Clinical trial NCT02515305
Conditions: Acne
Sponsor: Padagis LLC
Start date: 2015-07-01; Completion date: 2016-06-01
Enrollment: 890 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to compare the safety and efficacy of Perrigo's product to an FDA approved product for the treatment acne vulgaris

Detailed description:

Arms: arm 1: None arm 2: None arm 3: None
Interventions: intervention 1: Clindamycin and Benzoyl Peroxide Gel (combination) intervention 2: Clindamycin and Benzoyl Peroxide Gel (Reference) (combination) intervention 3: Placebo gel (combination)
Intervention descriptions: intervention 1: None intervention 2: None intervention 3: None

Protocol documents:
Prot_001.pdf: 
 
 
NCT02515305 
 
06-12-2015 


A M ulti- C e nt er, D o u bl e- Bli n d, R a n d o mi z e d, V e hi cl e- C o ntr oll e d, P ar all el- Gr o u p 
St u d y t o C o m p ar e P erri g o U K FI N C O Cli n d a m y ci n P h e > $ p h at e a n d B- e n z o yl P er o xi d e 
T o pi c al Gel 1. 2"/ 3. 7 5 % t o V al e a nt P har mace uticals N ort h A m eri c a, L L C O ne xt o n:.,.. 
T o pi c al G el ( Cll n d a m y cl n P h o s p h at e a n d B e n z o yl P er o xi d e G el 1. 2 %/ 3. 7 $ %), a n d 
B ot h A cti v e Tr e at m e nt s t o a V e hi cl e C o ntr ol i n.t h e Tr e at m e nt of A c n e V ul g ari s 
Pr ot o c ol N o .: P R G- N Y- 1 5- Q 0 a 
C o nfi d e nti al 
T he c.o nfi de ntlal hif or matl.o n pr o vi d e d i n t his d o c u m e nt is f or us e b y p arti es directl y I n v ol ve d I n 
t his I n vesti gati o n. B y a c c e pti n g t his d o c u m e nt, y o u a gr e e t h at t h e I nf or mati o n c o nt ai n e d h er ei n 
will n ot b e dis cl os e d t o a n v p ers o n n ot directl y i n v ol ve d i n t his i n v esti g ati o n wit h o ut writt e n 
a ut h ori z ati o n fr o m Perri g o U K FI N C O Li mite d P art n ers hi p. 
P a ge 4 of 5 2 


Pr ot o c ol N o: P R G- N V- 1 5- 0 0 3 
P R O T O C O L SI G N A T U R E P A G E 
P R O T O C O L N U M B E R: P R G- N Y -1 5 -0 0 3 
P R O T O C O L TI T L E: 
A 
M ulti -C e nt er, 
D o u bl e- Bli n d , R a n d o mi z e d, 
V e hi cl e- C o ntr oll e d, 
P ar afl ·el-
Gr o u p St u d y t o C o m p ar e P erri g o U K FI N C O Cli n d a m y ci n P h o s p h at e a n d 
B e n z o y l P er o xi d e T o pi c al G el 1. 2 %/ 3 .7 5 % t o V al e a nt P h ar m a c e uti c al s N ort h 
A m eri c a , L L C O n e xt o n"' T o pi c al G el 
( Cli n d a m y ci n P h o s p h at e a n d B e n z o yt 
P er o xi d e G el 1. 2 %/ 3, 7 5 %) , a n d B ot h A cti v e Tr e at m e nt s t o a V e hi cl e C o ntr o l 
i n t h e Tr e at m e nt of A c n e V ul g ari s 
Si g n at ur e s of r e pr e s e nt ati v e s b el o w in di c at e t hi s i s t h e a gr e e d u p o n fi n al v er si o n of t h e pr ot o c ol: 
• 
Pa ge 2 of 4 9 
Pa ge 5 of 5 2 


