Clinical Evaluation of the Safety and Performance of Fractional Radiofrequency for the Treatment and Reduction of Acne Scarring
Phase: NA
Conditions: Acne Scars
Sponsor: Venus Concept

Cli nic al  E v al u ati o n  of t h e  S af et y  a n d  P erf or m a nc e  of 
Fr acti o n al  R a di ofr e q u e nc y f or t h e  Tr e at m e nt  a n d 
R e d ucti o n  of  Ac n e  Sc arri n g  
Pr ot oc ol I d e ntif yi n g  N u m b er:   VI 1 1 1 8 
 
 
V ersi o n  N u m b er:  1. 0 
Oct o b er  9,  2 0 1 8 
 
 
  
 
 
 
  
 
       
 
 
  
  
 
N C T 3 8 2 1 3 2 4

ii 
 
Ta bl e of C o nt e nts  
S T A T E M E N T O F C O M P LI A N C E  ............................................................................................................................. 1 
P R O T O C O L S U M M A R Y  ........................................................................................................................................... 3 
S C H E M A TI C O F S T U D Y D E SI G N  .......................................................................................................................... 4 
1  
K E Y R O L E S  .................................................................................................................................................... 4 
2  
I N T R O D U C TI O N: B A C K G R O U N D I N F O R M A TI O N A N D S CI E N TI FI C R A TI O N A L E ........................ 5 
2. 1  
B a c k gr o u n d I nf or m ati o n  ...................................................................................................................... 5 
2. 2  
R ati o n al e  ............................................................................................................................................... 5 
2. 3  
P ot e nti al Ri s k s a n d B e n efit s  .............................................................................................................. 6 
2. 3. 1  
K n o w n P ot e nti al  Ri s k s  ..................................................................................................... 6 
2. 3. 2  
K n o w n P ot e nti al B e n efit s  ................................................................................................ 6 
3  
O B J E C TI V E S A N D P U R P O S E  .................................................................................................................... 6 
4  
S T U D Y D E SI G N A N D E N D P OI N T S  ........................................................................................................... 7 
4. 1  
D e s cri pti o n of t h e St u d y D e si g n  ........................................................................................................ 7 
4. 2. 1  
Pri m ar y E n d p oi nt  .............................................................................................................. 7 
4. 2. 2  
S e c o n d ar y P erf or m a n c e E n d p oi nt s  ............................................................................... 7 
4. 2. 3  
S af et y E n d p oi nt s  .............................................................................................................. 7 
5  
S T U D Y E N R O L L M E N T A N D WI T H D R A W A L  ........................................................................................... 7 
5. 1  
S T U D Y P O P U L A TI O N  ........................................................................................................................ 7 
5. 2  
P arti ci p a nt I n cl u si o n Crit eri a  .............................................................................................................. 7 
5. 3  
P a rti ci p a nt E x cl u si o n Crit eri a ............................................................................................................. 7 
5. 4  
Str at e gi e s f or R e cr uit m e nt a n d R et e nti o n  ........................................................................................ 8 
5. 5  
P arti ci p a nt Wit h dr a w al or t er mi n ati o n  ............................................................................................... 8 
5. 5. 1  
R e a s o n s f or Wit h dr a w al or T er mi n ati o n  ....................................................................... 8 
5. 5. 2  
H a n dli n g of P arti ci p a nt Wit h dr a w al s or t er mi n ati o n  .................................................... 9 
5. 6  
Pr e m at ur e T er mi n ati o n or S u s p e n si o n of St u d y  ............................................................................. 9 
6  
I N V E S TI G A TI O N A L D E VI C E ..................................................................................................................... 1 0  
6. 1  
I n v e sti g ati o n al d e vi c e a n d C o ntr ol D e s cri pti o n ............................................................................. 1 0  
6. 1. 1  
A c q ui siti o n  ....................................................................................................................... 1 0  
6. 1. 2  
D e vi c e S p e cifi c C o n si d er ati o n s  ................................................................................... 1 0  
6. 2  
I n v e sti g ati o n al d e vi c e A c c o u nt a bilit y Pr o c e d ur e s ......................................................................... 1 1  
7  
S T U D Y P R O C E D U R E S A N D S C H E D U L E  .............................................................................................. 1 1  
7. 1  
St u d y Pr o c e d ur e s/ E v al u ati o n s  ......................................................................................................... 1 1  
7. 1. 1  
St u d y s p e cifi c pr o c e d ur e s  ............................................................................................. 1 1  
7. 2  
L a b or at or y Pr o c e d ur e s/ E v al u ati o n s  ................................................................................................ 1 1  
7. 2. 1  
Cli ni c al L a b or at or y E v al u ati o n s  .................................................................................... 1 1  
7. 2. 2  
Ot h er A s s a y s or Pr o c e d ur e s  ........................................................................................ 1 1  
7. 3  
St u d y S c h e d ul e  .................................................................................................................................. 1 1  
7. 3. 1  
E nr oll m e nt/ S cr e e ni n g  .................................................................................................... 1 1  
7. 3. 2  
B a s eli n e Vi sit  .................................................................................................................. 1 2  
7. 3. 3  
Tr e at m e nt Vi sit s  ............................................................................................................. 1 2  
7. 3. 4  
F oll o w U p Vi sit s  .............................................................................................................. 1 5  
7. 3. 5  
E arl y T er mi n ati o n Vi sit  .................................................................................................. 1 5  
7. 3. 6  
U N S C H E D U L E D Vi sit  ................................................................................................... 1 5  
7. 3. 7  
S c h e d ul e of E v e nt s T a bl e  ............................................................................................. 1 6  
7. 4  
J u stifi c ati o n f or S e n siti v e Pr o c e d ur e s  ............................................................................................. 1 6  

iii 
 
7. 5  
C o n c o mit a nt M e di c ati o n s, Tr e at m e nt s, a n d Pr o c e d ur e s  ............................................................. 1 6  
7. 6  
Pr o hi bit e d M e di c ati o n s, Tr e at m e nt s, a n d Pr o c e d ur e s  ................................................................. 1 7  
7. 7  
Pr o p h yl a cti c M e di c ati o n s, Tr e at m e nt s, a n d Pr o c e d ur e s  ............................................................. 1 7  
7. 8  
R e s c u e M e di c ati o n s, Tr e at m e nt s, a n d Pr o c e d ur e s  ..................................................................... 1 7  
8  
A S S E S S M E N T O F S A F E T Y  ...................................................................................................................... 1 7  
8. 1  
S p e cifi c ati o n of S af et y P ar a m et er s  ................................................................................................. 1 7  
8. 1. 1  
D efi niti o n of A d v er s e E v e nt s ( A E) a n d a d v er s e d e vi c e eff e ct ( A D E)  ..................... 1 7  
8. 1. 2  
D efi niti o n of S eri o u s A d v er s e E v e nt s ( S A E)  .............................................................. 1 8  
8. 1. 3  
D efi niti o n of s eri o u s a d v er s e d e vi c e eff e ct ( S A D E)  .................................................. 1 8  
8. 1. 4  
D efi niti o n of D e vi c e d efi ci e n c y  ..................................................................................... 1 8  
8. 2  
Cl a s sifi c ati o n of a n A d v er s e E v e nt  ................................................................................................. 1 9  
8. 2. 1  
S e v erit y of E v e nt  ............................................................................................................ 1 9  
8. 2. 2  
R el ati o n s hi p t o I N V E S TI G A TI O N A L D E VI C E  ........................................................... 1 9  
8. 2. 3  
E x p e ct e d n e s s  ................................................................................................................. 2 0  
8. 3  
Ti m e P eri o d a n d Fr e q u e n c y f or E v e nt A s s e s s m e nt a n d F oll o w -U p  .......................................... 2 0  
8. 4  
R e p orti n g Pr o c e d ur e s  ....................................................................................................................... 2 1  
8. 4. 1  
A d v er s e E v e nt R e p orti n g  .............................................................................................. 2 1  
8. 4. 2  
S eri o u s A d v er s e E v e nt R e p orti n g  ............................................................................... 2 1  
8. 4. 4  
R e p orti n g of Pr e g n a n c y  ................................................................................................ 2 2  
8. 5  
St u d y H alti n g R ul e s  ........................................................................................................................... 2 2  
8. 6  
S af et y O v er si g ht  ................................................................................................................................ 2 2  
8. 7  
Tr ai ni n g R e q uir e m e nt s  ...................................................................................................................... 2 2  
9  
C L I NIC A L M O NI T O RI N G  ............................................................................................................................ 2 2  
1 0  
S T A TI S TI C A L C O N SI D E R A TI O N S  .......................................................................................................... 2 3  
1 0. 1  
St ati sti c al a n d A n al yti c al Pl a n s  ........................................................................................................ 2 3  
1 0. 2  
St ati sti c al H y p ot h e s e s  ....................................................................................................................... 2 3  
1 0. 3  
A n al y si s D at a s et s  .............................................................................................................................. 2 3  
1 0. 4  
D e s cri pti o n of St ati sti c al M et h o d s  ................................................................................................... 2 4  
1 0. 4. 1  
G e n er al A p pr o a c h  .......................................................................................................... 2 4  
1 0. 4. 2  
A n al y si s of t h e Pri m ar y Effi c a c y E n d p oi nt( s)  ............................................................. 2 4  
1 0. 4. 3  
A n al y si s of t h e S e c o n d ar y E n d p oi nt( s)  ....................................................................... 2 5  
1 0. 4. 4  
S af et y A n al y s e s  .............................................................................................................. 2 5  
1 0. 4. 5  
A d h er e n c e a n d R et e nti o n A n al y s e s  ............................................................................ 2 6  
1 0. 4. 6  
B a s eli n e D e s cri pti v e St ati sti c s  ..................................................................................... 2 7  
1 0. 4. 7  
Pl a n n e d I nt eri m A n al y s e s  ............................................................................................. 2 7  
1 0. 4. 9  
M ulti pl e C o m p ari s o n/ M ulti pli cit y ................................................................................... 2 7  
1 0. 4. 1 0  
T a b ul ati o n of I n di vi d u al R e s p o n s e D at a  ..................................................................... 2 7  
1 0. 4. 1 1  
E x pl or at or y A n al y s e s  ..................................................................................................... 2 7  
1 0. 5  
S a m pl e Si z e  ....................................................................................................................................... 2 7  
1 0. 6  
M e a s ur e s t o Mi ni mi z e Bi a s  .............................................................................................................. 2 8  
1 0. 6. 1  
E nr oll m e nt/ R a n d o mi z ati o n/ M a s ki n g Pr o c e d ur e s  .................................................... 2 8  
1 0. 6. 2  
E v al u ati o n of S u c c e s s of Bli n di n g  ............................................................................... 2 8  
1 0. 6. 3  
Br e a ki n g t h e St u d y Bli n d/ P arti ci p a nt C o d e  ................................................................ 2 8  
1 1  
S O U R C E D O C U M E N T S A N D A C C E S S T O S O U R C E D A T A/ D O C U M E N T S  ................................... 2 9  
1 2  
Q U A LI T Y A S S U R A N C E A N D Q U A LI T Y C O N T R O L  .............................................................................. 2 9  
1 3  
E T HI C S/ P R O T E C TI O N O F H U M A N S U B J E C T S  ................................................................................... 3 0  

i v 
 
1 3. 1  
Et hi c al St a n d a r d ................................................................................................................................. 3 0  
1 3. 2  
Et hi c s c o m mitt e e a n d c o m p et e nt a ut h oriti e s  ................................................................................. 3 0  
1 3. 3  
I nf or m e d C o n s e nt Pr o c e s s ............................................................................................................... 3 0  
1 3. 3. 1  
C o n s e nt/ a s s e nt a n d Ot h er I nf or m ati o n al D o c u m e nt s Pr o vi d e d t o P arti ci p a nt s .... 3 0  
1 3. 3. 2  
C o n s e nt Pr o c e d ur e s a n d D o c u m e nt ati o n  .................................................................. 3 0  
1 3. 4  
P arti ci p a nt a n d d at a C o nfi d e nti alit y  ................................................................................................ 3 1  
1 3. 4. 1  
R e s e ar c h U s e of St or e d H u m a n S A M P L E S, S P E CI M E N S or D at a  ...................... 3 1  
1 3. 5  
F ut ur e U s e of St or e d S p e ci m e n s  .................................................................................................... 3 1  
1 4  
D A T A H A N D LI N G A N D R E C O R D K E E PI N G  .......................................................................................... 3 1  
1 4. 1  
D at a C oll e cti o n a n d M a n a g e m e nt R e s p o n si bil iti e s ...................................................................... 3 1  
1 4. 2  
St u d y R e c or d s R et e nti o n  .................................................................................................................. 3 2  
1 4. 3  
Pr ot o c ol D e vi ati o n s ............................................................................................................................ 3 2  
1 4. 4  
P u bli c ati o n a n d D at a S h ari n g P oli c y  ............................................................................................... 3 3  
1 5  
S T U D Y A D MI NI S T R A TI O N  ........................................................................................................................ 3 4  
1 5. 1  
St u d y L e a d er s hi p  ............................................................................................................................... 3 4  
1 6  
C O N F LI C T O F I N T E R E S T P O LI C Y  .......................................................................................................... 3 4  
1 7  
LI T E R A T U R E R E F E R E N C E S .................................................................................................................... 3 4  
A P P E N DI X I - A B B R E VI A TI O N S  ........................................................................................................................... 3 5  
LI S T O F A B B R E VI A TI O N S  ..................................................................................................................................... 3 5  
 

Cli nic al E v al u ati o n of t h e S af et y a n d P erf or m a nc e of F r acti o n al R a di ofr e q u e nc y f or t h e Tr e at m e nt a n d R e d ucti o n of Ac n e 
Sc arri n g  
V ersi o n 1. 0 
Pr ot oc ol # VI 1 1 1 8 
Oct o b er 9 , 2 0 1 8 
 
 
1 
 
 
S T A T E M E N T O F C O M P LI A N C E  
 
T his cli nic al st u dy will b e c o n d uct e d i n c o m pli a nc e wit h t h e l at est v ersi o n of t h e D ecl ar ati o n of H elsi n ki 
( 2 0 1 3), I S O 1 4 1 5 5: 2 0 1 1  (Cli nic al i nv esti g ati o n of m e dic al d e vic es f or h u m a n s u bj ects - G o o d cli nic al 
pr actic e ), M e dic al D evic es Dir ectiv e 9 3/ 4 2/ E E C, M E D D E V 2. 7/ 3, U nit e d St at es ( U S) C o d e of F e d er al 
R e g ul ati o ns ( C F R) a p plic a bl e t o cli nic al st u di es ( 4 5 C F R P art 4 6, 2 1 C F R P art 5 0, 2 1 C F R P art 5 6, 2 1 C F R P art 
3 1 2, a n d/ or 2 1 C F R P art 8 1 2)  a n d a ny of t h e a p plic a bl e r e gi o n al or n ati o n al r e g ul ati o ns p ert ai ni n g t o 
c o n d uct of a cli nic al i nv esti g ati o n of a m e dic al d evic e.  
T h e cli nic al i nv esti g ati o n s h all n ot b e gi n u ntil t h e r e q uir e d a p pr o v al or f av or a bl e o pi ni o n fr o m t h e et hics 
c o m mitt e e (E C ) h as b e e n o bt ai n e d a n d, if a p plic a bl e, a ny l oc al or n ati o n al r e g ul at or y a ut h orit y a p pr o v als 
or n otific ati o ns h av e b e e n o bt ai n e d.  
A ny a d diti o n al r e q uir e m e nts i m p os e d by t h e E C or a p pli c a bl e r e g ul at ory a ut h ority s h all b e f oll o w e d i n t h e 
c o n d uct of t his cli nic al i nv esti g ati o n. 
T h e S p o ns or h as o bt ai n e d cli nic al i nv esti g ati o n i ns ur a nc e t h at will c ov er ex p e ns es i n t h e ev e nt of a ny 
p hysic al i nj ur y r es ulti n g fr o m r es e arc h pr oc e d ur es.  
 
 

Cli nic al E v al u ati o n of t h e S af et y a n d P erf or m a nc e of F r acti o n al R a di ofr e q u e nc y f or t h e Tr e at m e nt a n d R e d ucti o n of Ac n e 
Sc arri n g  
V ersi o n 1. 0 
Pr ot oc ol # VI 1 1 1 8 
Oct o b er 9 , 2 0 1 8 
 
 
3 
 
P R O T O C O L S U M M A R Y  
 
TI TL E  
Cli nic al E v al u ati o n of t h e S af et y a n d P erf or m a nc e of Fr acti o n al R a di ofr e q u e nc y  
f or t h e Tr e at m e nt a n d R e d ucti o n of Ac n e Sc arri n g . 
S U M M A R Y  
Pr os p ectiv e,  si n gl e c e ntr e, e v al u at or -bli n d st u dy of t h e sa f et y a n d p erf or m a nc e 
of fr acti o n al  r a di ofr e q u e ncy (R F ) f or t h e tr e at m e nt a n d r e d ucti o n of ac n e 
sc arri n g.  T h e s t u dy will ev al u at e t h e pr o gr ess of 1 5 s u bj ects re q u esti n g 
tr e at m e nt of ac n e sc arri n g .  T h e  st u dy will i nv ol v e t hr e e tr e at m e nts o n b ot h 
si d es of th e f ac e wit h 3 - 5 w e e k i nt er v als b et w e e n e ac h tr e at m e nt.   Su bj ects will 
b e f oll o w e d a t 6 a n d 1 2 w e e ks  aft er t h eir l ast tr e at m e nt.  A n al ysis will b e 
p erf or m e d o n all s u bj ects w h o r ec eiv e at l e ast o n e tr e at m e nt.  
O BJ E C TI V E S  
T h e o bj ectiv e of t his cli nic al st u dy is t o ev al u at e t h e s af et y a n d p erf or m a nc e of 
fr acti o n al R F f or t h e tr e at m e nt a n d r e d ucti o n of ac n e sc arri n g . 
E N D P OI N T  
Pri m ar y p erf or m a nc e e n d p oi nts  
•  
I m pr ov e m e nt i n ac n e  sc arri n g at  6 w e e ks  a n d  1 2  w e e ks   p ost -tr e at m e nt 
c o m p ar e d t o b as eli n e  as  ass ess e d by bli n d e d  ev al u at ors  by  
p h ot o gr a p hic  ass ess m e nt utilizi n g  t h e Gl o b al  A est h etic  I m pr ov e m e nt 
Sc al e   
 
S ec o n d ar y p erf or m a nc e e n d p oi nts  
•  
S u bj ects’ ass ess m e nt of s atisf acti o n wit h t h e tr e at m e nt usi n g a S u bj ect  
S atisf acti o n Sc al e at 6 w e eks a n d 1 2 w e eks  p ost -tr e at m e nt. 
 
S af et y e n d p oi nts  
•  
S u bj ect’s ass ess m e nt of disc o mf ort a n d p ai n aft er tr e at m e nt s as 
m e as ur e d by a 1 0 c m vis u al a n al o g sc al e ( V A S)  a n d T ol er a bilit y Sc al e  
•  
S u bj ects ex p eri e nci n g a tr e at m e nt -r el at e d a dv ers e ev e nt ( A E ) by 1 2 
w e eks  p ost -tr e at m e nt. 
 
