisfaction Survey (PSS) 
 
 
Baseline Question 
 
On a scale of 1-10 with 1 being the least satisfied and 10 being the most satisfied please rate your 
level of satisfaction with your prior facial acne therapy. 
 
 
 
 
Week 12 Question 
 
On a scale of 1-10 with 1 being the least satisfied and 10 being the most satisfied please rate your 
level of satisfaction with your current facial acne study treatment. 
 
 
 

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17.5 Ac ne -S pecific Q u alit y of Lif e Q uesti o n n aire  ( Ac ne-Q o L)  
1.  I n t he p ast W E E K, h o w u nattracti ve di d y o u feel beca use of y o ur facial ac ne?  
 e xtre mel y  ver y  m uc h  q uite  a bit 
a g o o d bit  
s o me w hat a little bit n ot at  all 
2.  I n t he p ast W E E K, h o w e m barrasse d di d y o u feel beca use of y o ur facial ac ne?  
 e xtre mel y  ver y  m uc h  q uite  a bit 
a g o o d bit  
s o me w hat a little bit n ot at  all 
3.  I n t he p ast W E E K, h o w s elf-c o nsci o us ( u neas y a b o ut o neself) di d y o u feel a b o ut y o ur facial 
ac ne?  
 e xtre mel y  ver y  m uc h  q uite  a bit 
a g o o d bit  
s o me w hat a little bit n ot at  all 
4.  I n t he p ast W E E K, h o w u pset were y o u a b o ut ha vi n g facial ac ne? 
 e xtre mel y  ver y  m uc h  q uite  a bit 
a g o o d bit  
s o me w hat a little bit n ot at  all 
5.  I n t he p ast W E E K, h o w a n n o ye d di d y o u feel at h a vi n g t o s pe n d ti me e ver y da y clea ni n g a n d 
treati n g y o ur face b eca us e of y o ur facial ac n e?  
 e xtre mel y  ver y  m uc h  q uite  a bit 
a g o o d bit  
s o me w hat a little bit n ot at  all 
6.  I n t he p ast W E E K, h o w dissatisfie d wit h y o ur self-a p peara n ce di d y o u feel beca use of y o ur 
facial ac n e?  
 e xtre mel y  ver y  m uc h  q uite  a bit 
a g o o d bit  
s o me w hat a little bit n ot at  all 
7.  I n t he p ast W E E K, h o w c o ncer ne d or w orrie d were y o u a b o ut n ot l o o ki n g y o ur b est beca use 
of y o ur facial ac n e?  
 e xtre mel y  ver y  m uc h  q uite  a bit 
a g o o d bit  
s o me w hat a little bit n ot at  all 
8.  I n t he p ast W E E K, h o w c o ncer ne d or w orrie d were y o u t h at y o ur ac n e me dicati o n pr o d ucts 
were w or ki n g fast e n o u g h i n cleari n g u p t he ac ne o n y o ur  face? 
 e xtre mel y  ver y  m uc h  q uite  a bit 
a g o o d bit  
s o me w hat a little bit n ot at  all 
9.  I n t he p ast W E E K, h o w b ot here d di d y o u feel a b o ut t he nee d t o al wa ys h a v e me dicati o n or 
c o ver-u p a vaila ble f or t h e ac n e o n y o ur  face? 
 e xtre mel y  ver y  m uc h  q uite  a bit 
a g o o d bit  
s o me w hat a little bit n ot at  all 
1 0.  I n t he p ast W E E K, h o w m uc h was y o ur self-c o nfi de nce (s ure of y o urself) ne gati vel y aff ecte d 
beca use of y o ur f acial  ac ne?  
 e xtre mel y  ver y  m uc h  q uite  a bit 
a g o o d  bit  
s o me w hat a little bit n ot at  all 
1 1.  I n t he p ast W E E K, h o w c o ncer ne d or w orrie d were y o u a b o ut meeti n g ne w pe o ple beca use 
of y o ur facial ac n e?  
 e xtre mel y  ver y  m uc h  q uite  a bit 
a g o o d bit  
s o me w hat a little bit n ot at  all 
1 2.  I n t he p ast W E E K, h o w c o ncer ne d or w orrie d were y o u a b o ut g oi n g o ut i n p u blic beca use  of 
y o ur faci al ac n e?  
 e xtre mel y  ver y  m uc h  q uite  a bit 
a g o o d bit  
s o me w hat a little bit n ot at  all 