Pr ot o c ol N o: P R G- N Y -1 5- 0 0 3 
T A B L E O F C O N T E N T S 
T A B L E O F C O N T E N T S ............................................................................................................................ 3 
1. 
B A C K G R O U N D ..................................................................................................................... 8 
2. 
S T U D Y O B J E C TI V E S .............................................................................................................. 8 
2. 1 
E n d p oi nt s ................................ ............................................................................................... 8 
2. 2 
S af et y ...................................... ............................................................................................... 8 
3. 
S T U D Y D E SI G N .................................................................................................................... 8 
3. 1 
T y p e/ D e si g n of St u d y ............................................................................................................ 8 
3 . 2 
St u d y P o p u l ati o n ............................. ...................................................................................... 9 
4. 
S E L E C TI O N A N D WI T H D R A W A L O F S T U D Y S U B J E C T S ............................................................ 9 
4. 1 
I n cl u si o n Cr it eri a .................................................................................................................... 9 
4. 2 
E x cl u si o n Cr it eri a ................................................................................................................. 1 0 
4. 3 
Pr o hi bit e d M e di c ati o n s ....................................................................................................... 1 1 
4. 4 
Pr e c a uti o n s .......................................................................................................................... 1 2 
s. 
P R O C E D U R E S .................................................................................................................... 1 4 
5. 1 
S u bj e ct S cr e e ni n g a n d E nr oll m e nt ...................................................................................... 1 4 
5. 2 
A s si g n m e nt of S u bj e ct N u m b er ........................................................................................... 1 4 
5. 3 
D e m o gr a p hi c s/ M e d i cal Hi st or y ....... .................................................................................... 1 4 
5. 4 
C o n c o mit a nt M e di c ati o n s ................................................................................................... 1 4 
5. 5 
P h y si c al E x a mi n ati o n ........................................................................................................... 1 4 
5. 6  
Ur i ne  P r e g n a n c y T e st .. .. .. ....................................................................................... .............. 1 5 
5. 7 
D er m a t olo gi c a l A s s e s s m e nt ( Di a g n o sis) .............................................................................. 1 5 
5. 8 
I n v est ig at or' s Gl o b al A s s e s s m e nt  ( I G A) ............................................................................... 1 5 
5. 9 
L e s io n Co u nt i n g ............ ....................................................................................................... 1 6 
5. 9. 1 I nfl a m m at or y L e s i o n C o u nt ................................... ...................................................................... 1 6 
5. 9. 2 N o n-i n fl a m m at or y L e s io n C o u nt ................................................................................................ 1 6 
5. 9. 3 N o d ul o c y sti c L e si o n Co u nt ........ .................................................................................................. 1 6 
5. 1 0 
A p pli c at i o n Site Re a cti o n A s s e s s m e n t.. ............................................................................... 1 7 
5. 1 1 
St u d y M e di c ati o n U s e, S u bj e ct In st ru cti o n s a n d Di ar y ....................................................... 1 8 
5. 1 2 
Vi si t S p e c if i c Pro c e d u re s ................................................................................................... ... 1 9 
5. 1 2. 1 
B a s eli n e . Vi sit/ D a y 1 . .......................... ................................................................................. 1 9 
5. 1 2. 2 
T el e p h o n e C o nt a ct/ W e e k 2/ D a y 1 4 ( ± 4 d a y s) .................................................................... 1 9 
5. 1 2. 3 
Vi sit 2/ W e e k 4/ D a y 2 8 ( ± 4 d a y s) ........................................................................................ 1 9 
5. 1 2. 4 
Vi sit 3/ W e e k 8/ D a y 5 6 ( ± 4 d a y s) ........................................................................................ 2 0 
5. 1 2. 5 
Vi sit 4/ W e e k 1 2 / D a y 8 4 ( ± 4 d a y s) E n d of T r e at m e nt/ E arl y T er mi n ati o n Vi sit.. ....... .......... 2 0 
5. 1 2. 6 
U n s c h e d ul e d Vi s it ................................................................................................................ 2 0 
5. 1 3 
S u m m ar y of A s s e s s m e nt s .................................................................................................... 2 2 
5. 1 4 
S cr e e n F ail ur e s ......................... ............................................................................................ 2 3 
5. 1 5 
Pr ot o c ol D e vi ati o n s/ Vi ol ati o n s ............................................................................................ 2 3 
5. 1 6 
S u bj e ct/ Tr e at m e nt C o m pli a n c e .......................................................................................... 2 3 
5. 1 7 
Di s c o nti n u at i o n/ Wit h dr a w al of St u d y S u bj e ct s .................................................................. 2 4 
6. 
M A T E RI A L S A N D S U P P LI E S ................................................................................................. 2 5 
6. 1 
St u d y M e di c ati o n ............................. ....... ............................................................................ 2 5 
6. 2 
M e di c ati o n M a n a g e m e nt .... .............................................. .................................................. 2 5 
6. 2. 1 
L a b e li ng, P a c k a gi n g a n d Di st ri b uti o n .................................................................................. 2 5 
6. 2 . 2 R et e nti o n S a m pl e s ...................................................................................................................... 2 6 
P a g e 3 of 4 9 
P a ge 6 of 5 2 





























































