P O P UL A T I O N 
T h e st u dy will e nr oll 1 5 m al e or f e m al e a d ult s u bj ects re q u esti n g fr acti o n al 
ra di ofr e q u e ncy tr e at m e nt of ac n e sc arri n g  acc or di n g t o t h e  st u dy pr ot oc ol.   
P H A S E  
P ost -M ark et  
N U M B E R O F SI T E S  1   
D E S C RI P TI O N O F 
D E VI C E  
T h e V e n us Viv a ™ fr acti o n al R F d e vic e  h as b e e n s h o w n i n cli nic al st u di es t o 
i m pr ov e v ari o us ski n c o n diti o ns r el at e d t o a gi n g a n d alt er c oll a g e n str uct ur es 
s uc h as wri n kl es, r hyti ds a n d sc ars .  T h e d evic e off ers t h e o pti o n of 8 0 a n d 1 6 0  
pi n ti ps, t o d eliv er n a n o fr acti o n al R F e n er gy t o t h e tr e at m e nt sit e. 
S T U D Y D U R A TI O N  A p pr oxi m at ely 8 m o nt hs  
P A R TI CI P A N T 
D U R A TI O N  
6 m o nt hs  
 
 
 

Cli nic al E v al u ati o n of t h e S af et y a n d P erf or m a nc e of F r acti o n al R a di ofr e q u e nc y f or t h e Tr e at m e nt a n d R e d ucti o n of Ac n e 
Sc arri n g  
V ersi o n 1. 0 
Pr ot oc ol # VI 1 1 1 8 
Oct o b er 9 , 2 0 1 8 
 
 
4 
S C H E M A TI C O F S T U D Y D E SI G N  
 
Scr e e ni n g Visit  
 
Scr e e n P ot e nti al S u bj ects B y Incl usi o n a n d E xcl usi o n E nr oll m e nt C rit eri a; O bt ai n 
Inf or m e d C o ns e nt , Me dic al H ist ory, A d mi nist er  T e st Sp ot, P hysic al Ex a m,  
D e m o gr a p hics  
 
 
Visit 1 –   
B as eli n e / T x 1 
D a y 0  
E x a mi n e T est S p ot , C o nfir m Eli gi bility st at us, A Es, C o nc o mit a nt M e dic ati o n, 
P h ot o gr a p hs , Ad mi nist er Initi al S t u dy T r e at m e nt, 1 0 cm P ai n V A S  a n d 
T ol er a bility Sc al e  
 
 
Visit 2  -T x 2  
W e ek 4   
(+/ - 1 w e ek ) 
A Es, C o nc o mit a nt M e dic ati o n ,  Ad mi nist er S t u dy T r e at m e nt, 1 0 cm P ai n V A S  a n d 
T ol er a bility Sc al e  
 
 
Visit 3  -T x 3  
W e ek 8  
( +/- 1 w e ek )  
A Es, C o nc o mit a nt M e dic ati o n , , Ad mi nist er S t u dy T r e at m e nt, 1 0 cm P ai n V A S  
a n d T ol er a bilit y Sc al e  
 
 
Visit 4  –  F U 1  
6 w e e ks  p ost - fi n al 
tr e at m e nt 
( +/- 1 w e ek)  
A Es, C o nc o mit a nt M e dic ati o n, P h ot o gr a p hs, S u bj ect  Satisf acti o n  Sc al e, 
Tr e at m e nt Ev al u ati o n Q u esti o n n air e   
 
 
Visit 5  -F U 2  
1 2  w e e k s p ost-
fi n al tr e at m e nt 
( +/- 1 w e ek)  
A Es, C o nc o mit a nt M e dic ati o n, P h ot o gr a p hs,  S u bj ect  S atisf acti o n Sc al e, 
Tr e at m e nt Ev al u ati o n Q u esti o n n air e   
 
 
1 
K E Y R O L E S  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

Cli nic al E v al u ati o n of t h e S af et y a n d P erf or m a nc e of F r acti o n al R a di ofr e q u e nc y f or t h e Tr e at m e nt a n d R e d ucti o n of Ac n e 
Sc arri n g  
V ersi o n 1. 0 
Pr ot oc ol # VI 1 1 1 8 
Oct o b er 9 , 2 0 1 8 
 
 
5 
2  
I N T R O D U C TI O N: B A C K G R O U N D I N F O R M A TI O N A N D S CI E N TI FI C R A TI ON A L E  
 
2. 1  
B A C K G R O U N D I N F O R M A TI O N  
F aci al  t ext ur e irr e g ul ariti es s uc h as p ost ac n e sc ars, a n d wri n kl es, cli nic all y r ef err e d t o as r hyti d es, ar e 
c o m m o n ski n c o n diti o ns i n b ot h m e n a n d w o m e n. Ac n e sc arri n g i n p artic ul ar, m ay  b e q uit e ext e nsiv e 
a n d c a n c a us e si g nific a nt distr ess f or i n divi d u als s uff eri n g fr o m t h es e p ost-ac n e s e q u el a e 2.  C urr e nt  
pr oc e d ur es s uc h as c h e mic al or l as er p e els, d er m a br asi o n or n o n a bl ati v e l as er r es urf aci n g ar e us u ally 
ass oci at e d wit h pr ol o n g e d r ec ov ery ti m es as w ell as ar d u o us si d e eff ects 1. T o circ u m v e nt t h es e iss u es, 
t h e us e of n o n-i nv asiv e, n o ns ur gic al a p pr o ac h es t h at d o n ot r e q uir e d o w nti m e ar e b ec o mi n g t h e 
pr ef err e d m et h o d of c h oic e f or p ati e nts s e e ki n g  c os m etic i m pr ov e m e nts.  A n i n n o v ati v e t ec h ni q u e t h at 
w as i ntr o d uc e d t o r e d uc e f aci al wri n kl es a n d r hyti d es is k n o w n as r a di ofr e q u e ncy ( R F).  
Tr e at m e nt of ac n e sc ars wit h fr acti o n al R F t h er a py h as b e e n s h o w n t o pr o m ote r e m o d eli n g of t h e 
d er mis t o r e pl ac e ac n e  sc ar-ass oci at e d irr e g ul ariti es  wit h a  m or e n or m al arc hit ect ur e, p artic ul arly i n t h e 
c as e of el astic fi b ers a n d o v er -d e p ositi o n of el asti n 6. 
T h e pr e mis e b e hi n d R F t ec h n ol o gy is d er m al h e ati n g,  w hic h i niti at es t h e d e n at ur ati o n of c oll a g e n a n d 
t h e sti m ul ati o n of n e oc oll a g e n esis t hr o u g h t h e i n d ucti o n of i nfl a m m ati o n t h at l e a ds t o t h e pr o d ucti o n of 
fi br o bl asts at t h e h e at e d ar e a a n d t h e s u bs e q u e nt d e v el o p m e nt of n e w c oll a g e n. 2 R F e n er gy pr o d uc es 
a n oscill ati n g el ectric a l c urr e nt t h at c a n p e n etr at e t h e d er mis a n d hy p o d er m al tiss u es wit h o ut dist ur bi n g 
t h e e pi d er m al-d er m al b arri er. T h e g e n er ati o n of t h e h e at e n er gy is t h e r es ult of t h e n at ur al r esist a nc e 
t h at d er m al tiss u e h as t o t h e m ov e m e nt of i o ns wit h a n el ectr o m a g n etic fi el d. Acc or di n gl y, t h e 
oscill ati n g el ectric al c urr e nt c a us es c ollisi o ns b et w e e n c h ar g e d i o ns t h at ar e tr a nsf or m e d i nt o h e at 
e n er gy. 2 T h e pr o d ucti o n of h e at e n er gy t hr o u g h R F ty pic all y r es ults i n a bl ati o n, c o a g ul ati o n, a n d s ki n 
r es urf aci n g.   
M o n o -p ol ar R F d evic es w er e us e d i niti ally f or f aci al tr e at m e nts, a n d alt h o u g h t h e r es ults a p p e ar e d t o b e 
pr o misi n g, t his a p pr o ac h w as ass oci at e d wit h s eri o us p ai n as w ell as t h e hi g h i nci d e nc e of a dv ers e 
e v e nts i ncl u di n g s ec o n d -d e gr e e b ur ns t h at ar e c a us e d by t h e d e e p l y p e n etr ati n g h e at pr o d ucti o n of t h e 
si n gl e el ectr o d e. 5 Bi p ol ar a n d m ulti -p ol ar R F d evic es all o w t h e h e at e n er gy t o b e distri b ut e d m or e ev e nl y 
wit h l ess d e pt h -p e n etr ati o n, t h er e by r es ulti n g i n l ess p ai n a n d i m pr ov e d s af ety pr ofil es b ut c o nc er ns 
r e m ai n e d r e g ar di n g t h e a bilit y t o pr ecis ely c o ntr ol t h e d e gr e e of a bl ati o n a n d c o a g ul ati o n t h at is 
r e q uir e d d e p e n di n g o n a p ati e nt’s s ki n ty p e.   
T h er ef or e, R F t ec h ni q u es t h at i m pr o v e t h e a bilit y t o c o ntr ol t h e a bl ati o n a n d c o a g ul ati o n of t h e s ki n c a n 
r es ult i n tr e at m e nt c o nsist e nc y t h at will pr ovi d e m or e fl exi bilit y t o tr e at a wi d er v ari et y of s ki n 
c o n diti o ns.  
2. 2  
R A TI O N A L E  
Fr acti o n al  R F t ec h n ol o gy h as b e e n s h o w n i n cli nic al st u di es t o i m pr ov e ski n l axity, a n d t o tr e at v ari o us 
s ki n c o n diti o ns r el at e d t o a gi n g a n d alt er n at e c oll a g e n str uct ur es s uc h as wri n kl es, r hyti ds  a n d sc ars .   
T h e o bj ectiv e of t his cli nic al st u dy is t o ev al u at e t h e s af et y a n d p erf or m a nc e of fr acti o n al  R F f or t h e 
tr e at m e nt of  ac n e sc arri n g  a n d wri n kl es.  
T h e us e of t h e V e n us Vi v a ™ h as  b e e n d et er mi n e d t o pr es e nt n o n -si g nific a nt ris k i n acc or d a nc e wit h 2 1 
C F R 8 1 2. 3 f or t h e i nt e n d e d us e i n t his st u dy, b ec a us e t h e d e vic e is n ot:  

Cli nic al E v al u ati o n of t h e S af et y a n d P erf or m a nc e of F r acti o n al R a di ofr e q u e nc y f or t h e Tr e at m e nt a n d R e d ucti o n of Ac n e 
Sc arri n g  
V ersi o n 1. 0 
Pr ot oc ol # VI 1 1 1 8 
Oct o b er 9 , 2 0 1 8 
 
 
6 
•  
I nt e n d e d as a n i m pl a nt; 
•  
P ur p ort e d or r e pr es e nt e d t o b e f or us e s u p p orti n g or s ust ai ni n g h u m a n lif e;  
•  
S u bst a nti al i m p ort a nc e i n di a g n osi n g, c uri n g, miti g ati n g, or tr e ati n g dis e as e, or ot h er wis e 
pr e v e nti n g i m p air m e nt of h u m a n h e alt h  
•  
Ot h er wis e pr es e nti n g  a p ot e nti al f or s eri o us risk t o t h e h e alt h, s af ety, or w elf ar e of a s u bj ect.  
T his st u dy will b e c o n d uct e d i n c o m pli a nc e wit h t h e pr ot oc ol a n d acc or di n g t o G o o d Cli nic al Pr actic e 
( G C P) st a n d ar ds. 
2. 3  
P O T E N TI A L RI S K S A N D B E N E FI T S  
 
2. 3. 1  K N O W N  P O T E N TI A L RI S K S  
T h e p ot e nti al ris ks f or a dv ers e e v e nts of t h e tr e at m e nt pr oc e d ur e i ncl u d e b ut ar e n ot li mit e d t o 
d isc o mf ort or si g nific a nt pai n p ost -tr e at m e nt, exc essiv e s ki n r e d n ess ( er yt h e m a) a n d/ or s w elli n g 
( e d e m a), in- gr o w n h airs , da m a g e t o n at ur al ski n t ext ur e (cr ust, blist er, b ur n) , ch a n g e of pi g m e nt ati o n 
( hy p er- a n d hy p o -pi g m e nt ati o n)  a n d sc arri n g. Tr e at m e nt of h air -b e ari n g ar e as i n m ale p ati e nts m ay 
r es ult i n s o m e d a m a g e t o t h e f ollicl es a n d s u bs e q u e nt l oss of h air.  Av oi d t h e b e ar d ar e a a n d ot h er h air - 
gr o wi n g z o n es if t h e p ati e nt d o es n ot wis h t o ex p eri e nc e h air gr o wt h r e d ucti o n.   
F urt h er i nf or m ati o n a b o ut r esi d u al ris ks ass oci at e d wi t h t h e d evic e a n d  wit h p artici p ati o n  i n t h e cli nic al 
i nv esti g ati o n ar e r e p ort e d i n t h e d evic e Us er M a n u al . 
R esi d u al ris ks will b e miti g at e d as f oll o ws:  
− S el ecti o n of a n i nv esti g at or wit h ex p eri e nc e i n t h e  t h er a p e utic ar e a of t h e cli nic al i nv esti g ati o n 
− I nv esti g at or a n d sit e st aff will h a v e alr e a dy u n d er g o n e  tr ai ni n g pri or t o p ati e nts’ e nr oll m e nt 
− Pri or t o  t h e first pr oc e d ur e, t h e i nv esti g at or a n d sit e st aff will u n d er g o a r e-tr ai ni n g s essi o n by 
t h e s p o ns or r e pr es e nt ativ e o n t h e us e of t h e d evic e 
− P ati e nts will b e ri g or o usly scr e e n e d pri or t o t h eir e nr oll m e nt  
− P ati e nts will b e ri g or o usly f oll o w e d o v er t h e c o urs e of t h e st u dy  
 
2. 3. 2  K N O W N P O T E N TI A L B E N E FI T S  
If t h e s u bj ect a gr e es t o p artici p at e i n t his st u dy, h e/ s h e will b e c o ntri b uti n g t o t h e u n d erst a n di n g of t h e 
d e vic e’s i m p act a n d t h e bi ol o gic al pr oc ess es t h at ar e occ urri n g r e g ar di n g ac n e sc ar  f or m ati o n. T his 
u n d erst a n di n g m a y l e a d t o o pti miz ati o n of t h e tr e at m e nt wit h t his d evic e f or t h es e i n dic ati o ns.  I n 
a d diti o n,  t h e s u bj ect m a y b e n efit fr o m i m pr ov e m e nt i n ac n e sc ar  a p p e ar a nc e i n t h e tr e at e d ar e as. 
3 
O BJ E C TI V E S A N D  P U R P O S E  
T his cli nic al st u dy is b ei n g c o n d uct e d  t o e v al u at e t h e s af et y a n d p erf or m a nc e of n a n o fr acti o n al R F f or 
t h e tr e at m e nt a n d r e d ucti o n of ac n e sc arri n g . T ot al ex p ect e d d ur ati o n of t h e cli nic al i nv esti g ati o n  is 
ei g ht m o nt hs  ( e nr ol m e nt p eri o d of 2 m o nt hs, f oll o w -u p p eri o d of 6 m o nt hs ), w hil e i n di vi d u al s u bj ect 
p artici p ati o n will t ak e  a p pr oxi m at ely  6 m o nt hs.  
 
 

Cli nic al E v al u ati o n of t h e S af et y a n d P erf or m a nc e of F r acti o n al R a di ofr e q u e nc y f or t h e Tr e at m e nt a n d R e d ucti o n of Ac n e 
Sc arri n g  
V ersi o n 1. 0 
Pr ot oc ol # VI 1 1 1 8 
Oct o b er 9 , 2 0 1 8 
 
 
7 
 
4 
S T U D Y D E SI G N A N D E N D P OI N T S  
 
4. 1  
D E S C RI P TI O N O F T H E S T U D Y D E SI G N  
T his is a pr os p ecti v e, ev al u at or -bli n d st u dy of t h e s af et y a n d p erf or m a nc e of fr acti o n al  R F f or t h e 
tr e at m e nt a n d r e d ucti o n  of ac n e sc arri n g . 
4. 2 . 1 P RI M A R Y E N D P OI N T  
•  
I m pr ov e m e nt i n ac n e sc arri n g  at 6 w e e ks a n d 1 2 w e e ks  p ost -i nt erv e nti o n c o m p ar e d t o b as eli n e 
as ass ess e d by bli n d e d ev al u at ors by p h ot o gr a p hic ass ess m e nt utilizi n g t h e  Gl o b al A est h etic 
I m pr ov e m e nt Sc al e ( G AI S) f or ac n e sc arri n g. 
4. 2 . 2 S E C O N D A R Y P E R F O R M A N C E E N D P OI N T S  
 
•  
S u bj ects’ ass ess m e nt of s atisf acti o n wit h t h e tr e at m e nt usi n g a S u bj ect S atisf acti o n Sc al e  at 6 
w e eks  a n d 1 2 w e e ks p ost -tr e at m e nt. 
4. 2. 3   SA F E T Y E N D P OI N T S  
•  
S u bj ects ’ ass ess m e nt of disc o mf ort a n d p ai n  aft er tr e at m e nt s as m e as ur e d by a 1 0 c m vis u al 
a n al o g sc al e ( V A S).  
•  
S u bj ects ex p eri e nci n g a tr e at m e nt -r el at e d a dv ers e ev e nt ( A E) by 1 2 w e e k s p ost-tr e at m e nt. 
5 
S T U D Y E N R O L L M E N T A N D WI T H D R A W A L  
 
5. 1  
S T U D Y P O P U L A TI O N  
T h e st u dy will e nr oll 1 5 m al e or f e m al e a d ult s u bj ects r e q u esti n g fr acti o n al r a di ofr e q u e nc y tr e at m e nt of 
ac n e sc arri n g acc or di n g t o st u dy pr ot oc ol .   
5. 2  
P A R TI CI P A N T  I N C L U SI O N C RI T E RI A 
1.  H e alt hy , m al e or  f e m al e s u bj ects o v er 2 1 y e ars of a g e  w h o ar e s e e ki n g tr e at m e nt a n d r e d ucti o n 
of  t h eir ac n e sc arri n g . 
2.  A bl e t o r e a d, u n d erst a n d a n d v ol u nt arily pr ovi d e writt e n I nf or m e d C o ns e nt . 
3.  A bl e a n d willi n g t o c o m pl y wit h t h e tr e at m e nt/f oll o w -u p sc h e d ul e a n d r e q uir e m e n ts. 
4.  W o m e n of c hil d -b e ari n g a g e ar e r e q uir e d t o b e usi n g a r eli a bl e m et h o d of birt h c o ntr ol at l e ast 3 
m o nt hs pri or t o st u dy e nr oll m e nt  a n d f or t h e d ur ati o n of t h e st u dy a n d  h a v e a n e g ati v e Uri n e 
Pr e g n a nc y t est at b as eli n e.  
5. 3 
P A R TI CI P A N T  E X C L U SI O N C RI T E RI A 
1.  I m pl a nt a bl e d efi brill at ors, c ar di ac p ac e m a k ers, a n d ot h er m et al i m pl a nts 
2.  S u bj ects wit h a ny i m pl a nt a bl e m et al d evic e i n t h e tr e at m e nt ar e a  

Cli nic al E v al u ati o n of t h e S af et y a n d P erf or m a nc e of F r acti o n al R a di ofr e q u e nc y f or t h e Tr e at m e nt a n d R e d ucti o n of Ac n e 
Sc arri n g  
V ersi o n 1. 0 
Pr ot oc ol # VI 1 1 1 8 
Oct o b er 9 , 2 0 1 8 
 
 
8 
3.  P ac e m ak er or i nt er n al d efi brill at or, or a ny ot h er activ e el ectric al i m pl a nt a ny w h er e i n t h e b o dy 
( e. g. c oc hl e ar i m pla nt).  
4.  P er m a n e nt i m pl a nt i n t h e tr e at e d ar e a, s uc h as m et al pl at es a n d scr e ws, or a n i nj ect e d c h e mic al 
s u bst a nc e. 
5.  C urr e nt or hist or y of a ny ki n d of c a nc er, or pr e -m ali g n a nt m ol es.  
6.  S e v er e c o nc urr e nt c o n diti o ns, s uc h as c ar di ac dis or d ers.  
7.  Pr e g n a nc y or i nt e n di n g t o b ec o m e pr e g n a nt d uri n g t h e st u dy a n d n ursi n g.  
8.  I m p air e d i m m u n e syst e m d u e t o i m m u n os u p pr essi v e dis e as es, s uc h as AI D S a n d HI V, or us e of 
i m m u n os u p pr essiv e m e dic ati o ns.  
9.  Hist or y of dis e as es sti m ul at e d by h e at, s uc h as r ec urr e nt h er p es si m pl ex i n t h e tr e at m e nt ar e a; 
m a y b e e nr oll e d o nl y aft er a pr o p hyl actic r e gi m e h as b e e n f oll o w e d f or 2 w e e ks or l o n g er pri or 
t o e nr oll m e nt, or acc or di n g t o I nv esti g at or’s discr eti o n. 
1 0.  P o orl y c o ntr oll e d e n d ocri n e dis or d ers, s uc h as di a b et es.  
1 1.  A ny activ e c o n diti o n i n t h e tr e at m e nt ar e a, s uc h as s or es, ps ori asis, ecz e m a, a n d r as h.  
1 2.  Hist or y of s ki n dis or d ers, s uc h as k el oi ds, a b n or m al w o u n d h e ali n g, as w ell as v ery dr y a n d 
fr a gil e s ki n. 
1 3.  Hist or y of bl e e di n g c o a g ul o p at hi es, or us e of a ntic o a g ul a nts  ( excl u di n g d ail y as piri n). 
1 4.  F aci al d er m a br asi o n, f aci al r es urf aci n g, or d e e p c h e mic al p e eli n g wit hi n t h e l ast t hr e e m o nt hs, if 
f ac e is tr e at e d. 
1 5.  Us e of is otr eti n oi n ( Acc ut a n e ®) or ot h er s yst e mic r eti n oi ds wit hi n six m o nt hs or t o pic al r eti n oi ds 
wit hi n t hr e e m o nt hs pri or t o tr e at m e nt; or as p er p hysici a n’s discr eti o n . 
1 6.  Us e of n o n -st er oi d al a nti-i nfl a m m at or y dr u gs ( N S AI D S, e. g. i b u pr of e n-c o nt ai ni n g a g e nts) o n e 
w e ek b ef or e a n d aft er e ac h tr e at m e nt s essi o n.  
1 7.  A ny s ur gic al pr oc e d ur e i n t h e tr e at m e nt ar e a wit hi n t h e l ast six m o nt hs or b ef or e c o m pl et e 
h e ali n g.  
1 8.  Tr e ati n g o v er t att o o or p er m a n e nt m ak e u p.  
1 9.  Exc essiv ely t a n n e d s ki n fr o m s u n, t a n ni n g b e ds or t a n ni n g cr e a ms wit hi n t h e l ast t w o w e eks.  
2 0.  As p er t h e pr actiti o n er's discr eti o n, r efr ai n fr o m tr e ati n g a ny c o n diti o n w hic h mi g ht m ak e it 
u ns af e f or t h e p ati e nt.   
5. 4 
S T R A T E GI E S F O R R E C R UI T M E N T A N D R E T E N TI O N  
M al e or  f e m al e s u bj ects r e q u esti n g tr e at m e nt f or t h e r e d ucti o n of ac n e sc arri n g will  b e e nr oll e d at t h e 
si n gl e i nv esti g ati v e sit e u ntil a t ot al of 1 5 p ati e nts  h a v e b e e n tr e at e d acc or di n g t o t h e st u dy pr ot oc ol .  It 
is a ntici p at e d t h at it will t ak e u p t o ei g ht m o nt hs  t o c o m pl et e t h e st u dy.  S u bj ects  will   pri m aril y b e 
r ecr uit e d fr o m t h e i nv esti g at or’s pr actic e.  A ny a dv ertisi n g c a m p ai g ns a n d m at eri als will b e r evi e w e d 
a n d a p pr o v e d by a n Et hics  C o m mitt e e or I ns tit uti o n al R e vi e w B o ar d ( E C or  I R B) b ef or e i m pl e m e nt ati o n.  
D u e t o t h e l o n g d ur ati o n of t h e st u dy, s u bj ects will b e c o nt act e d by t h e i nv esti g ati v e sit e  o n a r e g ul ar 
b asis t o e n h a nc e r et e nti o n.  
5. 5 
P A R TI CI P A N T  WI T H D R A W A L  O R T E R MI N A TI O N  
 
5. 5 . 1 R E A S O N S F O R WI T H D R A W A L  O R T E R MI N A TI O N  
S u bj ects  ar e fr e e t o wit h dr a w fr o m p artici p ati o n i n t h e st u dy wit h o ut pr ej u dic e at a ny ti m e u p o n 
r e q u est.  I n t h e e v e nt t h at a s u bj ect dr o ps o ut of t h e st u dy or is wit h dr a w n fr o m t h e st u dy, t h e E n d of 
St u dy /E arly Disc o nti n u ati o n  C R F  f or m s h o ul d b e c o m pl et e d.  O n t h e disc o nti n u ati o n  p a g e , t h e 
I nv esti g at or s h o ul d r ec or d t h e d at e of t h e wit h dr a w al a n d t h e r e as o n f or wit h dr a w al.  