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1 3.  I n t he p ast W E E K, h o w m uc h was s ocializi n g wit h pe o ple a pr o ble m f or y o u beca use of  y o ur 
facial ac n e?  
 e xtre mel y  ver y  m uc h  q uite  a bit 
a g o o d bit  
s o me w hat a little bit n ot at  all 
1 4.  I n t he p ast W E E K, h o w m uc h was i nteracti n g wit h t he o p p osite se x ( or sa me se x if ga y or 
les bia n) a pr o ble m f or y o u beca use of y o ur facial acne?  
 e xtre mel y  ver y  m uc h  q uite  a bit 
a g o o d bit  
s o me w hat a little bit n ot at  all 
1 5.  I n t he p ast W E E K, h o w ma n y b u m ps di d y o u ha v e o n y o ur face? 
 E xte nsi ve   A  w h ole  l ot A  l ot A  m o derate  a m o u nt S o me Ver y fe w  N o ne  
1 6.  I n t he p ast W E E K, h o w ma n y b u m ps f ull of p us di d y o u ha v e o n y o ur  face? 
 E xte nsi ve   A  w h ole  l ot A  l ot A  m o derate  a m o u nt S o me Ver y fe w  N o ne  
1 7.  I n t he p ast W E E K, h o w m uc h sca b bi n g fr o m y o ur faci al ac n e di d y o u ha v e?  
 E xte nsi ve   A  w h ole  l ot A  l ot A  m o derate  a m o u nt S o me Ver y fe w N o ne  
1 8.  I n t he p ast W E E K, h o w c o ncer ne d or w orrie d were y o u a b o ut scarri n g fr o m y o ur facial ac ne?  
 e xtre mel y  ver y  m uc h  q uite  a bit 
a g o o d bit  
s o me w hat a little bit n ot at  all 
1 9.  I n t he p ast W E E K, h o w oil y was y o ur facial s ki n? 
 e xtre mel y  ver y  m uc h  q uite  a bit 
a g o o d bit  
s o me w hat a little bit n ot at  all 
 
 
 
 
C o p yri g ht © 1 9 9 7 Merc k & C o., I nc.  
W hite h o use Stati o n, NJ, U S A 
Use d wit h P er missi o n  

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Fec h a:    
 
 
C uesti o n ari o s o bre l a c ali d a d de vi d a, es pecífic o al ac né  
 
  
N o. de  I de ntific aci ó n: 
 
 
( F av or de m arc ar u n a c asill a p ar a c a d a pre g u nt a) 
 
 
de masia d o  
m uc h o  
m u y  
basta nte  
al g o 
u n p oc o  
na da  
 
 
 
 
 
 
 
 
 
de masia d o  
m uc h o  
m u y  
basta nte  
al g o 
u n p oc o  
na da  
 
 
 
 
 
 
 
 
 
de masia d o  
m uc h o  
m u y  
basta nte  
al g o 
u n p oc o  
na da  
 
 
 
 
 
 
 
 
 
de masia d o  
m uc h o  
m u y  
basta nte  
al g o 
u n p oc o  
na da  
 
 
 
 
 
 
 
 
 
de masia d o  
m uc h o  
m u y  
basta nte  
al g o 
u n p oc o  
na da  
 
 
 
 
 
 
 
 
 
de masia d o  
m uc h o  
m u y  
basta nte  
al g o 
u n p oc o  
na da  
 
 
 
 
 
 
 
 
 
de masia d o  
m uc h o  
m u y  
basta nte  
al g o 
u n p oc o  
na da  
 
 
 
 
 
 
 
1. D ura nte la S E M A N A pasa da, ¿ q ué ta n p oc o atr acti v o( a) t e se ntiste de bi d o al ac né d e la 
cara?  
2. D ura nte la S E M A N A pasa da, ¿ q ué ta n a ver g o nz a d o( a) te se ntiste de bi d o al ac né d e la cara? 
3. D ura nte la S E M A N A pasa da, ¿ q ué ta n ac o m pl ej a d o( a), [i nc ó m o d o(a) c o nti g o mis m o(a)], te 
se ntiste de bi d o al ac n é de la car a? 
4. D ura nte la S E M A N A pasa da, ¿ q ué ta n dis g ust a d o( a) te se ntiste p or te n er ac n é de la cara? 
5. D ura nte la S E M A N A pasa da, ¿ q ué ta n m ol est o( a) te se ntiste p or t o mar t a nt o tie m p o 
diaria me nte li m piá n d ote y trat á n d ote la cara, d e bi d o al ac né d e la cara?  
6. D ura nte la S E M A N A pasa da, ¿ q ué ta n i ns atisfec h o( a) te se ntiste c o n t u as pect o pers o nal, 
de bi d o al ac n é de la car a?  
7. D ura nte la S E M A N A pasa da, ¿ q ué ta n i ntr a n q uil o( a) o pre oc u p a d o( a) est u viste de n o verte 
l o mej or p osi ble, de bi d o al ac né d e la cara? 

