A Randomized, Evaluator-blind, Single-center and Two-arm Clinical Study Designed to Evaluate the Local Tolerance and Cosmetic Efficacy of a Topical Skin Care Formulation in Healthy Female Subjects With Mild to Advanced Photo-damaged Facial Skin Who Have Undergone a 70% Glycolic Acid Facial Peel Procedure
Phase: NA
Conditions: Skin Care
Sponsor: GlaxoSmithKline

C o p y rig ht:  Gl a x o S mit h Kli ne.  A n u n p u blis he d w or k s u bject t o tra de secret 
pr otect i on.  T hi s w or k c o ntai ns c o nfi de ntial a n d pr o prietar y inf or mat i on of 
Gl a x o S mit hKli ne a n d s h o ul d n ot be c o pie d, circ ulate d, or distri b ute d t o pers o ns n ot 
e mpl o y e d b y Gla x o S mit hKli ne u nless s pecificall y a ut h orize d.  U na ut h orize d 
di s clos ure of t his w or k is e x pressl y  pr o hi bite d.
Cli nical Pr ot oc ol
2 0 6 8 2 7
 
D oc u m e nt N a m e  
 
T y p e  
V ersi o n  
D oc u m e nt I d e ntifi er  
Eff ecti v e D at e  
 
 
 
 
R e as o n F or Iss u e  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
1 5- S e p- 2 0 1 7 0 9: 2 7: 1 5
 
Pr ot o c ol 2 0 6 8 2 7 
d o c
el d o _ c o ntr oll e d
4. 0; M o st- R e c e nt; Eff e cti v e; C U R R E N T
A ut o I s s u e
0 9 0 0 3 2 d 5 8 0 d 9 8 e b 9
Pa ge 1 of 9 3
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C O N FI D E N TI A L
S U M M A R Y I N F O R M A TI O N



Title:
A ra n d o mize d, e val uat or -bli n d, si n gle -ce nter a n d t w o -
ar m cli nical st u d y desi g ne d t o e val uate t he l ocal 
t olera nce a n d c os met ic efficac y of a t o pical s ki n care 
f or mulat i on i n healt h y fe male s u bjects wit h m o derate t o 
a d va nce d p h ot o -da ma ge d facial s ki n w h o ha ve 
u n der g o ne a 7 0 % Gl yc o lic Aci d facial peel pr oce d ure.
Pr ot oc ol N u m ber:
2 0 6 8 2 7
S p o ns or:
Gl a x o S mit hKli ne ( G S K)
R ua H u n gria, 1. 2 4 0 - 40 a n dar
Jar di m E ur o pa - Sa o Pa ul o - S P
C E P: 0 1 4 5 5 -0 0 0, Brazil
T el : 
Pr o d uct N a me:
P h ysi o gel Cal mi n g Relief Rest ori n g Li pi d Bal m
De vel o p me nt P h ase:
N o t A p plica ble
E x pert A d vice O utsi de of N or m al 
W or ki n g H o urs:
T el : 
Ke y Pr ot oc ol A ut h ors:
Cli nic al Rese arc h Scie ntist
, P h D.
Gl a x o S mit hKli ne C o ns u mer Healt hcare 
( G S K C H)
St Ge or ge’s A ve n ue
We y bri d ge, S urre y , K T 1 3 0 D E
T el : 
P RI M A R Y C O N T A C T
Cli nic al St u d y M a n a ger:
, P hD.
Gl a x o S mit hKli ne C o ns u mer Healt hcare 
( G S KC H )
R ua H u n gria, 1. 2 4 0 - 4o a n dar
Jar di m E ur o pa - Sa o Pa ul o - S P
C E P: 0 1 4 5 5 -0 0 0, Brazil
 
D oc u m e nt N a m e  
 
T y p e  
V ersi o n  
D oc u m e nt I d e ntifi er  
Eff ecti v e D at e  
 
 
 
 
R e as o n F or Iss u e  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
1 5- S e p- 2 0 1 7 0 9: 2 7: 1 5
 
Pr ot o c ol 2 0 6 8 2 7 
d o c
el d o _ c o ntr oll e d
4. 0; M o st- R e c e nt; Eff e cti v e; C U R R E N T
A ut o I s s u e
0 9 0 0 3 2 d 5 8 0 d 9 8 e b 9
Pa ge 2 of 9 3
P P D
P P D
P P D
P P D
P P D
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T el : 
Bi ost atistici a n:
, M Sc, C S T A T.
Gl a x o S mit hKli ne C o ns u mer Healt hcare 
( G S K C H)
St Ge or ge’s A ve n u e
We y bri d ge, S urre y , K T 1 3 0 D E
T el : 
Ot her Pr ot oc ol A ut h ors:
Me dic all y Q u alifie d Pers o n:
, M D, P h D.
Me dic al Aff airs Le a d:
, M. D., S. P. R. A. S
Cli nic al S u p plies:
, M Sc.
D at a M a n a ger:
, B Phar m.

Pri nci p al I n vesti g at or:
Mari a ne M osca , B Sc.
St u d y Site N a me & A d dress:
A L L E R GI S A - A v. Dr. R o me u T órti ma, 
4 5 2/ 4 6 6 – Barã o Geral d o – Ca m pi nas –
S P
St u d y Site Tele p h o ne N u m ber:
( b usi ness h o urs) or 
 ( 2 4 h o urs)


 
D oc u m e nt N a m e  
 
T y p e  
V ersi o n  
D oc u m e nt I d e ntifi er  
Eff ecti v e D at e  
 
 
 
 
R e as o n F or Iss u e  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
1 5- S e p- 2 0 1 7 0 9: 2 7: 1 5
 
Pr ot o c ol 2 0 6 8 2 7 
d o c
el d o _ c o ntr oll e d
4. 0; M o st- R e c e nt; Eff e cti v e; C U R R E N T
A ut o I s s u e
0 9 0 0 3 2 d 5 8 0 d 9 8 e b 9
Pa ge 3 of 9 3
P P D
P P D
P P D
P P D
P P D
P P D
P P D
P P D
P P D
P P
D
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P RI N CI P A L I N V E S TI G A T O R P R O T O C O L A G R E E M E N T 
P A G E

I c o nfir m a gree me nt t o c o n d uct t he st u d y in c o m p lia nce with t he pr ot oc ol a n d 
a n y a me n d me nts a n d acc or di n g t o t he c urre nt I C H G C P g ui deli nes.

I ac k n o wle d ge t hat I a m res p o nsi ble f or o verall st u d y c o n d uct. I a gree t o 
pers o nall y c o n d uct or s u per vise t he descri be d st u d y.

I a gree t o e ns ure t hat all ass ociates, c ollea g ues a n d e m pl oyees assist i n g i n t he 
c o n d uct of t he st u d y are i nf or me d a b o ut t heir o bli gatio ns. Mec h a nis ms are i n 
pl ace t o e ns ure site staff recei ves all a p pr o priate i nf or mat i on t hr o u g h o ut t he 
st u d y.

I a gree t o c o n d uct t his st u d y in f ull c o nf or ma nce with t he l a ws a n d re g ulati o ns 
of  t he c o u ntr y in w hic h t he researc h is c o n d ucte d a n d t he Declarati o n of 
H el si n ki.
I n vesti gat or Na me:
I n vesti gat or Q ualificati ons:
I n vesti gat or Si g nat ure:
Date of Si g nat ure/ A gree me nt:
D D/ M M M/ Y Y Y Y
 
D oc u m e nt N a m e  
 
T y p e  
V ersi o n  
D oc u m e nt I d e ntifi er  
Eff ecti v e D at e  
 
 
 
 
R e as o n F or Iss u e  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
1 5- S e p- 2 0 1 7 0 9: 2 7: 1 5
 
Pr ot o c ol 2 0 6 8 2 7 
d o c
el d o _ c o ntr oll e d
4. 0; M o st- R e c e nt; Eff e cti v e; C U R R E N T
A ut o I s s u e
0 9 0 0 3 2 d 5 8 0 d 9 8 e b 9
Pa ge 4 of 9 3
P P D
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T A B L E O F C O N T E N T S
S U M M A R Y I N F O R M A TI O N ...............................................2
P RI N CI P A L I N V E S TI G A T O R P R O T O C O L A G R E E M E N T 
P A G E .......................................................................................4
T A B L E O F C O N T E N T S ........................................................5
P R O C E S S F O R A M E N DI N G T H E P R O T O C O L ...............1 3
P R O T O C O L A M E N D M E N T P A G E ....................................1 4
P R O T O C O L S Y N O P SI S F O R S T U D Y 2 0 6 8 2 7 ...................1 9
1. I N T R O D U C TI O N ...............................................................2 6
2. O B J E C TI V E( S) A N D E N D P OI N T( S) ...............................2 8
3. S T U D Y P L A N .....................................................................2 9
3. 1. St u d y Desi g n ....................................................................2 9
3. 2. S u bject Restricti o ns .........................................................3 2
3. 3. T y pe a n d Pl a n ne d N u m ber of S u bjects ..........................3 3
3. 4. St u d y Desi g n a n d D ose J ustific ati o n ..............................3 3
4. S E L E C TI O N O F S T U D Y P O P U L A TI O N A N D 
WI T H D R A W A L C RI T E RI A
................................................3 8
4. 1. I ncl usi o n Criteri a ............................................................3 8
4. 2. E xcl usi o n Criteri a ...........................................................3 9
4. 3. Scree ni n g/ B aseli ne F ail ures ...........................................4 1
4. 4. Wit h dr a w al/ St o p pi n g Criteri a .......................................4 1
4. 5. S u bject Re pl ace me nt .......................................................4 2
4. 6. S u bject a n d St u d y C o m pleti o n .......................................4 2
5. P R O D U C T I N F O R M A TI O N .............................................4 3
5. 1. St u d y Pr o d uct ..................................................................4 3
 
D oc u m e nt N a m e  
 
T y p e  
V ersi o n  
D oc u m e nt I d e ntifi er  
Eff ecti v e D at e  
 
 
 
 
R e as o n F or Iss u e  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
1 5- S e p- 2 0 1 7 0 9: 2 7: 1 5
 
Pr ot o c ol 2 0 6 8 2 7 
d o c
el d o _ c o ntr oll e d
4. 0; M o st- R e c e nt; Eff e cti v e; C U R R E N T
A ut o I s s u e
0 9 0 0 3 2 d 5 8 0 d 9 8 e b 9
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5. 2. A p plic ati o n Sc he d ule .......................................................4 4
5. 3. A p plic ati o n M o dific ati o n ................................................4 5
5. 4. Pr o d uct C o m pli a nce ........................................................4 5
5. 5. Prec a uti o ns ......................................................................4 6
5. 6. O ver d ose ..........................................................................4 6
5. 7. Resc ue T her a p y ...............................................................4 6
5. 8. Pr o d uct Assi g n me nt ........................................................4 6
5. 8. 1 R a n d o miz ati o n .........................................................4 6
5. 8. 2 Bli n di n g .....................................................................4 7
5. 8. 3 C o de Bre a ks ..............................................................4 7
5. 9. P ac k a gi n g a n d L a belli n g .................................................4 7
5. 9. 1. Acc o u nt a bilit y of Pr o d uct .......................................4 7
5. 9. 2. St or a ge of Pr o d uct ..................................................4 8
6. S T U D Y A S S E S S M E N T S A N D P R O C E D U R E S ..............4 9
6. 1. Visit 1 – Scree ni n g / W as h o ut Visit ................................4 9
6. 1. 1. I nf or me d C o nse nt ...................................................4 9
6. 1. 2. De m o gr a p hics ..........................................................5 0
6. 1. 3. Me dic al Hist or y a n d C o nc o mit a nt Me dic ati o n .....5 0
6. 1. 4. Fitz p atric k S ki n T y pe Assess me nt .........................5 0
6. 1. 5. Gl o g a u P h ot o a gi n g T y pe Assess me nt .....................5 0
6. 1. 6. I ncl usi o n / E xcl usi o n Criteri a ................................. 5 1
6. 1. 7. S u bject Eli gi bilit y ....................................................5 1
6. 1. 8. St u d y M ateri al Se nsiti vit y Test ..............................5 1
6. 1. 9. S u bject Self -Assess me nt of Se nsiti vit y ...................5 2
6. 1. 1 0. Der m at ol o gist Assess me nt of Se nsiti vit y ..............5 2
6. 1. 1 1. E xcl usi o n Criteri a 9 ..............................................5 3
6. 1. 1 2. S u bject Eli gi bilit y ..................................................5 3
6. 1. 1 3. W as h o ut Pr o d ucts a n d W as h o ut Di ar y Dis pe nsi n g
............................................................................................5 3
6. 2. Visit 2 – 1 d a y after Visit 1 ..............................................5 4
 
D oc u m e nt N a m e  
 
T y p e  
V ersi o n  
D oc u m e nt I d e ntifi er  
Eff ecti v e D at e  
 
 
 
 
R e as o n F or Iss u e  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
1 5- S e p- 2 0 1 7 0 9: 2 7: 1 5
 
Pr ot o c ol 2 0 6 8 2 7 
d o c
el d o _ c o ntr oll e d
4. 0; M o st- R e c e nt; Eff e cti v e; C U R R E N T
A ut o I s s u e
0 9 0 0 3 2 d 5 8 0 d 9 8 e b 9
Pa ge 6 of 9 3
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6. 2. 1. C urre nt / C o nc o mit a nt Me dic ati o n ........................5 4
6. 2. 2. A d verse E ve nts ........................................................5 4
6. 2. 3. C o nti n ue d S u bject Eli gi bilit y ................................. 5 4
6. 2. 4. C o m pli a nce ( Di ar y Re vie w) ....................................5 4
6. 2. 5. S u bject Self -Assess me nt of Se nsiti vit y ...................5 4
6. 2. 6. Der m at ol o gist Assess me nt of Se nsiti vit y ................5 5
6. 2. 7. E xcl usi o n Criteri a ...................................................5 5
6. 2. 8. S u bjec t Eli gi bilit y....................................................5 5
6. 3. Visit 3 – D a y of Pr oce d ure - 6 d a ys after Visit 2 ............5 5
6. 3. 1. C urre nt / C o nc o mit a nt Me dic ati o n ........................5 5
6. 3. 2. A d verse E ve nts ........................................................5 5
6. 3. 3. C o nti n ue d S u bject Eli gi bilit y ................................. 5 6
6. 3. 4. C o m pli a nce ( Di ar y Re vie w) ....................................5 6
6. 3. 5. S u bject Self -Assess me nt of Se nsiti vit y ...................5 6
6. 3. 6. Der m at ol o gist Assess me nt of Se nsiti vit y ................5 6
6. 3. 7. E xcl usi o n Criteri a ...................................................5 6
6. 3. 8. S u bject Eli gi bilit y ....................................................5 7
6. 3. 9. S u bject R a n d o mis ati o n ...........................................5 7
6. 3. 1 0. I nstr u me nt al Me as ure me nts Pre -Pr oce d ure .......5 7
6. 3. 1 1. I m a ge C a pt ure ( VI SI A) Pre -Pr oce d ure ...............5 7
6. 3. 1 2. S u bject Self -Assess me nt Pre -Pr oce d ure ..............5 8
6. 3. 1 3. Der m at ol o gist Assess me nt Pre -Pr oce d ure ...........5 8
6. 3. 1 4. Der m at ol o gic al Pr oce d ure ( F aci al Peel) ...............5 9
6. 3. 1 5. Der m at ol o gist Assess me nt P ost -Pr oce d ure, Pre -
Tre at me nt ( B A S E LI N E) ...................................................6 0
6. 3. 1 6. I nstr u me nt al Me as ure me nts P ost -Pr oce d ure, Pre -
Tre at me nt ( B A S E LI N E) ...................................................6 0
6. 3. 1 7. I m a ge C a pt ure ( VI SI A) P ost -Pr oce d ure, Pre -
Tre at me nt ( B A S E LI N E) ...................................................6 0
6. 3. 1 8. S u bject Self -Assess me nt P ost -Pr oce d ure, Pre -
Tre at me nt ( B A S E LI N E) ...................................................6 1
 
D oc u m e nt N a m e  
 
T y p e  
V ersi o n  
D oc u m e nt I d e ntifi er  
Eff ecti v e D at e  
 
 
 
 
R e as o n F or Iss u e  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
1 5- S e p- 2 0 1 7 0 9: 2 7: 1 5
 
Pr ot o c ol 2 0 6 8 2 7 
d o c
el d o _ c o ntr oll e d
4. 0; M o st- R e c e nt; Eff e cti v e; C U R R E N T
A ut o I s s u e
0 9 0 0 3 2 d 5 8 0 d 9 8 e b 9
Pa ge 7 of 9 3
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6. 3. 1 9. Test Pr o d uct a n d Test Di ar y Dis pe nsi n g. W as h o ut 
Di ar y C ollecti o n. ...............................................................6 1
6. 3. 2 0. S u per vise d Test Pr o d uct A p plic ati o n P ost -
Pr oce d ure ..........................................................................6 1
6. 3. 2 1. I nstr u me nt al Me as ure me nts P ost -Pr oce d ure, P o st-
Tre at me nt ..........................................................................6 1
6. 3. 2 2. S u bject Self -Assess me nt P ost -Pr oce d ure, P ost -
Tre at me nt ..........................................................................6 1
6. 3. 2 3. E v al u at or ( Der m at ol o gist) Assess me nt P ost -
Pr oce d ure, P ost -Tre at me nt ..............................................6 1
6. 4. Visit 4 – 1 d a y after Visit 3 ..............................................6 2
6. 4. 1. C urre nt / C o nc o mit a nt Me dic ati o n ........................6 2
6. 4. 2. A d verse E ve nts ........................................................6 2
6. 4. 3. C o nti n ue d S u bject Eli gi bilit y ................................. 6 2
6. 4. 4. C o m pli a n ce ( Di ar y Re vie w) ....................................6 2
6. 4. 5. I nstr u me nt al Me as ure me nts P ost -Pr oce d ure, P ost -
Tre at me nt ( 2 4 ± 4 h o urs after F aci al Peel) ........................6 3
6. 4. 6. I m a ge C a pt ure ( VI SI A) P ost-Pr oce d ure, P ost -
Tre at me nt ( 2 4 ± 4 h o urs after F aci al Peel) ........................6 3
6. 4. 7. S u bject Self -Assess me nt P ost -Pr oce d ure, P ost -
Tre at me nt ( 2 4 ± 4 h o urs after F aci al Peel) ........................6 3
6. 4. 8. Der m at ol o gist Assess me nt P ost -Pr oce d ure, P ost -
Tre ate me nt ( 2 4 ± 4 h o urs after F aci al Peel) ......................6 3
6. 4. 9. S u per vise d Test Pr o d uct A p plic at i o n.....................6 3
6. 4. 1 0. S u per vise d S u nscree n A p plic ati o n .......................6 3
6. 5. Visit 5 – 1 d a y after Visit 4 ..............................................6 3
6. 5. 1. C urre nt / C o nc o mit a nt Me dic ati o n ........................6 4
6. 5. 2. A d verse E ve nts ........................................................6 4
6. 5. 3. C o nti n ue d S u bject Eli gi bilit y ................................. 6 4
6. 5. 4. C o m pli a nce ( Di ar y Re vie w) ....................................6 4
6. 5. 5. I nstr u me nt al Me as ure me nts P ost -Pr oce d ure, P ost -
Tre at me nt ( 4 8 ± 4 h o urs after F aci a l Peel)........................6 4
 
D oc u m e nt N a m e  
 
T y p e  
V ersi o n  
D oc u m e nt I d e ntifi er  
Eff ecti v e D at e  
 
 
 
 
R e as o n F or Iss u e  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
1 5- S e p- 2 0 1 7 0 9: 2 7: 1 5
 
Pr ot o c ol 2 0 6 8 2 7 
d o c
el d o _ c o ntr oll e d
4. 0; M o st- R e c e nt; Eff e cti v e; C U R R E N T
A ut o I s s u e
0 9 0 0 3 2 d 5 8 0 d 9 8 e b 9
Pa ge 8 of 9 3
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6. 5. 6. S u bject Self -Assess me nt P ost -Pr oce d ure, P ost -
Tre at me nt ( 4 8 ± 4 h o urs after F aci al Peel) ........................6 5
6. 5. 7. Der m at ol o gist Assess me nt P ost -Pr oce d ure, P ost -
Tre ate me nt ( 4 8 ± 4 h o urs after F aci al Peel) ......................6 5
6. 5. 8. S u per vise d Test Pr o d uct A p plic ati o n .....................6 5
6. 5. 9 . S u per vise d S u nscree n A p plic ati o n.........................6 5
6. 6. Visit 6 – 1 d a y after Visit 5 ..............................................6 5
6. 6. 1. C urre nt / C o nc o mit a nt Me dic ati o n ........................6 5
6. 6. 2. A d verse E ve nts ........................................................6 5
6. 6. 3. C o nti n ue d S u bject Eli gi bilit y ................................. 6 6
6. 6. 4. C o m pli a nce ( Di ar y Re vie w) ....................................6 6
6. 6. 5. I nstr u me nt al Me as ure me nts P ost -Pr oce d ure, P ost -
Tre at me nt ( 7 2 ± 4 h o urs after F aci al Peel) ........................6 6
6. 6. 6. S u bject Self -Assess me nt P ost -Pr oce d ure, P ost -
Tre at me nt ( 7 2 ± 4 h o urs after F aci al Peel) ........................6 6
6. 6. 7. Der m at ol o gist Assess me nt P ost -Pr oce d ure, P ost -
Tre ate me nt ( 7 2 ± 4 h o urs after F aci al Peel) ......................6 6
6. 6. 8. S u per vise d Test Pr o d uct A p plic ati o n .....................6 6
6. 6. 9. S u per vise d S u nscree n A p plic ati o n .........................6 7
6. 7. Visit 7 – 4 d a ys after Visit 6 ............................................6 7
6. 7. 1. C urre nt / C o nc o mit a nt Me dic ati o n ........................6 7
6. 7. 2. A d verse E ve nts ........................................................6 7
6. 7. 3. C o nti n ue d S u bject Eli gi bilit y ................................. 6 7
6. 7. 4. C o m pli a nce ( Di ar y Re vie w) ....................................6 8
6. 7. 5. I nstr u me nt al Me as ure me nts P ost -Pr oce d ure, P ost -
Tre at me nt ( 1 6 8 ± 4 h o urs after F aci al Peel) ......................6 8
6. 7. 6. S u bject Self -Assess me nt P ost -Pr oce d ure, P ost -
Tre at me nt ( 1 6 8 ± 4 h o urs af ter F aci al Peel)......................6 8
6. 7. 7. Der m at ol o gist Assess me nt P ost -Pr oce d ure, P ost -
Tre ate me nt ( 1 6 8 ± 4 h o urs after F aci al Peel) ....................6 8
6. 7. 8. S u per vise d Test Pr o d uct A p plic ati o n .....................6 8
6. 7. 9. S u per vise d S u nscree n A p plic ati o n .........................6 8
 
D oc u m e nt N a m e  
 
T y p e  
V ersi o n  
D oc u m e nt I d e ntifi er  
Eff ecti v e D at e  
 
 
 
 
R e as o n F or Iss u e  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
1 5- S e p- 2 0 1 7 0 9: 2 7: 1 5
 
Pr ot o c ol 2 0 6 8 2 7 
d o c
el d o _ c o ntr oll e d
4. 0; M o st- R e c e nt; Eff e cti v e; C U R R E N T
A ut o I s s u e
0 9 0 0 3 2 d 5 8 0 d 9 8 e b 9
Pa ge 9 of 9 3
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6. 8. Visit 8 – 7 d a ys after Visit 7 ............................................6 8
6. 8. 1. C urre nt / C o nc o mit a nt Me dic ati o n ........................6 9
6. 8. 2. A d verse E ve nts ........................................................6 9
6. 8. 3 . C o nti n ue d S u bject Eli gi bilit y ................................. 6 9
6. 8. 4. C o m pli a nce ( Di ar y Re vie w) ....................................6 9
6. 8. 5. I nstr u me nt al Me as ure me nts P ost -Pr oce d ure, P ost -
Tre at me nt ( 3 3 6 ± 4 h o urs after F aci al Peel) ......................6 9
6. 8. 6. I m a ge C a pt ure ( VI SI A) P ost -Pr oce d ure, P ost -
Tre at me nt ( 3 3 6 ± 4 h o urs after F aci al Peel) ......................7 0
6. 8. 7. S u bject Self -Assess me nt P ost -Pr oce d ure, P ost -
Tre at me nt ( 3 3 6 ± 4 h o urs after F aci al Peel) ......................7 0
6. 8. 8. S u bject Gl o b al Self -Assess me nt ..............................7 0
6. 8. 9. Der m at ol o gist Asses me nt P ost -Pr oce d ure, P ost -
Tre at me nt ( 3 3 6 ± 4 h o urs after F aci al Peel) ......................7 0
6. 8. 1 0. Der m at ol o gist Gl o b al Assess me nt ........................7 0
6. 8. 1 1. Pr o d ucts a n d Test Di ar y Ret ur n ..........................7 1
6. 8. 1 2. Disc h ar ge fr o m St u d y ...........................................7 1
7. S A F E T Y A S S E S S M E N T S ..................................................7 2
7. 1. Defi niti o ns of a n A d verse E ve nt a n d Seri o us A d verse 
E ve nt .......................................................................................7 2
7. 1. 1. A d verse E ve nts ........................................................7 2
7. 1. 2. Seri o us A d verse E ve nts ...........................................7 3
7. 2. Rec or di n g A d verse E ve nts a n d Seri o us A d verse E ve nts
7 4
7. 3. E v al u ati n g A d verse E ve nts a n d Seri o us A d verse E ve nts
7 4
7. 4. Re p orti n g A d verse E ve nts a n d Seri o us A d verse E ve nts
7 5
7. 5. F oll o w - up of A d verse E ve nts a n d Seri o us A d verse E ve nts
7 7
7. 6. C ollecti o n of Pre g n a nc y I nf or m ati o n .............................7 8
 
D oc u m e nt N a m e  
 
T y p e  
V ersi o n  
D oc u m e nt I d e ntifi er  
Eff ecti v e D at e  
 
 
 
 
R e as o n F or Iss u e  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
1 5- S e p- 2 0 1 7 0 9: 2 7: 1 5
 
Pr ot o c ol 2 0 6 8 2 7 
d o c
el d o _ c o ntr oll e d
4. 0; M o st- R e c e nt; Eff e cti v e; C U R R E N T
A ut o I s s u e
0 9 0 0 3 2 d 5 8 0 d 9 8 e b 9
Pa ge 1 0 of 9 3
C CI

1 1
7. 6. 1. Ti me Peri o d f or C ollecti n g of Pre g n a nc y 
I nfor m ati o n .......................................................................7 8
7. 6. 2. Acti o n t o be T a ke n if Pre g n a nc y Occ urs ...............7 8
8. D A T A M A N A G E M E N T ....................................................7 9
8. 1. S o urce D oc u me nts/ D at a .................................................7 9
8. 2. Electr o nic C ase Re p ort F or m .........................................7 9
8. 3. D at a H a n dli n g ..................................................................8 0
8. 3. 1. D at a Q ueries ............................................................8 0
8. 4. E xter n al D at a ...................................................................8 0
9. S T A TI S TI C A L C O N SI D E R A TI O N S A N D D A T A 
A N A L Y S E S .............................................................................8 2
9. 1 S a m ple Size Deter mi n ati o n ..............................................8 2
9. 2. Ge ner al C o nsi der ati o ns ...................................................8 2
9. 2. 1. Defi niti o n of A n al ysis P o p ul ati o ns .........................8 2
9. 2. 2. E xcl usi o n of D at a fr o m A n al ysis ............................8 3
9. 2. 3. Criter i a f or E v al u ati o n ...........................................8 3
9. 2. 4. Criteri a f or Assessi n g Effic ac y ...............................8 3
9. 2. 5. Criteri a f or Assessi n g L oc al T oler a nce ..................8 3
9. 2. 6. H a n dli n g of Dr o p o uts a n d Missi n g D at a ...............8 3
9. 3. St atistic al Met h o ds a n d A n al ytic al Pl a n ........................8 3
9. 3. 1. De m o gr a p hic a n d B aseli ne C h ar acteristics ...........8 4
9. 3. 2. Pri m ar y A n al ysis(es) ...............................................8 4
9. 3. 3. Sec o n d ar y A n al ysis(es) ...........................................8 4
9. 3. 4. S afet y A n al ysis(es) ...................................................8 4
1 0. S T U D Y G O V E R N A N C E C O N SI D E R A TI O N S .............8 4
1 0. 1. P osti n g of I nf or m ati o n o n P u blicl y A v ail a ble Cli nic al 
Tri als Re gisters .......................................................................8 4
1 0. 2. Re g ul at or y a n d Et hic al C o nsi der ati o ns, I ncl u di n g t he 
I nf or me d C o nse nt...................................................................8 4
 
D oc u m e nt N a m e  
 
T y p e  
V ersi o n  
D oc u m e nt I d e ntifi er  
Eff ecti v e D at e  
 
 
 
 
R e as o n F or Iss u e  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
1 5- S e p- 2 0 1 7 0 9: 2 7: 1 5
 
Pr ot o c ol 2 0 6 8 2 7 
d o c
el d o _ c o ntr oll e d
4. 0; M o st- R e c e nt; Eff e cti v e; C U R R E N T
A ut o I s s u e
0 9 0 0 3 2 d 5 8 0 d 9 8 e b 9
Pa ge 1 1 of 9 3
C CI

1 2
1 0. 3. Q u alit y C o ntr ol ( St u d y M o nit ori n g) ............................8 5
1 0. 4. Q u alit y Ass ur a nce .........................................................8 6
1 0. 5. C o n diti o ns f or Ter mi n ati n g t he St u d y .........................8 6
1 0. 6. Rec or ds Rete nti o n .........................................................8 7
1 0. 7. Pr o visi o n of St u d y Res ults t o I n vesti g at ors, p osti n g of 
I nf or m ati o n o n P u blicl y A v ail a ble Cli nic al Tri als Re gisters 
a n d P u blic ati o n .......................................................................8 8
1 1. R E F E R E N C E S ..................................................................8 9
1 2. A P P E N DI C E S ...................................................................9 0
1 2. 1. A p pe n di x 1 - A b bre vi ati o ns a n d Tr a de m ar ks .............9 0
1 2. 2. A p pe n di x 2 - Fitz p atric k S ki n T y pe .............................9 1
1 2. 3. A p pe n di x 3 - Gl o g a u P h ot o a gi n g Sc ale ........................9 1
1 2. 4. A p pe n di x 4 - E xcl usi o n Criteri a f or Re vie w at Visit 2 
a n d 3 ........................................................................................9 1
 
D oc u m e nt N a m e  
 
T y p e  
V ersi o n  
D oc u m e nt I d e ntifi er  
Eff ecti v e D at e  
 
 
 
 
R e as o n F or Iss u e  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
1 5- S e p- 2 0 1 7 0 9: 2 7: 1 5
 
Pr ot o c ol 2 0 6 8 2 7 
d o c
el d o _ c o ntr oll e d
4. 0; M o st- R e c e nt; Eff e cti v e; C U R R E N T
A ut o I s s u e
0 9 0 0 3 2 d 5 8 0 d 9 8 e b 9
Pa ge 1 2 of 9 3
C CI

1 3
P R O C E S S F O R A M E N DI N G T H E P R O T O C O L

Pr ot oc ol  mo dificati o ns t o o n g oi n g st u dies w hic h c o ul d p ote ntiall y a d versel y affect t he 
safety of  s u bjects or w hic h alter t he sc o pe of t he i n vesti gati o n, t he scie ntific q uality of  
t he st u d y, t he e x peri me ntal desi g n, d osa ges, d urati o n of t hera p y, assess me nt 
varia bles, t he n u m ber of s u bjects treate d, or s u bject select i on cri t eria are c o nsi dere d 
maj or/s u bsta nt ial a me n d me nts a n d m ust be ma de o nl y after a p pr o priate c o ns ult atio n 
bet wee n a n a p pr o pr iate re prese ntati ve of G S K C H a n d t he i n vest i gat or.
Details o f a me n d me nts t o t he pr ot oc ols s h o ul d be rec or de d o n t he f o ll owi n g pa ge. 
Pr ot oc ol  mo dificati o ns m ust be pre pare d b y  a re prese ntati ve of G S K C H.  All c ha n ges 
m ust be j ust ifie d i n t he Reas o n f or A me nd me nt secti o n of  t h e fol l owi n g Pr ot oc ol  
A me n d me nt Pa ge. A p pr o val of a me n d me nts will be ma de b y t he ori gi nal pr ot oc ol 
sig n at ori es or t heir a p pr o priate desig nees.
All maj or/s u bsta nt ial pr ot oc ol  mo dificat i ons m ust be re vie we d a n d a p pr o ve d b y t he 
a p pr o priate I n de pe n de nt Et hics C o m mittee (I E C) i n acc or da nce with l ocal 
re q uire me nts, bef ore t he re vise d e diti on ca n be i m ple me nte d. 
All n o n-s u bsta nt ial/ mi n or/ a d mi nistrati ve a me n d me nts s h o ul d be s u b mitte d t o t he 
I E C as per c o u ntr y s pecific re q uire me nts. I n s o me c o u ntri es pre-a p pr o val of a mi n or 
a me n d me nt is n ot re q uire d a n d will j ust be hel d o n file b y t he s p o ns or a n d 
i n vesti gat or.
 