Cli nic al E v al u ati o n of t h e S af et y a n d P erf or m a nc e of F r acti o n al R a di ofr e q u e nc y f or t h e Tr e at m e nt a n d R e d ucti o n of Ac n e 
Sc arri n g  
V ersi o n 1. 0 
Pr ot oc ol # VI 1 1 1 8 
Oct o b er 9 , 2 0 1 8 
 
 
9 
R e as o n a bl e eff ort s h o ul d b e m a d e t o c o nt act a ny s u bj ect l ost t o f oll o w u p d uri n g t h e c o urs e of t h e st u dy 
i n or d er t o c o m pl et e ass ess m e nts a n d r etri e v e a ny o utst a n di n g d at a.  T h e r ec or ds of s u bj ects w h o 
t er mi n at e pri or t o c o m pl eti n g t h e st u dy will b e r et ai n e d a n d t h e r e as o n f or t er mi n ati o n will b e 
d oc u m e nt e d.  
T h e  i nv esti g at or m ay t er mi n at e p artici p ati o n i n t h e st u dy if: 
•  
A ny cli nic al a dv ers e ev e nt ( A E), l a b or at ory a b n or m ality, or ot h er m e dic al c o n diti o n or sit u ati o n 
occ urs s uc h t h at c o nti n u e d p artici p ati o n i n t h e st u dy w o ul d n ot b e i n t h e b est i nt er est of t h e 
s u bj ect. 
•  
T h e s u bj ect m e ets a n excl usi o n crit eri o n ( eit h er  n e wl y d e v el o p e d or n ot pr e vi o usl y r ec o g niz e d) 
t h at pr ecl u d es f urt h er st u dy p artici p ati o n. 
5. 5 . 2 H A N D LI N G O F P A R TI CI P A N T  WI T H D R A W A L S O R T E R MI N A TI O N  
E v ery eff ort will b e m a d e t o c o nti n u e f oll o w -u p of wit h dr a w n or t er mi n at e d s u bj ects or s u bj ects w h o 
disc o nti n u e t h e i nt er v e nti o n b ut r e m ai n i n t h e st u dy f or f oll o w -u p, es p eci all y f or s af et y a n d  
p erf or m a nc e  st u dy e n d p oi nts.  Ev er y eff ort will  b e m a d e t o c o n d uct a n exit visit (fi n al st u dy visit, s e e 
s ecti o n 7. 3. 5)  t o wit h dr a w n p ati e nts , a n d t o u n d ert a k e pr ot oc ol -sp ecifi e d s af et y f oll o w -u p pr oc e d ur es 
t o c a pt ur e A Es, s eri o us a dv ers e e v e nts ( S A Es) a nd d evic e d efici e nci es.   
5. 6 
P R E M A T U R E T E R MI N A TI O N O R S U S P E N SI O N O F S T U D Y  
T h e s p o ns or m ay s us p e n d or pr e m at ur ely t er mi n at e t his st u dy at  t h e i nv esti g ati o n sit e f or si g nifica nt a n d 
d oc u m e nt e d r e as o ns.  
 
A  pri nci p al  i nv esti g at or,  E C/I R B,  or  r e g ul at ory  a ut h ority  m a y  s us p e n d  or  pr e m at ur el y  t er mi n at e  
p artici p ati o n i n t h e st u dy at t h e i nv esti g ati o n sit e f or w hic h t h ey ar e r es p o nsi bl e.  
 
If s us pici o n of a n u n acc e pt a bl e ris k t o s u bj ects aris es d uri n g t h e st u dy, or w h e n s o i nstr uct e d by t h e E C/I R B 
or r e g ul at ory a ut h oriti es, t h e s p o ns or s h all s us p e n d t h e cli nic al i nv esti g ati o n w hil e t h e risk is ass ess e d.  
T h e s p o ns or s h all t er mi n at e t h e st u dy if a n u n acc e pt a bl e ris k is c o nfir m e d.  
 
T h e  s p o ns or  s h all c o nsi d er  t er mi n ati n g  or s us p e n di n g  t h e  p artici p ati o n  of  t h e i nv esti g ati o n  sit e or 
i nv esti g at or i n t h e st u dy if m o nit ori n g or a u diti n g i d e ntifi es s eri o us or r e p e at e d d e vi ati o ns o n t h e p art of 
a n i nv esti g at or.  
 
If s us p e nsi o n or pr e m at ur e t er mi n ati o n occ urs, t h e t er mi n ati n g p arty s h all j ustif y its d ecisi o n i n writi n g 
a n d pr o m ptl y i nf or m t h e ot h er p arti es wit h w h o m t h e y ar e i n dir ect c o m m u nic ati o n. T h e pri nci p al 
i nv esti g at or a n d s p o ns or s h all k e e p e ac h ot h er i nf or m e d of a ny c o m m u nic ati o n r ec eiv e d fro m eit h er t h e 
E C/I R B or t h e r e g ul at ory a ut h ority.  
 
If, f or a ny r e as o n, t h e s p o ns or s us p e n ds or pr e m at ur ely t er mi n at es t h e st u dy at t h e i nv esti g ati o n sit e, t h e 
s p o ns or s h all i nf or m t h e r es p o nsi bl e r e g ul at ory a ut h orit y as a p pr o pri at e a n d e ns ur e t h at t h e E C/I R B is 
n otifi e d, eit h er by t h e pri nci p al i nv esti g at or or by t h e s p o ns or.  If t h e s us p e nsi o n or pr e m at ur e t er mi n ati o n 
w as i n t h e i nt er est of s af ety, t h e s p o ns or s h all i nf or m all ot h er pri nci p al i nv esti g at ors.  
 
If s us p e nsi o n or pr e m at ur e t er mi n ati o n occ urs, 

Cli nic al E v al u ati o n of t h e S af et y a n d P erf or m a nc e of F r acti o n al R a di ofr e q u e nc y f or t h e Tr e at m e nt a n d R e d ucti o n of Ac n e 
Sc arri n g  
V ersi o n 1. 0 
Pr ot oc ol # VI 1 1 1 8 
Oct o b er 9 , 2 0 1 8 
 
 
1 0  
a)  th e s p o ns or s h all r e m ai n r es p o nsi bl e f or pr ovi di n g r es o urc es t o f ulfil t h e o bli g ati o ns fr o m t h e 
cli nic al i nv esti g ativ e pl a n a n d existi n g a gr e e m e nts f or f oll o wi n g u p t h e s u bj ects e nr oll e d i n t h e 
st u dy, a n d 
b)  t h e pri nci p al i nv esti g at or or a ut h oriz e d d esi g n e e s h all pr o m ptl y i nf or m t h e e nr oll e d s u bj ects at 
t h e i nv esti g ati o n sit e, if a p pr o pri at e 
 
I n c as e of e arly t er mi n ati o n, fi n al st u dy activiti es acc or di n g t o t h e pr ot oc ol, i ncl u di n g t h e f oll o w u p visits 
a n d pr oc e d ur es t o ass ess t h e s af et y a n d effic acy of t h e d e vi c e will b e c o n d uct e d, r e g ar dl ess of t h e 
s p o ns or's i nt er est i n t h e st u dy.  F oll o w -u p activiti es will b e c o n d uct e d s o t h at d evic e d efici e nci es c a n b e 
i d e ntifi e d a n d a p pro pri at e s af et y m e as ur es c a n b e i m pl e m e nt e d.  
 
At t h e c o m pl eti o n or t er mi n ati o n of t h e st u d y, t h e I nv esti g at or will r et ur n all r e m ai ni n g cli nic al s u p pli es 
t o S p o ns or al o n g wit h a c o py of t h e d e vic e s u p pl y a n d i nv e nt or y r ec or ds. 
 
Circ u mst a nc es t h at m ay w arr a nt t er mi n ati o n or s us p e nsi o n i ncl u d e, b ut ar e n ot li mit e d t o:  
•  
D et er mi n ati o n of u n ex p ect e d,  si g nific a nt, or u n acc e pt a bl e ris k t o p artici p a nts ( ex a m pl es of 
fi n di n gs t h at mi g ht tri g g er a s af ety r e vi e w ar e t h e n u m b er of S A Es ov er all, t h e n u m b er of 
occ urr e nc es of a p artic ul ar t y p e of S A E, s ev er e A Es/r e acti o ns, or i ncr e as e d fr e q u e nc y of e v e nts  – 
r efe r t o s ecti o n 8. 5 S T U D Y H AL TI N G R UL E S . 
•  
D e m o nstr ati o n of p erf or m a nc e  t h at w o ul d w arr a nt st o p pi n g 
•  
I ns uffici e nt c o m pli a nc e t o pr ot oc ol r e q uir e m e nts 
•  
D at a t h at ar e n ot s uffici e ntl y c o m pl et e a n d/ or ev al u a bl e  
•  
D et er mi n ati o n of f utilit y  
St u dy m ay r es u m e o nc e c o nc er n s a b o ut s af et y, pr ot oc ol c o m pli a nc e, d at a q u ality ar e a d dr ess e d a n d 
s atisf y t h e s p o ns or, E C / I R B a n d/ or r e g ul at or y a ut h oriti es. 
6 
I N V E S TI G A TI O N A L D E VIC E  
 
6. 1   
IN V E S TI G A TI O N A L D E VI C E A N D C O N T R O L D E S C RI P TI O N  
 
6. 1. 1   AC Q UI SI TI O N   
If t h e i nv esti g ativ e sit e d o es  n ot o w n a V e n us Vi v a ™,  a d e vic e  will b e pr o vi d e d  by  t h e s p o ns or.  A n 
activ ati o n c o d e will b e r e q uir e d t o activ at e t h e d e vic e  ( n ot a p plic a bl e if t h e sit e o w ns t h e d e vic e).  T his 
c o d e will b e pro vi d e d t o t h e i nv esti g ativ e sit e o nc e  all r e g ul at ory a n d E C /I R B a p pr o v als ar e i n pl ac e a n d 
t h e sit e h as r ec eiv e d tr ai ni n g f or b ot h t h e d e vic e a n d t h e st u dy (if a p plic a bl e).  
6. 1. 2 
D E VI C E S P E CI FI C C O N S I D E R A TI O N S 
•  
D evic e m o d el(s)  - V e n us Vi v a ™  
•  
D evic e s etti n gs a n d pr o gr a m mi n g – A bl ati o n a n d C o a g ul ati o n  M o d e ; 1 8 0 - 28 0  v olt s, 5- 30 ms 
p uls e d ur ati o n  
•  
D ur ati o n of ex p os ur e a n d fr e q u e nc y –   
o  F or all s u bj ects - m o nt hl y tr e at m e nt f or 3 m o nt hs.   
T h e V e n us Viv a ™ is a n o n-i nv asi v e m e dic al a est h etic d e vic e, i nt e n d e d f or us e i n d er m at ol o gic a n d 
g e n er al s ur gic al pr oc e d ur es, r e q uiri n g a bl ati o n a n d r es urf aci n g of t h e ski n, usi n g t h e Vi v a a p plic at or.    

Cli nic al E v al u ati o n of t h e S af et y a n d P erf or m a nc e of F r acti o n al R a di ofr e q u e nc y f or t h e Tr e at m e nt a n d R e d ucti o n of Ac n e 
Sc arri n g  
V ersi o n 1. 0 
Pr ot oc ol # VI 1 1 1 8 
Oct o b er 9 , 2 0 1 8 
 
 
1 1  
T h e s yst e m c o nsists of a h a n d h el d a p plic at or  wit h dis p os a bl e ti ps.  T h e ti p o pti o ns  i ncl u d e a n 8 0 a n d 1 6 0  
pi n   ti ps, 8x 2 0 m m i n siz e, t h at d eli v ers t h e M ulti P ol ar R a di ofr e q u e nc y ( R F) t o t h e ski n .  F urt h er  d et ails 
a b o ut t h e V e n us Viv a ™ c a n b e f o u n d i n t h e d evic e Us er M a n u al . 
6. 2 
I N V E S TI G A TI O N A L D E VI C E A C C O U N T A BI LI T Y P R O C E D U R E S  
If t h e d evic e is s u p pli e d by t h e s p o ns or, tr ac e a bilit y s h all b e ac hi ev e d d uri n g a n d aft er t h e cli nic al 
i nv esti g ati o n by  assi g n m e nt of  s eri al n u m b ers t o d evic e a n d a p plic at ors.  Dis p os al ti ps will b e pr ovi d e d 
by t h e s p o ns or.  
7 
S T U D Y P R O C E D U R E S A N D  S C H E D U L E  
 
 
 
7 . 1 
S T U D Y P R O C E D U R E S/ E V A L U A TI O N S  
7. 1. 1  S T U D Y S P E CI FI C  P R O C E D U R E S   
T h e f oll o wi n g pr oc e d ur es a n d e v al u ati o ns will b e d o n e as p art of t h e st u dy : 
D e m o gr a p hics  
M e dic al /s ur gic al hist ory ( o bt ai n e d by i nt er vi e w a n d/ or m e dic al r ec or ds)  
P hysic al ex a mi n ati o n  
Ass ess m e nt of eli gi bilit y  
P h ot o gr a p hs   
Bli n d e d ass ess m e nt  
A d mi nistr ati o n of q u esti o n n air es a n d sc al es f or bli n d e d r e vi e w er  a n d p ati e nt -r e p ort e d o utc o m es 
A dv ers e ev e nt r ec or di n g  
C o nc o mit a nt m e dic ati o ns  
7. 2  
L A B O R A T O R Y P R O C E D U R E S/ E V A L U A TI O N S  
  
 
7 . 2. 1 C LI NI C A L L A B O R A T O R Y E V A L U A TI O N S  
Uri n e pr e g n a nc y t est t o b e p erf or m e d wit hi n 2 4 h o urs of st u dy i nt er v e nti o n wit h r es ults av ail a bl e pri or 
t o a d mi nistr ati o n of tr e at m e nt.    
7 . 2. 2 O T H E R  A S S A Y S O R P R O C E D U R E S  
N o n e.   
7. 3  
S T U D Y S C H E D U L E  
 
7. 3. 1  E N R O L L M E N T / S C R E E NI N G  
 
Scr e e ni n g a n d E nr ol m e nt  Visit (D a y -7 t o - 2) 
 

Cli nic al E v al u ati o n of t h e S af et y a n d P erf or m a nc e of F r acti o n al R a di ofr e q u e nc y f or t h e Tr e at m e nt a n d R e d ucti o n of Ac n e 
Sc arri n g  
V ersi o n 1. 0 
Pr ot oc ol # VI 1 1 1 8 
Oct o b er 9 , 2 0 1 8 
 
 
1 2  
If t h e s u bj ect m e ets t h e pr eli mi n ary st u dy crit eri a, t h e st u dy d oct or, a n d/ or his/ h er d esi g n e e, will o bt ai n 
a n i nf or m e d c o ns e nt fr o m t h e s u bj ect  pri or t o a ny st u dy pr oc e d ur e , cl e arl y i n dic ati n g his/ h er 
u n d erst a n di n g of t h e r e q uir e m e nts a n d p ossi bl e ris ks ass oci at e d wit h st u dy p artici p ati o n a n d ot h er 
a p plic a bl e tr e at m e nt o pti o ns.  S u bj ects will r ec eiv e a u ni q u e i d e ntif yi n g n u m b er t h at will b e c o m p os e d 
of a t w o -di git sit e n u m b er a n d a t w o -di git s u bj ect n u m b er i n s e q u e nc e.  T his u ni q u e i d e ntifi er will b e 
us e d t hr o u g h o ut t h e e ntir e st u dy a n d will b e e nt er e d i n t h e s u bj ect's c as e r e p ort f or m ( C R F).  
D uri n g t h e first visit, t h e st u dy i nv esti g at or, a n d/ or his / h er d esi g n e e, will scr e e n t h e s u bj ect f or eli gi bilit y 
t o p artici p at e i n t h e cli nic al st u dy usi n g t h e incl usi o n / excl usi o n crit eri a.  A n e g ativ e uri n e pr e g n a ncy t est 
will b e o bt ai n e d  (i n p ati e nts of c hil d-b e ari n g p ot e nti al) .  D uri n g scr e e ni n g , t h e st u dy d oct or will r evi e w 
t h e s u bj ect's m e dic al/s ur gic al hist ory , d e m o gr a p hics, c o n d uct a p hysic al ex a m a n d ex a mi n e t h e s u bj ect's 
t ar g et e d tr e at m e nt ar e a t o e ns ur e t h at it m e ets t h e st u dy crit eri a.  T h e s u bj ect will c o m pl et e scr e e ni n g 
a n d t h e tr e at m e nt will b e sc h e d ul e d.  
T est S p ots  
A s m all t est s p ot will b e p erf or m e d i n a n o n -c o ns pic u o us ar e a of t h e tr e at m e nt sit e, pri or t o t h e first 
c o m pl et e s essi o n. T est s p ots ar e p erf or m e d t o est a blis h t h e f oll o w i n g r e q uir e m e nts: 
•  
C o nfir m t h e p ati e nt's s uit a bilit y f or tr e at m e nt:  
o  F or s ki n t y p es I -III, w ait 2 4 -4 8 h o urs  
o  F or s ki n t y p e I V -VI , w ait 5 – 7 d ays  b ef or e ass essi n g t h e s ki n r es p o ns e  
•  
Est a blis h a n d c o nfir m tr e at m e nt p ar a m et ers:   If t h e d esir e d e n d p oi nt of eryt h e m a a n d e d e m a – 
i n a ti p-s h a p e d p att er n – h as n ot b e e n ac hi e v e d wit hi n 1 0 -1 5 mi n ut es, i ncr e as e t h e R F i n dic at or 
l e v el a n d p erf or m a n ot h er t est s p ot.  If t h e r es p o ns e is exc essiv e, d ecr e as e t h e p ar a m et ers a n d 
p erf or m a n ot h er t est s p ot.  
T est s p ot r es ults will i n dic at e if t h e p ati e nt c a n t ol er at e t h e tr e at m e nt wit h o ut d ev el o pi n g a dv ers e 
eff ects.   Acc or di n g t o p ati e nt t ol er a nc e t o t h e t est s p ot, tr e at m e nt p ar a m et ers ar e d et er mi n e d a n d 
w h et h er a n est h esi a is n e e d e d.  I n a d diti o n, it is a dvis a bl e t o p erf or m a t est s p ot w h e n ev er c h a n gi n g 
p ar a m et ers.   
 
7. 3. 2  B A S E LI N E  VI SI T  
B as eli n e  Visit ( Visit 1 – D a y 0 ) 
S u bj ects will r et ur n t o t h e cli nic r o u g hl y 2- 7 d ays  fr o m t h e Scr e e ni n g visit f or t h e B as eli n e visit a n d t h e 
first of t hr e e tr e at m e nts (s e e 7. 3. 3).  T h e s u bj ect’s e li gi bilit y st at us at t his ti m e p oi nt acc or di n g t o t h e 
i ncl usi o n/ excl usi o n crit eri a will b e r e-c o nfir m e d.  A dv ers e ev e nts  fr o m t h e t est s p ot a n d a ny c h a n g es t o 
c o nc o mit a nt m e dic ati o ns will b e r ec or d e d. P h ot o gr a p hs of t h e tr e at m e nt ar e a will b e t a k e n.  
 