SAP_000.pdf: 
 
 
NCT02515305 
 
06-12-2015 




Perrigo, Inc.                                                                                                                 Protocol: PRG-NY-15-003                          
 
1  
CONFIDENTIAL 
Table of Contents 
1 
Purpose of Statistical Analysis Plan ........................................................................................................ 4 
2 
Study Objectives ....................................................................................................................................... 4 
3 
Study Design ............................................................................................................................................. 4 
4 
Populations To Be Analyzed .................................................................................................................... 5 
5 
Planned Analyses ...................................................................................................................................... 6 
5.1 
Methodological Considerations ........................................................................................................................ 6 
5.2 
Handling of Dropouts or Missing Data ............................................................................................................. 6 
5.3 
Demographics and Baseline Characteristics ..................................................................................................... 6 
5.4 
Subject Accountability ...................................................................................................................................... 7 
5.5 
Efficacy Variables and Analyses ...................................................................................................................... 7 
5.5.1 
Primary Endpoints ..................................................................................................................................... 7 
5.5.2 
Secondary Endpoint ................................................................................................................................... 8 
5.5.3 
Additional Efficacy Variables .................................................................................................................... 9 
5.6 
Safety Variables and Analyses .......................................................................................................................... 9 
6 
Appendices .............................................................................................................................................. 10 
6.1 
Handling of Missing or Incomplete Dates for Adverse Events and Concomitant Medications ...................... 10 
6.2 
Summary of Assessments ............................................................................................................................... 10 
7 
Tables and Listings ................................................................................................................................. 12 
Table 14.1.1- Subject Final Study Disposition ........................................................................................................ 14 
Table 14.1.2- Subject Enrollment and Protocol Violations ..................................................................................... 15 
Table 14.1.3- Subject Enrollment by Study Site ..................................................................................................... 16 
Table 14.1.4.1- Demographic Characteristics for Intent-to-Treat Population ......................................................... 17 
Table 14.1.4.2- Demographic Characteristics for Modified Intent-to-Treat Population ......................................... 18 
Table 14.1.4.3- Demographic Characteristics for Per-Protocol Population ............................................................ 18 
Table 14.1.5.1- Baseline Vital Signs for Intent-to-Treat Population ....................................................................... 19 
Table 14.1.5.2- Baseline Vital Signs for Modified Intent-to-Treat Population ....................................................... 20 
Table 14.1.5.3- Baseline Vital Signs for Per-Protocol Population .......................................................................... 20 
Table 14.2.1.1- Primary Efficacy Analysis: Mean Percent Change Baseline3 to Week 12 (Visit 4/Day 84) in 
Number of Inflammatory Lesion Counts ............................................................................................................. 21 
Table 14.2.1.2- Primary Efficacy Analysis: Mean Percent Change from Baseline3 to Week 12 (Visit 4/Day 84) in 
Number of Non-Inflammatory Lesion Counts ..................................................................................................... 22 
Table 14.2.2- Secondary Efficacy Analysis: Proportion of Subjects with Clinical Success on the Investigator’s 
Global Assessment (IGA) at Week 12 (Visit 4/Day 84) ...................................................................................... 23 
Table 14.2.3.1- Additional Efficacy Summary: Post-Baseline Inflammatory Lesion Count for Per-Protocol 
Population ............................................................................................................................................................ 24 
Table 14.2.3.2- Additional Efficacy Summary: Post-Baseline Inflammatory Lesion Count for Modified Intent-to-
Treat Population................................................................................................................................................... 25 
Table 14.2.3.3- Additional Efficacy Summary: Post-Baseline Non-Inflammatory Lesion Count for Per-Protocol 
Population ............................................................................................................................................................ 25 
Table 14.2.3.4- Additional Efficacy Summary: Post-Baseline Non-Inflammatory Lesion Count for Modified 
Intent-to-Treat Population.................................................................................................................................... 25 
Table 14.2.3.5- Additional Efficacy Summary: Post-Baseline Investigator’s Global Assessment (IGA) and 
Clinical Success for Per-Protocol Population ...................................................................................................... 26 
Page 3 of 60