D oc u m e nt N a m e  
 
T y p e  
V ersi o n  
D oc u m e nt I d e ntifi er  
Eff ecti v e D at e  
 
 
 
 
R e as o n F or Iss u e  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
1 5- S e p- 2 0 1 7 0 9: 2 7: 1 5
 
Pr ot o c ol 2 0 6 8 2 7 
d o c
el d o _ c o ntr oll e d
4. 0; M o st- R e c e nt; Eff e cti v e; C U R R E N T
A ut o I s s u e
0 9 0 0 3 2 d 5 8 0 d 9 8 e b 9
Pa ge 1 3 of 9 3
C CI

P R O T O C O L A M E N D M E N T P A G E
Details o f all a me n d me nts s h o ul d be rec or de d i n t he ta ble bel o w. Affecte d sec tio ns s h o uld be liste d i n t he ta b le; t he act ual 
a me n d me nt/ c ha n ge s h o ul d be ma de i n t he rele va nt secti o n of t he mai n pr ot oc ol. 
T o hi g hli g ht t he c ha n ge, t he f o ll owi n g feat ures will be use d: 
T o a d d te xt: Use of C A PI T A L L E T T E R S, B O L D A N D U N D E R LI N E
T o delete te xt: Use of Striket hr o u g h e. g. stri ket hr o u g h
A me n d me nt 
N o. & Ne w 
Pr ot oc ol 
Versi o n N o.
T y pe of A me n d me nt
Re as o n f or A me n d me nt
Ot her D oc u me nts 
Re q uiri n g A me n d me nt
Secti o n(s) 
A me n de d 
PI A me n d me nt 
A gree me nt
Si g n at ure & 
D ate
A me n d me nt 
N o.: 1
N o n -S u bsta nt ial/ Mi n or    T o i ncrease t he tar get n u m ber 
of  ra n d omise d s u bjects fr o m 
8 0 t o 1 0 0 i n res p o nse t o t he 
first 1 0 s u bjects bei n g 
i nc orrectl y ra n d o mise d i nt o 
t he st u d y.
I nf or me d C o nse nt   
Ye s 
N o
S af et y State m e nt     
Ye s 
N o
C R F                       
Ye s 
N o
Pr ot oc ol  
s y n o psis ( pa ge 
2 3)
Secti o n 3. 3 
( pa ge 3 3)
Secti o n 9. 1 
( pa ge 8 2)
Si g nat ure:
Pr ot oc ol 
Versi o n 
N o.: 4
S u bsta nt ial/ Maj or           
Date:
A me n d me nt 
N o.: 2
N o n -S u bsta nt ial/ Mi n or    T o u p date t he Data Ma na ger 
details f or t he st u d y .
I nf or me d C o nse nt   
Ye s 
N o
S af et y State m e nt     
Ye s 
N o
C R F                       
Ye s 
N o
S u m mar y  
i nf or mat i on 
( pa ge 3)
Si g nat ure:
Pr ot oc ol 
Versi o n 
N o.: 4
S u bsta nt ial/ Maj or           
Date:
 
D oc u m e nt N
 
T y p e  
V ersi o n  
D oc u m e nt I d e ntifi er  
Eff ecti v e D at e  
 
 
 
 
R e as o n F or Iss u e  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
1 5- S e p- 2 0 1 7 0 9: 2 7: 1 5
Pr ot o c ol 2 0 6 8 2 7 
d o c
el d o _ c o ntr oll e d
4. 0; M o st- R e c e nt; Eff e cti v e; C U R R E N T
A ut o I s s u e
0 9 0 0 3 2 d 5 8 0 d 9 8 e b 9
P P D
P P D
P P D
P P D
C CI

1 5
 
D oc u m e nt N
 
T y p e  
V ersi o n  
D oc u m e nt I d e ntifi er  
Eff ecti v e D at e  
 
 
 
 
R e as o n F or Iss u e  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
1 5- S e p- 2 0 1 7 0 9: 2 7: 1 5
Pr ot o c ol 2 0 6 8 2 7 
d o c
el d o _ c o ntr oll e d
4. 0; M o st- R e c e nt; Eff e cti v e; C U R R E N T
A ut o I s s u e
0 9 0 0 3 2 d 5 8 0 d 9 8 e b 9
C CI

1 6
A me n d me nt 
N o. & Ne w 
Pr ot oc ol 
Versi o n N o.
T y pe of A me n d me nt
Re as o n f or A me n d me nt
Ot her 
D oc u me nts 
Re q uiri n g 
A me n d me nt
Secti o n(s) A me n de d 
PI A me n d me nt 
A gree me nt
Si g n at ure & 
D ate
A me n d me nt 
N o.:
N o n -S u bsta nt ial/ Mi n or    
I nf or me d 
C o nse nt   
Ye s 
N o
S af et y 
State m e nt     
Ye s 
N o
C R F                       
Ye s 
N o
Si g nat ure:
Pr ot oc ol 
Versi o n 
N o.:
S u bsta nt ial/ Maj or           
Date:
A me n d me nt 
N o.:
N o n -S u bsta nt ial/ Mi n or    
I nf or me d 
C o nse nt   
Ye s 
N o
S af et y 
State m e nt     
Ye s 
N o
C R F                       
Ye s 
N o
Si g nat ure:
Pr ot oc ol 
Versi o n 
N o.:
S u bsta nt ial/ Major           
Date:
 
D oc u m e nt N
 
T y p e  
V ersi o n  
D oc u m e nt I d e ntifi er  
Eff ecti v e D at e  
 
 
 
 
R e as o n F or Iss u e  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
1 5- S e p- 2 0 1 7 0 9: 2 7: 1 5
Pr ot o c ol 2 0 6 8 2 7 
d o c
el d o _ c o ntr oll e d
4. 0; M o st- R e c e nt; Eff e cti v e; C U R R E N T
A ut o I s s u e
0 9 0 0 3 2 d 5 8 0 d 9 8 e b 9
P P D
P P D
P P D
P P D
C CI

S C H E D U L E O F E V E N T S
Pr oce d ure/ Assess me nt
Visit 1
Da y 1
Vis it 2
Da y 2
Visit 3 1
Da y 8
Visit 4 1
Da y 9
Visit 5 1
Da y 1 0
Visit 6 1
Da y 1 1
Visit 7 1
Da y 1 5
Visit 8 1
Da y 2 2
Scree ni n g/
Was h o ut
1 Da y After
Visit 1
6 Da ys after 
Visit 2, Da y 
of Pr oce d ure 
1 Da y after 
Visit 3
1 Da y after 
Visit 4
1 Da y after
Visit 5
4 Da ys after 
Visit 6
7 Da ys after 
Visit 7
I nf or me d C o nse nt
X
De m o gra p hics
X
Me dical Hist or y
X
C urre nt / C o nc o mita nt Me dicati o n
X
X
X
X
X
X
X
X
A d verse E ve nts
X
X
X
X
X
X
X
C o nti n ue d S u bject Eli gi bilit y
X
X
X
X
X
X
X
C o m plia nce ( Diar y re vie w) 2
X
X
X
X
X
X
X
Fitz patric k S ki n T y pe Assess me nt 
( A p pe n di x 2)
X
Gl o ga u P h ot oa gi n g T y pe Assess me nt 
( A p pe n di x 3)
X
I n/ E xcl usi o n Criteria
X 3
X 4
X 4
S u bject Eli gi bilit y
X
St u d y Material Se nsiti vit y Test
X 5
S u bject Se lf-Assess me nt Se nsiti vit y
X 6
X 7
X 8
Der mat ol o gist Assess me nt Se nsiti vit y
X 6
X 7
X 8
E xcl usi o n Criteria 9
X
X
X
S u bject Eli gi bilit y
X
X
X
S u bject Ra n d o misati o n
X
I nstr u me ntal Meas ure me nts Pre-Pr oce d ure
X
I ma ge ca pt ure ( VI SI A) Pr e-Pr oce d ure 
X
S u bject Self -Assess me nt Pre -Pr oce d ure 
X
Der mat ol o gist Assess me nt Pre -Pr oce d ure
X
Der mat ol o gical Pr oce d ure ( Facial Peel)
X 9
Der mat ol o gist Assess me nt P ost -Pr oce d ure, 
Pre -Treat me nt ( B A S E LI N E)
X 1 0
I nstr u me ntal Meas ure me nts P ost-
Pr oce d ure, Pre -Treat me nt ( B A S E LI N E)
X 1 0
I ma ge ca pt ure ( VI SI A) P ost-Pr oce d ure, 
Pre -Treat me nt ( B A S E LI N E)
X 1 0
S u bject Self -Assess me nt P ost -Pr oce d ure, 
Pre -Treat me nt ( B A S E LI N E)
X 1 0
Was h o ut Pr o d ucts a n d Was h o ut Diar y 
Dis pe nsi n g
X
Test Pr o d uct a n d Test Diar y Dis pe nsi n g , 
Was h o ut Diar y ret ur n.
X 1 1
S u per vise d Test -Pr o d uct A p plicati o n P ost -
Pr oce d ure
X 1 2
I nstr u me ntal Meas ure me nts P ost-
Pr oce d ure, P ost -Treat me nt 1 3
X
X
X
X
X
X
I ma ge ca pt ure ( VI SI A) P ost-Pr oce d ure, 
P ost -Treat me nt 1 4
X
X
S u bject Self -Assess me nt P ost -Pr oce d ure, 
P ost -Treat me nt 1 5
X
X
X
X
X
X
S u bject Gl o bal Self -Assess me nt
X
Der mat ol o gist Assess me nt P ost -Pr oce d ure, 
P ost -Treat me nt 1 5
X
X
X
X
X
X
Der mat ol o gist Gl o bal Assess me nt of 
T olera nce
X
S u per vise d Test -Pr o d uct A p plicati o n 1 6
X
X
X
X
S u per vise d S u nscree n A p plicati o n 1 7
X
X
X
X
Pr o d ucts a n d Test Diar y Ret ur n
X
Disc har ge fr o m St u d y
X
 
D oc u m e nt N a m e  
 
T y p e  
V ersi o n  
D oc u m e nt I d e ntifi er  
Eff ecti v e D at e  
 
 
 
 
R e as o n F or Iss u e  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
1 5- S e p- 2 0 1 7 0 9: 2 7: 1 5
 
Pr ot o c ol 2 0 6 8 2 7 
d o c
el d o _ c o ntr oll e d
4. 0; M o st- R e c e nt; Eff e cti v e; C U R R E N T
A ut o I s s u e
0 9 0 0 3 2 d 5 8 0 d 9 8 e b 9
Pa ge 1 7 of 9 3
C CI

1 8
1.
F or Visits 3- 8 , s u bjects will be i nstr ucte d t o clea nse t heir face at h o me usi n g t he clea nser pr o vi de d a n d m ust n ot use a n y ot her pr o d uct o n t heir face, 
i ncl u di n g t he test pr o d uct ( Gr o u p I o nl y) a n d s u nscree n. S u bjects will be i nstr ucte d t o bri n g t he dis pe nse d clea nser, s u nscree n a n d test pr o d uct ( Gr o u p I 
o nl y) wit h t he m t o all visits. S u bjects will be i n vite d t o t he site i n t he m or ni n g ( pri or t o 9 a m) t o a v oi d e x p os ure t o str o n g s u nli g ht. 
2.
T he I n vesti gat or or desi g nee will re vie w t he diar y t o m o nit or a n d e nc o ura ge c o m plia nce. A d diti o nal or misse d pr o d uc t a p plicati o ns will be rec or de d as 
de viati o ns. T he E val uat or m ust be bli n d t o diar y re vie w.
3.
E xcl usi o n Criteria 9 will n ot be i ncl u de d f or t his assess me nt. E xcl usi o n criteria 9 is e val uate d base d o n t he res ults fr o m t he se nsiti vit y test.
4.
T o i ncl u de a re vie w of t he i ncl usi o n/e xcl usi o n criteria s pecifie d i n A p pe n di x 4. S u bjects m ust be c o nsi dere d c o m plia nt wit h t hese i ncl usi o n/e xcl usi o n 
criteria i n or der t o re mai n eli gi ble f or t he st u d y.
5.
Peel re gi me n ( 7 0 % Gl yc olic Aci d facial peel s ol uti o n, Bicar b o nate Ne utral izi n g S ol uti o n a n d S u n ma x Se nsiti ve S P F 5 0) t o be a p plie d t o t he v olar f orear m 
of eac h s u bject b y a q ualifie d der mat ol o gist. 
6.
Assess me nts t o be ta ke n 4 5 ± 1 5 mi n utes after c o m pleti o n of t he st ud y material se nsiti vit y test.
7.
Assess me nts t o be ta ke n 2 4 ± 4 h o urs a fter c o m pleti o n of t he st u d y material se nsiti vit y test.
8.
Assess me nts t o be ta ke n 7 da ys after c o m pleti o n of t he st u d y material se nsiti vit y test.
9.
7 0 % Gl yc olic Aci d facial peel t o be a d mi nistere d b y a q ualifie d der mat ol o gist w h o m ust be bli n d t o ra n d o mizati o n. T he Gl yc olic Aci d treat me nt a n d 
ne utralizi n g s ol uti o n will be s o urce d c o m merciall y b y t he st u d y site. 
1 0.
Assess me nts t o be ta ke n 6 0 ± 1 5 mi n utes after c o m pleti o n of t he facial peel pr oce d ure.
1 1.
O nl y s u bjects ra n d o mise d t o Gr o u p I will be dis pe nse d test pr o d uc t. S u bjects i n Gr o u p I a n d II will be dis pe nse d differe nt test diaries t o reflect t he 
differe nce i n treat me nt all ocati o n. T he was h o ut diar y will be ret ur ne d at t he sa me ti me as test diar y dis pe nsi n g. 
1 2.
Test pr o d uct a p plicati o n will occ ur i m me diatel y after the p ost -pr oce d ure, pre -treat me nt ( Baseli ne) assess me nts are c o m plete a n d u n der t he s u per visi o n of 
t he I n vesti gat or or desi g nee t o s u bjects i n Gr o u p I, o nl y. S u bjects i n Gr o u p II will n ot a p pl y a n yt hi n g t o t heir face. T he E val uat or m ust be bli n d t o test 
pr o d uct a p plicati o n.
1 3.
Meas ure me nts t o be t a k e n 1 8 0 ± 1 5 mi n utes, 3 6 0 ± 1 5 mi n ut es , 2 4 ± 4 h o urs, 4 8 ± 4 h o urs, 7 2 ± 4 h o urs, 1 6 8 ± 4 h o urs a n d 3 3 6 ± 4 h o urs after c o m pleti o n of t he 
facial peel pr oce d ure. At Visit 3, t here m ust be at least 3 0 mi n utes bet wee n test pr o d uct a p p licati o n ( Gr o u p I, o nl y) a n d i nstr u me ntal meas ure me nts.  
1 4.
I ma ges t o be ca pt ure d 2 4± 4 h o urs after c o m pleti o n of t he facial peel pr oce d ure a n d at Visit 8 ( Da y 2 2).
1 5.
Assess me nts t o be ta ke n 1 8 0 ± 1 5 mi n utes, 2 4 ± 4 h o urs, 4 8 ± 4 h o urs, 7 2 ± 4 h o urs, 1 6 8 ± 4 h o urs a n d 3 3 6 ± 4 h o urs after c o m pleti o n of t he facial peel 
pr oce d ure.
1 6.
Test pr o d uct a p plicati o n will be c o n d ucte d u n der t he s u per visi o n of t he I n vesti gat or or desi g nee t o s u bjects i n Gr o u p I, o nl y . S u bjects i n Gr o u p II will n ot 
a p pl y t he test pr o d uct t o t heir face.
1 7.
S u ns cree n a p plicati o n will be c o n d ucte d u n der t he s u per visi o n of t he I n vesti gat or or desi g nee t o all s u bjects.
 
D oc u m e nt N a m e  
 
T y p e  
V ersi o n  
D oc u m e nt I d e ntifi er  
Eff ecti v e D at e  
 
 
 
 
R e as o n F or Iss u e  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
1 5- S e p- 2 0 1 7 0 9: 2 7: 1 5
 
Pr ot o c ol 2 0 6 8 2 7 
d o c
el d o _ c o ntr oll e d
4. 0; M o st- R e c e nt; Eff e cti v e; C U R R E N T
A ut o I s s u e
0 9 0 0 3 2 d 5 8 0 d 9 8 e b 9
Pa ge 1 8 of 9 3
C CI

1 9
P R O T O C O L S Y N O P SI S F O R S T U D Y 2 0 6 8 2 7

Brief S u m m ar y
T his is a ra n d o mize d, e val uat or -bli n d, si n gle -ce nter a n d t w o -ar m cli nical st u d y 
desi g ne d t o e val uate t he l ocal t olera nce a n d c os metic efficac y o f a t o pical s ki n care 
f or mulat i on i n healt h y fe male s u bjects wit h m o derate t o a d va nce d p h ot o- da ma ge d 
facial s ki n w h o ha ve u n der g o ne a 7 0 % Gl yc o lic Aci d f a ci al peel pr oce d ure. It is 
h y p ot hesize d t hat t he test pr o d uct, w hic h is s pecificall y desi g ne d as a m o ist urizi n g 
crea m for dr y , se nsitive s ki n, will prese nt a fa v ora ble l ocal t olera nce pr ofile i n t his 
p o p ul at i on .
O bjecti ve(s) a n d E n d p oi nt(s)
O bjecti ve(s)
E n d p oi nt(s)
Pri m ar y
Assess me nt of t he l ocal 
t olera nce of t he test pr o d uct 
i n s u bjects w h o ha ve 
u n der g o ne a 7 0 % Gl yc o lic 
Aci d facial peel
E val uat or ( Der mat ol o gist) g l obal a ssess me nt of 
t olera nce
Sec o n d ar y
Assess me nt of  s ki n
rec o ver y (c ha n ge fr o m 
bas eli ne) o ver a peri o d of 
1 4 da y s i n s u bjects w h o 
ha ve u n der g o ne a 7 0 % 
Gl yc o lic Aci d facial peel
C o m bi ne d (s u m o f) E val ua t or (Der mat ol o gist ) sc ores 
f or sig ns/s y m pt o m s of er yt he ma, e de ma, des q ua matio n 
a n d dr y ness
I n di vi d ual E val uat or ( Der mat ol o gist) sc ores f or 
er yt he ma, e de ma, des q ua mat i on a n d dr y ness
C o m bi ne d (s u m o f) s u bject self-assess me nt sc ores f or 
re d ness, pai n, sti n gi n g/ b ur ni n g, itc hi n g, ti g ht ness a n d 
dr y ness
I n di vi d ual su bject self-assess me nt sc ores f or re d ness, 
pai n, sti n gi n g/ b ur ni n g, itc hi n g, ti g ht ness a n d dr y ness
I nstr u me nt al meas ure me nt of  b arrier f unct i on 
( Te wa meter) a n d m o ist urisati o n ( C or ne o meter )
S u bject g l ob al  self-assess me nt
 
D oc u m e nt N a m e  
 
T y p e  
V ersi o n  
D oc u m e nt I d e ntifi er  
Eff ecti v e D at e  
 
 
 
 
R e as o n F or Iss u e  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
1 5- S e p- 2 0 1 7 0 9: 2 7: 1 5
 
Pr ot o c ol 2 0 6 8 2 7 
d o c
el d o _ c o ntr oll e d
4. 0; M o st- R e c e nt; Eff e cti v e; C U R R E N T
A ut o I s s u e
0 9 0 0 3 2 d 5 8 0 d 9 8 e b 9
Pa ge 1 9 of 9 3
C CI

2 0
Assess me nt of s ki n 
rec o ver y (c ha n ge fr o m 
baseli ne) bet wee n treat me nt 
gr o u ps .
All assess me nts a n d meas ure me nts liste d a b o ve
St u d y Desi g n

O ver all Desi g n
T his is a ra n d omize d, e val uat or -bli n d, si n gle -ce nter a n d t w o -ar m cli nical st u d y 
desi g ne d t o e val uate t he l ocal t olera nce a n d c os metic efficac y o f a t o pical s ki n care 
f or mulat i on i n heal t hy female s u bjects wit h m o d erate t o a d va nce d p h ot o-da ma ge d 
facial s ki n w h o ha ve u n der g o ne a 7 0 % Gl yc o lic Aci d f a ci al peel pr oce d ure. It is 
h y p ot hesize d t hat t he test pr o d uct, w hic h is s pecificall y desi g ne d as a m o ist urizi n g 
crea m for dr y , se nsitive s ki n, will  prese nt a fa v ora ble l ocal t olera nce pr ofile i n t his 
p o p ul at i on.
Visit 1 / D a y 1 (Scree ni n g / W as h o ut)
T he f o ll owi n g assess me nts will be c o n d ucte d i n t he or der writte n:
1.
I nf or me d C o nse nt
2.
D e m o gra p hics
3.
Me dical Hist or y
4.
C urre nt / C o nc o mita nt Me dicat i on
5.
Fi tz patric k S ki n T ype Assess me nt ( A p pe n di x 2)
6.
Gl o ga u P h ot oa gi n g T y pe Assess me nt ( A p pe n di x 3 )
7. I n/ E xcl usi o n Criteria ( N o t i ncl u di n g E xcl usi on Criteria 9)
8.
S u bject Eli gi bilit y
9.
St u d y  Material Se nsitivi t y Test
1 0. S u bject Self -Assess me nt Se nsit i vity *
1 1. D er m at olo gi st Assess me nt Se nsit i vity *
1 2. E xcl usi o n Cri t eria 9
1 3. S u bject Eli gi bilit y
1 4.
Was h o ut Pr o d ucts a n d Was h o ut
Diar y Dis pe nsi n g
* Assess me nts t o be ta ke n 4 5 ± 1 5 mi n utes after c o m pleti o n of t he st u d y material se nsiti vit y 
test
Visit 2 / D a y 2 (1 D a y after Visit 1)
T he f o ll owi n g assess me nts will be c o n d ucte d i n t he or der writte n:
1.
C urre nt / C o nc o mita nt Me dicat i on
2.
A d verse E ve nts
3.
C o nti n ue d S u bject Eli gi bilit y
4.
C o m plia nce ( Di ar y re vie w)
 
D oc u m e nt N a m e  
 
T y p e  
V ersi o n  
D oc u m e nt I d e ntifi er  
Eff ecti v e D at e  
 
 
 
 
R e as o n F or Iss u e  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
1 5- S e p- 2 0 1 7 0 9: 2 7: 1 5
 
Pr ot o c ol 2 0 6 8 2 7 
d o c
el d o _ c o ntr oll e d
4. 0; M o st- R e c e nt; Eff e cti v e; C U R R E N T
A ut o I s s u e
0 9 0 0 3 2 d 5 8 0 d 9 8 e b 9
Pa ge 2 0 of 9 3
C CI

2 1
5.
S u bject Self -Assess me nt Se nsit i vity *
6.
D er m at olo gi st Assess me nt Se nsiti vity *
7.
E xcl usi o n Cri t eria ( A p pe n di x 4)
8.
S u bject Eli gi bilit y
* Assess me nts t o be ta ke n 2 4 ± 4 h o urs after c o m pleti o n of t he st u d y material se nsiti vit y test
Visit 3 / D a y 8 ( 6 Da ys after Visit 2 - Da y of Pr oce d ure )
T he f o ll owi n g assess me nts will be c o n d ucte d i n t he or der writte n:
1.
C urre nt / C o nc o mita nt Me dicati on
2.
A d verse E ve nts
3.
C o nti n ue d S u bject Eli gi bilit y
4.
C o m plia nce ( Di ar y re vie w)
5.
Was h o ut Diar y Ret ur n
6.
S u bject Self -Assess me nt Se nsit i vity *
7.
D er m at olo gi st Assess me nt Se nsiti vity *
8.
E xcl usi o n Cri t eria ( A p pe n di x 4)
9.
S u bject Eli gi bilit y
1 0. S u bject Ra n d o m isati on
1 1. I nstr u me nt al Meas ure me nts Pre-Pr oce d ure
1 2. I ma ge ca pt ure ( VI SI A) Pre-Pr oce d ure 
1 3. S u bject Self -Assess me nt Pre -Pr oce d ure 
1 4. D er m at olo gi st Assess me nt Pre-Pr oce d ure
1 5. D er m at olo gi cal Pr oce d ure ( Facial Peel)
1 6. D er m at olo gi st Assess me nt P ost-Pr oce d ure, Pre -Treat me nt  ( B A S E LI N E) **
1 7. I nstr u me nt al Meas ure me nts P ost-Pr oce d ure, Pre -Treat me nt ( B A S E LI N E) * *
1 8. I ma ge ca pt ure ( VI SI A) P ost -Pr oce d ure, Pre -Treat me nt ( B A S E LI N E) * *
1 9. S u bject Self -Assess me nt P ost -Pr oce d ure, Pre -Treat me nt ( B A S E LI N E) * *
2 0. Test Pr o d uct a n d Test Diar y Dis pe nsi n g
2 1. S u per vise d Test -Pr o d uct A p plicati o n P ost -Pr oce d ure
2 2. I nstr u me nt al Meas ure me nts P ost-Pr oce d ure, P ost -Treat me nt * * *
2 3. S u bject Self -Assess me nt P ost -Pr oce d ure, P ost -Treat me nt * * * *
2 4. D er m at olo gi st Assess me nt P ost-Pr oce d ure, P ost -Treat me nt * * * *
* Assess me nts t o be ta ke n 7 da ys after c o m pleti o n of t he st u d y material se nsiti vit y test
* * Assess me nts t o be ta ke n 6 0 ± 1 5 mi n utes after c o m pleti o n of t he facial peel pr oce d ure
* * * Assess me nts t o be ta ke n 1 8 0 ± 1 5 a n d 3 6 0 ± 1 5 mi n utes after c o m pleti o n of t he facial peel 
pr oce d ure . 
* * * * Assess me nts t o be ta ke n 1 8 0 ± 1 5 mi n utes after c o m pleti o n of t he facial peel pr oce d ure . 
S u bjects s h o ul d re mai n at t he site u ntil 5: 0 0 P M t o pre ve nt e x p os ure t o i nte nse s u nli g ht.
Visit 4 / D a y 9 (1 D a y after Visit 3 )
T he f o ll owi n g assess me nts will be c o n d ucte d i n t he or der writte n:
 
D oc u m e nt N a m e  
 
T y p e  
V ersi o n  
D oc u m e nt I d e ntifi er  
Eff ecti v e D at e  
 
 
 
 
R e as o n F or Iss u e  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
1 5- S e p- 2 0 1 7 0 9: 2 7: 1 5
 
Pr ot o c ol 2 0 6 8 2 7 
d o c
el d o _ c o ntr oll e d
4. 0; M o st- R e c e nt; Eff e cti v e; C U R R E N T
A ut o I s s u e
0 9 0 0 3 2 d 5 8 0 d 9 8 e b 9
Pa ge 2 1 of 9 3
C CI

2 2
1.
C urre nt / C o nc o mita nt Me dicat i on
2.
A d verse E ve nts
3.
C o nti n ue d S u bject Eli gi bilit y
4.
C o m plia nce ( Di ar y re vie w)
5.
I nstr u me nt al Meas ure me nts P ost-Pr oce d ure, P ost -Treat me nt *
6.
I ma ge ca pt ure ( VI SI A) P ost -Pr oce d ure, P ost -Treat me nt *
7.
S u bject Self -Assess me nt P ost -Pr oce d ure, P ost -Treat me nt *
8.
D er m at olo gi st Assess me nt P ost-Pr oce d ure, P ost -Treat me nt *
9.
S u per vise d Test -Pr o d uct A p plicati o n
1 0. S u per vise d S u nscree n A p plicat i on
* Assess me nts t o be ta ke n 2 4 ± 4 h o urs after c o m pleti o n of t he facial peel pr oce d ure
Vi sit 5 / D a y 1 0 ( 1 D a y after Visit 4) ; Visit 6 / D a y 1 1 ( 1 Da y after Visit 5) , Visit 7
/ D a y 1 5 (4 D a ys After Visit 6)
T he f o ll owi n g assess me nts will be c o n d ucte d i n t he or der writte n:
1.
C urre nt / C o nc o mita nt Me dicat i on
2.
A d verse E ve nts
3.
C o nti n ue d S u bject Eli gi bilit y
4.
C o m plia nce ( Di ar y re vie w)
5.
I nstr u me nt al Meas ure me nts P ost-Pr oce d ure, P ost -Treat me nt *
6.
S u bject Self -Assess me nt P ost -Pr oce d ure, P ost -Treat me nt *
7.
D er m at olo gi st Assess me nt P ost-Pr oce d ure, P ost -Treat me nt *
8.
S u per vise d Test -Pr o d uct A p plicati o n
9.
S u per vise d S u nsc ree n A p plicati on
* Assess me nts t o be ta ke n 4 8 ± 4 ( Visit 5), 7 2 ± 4 ( Visit 6) a n d 1 6 8 ± 4 ( Visit 7) h o urs after 
c o m pleti o n of t he facial peel pr oce d ure
Visit 8 / D a y 2 2 ( 7 D a ys after Visit 7 )
T he f o ll owi n g assess me nts will be c o n d ucte d i n t he or der writte n:
1.
C u rre nt / C o nc o mita nt Me dicati on
2.
A d verse E ve nts
3.
C o nti n ue d S u bject Eli gi bilit y
4.
C o m plia nce ( Di ar y re vie w)
5.
I nstr u me nt al Meas ure me nts P ost-Pr oce d ure, P ost -Treat me nt *
6.
I ma ge ca pt ure ( VI SI A) P ost -Pr oce d ure, P ost -Treat me nt *
7.
S u bject Self -Assess me nt P ost -Pr oce d ure, P o st-Treat me nt *
8.
S u bject Gl o bal Self- Assess me nt
9.
D er m at olo gi st Assess me nt P ost-Pr oce d ure, P ost -Treat me nt *
1 0. D er m at olo gi st Glo bal  Assess me nt of T olera nce
1 1. Pr o d ucts a n d Test Diar y R et ur n
1 2. Di sc har ge fr o m St u d y
 
D oc u m e nt N a m e  
 
T y p e  
V ersi o n  
D oc u m e nt I d e ntifi er  
Eff ecti v e D at e  
 
 
 
 
R e as o n F or Iss u e  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
1 5- S e p- 2 0 1 7 0 9: 2 7: 1 5
 
Pr ot o c ol 2 0 6 8 2 7 
d o c
el d o _ c o ntr oll e d
4. 0; M o st- R e c e nt; Eff e cti v e; C U R R E N T
A ut o I s s u e
0 9 0 0 3 2 d 5 8 0 d 9 8 e b 9
Pa ge 2 2 of 9 3
C CI

2 3
* Assess me nts t o be ta ke n 3 3 6 ± 4 h o urs after c o m pleti o n of t he facial peel pr oce d ure
T y pe a n d Pl a n ne d N u m ber of S u bjects

A p pr o xi matel y  1 3 0 1 7 8 heal t h y fe males wit hi n t he a ges of 3 0 a n d 6 0 years 
(incl usi ve) wit h Fi t z p atric k S ki n Classificat i on II -I V a n d m o derate t o a d va nce d 
p h ot o -da ma ge d s ki n will be scree ne d t o ra n d o mize 8 0 1 0 0 s u bjects t o e ns ure 
a p pr o xi matel y 6 0 8 0 s u bjects (3 0 4 0 s u bjects per gr o u p) s uccessf ull y c o m p lete t he 
st u d y.  T he sa m ple size is base d o n cl i nical c o nsi derati o ns a n d literat ure prece de nt 
[Nar ur kar , Sc hal ka , S uli mo vic, Ki m ]. Wit h 3 0 s u bjects per treat me nt gr o u p, a c ha n ge 
fr om baseli ne i n Tra nse pi der mal Water L oss ( T E W L) at least half t he ma g nit u de o f 
t he sta n dar d de viati o n (e. g. ass u me st d = 4 (r ef. 
), a n d 2. 1 -p oi nt
mea n c ha n ge fr o m baseli ne) ca n be detecte d at t w o -side d al p ha = 0. 0 5 wit h 8 0 % 
p o wer.
M ai n Criteri a f or I ncl usi o n
Heal t h y fe male s u bjects a ge d 3 0-6 0 y ears (i ncl usi ve) wit h a Fi t z p atric k s ki n 
p h ot ot y pe II -IV a n d Gl o ga u p h ot oa gi n g t y pe II -III will be recr uite d f or t his st u d y .
 
D oc u m e nt N a m e  
 
T y p e  
V ersi o n  
D oc u m e nt I d e ntifi er  
Eff ecti v e D at e  
 
 
 
 
R e as o n F or Iss u e  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
1 5- S e p- 2 0 1 7 0 9: 2 7: 1 5
 
Pr ot o c ol 2 0 6 8 2 7 
d o c
el d o _ c o ntr oll e d
4. 0; M o st- R e c e nt; Eff e cti v e; C U R R E N T
A ut o I s s u e
0 9 0 0 3 2 d 5 8 0 d 9 8 e b 9
Pa ge 2 3 of 9 3
C CI
C CI

2 4
Pr o d uct I nf or m ati o n
Refere nce / 
W as h o ut Cle a nser
Test Pr o d uct
Refere nce / 
W as h o ut
S u nscree n
Pr o d uct N a me 
Si m ple
Ki n d t o 
S ki n M o isturi si n g 
Facial Was h
P h ysi o gel Cal mi n g 
Relief Rest ori n g 
Li pi d Bal m 
S u n ma x Se nsit i ve 
S P F 5 0
Pr o d uct 
F or m ul ati o n 
C o de
N ot A p plica ble
( C o m mercial, U K)
( C o m mercial, 
Brazil)
A p plic ati o n
Q u a ntit y
A p pr o xi matel y  0. 6-1 g r a ms ( g)
R o ute of 
A p plic ati o n
T o pi cal
A p plic ati o n 
I nstr ucti o ns
Wet face wit h water. 
I n yo ur ha n ds, w or k 
a s mall a mo u nt i nt o 
a lat her. Massa ge 
o nt o wet s ki n, ri nse 
wi t h water. 
A v o i d c o ntact wit h 
e yes. If c o ntact 
occ urs, rinse 
t hor o u g hl y wit h 
water.
Use t wice a da y 
( mor ni n g a n d 
e ve ni n g) 
Di s pe nse a pea-size d 
q ua nt ity of  pr o d uct 
o nt o t he fi n gerti ps 
a n d a p pl y t o t he f ull 
face.
A v o i d c o ntact wit h 
e yes. If c o ntact 
occ urs ri nse 
t hor o u g hl y wit h 
water.
A p pl y t wice a da y  
( mor ni n g a n d 
e ve ni n g)
D o n ot a p pl y i n t he 
m o r ni n g if yo u are 
visit i n g t he site o n 
t he sa me da y.
Di s pe nse a pea-size d 
q ua nt ity o nt o t he 
fi n gerti ps a n d ap pl y  
t o t he f ull face.
A v o i d c o ntact wit h 
e yes. If c o ntact 
occ urs ri nse 
t hor o u g hl y wit h 
water.
A p pl y t wice a d a y  
( mor ni n g a n d 
l u nc hti me) 
D o n ot a p pl y i n t he 
m o r ni n g if yo u are 
visit i n g t he site o n 
t he sa me da y. 
St atistic al Met h o ds
Descri pt i ve statistics ( N, %, 9 5 % c o nfi de nce i nter vals) will be use d t o s u m marize t he 
gl o bal  assess me nt of t olera nce. C ha n ges fr o m  baseli ne i n t he e val uat or, s u bject i ve 
a n d i nstr u me ntal en d p o i nts will be ta b ulate d b y pr o d uct gr o u p a n d s u m marize d 
descri pt i vel y a n d assesse d f or si g nifica nce ( differe nt fr om zer o) usi n g t-tests or 
Wilc o x o n si g ne d ra n k tests de pe n de nt u p o n t he distri b ut i on of t he data. Differe nces 
 
D oc u m e nt N a m e  
 
T y p e  
V ersi o n  
D oc u m e nt I d e ntifi er  
Eff ecti v e D at e  
 
 
 
 
R e as o n F or Iss u e  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
1 5- S e p- 2 0 1 7 0 9: 2 7: 1 5
 
Pr ot o c ol 2 0 6 8 2 7 
d o c
el d o _ c o ntr oll e d
4. 0; M o st- R e c e nt; Eff e cti v e; C U R R E N T
A ut o I s s u e
0 9 0 0 3 2 d 5 8 0 d 9 8 e b 9
Pa ge 2 4 of 9 3
C CI
C CI
C CI
C CI

2 5
bet wee n pr o d uct gr o u ps i n t he e val uat or, s u bject i ve a n d i nstr u me ntal e n d p oi nts will 
als o be e x pl ore d a n d t he ma g nit u de o f pr o d uct differe nces i n t he c ha n ge fr o m 
baseli ne f or eac h will be est i mate d. A d verse e ve nts will be ta b ulate d b y pr o d uct 
gr o u p.
 
D oc u m e nt N a m e  
 
T y p e  
V ersi o n  
D oc u m e nt I d e ntifi er  
Eff ecti v e D at e  
 
 
 
 
R e as o n F or Iss u e  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
1 5- S e p- 2 0 1 7 0 9: 2 7: 1 5
 
Pr ot o c ol 2 0 6 8 2 7 
d o c
el d o _ c o ntr oll e d
4. 0; M o st- R e c e nt; Eff e cti v e; C U R R E N T
A ut o I s s u e
0 9 0 0 3 2 d 5 8 0 d 9 8 e b 9
Pa ge 2 5 of 9 3
C CI

2 6
1. I N T R O D U C TI O N
A t otal o f 1 1. 7 milli o n c os m et ic pr oce d ures were perf or me d i n 2 0 0 7 i n t he U nite d 
States, a n d t he maj orit y ( 8 2 %) of t hese were n o n-s ur gical in nat ure. N o n -s ur gical 
tec h ni q ues are ai me d at re d uci n g t he si g ns of facial a gi n g, s uc h as h y per pi g me ntati o n, 
l oss of elasticity,  a n d wri n kles.  
Wit h all o f t hese n o n- s ur gical pr oce d ures, t here is a n i nte nti o nal ge nerati on of 
d a m a ge t o t he c uta ne o us barrier i n or der t o pr o m ote t he re pair of t he e pi der mis a n d 
i ncrease d cell re ne wal. B y pr o moti n g da ma ge t o t he strat u m c or ne u m or e pi der mis, 
s o me de gree of irritati o n, w hich tra nslates i nt o er y t he ma a n d/ or e de ma, i n a d ditio n  t o 
des q ua mat i on of greater or lesser i nte nsit y, is e x pecte d t o occ ur cli nicall y.
Facial c he mical e xf o liati on is a well-esta blis he d pr oce d ure i n w hic h t he der mat ol o gist 
uses s o me a ge nt ( us uall y aci ds) t o i ns ult t he s ki n, wit h c o nse q ue nt da ma ge t o t he 
c uta ne o us barrier. T here are differe nt  t ypes of c he mical e xf o lia nt ( peels), use d i n 
d er m at olo gi c practice, wit h t h e most c o m m o n  bei n g t he use of reti n o i ds a n d al p ha-
h y dr o x y  a cids ( A H As), i ncl u di n g gl yc olic ac i d ( G A).  A H A peels ha ve a nti-
i nfla m mat or y, kerat ol ytic, a n d a nti o xi da nt effects a n d gl yc olic aci d tar gets t he 
c or ne os o me b y e n ha nci n g brea k d o w n a n d decreasi n g c o hesi ve ness, ca usi n g 
des q ua mat i on. T he i nte nsit y of peel is deter mi ne d b y  t he c o nce ntratio n of  t he aci d, 
t he ve hicle use d t o carr y it, t he a mo u nt of aci d a p plie d, a n d t he tec h ni q ue use d. 7 0 % 
G A a p plie d t o s ki n f or 1 -3 mi n utes, f o ll owe d b y  ne utralizati on wi t h a bicar b o nate 
base is classifie d as a s u perficial facial peel pr oce d ure [ G uerrier o 2 0 1 4 ].
Pr i or t o a n d f oll owi n g facial res urfaci n g pr oce d ures, p h ysicia ns ofte n rec o m me n d t hat 
s u bjects use a ra n ge of t o pical s ki n care pr o d ucts .   
Pre -p r oce d ure Re gi me n :
Pre -pr oce d ure, s u bjects ma y be i nstr ucte d t o use a ge ntle, n o nirritati n g clea nser, a n 
e xf o lia nt, a n d crea ms c o ntai ni n g a reti n oi d a n d h y dr o q ui n o ne. S uc h a re gi me n ma y 
hel p a s u bject’s s ki n t o be i n o pti mal c o n diti on at t he ti me o f a pr oce d ure. 
P ost -pr oce d ure Re gi me n :
I n t he peri o d i m me diatel y aft er t he pr oce d ure, it is rec o m me n de d t hat t he 
d er m at o l ogi st i nstr uct t he s u bject in t he use of s u nscree n a n d m o ist urizi n g a ge nts t hat 
are a ble t o pr o vi de a rest orati ve acti o n o n t he c uta ne o us barrier. T his hel ps t o relie ve 
s y m pt o ms (s uc h as b ur ni n g, scali n g, a n d er yt he ma) a n d pr o motes t he q ui c k a n d 
 
D oc u m e nt N a m e  
 
T y p e  
V ersi o n  
D oc u m e nt I d e ntifi er  
Eff ecti v e D at e  
 
 
 
 
R e as o n F or Iss u e  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
1 5- S e p- 2 0 1 7 0 9: 2 7: 1 5
 
Pr ot o c ol 2 0 6 8 2 7 
d o c
el d o _ c o ntr oll e d
4. 0; M o st- R e c e nt; Eff e cti v e; C U R R E N T
A ut o I s s u e
0 9 0 0 3 2 d 5 8 0 d 9 8 e b 9
Pa ge 2 6 of 9 3
C CI

2 7
efficie nt re pair of t he s u perficial str uct ures of t he e pi der mis, i n partic ular t he strat u m 
c or ne u m. S o me p ost -pr oce d ure pr o d ucts, s uc h as a 1 % h y dr oc orti s o ne crea m, ca n 
hel p t o m a na ge t he a d verse effects of t he pr oce d ure s uc h as s welli n g a n d er yt he ma. 
Ot hers, li ke a s u nscree n, hel p pr otect heali n g s ki n d uri n g rec o ver y.
P h ysi o gel Cal mi n g Relief Rest ori n g Li pi d Bal m is a m oist urisi n g oil i n water 
e mulsi o n , f orm u late d t o be free of c ol oura nts a n d fra gra nces a n d is cli nicall y pr o ve n 
t o be s uita ble f or use b y s u bjects wit h dr y, se nsitive s ki n. It i s t heref ore e x pecte d t hat 
t his pr o d uct will hel p relie ve s ome of t he a d verse effects of c os met ic pr oce d ures, 
i ncl udi n g gl yc o lic aci d facial peels, a n d will be of be nefit t o s u bjects.
Si de - effects of t he Pr oce d ure :
Pr o per selecti o n of s u bjects, ti mi n g of peel, a n d ne utralizati on o n -ti me s h o ul d e ns ure 
g o o d res ul ts a n d mi ni mize si de effects [ S hara d 2 0 1 3]. T he mi n or si de effects re p orte d 
are: er yt he ma, des q ua mat i on, sti n gi n g se nsati on, se nsat i on of p ulli n g of facial s ki n, 
mil d b ur ni n g, a n d tra nsie nt p ost -i nfla m mat or y h y per pi g me ntati o n. U n b uffere d G A 
ca n ca use er osi ve blisters a n d scarri n g. I n rare cases, h yp o pi g me ntati o n, persiste nt 
er yt he ma, a n d flare -u p of  pi m ples ha ve bee n re p orte d [ Perić 2 0 1 1].
 