7. 3. 3  T R E A T M E N T VI SI T S   
B e gi n ni n g wit h t h e B as eli n e visit ( Visit 1 ), su bj ects will r ec eiv e a t ot al of 3 tr e at m e nts a p pr oxi m at ely 3- 5 
w e eks a p art .  T h e l eft a n d ri g ht si d e of t h e f ac e will b e tr e at e d a n d ass ess e d as i n d e p e n d e nt sit es, a n d 

Cli nic al E v al u ati o n of t h e S af et y a n d P erf or m a nc e of F r acti o n al R a di ofr e q u e nc y f or t h e Tr e at m e nt a n d R e d ucti o n of Ac n e 
Sc arri n g  
V ersi o n 1. 0 
Pr ot oc ol # VI 1 1 1 8 
Oct o b er 9 , 2 0 1 8 
 
 
1 3  
t h e s a m e a p plic at or ti p c o nfi g ur ati o n will b e us e d t o tr e at b ot h si d es at all 3 tr e at m e nt visits.  A dv ers e 
e v e nts a n d a ny c h a n g es t o c o nc o mit a nt m e dic ati o ns will b e r ec or d e d  at t h es e visits . 
S u bj ects will r ec ei v e tr e at m e nt as d escri b e d b el o w.   F oll o wi n g tr e at m e nt, t h e i nv esti g at o r will ex a mi n e 
t h e tr e at e d ar e a a n d r e p ort i m m e di at e a n d s h ort t er m r es p o ns e.  S u bj ects will c o m pl et e t h e 1 0 c m 
disc o mf ort/ p ai n V A S a n d T ol er a bility Sc al e i m m e di at el y aft er tr e at m e nt.   
T h e i nv es ti g at or will ex a mi n e t h e tr e at e d ar e as a n d r e p ort i m m e di at e a n d s h ort t er m r es p o ns e ( 3 0 
mi n ut es p ost -tr e at m e nt) ( p ai n d uri n g tr e at m e nt, h e m orr h a g e, b ur n, er yt h e m a, e d e m a, p ur p ur a) usi n g a 
5- p oi nt sc al e: 1 = n o n e; 2 =tr ac e; 3 = m o d er at e; 4 = m ark e d; 5 =s ev er e.    
T h e n or m al r es p o ns e t o t h es e tr e at m e nts is tr a nsi e nt er yt h e m a a n d e d e m a. If a ny ot h er si d e eff ects 
occ ur, as i n dic at e d i n t h e pr ot oc ol, t h ey m ust b e r ec or d e d.  
Visit 1 – D a y 0  
T h is Bas eli n e visit  i ncl u d es t h e first of t h e t hr e e tr e at m e nts. P h ot o gr a p hs of t h e tr e at m e nt ar e a ar e t o b e 
t a k e n pri or t o tr e at m e nt.  B as e d o n t h e t est s p ot ev al u ati o n fr o m t h e pr e vi o us visit, tr e at m e nt 
p ar a m et ers will b e s el ect e d by t h e i nv esti g at or.   I n a d diti o n t o t h e tr e at m e nt, c o nc o mit a nt m e dic ati o ns, 
A Es, a n d t h e p ai n V A S a n d T ol er a bility Sc al e ar e t o b e c o m pl et e d by t h e p ati e nt.  
Visit 2 – W e e k 4 (+/ - 7 d a ys)  
T h e S u bj ect is t o r et ur n t o t h e cli nic f or t h eir s ec o n d of t h e t hr e e tr e at m e nts.  I n a d diti o n t o t h e 
tr e at m e nt, c o nc o mit a nt m e dic ati o ns, A Es a n d t h e p ai n V A S a n d T ol er a bilit y Sc al e ar e t o b e c o m pl et e d 
by t h e p ati e nt.  
Visit 3 -- W e e k 8 ( +/- 7 d a ys)  
T h e S u bj ect is t o r et ur n t o t h e cli nic f or t h eir fi n al tr e at m e nt.  I n a d diti o n t o t h e tr e at m e nt, c o nc o mit a nt 
m e dic ati o ns, A Es a n d t h e p ai n V A S a n d T ol er a bilit y Sc al e ar e t o b e c o m pl et e d by t h e p ati e nt.  
 
Tr e at m e nt  
S u bj ects will b e ask e d t o pr es e nt t o t h e cli nic cl e a n s h a v e n pri or t o r ec eivi n g tr e at m e nt.  T h er e s h o ul d 
b e n o l oti o n, m a k e -u p, p erf u m e, p o w d er, or b at h/s h o w er oil pr es e nt o n t h e s ki n i n t h e ar e a t o b e 
tr e at e d.  E ns ur e t h at t h e ski n is c o m pl et el y dr y d uri n g t h e e ntir e tr e at m e nt. If t h e s ki n m oist e ns d uri n g 
tr e at m e nt (i. e. p ers pir ati o n, etc.) r e-wi p e t h e s ki n wit h a n alc o h ol p a d a n d e ns ur e t h at t h e s ki n is 
c o m pl et el y dry b ef or e c o nti n ui n g t h e tr e at m e nt.  
 
D e p e n di n g u p o n t h e s u bj ect’s s e nsiti vity t o t h e t est s p ot a d mi nistr ati o n, a t o pic al a n est h etic m a y b e 
pr escri b e d a n d a p pli e d t o t h e tr e at m e nt ar e a pri or t o tr e at m e nt at t h e i nv esti g at or’s discr eti o n.  T his 
t o pic al a n est h etic s h o ul d b e a p pli e d a p proxi m at ely o n e h o ur  t o t hirt y mi n ut es pri or t o st u dy tr e at m e nt.  
 
S et t h e tr e at m e nt p ar a m et ers  t o d esir e d tr e at m e nt m o d e a n d s el ect t h e a p pr o pri at e ti p ( 1 6 0 pi n or 8 0 
pi n ti p) .  T h e s el ect e d ti p will b e utiliz e d f or all of t h e s p ecific p ati e nt’s s u bs e q u e nt t r e at m e nts.  S et t h e 
d esir e d e n er gy l ev el acc or di n g t o t h e s ki n t y p e, s ev erity of t h e tr e at e d c o n diti o n, tr e at m e nt ar e a, b o n e 
pr oxi mit y, etc.  S et c o ns erv ati v e p ar a m et ers fr o m a t est s p ot f or t h e first tr e at m e nt, a n d t h e n gr a d u all y 

Cli nic al E v al u ati o n of t h e S af et y a n d P erf or m a nc e of F r acti o n al R a di ofr e q u e nc y f or t h e Tr e at m e nt a n d R e d ucti o n of Ac n e 
Sc arri n g  
V ersi o n 1. 0 
Pr ot oc ol # VI 1 1 1 8 
Oct o b er 9 , 2 0 1 8 
 
 
1 4  
i ncr e as e d uri n g tr e at m e nt or i n s u bs e q u e nt tr e at m e nts acc or di n g t o t h e d esir e d i m p act a n d t est s p ot 
r es ults. 
T o p erf or m t h e tr e at m e nt, pl ac e t h e ti p o n t h e t ar g et z o n e, p er p e n dic ul ar t o t h e s ki n s urf ac e a n d wit h 
f ull c o nt act wit h t h e s ki n.  E mit a p uls e by pr essi n g t h e a p plic at or's tri g g er; t his will cr e at e a ti p-s h a p e d 
p att er n o n t h e p ati e nt's s ki n t h at will a p p e ar 1 -2 mi n ut es l at er. M ov e t h e a p plic at or t o a n a dj ac e nt s p ot 
o n t h e s ki n o v erl a p pi n g by 1 0 % a n d e mit a n ot h er p uls e ( n ot a p plic a bl e t o t h e t est s p ot). T h er e s h o ul d b e 
n o u ntr e at e d g a ps b et w e e n t h e p uls es.  
Ex a mi n e t h e tr e at e d ar e a. T h e i m m e di at e r es p o ns es, i n dic ati v e of t h e d esir e d eff ect, ar e er yt h e m a a n d 
e d e m a i n t h e i m m e di at e ar e a of t h e ti p -s h a p e d p att er n a n d p ossi bl y als o ar o u n d it. T h e e d e m a us u all y 
a p p e ars 1 -2 mi n ut e s aft er p ulsi n g a n d r e ac h es its p e ak ( of u p t o m o d er at e e d e m a) wit hi n 3 0 mi n ut es. It 
s h o ul d b e n ot e d t h at er yt h e m a is n ot e asil y n otic e a bl e – if at all – i n d ar k er ski n ty p es. T h er ef or e, t h e 
e d e m a will b e m or e pr o mi n e nt i n t h es e p ati e nts. Aft er c o m pl eti n g a f ull p ass o n t h e e ntir e tr e at m e nt 
ar e a, if u ntr e at e d p atc h es of s ki n ar e a p p ar e nt, r e -tr e at t h es e p atc h es as p er t h e f oll o wi n g pr oc e d ur e: 
i. Wi p e t h e u ntr e at e d p atc h of ski n wit h a dr y g a uz e p a d. 
ii. Tr e at t h e u ntr e at e d p atc h es of s ki n as n or m all y. 
Fi n e -t u ni n g of t h e p ar a m et ers s h o ul d b e d o n e b ef or e pr oc e e di n g t o tr e at m e nt of t h e e ntir e s u b-ar e a 
wit h t h e s el ect e d p ar a m et ers.. T h e a p plic at or ti p s h o ul d b e pl ac e d o n t h e s ki n, a p uls e e mitt e d, t h e n 
lift e d a n d m ov e d t o a n a dj ac e nt s p ot of t h e ski n. T h e e mitt ed p uls es s h o ul d cr e at e ti p -s h a p e d p att er ns. 
L e av e, n o u ntr e at e d g a ps b et w e e n t h e p att er n m ar ks, w hil e als o b ei n g c ar ef ul n ot t o ov erl a p t h e tr e at e d 
z o n es. T h e p ar a m et ers c a n b e m o difi e d d uri n g s u bs e q u e nt visits, as p er t h e pr actiti o n er's discr eti o n.  
P ost - Tr e at m e nt C ar e 
P ost -tr e at m e nt c o oli n g is n ot n ec ess ary.  I n t h e e v e nt of p ost-tr e at m e nt disc o mf ort, it is r ec o m m e n d e d 
t o c o ol t h e tr e at e d ar e a i m m e di at el y wit h air c o oli n g.  C ol d ( n ot fr oz e n) p ac ks m ay als o b e us e d. 
Blist er e d or ulc er at e d s ki n c a n b e tr e at e d wit h a pr escri b e d cr e a m. Ti ny sc a bs of l ess t h a n 1 m m 
di a m et er will us u all y f or m 2 4 -7 2 h o urs p ost -tr e at m e nt a n d m ay r e m ai n f or s ev er al d a ys. T h e sc a bs 
s h o ul d n ot b e t o uc h e d or scr atc h e d e v e n if t h ey itc h, a n d s h o ul d b e all o w e d t o s h e d off n at ur all y. 
Blis t er e d or ulc er at e d s ki n c a n b e tr e at e d wit h a pr escri b e d a nti bi otic oi nt m e nt or b ur n tr e at m e nt cr e a m 
as p er p hysici a n's discr eti o n.  D uri n g t h e first t w o d a ys f oll o wi n g tr e at m e nt, c ar e s h o ul d b e t a k e n t o 
pr e v e nt tr a u m a t o t h e tr e at e d sit e.  H ot b at hs, m ass a g e, etc. s h o ul d b e a v oi d e d. T h e s ki n s h o ul d b e k e pt 
cl e a n t o av oi d c o nt a mi n ati o n or i nf ecti o n.  A ny m ec h a nic al or t h er m al d a m a g e t o t h e ar e a m ust b e 
av oi d e d.  M oist uriz er m a y b e a p pli e d o nly 2 4 h o urs aft er e ac h tr e at m e nt, a n d t h e n s h o ul d b e a p pli e d 
r e g ul arl y t hr o u g h o ut t h e c o urs e of t h e tr e at m e nt.  M a k e-u p m a y b e a p pli e d o nl y 2 4 h o urs aft er e ac h 
tr e at m e nt if d esir e d, u nl ess a n u n w a nt e d r e acti o n occ urs i n t h e ar e a.  G e n er ally, 2 4 h o urs aft er 
tr e at m e nt, p ati e nts m a y us e r e g ul ar s o a ps, b ut n ot scr u b s o a ps or exf oli a nts. T h e p ati e nt s h o ul d us e a 
hi g h -f act or s u nscr e e n ( at l e ast 3 0 S P F) a n d pr ot ect t h e tr e at e d ar e a fr o m s u nli g ht f or at l e ast o n e m o nt h 
aft er t h e tr e at m e nt.  T a n ni n g of a ny s ort (s u n ex p os ur e, t a n ni n g b e ds, a n d artifici al s u nl ess t a n ni n g 
l oti o ns) is n ot all o w e d i n t h e tr e at e d ar e as d uri n g t h e e ntir e c o urs e of t h e tr e at m e nt.  T a n ni n g aft er 
tr e at m e nt m a y c a us e hy p er pi g m e nt ati o n.  
P h ot o gr a p hy  
P h ot o gr a p hs will b e t a k e n pri or t o first tr e at m e nt a n d t hr o u g h o ut t h e st u dy acc or di n g t o s p ecifi e d ti m e 
p oi nts d et ail e d i n t h e Sc h e d ul e of Ev e nts T a bl e (s ecti o n 7. 3. 7), utilizi n g st a n d ar d sci e ntific e q ui p m e nt.     

Cli nic al E v al u ati o n of t h e S af et y a n d P erf or m a nc e of F r acti o n al R a di ofr e q u e nc y f or t h e Tr e at m e nt a n d R e d ucti o n of Ac n e 
Sc arri n g  
V ersi o n 1. 0 
Pr ot oc ol # VI 1 1 1 8 
Oct o b er 9 , 2 0 1 8 
 
 
1 5  
T h e p h ot os s h o ul d b e t a k e n i n a pri v at e r o o m or ar e a of t h e cli nic u n d er c o ntr oll e d c o n diti o ns, i ncl u di n g 
t h e dist a nc e, a n gl e, b ac k gr o u n d a n d li g hti n g i n or d er t o ac hi ev e hi g h -q u alit y s ets of p h ot o gr a p hs.   T h e 
s u bj ect s h o ul d b e pl ac e d i n t h e s a m e p ositi o n e ac h ti m e.  As e ac h p h ot o gr a p h is t a k e n, it s h o ul d b e 
vi e w e d t o e ns ur e t h at it is i n f oc us a n d is si mil ar t o its b as eli n e c o u nt er p art i n all t ec h nic al as p ects, 
i ncl u di n g li g hti n g, dist a nc e a n d a n gl e. 
F or c o nsist e nc y p ur p os es, t h e s a m e p ers o n s h o ul d i d e all y t a k e all st u dy p h ot o gr a p hs, es p eci ally p er 
s u bj ect.  T h e di git al fil es s h o ul d f oll o w a c o nsist e nt st a n d ar d n a mi n g sc h e m e. 
7. 3. 4  F O L L O W U P VI SI T S  
Visit 4 – 6 W e e k  F oll o w U p P ost Fi n al Tr e at m e nt ( +/ - 7 d a ys)  
S u bj ects will r et ur n t o t h e cli nic 6 w e eks  aft er t h e fi n al  tr e at m e nt.  A dv ers e e v e nts, a n d a ny c h a n g es t o 
c o nc o mit a nt m e dic ati o ns will b e r ec or d e d.  S u bj ects will c o m pl et e a S u bj ect  Satisf acti o n Sc al e a n d 
Tr e at m e nt Ev al u ati o n Q u esti o n n air e . 
P h ot o gr a p hs of t h e tr e at e d ar e a will b e t a k e n as d escri b e d i n s ecti o n 7. 3. 3 . T h e p h ot o gr a p hs will b e s e nt 
t o t h e bli n d e d i n d e p e n d e nt r evi e w er f or t h e Gl o b al A est h etic I m pr ov e m e nt Sc al e ( G AI S)  ass ess m e nt .   
Visit 5 – 1 2 W e e k  F oll o w U p P ost Fi n al Tr e at m e nt ( +/ - 7 d a ys)  
S u bj ects will r et ur n t o t h e cli nic f or a fi n al st u d y visit 1 2 w e e ks  aft er t h e fi n al tr e at m e nt.  A dv ers e 
e v e nts, a n d a ny c h a n g es t o c o nc o mit a nt m e dic ati o ns will b e r ec or d e d.  S u bj ects will c o m pl et e a S u bj ec t  
S atisf acti o n Sc al e a n d Tr e at m e nt E v al u ati o n Q u esti o n n air e . 
P h ot o gr a p hs of t h e tr e at e d ar e a will b e t a k e n as d escri b e d i n s ecti o n 7. 3. 3. T h e p h ot o gr a p hs will b e s e nt 
t o t h e bli n d e d i n d e p e n d e nt r evi e w er f or G AI S ass ess m e nt.   
T h e  t er mi n ati o n f or m will b e c o m pl et e d, a n d s u bj ects will b e t er mi n at e d fr o m t h e st u dy.  T h e PI will 
r ec or d all r e p ort a bl e ev e nts wit h st art d at es occ urri n g a ny ti m e aft er i nf or m e d c o ns e nt is o bt ai n e d u ntil 
7 (f or n o n -s eri o us A Es) or 3 0 d a ys (f or S A Es) aft er t h e l ast d a y of st u dy p art ici p ati o n. 
7. 3. 5 
E A R L Y T E R MI N A TI O N VI SI T  
If a su bj ect  r e q u ests t o exit t h e st u dy e arly f or a ny  r e as o n, a T er mi n ati o n C R F m ust b e c o m pl et e d .  
A dv ers e ev e nts a n d t h e r e as o n f or e arly t er mi n ati o n will b e r ec or d e d.  
7. 3. 6  U N S C H E D U L E D VI SI T  
If a n u nsc h e d ul e d visit occ urs, t h e r e as o n f or t h e u nsc h e d ul e d visit will b e d oc u m e nt e d. If t h e 
u nsc h e d ul e d visit is t h e r es ult of a n a dv ers e e v e nt, t h e e v e nt will b e r ec or d e d o n t h e a dv ers e ev e nt C R F.  
 
 
 
 
 
 

Cli nic al E v al u ati o n of t h e S af et y a n d P erf or m a nc e of F r acti o n al R a di ofr e q u e nc y f or t h e Tr e at m e nt a n d R e d ucti o n of Ac n e 
Sc arri n g  
V ersi o n 1. 0 
Pr ot oc ol # VI 1 1 1 8 
Oct o b er 9 , 2 0 1 8 
 
 
1 7  
 
7. 6 
P R O HI BI T E D M E DI C A TI O N S, T R E A T M E N T S, A N D P R O C E D U R E S  
Us e of i m m u n os u p pr essiv e m e dic ati o ns, a ntic o a g ul a nts, is otr eti n oi n a n d  n o n -st er oi d al a nti-
i nfla m m at ory dr u gs is pr o hi bit e d .   
7. 7 
P R O P H Y L A C TI C M E DI C A T I O N S, T R E A T M E N T S, A N D P R O C E D U R E S  
Pr o p hyl actic r e gi m e f or hist or y of dis e as es sti m ul at e d by h e at, s uc h as r ec urr e nt h er p es si m pl ex i n t h e 
tr e at m e nt ar e a. 
7. 8 
R E S C U E M E DI C A TI O N S, T R E A T M E N T S, A N D P R O C E D U R E S  
I n t h e ev e nt t h at t h e s u bj ect ex p eri e nc es p ai n, t h e pri nci p al i nv esti g at or m ay pr escri b e a ny a n al g esic  
d e e m e d a p pr o pri at e t o t h e l e v el of p ai n. If a s u bj ect ex p eri e nc es a ny first, s ec o n d or t hir d d e gr e e b ur n 
or p ai n b ey o n d n arc otics, t h e n t h e f oll o wi n g pr oc e d ur e will b e i m pl e m e nt e d:  
•  
I m m e di at e tri a g e a n d tr e at m e nt of t h e p ati e nt s h all b e d et er mi n e d by t h e tr e ati n g p hysici a n a n d 
b as e d u p o n s e v erit y a n d t y p e of b ur n i d e ntifi e d.  
•  
T h e ev e nt will b e r e p ort e d t o t h e s p o ns or st u dy Dir ect or wit hi n 2 4 h o urs of occ urr e nc e.  If t h e 
e v e nt m e ets t h e crit eri a of a S A E, t h e n it m ust b e r e p ort e d o n t h e S A E f or m.  
•  
A n a n o ny miz e d  c o py of t h e p ati e nt c h art a n d tr e at m e nt p ar a m et ers ar e t o b e f or w ar d e d t o t h e 
s p o ns or st u dy Dir ect or wit hi n 2 4 h o urs.   
T h e s p o ns or st u dy Dir ect or will b e r es p o nsi bl e f or iss ui n g a writt e n r e p ort t o t h e c o m p a ny a n d t h e E C or  
I R B C h air m a n n o l at er t h a n 7 d ays fr o m t h e e v e nt   
L o n g t er m f oll o w u p a n d c ar e s h all c o nti n u e at t h e discr eti o n of t h e tr e ati n g p hysici a n.  
All p ati e nts ex p eri e nci n g a c o m plic a ti o n of t h e d e vic e will b e f oll o w e d a mi ni m u m of 2 y e ars f oll o wi n g 
t h e i niti al i nj ur y.  L o n g er c ar e a n d o bs er v ati o n will b e at t h e discr eti o n of t h e tr e ati n g p hysici a n.   
All mi n or c o m plic ati o ns s uc h as a p p e ar a nc e or alt er e d s e ns ati o n, exc e pt f or p ai n, c a n  b e r e p ort e d wit hi n 
3 0 d ays of p ati e nt c o m pl ai nt.  B ot h c h art a n d tr e at m e nt p ar a m et ers ar e t o b e pr o vi d e d t o t h e st u dy 
Dir ect or a n d s h ar e d wit h t h e c o m p a ny a n d E C or  I R B c h air m a n.  
8 
A S S E S S M E N T O F S A F E T Y  
 