Perrigo, Inc.                                                                                                                 Protocol: PRG-NY-15-003                          
 
2  
CONFIDENTIAL 
Table 14.2.3.6- Additional Efficacy Summary: Post-Baseline Investigator’s Global Assessment (IGA) and 
Clinical Success for Modified Intent-to-Treat Population ................................................................................... 27 
Table 14.3.1- Duration of Treatment and Medication Compliance Rate for Intent-to-Treat Population ................ 28 
Table 14.3.2.1- Overall Summary of Treatment Emergent Adverse Events (TEAEs) for Intent-to-Treat Population
 ............................................................................................................................................................................. 29 
Table 14.3.2.2- Summary of Treatment-Emergent Adverse Events (TEAEs) by MedDRA System Organ Class and 
Preferred Term for Intent-to-Treat Population ..................................................................................................... 30 
Table 14.3.2.3- Summary of Treatment-Emergent Adverse Events (TEAEs) by MedDRA System Organ Class, 
Preferred Term, and Severity for Intent-to-Treat Population ............................................................................... 31 
Table 14.3.2.4- Summary of Treatment-Emergent Adverse Events (TEAEs) by MedDRA System Organ Class, 
Preferred Term, and Relationship to Study Medication for Intent-to-Treat Population ...................................... 32 
Table 14.3.2.5- Summary of Skin Related Treatment-Emergent Adverse Events (TEAEs) by MedDRA System 
Organ Class and Preferred Term for Intent-to-Treat Population ......................................................................... 33 
Table 14.3.2.6- Common Treatment-Emergent Adverse Events (TEAEs) by MedDRA System Organ Class and 
Preferred Term for Intent-to-Treat Population ..................................................................................................... 34 
Table 14.3.3.1- Application Site Reaction Assessment (Erythema) by Visit for Intent-to-Treat Population .......... 35 
Table 14.3.3.2- Application Site Reaction Assessment (Dryness) by Visit for Intent-to-Treat Population ............ 36 
Table 14.3.3.3- Application Site Reaction Assessment (Scaling/Peeling) by Visit for Intent-to-Treat Population 36 
Table 14.3.3.4- Application Site Reaction Assessment (Burning/Stinging) by Visit for Intent-to-Treat Population
 ............................................................................................................................................................................. 36 
Table 14.3.3.5- Application Site Reaction Assessment (Erosion) by Visit for Intent-to-Treat Population ............. 36 
Table 14.3.3.6- Application Site Reaction Assessment (Edema) by Visit for Intent-to-Treat Population .............. 36 
Table 14.3.3.7- Application Site Reaction Assessment (Pain) by Visit for Intent-to-Treat Population .................. 36 
Table 14.3.3.8- Application Site Reaction Assessment (Itching) by Visit for Intent-to-Treat Population .............. 36 
Subject Listings ............................................................................................................................................... 37 
Listing 16.2.1.1- Subject Analysis Status ................................................................................................................ 38 
Listing 16.2.1.2- Subject End-of-Study Status ........................................................................................................ 39 
Listing 16.2.1.3- Date of Visit ................................................................................................................................. 40 
Listing 16.2.2.1- Protocol Violations and Deviations ............................................................................................. 41 
Listing 16.2.2.2- Comments .................................................................................................................................... 42 
Listing 16.2.2.3- Inclusion/Exclusion Criteria ........................................................................................................ 43 
Listing 16.2.4.1- Demographics and Informed Consent at Baseline ....................................................................... 44 
Listing 16.2.4.2- Vital Signs at Baseline ................................................................................................................. 45 
Listing 16.2.4.3- Brief Physical Examination (With Abnormality Only) ................................................................ 46 
Listing 16.2.4.4- Subject Medical History (With Past or Current Findings) ........................................................... 47 
Listing 16.2.5.1- Study Medication/ Diary Card Dispensing .................................................................................. 48 
Listing 16.2.5.2- Subject Compliance During Study ............................................................................................... 49 
Listing 16.2.5.3- Telephone Contact ....................................................................................................................... 50 
Listing 16.2.5.4- Treatment Record ........................................................................................................................ 51 
Listing 16.2.5.5- Subject Compliance at End of Study ........................................................................................... 52 
Listing 16.2.6.1- Dermatological Assessment and Investigator’s Global Assessment (IGA) ................................. 53 
Listing 16.2.6.2- Efficacy Response for Per-Protocol Population ........................................................................... 54 
Listing 16.2.6.3- Efficacy Response for Modified Intent-to-Treat Population ........................................................ 54 
Listing 16.2.7.1- Adverse Events ............................................................................................................................ 55 
Listing 16.2.7.2- Adverse Events Leading to Study Treatment Interruption/Discontinuation ................................ 55 
Listing 16.2.7.3- Serious Adverse Events ............................................................................................................... 55 
Listing 16.2.8.1- Urine Pregnancy Test (Female Subjects Only) ............................................................................ 56 
Listing 16.2.9.1- Application Site Reaction Assessment ........................................................................................ 57 
Listing 16.2.9.2- Previous or Concomitant Medications ......................................................................................... 58 
 