D oc u m e nt N a m e  
 
T y p e  
V ersi o n  
D oc u m e nt I d e ntifi er  
Eff ecti v e D at e  
 
 
 
 
R e as o n F or Iss u e  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
1 5- S e p- 2 0 1 7 0 9: 2 7: 1 5
 
Pr ot o c ol 2 0 6 8 2 7 
d o c
el d o _ c o ntr oll e d
4. 0; M o st- R e c e nt; Eff e cti v e; C U R R E N T
A ut o I s s u e
0 9 0 0 3 2 d 5 8 0 d 9 8 e b 9
Pa ge 2 7 of 9 3
C CI

2 8
2. O B J E C TI V E( S) A N D E N D P OI N T( S)
O bjecti ve(s)
E n d p oi nt(s)
Pri m ar y
Assess me nt of t he l ocal 
t olera nce of t he test pr o d uct 
i n s u bjects w h o ha ve 
u n der g o ne a 7 0 % Gl yc o lic 
Aci d facial peel
E val uat or ( Der mat ol o gist) gl o bal assess me nt of 
t olera nce
Sec o n d ar y
Assess me nt of s ki n 
reco ver y  (c ha n ge fr o m 
baseli ne) o ver a peri o d of 
1 4 da y s i n s u bjects w h o 
ha ve u n der g o ne a 7 0 % 
Gl yc o lic Aci d facial peel
C o m bi ne d (s u m o f) E val uat or ( Der mat ol o gist) sc ores 
f or sig ns/s y m pt o m s of er yt he ma, e de ma, des q ua matio n 
a n d dr y ness
I n di vi d ual E val uat or ( Der mat ol o gist) sc ores f or 
er yt he ma, e de ma, des q ua mat i on a n d dr y ness
C o m bi ne d (s u m o f) s u bject self-assess me nt sc ores f or 
re d ness, pai n, sti n gi n g/ b ur ni n g, itc hi n g, ti g ht ness a n d 
dr y ness
I n di vi d ual su bject self-assess me nt sc ores f or re d ness, 
pai n, sti n gi n g/b ur ni n g, itc hi n g, ti g ht ness a n d dr y ness
I nstr u me nt al meas ure me nt of  b arrier f unct i on 
( Te wa meter) a n d m o ist urisati o n ( C or ne o meter )
S u bject gl o bal self -assess me nt
Assess me nt of s ki n 
rec o ver y (c ha n ge fr o m 
baseli ne) bet wee n treat me nt 
gr o u ps .
All assess me nts a n d meas ure me nts liste d a b o ve
 
D oc u m e nt N a m e  
 
T y p e  
V ersi o n  
D oc u m e nt I d e ntifi er  
Eff ecti v e D at e  
 
 
 
 
R e as o n F or Iss u e  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
1 5- S e p- 2 0 1 7 0 9: 2 7: 1 5
 
Pr ot o c ol 2 0 6 8 2 7 
d o c
el d o _ c o ntr oll e d
4. 0; M o st- R e c e nt; Eff e cti v e; C U R R E N T
A ut o I s s u e
0 9 0 0 3 2 d 5 8 0 d 9 8 e b 9
Pa ge 2 8 of 9 3
C CI

2 9
3. S T U D Y P L A N
3. 1. St u d y Desi g n

O ver all Desi g n
T his is a ra n d o mize d, e val uat or -bli n d, si n gle -ce nter a n d t w o -ar m cli nical st u d y 
desi g ne d t o e val uate t he l ocal t olera nce a n d c os metic efficac y o f a t o pical s ki n care 
f or mulat i on i n healt h y fe male s u bjects wit h m o derate t o a d va nce d p h ot o- da ma ge d 
facial s ki n w h o ha ve u n der g o ne a 7 0 % Gl yc o lic Aci d f a ci al peel pr oce d ure. It is 
h y p ot hesize d t hat t he test pr o d uct, w hic h is s pecificall y desi g ne d as a m o ist urizi n g 
crea m for dr y , se nsitive s ki n, will prese nt a fa v ora ble l ocal t olera nce pr ofile i n t his 
p o p ul at i on.
Visit 1 / D a y 1 (Scree ni n g / W as h o ut)
T he f o ll owi n g assess me nt s will be c o n d ucte d i n t he or der writte n:
1.
I nf or me d C o nse nt
2.
D e m o gra p hics
3.
Me dical Hist or y
4.
C urre nt / C o nc o mita nt Me dicat i on
5.
Fi tz patric k S ki n T ype Assess me nt ( A p pe n di x 2)
6.
Gl o ga u P h ot oa gi n g T y pe Assess me nt ( A p pe n di x 3)
7.
I n/ E xcl usi o n Criteria ( N ot i ncl u di n g E xcl usio n  Criteria 9)
8.
S u bject Eli gi bilit y
9.
St u d y  Material Se nsitivi t y Test
1 0. S u bject Self -Assess me nt Se nsit i vity *
1 1. D er m at olo gi st Assess me nt Se nsiti vity *
1 2. E xcl usi o n Cri t eria 9
1 3. S u bject Eli gi bilit y
1 4. Was h o ut Pr o d ucts a n d Was h o ut Diar y  Dis pe nsi n g
* Assess me nts t o be ta k e n 4 5 ± 1 5 mi n utes after c o m pleti o n of t he st u d y material se nsiti vit y 
test
Visit 2 / D a y 2 ( 1 D a y after Visit 1)
T he f o ll owi n g assess me nts will be c o n d ucte d i n t he or der writte n:
1.
C urre nt / C o nc o mita nt Me dicat i on
2.
A d verse E ve nts
3.
C o nti n ue d S u bject Eli gi bilit y
4.
C o m plia nce ( Di ar y re vie w)
5.
S u bject Self -Assess me nt Se nsit i vity *
6.
D er m at olo gi st Assess me nt Se nsiti vity *
 
D oc u m e nt N a m e  
 
T y p e  
V ersi o n  
D oc u m e nt I d e ntifi er  
Eff ecti v e D at e  
 
 
 
 
R e as o n F or Iss u e  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
1 5- S e p- 2 0 1 7 0 9: 2 7: 1 5
 
Pr ot o c ol 2 0 6 8 2 7 
d o c
el d o _ c o ntr oll e d
4. 0; M o st- R e c e nt; Eff e cti v e; C U R R E N T
A ut o I s s u e
0 9 0 0 3 2 d 5 8 0 d 9 8 e b 9
Pa ge 2 9 of 9 3
C CI

3 0
7.
E xcl usi o n Cri t eria ( A p pe n di x 4)
8.
S u bject Eli gi bilit y
* Assess me nts t o be ta ke n 2 4 ± 4 h o urs after c o m pleti o n of t he st u d y material se nsiti vit y test
Visit 3 / D a y 8 ( 6 D a ys after Visit 2 - D a y of Pr oce d ure)
T he f o ll owi n g assess me nts will be c o n d ucte d i n t he or der writte n:
1.
C urre nt / C o nc o mita nt Me dicat i on
2.
A d verse E ve nts
3.
C o nti n ue d S u bject Eli gi bilit y
4.
C o m plia nce ( Di ar y re vie w)
5.
Was h o ut Diar y Ret ur n
6.
S u bject Self - Assess me nt Se nsiti vity *
7.
D er m at olo gi st Assess me nt Se nsiti vity *
8.
E xcl usi o n Cri t eria ( A p pe n di x 4)
9.
S u bject Eli gi bilit y
1 0. S u bject Ra n d o misat i on
1 1. I nstr u me nt al Meas ure me nts Pre-Pr oce d ure
1 2. I ma ge ca pt ure ( VI SI A) Pre-Pr oce d ure 
1 3. S u bject Self -Assess me nt Pre -Pr oce d ure 
1 4. D er m at olo gi st Assess me nt Pre-Pr oce d ure
1 5. D er m at olo gi cal Pr oce d ure ( Facial Peel)
1 6. D er m at olo gi st Assess me nt P ost-Pr oce d ure, Pre -Treat me nt ( B A S E LI N E) * *
1 7. I nstr u me nt al Meas ure me nts P ost-Pr oce d ure, Pre -Treat me nt ( B A S E LI N E) * *
1 8. I ma ge ca pt ure ( VI SI A) P ost -Pr oce d ure, Pre -Trea t me nt ( B A S E LI N E) **
1 9. S u bject Self -Assess me nt P ost -Pr oce d ure, Pre -Treat me nt ( B A S E LI N E) * *
2 0. Test Pr o d uct a n d Test Diar y  Dis pe nsi n g
2 1. S u per vise d Test -Pr o d uct A p plicati o n P ost -Pr oce d ure
2 2. I nstr u me nt al Meas ure me nts P ost-Pr oce d ure, P ost -Treat me nt * * *
2 3. S u bject Self -Assess m e nt P ost -Pr oce d ure, P ost -Treat me nt * * * *
2 4. D er m at olo gi st Assess me nt P ost-Pr oce d ure, P ost -Treat me nt * * * *
* Assess me nts t o be ta ke n 7 da ys after c o m pleti o n of t he st u d y material se nsiti vit y test
* * Assess me nts t o be ta ke n 6 0 ± 1 5 mi n utes after c o m pleti o n of t he fac ial peel pr oce d ure
* * * Assess me nts t o be ta ke n 1 8 0 ± 1 5 a n d 3 6 0 ± 1 5 mi n utes after c o m pleti o n of t he facial peel 
pr oce d ure . 
* * * * Assess me nts t o be ta ke n 1 8 0 ± 1 5 mi n utes after c o m pleti o n of t he facial peel pr oce d ure . 
S u bjects s h o ul d re mai n at t he site u ntil 5: 0 0 P M t o pre ve nt e x p os ure t o i nte nse s u nli g ht.
Visit 4 / D a y 9 (1 D a y after Visit 3)
T he f o ll owi n g assess me nts will be c o n d ucte d i n t he or der writte n:
1.
C urre nt / C o nc o mita nt Me dicat i on
2.
A d verse E ve nts
 
D oc u m e nt N a m e  
 
T y p e  
V ersi o n  
D oc u m e nt I d e ntifi er  
Eff ecti v e D at e  
 
 
 
 
R e as o n F or Iss u e  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
1 5- S e p- 2 0 1 7 0 9: 2 7: 1 5
 
Pr ot o c ol 2 0 6 8 2 7 
d o c
el d o _ c o ntr oll e d
4. 0; M o st- R e c e nt; Eff e cti v e; C U R R E N T
A ut o I s s u e
0 9 0 0 3 2 d 5 8 0 d 9 8 e b 9
Pa ge 3 0 of 9 3
C CI

3 1
3.
C o nti n ue d S u bject Eli gi bilit y
4.
C o m plia nce ( Di ar y re vie w)
5.
I nstr u me nt al Meas ure me nts P ost-Pr oce d ure, P ost -Treat me nt *
6.
I ma ge ca pt ure ( VI SI A) P ost -Pr oce d ure, P ost -Treat me nt *
7.
S u bject Self -Assess me nt P ost -Pr oce d ure, P ost -Treat me nt *
8.
D er m at olo gi st Assess me nt P ost-Pr oce d ure, P ost -Treat me nt *
9.
S u per vise d Test -Pr o d uct A p plic atio n
1 0. S u per vise d S u nscree n A p plicat i on
* Assess me nts t o be ta ke n 2 4 ± 4 h o urs after c o m pleti o n of t he facial peel pr oce d ure
Visit 5 / D a y 1 0 ( 1 D a y after Visit 4) ; Visit 6 / D a y 1 1 ( 1 Da y after Visit 5), Visit 7
/ D a y 1 5 (4 D a ys After Visit 6)
T he f o ll owi n g assess me nts will be c o n d ucte d i n t he or der writte n:
1.
C urre nt / C o nc o mita nt Me dicat i on
2.
A d verse E ve nts
3.
C o nti n ue d S u bject Eli gi bilit y
4.
C o m plia nce ( Di ar y re vie w)
5.
I nstr u me nt al Meas ure me nts P ost-Pr oce d ure, P ost -Treat me nt *
6.
S u bject Self -Assess me nt P ost -Pr oce d ure, P ost -Treat me nt *
7.
D er m at olo gi st Assess me nt P ost-Pr oce d ure, P ost -Treat me nt *
8.
S u per vise d Test -Pr o d uct A p plicati o n
9.
S u per vise d S u nscree n A p plicat i on
* Assess me nts t o be ta ke n 4 8 ± 4 ( Visit 5), 7 2 ± 4 ( Visit 6) a n d 1 6 8 ± 4 ( Visit 7) h o urs after 
c o m pleti o n of t he facial peel pr oce d ure
Visit 8 / D a y 2 2 ( 7 D a ys after Visit 7 )
T he f o ll owi n g assess me nts will be c o n d ucte d i n t he or der writte n:
1.
C urre nt / C o nc o mita nt Me dicat i on
2.
A d verse E ve nts
3.
C o nti n ue d S u bject Eli gi bilit y
4.
C o m plia nce ( Di ar y re vie w)
5.
I nstr u me nt al Meas ure me nts P ost-Pr oce d ure, P ost -Treat me nt *
6.
I ma ge ca pt ure ( VI SI A) P ost -Pr oce d ure, P ost -Treat me nt *
7.
S u bject Self -Assess me nt P ost -Pr oce d ure, P ost -Treat me nt *
8.
S u bject Gl o bal Self- Assess me nt
9.
D er m at olo gi st Assess me nt P ost-Pr oce d ure, P ost -Treat me nt *
1 0. D er m at olo gi st Glo bal  Assess ment  of T olera nce
1 1. Pr o d ucts a n d Test Diar y  R et ur n
1 2. Di sc har ge fr o m St u d y
* Assess me nts t o be ta ke n 3 3 6 ± 4 h o urs after c o m pleti o n of t he facial peel pr oce d ure
 
D oc u m e nt N a m e  
 
T y p e  
V ersi o n  
D oc u m e nt I d e ntifi er  
Eff ecti v e D at e  
 
 
 
 
R e as o n F or Iss u e  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
1 5- S e p- 2 0 1 7 0 9: 2 7: 1 5
 
Pr ot o c ol 2 0 6 8 2 7 
d o c
el d o _ c o ntr oll e d
4. 0; M o st- R e c e nt; Eff e cti v e; C U R R E N T
A ut o I s s u e
0 9 0 0 3 2 d 5 8 0 d 9 8 e b 9
Pa ge 3 1 of 9 3
C CI

3 2
3. 2. S u bject Restricti o ns



Lifest yle/ Diet ar y
D uri n g t he e nt ire st u d y (scree ni n g – Last -S u bject, Last -Vi sit (L S L V ));
1.
N ot t o partici pate i n a n y ot her c os met ic or t hera pe utic st u d y
2.
N ot t o a d d a n y ne w c os met ic pr o d uct t o t heir c urre nt pers o nal care re gi me n 
(e. g. s ha m p o o, s h o wer gel, ha n d s oa p) or s wit c h br a n ds of la u n dr y pr o d ucts 
d uri n g t he st u d y
Me dic ati o ns a n d Tre at me nts
O n t he da y  of sit e visit;
1.
N ot t o a p pl y a n y deter ge nts (e. g. s oa ps, s ha m p o os, bat h a n d s ho wer pr o d ucts) 
t o t heir face ot her t ha n t he clea nser pr o vi de d ( Si m ple Ki n d t o S ki n 
M oist urisi n g Facial Was h)
2.
N ot t o a p pl y a n y lea ve-o n c os m et ics (e. g. crea ms, l otio ns, oil y  clea nsi n g 
pr o d ucts , mascara) i ncl u di n g t he test pr o d uct (P h ysi o gel Cal mi n g Relief
R est orin g Li pi d Bal m ) a n d s u nscree n ( S u n ma x Se nsiti ve S P F 5 0) t o t heir face 
or e yelas hes
3.
N ot t o c o ns u me a n y caffei ne
4.
N ot t o s m o ke (i ncl u des ci garettes, s his ha, ci gars)
D uri n g t he e nt ire st u d y (scree ni n g – L S L V) ;
1.
N ot t o a p pl y a n y deter ge nts (e. g. s oa ps, s ham p o os, bat h a n d s h o wer pr o d ucts) 
t o t heir face ot her t ha n t he clea nser pr o vi de d ( Si m ple Ki n d t o S ki n 
M oist urisi n g Facial Was h)
2.
N ot t o use a n y  facial s ki n treat me nt s or c os metic pr o d ucts ot her t ha n t he 
p r o d ucts pr o vi de d f or t his st u d y. S u bjects are per mitted t o wear t heir us ual 
mascara d uri n g t his st u d y
3.
N ot t o use a n y  st u d y pr o hi bite d me dicati on as s pecifie d i n t he e xcl usi o n 
criteria, i ncl u di n g a nti-i nfla m mat or y, a nal gesic or p h ot ose nsitizi n g treat me nts
4.
T o a v oi d di rect e x p os ure t o s u nli g ht b y see ki n g t he s hade a n d t o wear a s u n 
hat a n d s u n glasses w he n o utsi de as far as pract icall y p ossi ble
5.
T o a v oi d u ltra vi olet ( UV) treat me nts a n d ta n ni n g sal o ns
6.
Fe male s u bjects of c hil d - beari n g p ote ntial m ust use effecti ve c o ntrace pti o n
7.
S u bjects m ust n ot c ha n ge a n y h or m o nal tr eat me nt or c o ntrace pti o n t hat t he y 
ma y be recei vi n g a n d m ust ha ve use d t he sa me c o ntrace pti o n f or 3 m o nt hs 
pri or t o scree ni n g
8.
S u bjects m ust n ot u n der g o a n y aest het ic, c os metic or der mat ol o gical treat me nt 
i n t he treat me nt area (face or e yes)
9.
Use of facial s cr u bs, de pilat or y crea ms, wa xi n g, bleac hi n g, 
micr o der ma brasi o n, a n d laser hair re m o val  
 
D oc u m e nt N a m e  
 
T y p e  
V ersi o n  
D oc u m e nt I d e ntifi er  
Eff ecti v e D at e  
 
 
 
 
R e as o n F or Iss u e  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
1 5- S e p- 2 0 1 7 0 9: 2 7: 1 5
 
Pr ot o c ol 2 0 6 8 2 7 
d o c
el d o _ c o ntr oll e d
4. 0; M o st- R e c e nt; Eff e cti v e; C U R R E N T
A ut o I s s u e
0 9 0 0 3 2 d 5 8 0 d 9 8 e b 9
Pa ge 3 2 of 9 3
C CI

3 3
3. 3. T y pe a n d Pl a n ne d N u m ber of S u bjects

A p pr o xi matel y  1 3 0 1 7 8 Heal t h y fe males wit hi n t he a ges of 3 0 a n d 6 0 years 
(incl usi ve) wi t h Fit z p atric k S ki n Classificat i on II -I V a n d m o derate t o a d va nce d 
p h ot o -da ma ge d s ki n will be scree ne d t o ra n d o mize 8 0 1 0 0 s u bjects t o e ns ure 
a p pr o xi matel y 6 0 8 0 s u bjects (3 0 4 0 s u bjects per gr o u p) s uccessf ull y c o m p lete t he 
st u d y. T he sa m ple size is b ase d o n cli nical c o nsi derati o ns a n d literat ure prece de nt 
[ Nar ur kar, Sc hal ka, S uli m ovic, Ki m]. Wit h 3 0 s u bjects per treat me nt gr o u p, a c ha n ge 
fr om baseli ne i n Tra nse pi der mal Water L oss ( T E W L) at least half t he ma g nit u de o f 
t he sta n dar d de viati o n (e. g. ass u me st d = 4 (ref. 
), a n d 2. 1-p oi nt 
mea n c ha n ge fr o m baseli ne) ca n be detecte d at t w o -side d al p ha = 0. 0 5 wit h 8 0 % 
p o wer.
S u bjects will be recr uite d fr o m t he site data base a n d via l ocal a d vert ise me nt.
3. 4. St u d y Desi g n a n d D ose J ustific ati o n
T his st u d y  is a ra n d o mize d, e val uat or-bli n d, si n gle -ce nter a n d t wo- ar m cli nical st u d y 
desi g ne d t o e valuate t he l o c al  t olera nce a n d c os metic efficac y o f a t o pical s ki n care 
f or mulat i on i n healt h y female s u bjects wi t h mo d erate t o a d va nce d p h ot o-da ma ge d 
facial s ki n w h o ha ve u n der g o ne a 7 0 % Gl yc o lic Aci d f a ci al peel pr oce d ure. Gl yc o lic 
acid is selecte d d ue t o its wi des prea d use a n d fa v o ura ble t olera nce pr ofile. [ S hara d] 
T he test pr o d uct ( P h y sio gel Cal mi n g Relief R est ori n g Li pi d Bal m ) is desi g ne d f or 
s u bjects wit h dr y, irritate d s ki n a n d t here is fa v o ura ble l ocal t olera nce cli nical data t o 
s u p p ort its use f or a p plicati on t o se nsit i ve, p ost-pr oce d ure s ki n. I n a d dit i on, t he test 
pr o d uct has bee n mar kete d i n Brazil f or ma n y  years a n d has a fa v o ura ble be nefit -ris k 
pr ofile base d o n p ost -mar keti n g data. T he test pr o d uct will be a p plie d t wice dail y , as 
c o nsiste nt wit h t he mar kete d i nstr ucti o ns f or use. 
A 7 da y  was h o ut p hase is i ncl u de d t o sta n dar dize s u bjects’ s ki n care re gi me ns. 
S u bjects will be pr o vi de d wit h a c o m merciall y a vaila ble facial clea nse r ( Si mple Ki n d 
t o S ki n M oisturi si n g Facial Was h) a n d s u nscree n ( S u n ma x Se nsit i ve S P F 5 0 ) as 
sta n dar d of care. S u bjects will be i nstr ucte d t o use t he facial clea nser d uri n g t he 
m o r ni n g a n d e ve ni n g, a n d t o a p pl y t he s u nscree n i n t he mor ni n g (after cl ea nsi n g) a n d 
at lu nc hti me. S u n ma x Se nsit i ve S P F 5 0 is desi g ne d f or s u bjects wit h se nsiti ve s ki n 
a n d has fa v o ura ble l ocal t olera nce cli nical data t o s u p p ort its use f or a p plicat i on t o 
se nsiti ve, p ost-pr oce d ure s ki n . Si m ple Ki n d t o S ki n M o isturi si n g Facial Was h is als o 
desi g ne d f or s u bjects wit h se nsit i ve s ki n. 
 
D oc u m e nt N a m e  
 
T y p e  
V ersi o n  
D oc u m e nt I d e ntifi er  
Eff ecti v e D at e  
 
 
 
 
R e as o n F or Iss u e  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
1 5- S e p- 2 0 1 7 0 9: 2 7: 1 5
 
Pr ot o c ol 2 0 6 8 2 7 
d o c
el d o _ c o ntr oll e d
4. 0; M o st- R e c e nt; Eff e cti v e; C U R R E N T
A ut o I s s u e
0 9 0 0 3 2 d 5 8 0 d 9 8 e b 9
Pa ge 3 3 of 9 3
C CI
C CI

3 4
Wit hi n t he was h o ut p hase, a st u d y mat erial se nsitivit y test is i ncl u de d t o i de ntif y 
s u bjects w h o ma y be se nsiti ve t o t he st u d y materials i n or der t o deter mi ne w het her 
t he y are s uita ble t o u n der g o t he facial peel pr oce d ure. A q ualifie d der mat ol o gist will 
di s pe nse a t hi n la yer of t he 7 0 % gl yc olic aci d peel s ol uti on t o c o ver a de marcate d 5 x 
5 c m  s q uare area o n t he v o lar s urface of t he f orear m a n d, wit hi n a perio d of  3 0- 6 0 
sec o n ds, will ne utralize t he 7 0 % gl yc olic aci d peel s ol uti on wi t h t he bicar b o nate 
ne utralizi n g a ge nt a n d t he n rinse t he s ki n t h or o u g hl y wit h water a n d pat dr y  wit h a 
s oft t o wel. O nce dr y, t he der mat olo gist will a p pl y a t hi n la yer of t he S u n ma x 
Se nsit i ve S P F 5 0 S u nscree n t o t he 5 x 5 c m s q uare ar ea. Der mat olo gi st a n d s u bject 
self- assess me nts will be use d t o e val uate l ocal t olera nce. If s u bject data f or t he st u d y 
materi al se nsiti vity st u d y c o ntai ns a der mat olo gist or s u bject self -assess me nt sc ore of
“ Se vere” f or a n y attri b ute, t his s u bject will be dee me d t o be i n vi o lati on of e xcl usi o n 
criteria 9 a n d m ust disc har ge d fr o m t he st u d y.
U p o n c o m plet i on of t he was h o ut p hase, s u bjects c o nsi dere d t o be eli gi ble f or t he test 
p hase will be ra n d o mise d t o t w o gr o u ps ( Gr o u p I: Test pr o d uct; Gr o u p 2: N o -
treat me nt) a n d a q ualifie d der mat ol o gist wit h e x perie nce a d mi nisteri n g facial peels  
will c o n d uct t he 7 0 % Gl yc o lic Aci d pr oce d ure.
S u bjects ra n d o mise d t o Gr o u p I will be i nstr ucte d t o a p pl y t he test pr o d uct t wice -
dail y  ( mor ni n g a n d e ve ni n g) after clea nsi n g, f or a t otal of 1 4 c o nsec uti ve da ys. All 
s u bjects will be i nstr ucte d t o c o nti n ue usi n g t he facial clea nser t wice-dail y  d uri n g t he 
m o r ni n g a n d e ve ni n g, a n d t o a p pl y t he s u nscree n i n t he mor ni n g a n d at l unc ht i me. A 
s u m mar y of t he s u bject’s p ost-ra n d o mizati on re gi m e n is i ncl u de d bel o w f or clarit y.
R a n d o mize d 
Gr o u p
M or ni n g
L u nc hti me *
E ve ni n g
Gr o u p 1
1.
Cl ea nsi n g
2.
Test Pr o d uct
3.
S u nscree n
1.
S u nscree n
1.
Cl ea nsi n g
2.
Test Pr o d uct
Gr o u p 2
1.
Cl ea nsi n g
2.
S u nscree n
1.
S u nscree n
1.
Cl ea nsi n g
* L u nc hti me a p plicat i on m ust be at least 3 h o urs aft er pre vi o us s u nscree n a p plicat i on
S u bjects will n ot a p pl y  a n y s u nscree n o n t he da y of t he facial peel pr oce d ure ( Da y 8), 
si nce t he y will re mai n at site u ntil t he e ve ni n g (after 5 p m).  O n t he m o r ni n g of eac h 
visit, pri or t o arri vi n g at t he site, s u bjects will be i nstr ucte d t o clea nse t heir face a n d 
n ot t o a p pl y  a n y test pr o d uct or s u nscree n u ntil after all meas ure me nts a n d 
assess me nts ha ve bee n c o m p lete d. Bef ore lea vi n g t he site, s u bjects will u n der g o
 
D oc u m e nt N a m e  
 
T y p e  
V ersi o n  
D oc u m e nt I d e ntifi er  
Eff ecti v e D at e  
 
 
 
 
R e as o n F or Iss u e  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
1 5- S e p- 2 0 1 7 0 9: 2 7: 1 5
 
Pr ot o c ol 2 0 6 8 2 7 
d o c
el d o _ c o ntr oll e d
4. 0; M o st- R e c e nt; Eff e cti v e; C U R R E N T
A ut o I s s u e
0 9 0 0 3 2 d 5 8 0 d 9 8 e b 9
Pa ge 3 4 of 9 3
C CI

3 5
s u per vise d test pr o d uct a n d/ or s u nscree n a p plicati o n. A fter lea vi n g t he site, s u bjects 
s h o uld a p pl y t he s u nscree n a sec o n d ti me, b ut n o s o o ner t ha n 3 h o urs after t he 
pre vi o us a p plicat i on.
Meas ure me nts of s ki n h y drat i on ( C or ne o meter) a n d tra nse pi der mal water l oss 
( Te wa meter), Der mat ol o gist a n d S u bject self-assess me nts a n d p h ot o gra p hs (i ma ge 
ca pt ure) will be perf or me d t hr o u g h o ut t he st u d y  o n t he sc he d ule d da ys. S u bjects will 
be i nstr ucte d t o c o m plete a diar y e ver y da y t o e nc o ura ge a n d rec or d c o m plia nce. T he 
di ar y will be re vie we d b y t he I n vesti gat or or desi g nee at eac h visit a n d a n y a d ditio n al  
or misse d pr o d uct a p plicat i ons will be rec or de d as de viat i ons. Der m at olo gists a n d 
ot her m e m bers of t he st u d y staff i n v ol ve d i n t he assess me nt of a n y st u d y e n d p oi nts 
will be bli n d t o ra n d o mizati o n. All pract ical eff orts will be ma de t o e ns ure t he sa me 
D er m at olo gi st assesses t he sa me s u bject t hr o u g h o ut t he st u d y.
A c o m pre he nsi ve lit erat ure searc h of c os metic pr oce d ures a n d s ki n care pr o d ucts 
clai mi n g use p ost -c o s metic pr oce d ure was c o n d ucte d t o i nf or m t he de vel o p me nt of 
t his st u d y. T he literat ure searc h was li mite d t o h o me-use t o pi cal pr o d ucts a n d ai me d 
t o ide nt if y all rele va nt cli nical st u dies c o ncer ne d wit h p ost -pr oce d ure c uta ne o us 
t olera bilit y a n d efficac y. S o urces use d i n t he searc h i ncl u de d co m pa n y w e bsites, 
G N P D, e -c o m mer ce sit es, G o o gle Searc h (t o ide ntif y  pr o d ucts), Pr o q uest, P u b me d, 
Sc o p us a n d G o o gle Sc h o lar. T he searc h i de ntifie d a t otal of 3 0 cli nical st u dies
pri maril y c o ncer ne d wit h e val uat i n g t he l ocal t olera nce of c os met ic pr o d ucts f or 
t o pical a p plicat i on f oll owi n g laser peel, p h ot o d y na mic t hera p y a n d c he mical peels. 
I n partic ular, S uli m o vic ( 2 0 0 2) st u die d t he c os metic be nefits pr o vi de d b y t o pical 
a p plicati on of a water treat m e nt ( A ve ne E xtra Ge ntle Clea nser) c o m pare d t o place b o
( Petr ole u m) i n a sa m ple of 7 4 s u bjects w h o u n der we nt C O 2 p ulse d -laser treat me nt. 4 0 
s u bjects were ra n d o mise d t o t he c os metic water gr o u p a n d 2 3 s u bjects t o t he p lace b o. 
S u bjects were e xa mi ne d re g ularl y o ver a t otal p ost -treat me nt peri o d of 8 4 da ys.  
D uri n g t he treat me nt c o urse, t he o verall s e verit y of er yt he ma was less i n t he water 
gr o u p t ha n i n t he c o ntr ol gr o u p, a differe nce s h o w n t o be statist icall y si g nifica nt 
( p< 0. 0 4) fr o m d a y  1 4 u ntil t he e n d of treat me nt, e xce pt at da y 2 8 ( p< 0. 0 7). 
E v ol ut i ons of t he f u ncti o nal s y m pt o ms ( pai n, itc hi n g, sti n gi n g a n d ti g hte ni n g) i n t he 
t wo gr o u ps were all statist icall y si g nifica ntl y i m pr o ve d c o mpare d t o t he p ost -
pr oce d ure baseli ne ( p < 0. 0 5) after 3 -4 wee ks of treat me nt , alt h o u g h i nter -gr o u p 
sig nifica nce was o nl y o bser ve d f or mea n itc hi n g ( D a y 2 8), sti n gi n g ( Da ys 1 4 a n d 2 1) 
a n d ti g hte ni n g ( Da ys 1 2 a n d 2 1). I n vest i gat or-assesse d gl o bal efficac y a n d s u bject
self-assesse d gl o bal t olera nce at t he e n d of t he st u d y was statisticall y si g nifica nt l y i n 
fa v o ur of t he water gr o u p c o m pare d t o place b o ( p< 0. 0 5). T hree trea t me nt -relate d 
 
D oc u m e nt N a m e  
 
T y p e  
V ersi o n  
D oc u m e nt I d e ntifi er  
Eff ecti v e D at e  
 
 
 
 
R e as o n F or Iss u e  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
1 5- S e p- 2 0 1 7 0 9: 2 7: 1 5
 
Pr ot o c ol 2 0 6 8 2 7 
d o c
el d o _ c o ntr oll e d
4. 0; M o st- R e c e nt; Eff e cti v e; C U R R E N T
A ut o I s s u e
0 9 0 0 3 2 d 5 8 0 d 9 8 e b 9
Pa ge 3 5 of 9 3
C CI

3 6
l ocal si de-effects were re p orte d d uri n g t he st u d y. O ne s u bject e x perie nce d a n aller gic 
c o ntact der mat itis of u n deter mi ne d ori gi n a n d was wit h dra w n fr o m t he st u d y at t he 
2 8- d a y  visit. O ne s u bject prese nte d peri-la bial p ust ules a n d was with dra w n at Da y  7. 
A t hi r d s u bject prese nte d clea nser-i m p ute d c o ntact aller g y at t he e n d of st u d y. N o 
s yste mic a d verse effects t hat were c o nsi dere d p ossi ble or pr o ba bl y relate d t o test 
treat me nt were rec or de d f or eit her gr o u p.
Nar ur kar ( 2 0 1 0) c o n d ucte d a 1 4 -wee k o pe n -label st u d y t o e valuate t he efficac y a n d 
safety of  a t o pical c os m etic s ki n care re gi me n f or mi ni mizi n g l ocalize d A d verse 
E ve nts ( A Es ) d uri n g t w o 6 -wee k pr oce d ure c ycles wit h fract i onate d laser or i nte nse 
p ul se d li g ht. T he s ki n care re gi me n c o nsiste d of a 2-wee k pre -pr oce d ure p hase, a 1 -
wee k p ost -pr oce d ure p hase a n d a 3 -wee k mai nte na nce p hase. I n vest i gat ors a n d 
s u bjects rate d t he prese nce a n d se verit y of  er yt he ma, itc hi n g, sti n gi n g/ b ur ni n g, 
e de ma, pai n, pr urit us, s welli n g, cr usts/er osi o ns a n d p h ot o-da ma ge. T w o da y s after 
eac h pr oce d ure, m ost assess me nts were near baseli ne val ues a n d at 4 wee ks all 
i n vesti gat or sc ores were c o m para ble t o baseli ne.  T w o wee ks p ost-pr oce d ure, mea n 
s u bject rati n gs f or m ost e n d p oi nts were ‘ n o ne’ t o ‘ mil d’. F o urtee n s u bjects rep orte d a 
t otal of 1 6 A E’s. Of t hese, 4 s u bjects ( 1 5 %) re p orte d A E’s c o nsi dere d p ossi bl y 
r elate d t o t he n o n-a blat i ve c os metic pr oce d ure or t he test pr o d uct re gi me n. T hese 
A E’s i ncl u de d ac ne a n d facial ras h a n d were mil d i n i nte nsit y.  T w o s u bjects wit hdre w 
fr o m t he st u d y d ue t o a n A E. O ne s u bject ha d a se vere ras h was c o nsi dere d pr o ba bl y 
r elate d t o t he st u d y treat me nt a n d o ne s u bject de vel o pe d s hi n gles, w hic h was 
c o nsi dere d u nrelate d t o treat me nt.
Sc hal ka ( 2 0 1 3) p u blis he d t he res ults of a cli nical st u d y w hic h i n vesti gate d t he 
efficac y a nd safet y  of a n o vel c os met ic s ki n care pr o d uct i n s u bjects w h o u n der we nt a 
5 % reti n o ic aci d facial peel. T his c om parat i ve, o pe n-la bel cli nical st u d y ra n d o mize d 
5 2 s u bjects w h o were di vi de d i nt o t w o gr o u ps, wit h 2 6 s u bjects all o cate d t o eac h 
gr o u p . O ne gr o u p was pr o vi de d with a S u n Pr otecti o n Fact or ( S P F ) 3 0 crea m 
(c o ntr ol) a n d t he ot her gr o u p was pr o vi de d wit h t he test pr o d uct a n d S P F 3 0 c o ntr ol. 
Re g ular cli nical assess me nt a n d bi o p h ysical meas ure me nts w ere c o n d ucte d f or a 
p eri o d of 1 wee k p ost -pr oce d ure. Fift y s u bjects c o m plete d t he st u d y, wit h o ne s u bject 
wi t hdra wi n g f or pers o nal reas o ns a n d t he ot her disc o nti n ue d fr o m t he st u d y d ue t o t he 
occ urre nce of mil d c o ntact der mat itis i n t he test pr o d uct pl us s u nscree n gr o u p. 
Stati sticall y si g nifica nt ( p < 0. 0 5) c os met ic be nefits were o bser ve d f or cli nicall y -
assesse d des q ua mat i on ( D a ys 4 t o 7) a n d i nstr u me ntal C or ne omet er meas ure me nts 
( Da ys 2 t o 4) f or t he treat me nt gr o u p o ver t he c o ntr ol gr o u p. Cr uciall y, t he ma g nit u de 
of  c os met ic assessme nts bet wee n gr o u ps w as n u mericall y lar gest bet wee n da ys 2 a n d 
4, pres u ma bl y beca use t he s ki n ’s nat ural  re pair pr ocesses were c o nti n uall y re d uci n g 
 
D oc u m e nt N a m e  
 
T y p e  
V ersi o n  
D oc u m e nt I d e ntifi er  
Eff ecti v e D at e  
 
 
 
 
R e as o n F or Iss u e  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
1 5- S e p- 2 0 1 7 0 9: 2 7: 1 5
 
Pr ot o c ol 2 0 6 8 2 7 
d o c
el d o _ c o ntr oll e d
4. 0; M o st- R e c e nt; Eff e cti v e; C U R R E N T
A ut o I s s u e
0 9 0 0 3 2 d 5 8 0 d 9 8 e b 9
Pa ge 3 6 of 9 3
C CI

3 7
t he c uta ne o us da ma ge f or b ot h gr o u ps, ma k i n g it more diffic ul t t o meas ure a c os metic 
be nefit o ver ti me.  Bar rier fu nct i on was o bser ve d t o gra d uall y w orse n o ver t he 
d urati o n of  t he st u d y, wit h wea k i n dicati o ns of  im pr o ve m e nt bet wee n da ys 4 a n d 7.  
T here was n o statisticall y si g nifica nt barrier f u nct i o n be nefit bet wee n gr o u ps at a n y 
ti me p oi nt.
Base d o n t his liter at ure re vie w, su bject vi sits ha ve bee n i ncl u de d at 2 4- 7 2 h o urs p ost -
pr oce d ure, w here differe nces bet wee n c o ntr ol a n d test gr o u ps are e x pecte d t o be 
lar gest. W hile it is e x pecte d t he s ki n’s barrier f u ncti on will ret ur n t o n or mal 2 4 t o 4 8 
h o urs f oll owi n g t he pr oce d ure , t he t otal d urati o n of t he test p hase is 1 4 da ys t o e na ble 
s ufficie nt ti me t o m o nit or des q ua mati o n a n d er yt h e ma c o mpare d t o t he p ost -
pr oce d ure , pre-treat me nt baseli ne. 
 