8 . 1 
S P E CI FI C A TI O N O F S A F E T Y P A R A M E T E R S  
In a d diti o n t o s p o nt a n e o us r e p orts of a dv ers e ev e nts, s u bj ects will c o m pl et e a 1 0 c m  disc o mf ort/ p ai n 
V A S a n d t h e pri nci p al i nv esti g at or will ex a mi n e t h e tr e at e d ar e a a n d r e p ort i m m e di at e a n d s h ort t er m 
r es p o ns e. 
8 . 1. 1 D E FI NI TI O N O F A D V E R S E E V E N T S  ( A E) A N D A D V E R S E D E VI C E E F F E C T ( A D E)  
A dv ers e ev e nt m e a ns a ny u nt o w ar d m e dic al occ urr e nc e, u ni nt e n d e d dis e as e or i nj ur y, or u nt o w ar d 
cli nic al si g ns (i ncl u di n g a b n or m al l a b or at ory fi n di n gs) i n s u bj ects, us ers or ot h er p ers o ns, w h et h er or n ot 

Cli nic al E v al u ati o n of t h e S af et y a n d P erf or m a nc e of F r acti o n al R a di ofr e q u e nc y f or t h e Tr e at m e nt a n d R e d ucti o n of Ac n e 
Sc arri n g  
V ersi o n 1. 0 
Pr ot oc ol # VI 1 1 1 8 
Oct o b er 9 , 2 0 1 8 
 
 
1 8  
r el at e d t o t h e i nv esti g ati o n al m e dic al d evic e. T his d efi niti o n i ncl u d es e v e nts r el at e d t o t h e 
i nv esti g ati o n al m edic al d evic e or t h e c o m p ar at or.  T his d efi niti o n i ncl u d es ev e nts r el a t e d t o t h e 
pr oc e d ur es i nv ol v e d.  F or us ers or ot h er p ers o ns, t his d efi niti o n is r estrict e d t o ev e nts r el at e d t o 
i nv esti g ati o n al m e dic al d evic es (I S O 1 4 1 5 5:2 0 1 1 ). 
A dv ers e d e vic e eff ect m e a ns a ny a dv ers e ev e nt r el at e d t o t h e us e of a n i nv esti g ati o n al m e dic al d e vic e . 
T his d efi niti o n i ncl u d es a dv ers e e v e nts r es ulti n g fr o m i ns uffici e nt or i n a d e q u at e i nstr ucti o ns f or us e , 
d e pl o y m e nt, i m pl a nt ati o n, i nst all ati o n, or o p er ati o n, or a ny m alf u ncti o n of t h e i nv esti g ati o n al m e dic al 
d e vic e.  T his d efi niti o n i ncl u d es a ny e v e nt r es ulti n g fr o m us e err or or fr o m i nt e nti o n a l mis us e of t h e 
i nv esti g ati o n al m e dic al d evic e  (I S O 1 4 1 5 5: 2 0 1 1). 
8 . 1. 2 D E FI NI TI O N O F S E RI O U S A D V E R S E E V E N T S  ( S A E) 
N O T E: T h e t er m s eri o us is n ot sy n o ny m o us wit h s e v erit y, w hic h m a y b e us e d t o d escri b e t h e i nt e nsit y of 
a n e v e nt ex p eri e nc e d by t h e s u bj ect).  A n A E t h at d o es n ot m e et a ny of t h e b el o w crit eri a will b e 
cl assifi e d as n o n-s eri o us. 
A s eri o us A E  is a ny a dv ers e e v e nt t h at:  
•  
l e d t o d e at h, 
•  
l e d t o s eri o us d et eri or ati o n i n t h e h e alt h of t h e s u bj ect, t h at eit h er r es ult e d i n 
− a lif e -t hr e at e ni n g ill n ess or i nj ur y, or 
− a p er m a n e nt i m p air m e nt of a b o dy str uct ur e or a b o dy f u n cti o n, or 
− i n-p ati e nt or pr ol o n g e d h os pit aliz ati o n, or  
− m e dic al or s ur gic al i nt erv e nti o n t o pr ev e nt lif e -t hr e at e ni n g ill n ess or i nj ur y or p er m a n e nt 
i m p air m e nt t o a b o dy str uct ur e or a b o dy f u ncti o n, 
•  
l e d t o f et al distr ess, f et al d e at h or a c o n g e nit al a b n or m ality or birt h d ef ect 
Pl a n n e d h os pit aliz ati o n f or a pr e -existi n g c o n diti o n, or a pr oc e d ur e r e q uir e d by t h e CI P, wit h o ut s eri o us  
d et eri or ati o n i n h e alt h, is n ot c o nsi d er e d a s eri o us a dv ers e e v e nt  (I S O 1 4 1 5 5: 2 0 1 1). 
8 . 1. 3 D E FI NI TI O N O F  S E RI O U S A D V E R S E D E VI C E E F F E C T ( S A D E) 
T his d efi niti o n  i ncl u d es a n y a dv ers e d evic e eff ect t h at h as r es ult e d i n a ny of t h e c o ns e q u e nc es 
c h ar act eristic of a s eri o us a dv ers e ev e nt .  Un a ntici p at e d s eri o us a dv ers e d evic e eff ect ( U S A D E ) is a ny 
s eri o us a dv ers e d evic e eff ect w hic h by its n at ur e, i nci d e nc e, s e v erity or o utc o m e h as n ot b e e n i d e ntifi e d 
i n t h e c urr e nt v ersi o n of t h e ris k a n alysis r e p ort .  A ntici p at e d s eri o us a dv ers e d evic e eff ect ( A S A D E) is a n 
eff ect w hic h by its  n at ur e, i nci d e nc e, s e v erit y or o utc o m e h as b e e n i d e ntifi e d i n t h e ris k a n alysis r e p ort 
(I S O 1 4 1 5 5: 2 0 1 1). 
8. 1. 4  D E FI NI TI O N O F  D E VI C E D E FI CI E N C Y  
In a d e q u ac y of a m e dic al d evic e wit h r es p ect t o its i d e ntit y, q u ality, d ur a bility, r eli a bilit y, s af et y or 
p erf or m a nc e .  D e vic e d efici e nci es i ncl u d e m alf u ncti o ns, us e err ors, a n d i n a d e q u at e l a b elli n g (I S O 
1 4 1 5 5: 2 0 1 1).  
A ny I nv esti g ati o n al M e dic al D evic e D efici e ncy t h at mi g ht h a v e l e d t o a S A E if a) s uit a bl e acti o n h a d n ot 
b e e n t a k e n or b) i nt er v e nti o n h a d n ot b e e n m a d e or c) if circ u mst a nc es h a d b e e n l ess f ort u n at e is 
s u bj ect t o t h e s am e r e p orti n g r e q uir e m e nt of S A Es ( M E D D E V 2. 7/ 3 r e visi o n 3).  
 

Cli nic al E v al u ati o n of t h e S af et y a n d P erf or m a nc e of F r acti o n al R a di ofr e q u e nc y f or t h e Tr e at m e nt a n d R e d ucti o n of Ac n e 
Sc arri n g  
V ersi o n 1. 0 
Pr ot oc ol # VI 1 1 1 8 
Oct o b er 9 , 2 0 1 8 
 
 
1 9  
8 . 2 
C L A S SI FI C A TI O N O F A N  A D V E R S E E V E N T  
 
8 . 2. 1 S E V E RI T Y O F E V E N T  
F or A Es n ot i ncl u d e d i n t h e pr ot oc ol d efi n e d gr a di n g syst e m, t h e f oll o wi n g g ui d eli n es will b e us e d t o 
d escri b e s e v erit y.  
•  
Mil d  – E v e nts r e q uir e mi ni m al or n o tr e at m e nt a n d d o n ot i nt erf er e wit h t h e p artici p a nt’s d ail y 
activiti es.  
•  
M o d er at e  – E v e nts r es ult i n a l o w l ev el of i nc o nv e ni e nc e or c o nc er n wit h t h e t h er a p e utic 
m e as ur es.  M o d er at e ev e nts m a y c a us e s o m e i nt erf er e nc e wit h f u ncti o ni n g.  
•  
S e v er e  – Ev e nts i nt err u pt a p artici p a nt’s us u al d aily acti vity a n d m a y r e q uir e syst e mic dr u g 
t h er a py or ot h er tr e at m e nt. S e v er e ev e nts ar e us u all y p ot e nti ally lif e-t hr e at e ni n g or 
i nc a p acit ati n g. 
8 . 2. 2 R E L A TI O N S HI P T O I N V E S TI G A TI O N A L D E VIC E  
T h e cli nici a n’s ass ess m e nt of a n A E's r el ati o ns hi p t o t h e i nv esti g ati o n al d e vic e is p art of t h e 
d oc u m e nt ati o n pr oc ess, b ut it is n ot a f act or i n d et er mi ni n g w h at is or is n ot r e p ort e d i n t h e st u dy.  If 
t h er e is a ny d o u bt as t o w h et h er a cli nic al o bs erv ati o n is a n A E, t h e e v e nt s h o ul d b e r e p ort e d.  All A Es 
m ust h av e t h eir r el ati o ns hi p t o i nv esti g ati o n al d e vic e ass ess e d.  I n a cli nic al tri al, t h e st u dy pr o d uct m ust 
al w a ys b e s us p ect. T o h el p ass ess m e nt , t h e f oll o wi n g g ui d eli n es ar e us e d. 
•  
N ot R el at e d  – r el ati o n t o t h e d e vic e or pr oc e d ur e c a n b e excl u d e d  w h e n:  
− T h e ev e nt is n ot a k n o w n si d e eff ect of t h e pr o d uct c at e g or y t h e d e vic e b el o n gs t o or of si mil ar 
d e vic es a n d pr oc e d ur es;  
− t h e ev e nt h as n o t e m p or al r el ati o ns hi p wit h t h e us e of t h e i nv esti g ati o n al d evic e or t h e 
pr oc e d u r es; 
− t h e s eri o us e v e nt d o es n ot f oll o w a k n o w n r es p o ns e p att er n t o t h e m e dic al d evic e (if t h e r es p o ns e 
p att er n is pr e vi o usl y k n o w n) a n d is  bi ol o gic all y i m pl a usi bl e  
− t h e disc o nti n u ati o n of m e dic al d e vic e a p plic ati o n or t h e r e d ucti o n of t h e l ev el of 
activ ati o n/ ex p os ur e - w h e n cli nic all y f e asi bl e – a n d  r ei ntr o d ucti o n of its us e ( or i ncr e as e of t h e 
l e v el of activ ati o n/ ex p os ur e), d o n ot i m p act o n t h e s eri o us ev e nt;  
− t h e ev e nt i nv ol v es a b o dy-sit e or a n or g a n n ot ex p ect e d t o b e aff ect e d by t h e d evic e or 
pr oc e d ur e;  
− t h e s eri o us e v e nt c a n b e attri b ut e d t o a n ot h er c a us e ( e. g. a n u n d erl yi n g or c o nc urr e nt ill n ess/ 
cli nic al c o n diti o n, a n eff ect of a n ot h er d e vic e,  dr u g, tr e at m e nt or ot h er ris k f act ors) . 
•  
U nli k el y : t h e r el ati o ns hi p wit h t h e us e of t h e d evic e s e e ms n ot r el e v a nt a n d/ or t h e e v e nt c a n b e 
r e as o n a bly ex pl ai n e d by a n ot h er c a us e, b ut a d diti o n al i nf or m ati o n m a y b e o bt ai n e d. 
•  
P ossi bl e : t h e r el ati o ns hi p wit h t h e us e of t h e i nv esti g ati o n al d evic e is w e a k b ut c a n n ot b e r ul e d o ut 
c o m pl et el y.  Alt er n ativ e c a us es ar e als o p oss i bl e ( e. g. a n u n d erl yi n g or c o nc urr e nt ill n ess/ cli nic al 
c o n diti o n or/ a n d a n eff ect of a n ot h er d e vic e, dr u g or tr e at m e nt).  C as es w er e r el at e d n ess c a n n ot b e 
ass ess e d or n o  i nf or m ati o n h as b e e n o bt ai n e d s h o ul d als o b e cl assifi e d as p ossi bl e. 
•  
Pr o b a bl e : t h e rel ati o ns hi p wit h t h e us e of t h e i nv esti g ati o n al d evic e s e e ms  r el e v a nt a n d/ or t h e 
e v e nt c a n n ot r e as o n a bly b e ex pl ai n e d  by a n ot h er c a us e, b ut  a d diti o n al i nf or m ati o n m a y b e 
o bt ai n e d.  
•  
C a us al r el ati o ns hi p : t h e s eri o us ev e nt is ass oci at e d wit h t h e i nv esti g ati o n al d e vic e or wit h 
pr oc e d ur es b e y o n d r e as o n a bl e d o u bt w h e n:  

Cli nic al E v al u ati o n of t h e S af et y a n d P erf or m a nc e of F r acti o n al R a di ofr e q u e nc y f or t h e Tr e at m e nt a n d R e d ucti o n of Ac n e 
Sc arri n g  
V ersi o n 1. 0 
Pr ot oc ol # VI 1 1 1 8 
Oct o b er 9 , 2 0 1 8 
2 0  
−
t h e ev e nt is a k n o w n si d e eff ect of t h e pr o d uct c at e g or y t h e d e vic e b el o n gs t o or of si mil ar
d e vic es a n d pr oc e d ur es;
−
t h e ev e nt h as a t e m p or al r el ati o ns hi p wit h i nv esti g ati o n al d evic e us e/ a p plic ati o n or pr oc e d ur es;
−
t h e ev e nt i nv ol v es a b o dy-sit e or or g a n t h at t h e i nv esti g ati o n al d evic e or pr oc e d ur es ar e a p pli e d
t o or t h e i nv esti g ati o n al d evic e or pr oc e d ur es h av e a n eff ect o n;
−
t h e s eri o us e v e nt f oll o ws a k n o w n r es p o ns e p att er n t o t h e m e dic al d e vic e (if  t h e r es p o ns e
p att er n is pr e vi o usl y k n o w n);
−
t h e disc o nti n u ati o n of m e dic al d e vic e a p plic ati o n ( or r e d ucti o n of t h e l ev el of
activ ati o n/ ex p os ur e) a n d r ei ntr o d ucti o n of its us e ( or i ncr e as e of t h e  l ev el of
activ ati o n/ ex p os ur e), i m p act o n t h e s eri o us ev e nt ( w h e n  cli nic all y f e asi bl e);
−
ot h er p ossi bl e c a us es ( e. g. a n u n d erl yi n g or c o nc urr e nt ill n ess/ cli nic al  c o n diti o n or/ a n d a n
eff ect of a n ot h er d evic e, dr u g or tr e at m e nt) h a v e  b e e n a d e q u at el y r ul e d o ut;
−
h ar m t o t h e s u bj ect is d u e t o err or i n us e;
8 . 2. 3 E X P E C T E D N E S S 
Ex p ect e d  ( a ntici p at e d) a dv ers e r e acti o ns ar e A Es t h at ar e c o m m o n a n d k n o w n t o occ ur f or t h e 
i nv esti g ati o n al d evic e b ei n g  st u di e d.  Ex p ect e d  a dv ers e ev e nts i n t his st u dy i ncl u d e d isc o mf ort or 
si g nific a nt p ai n p ost-tr e at m e nt, exc essiv e s ki n r e d n ess ( eryt h e m a) a n d/ or s w elli n g ( e d e m a) , in- gr o w n 
h airs , da m a g e t o n at ur al s ki n t ext ur e (cr ust, blist er, b ur n) , ch a n g e of pi g m e nt ati o n ( hy p er - a n d hy p o -
pi g m e nt ati o n) , sc arri n g. Tr e at m e nt of h air -b e ari n g ar e as i n m al es m ay r es ult i n s o m e d a m a g e t o t h e 
f ollicl es a n d s u bs e q u e nt l oss of h air.  
A n A E or s us p ect e d a dv ers e r e acti o n is c o nsi d er e d " u n ex p ect e d"  (u n a ntici p at e d) if it is n ot k n o w n t o 
occ ur f or t h e i nv esti g ati o n al d e vic e b ei n g  st u di e d a n d at t h e s p ecificit y or s ev erity t h at h as b e e n 
o bs erv e d  ( A E n ot d escri b e d i nt o t h e Cli nic al pr ot oc ol  or Us er M a n u al ). 
8 . 3 
TI M E P E RI O D A N D F R E Q U E N C Y F O R E V E N T A S S E S S M E N T A N D F O L L O W -U P  
T h e occ urr e nc e of a n A E or S A E m ay c o m e t o t h e att e nti o n of st u dy p ers o n n el d uri n g st u dy visits a n d 
i nt ervi e ws of a st u dy p artici p a nt pr es e nti n g f or m e dic al c ar e, or u p o n r evi e w by a st u dy m o nit or.  All A Es 
i ncl u di n g l oc al a n d s yst e mic r e acti o ns n ot m e eti n g t h e crit eri a f or S A Es will b e c a pt ur e d o n t h e 
a p pr o pri at e C R F.   I nf or m ati o n t o b e c oll ect e d i ncl u d es e v e nt d escri pti o n, ti m e of o ns et, cli nici a n’s 
ass ess m e nt of s ev erity, r el ati o ns hi p t o i nv esti g ati o n al d e vic e a n d st u dy pr oc e d ur es (ass ess e d o nly by 
t h os e wit h t h e tr ai ni n g a n d a ut h ority t o m a k e a di a g n osis), a n d ti m e of r es ol uti o n/st a biliz ati o n of t h e 
e v e nt.  All A Es occ urri n g w hil e o n st u dy m ust b e d oc u m e nt e d a p pr o pri at el y r e g ar dl ess of r el ati o ns hi p. 
All A Es will b e f oll o w e d t o a d e q u at e r es ol uti o n.  
A ny m e dic al c o n diti o n t h at is pr es e nt at t h e ti m e t h at t h e p artici p a nt is scr e e n e d will b e c o nsi d er e d as 
b as eli n e a n d n ot r e p ort e d as a n A E. H o w ev er, if t h e st u dy p artici p a nt’s c o n diti o n d et eri or at es at a ny 
ti m e d uri n g t h e st u dy, it will b e r ec or d e d as a n A E. 
C h a n g es i n t h e s ev erity of a n A E will b e d oc u m e nt e d t o all o w a n ass ess m e nt of t h e d ur ati o n of t h e ev e nt 
at e ac h l e v el of s e v erit y t o b e p erf or m e d.  A E s c h ar act eriz e d as i nt er mitt e nt r e q uir e d oc u m e nt ati o n of 
o ns et a n d d ur ati o n of e ac h e pis o d e.  
T h e PI will r ec or d all a dv ers e ev e nts  wit h st art d at es occ urri n g a ny ti m e aft er i nf or m e d c o ns e nt is 
o bt ai n e d.  At e ac h st u dy visit, t h e i nv esti g at or will i n q uir e stu dy s u bj ects a b o ut t h e occ urr e nc e of 

Cli nic al E v al u ati o n of t h e S af et y a n d P erf or m a nc e of F r acti o n al R a di ofr e q u e nc y f or t h e Tr e at m e nt a n d R e d ucti o n of Ac n e 
Sc arri n g  
V ersi o n 1. 0 
Pr ot oc ol # VI 1 1 1 8 
Oct o b er 9 , 2 0 1 8 
2 1  
A E/ S A Es si nc e t h e l ast visit. All a dv ers e e v e nts n e e d t o b e f oll o w e d u ntil r es ol uti o n or u ntil st u dy e n d, 
w hic h e v er occ urs first . 
8 . 4 
R E P O R TI N G P R O C E D U R E S  
8 . 4. 1 A D V E R S E E V E N T R E P O R T I N G 
All A Es will b e r ec or d e d o n t h e a p pr o pri at e C R F a n d will i ncl u d e i nf or m ati o n a b o ut t h e st art a n d st o p 
d at es, s e v erit y a n d r el at e d n ess.  T h er e s h o ul d b e a n att e m pt t o r e p ort a “ di a g n osis” r at h er t h a n t h e 
i n divi d u al si g ns, s y m pt o ms a n d a b n or m al l a b or at ory v al u es ass oci at e d wit h t h e di a g n osis. H o w ev er, a 
di a g n osis s h o ul d b e r e p ort e d o nl y if, i n t h e I nv esti g at or’s j u d g m e nt, it is r el ativ ely c ert ai n (i. e., d efi nit e 
or p ossi bl e). Ot h er wis e i n divi d u al si g ns, sy m pt o ms a n d a b n or m al l a b or at ory v al u es s h o ul d b e r e p ort e d 
as disti nct  a dv ers e ev e nts.  
8. 4. 2  S E RI O U S A D V E R S E E V E N T R E P O R TI N G 
All s eri o us A E, w h et h er or n ot d e e m e d pr oc e d ur e or  d e vic e r el at e d, m ust b e r e p ort e d t o t h e  s p o ns or’s 
cli nic al r es e arc h d e p art m e nt i m m e di at el y or wit hi n 2 4 h o urs by t el e p h o n e  or by e m ail  (s e e c o nt act 
d et ails b el o w).  
 