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( F av or de m arc ar u n a c asill a p ar a c a d a pre g u nt a)  
 
 
de masia d o  
m uc h o  
m u y  
basta nte  
al g o 
u n p oc o  
na da  
 
 
 
 
 
 
 
 
 
de masia d o  
m uc h o  
m u y  
basta nte  
al g o 
u n p oc o  
na da  
 
 
 
 
 
 
 
 
 
de masia d o  
m uc h o  
m u y  
basta nte  
al g o 
u n p oc o  
na da  
 
 
 
 
 
 
 
 
 
de masia d o  
m uc h o  
m u y  
basta nte  
al g o 
u n p oc o  
na da  
 
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 
 
 
de masia d o  
m uc h o  
m u y  
basta nte  
al g o 
u n p oc o  
na da  
 
 
 
 
 
 
 
 
 
de masia d o  
m uc h o  
m u y  
basta nte  
al g o 
u n p oc o  
na da  
 
 
 
 
 
 
 
 
 
 
de masia d o  
m uc h o  
m u y  
basta nte  
al g o 
u n p oc o  
na da  
 
 
 
 
 
 
 
8. D ura nte la S E M A N A pasa da, ¿ q ué ta n i ntr a n q uil o( a) o pre oc u p a d o( a) est u viste de q ue l os 
me dica me nt os y pr o d uct os para el ac né est u viese n f u nci o na n d o l o s uficie nte me nte rá pi d o 
para eli mi nar el ac n é de l a car a?  
9. D ura nte la S E M A N A pasa da, ¿ q ué ta n m ol est o( a) te se ntiste p or la n ecesi da d de te ner 
sie m pre dis p o ni bles me dica me nt os o cre mas para c u brir el ac né d e la cara?  
1 0. D ura nte la S E M A N A pasa da, ¿ q ué ta n ne g ati v o f ue el efect o d el ac né e n t u c o nfia nza e n ti 
mis m o(a)?  
1 1. D ura nte la S E M A N A pasa da, ¿ q ué ta n i ntr a n q uil o( a) o pre oc u p a d o( a) te se ntiste al 
c o n ocer a n ue v as pers o n as, de bi d o al ac n é de la cara?  
1 2. D ura nte la S E M A N A pasa da, ¿ q ué ta n i ntr a n q uil o( a) o pre oc u p a d o( a) te se ntiste al salir y 
estar e ntr e la ge nte, d e bi d o al ac né d e la cara?  
1 3. D ura nte la S E M A N A pasa da, ¿ q ué t a n pr o ble m átic o f ue p ar a ti s oci aliz ar c o n l as 
pers o n as, de bi d o al ac né de la cara?  
1 4. D ura nte la S E M A N A pasa da, ¿ q ué t a n pr o ble m átic o f ue p ar a ti rel aci o n arte c o n 
pers o n as del se x o o p uest o ( o del mis m o se x o, para h o m ose x uales), de bi d o al ac né d e la 
cara?  

Pr ot oc ol V 0 1 -1 2 1 A -3 0 2, I D P -1 2 1  
Valea nt Researc h & De vel o p me nt  
Versi o n 4, 7 Oct o ber 2 0 1 6  
C O N FI D E N TI A L  
7 3  
 
 
( F av or de m arc ar u n a c asill a p ar a c a d a pre g u nt a)  
 
 
 
a b u n da ntes 
u na gra n  
ca nti da d 
 
m uc h os  
u na ca nti da d  
m o dera da  
 
al g u n os 
m u y  
p oc os  
 
ni n g u n o  
 
 
 
 
 
 
 
 
 
 
a b u n da ntes 
u na gra n  
ca nti da d 
 
m uc h os  
u na ca nti da d  
m o dera da  
 
al g u n os 
m u y  
p oc os  
 
ni n g u n o  
 
 
 
 
 
 
 
 
 
 
a b u n da ntes 
u na gra n  
ca nti da d 
 
m uc has  
u na ca nti da d  
m o dera da  
 
al g u nas 
m u y  
p ocas  
 
ni n g u na  
 
 
 
 
 
 
 
 
 
de masia d o  
m uc h o  
m u y  
basta nte  
al g o 
u n p oc o  
na da  
 
 
 
 
 
 
 
 
 
de masia d o  
m uc h o  
m u y  
basta nte  
al g o 
u n p oc o  
na da  
 
 
 
 
 
 
 
 
1 5. D ura nte la S E M A N A pasa da, ¿c uá nt os gr a n os te nías e n la cara? 
1 6. D ura nte la S E M A N A pasa da, ¿c uá nt os gr a n os i nfect a d os te nías e n la cara? 
1 7. D ura nte la S E M A N A pasa da, ¿c uá ntas c ostr as o p ostill as (es pi nill as sec as) te nías, de bi d o al 
ac né d e la cara?  
1 8. D ura nte la S E M A N A pasa da, ¿ q ué ta n i ntr a n q uil o( a) o pre oc u p a d o( a) est u viste p or las 
marcas y o cicatrices, q u e q ue dar o n d el ac n é de la cara?  
1 9. D ura nte la S E M A N A pasa da, ¿ q ué ta n gr as os o esta ba el c utis?