D oc u m e nt N a m e  
 
T y p e  
V ersi o n  
D oc u m e nt I d e ntifi er  
Eff ecti v e D at e  
 
 
 
 
R e as o n F or Iss u e  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
1 5- S e p- 2 0 1 7 0 9: 2 7: 1 5
 
Pr ot o c ol 2 0 6 8 2 7 
d o c
el d o _ c o ntr oll e d
4. 0; M o st- R e c e nt; Eff e cti v e; C U R R E N T
A ut o I s s u e
0 9 0 0 3 2 d 5 8 0 d 9 8 e b 9
Pa ge 3 7 of 9 3
C CI

3 8
4. S E L E C TI O N O F S T U D Y P O P U L A TI O N A N D 
WI T H D R A W A L C RI T E RI A
S pecific i nf or ma tio n re gar di n g war ni n gs, preca uti o ns, c o ntrai n dicati o ns, a d verse 
e ve nts, a n d ot her perti ne nt i nf or mat i on o n t he G S K i n vesti gati onal pr o d uct or ot her 
st u d y tr e at me nt t hat ma y i m pact s u bject eli gi bility is pr o vi de d i n t he Pr o d uct La bel.
De viat i ons fr o m  incl u sio n  a n d e xclusi o n  crit eria are n ot all o we d beca use t he y ca n 
p ote nti all y je o par dize t he scie nt ific i nte grity of  t he st u d y, re g ulat or y acce pta bility or 
s u bject safet y. T heref ore, a d here nce t o t he criteria as s pecifie d i n t he pr ot oc ol is 
esse nt ial.
4. 1. I ncl usi o n Criteri a
A s u bject will be eli gi bl e for i ncl usi o n  in t his st u d y  o nl y if all of t h e fol l owi n g criteria 
a p pl y:

1. C O N S E N T
D e m o nstrates u n dersta n di n g of t he st u d y  pr oce d ures, restricti o ns a n d willi n g ness t o 
parti ci pate as e vi de nce d b y vol u nt ar y  writte n i nf or me d c o nse nt a n d has recei ve d a 
sig ne d a n d date d c o p y  of t he i nf or me d c o nse nt for m .
2. A G E
A ge d bet wee n 3 0 a n d 6 0 years i ncl usi ve .
3. G E N D E R
Fe male.
4. G E N E R A L H E A L T H
G o o d ge neral a n d me ntal healt h wi t h, i n t he o pi ni o n of t he i n vest i gat or or me dicall y 
q ualifie d desi g nee n o cli nicall y si g nifica nt a n d rele va nt a b n or malit ies i n me dical 
hist or y  or u p o n p h y sical e xa mi nati on.
5. C O M P LI A N C E
Willi n g ness t o acti vel y partici pate i n t he st u d y
a n d t o atte n d all sc he d ule d visits.
6. S KI N T Y P E
A)
Fi tz patric k p h ot ot ype II -IV ( A p pe n di x 2 ).
B)
S u bjects wit h Gl o ga u p h ot oa gi n g t y pe II -III ( A p pe n di x 3).
 
D oc u m e nt N a m e  
 
T y p e  
V ersi o n  
D oc u m e nt I d e ntifi er  
Eff ecti v e D at e  
 
 
 
 
R e as o n F or Iss u e  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
1 5- S e p- 2 0 1 7 0 9: 2 7: 1 5
 
Pr ot o c ol 2 0 6 8 2 7 
d o c
el d o _ c o ntr oll e d
4. 0; M o st- R e c e nt; Eff e cti v e; C U R R E N T
A ut o I s s u e
0 9 0 0 3 2 d 5 8 0 d 9 8 e b 9
Pa ge 3 8 of 9 3
C CI

3 9
7. C O N T R A C E P TI O N
Fe males of c hil d beari n g p ot e ntial w h o are, i n t he o pi ni o n of t he i n vesti gat or, 
practi si n g a relia ble met h o d of c o ntrace pti o n.  A de q uate c o ntrace pti o n is defi ne d as 
a bsti ne nce, oral c o ntrace pti ve, eit her c o m bi ne d or pr o gest o ge n al o ne O R i njecta ble 
pr o gest o ge n O R i m pla nts of le v o n or ge strel O R estr o ge nic va gi nal ri n g O R 
perc uta ne o us c o ntrace pti ve patc hes O R i ntra uteri ne de vice or i ntra uteri ne s yste m O R 
d o u bl e barrier met h o d (c o n d o m or occlusi ve ca p [ di a p hra g m or cer vical va ult ca ps] 
pl us s per mici dal a ge nt [f oa m, gel, fil m, crea m, s u p p os itor y ]) O R male part ner 
sterilizati on pri or t o t he fe male s u bject's e ntr y  int o t he st u d y , a n d t his male is t he s ole 
part ner f or t hat s u bject.
4. 2. E xcl usi o n Criteri a
A s u bject will n ot be eli gi ble f or i ncl usi o n i n t his st u d y if a n y of t he f oll owi n g cri t eria 
a p pl y:
1. P R E G N A N C Y
W o me n w h o are k n o w n t o be pre g na nt or w h o are i nte n di n g t o bec o me pre g na nt o ver 
t he d urati o n of t he st u d y.

2. B R E A S T -F E E DI N G
W o me n w h o are breast -fee di n g.
3. C O N C U R R E N T M E DI C A TI O N/ M E DI C A L HI S T O R Y 
A.
Act i ve s ki n disease or o pe n w o u n d i n t he test area.
B.
M e dical hist or y of usi n g a me dicate d ac ne treat me nt (e. g. Be nz o yl Per o xi de, 
Cli n da m yci n, is otreti n o i n) wit hi n t he last 2 4 m o nt hs.
C.
Me dical hist or y  of d ys plastic ne vi or mela n oma.
D.
Pree xist i n g i nfla m mat or y d er mat oses s uc h as ps oriasis, at o pic der matit is
E.
M oles, tatt o os, scars, irritate d s ki n, hairs, etc. at t he test area t hat c o uld, i n t he 
o pi ni o n of t he i n vest i gat or, i nfl ue nce t he i n vesti gati on.
F.
S y ste mic t hera p y wit h im m u n o -s u p pressi ve dr u gs (e. g. c ortic oster oi ds) a n d/ or 
a nt i hista mi nes wit hi n 7 da ys pri or t o scree ni n g a n d/ or t hr o u g h o ut t he e ntire 
c o urse of t he st u d y.
G.
S y ste mic use of o ver -t he- c o u nter ( O T C ) a nal gesics or a nti -i nfla m mat or y 
dr u gs 2 4 h o urs pri or t o scree ni n g.
H.
S y ste mic use of a n y p h ot ose nsit izi n g me dicati on 2 wee ks pri or t o scree ni n g.
I.
I nte nse s u n e x p os ure, U V-treat me nts or ta n ni n g sal o n visit wit hi n t w o wee ks 
pr i or t o scree ni n g.
J.
O ne of t he f o ll owi n g ill nesses t hat mi g ht re q uire re g ular s yste mic me dicat i on: 
I ns uli n-de pe n de nt dia betes, ca ncer .
 
D oc u m e nt N a m e  
 
T y p e  
V ersi o n  
D oc u m e nt I d e ntifi er  
Eff ecti v e D at e  
 
 
 
 
R e as o n F or Iss u e  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
1 5- S e p- 2 0 1 7 0 9: 2 7: 1 5
 
Pr ot o c ol 2 0 6 8 2 7 
d o c
el d o _ c o ntr oll e d
4. 0; M o st- R e c e nt; Eff e cti v e; C U R R E N T
A ut o I s s u e
0 9 0 0 3 2 d 5 8 0 d 9 8 e b 9
Pa ge 3 9 of 9 3
C CI

4 0
K.
O ne of t he f o ll owi n g ill nesses if n ot me dicate d: Ast h ma, h y perte nsi o n
L.
Me dical hist or y  of a b n or mal res p o nse t o s u nli g ht.
M.
S u b jects wit h a hist or y of me nt al ill ness.
N.
Oc ul ar s ur ger y wit hi n t he last 1 2 m o nt hs.
O.
Oc ul ar tra u ma, i nfect i on or i nfla m mat i on wi t hi n t he last 3 mo nt hs.
P.
Act i ve b le p haritis, c o nj u ncti vitis, u veitis.
Q.
A n y oc ul ar pat h olo g y  re q uirin g t o pi cal oc ular treat me nt wit hi n t he last 1
m o nt h.
R.
O c ular laser wit hi n t he last 3 mo nt hs.
S.
Aest het ic, c os metic or der mat ol o gical treat me nt i n t he treat me nt area (face), 
i ncl u di n g t he use of s ki n t o ne li g ht ni n g pr o d ucts, wit hi n t he last 3 m o nt hs. 
T.
Use of facial scr u bs, de pilat or y crea ms, wa xi n g a n d/ or bleac hi n g wi t hi n t he 
last 2 wee ks pri or t o scree ni n g.
U.
M icr o der ma brasio n  a n d/ or laser hair re mo val  wit hi n t he last 4 wee k s pri or t o 
scree ni n g.
V.
Me dical hist or y  of Her pes Si m ple x ( C old S ores).
4. A L L E R G Y/ I N T O L E R A N C E
A.
K n o w n or s us pecte d i nt olera nce or h y perse nsi tivi t y t o t he st u d y mat erials ( or 
clos el y  relate d c o mp o u n ds) or a n y  of t heir state d i n gre die nts.
B.
D oc u m e nte d aller gies t o c os met ic pr o d ucts or st u d y i n gre die nts.
5. C LI NI C A L S T U D Y/ E X P E R IM E N T A L P R O D U C T
A.
P arti cip ati o n i n a n ot her cli n ical st u d y (i ncl u di n g c os metic st u dies) or recei pt 
of  a n i n vesti gati onal dr u g wi t hi n 3 0 da ys of t he scree ni n g visit.
B.
Pre vi o us partici pat i on i n t his st u d y.
6. S U B S T A N C E A B U S E
Rece nt hist or y  ( wit hi n t he last 5 years) of alc o h ol or ot her s u bsta nce a b use.
 
D oc u m e nt N a m e  
 
T y p e  
V ersi o n  
D oc u m e nt I d e ntifi er  
Eff ecti v e D at e  
 
 
 
 
R e as o n F or Iss u e  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
1 5- S e p- 2 0 1 7 0 9: 2 7: 1 5
 
Pr ot o c ol 2 0 6 8 2 7 
d o c
el d o _ c o ntr oll e d
4. 0; M o st- R e c e nt; Eff e cti v e; C U R R E N T
A ut o I s s u e
0 9 0 0 3 2 d 5 8 0 d 9 8 e b 9
Pa ge 4 0 of 9 3
C CI

4 1
7. P E R S O N N E L
A n e m pl o yee of t he s p o ns or or t he st u d y  sit e or me m bers of t heir i m me diate fa mil y.
8. LI F E S T Y L E
A.
Re q ui re d t o w or k o utside d uri n g da yli g ht h o urs o ver t he d urat i on of t he st u d y .
B.
Re q ui re d or ot her wise i nte n di n g t o s pe n d pr ol o n ge d peri o ds of ti me o utsi de 
d uri n g da yli g ht h o urs o ver t he d urati o n of t he st u d y (e. g. h o li da y, s u n bat hi n g, 
a n d gar de ni n g ).
9. S T U D Y M A T E RI A L S E N SI TI VI T Y T E S T
A sc ore of “ Se vere” f or a n y  Der mat olo gi st or S u bject Self-Assesse d e n d p o i nt at a n y 
ti me f or t he st u d y material se nsitivit y test. 
4. 3. Scree ni n g/ B aseli ne F ail ures
Scree n fail ures are defi ne d as s u bjects w h o c o nse nt t o partici pate i n t he st u d y  b ut are 
n e ver s u bse q ue nt l y ra n d omize d.  I n or der t o e ns ure tra ns pare nt re p orti n g of scree n 
fail ure s u bjects, a mi ni mal set of scree n fail ure i nf or mati o n is re q uire d i ncl u di n g 
D e m o gra p h y , Scree n Fail ure details, Eli gi bility Criteri a, a n d a n y S erio us A d verse 
E ve nts (S A Es) . Re-scree ni n g of s u bjects will n ot be all o we d i n t his st u d y.
4. 4. Wit h dr a w al/ St o p pi n g Criteri a
A s u bject m a y wit hdra w fr o m  t he st u d y at a n y time at his/ her o w n re q uest, o r ma y b e 
wi t hdra w n at a n y  ti me at t he discretio n of  t he i n vestigat or f or safet y,  be ha vi o ural or 
a d mi nistrati ve reas o ns.
If t he reas o n f or re m o val of a s u bject fr o m t he st u d y is a n A E or a n a b n or mal 
la b orat or y test res ult, t he pri nci pal s pecific e ve nt or test will be rec or d e d o n t he 
ele ctr o nic Case R e p ort F or m  (eC R F).  If a s u bject is wit h dra w n fr o m t he st u d y  
beca use of a pr o d uct li mit i n g A E, t h or o u g h eff orts s h o ul d be clearl y ma de t o 
d oc u m e nt t he o utc o me. A n y A Es o n g oi n g at t he fi nal visit will be f oll o we d u p u nt il 
res ol ve d, t he c o n diti on sta bilizes, is ot her wise e x plai ne d, or t he s u bject is l ost t o 
f oll ow- u p.
T he f o ll owi n g acti o ns m ust be ta ke n i n relati o n t o a s u bject w h o fails t o atte n d t he 
cli nic f or a re q uire d st u d y visit:

T he site m ust atte m pt t o c o nt act t he s u bject a n d re -sc he d ule t he misse d visit as 
s o o n as p ossi ble. 
 
D oc u m e nt N a m e  
 
T y p e  
V ersi o n  
D oc u m e nt I d e ntifi er  
Eff ecti v e D at e  
 
 
 
 
R e as o n F or Iss u e  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
1 5- S e p- 2 0 1 7 0 9: 2 7: 1 5
 
Pr ot o c ol 2 0 6 8 2 7 
d o c
el d o _ c o ntr oll e d
4. 0; M o st- R e c e nt; Eff e cti v e; C U R R E N T
A ut o I s s u e
0 9 0 0 3 2 d 5 8 0 d 9 8 e b 9
Pa ge 4 1 of 9 3
C CI

4 2

T he site m ust c o u nsel t he s u bject o n t he i m p orta nce of mai ntai ni n g t he 
assi g ne d visit sc he d ule a n d ascertai n w het her or n ot t he s u bject wis hes t o 
a n d/ or s h o uld c o nti n ue i n t he st u d y . 

I n cases w here t he s u bject is dee me d ‘l ost t o f oll ow u p’, t he i n vesti gat or or 
desi g nee m ust ma ke e ver y eff ort t o re gai n c o ntact wit h t h e s u bject ( w here 
p ossi ble, at least 2 tele p h o ne calls). T he c o ntact atte m pt s h o ul d be 
d oc u m e nte d i n t he s u bject’s rec or d . 

S h o ul d t he s u bject c o nti n ue t o be u nreac ha ble, o nl y  t he n will he/s he be 
c o nsi dere d t o ha ve wit h dra w n fr o m t he st u d y wit h a pri mar y reas o n of “ L ost 
t o F oll o w-u p”.
4. 5. S u bject Re pl ace me nt
S u bjec ts w h o wit h dra w fr o m t he st u d y p ost-ra n d o mizati on will n ot be re place d.
4. 6. S u bject a n d St u d y C o m pleti o n
A c o m p lete d s u bject is o ne w h o has c om p lete d all p hases of t he st u d y.
T he e n d o f t he st u d y is defi ne d as t he date of t he last s u bject’s last visit.
 
D oc u m e nt N a m e  
 
T y p e  
V ersi o n  
D oc u m e nt I d e ntifi er  
Eff ecti v e D at e  
 
 
 
 
R e as o n F or Iss u e  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
1 5- S e p- 2 0 1 7 0 9: 2 7: 1 5
 
Pr ot o c ol 2 0 6 8 2 7 
d o c
el d o _ c o ntr oll e d
4. 0; M o st- R e c e nt; Eff e cti v e; C U R R E N T
A ut o I s s u e
0 9 0 0 3 2 d 5 8 0 d 9 8 e b 9
Pa ge 4 2 of 9 3
C CI

4 3
5 . P R O D U C T I N F O R M A TI O N
5 . 1. St u d y Pr o d uct
T he f o ll owi n g st u d y  pr o d ucts will be s u p plie d b y t he Cli nical S u p plies De part me nt, 
G S K C H:
Refere nce / 
W as h o ut Cle a nser
Test Pr o d uct
Refere nce / 
W as h o ut
S u nscree n
Pr o d uct N a me 
Si m pl
Ki n d t o S ki n 
M oist uri si n g Facial 
Was h
P h ysi o gel Cal mi n g 
Relief Rest ori n g Li pi d 
Bal m 
S u n ma x Se nsiti ve S P F 
5 0
Pr o d uc t 
F or m ul ati o n 
C o de
N/ A  
( C o m mercial, U K)
A p plic ati o n 
Q u a ntit y
A p pr o xi matel y 0. 6 -1 g
R o ute of 
A p plic ati o n
T o pical
A p plic ati o n 
I nstr ucti o ns
I n yo ur ha n ds, w or k 
a s mall a mo u nt i nt o 
a lat her. Massa ge 
o nt o wet s ki n, ri nse 
wi t h water. 
A v o i d c o ntact wit h 
e yes. If c o ntact 
occ urs, ri nse 
t hor o u g hl y wit h 
water.
A p pl y t wice a da y  
( mor ni n g a n d 
e ve ni n g)  
Di s pe nse a pea-size d 
q ua nt ity o nt o t he 
fi n gerti ps a n d a p pl y 
t o t he f ull face.
A v o i d c o ntact wit h 
e yes. If c o ntact 
occ urs ri nse 
t hor o u g hl y wit h
water.
A p pl y t wice a da y  
( mor ni n g a n d 
e ve ni n g)
D o n ot a p pl y i n t he 
m o r ni n g if yo u are 
visit i n g t he site o n 
t he sa me da y.
Di s pe nse a pea-size d 
q ua nt ity o nt o t he 
fi n gerti ps a n d a p pl y 
t o t he f ull face.
A v o i d c o ntact wit h 
e yes. If c o ntact 
occ urs ri nse 
t hor o u g hl y wit h 
water.
A p pl y t wice a da y  
( mor ni n g a n d 
l u nc hti me) 
D o n ot a p pl y i n t he 
m o r ni n g if yo u are 
visit i n g t he site o n 
t he sa me da y. 
 
D oc u m e nt N a m e  
 
T y p e  
V ersi o n  
D oc u m e nt I d e ntifi er  
Eff ecti v e D at e  
 
 
 
 
R e as o n F or Iss u e  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
1 5- S e p- 2 0 1 7 0 9: 2 7: 1 5
 
Pr ot o c ol 2 0 6 8 2 7 
d o c
el d o _ c o ntr oll e d
4. 0; M o st- R e c e nt; Eff e cti v e; C U R R E N T
A ut o I s s u e
0 9 0 0 3 2 d 5 8 0 d 9 8 e b 9
Pa ge 4 3 of 9 3
C CI
C CI
C CI
C CI

4 4
Ot her ite ms t o be s u p plie d b y t he Cli nical S u p plies De part me nt, G S K C H:
N a me of Ite m
P ur p ose
N ot A p plica ble
N ot A p plica ble
Ot her ite ms t o be s u p plie d b y t he Si t e:
N a me of Ite m
P ur p ose
7 0 % Gl yc o lic Aci d Treat me nt - S M 
E m pre n di me nt os Far m acê ut ic os ( Fa gr o n) 
fr om Ma gis P har m a
Gl yc o lic aci d s ol uti on wi t h w hic h t o 
e xec ute t he facial peel pr oce d ure
S o di u m  Bicar b o nate Ne utralizi n g 
S ol uti o n - La bs y nt h Pr o d ut os para 
La b orat óri os ( S y nt h) fr o m Ma gis P har ma
Ne utralizi n g a ge nt use d i n t he fi nal ste p 
of  t he facial peel pr oce d ure
5 . 2. A p plic ati o n Sc he d ule
A 7 da y  was h o ut p hase is i ncl u de d t o sta n dar dize s u bjects’ s ki n care re gi me ns. 
S u bjects will be pr o vi de d wit h a c o m merciall y a vaila ble facial clea nser ( Si m ple Ki n d 
t o S ki n M oisturi si n g Facial Was h) a n d s u nscree n ( S u n ma x Se nsit i ve S P F 5 0) as 
sta n dar d of care. S u bjects will be i nstr ucte d t o use t he facial clea nser d uri n g t he 
m o r ni n g a n d e ve ni n g, a n d t o a p pl y t he s u nscree n i n t he mor ni n g (after cl ea nsi n g) a n d 
at lu nc hti me. S u n ma x Se nsit i ve S P F 5 0 is desi g ne d f or s u bjects wit h se nsiti ve s ki n 
a n d has fa v o ura ble l ocal t olera nce cli nical data t o s u p p ort its use f or a p plicat i on t o 
se nsiti ve, p ost -pr oce d ure s ki n. Si m ple Ki n d t o S ki n M o isturi si n g Facial Was h is als o 
desi g ne d f or s u bjects wit h se nsit i ve s ki n. 
Wit hi n t he was h o ut p hase, a st u d y mat erial se nsitivit y test is i ncl u de d t o i de ntif y 
s u bjects w h o ma y be se nsiti ve t o t he st u d y materia ls i n or der t o deter mi ne w het her 
t he y are s uita ble t o u n der g o t he facial peel pr oce d ure. A q ualifie d der mat ol o gist will 
di s pe nse a t hi n la yer of t he 7 0 % gl yc olic aci d peel s ol uti on t o c o ver a de marcate d 5 x 
5 c m  s q uare area o n t he v o lar s urface of t he f orear m a n d, wit hi n a perio d of  3 0- 6 0 
sec o n ds, will ne utralize t he 7 0 % gl yc o lic aci d peel s ol uti on wi t h t he bicar b o nate 
ne utralizi n g a ge nt a n d t he n ri nse t he s ki n t h or o u g hl y wit h water a n d pat dr y  wit h a 
s oft t o wel. O nce dr y, t he der mat olo gist will a p pl y a t hi n la yer of t he S u n ma x 
Se nsit i ve S P F 5 0 su nscree n t o t he 5 x 5 c m s q uare area. Der mat ol o gist a n d s u bject 
self- assess me nts will be use d t o e val uate l ocal t olera nce. If s u bject data f or t he st u d y 
materi al se nsiti vity st u d y c o ntai ns a der mat olo gist or s u bject s elf-assess me nt sc ore of
“ Se vere” f or a n y attri b ute, t his s u bject will be dee me d t o be i n vi o lati on of e xcl usi o n 
cr iteria 9 a n d m ust be disc har ge d fr om t he st u d y.
 
D oc u m e nt N a m e  
 
T y p e  
V ersi o n  
D oc u m e nt I d e ntifi er  
Eff ecti v e D at e  
 
 
 
 
R e as o n F or Iss u e  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
1 5- S e p- 2 0 1 7 0 9: 2 7: 1 5
 
Pr ot o c ol 2 0 6 8 2 7 
d o c
el d o _ c o ntr oll e d
4. 0; M o st- R e c e nt; Eff e cti v e; C U R R E N T
A ut o I s s u e
0 9 0 0 3 2 d 5 8 0 d 9 8 e b 9
Pa ge 4 4 of 9 3
C CI

4 5
U p o n c o m plet i on of t he was h o ut p hase, s u bjects c o nsi dere d t o be eli gi ble f or t he test 
p hase w ill be ra n d o mise d t o t w o gr o u ps ( Gr o u p I: Test pr o d uct; Gr o u p 2: N o -
treat me nt) a n d a q ualifie d der mat ol o gist wit h e x perie nce a d mi nisteri n g facial peels  
will c o n d uct t he 7 0 % Gl yc o lic Aci d pr oce d ure.
S u bjects ra n d o mise d t o Gr o u p I will be i nstr ucte d t o a p p l y t he test pr o d uct t wice-
dail y  ( mor ni n g a n d e ve ni n g) after clea nsi n g, f or a t otal of 1 4 c o nsec ut i ve da ys. All 
s u bjects will be i nstr ucte d t o c o nti n ue usi n g t he facial clea nser t wice-dail y  d uri n g t he 
m o r ni n g a n d e ve ni n g, a n d t o a p pl y t he s u nscree n i n t he mor ni n g a n d at l unc ht i me. A 
s u m mar y of t he s u bject’s p ost-ra n d o mizati on re gi me n is i ncl u de d bel o w f or clarit y.  
R a n d o mize d 
Gr o u p
M or ni n g
L u nc hti me *
E ve ni n g
Gr o u p 1
1.
Cl ea nsi n g
2.
Test Pr o d uct
3.
S u nscree n
2.
S u nscree n
1.
Cl ea nsi n g
2.
Test Pr o d uct
Gr o u p 2
1.
Cl ea nsi n g
2.
S u nscr ee n
2.
S u nscree n
2.
Cl ea nsi n g
* L u nc hti me a p plicat i on m ust be at least 3 h o urs after pre vi o us s u nscree n a p plicat i on
S u bjects will n ot a p pl y  a n y s u nscree n o n t he da y of t he facial peel pr oce d ure ( Da y 8), 
si nce t he y will re mai n at site u ntil t he e ve ni n g (after 5 p m).  O n t he mor ni n g o f eac h 
visit, pri or t o arri vi n g at t he test site, s u bjects will be i nstr ucte d t o clea nse t heir face 
a n d n ot t o a p pl y a n y test pr o d uct or s u nscree n u ntil after all meas ure me nts a n d 
assess me nts ha ve bee n c o m p lete d. Bef ore lea vi n g t he si te, s u bjects will u n der g o test 
pr o d uct a n d/ or s u nscree n a p plicat i on u n der s u per visi o n . After lea vi n g t he site, 
s u bjects s h o ul d a p pl y t he s u nscree n a sec o n d ti me, b ut n o s o o ner t ha n 3 h o urs after 
t he pre vi o us a p plicati o n.
5. 3 . A p plic ati o n M o dific ati o n
N o m o dificat i on of  pr o d uct a p plicati on is per mitte d i n t his st u d y.
5 . 4. Pr o d uct C o m pli a nce
A dail y  d air y will be use d t o m o nit or a n d pr o m ot e c o mplia nce. S u bjects will n ot be 
e xcl u de d d ue t o misse d a p plicati o ns, b ut will be re mi n de d t o use t he pr o d ucts as per 
t he i nstr uctio ns pr o vi de d a n d t o c o m plete t he di ar y car d o n a dail y basis t o e nc o ura ge 
co m plia nce. Misse d or a d di tio n al  pr o d uct a p plicati o ns will be rec or de d b y t he 
 
D oc u m e nt N a m e  
 
T y p e  
V ersi o n  
D oc u m e nt I d e ntifi er  
Eff ecti v e D at e  
 
 
 
 
R e as o n F or Iss u e  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
1 5- S e p- 2 0 1 7 0 9: 2 7: 1 5
 
Pr ot o c ol 2 0 6 8 2 7 
d o c
el d o _ c o ntr oll e d
4. 0; M o st- R e c e nt; Eff e cti v e; C U R R E N T
A ut o I s s u e
0 9 0 0 3 2 d 5 8 0 d 9 8 e b 9
Pa ge 4 5 of 9 3
C CI

4 6
I n vesti gat or or desi g nee as de viati ons. S u bjects will be as ke d t o bri n g t heir was h o ut 
a n d test pr o d ucts t o eac h site visit .
T o be c o nsi dere d c o m p lia nt a n d part of t he per-pr ot oc o l ( P P) p o p ulat i on, a s u bject 
m ust ha ve use d t he test pr o d uct a n d/ or s u nscree n at least 8 0 % of t he i nstr ucte d 
n u m ber of a p plicati o ns f o ll owi n g c o m plet i on of t he facial peel pr oce d ure.
5. 5. Prec a uti o ns
N o s pecial preca ut i ons are re q uire d pr o vi di n g t he st u d y  is carrie d o ut i n acc or da nce 
wi t h t his pr ot oc ol.
5. 6. O ver d ose
A n o ver d ose is a deli berate or i na d verte nt a d mi nistrati o n of a pr o d uct at a d ose hi g her 
t ha n s pecifie d i n t he pr ot oc ol.
O ver d ose is n ot li kel y t o occ ur i n t h is st u d y.  Li mit ed q ua nt ities of t he pr o d uct will be 
s u p plie d, a n d cl osel y mo ni t or e d b y t he sit e for eac h s u bject.
O ver d ose per se is n ot a n A E.  H o we ver, a n y  cli nical se q uelae of a n o ver d ose s h o ul d 
be re p orte d as a n A E (a n d seri o us a d verse e ve nt ( S A E), i f a p pr o priate).  F or 
re p orti n g, f oll ow t he A E a n d S A E re p orti n g i nstr ucti o ns.
5. 7. Resc ue T her a p y
N o resc ue t hera p y  is re q uire d i n t his st u d y.
5. 8. Pr o d uct Assi g n me nt
S u bjects will be assi g ne d t o st u d y  pr o d uct i n acc or da nce wit h t he ra n d o mizati on 
sc he d ule ge nerate d b y t he Biost ati stics De part me nt, G S K C H, prior t o t he start of t he 
st u d y, usi n g vali date d i nter nal s oft ware.
5. 8 . 1 R a n d o miz ati o n
A u ni q ue sc ree ni n g n u m ber will i de ntif y eac h s u bject scree ne d f or st u d y 
p artici pat i on.  Scree ni n g n u m bers will be assi g ne d i n asce n di n g n u merical or der as 
eac h s u bject si g ns t heir c o nse nt f or m.  S u bjects w h o meet all i ncl usi o n a n d e xcl usi o n 
criteria will be ra n do m ized acc or di n g t o t he ra n d o miz at i on sc he d ule.  Ra n d o mizat i on 
n u m bers will be assi g ne d i n asce n di n g n u merical or der as eac h s u bject is deter mi ne d 
t o be f ull y eli gi ble.
 
D oc u m e nt N a m e  
 
T y p e  
V ersi o n  
D oc u m e nt I d e ntifi er  
Eff ecti v e D at e  
 
 
 
 
R e as o n F or Iss u e  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
1 5- S e p- 2 0 1 7 0 9: 2 7: 1 5
 
Pr ot o c ol 2 0 6 8 2 7 
d o c
el d o _ c o ntr oll e d
4. 0; M o st- R e c e nt; Eff e cti v e; C U R R E N T
A ut o I s s u e
0 9 0 0 3 2 d 5 8 0 d 9 8 e b 9
Pa ge 4 6 of 9 3
C CI

4 7
5. 8 . 2 Bli n di n g
T his is a n e val uat or -bli n d cli nical st u d y. T heref ore, all pers o n nel  a n d eval uat ors w h o 
ma y i nfl ue nce st u d y  o ut c o mes are bli n de d t o t he pr o d uct all ocati o n of s u bjects a n d 
t heir diaries. T he I n vest i gat or or t heir desi g nees w h o are n ot i n v ol ve d i n pr oce d ures 
or pr ocesses w hic h ma y i nfl ue nce st u d y  o ut c o mes are n ot re q uire d t o be bli n de d t o 
t he pr o d uct all ocat i on of s u bjects a n d will ha ve visi bilit y of  t he s u bject diar y.
5. 8 . 3 C o de Bre a ks
T he bli n d m ust o nl y be br o ke n i n a n e mer ge nc y w here it is esse nt ial t o k n o w w hic h 
pr o d uct a s u bject recei ve d i n or der t o gi ve t he a p pr o priate me dical care.  W here ver 
p ossi ble t he I n vest i gat or ( or desi g nee) m ust c o ntact t he S p o ns or pri or t o brea ki n g t he 
bli n d.  T he i n vest i gat or m ust d oc u me nt t he reas o n f or brea ki n g t he c o de a n d si g n a n d 
date t he a p pr o priate d oc u me nt.
T he st u d y  bli n d must be ret ur ne d t o G S K C H at t he e n d of t he st u d y .
5. 9. P ac k a gi n g a n d L a belli n g
T he Was h o ut/ Refere nce pr o d ucts ( Si m ple Ki n d t o S ki n M o isturi si n g Facial Was h 
a n d S u n ma x Se nsit i ve S P F 5 0) a n d Test Pr o d uct (P h ysi o gel Cal mi n g Relief R est orin g 
Li pi d Bal m ) will be o ver-wra p pe d i n o pa q ue vi n yl a n d a n y bra n di n g o n t he 
c o m mercial pr o d ucts will be o bsc ure d. 
A ne w la bel will be create d b y t he Cli nical S u p plies De part me nt, G S K C H a n d 
a p plie d t o eac h pr o d uct. T he c o nte nts of t he la bel will be i n acc or da nce wit h all 
a p plica ble re g ulat or y r e q uire me nts a n d will be t he res p o nsi bility of t he Cli nical 
S u p plies De part me nt , G S K C H. Eac h st u d y la b el will c o ntai n, b ut n ot be li mite d t o, 
pr ot oc ol  n u m ber, pr o d uct c o de letter f or Test Pr o d uct o nl y a n d directi ons f or st ora ge.
Care s h o ul d be ta ke n wit h t he s u p plie d pr o d ucts a n d t heir la bels s o t hat t he y  are 
mai ntai ne d i n g o o d c o n diti o n.  It is i m p orta nt t hat all la bels re mai n i ntact a n d le gi ble 
f or t he d uratio n of  t he st u d y. S u bjects s h o uld be i nstr ucte d t o n o t re mo ve or deface 
a n y part of t he st u d y la bel.
5 . 9. 1. Acc o u nt a bilit y of Pr o d uct
All pr o d ucts s u p plie d are f or use o nl y i n t his cli nical st u d y  a n d s h o uld n ot be use d f or 
a n y ot her p ur p ose.
T he i n vest i gat or or desi g nee will mai ntai n a f ull rec or d of st u d y  pr o d uct 
acc o u nta bilit y. A Pr o d uct Dis pe nsi n g L o g m ust be ke pt c urre nt a n d will c o ntai n t he 
f oll owi n g i nf or mat i on:
 
D oc u m e nt N a m e  
 
T y p e  
V ersi o n  
D oc u m e nt I d e ntifi er  
Eff ecti v e D at e  
 
 
 
 
R e as o n F or Iss u e  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
1 5- S e p- 2 0 1 7 0 9: 2 7: 1 5
 
Pr ot o c ol 2 0 6 8 2 7 
d o c
el d o _ c o ntr oll e d
4. 0; M o st- R e c e nt; Eff e cti v e; C U R R E N T
A ut o I s s u e
0 9 0 0 3 2 d 5 8 0 d 9 8 e b 9
Pa ge 4 7 of 9 3
C CI

4 8
1.
T he i de nt ificati on of t he s u bject t o w h o m t he st u d y pr o d uct was dis pe nse d.
2.
T he date(s) a n d q ua ntit y of  t he st u d y pr o d uct dis pe nse d t o t he s u bject.
3.
T he date(s) a n d q ua ntit y of  t he st u d y pr o d uct ret ur ne d b y t he s u bject (if 
a p plica ble).
T he i n ve nt or y  must be a vaila ble f or i ns pect i on b y t he st u d y  mo ni t or d uri n g t he st u d y. 
At  t he e n d of t he st u dy,  st u d y pr o d uct s u p plies will be verifie d b y t he m o nit or.  St u d y 
pr o d uct s u p plies will t he n be eit her c ollecte d b y  t he st u d y mo ni t or or ret ur ne d b y t he 
i n vesti gat or or desi g nee t o t he G S K C H Cli nical S u p plies De partme nt  or desi g nate d 
ve n d or.
5. 9. 2. St or a g e of Pr o d uct
St u d y  pr o d uct s u p plies m ust be st ore d i n c o m plia nce wit h t he la bel re q uire me nts i n a 
sec ure pla c e wit h li mite d or c o ntr olle d access.
 
D oc u m e nt N a m e  
 
T y p e  
V ersi o n  
D oc u m e nt I d e ntifi er  
Eff ecti v e D at e  
 
 
 
 
R e as o n F or Iss u e  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
1 5- S e p- 2 0 1 7 0 9: 2 7: 1 5
 
Pr ot o c ol 2 0 6 8 2 7 
d o c
el d o _ c o ntr oll e d
4. 0; M o st- R e c e nt; Eff e cti v e; C U R R E N T
A ut o I s s u e
0 9 0 0 3 2 d 5 8 0 d 9 8 e b 9
Pa ge 4 8 of 9 3
C CI

4 9
6 . S T U D Y A S S E S S M E N T S A N D P R O C E D U R E S
T his sect i on lists t he pr oce d ures a n d para meters of eac h pla n ne d st u d y assess me nt.  
T he e xact ti mi n g of eac h assess me nt at  eac h sc he d ule d visit is liste d i n t he Sc he d ule 
of E ve nts secti o n.
A d here nce t o t he st u d y  desi g n re q uire me nts, i ncl u di n g all assess me nts a n d 
pr oce d ures are esse ntial a n d re q uire d f or st u d y  c o n d uct.
6 . 1. Visit 1 – Scree ni n g / W as h o ut Visit
6 . 1.1 . I nf or me d C o nse nt
T he i n vest i gat or, or desi g nee, m ust o btai n writte n (si g ne d a n d date d b y t he s u bject) 
i nf or me d c o nse nt fr o m eac h s u bject participati n g i n t his st u d y  after a de q uate 
e x pla nat i on of t he ai ms, met h o ds, o bjecti ves, a n d p ote ntial hazar ds of t he st u d y.
T he i n vest i gat or, or desi g nee, m ust als o e x plai n t o t he s u bjects t hat t he y are 
c o mpletel y free t o ref use t o e nter t he st u d y  or t o wit hdra w fr o m  it at a n y ti me.  
A p pr o priate f or ms f or d oc u me nt i n g a writte n c o nse nt will be pr o vi de d b y t he 
i n vestigat or or b y  G S K C H.  T he i n vesti gat or, or desi g nee, s h o ul d si g n a n d date t he 
c o nse nt f or m t o c o nfir m t hat t he c o nse nt pr ocess was c o m plete d c orrectl y .  T he 
s u bject will be pr o vi de d wi t h a c o p y of t heir si g ne d a n d date d i nf or me d c o nse nt f or m
(I C F) a n d a n y ot her writte n i nf or mati o n w hic h t he y s h o ul d be i nstr ucte d t o retai n.
A list of t he c he mical e ntities prese nt i n all f or m ulati o ns will be pr o vi de d t o s u bjects 
s o t hat t he y ma y e val uate t he list f or a n y k n o w n se nsiti vity or i nt ol era nce t o t he st u d y 
materi als. It will be ma de clear o n t he I C F t hat s u bjects w h o ha ve a k n o w n se nsiti vity 
or i nt ol era nce t o t he st u d y materials s h o uld n ot pr o vi de t heir c o nse nt t o c o nti n ue.
If, d uri n g a s u bject’s partici pati on i n t he st u d y, a n y ne w i nf or mati o n bec ome s 
a vaila ble t hat ma y affect t he s u bject’s willi n g ness t o partici pate i n t he st u d y , eac h 
o n g oi n g s u bject s h o ul d recei ve a c o p y  of t his ne w i nf or mat i on a n d be re -c o nse nte d 
i nto t he st u d y . S u bjects s h o uld be pr o vi de d wi t h a c o p y of t he si g ne d a n d date d 
a me n de d c o nse nt f or m. T he date of c o nse nt will be rec or de d o n t he e C R F.
P h ot o gra p hs (I ma ge Ca pt ure – VI SI A) are t o be ca pt ure d f or b ot h cli nical assess me nt 
a n d p ot e nti al c o m mercial e x ploi t atio n . Su bjects will be re q ueste d t o pr o vi de t heir 
c o nse nt o n t he I C F. S u bjects w h o d o n ot pr o vi de c o nse nt f or t he p ote ntial c o m mercial 
e x pl o itat i on of t heir p h ot o gra p hic data will st ill be c o nsi dere d eli gi ble f or t he st u d y. 
All s u bjects will ha ve t heir p h ot o gra p hs ta ke n at t he sc he d ule d ti me p oi nts t o e na ble 
 
D oc u m e nt N a m e  
 
T y p e  
V ersi o n  
D oc u m e nt I d e ntifi er  
Eff ecti v e D at e  
 
 
 
 
R e as o n F or Iss u e  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
1 5- S e p- 2 0 1 7 0 9: 2 7: 1 5
 
Pr ot o c ol 2 0 6 8 2 7 
d o c
el d o _ c o ntr oll e d
4. 0; M o st- R e c e nt; Eff e cti v e; C U R R E N T
A ut o I s s u e
0 9 0 0 3 2 d 5 8 0 d 9 8 e b 9
Pa ge 4 9 of 9 3
C CI

5 0
t he E valuat or t o m a ke a n acc urate assess me nt of gl o bal t olera nce a n d c os metic 
efficac y. 
6. 1. 2 . De m o gr a p hics
T he f o ll owi n g de m o gra p hic para meters will be ca pt ure d b y  t he I n vestigat or or 
desi g nee a n d rec or de d o n t he e C R F: year of birt h, race a n d ge n der .
6. 1. 3 . Me dic al Hist or y a n d C o nc o mit a nt Me dic ati o n
Me dical hist or y  will be assesse d as relate d t o t he i ncl usi o n/e xcl usi on cri t eria b y t he 
I n vesti gat or or desi g nee.  Details of a n y rele va nt me dical or s ur gical hist or y wit hi n 
t he last year , i nclu di n g aller gies or dr u g se nsit i vity, will be rec or de d o n t he e C R F.  
A n y c o nc o mit a nt t hera p y ta ke n i n t he 3 0 da ys prior t o t he Scree ni n g Visit a n d 
t hr o u g h o ut t he st u d y will als o be rec or de d.
6. 1. 4. Fitz p atric k S ki n T y pe Assess me nt
Fi tz patric k s ki n ty pe assess me nt will be c o n d ucte d b y a trai ne d, q ualifie d tec h nicia n
a n d rec or de d o n t he e C R F usi n g t he scale bel o w.
T y pe
Descri pti o n
I
Al wa ys b ur ns, ne ver ta ns
II
us uall y b ur ns, ta ns mi ni mall y
III
s o meti mes mil d b ur n, ta ns u nif or ml y (crea m w hite; fair wit h a n y hair or 
e ye c olor)
I V
b ur ns mi ni mall y, al wa ys ta ns well ( m o derate br o w n)
V
ver y  rarel y bur ns, ta ns ver y  easil y ( dar k br o w n)
VI
Ne ver b ur ns, ne ver ta ns ( dee pl y pi g me nte d dar k br o w n t o dar kest 
br o w n)
6. 1. 5. Gl o g a u P h ot o a gi n g T y pe Assess me nt
Gl o ga u p h ot oa gi n g t y pe assess me nt wi ll be c o nfir me d b y a trai ne d, q ualifie d 
tec h nicia n a n d rec or de d o n t he e C R F usi n g t he scale bel o w.
 