 
A writt e n r e p ort pr e p ar e d by t h e Pri nci p al I nv esti g at or  ( or d esi g n at e) m ust f oll o w  wit hi n s e v e n w or ki n g 
d a ys t o t h e cli nic al m o nit or a n d s h o ul d i ncl u d e a f ull d escri pti o n of t h e e v e nt a n d s e q u e nc e.  
T h e st u dy i nv esti g at or s h all c o m pl et e a S eri o us A dv ers e E v e nt  / S eri o us A dv ers e D evic e Eff ect F or m a n d 
s u b mit t o t h e st u dy s p o ns or as  s o o n as p ossi bl e, b ut i n n o ev e nt l at er t h a n 1 0 w orki n g d a ys aft er t h e 
i nv esti g at or first l e ar ns of t h e eff ect. 
I n acc or d a nc e wit h t h e r e q uir e m e nts of Dir ectiv e 9 3/ 4 2/ E E C, a n d wit h M E D D E V 2. 7/ 3, t h e f oll o wi n g 
e v e nts ar e c o nsi d er e d r e p ort a bl e ev e nts:  
1.
a ny S A E ( w h e t h er or n ot st u dy  pr oc e d ur e or d evic e r el at e d),
2.
a ny I nv esti g ati o n al M e dic al D evic e D efici e ncy t h at mi g ht h a v e l e d t o a S A E if a) s uit a bl e acti o n
h a d n ot b e e n t ak e n or b) i nt er v e nti o n h a d n ot b e e n m a d e or c) if circ u mst a nc es h a d b e e n l ess
f ort u n at e,
3.
n e w fi n di n gs/ u p d at es i n r el ati o n t o alr e a dy r e p ort e d ev e nts.
T h e s p o ns or will r e p ort t h e a b o v e -m e nti o n e d  ev e nts t o t h e C o m p et e nt A ut h oriti es of all c o u ntri es 
w h er e t h e st u dy is b ei n g c o n d uct e d, wit hi n t h e f oll o wi n g ti m eli n es:  
−
A ny S A E w hic h i n dic at es a n i m mi n e nt ris k of d e at h, s eri o us i nj ur y, or s eri o us ill n ess A N D t h at
r e q uir es pr o m pt r e m e di al acti o n f or ot h er p ati e nts/s u bj ects, us ers or ot h er p ers o ns or a n e w
fi n di n g t o it: i m m e di at ely, b ut n ot l at er t h a n 2 c al e n d ar d a ys aft er a w ar e n ess by s p o ns or of a
n e w r e p ort a bl e ev e nt or of n e w i nf or m ati o n i n r el ati o n wit h a n alr e a dy r e p ort e d e v e nt.
−
A ny ot h er r e p ort a bl e ev e nt or a n e w fi n di n g / u p d at e t o it: i m m e di at ely, b ut n ot l at er t h a n 7
c al e n d ar d a ys f oll o wi n g t h e d at e of a w ar e n ess by t h e s p o ns or of t h e n e w r e p ort a bl e e v e nt or of
n e w i nf or m ati o n i n r el ati o n wit h a n alr e a dy r e p ort e d e v e nt.

Cli nic al E v al u ati o n of t h e S af et y a n d P erf or m a nc e of F r acti o n al R a di ofr e q u e nc y f or t h e Tr e at m e nt a n d R e d ucti o n of Ac n e 
Sc arri n g  
V ersi o n 1. 0 
Pr ot oc ol # VI 1 1 1 8 
Oct o b er 9 , 2 0 1 8 
 
 
2 2  
 
R e p orti n g of t h e ev e nts list e d a b ov e ( u n d er b ull ets 1 -3) t o t h e E Cs of  t h e p artici p ati n g sit es a n d t o t h e 
ot h er i nv esti g at ors will b e p erf or m e d acc or di n g t o c o u ntr y a n d/ or sit e-s p ecific r e q uir e m e nts. 
 
8. 4. 4 
R E P O R TI N G O F P R E G N A N C Y  
If a s u bj ect b ec o m es pr e g n a nt d uri n g t h e c o urs e of t h e st u dy, t h e s u bj ect will b e t er mi n at e d fr o m t h e 
st u dy.  T h e pr e g n a nc y will b e i m m e di at el y r e p ort e d t o t h e s p o ns or o n t h e N otific ati o n of S u bj ect or 
P art n er  Pr e g n a nc y f or m usi n g t h e s a m e r e p orti n g ti m eli n es as a S A E.  T h e i nv esti g at or will f oll o w t h e 
pr e g n a nc y u ntil c o m pl eti o n a n d will r e p ort t h e o utc o m e of t h e pr e g n a nc y t o t h e s p o ns or o n t h e 
N otific ati o n of S u bj ect or P art n er Pr e g n a nc y O utc o m e f or m wit hi n 1 0  b usi n ess d ays.  
8 . 5 
S T U D Y H A L TI N G R U L E S  
T h e st u dy m a y b e h alt e d at a ny ti m e by t h e s p o ns or, t h e E C / I R B, C o m p et e nt A ut h oriti es d u e  t o s af ety 
c o nc er ns.  Ex a m pl es of fi n di n gs t h at mi g ht tri g g er a s af et y r e vi e w ar e t h e n u m b er of S A Es ov er all, t h e 
n u m b er of occ urr e nc es of a p artic ul ar ty p e of S A E, s ev er e A Es/r e acti o ns, or i ncr e as e d fr e q u e nc y of 
e v e nts.   If t h e st u dy is h alt e d, t h e s p o ns or will i m m e di at el y n otify all i nv esti g ati o n al sit es, t h e E C / I R B(s), 
t h e C o m p et e nt A ut h oriti es of all c o u ntri es w h er e t h e s t u dy is b ei n g c o n d uct e d. 
8 . 6 
S A F E T Y O V E R SI G H T  
I n d e p e n d e nt ov ersi g ht is a n i m p ort a nt c o m p o n e nt t o e ns ur e  h u m a n s u bj ects' pr ot ecti o n.  S af ety 
o v ersi g ht will b e u n d er t h e dir ecti o n of t h e s p o ns or a n d a m e dic al m o nit or.  
8 . 7 
T R AI NI N G R E Q UI R E M E N T S  
Pri or t o p ati e nts’ e nr oll m e nt, t h e S p o ns or will pr o vi d e tr ai ni n g r el e v a nt a n d p erti n e nt t o t h e 
i nv olv e m e nt of p ers o n n el c o n d ucti n g st u dy activiti es. Tr ai ni n g f or i nv esti g at ors a n d st aff will i ncl u d e 
st u dy-s p ecific pr ot oc ol a n d C R F c o m pl eti o n tr ai ni n g by t h e s p o ns or or d esi g n at e a n d o n -sit e tr ai ni n g o n 
t h e us e of t h e i nv esti g ati o n al d e vic e by t h e s p o ns or.  Evi d e nc e of tr ai ni n g will b e d oc u m e nt e d d uri n g t h e 
sit e i niti ati o n visit a n d by t h e iss u a nc e of a d evic e tr ai ni n g c ertific at e. 
9  
C L I NIC AL M O NI T O RI N G 
Cli nic al sit e m o ni t ori n g is c o n d uct e d t o e ns ur e t h at t h e ri g hts a n d w ell-b ei n g of h u m a n s u bj ects ar e 
pr ot ect e d, t h at t h e r e p ort e d tri al d at a ar e acc ur at e, c o m pl et e, a n d v erifi a bl e, a n d t h at t h e c o n d uct of 
t h e tri al is i n c o m pli a nc e wit h t h e c urr e ntl y a p pr ov e d pr ot oc ol/ a m e n d m e nt(s), wit h G C P, a n d wit h 
a p plic a bl e r e g ul at or y r e q uir e m e nt(s).  
•  
M o nit ori n g f or t his st u dy will b e p erf or m e d by t h e s p o ns or or d esi g n at e. 
•  
O n- sit e m o nit ori n g will occ ur wit hi n 4 w e e ks of first e nr oll e d s u bj ect a n d will occ ur at a 
fr e q u e nc y d escri b e d i n t h e M o nit ori n g Pl a n.  
•  
V ari a bl es t o b e m o nit or e d will b e d escri b e d i n t h e M o nit ori n g Pl a n.  
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T h e St u dy Dir ect or or d esi g n at e will b e pr o vi d e d c o pi es of m o nit ori n g r e p orts wit hi n 1 5 b usi n ess 
d a ys of visit.  
 

Cli nic al E v al u ati o n of t h e S af et y a n d P erf or m a nc e of F r acti o n al R a di ofr e q u e nc y f or t h e Tr e at m e nt a n d R e d ucti o n of Ac n e 
Sc arri n g  
V ersi o n 1. 0 
Pr ot oc ol # VI 1 1 1 8 
Oct o b er 9 , 2 0 1 8 
 
 
2 3  
1 0 
S T A TI S TI C A L C O N SI D E R A TI O N S   
 
1 0. 1  
S T A TI S TI C A L A N D  A N A L Y TI C A L P L A N S  
T h e St atistic al a n d A n al ytic al Pl a ns ( S A P) m a y b e r e vis e d d uri n g t h e st u dy t o acc o m m o d at e Cli nic al Tri al 
Pr ot oc ol A m e n d m e nts a n d t o m a k e c h a n g es t o a d a pt t o u n ex p ect e d iss u es i n st u dy ex ec uti o n a n d d at a 
t h at aff ect pl a n n e d a n alys es. If r e vis e d, a f or m al St atistic al a n d A n al ytic al Pl a ns ( S A P) will b e c o m pl et e d 
a n d iss u e d pri or t o d at a b as e l oc k a n d u n bli n di n g of t h e st u dy d at a.   
1 0. 2  
S T A TI S TI C A L H Y P O T H E S E S  
T h e n ull a n d alt er n ati v e hy p ot h es es f or t h e st u dy’s pri m ar y, k e y s ec o n d ar y a n d s af et y e n d p oi nts ar e;  
•  
Pri m ar y Effic acy E n d p oi nt:  
N ull Hy p ot h esis ( Ho : µ d  = µ p ost  – µ pr e  = 0 ) – T h er e is n o i m pr ov e m e nt i n ac n e sc arri n g at 6 -w e e k a n d 
1 2 -w e ek p ost -tr e at m e nt c o m p ar e d t o b as eli n e as ass ess e d by bli n d e d ev al u at ors by p h ot o gr a p hic 
ass ess m e nt usi n g t h e Gl o b al A est h etic I m pr ov e m e nt Sc al e ( G AI S).  
 
Alt er n ati v e Hy p ot h esis ( Ha : µ d  = µ p ost  – µ pr e  ≠ 0) – T h er e is a n I m pr o v e m e nt i n ac n e sc arri n g at 6 -
w e ek a n d 1 2 -w e e k p ost -tr e at m e nt c o m p ar e d t o b as eli n e as ass ess e d by bli n d e d e v al u at ors by 
p h ot o gr a p hic ass ess m e nt usi n g t h e Gl o b al A est h etic I m pr ov e m e nt Sc al e ( G AI S). T h e effic acy 
e n d p oi nt i m pr ov e m e nt is  d efi n e d as a sc or e of > 0. 7 5 o n t h e Gl o b al A est h etic I m pr o v e m e nt Sc al e 
( G AI S). T his is t h e ex p ect e d m e a n diff er e nc e i n G AI S  sc or e at 6- w e e k a n d 1 2 -w e e k p ost -tr e at m e nt 
ass ess m e nt c o m p ar e d t o b as eli n e.   
 
•  
S ec o n d ar y Effic ac y E n d p oi nt(s):  
T h e f oll o wi n g N ull H y p ot h es es ( Ho : µ d  = µ p ost  – µ pr e  = 0 ) - T h er e is n o i m pr o v e m e nt i n s u bj ects’ 
ass ess m e nt of s atisf acti o n wit h t h e tr e at m e nt usi n g a S u bj ect S atisf acti o n Sc al e at 6 w e e ks a n d 
1 2 w e e ks p ost -tr e at m e nt. 
 
T h e f oll o wi n g Alt er n ati v e Hy p ot h es es ( Ha : µ d  = µ p ost   – µ pr e  ≠  0)  - T h er e is a n i m pr ov e m e nt i n 
s u bj ects’ ass ess m e nt of s atisf acti o n wit h t h e tr e at m e nt usi n g a S u bj ect S atisf acti o n  Sc al e at 6 
w e eks a n d 1 2 w e e ks p ost -tr e at m e nt. 
 
•  
S af et y E n d p oi nt:  
N ull Hy p ot h esis ( Ho : µ d  = µ p ost  – µ pr e  = 0 ) – T h er e is n o diff er e nc e i n s u bj ects’ 1 0 c m disc o mf ort/ p ai n 
V A S sc or e a n d T ol er a bility Sc al e ex p eri e nc e d at Visit 4 tr e at m e nt c o m p ar e d t o t h at w hic h w as 
ex p eri e nc e d at b as eli n e tr e at m e nt ( Visit 2).  
 
Alt er n ati v e Hy p ot h esis ( Ha : µ d  = µ p ost  – µ pr e  ≠ 0) – T h er e is a diff er e nc e i n s u bj e cts’ 1 0 c m 
disc o mf ort/ p ai n V A S sc or e a n d T ol er a bilit y Sc al e ex p eri e nc e d at Visit 4 tr e at m e nt c o m p ar e d t o 
t h at w hic h w as ex p eri e nc e d at b as eli n e tr e at m e nt ( Visit 2). 
 
1 0. 3  
A N A L Y SI S D A T A S E T S  

Cli nic al E v al u ati o n of t h e S af et y a n d P erf or m a nc e of F r acti o n al R a di ofr e q u e nc y f or t h e Tr e at m e nt a n d R e d ucti o n of Ac n e 
Sc arri n g  
V ersi o n 1. 0 
Pr ot oc ol # VI 1 1 1 8 
Oct o b er 9 , 2 0 1 8 
 
 
2 4  
M o difi e d I nt e nti o n -t o-Tr e at A n al ysis D at as et will b e us e d; Effic ac y  a n d s af ety a n al ys es will b e c arri e d o ut 
o n all s u bj ects w h o r ec ei v e d at l e ast o n e tr e at m e nt of V e n us Vi v a ™ fr acti o n al R F d e vic e a n d f or w h o m at 
l e ast o n e v ali d p ost-b as eli n e effic ac y a n d s af ety e v al u ati o n w er e o bt ai n e d.  
1 0. 4  
D E S C RI P TI O N O F S T A TI S TI C A L M E T H O D S  
 
1 0. 4. 1  G E N E R A L A P P R O A C H  
T his is a pr os p ectiv e, si n gl e c e nt er, ev al u at or -bli n d st u dy of t h e s af et y a n d p erf or m a nc e of fr acti o n al 
r a di ofr e q u e ncy ( R F) f or t h e tr e at m e nt a n d r e d ucti o n of ac n e sc arri n g.  
All s u m m ary t a bl es f or q u a ntit ati v e p ar a m et ers wil l dis pl a y m e a n, st a n d ar d d evi ati o n, m e di a n, r a n g e 
( mi ni m u m a n d m axi m u m), p erc e nt a g es as w ell as n u m b er of missi n g d at a (if r el ev a nt). All s u m m ary t a bl es 
f or q u alit ati v e p ar a m et ers will dis pl a y c o u nts, p erc e nt a g es a n d n u m b er of missi n g d at a if r el ev a nt. 
B as eli n e d at a ar e d efi n e d as t h e l ast m e as ur e m e nt, p h ot o gr a p h or ass ess m e nt p erf or m e d b ef or e t h e first 
tr e at m e nt o n Visit 2.  
All st atistic al t ests will b e o n e -si d e d.  T h e l ev el  of st atistic al si g nific a nc e f or  eff ectiv e n ess  a n al ys es is  5 % ( α 
= 0. 0 5) f or all t ests of diff er e nc es. W h er e a p pr o pri at e, P air e d t -t est a n d/ or Wilc ox o n Si g n e d-R a n ks T est 
f or M atc h e d P airs will b e us e d t o c o m p ar e t h e e v al u ati o ns at t h e b as eli n e a n d p ost tr e at m e nt s essi o ns. 
T his t est will e n a bl e us t o acc e pt or r ej ect t h e n ull hy p ot h es es. R ej ecti o n of n ull hy p ot h es es will est a blis h 
t h at: 
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T h e o n e -si d e d 9 5 % c o nfi d e nc e i nt erv al f or t h e diff er e nc e b et w e e n t h e m e a ns excl u d es z er o.  
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T h e t w o m e a ns ar e st atistic all y si g nific a ntl y diff er e nt at t h e 5 % l ev el ( P  < 0. 0 5) o n e -si d e d. 
U p o n r ej ecti o n of n ull  hy p ot h es es, f urt h er st atistic al t est t o ols s uc h as C o nfi d e nc e I nt er v al a n d/ or t -t est 
will b e us e d t o d et er mi n e t h e effic acy of t h e tr e at m e nt.  
I n ot h er t o acc o m m o d at e i m b al a nc es of s o m e b as eli n e G AI S  sc or es, c o v ari at e a dj ust m e nt a n al ysis m ay b e 
p erf or m e d i n S A P t o esti m at e a dj ust e d tr e at m e nt eff ects f or t h e pri m ar y e n d p oi nt a n al ysis.  
T h e ass u m pti o n f or t h e st atistic al t est is t h at t h e p air e d diff er e nc es of b as eli n e a n d p ost tr e at m e nt d at a 
ar e n or m ally distri b ut e d  
1 0. 4. 2  A N A L Y SI S O F T H E P RI M A R Y E F FI C A C Y E N D P OI N T( S)  
T h e f oll o wi n g will b e c o nsi d er e d f or t h e a n al ysis pri m ar y e n d p oi nt:  
S u m m ary t a bl e f or diff er e nc es of b as eli n e c o m p ar e d t o 6 -w e e k a n d b as eli n e c o m p ar e d t o 1 2 -w e e k p ost -
tr e at m e nt G AI S  sc or es will b e dis pl a y e d as m e a n diff er e nc e, st a n d ar d d e vi ati o n a nd st a n d ar d err or.  T h e 
Gl o b al A est h etic I m pr o v e m e nt Sc al e ( G AI S) is a 6- l ev el or di n al sc al e t o ol f or ass essi n g r e d ucti o n of ac n e 
sc arri n g. 
 
B ar, pi e c h arts or gr a p hs i n dic ati n g sc or es, p erc e nt a g es or pr o p orti o ns of s u bj ects wit h Gl o b al A est h etic 
I m pr ov e m e nt Sc al e ( G AI S). 
 
All st atistic al t ests will b e o n e -si d e d.  T h e l ev el  of st atistic al si g nific a nc e f or  eff ectiv e n ess  a n al ys es is  5 % ( α 
= 0. 0 5) f or all t ests of diff er e nc es. W h er e a p pr o pri at e, P air e d t -t est a n d/ or Wilc ox o n Si g n e d-R a n ks T est 

Cli nic al E v al u ati o n of t h e S af et y a n d P erf or m a nc e of F r acti o n al R a di ofr e q u e nc y f or t h e Tr e at m e nt a n d R e d ucti o n of Ac n e 
Sc arri n g  
V ersi o n 1. 0 
Pr ot oc ol # VI 1 1 1 8 
Oct o b er 9 , 2 0 1 8 
 
 
2 5  
f or M atc h e d P airs will b e us e d t o c o m p ar e t h e ev al u ati o ns b et w e e n b aseli n e a n d 6 -w e e k as w ell as 
b as eli n e a n d 1 2 -w e e k p ost tr e at m e nt ass ess m e nts. A n al ysis of C o v ari a nc e ( A N C O V A) m a y als o b e us e d 
w h er e a p pr o pri at e. Si nc e t h e pri m ary e n d p oi nt is b as e d o n ac hi e vi n g a fix e d sc al e p oi nt o n t h e G AI S , 
c o v ari at e a dj ust m e nt a n alysis m a y b e p erf or m e d i n S A P t o esti m at e a dj ust e d tr e at m e nt eff ects f or t h e 
pri m ar y e n d p oi nt a n al ysis i n c o v ari at e a dj ust m e nt a n al ysis m a y b e p erf or m e d i n S A P t o esti m at e a dj ust e d 
tr e at m e nt eff ects f or t h e pri m ar y e n d p oi nt a n al ysis.  
T h e P air e d t -t est a n d/ or Wilc ox o n Si g n e d-R a n ks T est f or M atc h e d P airs will e n a bl e us t o acc e pt or r ej ect 
t h e n ull hy p ot h es es. R ej ecti o n of n ull hy p ot h es es will est a blis h t h at: 
•  
T h e o n e -si d e d 9 5 % c o nfi d e nc e i nt erv al f or t h e diff er e nc e b et w e e n t h e m e a ns excl u d es z er o.  
•  
T h e t w o m e a ns ar e st atistic all y si g nific a ntl y diff er e nt at t h e 5 % l ev el ( P  < 0. 0 5) o n e -si d e d. 
U p o n r ej ecti o n of n ull hy p ot h es es, f urt h er st atistic al t est t o ols s uc h as C o nfi d e nc e I nt er v al a n d/ or t -t est 
will b e us e d t o t est ex p ect e d pri m ar y e n d p oi nt; t h at is alt er n ativ e hy p ot h esis t h at H a > 1. T his will b e us e d 
t o d et er mi n e if t h e st u dy m e ets t h e pri m ar y e n d p oi nt; G AI S  sc or e of > 0. 7 5 . 
G AI S  sc or es of all s u bj ects w h o r ec eiv e d at l e ast o n e tr e at m e nt of V e n us Vi v a ™ fr acti o n al R F d evic e a n d 
f or w h o m at l e ast o n e v ali d p ost-b as eli n e G AI S  ass ess m e nt w er e o bt ai n e d will b e a n al yz e d f or t h e 
pri m ar y e n d p oi nt. M ulti pl e i m p ut ati o n m et h o d or m o d elli n g of av ail a bl e d at a m ay b e us e d f or missi n g 
d at a as a p pr o pri at e . 
1 0. 4. 3  A N A L Y SI S O F T H E S E C O N D A R Y E N D P OI N T( S)  
F or t h e a n al ysis of s ec o n d ar y  e n d p oi nts, t h e f oll o wi n g a n al ysis will b e c o nsi d er e d:  
S u m m ary t a bl es f or diff er e nc es of b as eli n e c o m p ar e d t o 6 -w e e k a n d b as eli n e c o m p ar e d t o 1 2 -w e e k p ost -
tr e at m e nt of s u bj ects’ ass ess m e nt of s atisf acti o n wit h t h e tr e at m e nt usi n g a S u bj ect  S atisf acti o n Sc a l e will 
b e dis pl a y e d as m e a n diff er e nc e, st a n d ar d d e vi ati o n a n d st a n d ar d err or.  T h e p oi nt l e v el f or e ac h of t h es e 
or di n al sc al e ass ess m e nt t o ols will b e p ut i nt o c o nsi d er ati o n w h er e a p plic a bl e.  
 