Page 4 of 60


Perrigo, Inc.                                                                                                                 Protocol: PRG-NY-15-003                          
SAP Version: 1.0 
3  
CONFIDENTIAL 
List of Abbreviations 
 
AE 
Adverse Event 
ANOVA 
Analysis of Variance 
CI 
Confidence Interval 
CMH 
Cochran-Mantel Haenszel Test 
IGA 
Investigator’s Global Assessment 
ITT 
Intent-to-Treat (Population) 
LOCF 
Last Observation Carried Forward 
MedDRA 
Medical Dictionary for Regulatory Activities 
mITT 
Modified Intent-to-Treat (Population) 
PD 
Protocol Deviation 
PP 
Per-Protocol (Population) 
PV 
Protocol Violation 
SAE 
Serious Adverse Event 
SAP 
Statistical Analysis Plan 
TEAE 
Treatment-Emergent Adverse Event 
TESAE 
Treatment-Emergent Serious Adverse Event 
WHO Drug 
World Health Organization Drug Dictionary 
 
 
 
 
 
Page 5 of 60














Perrigo, Inc.                                                                                                                 Protocol: PRG-NY-15-003                          
SAP Version: 1.0 
10  
CONFIDENTIAL 
Frequency and distribution of application site reactions of erythema, dryness, scaling/peeling, 
burning/stinging, erosion, edema, pain and itching will be summarized and compared 
descriptively by visit. 
 
Safety comparisons will be performed only for the ITT population. 
6 
Appendices 
6.1 
Handling of Missing or Incomplete Dates for Adverse Events and Concomitant Medications 
Adverse Events 
Handling of partial dates is only considered for the start date. An adverse event with a partial 
start date is considered treatment emergent if: 
- only the day is missing and the start month/year is the same or after the month/year of the 
first dose 
- the day and month are missing and the start year is the same or greater than the year of the 
first dose date 
- the start date is completely missing 
Concomitant Medications 
Handling of partial dates is only considered for the stop date. A medication with a partial stop 
date is considered concomitant if: 
- 
only the day is missing and the stop month/year is the same or after the month/year of the 
first dose 
- 
the day and month are missing and the stop year is the same or greater than the year of the 
first dose date 
- 
the stop date is completely missing or the medication is ongoing 
6.2 
Summary of Assessments 
The schedule of visits and procedures to be conducted at each visit are summarized in the 
Schedule of Study Procedures. 
 
 
Page 12 of 60