D oc u m e nt N a m e  
 
T y p e  
V ersi o n  
D oc u m e nt I d e ntifi er  
Eff ecti v e D at e  
 
 
 
 
R e as o n F or Iss u e  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
1 5- S e p- 2 0 1 7 0 9: 2 7: 1 5
 
Pr ot o c ol 2 0 6 8 2 7 
d o c
el d o _ c o ntr oll e d
4. 0; M o st- R e c e nt; Eff e cti v e; C U R R E N T
A ut o I s s u e
0 9 0 0 3 2 d 5 8 0 d 9 8 e b 9
Pa ge 5 0 of 9 3
C CI

5 1
Gr o u p
Cl assific ati o n
S ki n C h ar acteristics
I
Mil d
Earl y P h ot oa gi n g: mil d pi g me nt c ha n ges, n o kerat osis, 
mi ni mal wri n kles, mi ni mal or n o ma ke u p
II
M o derate
Earl y t o M o derate P h ot oa gi n g: Earl y  br o w n s p ots visi ble, 
kerat osis pal pa ble b ut n ot visi ble, parallel s mile li nes be gi n 
t o a p pear, wears s o me f o u n dati o n
III
A d va nce d
A d va nce d P h ot oa gi n g: O b vi o us disc o l orati o ns, visi ble 
ca pillaries (tela n giectas ias), visi ble kerat osis, wears hea vier 
f ou n dat i on al wa ys
I V
Se vere
Se vere P h ot oa gi n g: Yell o w -gr a y  s ki n c olor, pri or s ki n 
mali g na ncies, wri n kles t hr o u g h o ut - n o n or m al s ki n, ca n n ot 
wear m a ke u p beca use it ca kes a n d crac ks
6. 1. 6 . I ncl usi o n / E xcl usi o n Criteri a
Incl usi o n/e xcl usi o n cri teria will be assesse d b y t he I n vest i gat or or me dicall y q ualifie d 
desi g nee a n d rec or de d o n t h e e C R F. E xcl usi o n 3 P will be assesse d b y  a q ualifie d 
o p ht hal m o l ogist. At t his p oi nt, e xcl usi on cri teria 9 will n ot be e val uate d u ntil after
c o mplet i on of t he st u d y  mat erial se nsitivi t y test a n d c orres p o n di n g Der mat ol o gist a n d 
S u bject self- assess me nt data. 
6. 1. 7 . S u bject Eli gi bilit y
S u bjects m eet i n g t he i ncl usi on a n d e xcl usi o n cri teria, w h o m pr o vide t hei r i nf or me d 
c o nse nt a n d w h o are als o c o nsi dere d eli gi ble f or e nr o ll me nt i n t he st u d y b y t he 
I n vesti gat or or me dicall y q ualifie d desi g nee will be e nr olle d i nt o t he st u dy.  
C o nfir mati o n o f w het her a s u bject was e nr olle d, or n ot, will be rec or de d o n t he e C R F.
6. 1. 8 . St u d y M ateri al Se nsiti vit y Test
T his pr oce d ure is i ncl u de d t o deter mi ne w het her eac h s u bject is overl y  se nsitive t o 
t he was h o ut pr o d ucts a n d gl yc o lic aci d peel re gi me n.  A q ualifie d der mat ol o gist will 
di s pe nse a t hi n la yer of t he 7 0 % gl yc olic aci d peel s ol uti on (a p pr o xi matel y 0. 5 ml) t o 
c o ver a de marcate d 5 x 5 c m s q uare area o n t he v olar s urface of t he f orear m a n d, 
wi t hi n a perio d of a p pr o xi matel y 3 0- 6 0 sec o n ds, will ne utralize t he 7 0 % gl yc o lic aci d 
peel  s olut i on wi t h t he bicar b o nate ne utralizi n g age nt t he n rinse t he s ki n t h or o u g hl y 
wi t h water a n d pat dr y wit h a s oft t o wel. O nce dr y, t he der mat olo gi st will a p pl y a t hi n 
la yer of t he S u n ma x Se nsit i ve S P F 5 0 s u nscree n t o t he f orear m. S uccessf ul 
c o mplet i on of t his pr oce d ure will be rec or de d o n t he e C R F.
 
D oc u m e nt N a m e  
 
T y p e  
V ersi o n  
D oc u m e nt I d e ntifi er  
Eff ecti v e D at e  
 
 
 
 
R e as o n F or Iss u e  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
1 5- S e p- 2 0 1 7 0 9: 2 7: 1 5
 
Pr ot o c ol 2 0 6 8 2 7 
d o c
el d o _ c o ntr oll e d
4. 0; M o st- R e c e nt; Eff e cti v e; C U R R E N T
A ut o I s s u e
0 9 0 0 3 2 d 5 8 0 d 9 8 e b 9
Pa ge 5 1 of 9 3
C CI

5 2
6. 1. 9 . S u bject Self- Assess me nt of Se nsiti vit y
T he f o ll owi n g assess me nts will be c o n d ucte d b y  test s u bjects reflect i ve of t heir s ki n 
c o n ditio n at t he 5 x 5 c m s q uare area o n t he v olar s urface of t he f orear m at t he ti me of 
e val uat i on a n d rec or de d o n t he e C R F.
Sc ore
P ai n
Sti n gi n g/ 
B ur ni n g
Itc hi n g
Ti g ht ness
Re d ness
Dr y ness
0
N o ne  
N o ne  
N o ne  
N o ne  
N o ne  
N o ne
1
Mil d  
Mil d  
Mil d  
Mil d  
Mil d  
Mil d
2
M o derate  
M o derate  
M o derate  
M o derate  
M o derate  
M o derate
3
Se vere 
Se vere 
Se vere 
Se vere 
Se vere 
Se vere
6. 1. 1 0 . Der mat ol o gist Assess me nt of Se nsiti vit y
T he f o ll owi n g assess me nts will be c o n d ucte d b y  a der mat olo gi st reflecti ve of t he 
s u bject’s s ki n c o n ditio n at t he 5 x 5 c m s q uare area o n t he v olar s urface of t he 
f orear m at t he ti me of t he e val uat i on a n d rec o r de d o n t he e C R F.  W he ne ver p ossi ble, 
it is prefera ble f or t he sa me der mat ol o gist t o e val uate t he sa me s u bject t hr o u g h t he 
e nt ire st u d y.
E r yt he m a
Sc ore
Descri pti o n
0
N o ne - N o  e vi de nce of er ythe ma prese nt
1
Mil d – Sl i g ht re d c ol orati o n
2 
M o derate - Def i nite re d ness
3
Se vere - Mar ke d er y t he ma, brig ht re d t o d us k y  dar k re d i n c ol or
Dr y ness
Sc ore
Descri pti o n
0
N o ne - N o  dr y ness
1
Mil d - Barel y perce pt i ble, fi ne scales or fla kes prese nt t o li mite d areas of 
t he test sit e
2
M o derate - Fi ne scales or fla k es ge neralize d t o all areas of t he test site
3
Se vere - Scali n g a n d peeli n g of s ki n o ver all areas of t he test site
 
D oc u m e nt N a m e  
 
T y p e  
V ersi o n  
D oc u m e nt I d e ntifi er  
Eff ecti v e D at e  
 
 
 
 
R e as o n F or Iss u e  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
1 5- S e p- 2 0 1 7 0 9: 2 7: 1 5
 
Pr ot o c ol 2 0 6 8 2 7 
d o c
el d o _ c o ntr oll e d
4. 0; M o st- R e c e nt; Eff e cti v e; C U R R E N T
A ut o I s s u e
0 9 0 0 3 2 d 5 8 0 d 9 8 e b 9
Pa ge 5 2 of 9 3
C CI

5 3
Des q u a m ati o n
Sc ore
Descri pti o n
0  
N o ne - No e vi de nce of des q ua mati o n/ peeli n g
1
Mil d - Barel y perce pt i ble scali n g; e vi de nt o nl y o n scratc hi n g
2
M o derate - Mi ni mal scali n g, a d here nt t o t he s ki n
3
Se vere - M o derate scali n g, l o osel y a d here nt t o t he s ki n a n d easil y 
r e mo va ble
E de m a
Sc ore
Descri pti o n
0
N o ne - N o  e de ma prese nt
1
Mil d - Barel y perce pt i ble e de ma prese nt
2
M o derate - Defi nite e de ma prese nt
3
Se vere - Mar ke d/ pr o n o u nce d e de ma prese nt
6. 1. 1 1 . E xcl usi o n Criteri a 9
D er m at olo gi st a n d S u bject self-assess me nt data will be e val uate d b y t he I n vesti gat or 
or desi g nee. A n y s u b ject wit h a sc ore of “ Se vere” f or a n y of t he Der mat olo gi st 
( Er yt he ma, Dr y ness, Des q ua mat i on, E de ma) or S u bject self - assesse d ( Pai n, 
Sti n gi n g/ B ur ni n g, Itc hi n g, Ti g ht ness, Re d ness, Dr y ness) para meters will be 
c o nsi dere d t o be i n vi o lati on of e xcl usi o n crit eria 9 a n d will be disc har ge d fr o m t he 
st u d y. All ot her s u bjects will be c o nsi dere d eli gi ble t o c o nti n ue i n t he st u d y.
A n y Der mat ol o gist or S u bject self -assesse d sc ore of “se vere” will als o be c o nsi dere d 
a n a d verse e ve nt a n d re p orte d as per t he pr oce d ures o ut li ne d i n Secti on 7. 
D er m at olo gi st or S u bject self- assesse d sc ores of “ n o ne”, “ mil d” a n d “ m o derate” will 
n ot be c o nsi dere d a d verse e ve nts. 
6. 1. 1 2 . S u bject Eli gi bilit y
See 6. 1. 7.
6. 1. 1 3 . W as h o ut Pr o d ucts a n d W as h o ut Di ar y Dis pe nsi n g
Di s pe nsi n g of was h o ut pr o d ucts a n d was h o ut diar y t o s u bjects t o sta n dar dize s ki n 
care re gi me n a n d usa ge i nstr ucti o ns will  be rec or de d o n t he e C R F.
 
D oc u m e nt N a m e  
 
T y p e  
V ersi o n  
D oc u m e nt I d e ntifi er  
Eff ecti v e D at e  
 
 
 
 
R e as o n F or Iss u e  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
1 5- S e p- 2 0 1 7 0 9: 2 7: 1 5
 
Pr ot o c ol 2 0 6 8 2 7 
d o c
el d o _ c o ntr oll e d
4. 0; M o st- R e c e nt; Eff e cti v e; C U R R E N T
A ut o I s s u e
0 9 0 0 3 2 d 5 8 0 d 9 8 e b 9
Pa ge 5 3 of 9 3
C CI

5 4
6. 2 . Visit 2 – 1 d a y after Visit 1
6. 2. 1. C urre nt / C o nc o mit a nt Me dic ati o n
A n y c o nc o mit a nt t hera p y ta ke n si nce t he last visit a n d t hr o u g h o ut t he stu d y will be 
rec or de d o n t he e C R F b y t he I n vesti gat or or desi g nee.
6. 2 . 2. A d verse E ve nts
A d verse e ve nts will be a ssesse d b y t he I n vesti gat or or desi g nee a n d rec or de d o n t he 
e C R F, as per t he pr ocess detaile d i n Sect i on 7.
As per Secti o n 7. 1, t he f oll o wi n g d oes n ot meet t he defi nit i on of a n a d verse e ve nt :
“ A n y cli nicall y si g nifica nt a b n or mal la b orat or y fi n di n gs (if a p plica ble) or ot her 
a b n or mal s af et y assess me nts w hic h are ass ociate d wit h t he u n derl yi n g disease, u nless 
j u d ge d b y t he i n vesti gat or t o be m ore se vere t ha n e x pecte d f or t he s u bject’s 
c o n ditio n.” T heref ore, t he Der mat ol o gist (er y t he ma, e de ma, dr y ness, a n d 
des q ua mat i on) a n d S u bject -self assess me nt ( pai n, sti n gi n g/ b ur ni n g, itc hi n g, ti g ht ness, 
re d ness, a n d dr y ness) gra des will o nl y be c o nsi dere d a d verse e ve nts if t he y are sc ore d 
as “ Se vere”, or if t he i n vesti gat or j u d ges t he m t o be m ore se vere t ha n e x pecte d i n 
c o nte xt of t he Gl yc olic Aci d treat me nt pr oce d ure. 
6. 2. 3. C o nti n ue d S u bject Eli gi bilit y
T he I n vesti gat or or desi g nee will ascertai n w het her t here ha ve bee n a n y de viat i ons 
fr om t he pr ot oc ol si nce t he last visit, w het her t he s u bject has a d here d t o t he lifest yle 
restrict i ons si nce t he last visit a n d w het her, i n t heir o pi ni o n, t he s u bject is eli gi ble t o 
c o nti n ue i n t he st u d y. S u bject C o nti n ue d S u bject Eli gi bilit y will be rec or de d o n t he 
e C R F.
6. 2 . 4. C o m pli a nce ( Di ar y Re vie w)
S u bject diaries will be re vie we d b y t he I n vest i gat or or t heir desi g nee. S u bjects w h o 
a p pl y t he was h o ut pr o d ucts m ore or less fre q ue nt l y t ha n t wice a da y will be 
c o nsi dere d t o ha ve de viate d fr o m t he pr ot oc ol a n d a d dit i onal/ misse d a p plicati o ns will 
rec or de d o n t he De viati ons L o g. T he t otal n u m b er of pr o d uct a p plicati o ns a n d t otal 
n u m ber of misse d pr o d uct a p plicat i ons will be rec or de d o n t he e C R F.
6. 2. 5 . S u bject Self-Assess me nt of Se nsiti vit y
Assess me nts t o be ta ke n as per 6. 1. 9, 2 4 ± 4 h o urs after c o m plet i on of t he st u d y 
materi al se nsiti vity test.
 
D oc u m e nt N a m e  
 
T y p e  
V ersi o n  
D oc u m e nt I d e ntifi er  
Eff ecti v e D at e  
 
 
 
 
R e as o n F or Iss u e  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
1 5- S e p- 2 0 1 7 0 9: 2 7: 1 5
 
Pr ot o c ol 2 0 6 8 2 7 
d o c
el d o _ c o ntr oll e d
4. 0; M o st- R e c e nt; Eff e cti v e; C U R R E N T
A ut o I s s u e
0 9 0 0 3 2 d 5 8 0 d 9 8 e b 9
Pa ge 5 4 of 9 3
C CI

5 5
6. 2 . 6. D e r m at ol o gist Assess me nt of Se nsiti vit y
Assess me nts t o be ta ke n as per 6. 1. 1 0 , 2 4 ± 4 h o urs after c o m pleti on of t he st u d y 
m at erial se nsitivi t y t est.
6. 2. 7 . E xcl usi o n Criteri a
T he e xclusi o n  crit eria descri be d i n A p pe n di x 4 will be c o nfir me d b y t he I n vest i gat or 
or m e dicall y q ualifie d desig nee a n d rec or de d o n t h e e C R F.
A n y s u bject wit h a sc ore of “ Se vere” f or a n y o f t he Der mat olo gist ( Er y t he ma, 
Dr y ness, Des q ua mat i on, E de ma) or S u bject self -assesse d ( Pai n, Sti n gi n g/ B ur ni n g, 
Itc hi n g, Ti g ht ness, Re d ness, Dr y ness) para meters will be c o nsi dere d to be i n vi o lati on 
of  e xclus i on crit eria 9 a n d will be disc har ge d fr o m t he st u d y. All ot her s u bjects will 
be c o nsi dere d eli gi ble t o c o nti n ue i n t he st u d y .
A n y Der mat ol o gist or S u bject self -assesse d sc ore of “se vere” will als o be c o nsi dere d 
a n a d verse e ve nt a n d re p orte d as per t he pr oce d ures o utli ne d i n Sect i on 7. 
D er m at olo gi st or S u bject self- assesse d sc ores of “ n o ne”, “ mil d” a n d “ m o derate” will 
n ot be c o nsi dere d a d verse e ve nts. 
6. 2 . 8. S u bject Eli gi bilit y
See 6. 1. 7.
6. 3 . Visit 3 – D a y of Pr oce d ure - 6 d a ys after Visit 2
6. 3. 1. C urre nt / C o nc o mit a nt Me dic ati o n
A n y c o nc o mit a nt t hera p y ta ke n si nce t he last visit a n d t hr o u g h o ut t he stu d y will be 
rec or de d o n t he e C R F b y t he I n vest i gat or or desi g nee.
6. 3. 2. A d verse E ve nts
A d v erse e ve nts will be assesse d b y t he I n vest i gat or or desi g nee a n d rec or de d o n t he
e C R F, as per t he pr ocess detaile d i n Secti on 7 .
As per Secti o n 7. 1, t he f oll o wi n g d oes n ot meet t he defi nit i on of a n a d verse e ve nt:
“ A n y cli nicall y si g nifica nt a b n or mal la b orat or y fi n di n gs (if a p plica ble) or ot her 
a b n or mal s af et y assess me nts w hic h are ass ociate d wit h t he u n derl yi n g disease, u nless 
j u d ge d b y t he i n vesti gat or t o be m ore se vere t ha n e x pecte d f or t he s u bject’s 
c o n ditio n.” T heref ore, t he Der mat ol o gist (er y t he ma, e dema, dr y ness, a n d 
des q ua mat i on) a n d S u bject -self assess me nt ( pai n, sti n gi n g/ b ur ni n g, itc hi n g, ti g ht ness, 
re d ness, a n d dr y ness) gra des will o nl y be c o nsi dere d a d verse e ve nts if t he y are sc ore d 
as “ Se vere”, or if t he i n vest i gat or j u d ges t he m t o be m ore se vere t ha n e x pecte d i n 
c o nte xt of t he Gl yc o lic Aci d treat me nt pr oce d ure. 
 
D oc u m e nt N a m e  
 
T y p e  
V ersi o n  
D oc u m e nt I d e ntifi er  
Eff ecti v e D at e  
 
 
 
 
R e as o n F or Iss u e  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
1 5- S e p- 2 0 1 7 0 9: 2 7: 1 5
 
Pr ot o c ol 2 0 6 8 2 7 
d o c
el d o _ c o ntr oll e d
4. 0; M o st- R e c e nt; Eff e cti v e; C U R R E N T
A ut o I s s u e
0 9 0 0 3 2 d 5 8 0 d 9 8 e b 9
Pa ge 5 5 of 9 3
C CI

5 6
6. 3. 3. C o nti n ue d S u bject Eli gi bilit y
T he I n vesti gat or or desi g nee will ascertai n w het her t here ha ve bee n a n y de viat i ons 
fr om t he pr ot oc ol si nce t he last visit, w het her t he s u bject has a dhere d t o t he lifest yle 
restrict i ons si nce t he last visit a n d w het her, i n t heir o pi ni o n, t he s u bject is eli gi ble t o 
c o nti n ue i n t he st u d y. S u bject C o nti n ue d S u bject Eli gi bilit y will be rec or de d o n t he 
e C R F.
6. 3. 4. C o m pli a nce ( Di ar y Re vie w)
S u bject diaries will be re vie we d b y  t he I n vesti gat or or t heir desi g nee. S u bjects w h o 
a p pl y t he was h o ut pr o d uct m ore or less fre q ue nt l y t ha n t wice a da y will be c o nsi dere d 
t o ha ve de viate d fr o m t he pr ot oc ol a n d a d diti onal/ misse d a p plicati o ns will rec or de d 
o n t he De viat i ons L o g. T he t otal n u m ber of pr o d uct a p plicat i ons a n d t otal n u m ber of 
misse d pr o d uct a p plicat i ons will be rec or de d o n t he e C R F. 
6. 3. 5 . S u bject Self-Assess me nt of Se nsiti vit y
Assess me nts t o be ta ke n as per 6. 1. 9, 7 da y s after c o m pleti o n of t he st u d y material 
se nsiti vit y test.
6. 3 . 6. Der mat ol o gist Assess me nt of Se nsiti vit y
Assess me nts t o be ta ke n as per 6. 1. 1 0 , 7 da ys after c o m pleti o n of t he st u d y material 
se nsiti vit y test.
6. 3. 7. E xcl usi o n Criteri a
E xcl usi o n cri t eria detaile d i n A p pe n di x 4 will  be assesse d b y t he I n vest i gat or or 
me dicall y q uali fie d desi g nee t o c o nfir m s u bje ct eli gi bilit y a n d rec or de d o n t he e C R F. 
S u bjects w h o tri g ger a n y o f t he e xcl usi o n cri t eria will be disc har ge d fr o m t he st u d y.
A n y s u bject wit h a sc ore of “ Se vere” f or a n y o f t he Der mat olo gist ( Er y t he ma, 
Dr y ness, Des q ua mat i on, E de ma) or S u bject self -assesse d ( Pai n, Sti n gi n g/ B ur ni n g, 
Itc hi n g, Ti g ht ness, Re d ness, Dr y ness) para meters will be c o nsi dere d t o be i n vi olati on 
of  e xclusi o n  crit eria 9 a n d will be disc har ge d fr o m t he st u d y. All ot her s u bjects will 
be c o nsi dere d eli gi ble t o c o nti n ue i n t he st u d y .
A n y Der mat ol o gist or S u bject self -assesse d sc ore of “se vere” will als o be c o nsi dere d 
a n a d verse e ve nt a n d re p orte d as per t he pr oce d ures o utli ne d i n Sect i on 7. 
D er m at olo gi st or S u bject self- assesse d sc ores of “ n o ne”, “ mil d” a n d “ m o derate” will 
n ot be c o nsi de re d a d verse e ve nts. 
 
D oc u m e nt N a m e  
 
T y p e  
V ersi o n  
D oc u m e nt I d e ntifi er  
Eff ecti v e D at e  
 
 
 
 
R e as o n F or Iss u e  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
1 5- S e p- 2 0 1 7 0 9: 2 7: 1 5
 
Pr ot o c ol 2 0 6 8 2 7 
d o c
el d o _ c o ntr oll e d
4. 0; M o st- R e c e nt; Eff e cti v e; C U R R E N T
A ut o I s s u e
0 9 0 0 3 2 d 5 8 0 d 9 8 e b 9
Pa ge 5 6 of 9 3
C CI

5 7
6. 3. 8 . S u bject Eli gi bilit y
See 6. 1. 7. N ote, t o be c o nsi dere d c o m plia nt eli gi ble t o c o nti n ue i n t he st u d y, a s u bject 
m ust n ot ha ve misse d m ore t ha n 5 a p plicat i ons of eit her t he was h o ut clea nser or 
s u nscree n. S u bjects faili n g t o meet t his criterio n will  be c o nsi dere d t o ha ve de viate d 
fr om t he pr ot oc ol a n d will be disc har ge d fr o m t he st u d y.
6. 3. 9 . S u bject R a n d o mi sati o n
S u bject ra n d o mi satio n will  be c o n d ucte d as per t he pr ocess detaile d i n Sect i on 5. 8. 1 
a n d d oc u me nte d o n t he e C R F.
6. 3. 1 0 . I nstr u me nt al Me as ureme nts Pre -Pr oce d ure
I nstr u me nt al meas ure me nts of Tra nse pi der mal  Water L oss a n d ski n h y drati o n will be 
c o n d ucte d b y t he I n vesti gat or or desi g nee a n d rec or de d o n t he e C R F. S ubjects will
accli mat ize t o t he c o ntr olle d r o o m te m perat ure ( 2 1 ± 1 º C) a n d h u mi dit y ( 5 0 ± 1 0 %) f or 
at least 3 0 mi n utes pri or t o i nstr u me ntal assess me nt. 
I nstr u me nt al Me as ure me nt of Tr a nse pi der m al W ater L oss
T E W L m eas ure me nt will be perf or me d b y e va p ori metr y wi t h a Te wa meter T M 3 0 0 
( C o ura ge & K haza ka, C ol o g ne, Ger ma n y) f oll owi n g t he E ur o pea n E x pert Gr o u p o n 
Efficac y Meas ure me nt of C os met ics a n d Ot her T o pical Pr o d ucts ( E E M C O) G ui da nce 
f or t he Assess me nt of Tra nse pi der mal Water L oss i n C os metic Scie nces. [ R o giers]  
Meas ure me nts will be ta ke n i n tri plicate o n t he l eft c hee k ( belo w t he c hee k b o ne, 
bet wee n t he n ose a n d ear a n d n ot o verla p pi n g wit h t he site pre vi o usl y use d f or T E W L 
meas ure me nts ) wit h u nit s of g/ m2/ hr. T E W L meas ure me nts will be ta ke n wit h t he 
s u bject lyi n g h ori z o ntall y, o n t heir bac k, s o t hat t he c hi m ne y of t he Te wa met er pr o be 
is ali g ne d verticall y.
I nstr u me nt al Me as ure me nt of M oist uris ati o n
Meas ure me nt of strat u m c or ne u m h y drati o n will be perf or me d b y t he electrical 
ca pacita nce met h o d wit h a C or ne o mete r C M 8 6 5 ( C o ura ge & K haza ka, C ol o g ne, 
G er m a n y) f ollo wi n g t he E E M C O G ui da nce f or t he Assess me nt of  Strat u m Cor ne u m  
H y drat i on . [ Berar desca] C or ne o m eter meas ure me nts will be ta ke n i n triplicate at t he 
left c hee k ( bel o w t he c hee k b o ne, bet wee n t he n ose a n d ear) wit h t he s u bject l yi n g 
h ori z o ntall y, o n t heir bac k. I nstr u me ntal data will be re p orte d i n C or ne o meter U nits
6. 3. 1 1 . I ma ge C a pt ure ( VI SI A) P re-Pr oce d ure
VI SI A C R ® hi g h res o l uti on p h ot o gra p hs of t he fr o nt, left a n d ri g ht si des of s u bject’s 
faces will be take n usi n g p o larise d a n d n o n-p ol arise d lig ht i n g a n d d oc u me nte d o n t he 
 
D oc u m e nt N a m e  
 
T y p e  
V ersi o n  
D oc u m e nt I d e ntifi er  
Eff ecti v e D at e  
 
 
 
 
R e as o n F or Iss u e  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
1 5- S e p- 2 0 1 7 0 9: 2 7: 1 5
 
Pr ot o c ol 2 0 6 8 2 7 
d o c
el d o _ c o ntr oll e d
4. 0; M o st- R e c e nt; Eff e cti v e; C U R R E N T
A ut o I s s u e
0 9 0 0 3 2 d 5 8 0 d 9 8 e b 9
Pa ge 5 7 of 9 3
C CI

5 8
e C R F. Je welr y will be re m o ve d a n d hair l o osel y t ie d bac k a n d c o vere d wit h a blac k 
veil s o t hat it d oes n ot i nterfere wit h t he p h ot o gra p h. S u bjects will be as ke d t o 
mai ntai n a rela xe d, ne u tr al e x pressi on wi t h t heir e yes close d. P h ot o gra p hic i ma ges of 
s u bjects are c o nsi dere d pers o nal i de nt ifia ble i nf or mati on ( PII) a n d will be tra nsferre d 
sec urel y fr o m t he site t o G S K. S u bjects w h o did n ot pr o vi de c o nse nt f or t he 
c o m mercial e x pl o itatio n of  t heir p h ot o gra p hic data will n ot ha ve t heir p h ot o gra p hs 
ta ke n.
6. 3. 1 2 . S u bject Self-Assess me nt Pre -Pr oce d ure
T he f o ll owi n g assess me nts will be c o n d ucte d b y  test s u bjects reflect i ve of t heir facial 
s ki n c o n ditio n  at t he ti me of e val uati on a n d rec or de d o n t he e C R F.
Sc ore
P ai n
Sti n gi n g/ 
B ur ni n g
Itc hi n g
Ti g ht ness
Re d ness
Dr y ness
0
N o ne  
N o ne  
N o ne  
N o ne  
N o ne  
N o ne
1
Mil d  
Mil d  
Mil d  
Mil d  
Mil d  
Mil d
2
M o derate  
M o derate  
M o derate  
M o derate  
M o derate  
M o derate
3
Se vere 
Se vere 
Se vere 
Se vere 
Se vere 
Se vere
6. 3. 1 3 . D e r m at o l o gist Assess me nt Pre -Pr oce d ure
T he f o ll owi n g assess me nts will be c o n d ucte d b y  a der mat olo gi st reflecti ve of t he 
s u bject’s facial s ki n c o n ditio n at t he ti me of t he e val uat i on a n d rec or de d o n t he e C R F.  
W he ne ver p ossi ble, it is prefera ble f or t he sa me der ma t olo gist t o e val uate t he sa m e 
s u bject t hr o u g h t he e ntire st u d y.
Er yt he m a
Sc ore
Descri pti o n
0
N o ne - N o  e vi de nce of er ythe ma prese nt
1
Mil d – Sl i g ht re d c ol orati o n
2 
M o derate - Defi nite re d ness
3
Se vere - Mar ke d er y t he ma, brig ht re d t o d us k y  dar k re d in c ol or
 
D oc u m e nt N a m e  
 
T y p e  
V ersi o n  
D oc u m e nt I d e ntifi er  
Eff ecti v e D at e  
 
 
 
 
R e as o n F or Iss u e  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
1 5- S e p- 2 0 1 7 0 9: 2 7: 1 5
 
Pr ot o c ol 2 0 6 8 2 7 
d o c
el d o _ c o ntr oll e d
4. 0; M o st- R e c e nt; Eff e cti v e; C U R R E N T
A ut o I s s u e
0 9 0 0 3 2 d 5 8 0 d 9 8 e b 9
Pa ge 5 8 of 9 3
C CI

5 9
Dr y ness
Sc ore
Descri pti o n
0
N o ne - N o  dr y ness
1
Mil d - Barel y perce pt i ble, fi ne scales or fla kes prese nt t o li mite d areas of 
t he face
2
M o derate - Fi ne scales or fla kes ge neralize d t o all areas of t he face
3
Se vere - Scali n g a n d peeli n g of s ki n o ver all areas of t he face
Des q u a m ati o n
Sc ore
Descri pti o n
0  
N o ne - No e vi de nce of des q ua mati o n/ peeli n g
1
Mil d - Barel y perce pt i ble scali n g; e vi de nt o nl y o n scratc hi n g
2
M o derate - Mi ni mal scali n g, a d here nt t o t he s ki n
3
Se vere - M o derate scali n g,
l oosel y  a d here nt t o t he s ki n a n d easil y 
r e mo va ble
E de m a
Sc ore
Descri pti o n
0
N o ne - N o  e de ma prese nt
1
Mil d - Barel y perce pt i ble e de ma prese nt
2
M o derate - Defi nite e de ma prese nt
3
Se vere - Mar ke d/ pr o n o u nce d e de ma prese nt
6. 3 . 14 . Der mat ol o gic al P r o ce d ure ( F aci al Peel)
T he 7 0 % Gl yc o lic Aci d facial peel pr oce d ure will be c o n d ucte d b y  a me dicall y 
q ualifie d pr ofessi o nal wit h ha n ds -o n e x peri e nce a d mi nisteri n g peels of t his nat ure. 
T he site will s o urce 7 0 % Gl yc o lic Aci d tr e at me nt (S M E m pre n di me nt os 
Far mac ê ut ic os ( Fa gr o n)) a n d S o diu m  Bicar b o nate ne utralizi n g s ol uti o n (La bs y nt h 
Pr o d ut os para La b orat óri os ( S y nt h) ) fr o m Ma gis P har ma a n d will retai n a c o p y of t he 
p urc hase or der a n d certificate of a nal ysis, w hic h will be st ore d i n t he Trial Master 
File ( T M F).
Pr i or t o t he Gl yc olic Aci d treat m e nt, t he s u bject’s s ki n will be de grease d b y wi pi n g 
wi t h a ga uze s oa ke d i n a n alc o h o l s olut i on ( 7 0 % ( w/ w) i n water). A fres h ga uze will 
 
D oc u m e nt N a m e  
 
T y p e  
V ersi o n  
D oc u m e nt I d e ntifi er  
Eff ecti v e D at e  
 
 
 
 
R e as o n F or Iss u e  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
1 5- S e p- 2 0 1 7 0 9: 2 7: 1 5
 
Pr ot o c ol 2 0 6 8 2 7 
d o c
el d o _ c o ntr oll e d
4. 0; M o st- R e c e nt; Eff e cti v e; C U R R E N T
A ut o I s s u e
0 9 0 0 3 2 d 5 8 0 d 9 8 e b 9
Pa ge 5 9 of 9 3
C CI

6 0
t he n be s oa ke d i n t he 7 0 % Gl yc o lic Aci d s ol uti on, w hic h will be a p plie d e ve nl y  o ver 
t he ent ire face (e xcl u di n g e yeli ds) starti n g i n t he ce nter a n d m o vi n g t o t he peri p her y 
of  t he face.  T he Gl yc olic Aci d s ol uti on will re mai n i n c o ntact wit h t he s ki n f or a 
mi ni m u m o f 1 mi n ute a n d a ma xi m u m o f 3 mi n utes. T he der mat ol o gist will 
deter mi ne t he e xact treat me nt ti me o n a s u bject b y s u bject basis b y mo ni t ori n g t heir 
i n di vi d ual res p o nse t o treat me nt.  T he der mat ol o gist ma y deter mi ne t hat it is i n t he 
i nterests of t he s u bject t o ter mi nate t he treat me nt p hase s o o ner t ha n 1 mi n ute after 
i nitial a p plicati on. T his will be c o nsi dere d a pr ot oc ol de viati o n a n d rec or de d o n t he 
De viat i ons L o g. Si milarl y, a treat me nt p hase of l o n ger t ha n 3 mi n utes will be 
re p orte d as a de viati on.  S u bjects w h o d o n ot recei ve at least 1 mi n ute or w h o recei ve 
m o re t ha n 3 mi n utes of  Gl yc olic Aci d treat me nt will st ill be c o nsi dere d eli gi ble t o 
c o nti n ue t he st u d y u nless t he der mat ol o gist belie ves t he m ot her wise u ns uita ble t o 
c o nti n ue (e. g. f or safet y reas o ns).
O nce t he Gl yc o lic Aci d treat me nt peri o d is c o m plete, a fres h ga uze will be soa ke d 
wi t h t he s o diu m bicar b o nate s ol uti o n, w hic h will be a p plie d e ve nl y  o ver t he e ntire 
face (e xcl u di n g e yeli ds) starti n g i n t he ce nter a n d m ovi n g t o t he peri p her y o f t he face. 
T his pr ocess will be re peate d u ntil t he der mat ol o gist c o nsi ders t he Gl yc o lic Aci d 
s olut i on t o be s uccessf ull y ne utralize d. T he der mat ol o gist will t he n ri nse t he s u bject’s 
face t h or o u g hl y wit h water. 
S u bjects will be i nstr ucte d t o c o ntact t he st u d y  sit e (i n pers o n or b y ph o ne) i n case of 
di sc o mf ort bet wee n visits. A me d icall y q ualifie d der mat olo gi st will e val uate t he 
s u bject’s re p orts of disc omf o rt a n d deter mi ne a n a p pr o priate c o urse of acti o n, 
i ncl u di n g w het her t o disc o nti n ue a s u bject’s i n v ol ve me nt i n t he st u d y. A d verse e ve nts 
will be re p orte d as per t he pr oce d ures i n Secti o n 7.
6. 3 . 15 . D e r m at ol o gist Assess me nt P ost -Pr oce d ure, Pre -Tre at me nt 
( B A S E LI N E)
Assess me nts t o be ta ke n a n d rec or de d as per 6. 3 . 1 4, 6 0 ± 1 5 mi n utes after c o m pleti on 
of  t he facial peel pr oce d ure.
6. 3. 1 6 . I nstr u me nt al Me as ureme nts P ost -Pr oce d ure, Pre -Tre at me nt 
( B A SE LI N E)
Assess me nts t o be ta ke n a n d rec or de d as per 6. 3. 10 , 6 0 ± 1 5 mi n utes after c o mplet i on 
of  t he facial peel pr oce d ure.
6. 3. 1 7 . I ma ge C a pt ure ( VI SI A) P o st-Pr oce d ure, Pre -Tre at me nt 
( B A S E LI N E)
Assess me nts t o be ta ke n a n d rec or de d as per 6. 3. 11 , 6 0 ± 1 5 mi n utes after c o m pleti on 
of  t he facial peel pr oce d ure.
 