B ar c h arts, pi e c h art, gr a p hs or a ny ot h er d escri pti v e st atistic al dis pl a ys i n dic ati n g sc or es, p erc e nt a g es or 
pr o p orti o ns of S u bj ects’ ass ess m e nt of s atisf acti o n wit h t h e tr e at m e nt usi n g a S u bj ect  S atisf acti o n Sc al e  
will b e us e d t o a n al ys e effic ac y.  
 
All st atistic al t ests t h at will b e o n e -si d e d. T h e l e v el of st atistic al si g nific a nc e f or eff ectiv e n ess a n al ys es is 
5 % ( α  =  0. 0 5) f or  all t ests  of  diff er e nc es.  W h er e  a p pr o pri at e,  P air e d t -t est a n d/ or Wilc ox o n Si g n e d-R a nks 
T est f or M atc h e d P airs will b e us e d t o c o m p ar e t h e e v al u ati o ns sc or e diff er e nc es of b as eli n e c o m p ar e d  t o 
6- w e e k a n d b as eli n e c o m p ar e d t o 1 2 -w e e k p ost tr e at m e nt ass ess m e nt. A n al ysis of C ov ari a nc e ( A N C O V A) 
m a y als o b e us e d w h er e a p pr o pri at e.  
S u bj ects’ ass ess m e nt of s atisf acti o n wit h t h e tr e at m e nt usi n g a S u bj ect  S atisf acti o n Sc al e  of all s u bj ects 
w h o r ec ei v e d at l e ast o n e tr e at m e nt of V e n us Viv a ™ fr acti o n al R F d e vic e a n d f or w h o m at l e ast o n e v ali d 
p ost -b as eli n e  ass ess m e nt  w as  o bt ai n e d  will  b e  a n al ys e d  f or  t h es e  s ec o n d ar y  e n d p oi nts.  M ulti pl e  
i m p ut ati o n m et h o d or m o d elli n g of av ail a bl e d at a m a y b e us e d f or missi n g d at a as a p pr o pri at e. 
1 0. 4. 4  S A F E T Y A N A L Y S E S  
T h e s af et y a n alysis will b e d o n e by a n al yzi n g s p o nt a n e o us r e p orts of a dv ers e ev e nts ( A E), s u bj ects 
c o m pl et e d 1 0 c m disc o mf ort/ p ai n V A S a n d T ol er a bility Sc al e as w ell as a n alysis of i m m e di at e a n d s h ort 

Cli nic al E v al u ati o n of t h e S af et y a n d P erf or m a nc e of F r acti o n al R a di ofr e q u e nc y f or t h e Tr e at m e nt a n d R e d ucti o n of Ac n e 
Sc arri n g  
V ersi o n 1. 0 
Pr ot oc ol # VI 1 1 1 8 
Oct o b er 9 , 2 0 1 8 
 
 
2 6  
t er m r es p o ns e r e p orts by t h e pri nci p al i nv esti g at or fr o m his/ h er o bs er v ati o n/ ex a mi n ati o n of t h e tr e at e d 
ar e a. A p pr o pri at e M e dic al Dicti o n ar y f or R e g ul at or y Acti viti es ( M e d D R A) c o d e will b e us e d t o d escri b e all 
s p o nt a n e o usl y r e p ort e d or ot h er st u dy r el at e d a dv ers e ev e nts. 
S u m m ari es of s p o nt a n e o usl y r e p ort e d or ot h er st u dy r el at e d a dv ers e ev e nts will b e pr es e nt e d as:  
o  N u m b er ( %) of s u bj ects wit h a ny A E,  
o  N u m b er ( %) of s u bj ects wit h a ny s eri o us a dv ers e ev e nts ( S A E),  
o  N u m b er ( %) of s u bj ects p er m a n e ntly wit h dr a w n fr o m tr e at m e nt d u e t o A E 
S u m m ari es  of  a n al ysis  of i m m e di at e a n d  s h ort -t er m  r es p o ns e  r e p orts  by  t h e  pri nci p al  i nv esti g at or 
ex a mi n ati o n will b e dis pl a y e d o n a b ar or pi e c h art as;  
o  t h e ov er all fr e q u e nc y of s u bj ects wit h e ac h ev e nt ( p ai n d uri n g tr e at m e nt, h e m orr h a g e, b ur n, 
er yt h e m a, e d e m a, p ur p ur a)  
o  Fr e q u e nc y of s u bj ects wit h s p ecific s e v erity/i nt e nsity f or e ac h e v e nt usi n g a 5 p oi nts sc al e: 
1 = n o n e; 2 =tr ac e; 3 = m o d er at e; 4 = m ark e d; 5 =s ev er e  
o  T h e o v er all p erc e nt a g e or pr o p orti o n of s u bj ect o bs er v e d wit h m ark e d or s e v er e i nt e nsit y of a ny 
e v e nt will b e c alc ul at e d a n d c o m p ar e d t o t h os e wit h n o n e, tr ac e or m o d er at e s e v erit y/i nt e nsity 
wit h t h e ai d of a b ar or pi e c h art.  
T h e f oll o wi n g will b e c o nsi d er e d f or t h e a n al ysis of 1 0 c m disc o mf ort/ p ai n V A S sc or es s af ety d at a:  
S u m m ary t a bl e f or diff er e nc es of b as eli n e a n d Visit 4 tr e at m e nt 1 0 c m disc o mf ort/ p ai n V A S sc or es will b e 
dis pl a y e d as m e a n diff er e nc e, st a n d ar d d e vi ati o n a n d st a n d ar d err or.  T h e 1 0 c m disc o mf ort/ p ai n V A S  is 
a 1 1 -l e v el ( 0 t o 1 0) or di n al sc al e t o ol f or ass essi n g p ain.  
 
B ar, pi e c h arts or gr a p hs i n dic ati n g sc or es, p erc e nt a g es or pr o p orti o ns of s u bj ects wit h Visit 4 tr e at m e nt 
a n d b as eli n e ( Visit 2) V A S sc or es diff er e nc e a n d T ol er a bilit y Sc al e will b e us e d t o a n alys e s u bj ects’ 
t ol er a bility of t his tr e at m e nt. 
 
All st atistic al t ests will b e o n e -si d e d.  T h e l ev el  of st atistic al si g nific a nc e f or  eff ectiv e n ess  a n al ys es is  5 % ( α 
= 0. 0 5) f or all t ests of diff er e nc es. W h er e a p pr o pri at e, P air e d t -t est a n d/ or Wilc ox o n Si g n e d-R a n ks T est 
f or M atc h e d P airs will b e us e d t o c o m p ar e t h e diff er e nc e b et w e e n b as eli n e a n d Visit 4 tr e at m e nt V A S 
sc or es. 
T h e P air e d t -t est a n d/ or Wilc ox o n Si g n e d-R a n ks T est f or M atc h e d P airs will e n a bl e us t o acc e pt or r ej ect 
t h e n ull hy p ot h es es. R ej ecti o n of n ull hy p ot h es es will est a blis h t h at: 
•  
T h e o n e -si d e d 9 5 % c o nfi d e nc e i nt erv al f or t h e diff er e nc e b et w e e n t h e m e a ns excl u d es z er o.  
•  
T h e t w o m e a ns ar e st atistic all y si g nific a ntl y diff er e nt at t h e 5 % l ev el ( P  < 0. 0 5) o n e -si d e d. 
U p o n r ej ecti o n of n ull hy p ot h es es, f urt h er st atistic al t est t o ols s uc h as C o nfi d e nc e I nt er v al a n d/ or t -t est 
will b e us e d t o t est ex p ect e d s af ety e n d p oi nt; t h at is alt er n ati v e hy p ot h esis, H a  < 1.  
1 0. 4. 5  A D H E R E N C E A N D  R E T E N TI O N A N A L Y S E S  
A d h er e nc e t o t h e pr ot oc ol will b e ass ess e d by c alc ul ati n g t h e n u m b er ( %) s u bj ects’ d at a f or e ac h e n d p oi nt 
ass e ss m e nt t h at is n ot pr o vi d e d i n s u bj ects C as e R e p ort F or ms. T his will b e f urt h er a n al ys e d as p er 

Cli nic al E v al u ati o n of t h e S af et y a n d P erf or m a nc e of F r acti o n al R a di ofr e q u e nc y f or t h e Tr e at m e nt a n d R e d ucti o n of Ac n e 
Sc arri n g  
V ersi o n 1. 0 
Pr ot oc ol # VI 1 1 1 8 
Oct o b er 9 , 2 0 1 8 
 
 
2 7  
fr e q u e nc y of e ac h e n d p oi nt d at a t h at is n ot a v ail a bl e d u e t o l oss t o f oll o w-u p, disc o nti n u ati o n of t h e 
i nt erv e nti o n or a ny ot h er r e as o n. 
 
1 0. 4. 6  B A S E LI N E D E S C R I P TI V E S T A TI S TI C S 
S u bj ects  b as eli n e  sc or es  of  all  e n d p oi nts  ( F W E S,  S u bj ect S atisf acti o n Sc al e,  Tr e at m e nt  Ev al u ati o n  
Q u esti o n n air e , V A S a n d T ol er a bility Sc al e) will b e c o m p ar e d usi n g d escri pti v e st atistics s uc h as m e a n 
sc or e, st a n d ar d d e vi ati o n, st a n d ar d err or, r a n g e a n d gr a p hic al pr es e nt ati o ns.  
1 0. 4. 7  P L A N N E D I N T E R I M A N A L Y S E S  
N/ A - T h er e will b e n o i nt eri m a n al ysis d uri n g t his st u dy.  
 
1 0. 4. 7. 1  
S A F E T Y R E VI E W  
T h er e will b e n o i nt eri m a n al ysis d uri n g t his st u dy. H o w e v er, t his st u dy m a y b e t e m p or aril y s us p e n d e d or 
pr e m at ur el y t er mi n at e d if t h er e is s uffici e nt r e as o n a bl e c a us e as p er s ecti o n 5. 5 a n d 8. 5.  
1 0. 4. 7. 2  
E F FI C A C Y R E VI E W  
T h er e will b e n o i nt eri m a n al ysis d uri n g t his st u dy. H o w e v er, t his st u dy m a y b e t e m p or aril y s us p e n d e d 
or pr e m at ur el y t er mi n at e d if t h er e is s uffici e nt r e as o n a bl e c a us e as p er s ecti o n 5. 5 a n d 8. 5.  
1 0. 4. 8  A D DI TI O N A L S U B- G R O U P A N A L Y S E S  
N ot A p plic a bl e - Pri m ary or s ec o n d ar y e n d p oi nt will n ot b e a n al yz e d b as e d o n a g e, s ex, r ac e/ et h nicity or 
ot h er d e m o gr a p hic c h ar act eristic(s).  
1 0. 4. 9  M U L TI P L E C O M P A RI S O N/ M U L TI P LI CI T Y  
N ot A p plic a bl e   
1 0. 4. 1 0  
T A B U L A TI O N O F I N DI VI D U A L R E S P O N S E D A T A  
I n divi d u al p artici p a nt d at a will b e list e d by m e as ur e a n d ti m e p oi nt as a p p e n dix t o t h e st u dy r e p ort. 
1 0. 4. 1 1  
E X P L O R A T O R Y A N A L Y S E S  
N ot A p plic a bl e   
1 0. 5  
S A M P L E SI Z E  
T h e pri m ar y a n d s af ety e n d p oi nts o utc o m e m e as ur es w er e us e d t o c alc ul at e t h e st u dy s a m pl e siz e.  
S a m pl e siz e c alc ul ati o n usi n g pri m ar y e n d p oi nt o utc o m e m e as ur e;  
•  
N ull a n d alt er n at e hy p ot h es es:  
o  N ull Hy p ot h esis ( Ho : µ d  = µ p ost  – µ pr e  = 0 ) – T h er e is n o i m pr o v e m e nt i n ac n e sc arri n g at 6 -
w e ek  a n d  1 2 -w e e k  p ost -tr e at m e nt  c o m p ar e d  t o  b as eli n e  as  ass ess e d  by  bli n d e d  

Cli nic al E v al u ati o n of t h e S af et y a n d P erf or m a nc e of F r acti o n al R a di ofr e q u e nc y f or t h e Tr e at m e nt a n d R e d ucti o n of Ac n e 
Sc arri n g  
V ersi o n 1. 0 
Pr ot oc ol # VI 1 1 1 8 
Oct o b er 9 , 2 0 1 8 
 
 
2 8  
e v al u at ors by p h ot o gr a p hic ass ess m e nt usi n g t h e Gl o b al A est h etic I m pr ov e m e nt Sc al e 
( G AI S). 
 
o  Alt er n ati v e Hy p ot h esis ( Ha : µ d  = µ p ost  – µ pr e  ≠ 0) – T h er e is a n I m pr o v e m e nt i n ac n e sc arri n g  
at 6 -w e e k a n d 1 2 -w e ek p ost -tr e at m e nt c o m p ar e d t o b as eli n e as ass ess e d by bli n d e d 
e v al u at ors by p h ot o gr a p hic ass ess m e nt usi n g t h e Gl o b al A est h etic I m pr ov e m e nt Sc al e 
( G AI S). T h e effic acy e n d p oi nt i m pr ov e m e nt is  d efi n e d as a sc or e of > 0. 7 5  o n t h e Gl o b al 
A est h etic I m pr ov e m e nt Sc al e ( G AI S). T his is t h e ex p ect e d m e a n diff er e nc e  i n F W E S sc or e 
at 6- w e ek a n d 1 2 -w e ek p ost -tr e at m e nt ass ess m e nt c o m p ar e d t o b as eli n e. 
•  
I n vi e w of t h e n at ur e of t his st u dy i n r e g ar d t o tr e at me nt a n d f oll o w -u p d ur ati o n, w e m a k e 
pr o visi o n f or 2 0 % st u dy dr o p o ut, wit h dr a w al or l oss t o f oll o w -u p.  
•  
1- T ail e d S a m pl e Siz e c alc ul ati o n f or m ul a f or M atc h e d S a m pl es w as us e d i n t h e t a bl e b el o w:  
 
( 1-β),  P o w er  
0. 8  
α, L ev el  of  Si g nific a nc e  
0. 0 5  
μ d, m e a n diff er e nc e; t his is t h e s m all est p ossi bl e c h a n g e 
ex p ect e d u n d er H a 
0. 7 5  
σ d, St a n d ar d D evi ati o n of t h e diff er e nc e sc or es ( F E W 
Sc al e r a n g e ÷ 4) = [( 9 -1) ÷ 4]  
1. 5  
Z 1- α/ 2  
1. 6 4 5  
Z 1- β, (f or  9 0 %)  
0. 8 4  
Es ti m at e d S a m pl e Siz e 
 
2 5  
Esti m at e d S a m pl e Siz e + 2 0 % dr o p o ut  
~ 3 0  
C o ncl usi o n:  T h e esti m at e d s a m pl e siz e f or tr e at m e nt sit es a n d t h e a d diti o n al 2 0 % pr o visi o n f or dr o p o ut 
( 30 tr e at m e nt sit es)  o bt ai n e d fr o m t h e pri m ar y e n d p oi nt o utc o m e m e as ur e c alc ul ati o n will b e us e d 
s u bj ects f or t his st u dy. 1 5 s u bj ects will u n d e r g o tr e at m e nt o n 2 diff er e nt sit es; o n e o n e ac h si d e of t h e 
f ac e t h at will b e will b e ass ess e d i n d e p e n d e ntl y as t w o s e p ar at e sit es. 
1 0. 6  
M E A S U R E S T O MI N I MI Z E BI A S 
 
1 0. 6. 1  E N R O L L M E N T / R A N D O MI Z A TI O N/ M A S KI N G P R O C E D U R E S  
At scr e e ni n g, o nc e a s u bj ect h as si g n e d t h e i nf or m e d c o ns e nt, a n d i ncl usi o n/ excl usi o n crit eri a h as b e e n 
m et, a s u bj ect n u m b er will b e assi g n e d. T h e s u bj ect n u m b er will c o nsist of a t w o -di git c o d e c orr es p o n di n g 
t o t h e sit e a n d a t w o-di git  s u bj ect c o d e i n n u m eric al s e q u e nc e. ( Ex a m pl e: 1 0-0 5 c orr es p o n ds t o sit e # 1 0, 
s u bj ect # 5.)  
1 0. 6. 2  E V A L U A TI O N O F  S U C C E S S O F B LI N DI N G   
N A - All s u bj ects will r ec ei v e tr e at m e nt.   
1 0. 6. 3  B R E A KI N G T H E S T U D Y B LI N D / P A R TI CI P A N T C O D E  
N/ A - All s u bj ects will r ec ei v e tr e at m e nt.     
   

Cli nic al E v al u ati o n of t h e S af et y a n d P erf or m a nc e of F r acti o n al R a di ofr e q u e nc y f or t h e Tr e at m e nt a n d R e d ucti o n of Ac n e 
Sc arri n g  
V ersi o n 1. 0 
Pr ot oc ol # VI 1 1 1 8 
Oct o b er 9 , 2 0 1 8 
 
 
2 9  
1 1 
S O U R C E D O C U M E N T S A N D A C C E S S T O S O U R C E D A T A / D O C U M E N T S  
E ac h p artici p ati n g sit e will m ai nt ai n a p pr o pri at e m e dic al a n d r es e arc h r ec or ds f or t his tri al, i n 
c o m pli a nc e wit h I S O 1 4 1 5 5: 2 0 1 1 , a n d r e g ul at ory a n d i nstit uti o n al r e q uir e m e nts f or  t h e pr ot ecti o n of 
c o nfi d e nti ality of p artici p a nts. E ac h sit e will p er mit a ut h oriz e d r e pr es e nt ati v es of t h e st u dy s p o ns or, 
et hic s c o m mitt e e a n d/ or r e g ul at or y a g e nci es t o ex a mi n e ( a n d w h e n p er mitt e d by a p plic a bl e l a w, t o 
c o py) cli nic al r ec or ds f or t h e p ur p os es of q u alit y ass ur a nc e r evi e ws, a u dits, a n d ev al u ati o n of t h e st u dy 
s af et y, pr o gr ess, a n d d at a v ali dit y.  
S o urc e d at a ar e all i nf or m ati o n, ori gi n al r ec or ds of cli nic al fi n di n gs, o bs erv ati o ns, or ot h er activiti es i n a 
cli nic al tri al n ec ess ary f or t h e r ec o nstr ucti o n a n d e v al u ati o n of t h e tri al. Ex a m pl es of t h es e ori gi n al 
d oc u m e nts a n d d at a r ec or ds i ncl u d e, b ut ar e n ot li mit e d t o, h os pit al r ec or ds, cli nic al a n d offic e c h arts, 
l a b or at or y n ot es, m e m or a n d a, p artici p a nts' m e m ory ai ds or e v al u ati o n c h ec klists, p h ar m acy dis p e nsi n g 
r ec or ds, r ec or d e d a u di o t a p es of c o u ns eli n g s essi o ns, r ec or d e d d at a fr o m a ut o m at e d i nstr u m e nts, 
c o pi es or tr a nscri pti o ns c ertifi e d aft er v erific ati o n as b ei n g acc ur at e a n d c o m pl et e, micr ofic h es, 
p h ot o gr a p hic n e g ati v es  ( w h er e a p plic a bl e) , micr ofil m or m a g n etic m e di a, x -r ays, a n d p artici p a nt fil es 
a n d r ec or ds k e pt at t h e p h ar m acy, at t h e l a b or at ori es, a n d m e dic o -t ec h nic al d e p art m e nts i nv olv e d i n 
t h e cli nic al tri al.  
It is acc e pt a bl e t o us e C R Fs as s o urc e d oc u m e nts.  T h e f oll o wi n g C R Fs c oll ect e d o n n o c ar b o n r e q uir e d 
( N C R) p a p er will b e s o urc e d oc u m e nts:  
•  
S u bj ect s elf -r e p ort e d V A S  a n d T ol er a bility  Sc al e, G AI S , S u bj ect S atisf acti o n Sc al e a n d Tr e at m e nt 
E v al u ati o n Q u esti o n n air e  
T h e r e m ai n d er of t h e d at a  c oll ect e d fr o m ot h er s o urc es. 
It is n ot acc e pt a bl e f or t h e C R F t o  b e t h e o nl y r ec or d of a s u bj ect’s p artici p ati o n i n t h e st u dy. T his is t o 
e ns ur e t h at a ny o n e w h o w o ul d acc ess t h e p ati e nt m e dic al r ec or d h as a d e q u at e k n o wl e d g e t h at t h e 
p ati e nt is p artici p ati n g i n a cli nic al tri al.  
1 2 
Q U A LI T Y A S S U R A N C E  A N D Q U A LI T Y C O N T R O L  
Pri or t o a ny i n d e p e n d e nt us e of t h e V e n us Viv a ™ d e vic e, st u dy p ers o n n el, will r ec ei v e pr o p er tr ai ni n g 
fr o m t h e s p o ns or. Sit e p ers o n n el will b e tr ai n e d o n t h e us e of t h e d evic e pri or t o st u dy i niti ati o n at t h e 
sit e.  A d diti o n al tr ai ni n g r e q uir e m e nts will b e disc uss e d d uri n g st u dy i niti ati o n a n d will i ncl u d e sit e 
r es p o nsi biliti es, a n d st u dy d oc u m e nt ati o n. I n a d diti o n, t h e s p o ns or will pr ovi d e pr ot oc ol s p ecific tr ai ni n g 
f or t h e sit e. T h e sit e will d oc u m e nt w hic h i n di vi d u al h as b e e n assi g n e d t o a s p ecific t as k a n d will e ns ur e 
t h at a p pr o pri at e tr ai ni n g h as occ urr e d f or t h at t ask. 
R e g ul ar m o nit ori n g a n d a n i n d e p e n d e nt a u dit, if c o n d uct e d, m ust b e p erf or m e d acc or di n g t o I S O 
1 4 1 5 5: 2 0 1 1 . S e e als o S ecti o n 9, Cli nic al M o nit ori n g . 
Q u alit y c o ntr ol ( Q C) pr oc e d ur es will b e i m pl e m e nt e d b e gi n ni n g wit h t h e d at a e ntr y syst e m a n d d at a Q C 
c h ec ks t h at will b e r u n o n t h e d at a b as e will b e g e n er at e d.  A ny missi n g d at a or d at a a n o m ali es will b e 
c o m m u nic at e d t o t h e sit e(s) f or cl arific ati o n/r es ol uti o n.  
M o nit ors wil l v erify t h at t h e cli nic al tri al is c o n d uct e d, a n d d at a ar e g e n er at e d, d oc u m e nt e d (r ec or d e d), 
a n d r e p ort e d i n c o m pli a nc e wit h t h e pr ot oc ol, G C P, a n d t h e a p plic a bl e r e g ul at ory r e q uir e m e nts.  