D oc u m e nt N a m e  
 
T y p e  
V ersi o n  
D oc u m e nt I d e ntifi er  
Eff ecti v e D at e  
 
 
 
 
R e as o n F or Iss u e  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
1 5- S e p- 2 0 1 7 0 9: 2 7: 1 5
 
Pr ot o c ol 2 0 6 8 2 7 
d o c
el d o _ c o ntr oll e d
4. 0; M o st- R e c e nt; Eff e cti v e; C U R R E N T
A ut o I s s u e
0 9 0 0 3 2 d 5 8 0 d 9 8 e b 9
Pa ge 6 0 of 9 3
C CI

6 1
6. 3. 1 8 . S u bject Self-Assess me nt P ost -P r o ce d ure, Pre -Tre at me nt 
( B A S E LI N E)
Assess me nts t o be ta ke n a n d rec or de d as per 6. 3 . 12 , 6 0 ± 1 5 mi n utes after c o mplet i on 
of  t he facial peel pr oce d ure.
6. 3. 1 9 . Test Pr o d uct a n d Test Di ar y Dis pe nsi n g . W as h o ut Di ar y 
C ollecti o n.
T he ti me a n d date of  test pr o d uct dis pe nsi n g will be d oc u m e nte d o n t he e C R F. Test 
pr o d uct diar y will be dis pe nse d a n d was h o ut diar y  c ollecte d.  S u bjects ra n d o mise d t o 
test pr o d uct will be dis pe nse d a differe nt diar y t ha n s u bjects w h o are n ot ra n d o mise d 
t o test pr o d uct. T he I n vesti gat or or desi g nee i n v o l ve d i n test pr o d uct a n d test diar y 
di s pe nsi n g must n ot be i n v ol ve d i n a n y assess me nt s i n or der t o pr otect t he bli n d.
6. 3. 2 0 . S u per vise d Test Pr o d uct A p plic ati o n P ost -Pr oce d ure
S u bjects ra n d o mize d t o test pr o d uct ( Gr o u p I) will be i nstr ucte d t o a p pl y t he test 
pr o d uct as per t he la belle d usa ge i nstr ucti o ns i m me diatel y after t he p ost -pr oce d ure, 
pre -treat me nt ( baseli ne) assess me nts are c o m plete . T he I n vesti gat or or desi g nee will 
o versee t his i nit ial pr o d uct a p plicati o n. Gr o u p II will n ot a p pl y  a n y test pr o d uct. 
Pr o d uct a p plicat i on will be rec or de d o n t he e C R F a n d s u bject diar y a n d m ust ha p pe n 
at least 3 0 mi n utes pri or t o a n y furt her i nstr u m e ntal meas ure me nts. T he I n vesti gat or 
or desi g nee i n v o l ve d i n t his ste p m ust n ot be i n v ol ve d i n a n y assess me nts i n or der t o 
pr otect t he bli n d.
6. 3. 2 1 . I nstr u me nt al Me as ureme nts P ost -Pr oce d ure , P ost-Tre at me n t
Meas ure me nt s t o be ta ke n a n d rec or de d as per 6. 3 . 10 , 1 8 0 ± 1 5 a n d 3 6 0 ± 1 5 mi n utes 
after c o mplet i on of t he facial peel pr oce d ure.
6. 3. 2 2 . S u bject Self -Assess me nt P ost -P r o ce d ure, P ost-Tre at me nt
Assess me nts t o be ta ke n a n d rec or de d as per 6.3 . 12 , 1 8 0 ± 1 5 mi n u t es after c o mplet i on 
of  t he facial peel pr oce d ure.
6. 3. 2 3 . E v al u at or ( Der m at ol o gist) Assess me nt P o st-Pr oce d ure , P ost-
Tre at m e nt
Assess me nts t o be ta ke n a n d rec or de d as per 6. 3. 13 , 1 8 0 ± 1 5 mi n utes after c o m plet i on 
of  t he facial peel pr oce d ure.
 
D oc u m e nt N a m e  
 
T y p e  
V ersi o n  
D oc u m e nt I d e ntifi er  
Eff ecti v e D at e  
 
 
 
 
R e as o n F or Iss u e  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
1 5- S e p- 2 0 1 7 0 9: 2 7: 1 5
 
Pr ot o c ol 2 0 6 8 2 7 
d o c
el d o _ c o ntr oll e d
4. 0; M o st- R e c e nt; Eff e cti v e; C U R R E N T
A ut o I s s u e
0 9 0 0 3 2 d 5 8 0 d 9 8 e b 9
Pa ge 6 1 of 9 3
C CI

6 2
S u bjects will re mai n at site u ntil at least 5: 0 0 P M t o pre ve nt e x p os ure t o i nte nse 
s u nli g ht.
6. 4 . Visit 4 – 1 d a y after Visit 3 
S u bjects will be i nstr ucte d t o arri ve at t he site pri or t o 9: 0 0 A M t o mi ni mize e x p os ure 
t o i nte nse s u nli g ht. 
6. 4. 1. C urre nt / C o nc o mit a n t Me dic ati o n
A n y c o nc o mit a nt t hera p y ta ke n si nce t he last visit a n d t hr o u g h o ut t he stu d y will be 
rec or de d o n t he e C R F b y t he I n vest i gat or or desi g nee.
6. 4. 2. A d verse E ve nts
A d verse e ve nts will be assesse d b y t he I n vest i gat or or desi g nee a n d rec or de d o n t he
e C R F, as per t he pr ocess detaile d i n Secti on 7.
As per Secti o n 7. 1, t he f oll o wi n g d oes n ot meet t he defi nit i on of a n a d verse e ve nt:
“ A n y cli nicall y si g nifica nt a b n or mal la b orat or y fi n di n gs (if a p plica ble) or ot her 
a b n or mal s af et y assess me nts w hic h are ass ociate d wit h t he u n derl yi n g disease, u nless 
j u d ge d b y t he i n vesti gat or t o be m ore se vere t ha n e x pecte d f or t he s u bject’s 
c o n ditio n.” T heref ore, t he Der mat ol o gist (er y t he ma, e de ma, dr y ness, a n d 
des q ua mat i on) a n d S u bject -self assess me nt ( pai n, sti n gi n g/ b ur ni n g, itc hi n g, tig ht ness, 
re d ness, a n d dr y ness) gra des will o nl y be c o nsi dere d a d verse e ve nts if t he y are sc ore d 
as “ Se vere”, or if t he i n vesti gat or j u d ges t he m t o be m ore se vere t ha n e x pecte d i n 
c o nte xt of t he Gl yc o lic Aci d treat me nt pr oce d ure. 
6. 4. 3. C o nti n ue d S u bject Eli gi bilit y
T he I n vesti gat or or desi g nee will ascertai n w het her t here ha ve bee n a n y de viat i ons 
fr om t he pr ot oc ol si nce t he last visit, w het her t he s u bject has a d here d t o t he lifest yle 
restrict i ons si nce t he last visit a n d w het her, i n t hei r o pi nio n , t he s u bject is eli gi ble t o 
c o nti n ue i n t he st u d y. S u bject C o nti n ue d S u bject Eli gi bilit y will be rec or de d o n t he 
e C R F.
6. 4. 4 . C o m pli a nce ( Di ar y Re vie w)
S u bject diaries will be re vie we d b y t he I n vest i gat or or t heir desi g nee. S u bjects w h o 
a p pl y t he was h o ut pr o d ucts ( All s u bjects) a n d test pr o d uct ( Gr o u p I, o nl y ) more or 
less fre q ue ntl y t ha n t wice a da y will be c o nsi dere d t o ha ve de viate d fr o m t he pr ot oc ol 
a n d a d dit i onal/ misse d a p plicat i ons will rec or de d o n t he De viat i ons L o g. T he t otal 
n u m ber of pr o d uct a p plicat i ons a n d t otal n u m ber of misse d pr o d uct a p plicat i on s will 
be rec or de d o n t he e C R F.
 
D oc u m e nt N a m e  
 
T y p e  
V ersi o n  
D oc u m e nt I d e ntifi er  
Eff ecti v e D at e  
 
 
 
 
R e as o n F or Iss u e  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
1 5- S e p- 2 0 1 7 0 9: 2 7: 1 5
 
Pr ot o c ol 2 0 6 8 2 7 
d o c
el d o _ c o ntr oll e d
4. 0; M o st- R e c e nt; Eff e cti v e; C U R R E N T
A ut o I s s u e
0 9 0 0 3 2 d 5 8 0 d 9 8 e b 9
Pa ge 6 2 of 9 3
C CI

6 3
6. 4 . 5. I nstr u me nt al Me as ure me nts P ost-Pr oce d ure, P ost -Tre at me nt ( 2 4 ± 4 
h o urs after F aci al Peel)
Meas ure me nt s t o be ta ke n a n d rec or de d as per 6.3. 1 0 , 2 4 ± 4 h o urs aft er c o m pleti o n o f 
t he facial peel pr oce d ure .
6. 4. 6 . I ma ge C a pt ure ( VI SI A) P o st-Pr oce d ure, P ost -Tre at me nt ( 2 4 ± 4 
h o urs after F aci al Peel)
Assess me nts t o be ta ke n a n d rec or de d as per 6. 3. 1 1 , 2 4 ± 4 h o urs aft er c o m pleti o n o f 
t he facial peel pr oce d ure .
6. 4. 7 . S u bject Self -Assess me nt P ost -Pr oce d ure , P ost-Tre at me nt ( 2 4 ± 4 
h o urs after F aci al Peel)
Assess me nts t o be ta ke n a n d rec or de d as per 6. 3. 12 , 2 4 ± 4 h o urs aft er c o m pleti o n o f 
t he facial peel pr oce d ure .
6. 4. 8 . Der mat ol o gist Assess me nt P ost -P r o ce d ure, P ost - Tre ate me nt ( 2 4 ± 4 
h o urs after F aci al Peel)
Assess me nts t o be ta ke n a n d rec or de d as per 6. 3. 1 3 , 2 4 ± 4 h o urs aft er c o m pleti o n o f 
t he facial peel pr oce d ure .
6. 4. 9. S u per vise d Test Pr o d uct A p plic ati o n
O nl y s u bjects i n Gr o u p I will u n der g o s u per vise d test pr o d uct a p plicati o n. T he 
I n vesti gat or or desi g nee will o versee a p plicati o n of t he test pr o d uct. Pr o d uct 
a p plicat i on will be rec or de d o n t he e C R F a n d s u bject diar y. T he I n vesti gat or or 
desi g nee i n v o l ve d i n t his ste p m ust n ot be i n v ol ve d i n a n y assess me nts i n or der t o 
pr otect t he bli n d.
6. 4 . 10 . S u per vise d S u nscree n A p plic ati o n
All s u bjects will u n der g o s u per vise d s u nscree n a p plicat i on. T he I n vest i gat or or 
desi g nee will o versee a p plicat i on of t he S P F 5 0 s u nscree n. Pr o d uct a p plicati on will 
be rec or de d o n t he e C R F a n d s u bject diar y. 
6. 5 . Visit 5 – 1 d a y after Visit 4  
S u bjects will be i nstr ucte d t o arri ve at t he site pri or t o 9: 0 0 A M t o mi ni mize e x p os ure 
t o i nte nse s u nli g ht. 
 
D oc u m e nt N a m e  
 
T y p e  
V ersi o n  
D oc u m e nt I d e ntifi er  
Eff ecti v e D at e  
 
 
 
 
R e as o n F or Iss u e  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
1 5- S e p- 2 0 1 7 0 9: 2 7: 1 5
 
Pr ot o c ol 2 0 6 8 2 7 
d o c
el d o _ c o ntr oll e d
4. 0; M o st- R e c e nt; Eff e cti v e; C U R R E N T
A ut o I s s u e
0 9 0 0 3 2 d 5 8 0 d 9 8 e b 9
Pa ge 6 3 of 9 3
C CI

6 4
6. 5. 1. C urre nt / C o nc o mit a nt Me dic ati o n
A n y c o nc o mit a nt t hera p y ta ke n si nce t he last visit a n d t hr o u g h o ut t he stu d y will be 
rec or de d o n t he e C R F b y t he I n vesti gat or or desi g nee.
6. 5. 2. A d verse E ve nts
A d verse e ve nts will be assesse d b y t he I n vesti gat or or desi g nee a n d rec or de d o n t he 
e C R F, as per t he pr ocess detaile d i n Sect i on 7.
As per Sect i on 7. 1, t he f oll o wi n g d oes n ot meet t he defi nit i on of a n a d verse e ve nt:
“ A n y cli nicall y si g nifica nt a b n or mal la b orat or y fi n di n gs (if a p plica ble) or ot her 
a b n or mal s af et y assess me nts w hic h are ass ociate d wit h t he u n derl yi n g disease, u nless 
j u d ge d b y t he i nvest i gat or t o be m ore se vere t ha n e x pecte d f or t he s u bject’s 
c o n ditio n.” T heref ore, t he Der mat ol o gist (er y t he ma, e de ma, dr y ness, a n d 
des q ua mat i on) a n d S u bject -self assess me nt ( pai n, sti n gi n g/ b ur ni n g, itc hi n g, ti g ht ness, 
re d ness, a n d dr y ness) gra des will o nl y be c o nsi dere d a d verse e ve nts if t he y are sc ore d 
as “ Se vere”, or if t he i n vesti gat or j u d ges t he m t o be m ore se vere t ha n e x pecte d i n 
c o nte xt of t he Gl yc o lic Aci d treat me nt pr oce d ure. 
6. 5. 3. C o nti n ue d S u bject Eli gi bilit y
T he I n vesti gat or or desi g nee will ascertai n w het her t here ha ve bee n a n y de viat i ons 
fr om t he pr ot oc ol si nce t he last visit, w het her t he s u bject has a d here d t o t he lifest yle 
restrict i ons si nce t he last visit a n d w het her, i n t heir o pi ni o n, t he s u bject is eli gi ble t o 
c o nti n ue i n t he st u d y. S ubject C o nti n ue d S u bject Eli gi bilit y will be rec or de d o n t he 
e C R F.
6. 5. 4. C o m pli a nce ( Di ar y Re vie w)
S u bject diaries will be re vie we d b y t he I n vest i gat or or t heir desi g nee. S u bjects w h o 
a p pl y t he was h o ut pr o d ucts ( All s u bjects) a n d test pr o d uct ( Gr o u p I, o n l y) m o re or 
less fre q ue ntl y t ha n t wice a da y will be c o nsi dere d t o ha ve de viate d fr o m t he pr ot oc ol 
a n d a d dit i onal/ misse d a p plicat i ons will rec or de d o n t he De viat i ons L o g. T he t otal 
n u m ber of pr o d uct a p plicat i ons a n d t otal n u m ber of misse d pr o d uct a p plicat io ns will  
be rec or de d o n t he e C R F. 
6. 5. 5 . I nstr u me nt al Me as ure me nts Post -Pr oce d ure, P ost -Tre at me nt ( 4 8 ± 4 
h o urs after F aci al Peel)
Meas ure me nt s t o be ta ke n a n d rec or de d as per 6. 3. 10 , 4 8 ± 4 h o urs aft er c o m pleti o n o f 
t he facial peel pr oce d ure .
 
D oc u m e nt N a m e  
 
T y p e  
V ersi o n  
D oc u m e nt I d e ntifi er  
Eff ecti v e D at e  
 
 
 
 
R e as o n F or Iss u e  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
1 5- S e p- 2 0 1 7 0 9: 2 7: 1 5
 
Pr ot o c ol 2 0 6 8 2 7 
d o c
el d o _ c o ntr oll e d
4. 0; M o st- R e c e nt; Eff e cti v e; C U R R E N T
A ut o I s s u e
0 9 0 0 3 2 d 5 8 0 d 9 8 e b 9
Pa ge 6 4 of 9 3
C CI

6 5
6. 5. 6 . S u bject Self-Assess me nt P ost -Pr oce d ure , P ost-Tre at me nt ( 4 8 ± 4 
h o urs after F aci al Peel)
Assess me nts t o be ta ke n a n d rec or de d as per 6. 3. 1 2 , 4 8 ± 4 h o urs aft er c o m pleti o n o f 
t he facial peel pr oce d ure .
6. 5. 7 . Der mat ol o gist Assess me nt P ost -P r o ce d ure, P ost-Tre ate me nt ( 4 8± 4 
h o urs after F aci al Peel)
Assess me nts t o be ta ke n a n d rec or de d as per 6. 3. 1 3 , 4 8 ± 4 h o urs aft er c o m pleti o n o f 
t he facial peel pr oce d ure .
6. 5. 8 . S u per vise d Test Pr o d uct A p plic ati o n
O nl y s u bjects i n Gr o u p I will u n der g o s u per vise d test pr o d uct a p plicati o n. T he 
I n vesti gat or or desi g nee will o versee a p plicati o n of t he test pr o d uct. Pr o d uct 
a p plicat i on will be rec or de d o n t he e C R F a n d s u bject diar y . T he I n vesti gat or or 
desi g nee i n v o l ve d i n t his ste p m ust n ot be i n v ol ve d i n a n y assess me nts i n or der t o 
pr otec t t he bli n d.
6. 5. 9 . S u per vise d S u nscree n A p plic ati o n
All s u bjects will u n der g o s u per vise d s u nscree n a p plicat i on. T he I n vest i gat or or 
desi g nee will o versee a p plicat i on of t he S P F 5 0 s u nscree n. Pr o d uct a p plicat i on will 
be rec or de d o n t he e C R F a n d s u bject di ar y. 
6. 6 . Visit 6 – 1 d a y after Visit 5  
S u bjects will be i nstr ucte d t o arri ve at t he site pri or t o 9: 0 0 A M t o mi ni mize e x p os ure 
t o i nte nse s u nli g ht. 
6. 6. 1. C urre nt / C o nc o mit a nt Me dic ati o n
A n y c o nc o mit a nt t hera p y ta ke n si nce t he last visit a n d t hr o u gh o ut t he stu d y will be 
rec or de d o n t he e C R F b y t he I n vesti gat or or desi g nee.
6. 6. 2. A d verse E ve nts
A d verse e ve nts will be assesse d b y t he I n vesti gat or or desi g nee a n d rec or de d o n t he 
e C R F, as per t he pr ocess detaile d i n Sect i on 7.
As per Secti o n 7. 1, t h e foll o wi n g d oes n ot meet t he defi nit i on of a n a d verse e ve nt:
“ A n y cli nicall y si g nifica nt a b n or mal la b orat or y fi n di n gs (if a p plica ble) or ot her 
a b n or mal s af et y assess me nts w hic h are ass ociate d wit h t he u n derl yi n g disease, u nless 
j u d ge d b y t he i n vesti gat or t o be more se vere t ha n e x pecte d f or t he s u bject’s 
 
D oc u m e nt N a m e  
 
T y p e  
V ersi o n  
D oc u m e nt I d e ntifi er  
Eff ecti v e D at e  
 
 
 
 
R e as o n F or Iss u e  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
1 5- S e p- 2 0 1 7 0 9: 2 7: 1 5
 
Pr ot o c ol 2 0 6 8 2 7 
d o c
el d o _ c o ntr oll e d
4. 0; M o st- R e c e nt; Eff e cti v e; C U R R E N T
A ut o I s s u e
0 9 0 0 3 2 d 5 8 0 d 9 8 e b 9
Pa ge 6 5 of 9 3
C CI

6 6
c o n ditio n.” T heref ore, t he Der mat ol o gist (er y t he ma, e de ma, dr y ness, a n d 
des q ua mat i on) a n d S u bject -self assess me nt ( pai n, sti n gi n g/ b ur ni n g, itc hi n g, ti g ht ness, 
re d ness, a n d dr y ness) gra des will o nl y be c o nsidere d a d verse e ve nts if t he y are sc ore d 
as “ Se vere”, or if t he i n vesti gat or j u d ges t he m t o be m ore se vere t ha n e x pecte d i n 
c o nte xt of t he Gl yc o lic Aci d treat me nt pr oce d ure. 
6. 6. 3. C o nti n ue d S u bject Eli gi bilit y
T he I n vesti gat or or desi g nee will ascertai n w het her t here ha ve bee n a n y de viat i ons 
fr om t he pr ot oc ol si nce t he last visit, w het her t he s u bject has a d here d t o t he lifest yle 
restrict i ons si nce t he last visit a n d w het her, i n t heir o pi ni o n, t he s u bject is eli gi ble t o 
c o nti n ue i n t he st u d y. S u bject C o ntin ue d S u bject Eli gi bilit y will be rec or de d o n t he 
e C R F.
6. 6. 4. C o m pli a nce ( Di ar y Re vie w)
S u bject diaries will be re vie we d b y t he I n vest i gat or or t heir desi g nee. S u bjects w h o 
a p pl y t he was h o ut pr o d ucts ( All s u bjects) a n d test pr o d uct ( Gr o u p I, o nl y ) mor e or
less fre q ue ntl y t ha n t wice a da y will be c o nsi dere d t o ha ve de viate d fr o m t he pr ot oc ol 
a n d a d dit i onal/ misse d a p plicat i ons will rec or de d o n t he De viat i ons L o g. T he t otal 
n u m ber of pr o d uct a p plicat i ons a n d t otal n u m ber of misse d pr o d uct a p plicat i ons will 
be rec or de d o n t he e C R F. 
6. 6. 5 . I nstr u me nt al Me as ure me nts P ost-Pr oce d ure, P ost -Tre at me nt ( 7 2 ± 4 
h o urs after F aci al Peel)
Meas ure me nt s t o be ta ke n a n d rec or de d as per 6. 3. 10 , 7 2 ± 4 h o urs aft er c o m pleti o n o f 
t he facial peel pr oce d ure .
6. 6. 6 . S u bject Self-Asse ss me nt P ost-Pr oce d ure , P ost-Tre at me nt ( 7 2 ± 4 
h o urs after F aci al Peel)
Assess me nts t o be ta ke n a n d rec or de d as per 6. 3. 1 2 , 7 2 ± 4 h o urs aft er c o m pleti o n o f 
t he facial peel pr oce d ure .
6. 6. 7 . Der mat ol o gist Assess me nt P ost -P r o ce d ure, P ost-Tre ate me nt ( 7 2 ± 4 
h o urs after F aci al Peel)
Assess me nts t o be ta ke n a n d rec or de d as per 6. 3. 1 3 , 7 2 ± 4 h o urs aft er c o m pleti o n o f 
t he facial peel pr oce d ure .
6. 6. 8 . S u per vise d Test Pr o d uct A p plic ati o n
O nl y s u bjects i n Gr o u p I will u n der g o s u per vise d test pr o d uct a p plicati o n. T he 
I n vesti gat or or desi g nee will o versee a p plicati o n of t he test pr o d uct. Pr o d uct 
 
D oc u m e nt N a m e  
 
T y p e  
V ersi o n  
D oc u m e nt I d e ntifi er  
Eff ecti v e D at e  
 
 
 
 
R e as o n F or Iss u e  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
1 5- S e p- 2 0 1 7 0 9: 2 7: 1 5
 
Pr ot o c ol 2 0 6 8 2 7 
d o c
el d o _ c o ntr oll e d
4. 0; M o st- R e c e nt; Eff e cti v e; C U R R E N T
A ut o I s s u e
0 9 0 0 3 2 d 5 8 0 d 9 8 e b 9
Pa ge 6 6 of 9 3
C CI

6 7
a p plicat i on will be rec or de d o n t he e C R F a n d s u bject diar y . T he I n vesti gat or or 
desi g nee i n v o l ve d i n t his ste p m ust n ot be i n v ol ve d i n a n y assess me nts i n or der t o 
pr otect t he bli n d.
6. 6. 9 . S u per vise d S u nscree n A p plic ati o n
All s u bjects will u n der g o s u per vise d s u nscree n a p plicat i on. T he I n vest i gat or or 
desi g nee will o versee a p plicat i on of t he S P F 5 0 s u nscree n. Pr o d uct a p plicat i on will 
be rec or de d o n t he e C R F a n d s u bject diar y. 
6. 7. Visit 7 – 4 d a ys after Visit 6 
S u bjects will be i nstr ucte d t o arri ve at t he site pri or t o 9: 0 0 A M t o mi ni mize e x p os ure 
t o i nte nse s u nli g ht. 
6. 7. 1. C urre nt / C o nc o mit a nt Me dic ati o n
A n y c o nc o mit a nt t hera p y ta ke n si nce t he last visit a n d t hr o u g h o ut t he stu d y will be 
rec or de d o n t he e C R F b y t he I n vesti gat or or desi g nee.
6. 7. 2. A d verse E ve nts
A d verse e ve nts will be assesse d b y t he I n vesti gat or or desi g nee a n d rec or de d o n t he 
e C R F, as per t he pr ocess detaile d i n Sect i on 7.
As per Secti o n 7. 1, t he f oll o wi n g d oes n ot m eet t he defi nit i on of a n a d verse e ve nt:
“ A n y cli nicall y si g nifica nt a b n or mal la b orat or y fi n di n gs (if a p plica ble) or ot her 
a b n or mal s af et y assess me nts w hic h are ass ociate d wit h t he u n derl yi n g disease, u nless 
j u d ge d b y t he i n vesti gat or t o be m ore se vere t ha n e x pecte d f or t he s u bject’s 
c o n ditio n.” T heref ore, t he Der mat ol o gist (er y t he ma, e de ma, dr y ness, a n d 
des q ua mat i on) a n d S u bject -self assess me nt ( pai n, sti n gi n g/ b ur ni n g, itc hi n g, ti g ht ness, 
re d ness, a n d dr y ness) gra des will o nl y be c o nsi dere d a d ver se e ve nts if t he y are sc ore d 
as “ Se vere”, or if t he i n vesti gat or j u d ges t he m t o be m ore se vere t ha n e x pecte d i n 
c o nte xt of t he Gl yc o lic Aci d treat me nt pr oce d ure. 
6. 7. 3. C o nti n ue d S u bject Eli gi bilit y
T he I n vesti gat or or desi g nee will ascertai n w het her t he re ha ve bee n a n y de viati ons 
fr om t he pr ot oc ol si nce t he last visit, w het her t he s u bject has a d here d t o t he lifest yle 
restrict i ons si nce t he last visit a n d w het her, i n t heir o pi ni o n, t he s u bject is eli gi ble t o 
c o nti n ue i n t he st u d y. S u bject C o ntin ue d S u bjec t Eli gi bility will be rec or de d o n t he 
e C R F.
 
D oc u m e nt N a m e  
 
T y p e  
V ersi o n  
D oc u m e nt I d e ntifi er  
Eff ecti v e D at e  
 
 
 
 
R e as o n F or Iss u e  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
1 5- S e p- 2 0 1 7 0 9: 2 7: 1 5
 
Pr ot o c ol 2 0 6 8 2 7 
d o c
el d o _ c o ntr oll e d
4. 0; M o st- R e c e nt; Eff e cti v e; C U R R E N T
A ut o I s s u e
0 9 0 0 3 2 d 5 8 0 d 9 8 e b 9
Pa ge 6 7 of 9 3
C CI

6 8
6. 7. 4. C o m pli a nce ( Di ar y Re vie w)
S u bject diaries will be re vie we d b y t he I n vest i gat or or t heir desi g nee. S u bjects w h o 
a p pl y t he was h o ut pr o d ucts ( All s u bjects) a n d test pr o d uct ( Gr o u p I, o nl y ) more or 
less fre q ue nt l y t ha n t wice a da y will be c o nsi dere d t o ha ve de viate d fr o m t he pr ot oc ol 
a n d a d dit i onal/ misse d a p plicat i ons will rec or de d o n t he De viat i ons L o g. T he t otal 
n u m ber of pr o d uct a p plicat i ons a n d t otal n u m ber of misse d pr o d uct a p plicat i ons will 
be rec or de d o n t he e C R F. 
6. 7. 5 . I nstr u me nt al Me as ure me nts Post -Pr oce d ure, P ost -Tre at me nt 
( 1 6 8± 4 h o urs after F aci al Peel)
Meas ure me nt s t o be ta ke n a n d rec or de d as per 6. 3. 10 , 1 6 8 ± 4 h o urs aft er c o mpleti o n 
of  t he facial peel pr oce d ure.
6. 7. 6 . S u bject Self-Assess me nt P o st-Pr oce d ure , P ost-Tre at me nt ( 1 6 8 ± 4 
h o urs after F aci al Peel)
Assess me nts t o be ta ke n a n d rec or de d as per 6. 3. 1 2 , 1 6 8 ± 4 h o urs aft er c o m pleti o n o f 
t he facial peel pr oce d ure .
6. 7. 7 . Der mat ol o gist Assess me nt P ost -P r o ce d ure, P ost-Tre ate me nt ( 1 6 8 ± 4 
h o urs after F aci al Peel)
Assess me nts t o be ta ke n a n d rec or de d as per 6. 3. 1 3 , 1 6 8 ± 4 h o urs aft er c o m pleti o n o f 
t he facial peel pr oce d ure .
6. 7. 8 . S u per vise d Test Pr o d uct A p plic ati o n
O nl y s u bjects i n Gr o u p I will u n der g o s u per vise d test pr o d uct a p plicati o n. T he 
I n vesti gat or or desig nee will  o versee a p plicatio n of  t he test pr o d uct. Pr o d uct 
a p plicat i on will be rec or de d o n t he e C R F a n d s u bject diar y . T he I n vesti gat or or 
desi g nee i n v o l ve d i n t his ste p m ust n ot be i n v ol ve d i n a n y assess me nts i n or der t o 
pr otect t he bli n d.
6. 7 . 9. S u per vise d S u nscree n A p plic ati o n
All s u bjects will u n der g o s u per vise d s u nscree n a p plicat i on. T he I n vest i gat or or 
desi g nee will o versee a p plicat i on of t he S P F 5 0 s u nscree n. Pr o d uct a p plicat i on will 
be rec or de d o n t he e C R F a n d s u bject diar y. 
6. 8 . Visit 8 – 7 d a ys after Visit 7  
S u bjects will be i nstr ucte d t o arri ve at t he site pri or t o 9: 0 0 A M t o mi ni mize e x p os ure 
t o i nte nse s u nli g ht. 
 
D oc u m e nt N a m e  
 
T y p e  
V ersi o n  
D oc u m e nt I d e ntifi er  
Eff ecti v e D at e  
 
 
 
 
R e as o n F or Iss u e  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
1 5- S e p- 2 0 1 7 0 9: 2 7: 1 5
 
Pr ot o c ol 2 0 6 8 2 7 
d o c
el d o _ c o ntr oll e d
4. 0; M o st- R e c e nt; Eff e cti v e; C U R R E N T
A ut o I s s u e
0 9 0 0 3 2 d 5 8 0 d 9 8 e b 9
Pa ge 6 8 of 9 3
C CI

6 9
6. 8. 1. C urre nt / C o nc o mit a nt Me dic ati o n
A n y c o nc o mit a nt t hera p y ta ke n si nce t he last visit a n d t hr o u g h o ut t he stu d y w ill be 
rec or de d o n t he e C R F b y t he I n vest i gat or or desi g nee.
6. 8. 2. A d verse E ve nts
A d verse e ve nts will be assesse d b y t he I n vest i gat or or desi g nee a n d rec or de d o n t he
e C R F, as per t he pr ocess detaile d i n Secti on 7.
As per Secti o n 7. 1, t he f oll o wi n g d oes n ot m eet t he defi nit i on of a n a d verse e ve nt:
“ A n y cli nicall y si g nifica nt a b n or mal la b orat or y fi n di n gs (if a p plica ble) or ot her 
a b n or mal s af et y assess me nts w hic h are ass ociate d wit h t he u n derl yi n g disease, u nless 
j u d ge d b y t he i n vesti gat or t o be m ore se vere t ha n e x pecte d f or t he s u bject’s 
c o n ditio n.” T heref ore, t he Der mat ol o gist (er y t he ma, e de ma, dr y ness, a n d 
des q ua mat i on) a n d S u bject -self assess me nt ( pai n, sti n gi n g/ b ur ni n g, itc hi n g, ti g ht ness, 
re d ness, a n d dr y ness) gra des will o nl y be c o nsi dere d a d verse e ve n ts if t he y are sc ore d 
as “ Se vere”, or if t he i n vesti gat or j u d ges t he m t o be m ore se vere t ha n e x pecte d i n 
c o nte xt of t he Gl yc o lic Aci d treat me nt pr oce d ure. 
6. 8. 3. C o nti n ue d S u bject Eli gi bilit y
T he I n vesti gat or or desi g nee will ascertai n w het her t here ha ve bee n a n y de viat i ons 
fr om t he pr ot oc ol si nce t he last visit, w het her t he s u bject has a d here d t o t he lifest yle 
restrict i ons si nce t he last visit a n d w het her, i n t heir o pi ni o n, t he s u bject is eli gi ble t o 
c o nti n ue i n t he st u d y. S u bject C o nti n ue d S u bject Eli gi bilit y will be rec or de d o n t he 
e C R F.
6. 8. 4 . C o m pli a nce ( Di ar y Re vie w)
S u bject diaries will be re vie we d b y t he I n vest i gat or or t heir desi g nee. S u bjects w h o 
a p pl y t he was h o ut pr o d ucts ( All s u bjects) a n d test pr o d uct ( Gr o u p I, o nl y ) more or 
less fre q ue ntl y tha n t wi ce a da y will be c o nsi dere d t o ha ve de viate d fr o m t he pr ot oc ol 
a n d a d dit i onal/ misse d a p plicat i ons will rec or de d o n t he De viat i ons L o g. T he t otal 
n u m ber of pr o d uct a p plicat i ons a n d t otal n u m ber of misse d pr o d uct a p plicat i ons will 
be rec or de d o n t he e C R F. 
6. 8. 5 . I nstr u me nt al Me as ure me nts P ost-Pr oce d ure, P ost -Tre at me nt 
( 3 3 6 ± 4 h o urs after F aci al Peel)
Meas ure me nt s t o be ta ke n a n d rec orde d as per 6. 3. 1 0 , 3 3 6 ± 4 h o urs after c o m pleti o n 
of  t he facial peel pr oce d ure.
 
D oc u m e nt N a m e  
 
T y p e  
V ersi o n  
D oc u m e nt I d e ntifi er  
Eff ecti v e D at e  
 
 
 
 
R e as o n F or Iss u e  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
1 5- S e p- 2 0 1 7 0 9: 2 7: 1 5
 
Pr ot o c ol 2 0 6 8 2 7 
d o c
el d o _ c o ntr oll e d
4. 0; M o st- R e c e nt; Eff e cti v e; C U R R E N T
A ut o I s s u e
0 9 0 0 3 2 d 5 8 0 d 9 8 e b 9
Pa ge 6 9 of 9 3
C CI

7 0
6. 8. 6 . I ma ge C a pt ure ( VI SI A) P ost -Pr oce d ure, P ost- Tre at me nt ( 3 3 6 ± 4 
h o urs after F aci al Peel)
Assess me nts t o be ta ke n a n d rec or de d as per 6. 3. 1 1 , 3 3 6± 4 h o urs after c o m pleti o n o f 
t he facial peel pr oce d ure.
6. 8 . 7. S u bject Self-Assess me nt P ost -Pr oce d ure, P ost -Tre at me nt ( 3 3 6 ± 4 
h o urs after F aci al Peel )
Assess me nts t o be ta ke n a n d rec or de d as per 6. 3. 1 2 , 3 3 6 ± 4 h o urs aft er c o m pleti o n o f 
t he facial peel pr oce d ure .
6. 8. 8 . S u bject Gl o b al Self-Assess me nt
Test s u bj ects will rate t he le vel o f satisfacti on wi t h t he p ost-pr oce d ure s ki n care 
re gi me n t o w hic h t hey were ra n d o mize d usi n g scale bel o w. T hese data will be 
rec or de d o n t he e C R F.
Sc ore
Descri pti o n
0
V er y  Satisfie d
1
S ati sfie d
2
P o orl y Sat isfie d
3
N ot at all Satisfie d
6. 8 . 9. Der mat ol o gist Asses me nt P ost -Pr oce d ure, P ost -Tre at me nt ( 3 3 6 ± 4 
h o urs after F a ci al Peel)
Assess me nts t o be ta ke n a n d rec or de d as per 6. 3. 1 3 , 3 3 6± 4 h o urs after c o m pleti o n o f 
t he facial peel pr oce d ure.
6. 8 . 10 . D e r m at ol o gist Gl o b al Assess me nt
T he Der m at olo gi st will assess t he lo c al  t olera nce of t he p ost -pr oce d ure s ki n care 
re gi me n i n c o nte xt of t he e x pecte d effects of t he pr oce d ure f or eac h s u bject usi n g t he 
scale bel o w a n d d oc u me nt t he sc ore o n t he e C R F. T o ma ke t his assess me nt, t he 
D er m at olo gi st will dra w o n t he t otal set of cli nical a n d s u bject self -assess me nt data 
f or eac h s u bject. T he Der mat ol o gist m u st be u na ware of w het her a s u bject was 
ra n d omize d t o test pr o d uct t o pr otect t he bli n d.  
 
D oc u m e nt N a m e  
 
T y p e  
V ersi o n  
D oc u m e nt I d e ntifi er  
Eff ecti v e D at e  
 
 
 
 
R e as o n F or Iss u e  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
1 5- S e p- 2 0 1 7 0 9: 2 7: 1 5
 
Pr ot o c ol 2 0 6 8 2 7 
d o c
el d o _ c o ntr oll e d
4. 0; M o st- R e c e nt; Eff e cti v e; C U R R E N T
A ut o I s s u e
0 9 0 0 3 2 d 5 8 0 d 9 8 e b 9
Pa ge 7 0 of 9 3
C CI

7 1
R ati n g
Descri pti o n
0 - Pr o d uct Re gi me n 
was Well T olerate d
N o cli nicall y si g nifica nt w orse ni n g of t he e x pecte d 
sig ns/s y m pt o m s of t he pr oce d ure. N o  ne w si g ns/s y m pt o ms 
ma nifest d uri n g pr o d uct use.
1 - Pr o d uct Re gi me n 
was N ot Well T o lerate d
Cl ear , cli nicall y rele va nt w o rse ni n g of t he se verity or 
fre q ue nc y of e x pecte d sig ns/s y m pt o m s of t he pr oce d ure 
a n d/ or a n y occ urre nce of ne w , u ne x pecte d sig ns/s y m pt o m s 
d uri n g pr o d uct use. 
6. 8 . 11 . Pr o d ucts a n d Test Di ar y Ret ur n
Was h o ut pr o d ucts, test pr o d uct
a n d test diar y will be ret ur ne d t o t he I n vest i gat or or 
desi g nee a n d d oc u me nte d o n t he e C R F. 
6. 8 . 12 . Disc h ar ge fr o m  St u d y
S u bjects will be e val uate d t o deter mi ne i f t he y c o m plete d all st u d y pr oce d ures or if 
t he y were disc o nti n ue d fr o m t he st u d y earl y.  If t he s u bject disc o nti n ue d at a n y p oi nt 
d uri n g t he st u d y , t he pri mar y reas o n f or wit hdra wal  s ho ul d be rec or de d o n t he St u d y  
C o ncl usi o n  pa ge of t he e C R F b y selecti n g o ne of t he o pti o ns bel o w.
1.
S u bject di d n ot meet st u d y  crit eria
2.
A d verse E ve nt
3.
L ost t o F oll o w U p
4.
Pr ot oc ol  Viol at i on
5.
Wit h dra wal o f C o nse nt
6.
Ot her
 
D oc u m e nt N a m e  
 
T y p e  
V ersi o n  
D oc u m e nt I d e ntifi er  
Eff ecti v e D at e  
 
 
 
 
R e as o n F or Iss u e  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
1 5- S e p- 2 0 1 7 0 9: 2 7: 1 5
 
Pr ot o c ol 2 0 6 8 2 7 
d o c
el d o _ c o ntr oll e d
4. 0; M o st- R e c e nt; Eff e cti v e; C U R R E N T
A ut o I s s u e
0 9 0 0 3 2 d 5 8 0 d 9 8 e b 9
Pa ge 7 1 of 9 3
C CI

7 2
7 . S A F E T Y A S S E S S M E N T S
7 . 1. Defi niti o ns of a n A d verse E ve nt a n d Seri o us A d verse E ve nt 
7 . 1. 1. A d verse E ve nts
T he i n vesti gat or or site staff will be res p o nsi ble f or detecti n g, d oc u me nti n g a n d 
re p orti n g e ve nts t hat meet t he defi niti on of a n A E or S A E.
A d verse E ve nt Defi niti o n:
1.
A n A E i s a n y u nt o war d me dical occ urr e nce i n a s u bject or cli nical 
i n vesti gati on s u bject, te m p orall y  ass o ciate d wit h t he use of a n i n vesti gati onal 
or was h o ut pr o d uct, w het her or n ot c o nsi dere d relate d t o t he i n vest i gati onal or 
was h o ut pr o d uct.
2.
N O T E: A n A E ca n t heref ore be a n y u nfa v ora ble a n d u ni nte n de d si g n 
(incl u di n g a n a b n or mal la b orat or y fi n di n g), s y m pt o m, or disease ( ne w or 
e xacer bate d) te m p orall y ass ociate d wit h t he use of a n i n vest i gati onal or 
was h o ut pr o d uct.
E ve nts meeti n g A E defi niti o n i ncl u de:
1.
A n y a b n or mal la b orat or y  test res ults (if a p plica ble) or ot her safet y 
assess me nts, i ncl u di n g t h ose t hat w orse n fr o m baseli ne, a n d felt t o be 
cli nicall y si g nifica nt i n t he me dical a n d scie nt ific j u d g me nt of t he 
i n vesti gat or.
2.
E xacer bat i on of a c hr o nic or i nter mitte nt pre -e xist i n g c o n diti on i ncl udi n g 
eit her a n i ncrease i n fre q ue nc y a n d/ or i nte nsit y of  t he c o n ditio n .
3.
Ne w c o n dit i on(s) detecte d or dia g n ose d after st u d y pr o d uct a d mi nistrati o n 
e ve n t h o u g h it ma y ha ve bee n prese nt pri or t o t he start of t he st u d y.
4.
Si g ns, s y m pt o ms, or t he cli nical se q uela e of a s us pecte d i nteracti o n.
5.
Si g ns, s y m pt o ms, or t he cli nical se q uelae of a s us pecte d o ver d ose of eit her 
st u d y pr o d uct or a c o nc o mita nt me dicati on ( o ver d ose per se will n ot be 
re p orte d as a n A E/ S A E).
E ve nts N O T meeti n g defi niti o n of a n A E i ncl u de:
1.
A n y cli nicall y sig nifica nt a b n or mal la b orat or y  fi n di n gs (if a p plica ble) or ot her 
a b n or mal s af et y assess me nts w hic h are ass ociate d wit h t he u n derl yi n g disease, 
u nless j u d ge d b y t he i n vesti gat or t o be m ore se vere t ha n e x pecte d f or t he 
s u bject’s c o n diti on. 
2.
T he d isease/ dis or der/ c o n diti on bei n g st u die d or e x pecte d pr o gressi o n, si g ns, 
or s y m pt o ms of t he disease/ dis or der bei n g st u die d, u nless m ore se vere t ha n 
e x pecte d f or t he s u bject’s c o n dit i on.. 
3.
Me dical or s ur gical pr oce d ure (e. g., e n d osc o p y , a p pe n dect o m y): t he co n di tio n 
t hat lea ds t o t he pr oce d ure is a n A E.
 
D oc u m e nt N a m e  
 
T y p e  
V ersi o n  
D oc u m e nt I d e ntifi er  
Eff ecti v e D at e  
 
 
 
 
R e as o n F or Iss u e  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
1 5- S e p- 2 0 1 7 0 9: 2 7: 1 5
 
Pr ot o c ol 2 0 6 8 2 7 
d o c
el d o _ c o ntr oll e d
4. 0; M o st- R e c e nt; Eff e cti v e; C U R R E N T
A ut o I s s u e
0 9 0 0 3 2 d 5 8 0 d 9 8 e b 9
Pa ge 7 2 of 9 3
C CI

7 3
4.
Si t u atio ns w here a n u nt o war d me dical occ urre nce di d n ot occ ur (s ocial a n d/ or 
c o n ve nie nce a d missi o n t o a h os pital).
5.
A nt ici pate d da y-t o-da y fl uct uati o ns of pre-e xist i n g disease(s) or c o n diti on(s) 
prese nt or dete ct e d at t he start of t he st u d y t hat d o n ot w orse n.
7 . 1. 2. Seri o us A d verse E ve nts
Seri o us A d verse E ve nt is defi ne d as a n y u nt o w ar d me dic al occ urre nce t h at, at 
a n y d ose:
A.
Res ults i n de at h
B.
Is life-t hre ate ni n g
N O T E: T he ter m 'life -t hreate ni n g' i n t he defi niti on of 'seri o us' refers t o a n 
e ve nt i n w hic h t he s u bject was at ris k of deat h at t he ti me 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 het icall y mi g ht ha ve ca use d deat h, if it were 
m o re se vere.
C.
Re q uires h os pit aliz ati o n or pr ol o n g ati o n of e xisti n g h os pit aliz ati o n
N O T E: I n ge neral, h os pitalizat i on si g nifies t hat t he s u bject has bee n detai ne d 
( us uall y i n v ol vi n g at least a n o ver ni g ht sta y) at the h os pital or e mer ge nc y 
war d f or o bser vati o n a n d/ or treat me nt t hat w o ul d n ot ha ve bee n a p pr o priate i n 
t he p h ysicia n’s office or o ut -s u bject setti n g.  C o m plicati ons t hat occ ur d uri n g 
h os pi talizatio n are A Es.  If a c o m plicati o n pr ol o n gs h os pi talizatio n or f ulfills 
a n y ot her seri o us criteria, t he e ve nt is seri o us.  W he n i n d o u bt as t o w het her 
“ h os pitalizat i on” occ urre d or was necessar y , t he A E s h o uld be c o nsi dere d 
serio us.
H os pitalizati o n f or elect i ve treat me nt of a pre-e xisti n g c o n dit i on t hat di d n ot 
w orse n fr o m baseli ne is n ot c o nsi dere d a n A E.
D.
Res ults i n dis a bilit y/i nc a p acit y
N O T E: T he ter m disa bilit y mea ns a s u bsta nt ial disr u ptio n of  a pers o n’s a bility 
t o c o n d uct n or mal life f u ncti ons.
T his defi nit i on is n ot i nte n de d t o i ncl u de e x perie nces of relati vel y mi n or 
me dical si g nifica nce s uc h as u nc o m p licate d hea dac he, na usea, v omit i n g, 
di arr hea, i nfl ue nza, a n d acci de ntal tra u ma (e. g. s prai ne d a n kle) w hic h ma y  
i nterfere or pre ve nt e ver yd a y  life f u ncti ons b ut d o n ot c o nstit ute a s u bsta nt ial 
di sr u pti on.
E.
Is a c o n ge nit al a n o m al y/ birt h defect
F.
Ot her Sit u ati o ns
1.
Me dical or scie nt ific j u d g me nt s h o ul d be e xercise d i n deci di n g 
w het her re p orti n g is a p pr o priate i n ot her sit uati o ns, s uc h as i m p orta nt 
me dical e ve nts t hat ma y n ot be i m me diatel y life -t hreate ni n g or res ult 
i n deat h or h os pitalizati on b ut ma y je o par dize t he s u bject or ma y 
re q uir e me dical or s ur gical i nter ve nt i on t o pre ve nt o ne of t he ot her 
o utc o m es liste d i n t he a b o ve defi nit i on. T hese s h o ul d als o be 
 
D oc u m e nt N a m e  
 
T y p e  
V ersi o n  
D oc u m e nt I d e ntifi er  
Eff ecti v e D at e  
 
 
 
 
R e as o n F or Iss u e  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
1 5- S e p- 2 0 1 7 0 9: 2 7: 1 5
 
Pr ot o c ol 2 0 6 8 2 7 
d o c
el d o _ c o ntr oll e d
4. 0; M o st- R e c e nt; Eff e cti v e; C U R R E N T
A ut o I s s u e
0 9 0 0 3 2 d 5 8 0 d 9 8 e b 9
Pa ge 7 3 of 9 3
C CI

7 4
c o nsi dere d seri o us.
2.
E xa m ples of s uc h e ve nts are i n vasi ve or mali g na nt ca ncers, 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 for aller gi c br o nc h os pas m, 
bl o o d d yscrasias or c o n v ulsi o ns t hat d o n ot res ult i n h os pitalizat i on or 
de vel o p me nt of dr u g de pe n de nc y  or dr u g a b use or re p orts of 
s p o nta ne o us a b orti o n.
7. 2 . R ec or di n g A d verse E ve nt s a n d Seri o us A d verse E ve nt s
Rec or di n g of a d verse e ve nts a n d seri o us a d verse e ve nts:
1.
T he i n vest i gat or or site staff will be res p o nsi ble f or detecti n g, d oc u me nti n g 
a nd re p orti n g e ve nts t hat meet t he defi nit i on of a n A E or S A E. 
2.
T he i n vest i gat or or site staff will t he n rec or d all rele va nt i nf or mati on 
re gar di n g a n A E/ S A E i n t he e C R F.
3.
T here m a y be i nsta nces w he n c o pies of me dical rec or ds f or certai n cases are 
re q ueste d b y G S K.  I n t hi s i nsta nce, all s u bject i de ntifiers, wit h t he e xce pti on 
of  t he s u bject n u m ber, will be bli n de d o n t he c o pies of t he me dical rec or ds 
pri or t o s u b missi o n t o G S K.
4.
T he i n vest i gat or will atte m pt t o esta blis h a dia g n osis of t he e ve nt base d o n 
sig ns, s y m pt o ms, a n d/ or ot her cli nical i nf or mati o n.  I n s uc h cases, t he 
di a g n osis will be d oc u me nte d as t he A E/ S A E a n d n ot t he i n di vi d ual 
sig ns/s y m pt o m s. Cli nical AEs will be descri be d b y dia g n osis a n d n ot b y  
s y m pt o ms w he n p ossi ble (e. g., u p per res pirat or y tract i nfecti o n, seas o nal 
aller g y, etc. i nstea d of r u n n y nose).
5.
A Es will be c o llecte d fr om t he start of t he st u d y m at erial se nsitivi t y test at 
Vi sit 1 a n d u nt il 5 da ys f oll owi n g last a d mi nistrati o n of t he st u d y  pr o d uct.
6.
S A Es will be c ollecte d o ver t he sa me ti me p eri o d as state d a b o ve f or A Es.  
H o we ver, a n y  S A Es assesse d as rel ate d t o st u d y p artici pat i on (e. g., 
i n vesti gati onal pr o d uct, pr ot oc ol ma n date d pr oce d ures, i n vasi ve tests, or 
c ha n ge i n e xist i n g t hera p y) or relate d t o a G S K c o nc omit a nt me dicat i on will 
be r ec or de d fr o m t he ti me a s u bject c o nse nts t o partici pate i n t he st u d y  u p t o 
a n d i ncl u di n g a n y f o ll ow- u p c o ntact.  
7.
Me dical c o n dit i ons re p orte d pri or t o t he ti me peri o d f or re p orti n g A Es/ S A Es 
s h o uld be rec or de d as part of t he s u bject’s me dical hist or y .
7. 3 . E v al u ati n g A d verse E ve nt s a n d Seri o us A d verse E ve nt s
Assess me nt of I nte nsit y:
T he i n vest i gat or or desi g nee will ma ke a n assess me nt of i nte nsity f or eac h A E a n d 
S A E re p orte d d uri n g t he st u d y  a n d will assi g n it t o o ne of t he f oll owi n g cate g ori es:
1.
Mil d:  A n e ve nt t hat is easil y t olerate d b y  t he s u bject, ca usi n g mi ni mal 
di sc o mf ort a n d n ot i nterferi n g wit h e ver y da y act i vities.
2.
M o derate:  A n e ve nt t hat is s ufficie nt l y disc omf o rti n g t o i nterfere wit h n or mal 
 
D oc u m e nt N a m e  
 
T y p e  
V ersi o n  
D oc u m e nt I d e ntifi er  
Eff ecti v e D at e  
 
 
 
 
R e as o n F or Iss u e  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
1 5- S e p- 2 0 1 7 0 9: 2 7: 1 5
 
Pr ot o c ol 2 0 6 8 2 7 
d o c
el d o _ c o ntr oll e d
4. 0; M o st- R e c e nt; Eff e cti v e; C U R R E N T
A ut o I s s u e
0 9 0 0 3 2 d 5 8 0 d 9 8 e b 9
Pa ge 7 4 of 9 3
C CI

7 5
e ver y da y act i vities
3.
Se vere:  A n e ve nt t hat pre ve nts n or mal e ver y da y acti vit ies. - a n A E t hat is 
assesse d as se vere will n ot be c o nf use d wit h a n S A E. Se verit y is a cate g or y 
utilize d f or rati n g t he i nte nsit y of a n e ve nt; a n d b ot h A Es a n d S A Es ca n be 
assesse d as se vere.
N ote: A n e ve nt is defi ne d as ‘seri o us’ w he n it meets at least o ne of t he pre -defi ne d 
o utc o m es as descri be d i n t he defi nit i on of a n S A E.
Assess me nt of C a us alit y:
1.
T he i n vest i gat or is o bli gate d t o assess t he relati o ns hi p bet wee n st u d y pr o d uct 
a n d t he occ urre nce of eac h A E/ S A E.
2.
A "reas o na ble p ossi bilit y" is me a nt t o c o n ve y t hat t here are facts/e vi de nce or 
ar g u me nts t o s u g gest a ca usal relati o ns hi p, rat her t ha n a relat i ons hi p ca n n ot be 
r ule d o ut.
3.
T he i n vest i gat or will use cli nical j u d g me nt t o deter mi ne t he relati ons hi p.
4.
Alt er nat i ve ca uses, s uc h as nat ural hist or y of t he u n derl yi n g diseases, 
c o nc o mita nt t hera p y, ot her ris k fact ors, a n d t he te m p oral relati ons hi p of t he 
e ve nt t o t he st u d y pr o d uct will be c o nsi dere d a n d i n vesti gate d.
5.
T he i n vest i gat or will als o c o ns ult t he Pr o d uct I nf or mati on, f or m ar kete d 
pr o d ucts, i n t he deter mi nat i on of his/ her assess me nt.
6.
F or eac h A E/ S A E t he i n vesti gat or m ust d oc u me nt i n t he me dical n otes 
(s o urce d oc u me nt) or e C R F t hat he/s he has re vie we d t he A E/ S A E a n d has 
pr o vi de d a n assess me nt of ca usalit y.
7.
T here ma y be sit uat i ons w he n a n S A E has occ urre d a n d t he i n vest i gat or has 
mi ni mal i nf or mat i on t o i ncl u de i n t he i nit ial re p ort t o G S K.  H o we ver, it is 
ver y i m p ort a nt t h at t he i n vesti g at or al w a ys m a ke a n assess me nt of 
c a us alit y f or e ver y e ve nt pri or t o t he i niti al tr a ns missi o n of t he S A E d at a 
t o G S K.
8.
T he i n vest i gat or ma y c ha n ge his/ her o pi ni on of ca usalit y i n li g ht of f oll ow- u p 
i nf or mat i on, a m e n di n g t he S A E data c ollect i on t o ol acc or di n gl y.
9.
T he ca usalit y assess me nt is o ne of t he crit eria use d w he n deter mi ni n g
re g ulat or y re p orti n g re q uire me nts.
7. 4 . Re p orti n g A d verse E ve nt s a n d Seri o us A d verse E ve nt s
A E Re p orti n g t o G S K C H:
1.
A Es will be rec or de d i n t he A E sect i on of t he e C R F. 
2.
Me dical c o n dit i ons rec or de d b y  t he s u bject o n a diar y car d or si milar 
d oc u m e nt t hat meet t he defi nit i on of a n A E m ust als o be rec or de d i n t he A E 
secti on of t he e C R F, if n ot pre vio usl y  w ell-c haracterize d b y t he i n vesti gat or i n 
t he s u bject’s me dical hist or y. 
3.
A Es elicite d b y t he i n vesti gat or i n a sta n dar d ma n ner at t he st u d y visits s h o ul d 
als o be rec or de d i n t he A E sect i on of t he eC R F .  T he i n vesti gat or or desi g nee 
m ust as k t he s u bject t he f o ll owi n g q uesti o n d uri n g eac h visit i ncl u di n g a n y 
 
D oc u m e nt N a m e  
 
T y p e  
V ersi o n  
D oc u m e nt I d e ntifi er  
Eff ecti v e D at e  
 
 
 
 
R e as o n F or Iss u e  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
1 5- S e p- 2 0 1 7 0 9: 2 7: 1 5
 
Pr ot o c ol 2 0 6 8 2 7 
d o c
el d o _ c o ntr oll e d
4. 0; M o st- R e c e nt; Eff e cti v e; C U R R E N T
A ut o I s s u e
0 9 0 0 3 2 d 5 8 0 d 9 8 e b 9
Pa ge 7 5 of 9 3
C CI

7 6
f oll ow- u p visits:  “ H ave y o u felt u n well, e x perie nce d a ny sy m pt o ms or t a ke n 
a ny me dic ati o n (si nce y o ur l ast visit) (t o d ay) (si nce y o ur l ast d ose) (si nce t he 
l ast sessi o n) ? ”
4.
T he m e dicall y q ualifie d i n vesti gat or s h o ul d re vie w a d verse e ve nts i n a ti mel y  
ma n ner; t his re vie w s h o ul d be d oc u me nte d i n writ i n g i n t he s o urce d oc u me nt 
or i n t he e C R F. 
5.
After t he st u d y  is c o mplete d at a gi ve n site, a n d t he site has recei ve d t heir 
st u d y data o n C o mpact Discs ( C Ds), t he el ectr o nic data c ollecti o n t o ol will be 
r e mo ve d fr o m  t he i nter net t o pre ve nt t he e ntr y of ne w data or c ha n ges t o 
e xist i n g data.
S A E Re p orti n g t o G S K C H:
A pa per c o p y  of t he S A E f or m pr o vide d i n t he i n vesti gat or st u d y master file s h o ul d 
be c o m p lete d as f ull y as p ossi ble. 
It is esse ntial t o e nter t he f oll o wi n g i nf or mati on: 
1.
Pr ot oc ol  a n d s u bject ide nt ifiers
2.
S u bject’s de m o gra p h y
3.
Descri pt i on of e ve nts, wit h dia g n osis if a vaila ble
4.
I n vesti gat or o pi ni on of  relatio ns hi p t o st u d y  pr o d uct (see secti o n 7 . 3)
5.
Cri t erio n f or s eri o us ness.
T he f o ll owi n g are desira ble a n d are of partic ular rele va nce f or i n vest i gat or a n d 
G S K C H assess me nt of t he S A E re p ort:
1.
Date of o nset of A E 
2.
Date A E st o p pe d, if rele va nt
3.
St u d y  pr o duct start date
4.
St u d y  pr o d uct e n d date if rele va nt
5.
Act i on ta ke n o n st u d y  pr o d uct
6.
O utc o m e if k n o w n
T he S A E f or m, c o m plete d as f ull y  as p ossi ble, a n d S A E fa x c o ver s heet m ust be 
fa xe d or e-maile d t o t he a p pr o priate G S K C H St u d y Ma na ger as s o o n as p ossi ble, b u t 
n ot l ater t h a n 2 4 h o urs after st u d y site pers o n nel lear n of t he e ve nt. T he G S K C H 
St u d y  Ma na ger s h o uld be n otifie d of t he sit uat i on b y tele p h o ne or e mail.
F a x Seri o us A d verse E ve nts t o:
U S: 
T he G S K C H S A E C o or di nat or will be res p o nsi ble f or f or war di n g t he S A E f or m t o 
t he Case Ma na ge me nt Gr o u p, Gl o bal Cli nical Safet y  a n d P har mac o vi gila nce , t he 
Me dical Direct or res p o nsi ble f or t he st u d y  a n d ot her G S K C H pers o n nel as 
a p pr o priate via e mail.
Br azil S A E C o or di n at or (
):
 
D oc u m e nt N a m e  
 
T y p e  
V ersi o n  
D oc u m e nt I d e ntifi er  
Eff ecti v e D at e  
 
 
 
 
R e as o n F or Iss u e  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
1 5- S e p- 2 0 1 7 0 9: 2 7: 1 5
 
Pr ot o c ol 2 0 6 8 2 7 
d o c
el d o _ c o ntr oll e d
4. 0; M o st- R e c e nt; Eff e cti v e; C U R R E N T
A ut o I s s u e
0 9 0 0 3 2 d 5 8 0 d 9 8 e b 9
Pa ge 7 6 of 9 3
P P D
P P D
C CI

7 7
T el : 
E- ma il: 
Br azil b ac k u p c o nt act (
):
T el : 
T he i nit ial re p ort will be f oll owe d u p wi t h more i nf or m at i on as rele va nt, or as 
re q ueste d b y t he G S K C H st u d y ma na ger.
7. 5 . F oll o w -u p of A d verse E ve nt s a n d Seri o us A d verse E ve nt s
F oll o w -u p of A Es a n d S A Es:
1.
After t he i nit ial re p ort, t he i n vesti gat or is re q uire d t o pr oacti vel y f oll ow u p 
wi t h eac h s u bject a n d pr o vi de f urt her i nf or mati on o n t he s u bject’s c o n dit i on.
2.
All A Es/ S A Es w ill be f oll owe d u nt il res ol uti on, u ntil t he c o n dit i on sta bilizes, 
u nt il t he e ve nt is ot her wise e x plai ne d, or u ntil t he s u bject is l ost t o f oll o w-u p.  
3.
T he i n vest i gat or is o bli gate d t o perf or m or arra n ge f or t he c o n d uct of 
s u p ple me ntal meas ure me nts a n d/ or e val uat i ons as ma y be i n dicate d or as 
re q ueste d b y G S K t o eluci date as f ull y  as p ossi ble t he nat ure a n d/ or ca usality 
of  t he A E or S A E.
4.
I n vesti gat ors are n ot o bli ge d t o acti vel y see k A Es or S A Es i n f or mer s u bjects.  
H o we ver, if t he i n vest i gat or lear ns of a n y S A E, i ncl u di n g t he deat h, at a n y  
ti me after a s u bject has bee n disc har ge d fr o m t he st u d y, a n d c o nsi ders t he 
e ve nt reas o na bl y relate d t o t he i n vest i gati onal pr o d uct or st u d y  partici pat i on, 
t he i n vest i gat or will pr om pt l y n otif y  G S K C H.
5.
T he i n vest i gat or will s u b mit a n y u p date d S A E data t o G S K wit hi n t he 
desi g nate d re p orti n g ti me fra mes.
Re g ul at or y a n d et hics re p orti n g re q uire me nts f or S A Es:
1.
T he i n vest i gat or will pr om pt l y re p ort all S A Es t o G S K C H withi n t he 
desi g nate d re p orti n g ti mefra mes ( wit hi n 2 4 h o urs of learni n g of t he e ve nt).  
G S K C H has a le gal res p o nsi bilit y t o n otif y, as a p pr o priate, t he lo c al  
re g ulat or y a ut h orit y a n d ot her re g ulat or y a ut h orities a b o ut t he safet y of a 
pr o d uct u n der cli nical i n vesti gati o n.  Pr o m pt n otificati o n of S A Es b y t he 
i n vesti gator t o G S K C H i s esse ntial s o t hat le gal o bli gati ons a n d et hical 
res p o nsi bilities t o war ds t he safety of  s u bjects are met.
2.
G S K C H will c o m p l y wit h c o u ntr y s pecific re g ulat or y re q uire me nts relati n g t o 
safety re p orti n g t o t he re g ulat or y a ut h orit y, I E C a n d i n vesti gat ors.
3.
I n vesti gat or safety re p orts are pre pare d acc or di n g t o G S K C H p olic y a n d are 
f or war de d t o i n vesti gat ors as necessar y.  A n i n vesti gat or safet y re p ort is 
pre pare d f or a S A E(s) t hat is b ot h attri b uta ble t o i n vesti gati o nal pr o d uct a n d 
u ne x pecte d.  T he p ur p ose of t he re p ort is t o f ulfill s pecific re g ulat or y a n d 
G C P re q uire me nts, re gar di n g t he pr o d uct u n der i n vesti gati o n.
4.
A n i n vesti gat or w h o recei ves a n i n vesti gat or safet y re p ort descri bi n g a S A E(s) 
or ot her s pecific safet y i nf or mati on (e. g., s u m mar y of li sti n g of S A Es) fr om 
 
D oc u m e nt N a m e  
 
T y p e  
V ersi o n  
D oc u m e nt I d e ntifi er  
Eff ecti v e D at e  
 
 
 
 
R e as o n F or Iss u e  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
1 5- S e p- 2 0 1 7 0 9: 2 7: 1 5
 
Pr ot o c ol 2 0 6 8 2 7 
d o c
el d o _ c o ntr oll e d
4. 0; M o st- R e c e nt; Eff e cti v e; C U R R E N T
A ut o I s s u e
0 9 0 0 3 2 d 5 8 0 d 9 8 e b 9
Pa ge 7 7 of 9 3
P P D
P P D
P P D
P P D
C CI

7 8
G S K C H will file it wit h t he I n vest i gat or Br oc h ure ( or safety state me nt) a n d 
will n otif y  t he I E C, if a p pr o priat e acc or di n g t o l ocal re q uire me nts.
7 . 6. C ollecti o n of Pre g n a nc y I nf or m ati o n
7 . 6.1. Ti m e Peri o d f or C ollecti n g of Pre g n a nc y I nf or m ati o n
C ollecti o n of Pre g n a nc y I nf or m ati o n:
1.
Pre g na nc y i nf or mat i on will be c o llecte d o n all preg na ncies re p orte d f o ll owi n g 
a d mi nistrati o n of a n y was h o ut pr o d uct . I nf or mat i on o n pre g na nc y i de nt ifie d 
d uri n g t he scree ni n g p hase a n d pri or t o i n vest i gati o nal (test pr o d uct) a n d 
was h o ut pr o d ucts a d mi nistrati o n d oes n ot nee d t o be c o llecte d.
7 . 6.2. Acti o n t o be T a ke n if Pre g n a nc y Occ urs
Acti o n t o be T a ke n:
1.
T he i n vest i gat or will c ollect pre g na nc y i nf or mati o n o n a n y s u bject w h o 
bec o me s pre g na nt w hile partici pati n g i n t he st u d y after a d mi nistratio n of  t he 
was h o ut pr o d uct. T he i n vesti gat or will rec or d pre g na nc y i nf or mat i on o n t he 
a p pr o priate f or m a n d s u b mit it t o G S K C H wit hi n 2 wee ks of lear ni n g of t he 
s u bject bec o mi n g pre g na nt. T he s u bject will be f o ll owe d t o deter mi ne t he 
o utc o m e of t he pre g na nc y. I nf or matio n o n t he stat us of t he m ot her a n d i nfa nt / 
ne o nate (i ncl u di n g c o nc o mit a nt me dicat i ons ta ke n b y t he m ot her d uri n g t he 
pre g na nc y) will be f or war de d t o G S K C H. Ge nerall y, f o ll ow- u p will be n o 
l on ger t ha n 6 t o 8 wee ks f o ll owi n g t he esti mate d deli ver y  date. A n y 
ter mi nati o n of t he pre g na nc y will be re p orte d.
2.
W hile pre g na nc y  itself is n ot c o nsi dere d t o be a n A E, a n y pre g na nc y 
c o mplicat i on or el ect i ve ter mi nati on f or me dical reas o ns will be rec or de d as 
a n A E or S A E.
3.
A s p o nta ne o us a b orti o n is al wa ys c o nsi dere d t o be a n S A E a n d will be 
re p orte d as s uc h. A n S A E occ urri n g i n ass ociati on wi t h a pre g na nc y, br o u g ht 
t o t he i n vesti gat or’s atte nti o n after t he s u bject c o m plete d t he st u d y a n d 
c o nsi dere d b y t he i n vesti gat or as p o ssi bl y relate d t o t he i n vesti gati o nal 
pr o d uct, m ust be pr o m ptl y f or war de d t o G S K.
4.
W hile t he i n vest i gat or is n ot o bli ge d t o acti vel y see k t his i nf or mati o n i n 
f or mer st u d y p artici pa nts, he or s he ma y lear n of a n S A E t hr o u g h s p o nta ne o us 
re p orti n g.
5.
If t he s u bject bec o mes pre g na nt d uri n g t he st u d y t he y s h o ul d be wit h dra w n 
fr om t he st u d y a n d t his s h o uld be rec or de d i n t he a p pr o priate sect i on of t he
eC R F .
 
D oc u m e nt N a m e  
 
T y p e  
V ersi o n  
D oc u m e nt I d e ntifi er  
Eff ecti v e D at e  
 
 
 
 
R e as o n F or Iss u e  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
1 5- S e p- 2 0 1 7 0 9: 2 7: 1 5
 
Pr ot o c ol 2 0 6 8 2 7 
d o c
el d o _ c o ntr oll e d
4. 0; M o st- R e c e nt; Eff e cti v e; C U R R E N T
A ut o I s s u e
0 9 0 0 3 2 d 5 8 0 d 9 8 e b 9
Pa ge 7 8 of 9 3
C CI

7 9
8 . D A T A M A N A G E M E N T
F or t hi s st u d y s u bject data will be e ntere d i nt o a n electr o nic case re p ort f or m, usi n g a 
G S K C H val i date d data s yst e m.
8 . 1. S o urce D oc u me nts/ D at a
T he s o urce d oc u me nts (e. g. h os pital rec or ds, cli nical a n d office c harts, la b orat or y  
n otes, m e mora n da, s u bjects’ diaries or e val uat i on c hec kli sts, p har mac y dis pe nsi n g 
rec or ds, rec or de d data fr o m a ut o mate d i nstr u me nts, micr ofic hes, p h ot o gra p hic 
ne gat i ves, micr ofil m or ma g netic me dia, x-ra ys, s u bject files a n d rec or ds ke pt at t he 
p har mac y, at t he la b orat or y  a n d at t he me dic o -tec h nical de part me nts i n v ol ve d i n t he 
cli nical st u d y) w hic h c o ntai n t he s o urce of data rec or de d i n t he e C R F s h o uld be 
s pecifie d i n t he S o urce D oc u me nt Desi g nati on F or m.  I n s o me cases t he e C R F ca n be 
use d as a s o urce d oc u me nt.
Eac h s u bject will be assi g ne d a n d i de nt ifie d b y a u ni q ue Scree ni n g N u m ber. A n y 
refere nce ma de t o a n i n di vi d ual s u bject wit hi n t he st u d y m ust be d o ne usi n g t he 
u ni q ue Scree ni n g N u m ber.
8. 2 . Electr o nic C ase Re p ort F or m
A n e C R F is a n electr o nic d o c u me nt desig ne d t o rec or d all of t he pr ot oc ol re q uire d 
i nf or mat i on t o be re p orte d t o t he s p o ns or o n eac h trial s u bject.
F or eac h s u bject w h o has gi ve n i nf or me d c o nse nt/asse nt a n d has bee n scree ne d, 
eC R F s m ust be c o m plete d a n d si g ne d b y t he Pri nci pal I n vest i gat or ( or a ut h orize d 
desi g nee) t o certif y t hat t he data a re c o m plete a n d c orrect.  
Ma na ge me nt of cli nical data will be perf or me d i n acc or da nce wit h a p plica ble 
G S K C H sta n dar ds a n d data clea ni n g pr oce d ures t o e ns ure t he i nte grit y o f t he data e. g. 
r e mo vi n g err ors a n d i nc o nsiste ncies i n t he data. 
I n or der t o pr otect t he pri vac y of s u bjects, n o Pers onall y I de nt ifia ble I nf or mati on
(incl u di n g t he s u bject's na me or i nit ials or birt h date) is t o be rec or de d i n t he e C R F or 
as part of t he q uer y te xt. P h ot o gra p hs will be c o llecte d of s u bject’s w h o pr o vi de t heir 
c o nse nt t o d o s o. T hese p h ot o gra p hs are c o nsi dere d PII a n d will be tra n sferre d 
sec urel y t o G S K. All p h ot o gra p hs will be a n o n y mize d.
A d verse e ve nts a n d c o nc o mit a nt me dicat i ons ter ms (if a p plica ble) will be c o de d 
usi n g Me d D R A ( Me dical Dicti o nar y  for Re g ul at or y A cti vities) a n d a n i nter nal 
vali date d m e dicat i on di ct i onar y, G S K Dr u g.  
 
D oc u m e nt N a m e  
 
T y p e  
V ersi o n  
D oc u m e nt I d e ntifi er  
Eff ecti v e D at e  
 
 
 
 
R e as o n F or Iss u e  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
1 5- S e p- 2 0 1 7 0 9: 2 7: 1 5
 
Pr ot o c ol 2 0 6 8 2 7 
d o c
el d o _ c o ntr oll e d
4. 0; M o st- R e c e nt; Eff e cti v e; C U R R E N T
A ut o I s s u e
0 9 0 0 3 2 d 5 8 0 d 9 8 e b 9
Pa ge 7 9 of 9 3
C CI

8 0
S u bject data will be e ntere d i nt o G S K C H defi ne d e C R Fs a n d tra ns mitte d 
ele ctr o nicall y t o G S K C H i n a vali date d ( 2 1 C F R Part 1 1 c o m plia nt) we b-base d 
ele ctr o nic data ca pt ure s yste m (I n F or m T M ).
All e C R F pa ges s h o ul d be c o m plete d d uri n g a s u bject self-assess me nt w he n t he e C R F
has bee n desi g nate d as t he s o urce.  Data t hat is s o urce d else w here s h o ul d be e ntere d 
i nto t he e C R F i n a n a gree d u p o n ti mefra me bet wee n t he I n vesti gat or a n d S p o ns or.  
T he e C R Fs (i nclu di n g q ueries, q uer y  res p o nses a n d a u dit trails) will be retai ne d b y 
G S K C H. Site data arc hi ve d c o m pact discs ( C D(s)) pre pare d b y  a t hir d part y will b e 
se nt t o t he i n vesti gat or t o mai ntai n as t he i n vesti gat or c o p y fol l owi n g t he 
dec o m missi o ni n g of t he st u d y.
8. 3 . D at a H a n dli n g
D oc u m e nt atio n of  all d at a ma na ge me nt acti vit ies s h o ul d all o w ste p- b y-ste p 
retr os pecti ve assess me nt of data q uality a n d st u d y  perf or ma nce. A n y c ha n ges or 
c orrectio ns t o data will be perf or me d i n t he Electr o nic Data Ca pt ure ( E D C) S y st e m, 
a n d it will i ncl u de rati o nale f or c ha n ges. T he E D C s yste m has a n a u dit trail, w hic h 
will pr o vi de a c o m plete rec or d of t he c ha n ges a n d c orrecti o ns e n d orse d b y  t he 
I n vesti gat or.
8. 3. 1 . D at a Q ueries
Pr o gra m me d e dit c hec ks will be ge nerate d a ut o maticall y , as t he data is bei n g e ntere d 
i nto t he s yste m . Data Ma na ge me nt will als o r u n re p orts a n d listi n gs o n t he e C R F data, 
i n a d ditio n t o t he q ueries alrea d y  pr o gra m me d a n d ge nerate d b y t he s yste m, t o r aise 
ma n ual q ueries as nee de d f or site clarificat i on or c orrecti o n. T he Cli n ical Dicti o n ar y  
De vel o p me nt a n d Ma na ge me nt Gr o u p will raise q ueries as nee de d o n safet y data t o 
c o de t he ter ms ( A d verse E ve nts a n d Dr u gs) are re p orte d a p pr o priatel y . 
T he st u d y  mo ni t or at t he st u d y sit e will re vie w t he e C R Fs i n acc or da nce wit h t he 
m o nit or i n g pla n, a n d a n y q ueries will be ge nerate d i n t he E D C S yste m t o t he 
I n vesti gat or or desi g nee, e na bli n g t he err ors t o be a d dresse d i n parallel with Data 
Ma na ge me nt re vie w. M o nit or ca n als o r u n re p orts a n d list i n gs o n t he e C R F s, t o raise 
ma n ual q ueries as n ee de d f or site clarificati on or c orrecti o n
8. 4 . E xter n al D at a
E xter nal Data are s u bject data o btai ne d e xter nall y  t o t he e C R F. T hese data are 
ge nerate d fr o m la b orat or y instr u m e nts, c o mp uters , p h ot o gra p hic ca meras or ot her 
s o urces a n d t he n tra nscri be d i nt o a file a n d f or mat a gree d u p o n b y G S K C H t o i de nt if y 
t he s u bject a n d ti me p o i nt refere nce d i n t he e C R F a n d/ or pr ot oc ol. I n t his st u d y, 
VI S E A p h ot o gra p hs are c o nsi dere d e xter nal data. 
 
D oc u m e nt N a m e  
 
T y p e  
V ersi o n  
D oc u m e nt I d e ntifi er  
Eff ecti v e D at e  
 
 
 
 
R e as o n F or Iss u e  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
1 5- S e p- 2 0 1 7 0 9: 2 7: 1 5
 
Pr ot o c ol 2 0 6 8 2 7 
d o c
el d o _ c o ntr oll e d
4. 0; M o st- R e c e nt; Eff e cti v e; C U R R E N T
A ut o I s s u e
0 9 0 0 3 2 d 5 8 0 d 9 8 e b 9
Pa ge 8 0 of 9 3
C CI

8 1
A n a gree d u p o n q ualit y c o ntr ol pr ocess is perfor m e d a gai nst t he tra nscri be d data t o 
t he s o urce t o e ns ure t he acc urac y of t he tra nscript i o n. T he tra nscri be d data is 
tra ns mitte d i n a n a gree d u p o n f or mat t o G S K C H via sec ure d we b p ortal or C D via 
mail carrier wit h trac ki n g ca pa bilit ies. 
Pr o per rec o nci liati on will be perf or me d bet wee n t he tra nscri be d data a n d t he cli nical 
data base t o e ns ure s u bject a n d ti me p oi nt refere nce d i n t he Cli nical Data base matc h 
bef ore Cli nical Data base Freeze (l oc ki n g of t he data base) ca n occ ur.
 
D oc u m e nt N a m e  
 
T y p e  
V ersi o n  
D oc u m e nt I d e ntifi er  
Eff ecti v e D at e  
 
 
 
 
R e as o n F or Iss u e  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
1 5- S e p- 2 0 1 7 0 9: 2 7: 1 5
 
Pr ot o c ol 2 0 6 8 2 7 
d o c
el d o _ c o ntr oll e d
4. 0; M o st- R e c e nt; Eff e cti v e; C U R R E N T
A ut o I s s u e
0 9 0 0 3 2 d 5 8 0 d 9 8 e b 9
Pa ge 8 1 of 9 3
C CI

8 2
9 . S T A TI S TI C A L C O N SI D E R A TI O NS A N D D A T A 
A N A L Y S E S
9 . 1 S a m ple Size Deter mi n ati o n
A p pr o xi matel y  1 3 0 1 7 8 heal t h y fe males wit hi n t he a ges of 3 0 a n d 6 0 years wit h 
Fi tz patric k S ki n Classificati on II -I V a n d m o derate t o a d va nce d p h ot o-da ma ge d s ki n 
will be scree ne d t o ra n d o mize 8 0 1 0 0 s u bjects t o e ns ure a p pr o xi matel y 6 0 8 0 s u bjects 
( 3 0 4 0 s u bjects per gr o u p) s uccessf ull y c om p lete t he st u d y. T he sa m ple size is base d 
o n cli nical c o nsi derati o ns a n d literat ure prece de nt [ Nar ur kar, Sc hal ka, S uli m o vic, 
Ki m].
Wit h 3 0 s u bjects per treat me nt gr o u p, a c ha n ge fr o m baseli ne i n T E W L at least half 
t he ma g nit u de of t he stan dar d de viat i on (e. g. ass u me st d = 4 (ref. 
 
), a n d 2. 1 p oi nt mea n c ha n ge fr o m baseli ne) ca n be detecte d at t w o-si de d 
alp ha = 0. 0 5 wi t h 8 0 % p o wer.
T H E FI R S T 1 0 S U B J E C T S W E R E MI S -A L L O C A T E D T R E A T M E N T. T O 
P R O T E C T T H E S T A TI S TI C A L P O W E R O F T H E S T U D Y F O R T H E 
S E C O N D A R Y T E W L E N D P OI N T, 2 0 A D DI TI O N A L S U B J E C T S WI L L B E 
R E C R UI T E D I N T O T H E S T U D Y. WI T H 1 0 0 S U B J E C T S R A N D O MI S E D, 8 0 
S U B J E C T S ( 4 0 S U B J E C T S P E R G R O U P) A R E E X P E C T E D T O C O M P L E T E 
T H E S T U D Y.
WI T H 4 0 S U B J E C T S P E R T R E A T M E N T G R O U P WI T H 5 S U B J E C T S P E R 
G R O U P R E C EI VI N G T H E I N C O R R E C T T R E A T M E N T D U E T O MI S -
A L L O C A TI O N , A WI T HI N C H A N G E F R O M B A S E LI N E I N T E W L O F 1. 8 3 
C A N B E D E T E C T E D A T T W O -SI D E D A L P H A = 0. 0 5 WI T H A N S D = 4. 0 5 3
A N D 8 0 % P O W E R.  
9 . 2. Ge ner al C o nsi der ati o ns
9. 2. 1. Defi niti o n of A n al ysis P o p ul ati o ns
A ll ra n d omize d s u bjects will be i ncl u de d i n t he i nte nt -t o-treat (I T T) p o p ulati on. All 
s u bjects wit h at least o ne a p plicati o n o f pr o d uct i n t he test p hase (i.e. test pr o d uct f or 
s u bjects i n Gr o u p I or s u nscree n f or s u bjects i n Gr o u p II) will be i ncl u de d i n the 
S af et y p o p ul at i on. 
 
D oc u m e nt N a m e  
 
T y p e  
V ersi o n  
D oc u m e nt I d e ntifi er  
Eff ecti v e D at e  
 
 
 
 
R e as o n F or Iss u e  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
1 5- S e p- 2 0 1 7 0 9: 2 7: 1 5
 
Pr ot o c ol 2 0 6 8 2 7 
d o c
el d o _ c o ntr oll e d
4. 0; M o st- R e c e nt; Eff e cti v e; C U R R E N T
A ut o I s s u e
0 9 0 0 3 2 d 5 8 0 d 9 8 e b 9
Pa ge 8 2 of 9 3
C CI
C CI

8 3
S u bjects will be c o nsi dere d eli gi ble f or a Per Pr ot oc ol ( P P) p o p ulat i on if t he y were 
ra n d omize d, recei ve d at least o ne a p plicat i on of test pr o d uct, ha d at least o ne p ost-
pr oce d ure, p ost -treat me nt assess me nt a vaila ble a n d were c o m pli a nt wit h b ot h test a n d 
was h o ut pr o d ucts p ost -pr oce d ure. Ot her c o nsi derati o ns f or eli gi bility f or t he P P 
p o p ul at i on i ncl u di n g b ut n ot li mite d t o use of c o nc o mita nt me dicati o ns will be 
detaile d i n t he Statist ical A nal ysis Pla n pri or t o data base u n bli n di n g.
9. 2. 2. E xcl usi o n of D at a fr o m A n al ysis
N o data will be e xcl u de d f r o m a n y a nal yses.
9. 2. 3. Criteri a f or E v al u ati o n
T he pri mar y  e val uati on of t ol era nce will be base d o n t he Der m at olo gi st gl o bal 
assess me nt. T he trial will be c o nsi dere d a s uccess if t he maj orit y (i. e. more t ha n 5 0 %) 
of  s u bjects i n t he test pr o d uct gr o u p ha ve a fa v ora ble Der mat ol o gist gl o bal 
assess me nt sc ore.
9. 2. 4. Criteri a f or Assessi n g Effic ac y
Efficac y meas ure me nts i n t his st u d y will be base d o n c ha n ges fr o m baseli ne i n 
T E W L a n d C or ne o met er val ues at eac h visit. T he baseli ne f or t hese meas ure me nts 
will be defi ne d as t he meas ure me nts ma de 6 0 ± 1 5 mi n utes after t he facial peel 
pr oce d ure, bef ore a n y  test pr o d uct a p plicati on. Differe nces bet wee n pr o d uct gr o u ps 
will als o be e x pl ore d.
9. 2. 5. Criteri a f or Assessi n g L oc al T o ler a nce
Sec o n dar y  assess me nt s of l ocal tol era nce will be base d o n De r mat olo gist a n d S u b ject 
self-assess me nt sc ores at eac h visit a n d re p orte d a d verse e ve nts. T he baseli ne f or 
t hese assess me nts will be defi ne d as t he assess me nts ma de 6 0 ± 1 5 mi n utes after t he 
facial peel pr oce d ure, bef ore a n y test pr o d uct a p plicati o n. 
9. 2. 6 . H a n dli n g of Dr o p o uts a n d Missi n g D at a
Missi n g data will n ot be i m p ute d. All data a vaila ble f or dr o p o uts will be c o nsi dere d 
i n a nal yses.
9 . 3. St atistic al Met h o ds a n d A n al ytic al Pl a n
A d di tio n al details of t he pr o p ose d statistical a nal ysis will be d oc u me nte d i n t he 
statistical a nal ysis pla n ( S A P), w hic h will be writte n f o ll owi n g fi nalizat i on of t he 
pr ot oc ol  a n d prior t o st u d y  u n bli n din g / a nal ysis (as a p pr o priate).
 
D oc u m e nt N a m e  
 
T y p e  
V ersi o n  
D oc u m e nt I d e ntifi er  
Eff ecti v e D at e  
 
 
 
 
R e as o n F or Iss u e  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
1 5- S e p- 2 0 1 7 0 9: 2 7: 1 5
 
Pr ot o c ol 2 0 6 8 2 7 
d o c
el d o _ c o ntr oll e d
4. 0; M o st- R e c e nt; Eff e cti v e; C U R R E N T
A ut o I s s u e
0 9 0 0 3 2 d 5 8 0 d 9 8 e b 9
Pa ge 8 3 of 9 3
C CI

8 4
9 . 3.1. De m o gr a p hic a n d B aseli ne C h ar acteristics
A ge will be s u m mar ize d descri pti vel y f or eac h pr o d uct gr o u p usi n g mea ns, me dia ns 
a n d sta n dar d de viat i ons. Race, g e n der, Fi tz patric k p h ot ot ype a n d Gl o ga u p h ot oa gi n g 
t ype will b e s u m marize d b y pr o d uct gr o u p usi n g fre q ue nc y c o u nts a n d perce nta ges. 
9 . 3.2. Pri m ar y A n al ysis(es)
Descri pt i ve statistics ( N, %, 9 5 % c o nfi de nce i nter vals) will be use d t o s u m marize t he 
pr o p orti o n of  s u bjects i n eac h pr o d uct gr o u p wit h a fa v ora ble E val uat or gl o bal 
assess me nt of t olera nce. T he pr o p orti o ns ma y als o be c o m pare d bet wee n pr o d uct 
gr o u ps usi n g C hi -s q uare test, a n d differe nce i n pr o p orti o n a n d 9 5 % c o nfi de nce 
i nter val.
9 . 3.3. Sec o n d ar y A n al ysis(es)
C ha n ges fr o m baseli ne i n t he E val uat or , S u bject self -assess me nt a n d i nstr u me ntal 
e n d p o i nts will be ta b ulate d b y pr o d uct gr o u p a n d s u m marize d descri pt i vel y usi n g 
mea ns, sta n dar d de viat i ons a n d 9 5 % c o nfi de nce i nter vals a n d assesse d f or 
sig nifica nce ( differe nt fr o m zer o) usi n g t -tests or Wilc o x o n si g ne d ra n k tests 
de pe n de nt u p o n t he distri b ut i on of t he data. 
Differe nces b et wee n pr o d uct gr o u ps i n t he mea n c ha n ges fr o m baseli ne i n E val uat or , 
S u bject self- assess me nt a n d i nstr u me nt al e n d p oi nts will als o be e x pl ore d usi n g t -tests 
or Wilc o x o n ra n k s u m tests a n d s u m marise d usi n g 9 5 % c o nfi de nce i nter vals. 
9 . 3.4. S afet y A n al ysis(es)
A d verse e ve nts will be ta b ulate d b y  pr o d uct gr o u p a n d liste d f or i ns pect i on.
1 0 . S T U D Y G O V E R N A N C E C O N SI D E R A TI O N S
1 0 . 1. P osti n g of I nf or m ati o n o n P u blicl y A v ail a ble Cli nic al Tri als 
Re gisters
St u d y  inf or m at i on fr om t his pr ot oc ol will be p oste d o n p u blicl y a vaila ble cli nical trial 
r e gisters bef ore e nr oll me nt of s u bjects be gi ns.
1 0. 2. Re g ul at or y a n d Et hic al C o nsi der ati o ns, I n cl u di n g t he I nf or me d 
C o nse nt
T he st u d y  will be c o n d ucte d i n acc or da nce wit h all a p plica ble re g ulat or y 
re q uire me nts, a n d wit h G S K p olic y.
 
D oc u m e nt N a m e  
 
T y p e  
V ersi o n  
D oc u m e nt I d e ntifi er  
Eff ecti v e D at e  
 
 
 
 
R e as o n F or Iss u e  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
1 5- S e p- 2 0 1 7 0 9: 2 7: 1 5
 
Pr ot o c ol 2 0 6 8 2 7 
d o c
el d o _ c o ntr oll e d
4. 0; M o st- R e c e nt; Eff e cti v e; C U R R E N T
A ut o I s s u e
0 9 0 0 3 2 d 5 8 0 d 9 8 e b 9
Pa ge 8 4 of 9 3
C CI

8 5
T he st u d y  will als o be c o n d ucte d i n acc or da nce wit h I C H Go o d Cli nical Pract ice 
( G C P), all a p plica ble s u bject pri vac y re q uire me nts, a n d t he g ui di n g pri nci ples of t he 
c urre nt versi o n of t he Declarat i on of Helsi n ki.  T his i ncl u des, b ut is n ot li mite d t o, t he 
f oll owi n g:

Bef ore i nit iati n g a trial, t he i n vesti gat or/insti t utio n s h o ul d ha ve wri tte n a n d 
date d a p pr o val/fa v ora ble o pi ni o n  fr o m t he I E C f or t he trial pr ot oc ol (i ncl u di n g 
a me n d me nts), writte n i nf or me d c o nse nt f or m, c o nse nt f or m u p dates, s u bject 
recr uit me nt pr oce d ures (e. g., a d vertise me nts), i n vesti gat or br oc h ure/ safet y 
state me nt (i ncl u di n g a n y u p dates) a n d a n y ot her writte n i nf or mat i on t o be 
pr o vi de d t o s u bj ects. A letter or certificate of a p pr o val will be se nt b y t he 
i n vesti gat or t o t he s p o ns or pri or t o i nitiati on of t he st u d y , a n d als o w he n 
s u bse q ue nt a me n d ment s t o t he pr ot oc ol are ma de.

Si g ne d i nf or me d c o nse nt  t o be o btai ne d f or eac h s u bject bef ore partici pati o n 
i n t he st u d y ( a n d for a m e n d me nts as a p plica ble)

I n vesti gat or re p orti n g re q uire me nts (e. g. re p orti n g of A Es/ S A Es/ pr ot oc ol 
de viat i ons t o I E C)

G S K will pr o vi de f ull details of t he a b o ve pr oce d ures, eit her ver ball y, i n 
wri ti n g, or b ot h.
1 0. 3. Q u alit y C o ntr ol ( St u d y M o nit ori n g)
I n acc or da nce wit h a p plica ble re g ulati o ns i ncl u di n g G C P, a n d G S K pr oce d ures, G S K 
or desi g nee (i . e. t hir d part y ve n d or) mo ni t ors will c o ntact t he site prior t o t he start of 
t he st u d y t o re vie w wit h t he site staff t he pr ot oc ol, st u d y re q uire me nts, a n d t heir 
res p o nsi bilities t o satisf y re g ulat or y, et hical, a n d G S K re q uire me nts.
W he n re vie wi n g data c ollect i on pr oce d ures, t he disc ussi o n will i ncl u de i de nt ificati o n, 
a gree me nt a n d d oc u me ntatio n of  data it e ms for w hic h t he e C R F will ser ve as t he 
s o urce d oc u me nt.
G S K or desi g nee will m o nit or t he st u d y  a n d site acti vit y t o verif y t hat t he:

Data are a ut he ntic, acc urate, a n d c o m plete.

S af et y a n d rig hts of  s u bjects are bei n g pr otecte d.

St u d y  is c o n d ucte d i n acc or da nce wit h t he c urre ntl y a p pr o ve d pr ot oc ol a n d 
a n y ot her st u d y a gree me nts, G C P, a n d all a p plica ble re g ulat or y re q uire me nts.
T he e xte nt a n d nat ure of m o nit ori n g will be descri be d i n a writte n m o nit ori n g pla n o n 
file at G S K C H. T he i n vesti gat or ( or desi g nee) a grees t o all o w t he m o nit or direct 
access t o all rele va nt d oc u me nts a n d a grees t o c o- o perate wi t h t he mo ni t or t o e ns ure 
t hat a n y pr o ble ms detecte d i n t he c o urse of t hese m onit ori n g visits are res ol ve d.
 
D oc u m e nt N a m e  
 
T y p e  
V ersi o n  
D oc u m e nt I d e ntifi er  
Eff ecti v e D at e  
 
 
 
 
R e as o n F or Iss u e  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
1 5- S e p- 2 0 1 7 0 9: 2 7: 1 5
 
Pr ot o c ol 2 0 6 8 2 7 
d o c
el d o _ c o ntr oll e d
4. 0; M o st- R e c e nt; Eff e cti v e; C U R R E N T
A ut o I s s u e
0 9 0 0 3 2 d 5 8 0 d 9 8 e b 9
Pa ge 8 5 of 9 3
C CI

8 6
1 0. 4. Q u alit y Ass ur a nce
T o e ns ure c o m plia nce wit h G C P a n d all a p plica ble re g ul at or y re q uire me nts, G S K 
ma y c o n d uct a q ualit y ass ura nce assess me nt a n d/ or a u dit of t he site rec or ds, a n d t he 
re g ulat or y a ge ncies ma y c o n d uct a re g ulat or y ins pecti o n at a n y  time d uri n g or after 
c o mplet i on of t he st u d y . 
I n t he e ve nt of a n assess me nt, a u dit or i ns pecti on, t he i n vest i gat or (a n d i nstitut i on) 
m ust a gree t o gra nt t he a d vis or(s), a u dit or(s) a n d i ns pect or(s) direct access t o all 
r ele va nt d oc u me nts a n d t o all ocate t heir ti me a n d t he ti me o f t heir staff t o disc uss t he 
c o n d uct of t he st u d y, a n y fi n di n gs/rele va nt iss ues a n d t o i m ple me nt a n y c orrective 
a n d/ or pre ve ntati ve act i ons t o a d dress a n y fi n di n gs/iss ues i de nt ifie d.
T he s p o ns or will be a vaila ble t o hel p i n vesti gat ors pre pare f or a n i ns pecti o n.
1 0. 5. C o n diti o ns f or Ter mi n ati n g t he St u d y
U p o n c o m plet i on or pre mat ure disc o nt i n uati on of t he st u d y , t he G S K C H mo ni t or will 
c o n d uct site cl os ure acti vit ies wit h t he i n vesti gat or or site staff, as a p pr o priate, i n 
acc or da nce wit h a p plica ble re g ulat i ons i ncl u di n g G C P, a n d G S K C H Sta n d ar d 
O perati n g Pr oce d ures.
B ot h G S K C H a n d t he I n vest i gat or reser ve t he ri g ht t o te m p oraril y s us pe n d or 
pr e m at urel y disc o nti n ue t his st u d y at a n y time f or reas o ns i ncl u di n g, b ut n ot li mite d 
t o, safety or et hi cal iss ues or se vere n o n-c o m p lia nce. F or m ultice nter st u dies (if 
a p plica ble), t his ca n occ ur at o ne or m ore or at all sites.  
If t he trial is pre mat urel y ter mi nate d or s us pe n de d f or a n y reas o n, t he i n vesti gat or site 
s h o uld pr o m pt l y i nf or m t he trial s u bjects a n d s h o ul d ass ure a p pr o priate t hera p y/ 
f oll ow- u p f or t he s u bjects. W here re q uire d b y  t he a p plica ble re g ulat or y re q uire me nts, 
G S K C H s h o ul d i nf or m t he re g ulat or y  a ut h orit y(ies). 
I n a d diti on: 
1.
If t he i n vesti gat or ter mi nates or s us pe n ds a trial wit h o ut pri or a gree me nt of 
G S K C H, t he i n vesti gat or site s h o ul d pr o m pt l y i nf or m t he s p o ns or a n d t he 
I E C, a n d s h o ul d pr o vi de t he s p o ns or a n d t he I E C a detaile d writte n 
e x pla nat i on of t he ter mi nat i on or s us pe nsi o n.
2.
If t he G S K C H ter mi nates or s us pe n ds a trial, t he i n vesti gat or s h o ul d pr o m ptl y 
i nf or m t he I E C a n d pr o vi de t he I E C a detaile d writte n e x pla nat i on of t he 
ter mi nati o n or s us pe nsi on. 
3.
If t he I E C ter mi nates or s us pe n ds its a p pr o val/fa v ora ble o pi ni on of a tri al, t he 
i n vesti gat or s h o ul d pr o m ptl y n otif y  t he G S K C H a n d pr o vide G S K C H wi t h a 
detaile d writte n e x pla nat io n of  t he ter mi nati on or s us pe nsi o n.
 
D oc u m e nt N a m e  
 
T y p e  
V ersi o n  
D oc u m e nt I d e ntifi er  
Eff ecti v e D at e  
 
 
 
 
R e as o n F or Iss u e  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
1 5- S e p- 2 0 1 7 0 9: 2 7: 1 5
 
Pr ot o c ol 2 0 6 8 2 7 
d o c
el d o _ c o ntr oll e d
4. 0; M o st- R e c e nt; Eff e cti v e; C U R R E N T
A ut o I s s u e
0 9 0 0 3 2 d 5 8 0 d 9 8 e b 9
Pa ge 8 6 of 9 3
C CI

8 7
1 0. 6. Rec or ds Rete nti o n
F o ll owi n g cl os ure of t he st u d y , t he i n vesti gat or m ust mai ntai n all site st u d y rec or ds 
(e xce pt f or t h ose re q uire d b y l ocal re g ulati o ns t o be mai ntai ne d else w here), i n a safe 
a n d sec ure l ocati o n.  
T he r ec or ds (st u d y/ sit e master file) m ust be mai nt ai ne d t o all o w eas y a n d ti mel y 
retrie v al, w he n nee de d (e. g., f or a G S K a u dit or re g ulat or y ins pect i on) a n d m ust be 
a vaila ble f or re vie w i n c o nj u nct i on wi t h assess me nt of t he facility,  s u p p orti n g 
s yste ms, a n d releva nt si te staff.
W here per mitte d b y  lo c al  la ws/re g ulat i ons or i nstit uti o nal p o lic y, s ome or all o f t hese 
rec or ds ca n be mai ntai ne d i n a f or mat ot her t ha n har d c o p y (e. g., micr ofic he, sca n ne d, 
ele ctr o nic); h o we ver, ca uti o n nee ds t o be e xercise d bef ore s u c h act i on is ta ke n. 
T he i n vest i gat or m ust e ns ure t hat all re pr o d ucti o ns are le gi ble a n d are a tr ue a n d 
acc urate c o p y of t he origi nal  a nd m eet accessi bilit y a n d retrie val sta n dar ds, i ncl u di n g 
r e-ge nerati n g a har d c o p y , if re q uire d.  F urt her more, t he i n ves tigat or m ust e ns ure 
t here is a n acce pta ble bac k -u p of  t hese re pr o d ucti o ns a n d t hat a n acce pta ble q uality 
c o ntr ol pr ocess e xists f or ma ki n g t hese re pr o d ucti o ns.
T he i n vest i gat or m ust ass ure t hat t he s u bject’s a n o n y mity will  b e mai ntai ne d.  O n
e C R Fs or ot her d oc u me nts s u b mitte d t o G S K C H, s u bjects s h o ul d n ot be i de ntifie d b y 
t heir na mes or i nitials, b ut b y a n ide nt ificati on c o de. T he i n vest i gat or s h o ul d kee p a 
se parate l o g of s u bjects’ c o des, na mes a n d a d dresses.  D oc u me nts n ot f or s u b missi o n 
t o G S K C H, e. g. su bjects’ writte n c o nse nt f or ms, s h o ul d be mai ntai ne d b y t he 
i n vesti gat or i n strict c o nfi de nce.
G S K will i nf or m t he i n vest i gat or of t he ti me peri o d f or retai ni n g t hese rec or ds t o 
c o mpl y  wit h all a p plica ble re g ulat or y re q uire me nts ( G S K C H rec o m me n ds t hat 
d o c u me nts be ke pt f or 1 0 y ears). T he i n vest i gat or is als o re q uire d t o kee p s u bject 
i de ntificati on c o des o n file f or at least 1 5 y ears aft er c o mpl et i on or di sc o nti n uati on of 
t he st u d y. T he mi ni m u m rete nti on ti me will meet t he strictest sta n dar d a p plica ble t o 
that site f or t he st u d y, as dictate d b y a n y i nst ituti o n al  re q uire me nts or lo c al  la ws or 
re g ulat i ons, G S K sta n dar ds/ pr oce d ures, a n d/ or i nstit ut i onal re q uire me nts.  
N o st u d y  d oc u me nt s h o ul d be destr o ye d wit ho ut a pri or wri tte n a gree me nt bet wee n 
G S K C H a n d t h e i n vest i gat or. T he i n vesti gat or m ust n otif y G S K of a n y c ha n ges i n t he 
arc hi val arra n ge me nts, i ncl u di n g, b ut n ot li mite d t o, arc hi val at a n off-sit e facilit y or 
tra nsfer of o w ners hi p of t he rec or ds i n t he e ve nt t he i n vesti gat or is n o l o n ger 
ass ociat e d wit h t he sit e.
 
D oc u m e nt N a m e  
 
T y p e  
V ersi o n  
D oc u m e nt I d e ntifi er  
Eff ecti v e D at e  
 
 
 
 
R e as o n F or Iss u e  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
1 5- S e p- 2 0 1 7 0 9: 2 7: 1 5
 
Pr ot o c ol 2 0 6 8 2 7 
d o c
el d o _ c o ntr oll e d
4. 0; M o st- R e c e nt; Eff e cti v e; C U R R E N T
A ut o I s s u e
0 9 0 0 3 2 d 5 8 0 d 9 8 e b 9
Pa ge 8 7 of 9 3
C CI

8 8
1 0. 7. Pr o visi o n of St u d y Res ults t o I n vesti g at ors, p osti n g of 
I nfor m ati o n o n P u blicl y A v ail a ble Cli nic al Tri als Re gisters a n d 
P u blic ati o n
W here re q uire d
b y a p plica ble re g ulat or y  re q uire me nts, a n i n vesti gat or si g nat or y will 
be i de ntifie d f or t he a p pr o val of t he cli nical st u d y re p ort.  T he i n vesti gat or will be 
pr o vi de d reas o na ble access t o statist ical ta bles, fi g ures, a n d rele va nt re p orts a n d will 
ha ve t he o p p ort u ni t y t o re vie w t he c o m plete st u d y res ults at a G S K site or ot her 
m ut uall y -a greea ble l ocati o n.
G S K will als o pr o vi de t he i n vest i gat or wit h t he f ull s u m mar y of t he st u d y res ults.  
T he i n vest i gat or is e nc o ura ge d t o s hare t he s u m mar y res ults wit h t he st u d y s u bjects, 
as a p pr o priate.
T he pr oce d ures a n d ti mi n g f or p u blic discl os ure of t he res ults s u m mar y a n d f or 
de vel o p me nt of a ma n uscri pt f or p u blicat i on will be i n acc or da nce wit h G S K P olic y.
A ma n uscri pt will be pr o gresse d f or p u blicat i on i n t he scie nt ific literat ure if t he 
res ults pr o vide i m p orta nt sci e nt ific or me dical k n o wle d ge.
 
D oc u m e nt N a m e  
 
T y p e  
V ersi o n  
D oc u m e nt I d e ntifi er  
Eff ecti v e D at e  
 
 
 
 
R e as o n F or Iss u e  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
1 5- S e p- 2 0 1 7 0 9: 2 7: 1 5
 
Pr ot o c ol 2 0 6 8 2 7 
d o c
el d o _ c o ntr oll e d
4. 0; M o st- R e c e nt; Eff e cti v e; C U R R E N T
A ut o I s s u e
0 9 0 0 3 2 d 5 8 0 d 9 8 e b 9
Pa ge 8 8 of 9 3
C CI

8 9
1 1 . R E F E R E N C E S
Hatc her R A, Tr ussell J, Nels o n A L, Cates W Jr, Ste wart F, K o wal D, e dit ors. 
C o ntrace pti ve Tec h n o l og y . 1 9t h e ditio n. Ne w Y or k: Ar de nt Me dia, 2 0 0 7 ( b):2 8
I C H T o pic 6 G uideli ne f or G o o d Cli nical Pract ice C P M P/I C H/ 1 3 5/ 9 5 1 7t h J ul y 1 9 9 6
W o rld Me dical Ass oci at i on Declarati o n of Helsi n ki, 5 9t h Ge neral Asse m bl y, Se o ul 
2 0 0 8
S uli m o vic L, Li c u D, Le d o E, Nae yaert J M, Pigatt o P, Tzer mias C, Vas q uez D o val J,
D u p u y  P, Der m at ol S ur g., 2 0 0 2; 2 8 ( 5): 4 1 5- 4 1 8
Sc hal ka S, A gel u ne C M, N o g ueira A T, A bre u F F , S ur g C os met Der m at ol., 
2 0 1 3; 5( 4): 3 3 7 - 3 4 3
Nar ur kar V A, Beer L R, C o he n J L, J o ur n al of C os metic a n d L aser T her a py , 
2 0 1 0; 1 2: 2 8 8 – 2 9 5
Ki m J M, Ki m WI, K o H C, Ki m M, Ki m B S, J o ur n al of t he E ur o pe a n Ac a de my of 
Der m at ol o gy a n d Ve nere ol o gy , 2 0 1 6. D OI: 1 0. 1 1 1 1/j d v. 1 3 7 5 0
Mi ni mall y I n vasi ve Pr oce d ures f or Facial Rej u ve nati o n, Gi use p pe G uerrier o a n d 
La ura Del Re g n o,  Oct o ber, 2 0 1 4 ( O MI C S Gr o u p e B o o ks)
S hara d J. Cli nic al, C os me tic a n d I nvesti g ati o n al Der m at ol o gy 2 0 1 3; 6: 2 8 1 – 2 8 8
P eri ć S, B u ba nj M, B u ba nj S, Ja nčić S. J B asic Me d Sci. 2 0 1 1; 1 1( 1): 5 2 – 5 7
Vi s h al B, Ra o S S, Pa vit hra S, S he n oy M M. J C ut a n Aest het S ur g. 2 0 1 2; 5( 1): 5 8 – 5 9
R o gi ers V, S ki n P har mac o l A p pl S ki n P h ysi o l 2 0 0 1; 14: 1 1 7 – 1 2 8
Berar desca E, S ki n Researc h a n d Tec h n ol o g y  1 9 9 7; 3( 2): 1 2 6- 1 3 2
 
D oc u m e nt N a m e  
 
T y p e  
V ersi o n  
D oc u m e nt I d e ntifi er  
Eff ecti v e D at e  
 
 
 
 
R e as o n F or Iss u e  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
1 5- S e p- 2 0 1 7 0 9: 2 7: 1 5
 
Pr ot o c ol 2 0 6 8 2 7 
d o c
el d o _ c o ntr oll e d
4. 0; M o st- R e c e nt; Eff e cti v e; C U R R E N T
A ut o I s s u e
0 9 0 0 3 2 d 5 8 0 d 9 8 e b 9
Pa ge 8 9 of 9 3
C CI

9 0
1 2 . A P P E N DI C E S
1 2 . 1. A p pe n di x 1 - A b bre vi ati o ns a n d Tr a de m ar ks
A b bre vi ati o ns
A E
A d verse E ve nt
A H A
Al p ha H y dr o x y  Aci d
A N VI S A
A gê ncia Naci o nal de Vi gilâ ncia Sa nitária
C D
C o m p a ct Di s c
eC R F
Electr o nic Case Re p ort F or m
E D C
Electr o nic Data Ca pt ure
E E M C O
Efficac y Meas ure me nt of C os met ics a n d Ot her T o pical Pr o d ucts
g
Gr a m s
G A
Gl yc o lic Aci d
G C P
G o o d Cli nical Pract ice
G S K C H
Gl a x o S mit hKli ne C o ns u mer Healt hcare
h
H o urs
I C H
I nter nati o nal C o nfere nce o n Har m o nizati on of T ec h nical Re q uire me nts 
f or Re gistratio n of  P har mace uticals f or H u ma n Use
I C F
I nf or me d C o nse nt F or m
I E C
I n de pe n de nt Et hics C o m mittee
I T T
I nte nti o n t o Treat
L S L V
Last -S u bject, Last Visit
Me d D R A
Me dical Dict i onar y f or Re g ulat or y  Acti vities
mi n
Mi n utes
O T C
O ver t he C o u nter
PII
Pers o nall y I de nt ifia ble I nf or mati on
P P
Per Pr ot oc ol
S A E
S eri o us A d verse E ve nt
S A P
Stati stical A nal ysis Pla n
S P F
S u n Pr otecti o n Fact or
T E W L
Tra nse pi der mal Water L oss
T M F
Tri al Master File
U V
Ul tra viol et
Tr a de m ar k I nf or m ati o n
Tr a de m ar ks of t he Gl a x o S mit h Kli ne gr o u p of c o m p a nies:
P h ysi o gel
S u n Ma x
 
D oc u m e nt N a m e  
 
T y p e  
V ersi o n  
D oc u m e nt I d e ntifi er  
Eff ecti v e D at e  
 
 
 
 
R e as o n F or Iss u e  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
1 5- S e p- 2 0 1 7 0 9: 2 7: 1 5
 
Pr ot o c ol 2 0 6 8 2 7 
d o c
el d o _ c o ntr oll e d
4. 0; M o st- R e c e nt; Eff e cti v e; C U R R E N T
A ut o I s s u e
0 9 0 0 3 2 d 5 8 0 d 9 8 e b 9
Pa ge 9 0 of 9 3
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9 1
Tr a de m ar ks n ot o w ne d b y t he Gl a x o S mit h Kli ne gr o u p of c o m p a nies:
Si m ple
1 2. 2 . A p pe n di x 2 - Fitz p atric k S ki n T y pe
T y pe
Descri pti o n
I
Al wa ys b ur ns, ne ver ta ns
II
us uall y b ur ns, ta ns mi ni mall y
III
s o meti mes mil d b ur n, ta ns u nif or ml y (crea m w hite; fair wit h a n y hair or 
e ye c olor)
I V
b ur ns mi ni mall y, al wa ys ta ns w ell ( mo derate br o w n)
V
ver y  rarel y bur ns, ta ns ver y  easil y ( dar k br o w n)
VI
Ne ver b ur ns, ne ver ta ns ( dee pl y pi g me nte d dar k br o w n t o dar kest 
br o w n)
1 2. 3 . A p pe n di x 3 - Gl o g a u P h ot o a gi n g Sc ale
Gr o u p
Cl assific ati o n
S ki n C h ar acteristics
I
Mil d
Earl y P h ot oa g i n g: mil d pi g me nt c ha n ges, n o kerat osis, 
mi ni mal wri n kles, mi ni mal or n o ma ke u p
II
M o derate
Earl y t o M o derate P h ot oa gi n g: Earl y  br o w n s p ots visi ble, 
kerat osis pal pa ble b ut n ot visi ble, parallel s mile li nes be gi n 
t o a p pear, wears s o me f o u n dati o n
III
A d va n ce d
A d va nce d P h ot oa gi n g: O b vi o us disc o l orati o ns, visi ble 
ca pillaries (tela n giectasias), visi ble kerat osis, wears hea vier 
f ou n dat i on al wa ys
I V
Se vere
Se vere P h ot oa gi n g: Yell o w -gr a y  s ki n c olor, pri or s ki n 
mali g na ncies, wri n kles t hr o u g h o ut - n o n or m al s ki n, ca n n ot 
wear m a ke u p beca use it ca kes a n d crac ks
1 2. 4 . A p pe n di x 4 - E xcl usi o n Criteri a f or Re vie w at Visit 2 a n d 3
1. P R E G N A N C Y
W o me n w h o are k n o w n t o be pre g na nt or w h o are i nte n di n g t o bec o me pre g na nt o ver 
t he d urati o n of t he st u d y.

2. B R E A S T -F E E DI N G
W o me n w h o are breast -fee di n g.
 
D oc u m e nt N a m e  
 
T y p e  
V ersi o n  
D oc u m e nt I d e ntifi er  
Eff ecti v e D at e  
 
 
 
 
R e as o n F or Iss u e  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
1 5- S e p- 2 0 1 7 0 9: 2 7: 1 5
 
Pr ot o c ol 2 0 6 8 2 7 
d o c
el d o _ c o ntr oll e d
4. 0; M o st- R e c e nt; Eff e cti v e; C U R R E N T
A ut o I s s u e
0 9 0 0 3 2 d 5 8 0 d 9 8 e b 9
Pa ge 9 1 of 9 3
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9 2
3. C O N C U R R E N T M E DI C A TI O N/ M E DI C A L HI S T O R Y 
A.
Act i ve s ki n disease or o pe n w o u n d i n t he test area.
E.
M oles, tatt o os , scars, irritate d s ki n, hairs, etc. at t he test area t hat c o ul d 
i nfl ue nce t he i n vesti gati o n. 
9. S T U D Y M A T E RI A L S E N SI TI VI T Y T E S T
A sc ore of “ Se vere” f or a n y  Der mat olo gi st or S u bject Self-Assesse d e n d p o i nt at a n y 
ti me f or t he st u d y material se nsitivit y test. 
 
D oc u m e nt N a m e  
 
T y p e  
V ersi o n  
D oc u m e nt I d e ntifi er  
Eff ecti v e D at e  
 
 
 
 
R e as o n F or Iss u e  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
1 5- S e p- 2 0 1 7 0 9: 2 7: 1 5
 
Pr ot o c ol 2 0 6 8 2 7 
d o c
el d o _ c o ntr oll e d
4. 0; M o st- R e c e nt; Eff e cti v e; C U R R E N T
A ut o I s s u e
0 9 0 0 3 2 d 5 8 0 d 9 8 e b 9
Pa ge 9 2 of 9 3
C CI

 
 
SI G N A T U R E P A G E 
 
  
 
D ate  
Si g ne d B y
 
J ustific ati o n  
 
 
 
D ate  
Si g ne d B y
 
J ustific ati o n  
 
 
 
D ate  
Si g ne d B y
 
J ustific ati o n  
 
 
 
D ate  
Si g ne d B y
 
 
J ustific ati o n  
 
 
 
D ate  
Si g ne d B y
 
 
J ustific ati o n  
 
 
 
D ate  
Si g ne d B y
 
 
J ustific ati o n  
 
 
1 5- S e p- 2 0 1 7 0 9: 2 7: 1 0
 
Bi o st ati sti c s A p pr o v al
Cli ni c al O p er ati o n s A p pr o v al
1 4- S e p- 2 0 1 7 0 3: 5 2: 0 5
A p pr o v e d
Pr ot o c ol 2 0 6 8 2 7  
. d o c
1 3- S e p- 2 0 1 7 1 2: 3 8: 3 5
 
D oc u m e nt N a m e  
 
T y p e  
V ersi o n  
D oc u m e nt I d e ntifi er  
Eff ecti v e D at e  
 
 
 
 
R e as o n F or Iss u e  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
1 5- S e p- 2 0 1 7 0 9: 2 7: 1 5
 
Pr ot o c ol 2 0 6 8 2 7 
d o c
el d o _ c o ntr oll e d
4. 0; M o st- R e c e nt; Eff e cti v e; C U R R E N T
A ut o I s s u e
0 9 0 0 3 2 d 5 8 0 d 9 8 e b 9
Pa ge 9 3 of 9 3
P P D
P P D
P P D
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