Cli nic al E v al u ati o n of t h e S af et y a n d P erf or m a nc e of F r acti o n al R a di ofr e q u e nc y f or t h e Tr e at m e nt a n d R e d ucti o n of Ac n e 
Sc arri n g  
V ersi o n 1. 0 
Pr ot oc ol # VI 1 1 1 8 
Oct o b er 9 , 2 0 1 8 
 
 
3 0  
T h e i nv esti g ati o n al sit e will pr o vi d e dir ect acc ess t o all tri al r e l at e d sit es, s o urc e d at a/ d oc u m e nts, a n d 
r e p orts f or t h e p ur p os e of m o nit ori n g a n d a u diti n g by t h e s p o ns or, a n d i ns p ecti o n by l oc al a n d 
r e g ul at ory a ut h oriti es. 
1 3 
E T HI C S / P R O T E C TI O N O F  H U M A N S U BJ E C T S  
 
1 3 . 1 
E T HI C A L S T A N D A R D  
T h e i nv esti g at or will e ns ur e t h at  t his st u dy is c o n d uct e d i n f ull c o nf or mity wit h t h e l at est v ersi o n of t h e 
D ecl ar ati o n of H elsi n ki ( 2 0 1 3), I S O 1 4 1 5 5: 2 0 1 1 ( Cli nic al i nv esti g ati o n of m e dic al d e vic es f or h u m a n 
s u bj ects - G o o d cli nic al pr actic e) , F D A  a n d  a ny ot h er a p plic a bl e c o u ntry’s et hic a l p olic y st at e m e nt, 
w hic h e v er pr o vi d es t h e hi g h er l e v el of  pr ot ecti o n t o h u m a n s u bj ects.  
1 3 . 2 
E T HI C S C O M MI T T E E A N D  C O M P E T E N T A U T H O RI TI E S   
T h e pr ot oc ol, i nf or m e d c o ns e nt f or m(s), r ecr uit m e nt m at eri als, a n d all p artici p a nt m at eri als will b e 
s u b mitt e d t o t h e E C  / I R B f or r evi e w a n d a p pr o v al. A p pr o v al of b ot h t h e pr ot oc ol a n d t h e c o ns e nt f or m 
m ust b e o bt ai n e d b ef or e a ny p artici p a nt is e nr oll e d. A ny a m e n d m e nt t o t h e pr ot oc ol will r e q uir e r e vi e w 
a n d a p pr o v al by t h e E C / I R B b ef or e t h e c h a n g es ar e i m pl e m e nt e d t o t h e st u dy. All c h a n g es t o t h e 
c o ns e nt f or m will b e E C  / I R B a p pr ov e d; a d et er mi n ati o n will b e m a d e by S p o ns or r e g ar di n g w h et h er 
pr e vi o usly c o ns e nt e d p artici p a nts n e e d t o b e r e -c o ns e nt e d. 
1 3 . 3 
I N F O R M E D C O N S E N T P R OC E S S  
 
1 3 . 3. 1 C O N S E N T / A S S E N T A N D O T H E R IN F O R M A TI O N A L D O C U M E N T S P R O VI D E D T O 
P A R TI CI P A N T S 
I nf or m e d c o ns e nt is r e q uir e d f or all s u bj ects i n a st u dy.  I n o bt ai ni n g a n d d oc u m e nti n g i nf or m e d 
c o ns e nt, t h e i nv esti g at or s h o ul d c o m pl y wit h a p plic a bl e r e g ul at or y r e q uir e m e nts a n d s h o ul d a d h er e t o 
I S O 1 4 1 5 5: 2 01 1  a n d t o t h e l at est v ersi o n of t h e D ecl ar ati o n of H elsi nki ( 2 0 1 3).  Pri or t o t h e b e gi n ni n g of 
a tri al, t h e i nv esti g at or s h o ul d h a v e t h e E C / I R B's writt e n a p pr ov al f or t h e pr ot oc ol a n d t h e writt e n 
i nf or m e d c o ns e nt f or ms(s) a n d a ny ot h er writt e n i nf or m ati o n to b e pr ovi d e d t o t h e p artici p a nts.  
C o ns e nt f or ms d escri bi n g i n d et ail t h e i nv esti g ati o n al m e dic al d e vic e, st u dy pr oc e d ur es, a n d risks ar e 
giv e n t o t h e p artici p a nt a n d writt e n d oc u m e nt ati o n of i nf or m e d c o ns e nt is r e q uir e d pri or t o st arti n g 
i nt erv e nti o n wit h i nv esti g ati o n al m e dic al d e vic e. 
1 3 . 3. 2 CO N S E N T P R O C E D U R E S A N D D O C U M E N T A TI O N  
I nf or m e d c o ns e nt is a pr oc ess t h at is i niti at e d pri or t o t h e i n di vi d u al’s a gr e ei n g t o p artici p at e i n t h e 
st u dy a n d c o nti n u es t hr o u g h o ut t h e i n di vi d u al’s st u dy p artici p ati o n. Ext e nsiv e disc ussi o n of risks a n d 
p ossi bl e b e n efits of p artici p ati o n will b e pr o vi d e d t o t h e p artici p a nts a n d t h eir f a mili es.   C o ns e nt f or ms 
will b e E C or  I R B a p pr o v e d a n d t h e p artici p a nt will b e as k e d t o r e a d a n d r evi e w t h e d oc u m e nt. T h e 
i nv esti g at or will ex pl ai n t h e r es e arc h st u dy t o t h e p artici p a nt a n d a ns w er a ny q u esti o ns t h at m ay aris e. 
All p artici p a nts will r ec ei v e a v er b al ex pl a n ati o n i n t er ms s uit e d t o t h eir c o m pr e h e nsi o n of t h e p ur p os es, 
pr oc e d ur es, p ot e nti al ris ks of t h e st u dy a n d t h eir ri g hts as r es e arc h p artici p a nts.   P artici p a nts will h av e 
t h e o p p ort u nity t o c ar ef ully r evi e w t h e writt e n c o ns e nt f or m a n d ask q u esti o ns pri or t o si g ni n g. T h e 
p artici p a nts s h o ul d h a v e t h e o p p ort u nit y t o disc uss t h e st u dy wit h t h eir s urr o g at es or t hi n k a b o ut it 
pri or t o a gr e ei n g t o p artici p at e.  T h e p artici p a nt will si g n t h e i nf or m e d c o ns e nt d oc u m e nt pri or t o a ny 

Cli nic al E v al u ati o n of t h e S af et y a n d P erf or m a nc e of F r acti o n al R a di ofr e q u e nc y f or t h e Tr e at m e nt a n d R e d ucti o n of Ac n e 
Sc arri n g  
V ersi o n 1. 0 
Pr ot oc ol # VI 1 1 1 8 
Oct o b er 9 , 2 0 1 8 
 
 
3 1  
pr oc e d ur es b ei n g d o n e s p ecific all y f or t h e st u dy. T h e p artici p a nts m a y wit h dr a w c o ns e nt at a ny ti m e 
t hr o u g h o ut t h e c o urs e of t h e tri al. A c o py of t h e i nf or m e d c o ns e nt d oc u m e nt will b e gi v e n t o t h e 
p artici p a nts f or t h eir r ec or ds. T h e ri g hts a n d w elf ar e of t h e p artici p a nts will b e pr ot ect e d by 
e m p h asizi n g t o t h e m t h at t h e q u alit y of t h eir m e dic al c ar e will n ot b e a dv ers el y aff ect e d if t h ey d ecli n e 
t o p artici p at e i n t his st u dy. 
1 3. 4 
P A R TI CI P A N T  A N D D A T A C O N FI D E N TI A LI T Y  
P artici p a nt c o nfi d e nti alit y is strictly h el d i n tr ust by t h e p artici p ati n g i nv esti g at ors, t h eir st aff, a n d t h e 
s p o ns or(s) a n d t h eir a g e nts. T his c o nfi d e nti ality is ext e n d e d t o c ov er t esti n g of bi ol o gic al  s a m pl es i n 
a d diti o n t o t h e cli nic al i nf or m ati o n r el ati n g t o p artici p a nts. T h er ef or e, t h e st u dy pr ot oc ol, 
d oc u m e nt ati o n, d at a, a n d all ot h er i nf or m ati o n g e n er at e d will b e h el d i n strict c o nfi d e nc e. N o 
i nf or m ati o n c o nc er ni n g t h e st u dy or t h e d at a will b e r el e as e d t o a ny u n a ut h oriz e d t hir d p art y wit h o ut 
pri or writt e n a p pr o v al of t h e s p o ns or.  
T h e st u dy m o nit or, ot h er a ut h oriz e d r e pr es e nt ati v es of t h e s p o ns or, r e pr es e nt ati v es of t h e E C / I R B a n d 
C o m p et e nt A ut h oriti es or d e vic e  c o m p a ny s u p pl yi n g st u dy pr o d uct m a y i ns p ect all d oc u m e nts a n d 
r ec or ds r e q uir e d t o b e m ai nt ai n e d by t h e i nv esti g at or, i ncl u di n g b ut n ot li mit e d t o, m e dic al r ec or ds 
( offic e, cli nic, or h os pit al) a n d p h ar m ac y r ec or ds f or t h e p artici p a nts i n t his st u dy. T h e cli nic al st u dy sit e 
will p er mit acc e ss t o s uc h r ec or ds. 
T h e st u dy p artici p a nt’s c o nt act i nf or m ati o n will b e s ec ur el y st or e d at e ac h cli nic al sit e f or i nt er n al us e 
d uri n g t h e st u dy. At t h e e n d of t h e st u dy, all r ec or ds will c o nti n u e t o b e k e pt i n a s ec ur e l oc ati o n f or as 
l o n g a p eri o d as dictat e d by t h e s p o ns or,  a n d a ny a p plic a bl e r e g ul ati o ns  (r efe r t o s ecti o n 1 4. 2 S T U D Y 
R E C O R D S R E T E N TI O N ). 
St u dy p artici p a nt r es e arc h d at a, w hic h is f or p ur p os es of st atistic al a n al ysis a n d sci e ntific r e p orti n g, will 
b e tr a ns mitt e d t o a n d st or e d at t h e s p o ns or’s offic e . T his will n ot i ncl u d e t h e p artici p a nt’s c o nt act or 
i d e ntif yi n g i nf or m ati o n. R at h er, i n di vi d u al p artici p a nts a n d t h eir r es e arc h d at a will b e i d e ntifi e d by a 
u ni q u e st u dy i d e ntific ati o n n u m b er. T h e st u dy d at a e ntr y a n d st u dy m a n a g e m e nt s yst e ms us e d by 
cli nic al sit es a n d by s p o ns or’s r es e arc h st aff will b e s ec ur e d a n d p ass w or d pr ot ect e d.  At t h e e n d of t h e 
st u dy, all st u dy d at a b as es will b e d e-i d e ntifi e d a n d arc hi v e d by  t h e s p o ns or. 
1 3. 4. 1 R E S E A R C H U S E O F S T O R E D H U M A N S A M P L E S, S P E CI M E N S  O R D A T A  
T h e i n v esti g at or will st or e all d at a acc or di n g t o t h e l oc al r e g ul at or y st a n d ar ds.  
1 3. 5 
F U T U R E U S E O F S T O R E D  S P E CI M E N S  
N ot a p plic a bl e  
1 4 
D A T A H A N D LI N G A N D R E C O R D K E E PI N G  
 
1 4. 1 
D A T A C O L L E C TI O N A N D M A N A G E M E N T R E S P O N SI B I LI TI E S  
D at a c oll ecti o n is t h e r es p o nsi bilit y of t h e cli nic al tri al st aff at t h e sit e u n d er t h e s u p er visi o n of t h e sit e 
P ri nci p al I nv esti g at or.  T h e i nv esti g at or is r es p o nsi bl e f or e ns uri n g t h e acc ur ac y, c o m pl et e n ess, l e gi bilit y, 
a n d ti m eli n ess of t h e d at a r e p ort e d.  

Cli nic al E v al u ati o n of t h e S af et y a n d P erf or m a nc e of F r acti o n al R a di ofr e q u e nc y f or t h e Tr e at m e nt a n d R e d ucti o n of Ac n e 
Sc arri n g  
V ersi o n 1. 0 
Pr ot oc ol # VI 1 1 1 8 
Oct o b er 9 , 2 0 1 8 
 
 
3 2  
All s o urc e d oc u m e nts s h o ul d b e c o m pl et e d i n a n e at, l e gi bl e m a n n er t o e ns ur e acc ur at e i nt er pr et ati o n 
of d at a.  Bl ac k i n k is r e q uir e d t o e ns ur e cl arity of r e pr o d uc e d c o pi es. W h e n m a ki n g c h a n g es or 
c orr ecti o ns, cr oss o ut t h e ori gi n al e ntr y wit h a si n gl e li n e, a n d i niti al a n d d at e t h e c h a n g e .  D O N O T 
E R A S E, O V E R W RI T E, O R U S E C O R R E C TI O N FL UI D O R T A P E O N T H E O RI GI N AL.  
C o pi es of t h e p a p er C R F will b e pr ovi d e d f or us e as s o urc e d oc u m e nts a n d m ai nt ai n e d f or r ec or di n g d at a 
f or e ac h p artici p a nt e nr oll e d i n t h e st u dy.  D at a r e p ort e d i n t h e C R F d eriv e d fr o m s o urc e d oc u m e nts 
s h o ul d b e c o nsist e nt wit h t h e s o urc e d oc u m e nts or t h e discr e p a nci es s h o ul d b e ex pl ai n e d a n d c a pt ur e d 
i n a pr o gr ess n ot e a n d m ai nt ai n e d i n t h e p artici p a nt’s offici al st u dy r ec or d.  S elf -r e p ort e d s u bj ect d at a 
a n d i nv esti g at or C R F r e p o rt e d d at a r ec or d e d o n t h e c o py C R F p a g e is p er mitt e d.  T h e ori gi n al f or m will 
b e c oll ect e d by t h e s p o ns or a n d t h e c o py will r e m ai n at t h e sit e.  
Cli nic al d at a (i ncl u di n g A Es, c o nc o mit a nt m e dic ati o ns, a n d ex p ect e d a dv ers e r e acti o ns d at a) a n d cli nic al 
l a b or ator y d at a fr o m p a p er C R Fs will b e e nt er e d dir ectl y o nt o p a p er C R Fs fr o m t h e s o urc e d oc u m e nts 
a n d will b e c oll ect e d by t h e st u dy s p o ns or.  
1 4. 2 
S T U D Y R E C O R D S R E T E N T I O N  
St u dy d oc u m e nts, i ncl u di n g c o pi es of t h e p a p er C R Fs, si g n e d i nf or m e d c o ns e nt f or ms, p h ot o g r a p hs 
( w h er e a p plic a bl e) , l a b or at or y r es ults, m e dic al r ec or ds, d at a cl arific ati o n f or ms a n d r e g ul at ory 
d oc u m e nts,  s h o ul d b e r et ai n e d f or a mi ni m u m p eri o d of 5 y e ars aft er t h e e n d of t h e cli nic al 
i nv esti g ati o n, or l o n g er if r e q uir e d by l oc al r e g ul ati o n. T h e  i nv esti g at or s h o ul d t ak e m e as ur es t o pr e v e nt 
acci d e nt al or e arl y d estr ucti o n of t h e st u dy r el at e d m at eri als .  N o r ec or ds will b e d estr oy e d wit h o ut t h e 
writt e n c o ns e nt of t h e s p o ns or, if a p plic a bl e.  It is t h e r es p o nsi bility of t h e s p o ns or t o i nf or m t h e 
i nv esti g at or w h e n t h es e d oc u m e nts n o l o n g er n e e d t o b e r et ai n e d.  
1 4. 3 
P R O T O C O L D E VI A TI O N S  
A pr ot oc ol d evi ati o n is a ny inst a nc e(s) of f ail ur e t o f oll o w, i nt e nti o n all y or u ni nt e nti o n all y, t h e 
r e q uir e m e nts of t h e Cli nic al I nv esti g ati o n Pl a n. A p plic a bl e d efi nit i o n f oll o w: 
− M aj or d evi ati o n: CI P d evi ati o ns t h at c a n h av e aff ect e d t h e ri g hts, s af et y or w ell -b ei n g of t h e s u bj ect 
or t h e sci e ntific i nt e grit y of t h e cli nic al i nv esti g ati o n.  
− Mi n or d e vi ati o n: CI P d evi ati o ns t h at d o N O T h av e aff ect e d t h e ri g hts, s af ety or w e ll-b ei n g of t h e 
s u bj ect or t h e sci e ntific i nt e grit y of t h e cli nic al i nv esti g ati o n. 
T h e n o nc o m pli a nc e m ay b e eit h er o n t h e p art of t h e p artici p a nt, t h e i nv esti g at or, or t h e st u dy sit e st aff.  
As a r es ult of d e vi ati o ns, c orr ectiv e acti o ns ar e t o b e d e v el o p e d  by t h e sit e a n d i m pl e m e nt e d pr o m ptly.  
T h es e pr actic es ar e c o nsist e nt wit h I S O 1 4 1 5 5: 2 0 1 1:  
•  
4. 5 C o m pli a nc e wit h Pr ot oc ol, s ecti o ns 4. 5. 1, 4. 5. 2, a n d 4. 5. 3  
•  
5. 1 Q u alit y Ass ur a nc e a n d Q u alit y C o ntr ol, s ecti o n 5. 1. 1  
•  
5. 2 0 N o nc o m pli a nc e, s ecti o ns 5. 2 0. 1, a n d 5. 2 0 . 2. 
Exc e pt i n e m er g e nc y sit u ati o ns, i m pl e m e nt ati o n of a ny cli nic al i nv esti g ati o n pl a n c h a n g e t h at aff ects 
p ati e nt s af et y, i nv esti g ati o n al sc o p e, or t h e sci e ntific q u alit y of t h e st u dy will n ot b e p er mitt e d u ntil all 
of t h e f oll o wi n g c o n diti o ns h a v e b e e n m e t: 
a. T h e I nv esti g at or, t h e S p o ns or a n d St atistici a n h av e a p pr o v e d t h e pr ot oc ol a m e n d m e nt a n d  

Cli nic al E v al u ati o n of t h e S af et y a n d P erf or m a nc e of F r acti o n al R a di ofr e q u e nc y f or t h e Tr e at m e nt a n d R e d ucti o n of Ac n e 
Sc arri n g  
V ersi o n 1. 0 
Pr ot oc ol # VI 1 1 1 8 
Oct o b er 9 , 2 0 1 8 
 
 
3 3  
b. T h e r es p o nsi bl e E C a n d C o m p et e nt A ut h orit y h as r e vi e w e d a n d a p pr o v e d t h e pr ot oc ol c h a n g e.  
U n d er e m er g e ncy circ u mst a nc es, d evi ati o ns fr o m t h e CI P t o pr ot ect t h e  ri g hts, s af et y a n d w ell-b ei n g of 
h u m a n s u bj ects m a y pr oc e e d wit h o ut pri or a p pr ov al of t h e s p o ns or a n d t h e E C.  S uc h d e vi ati o ns s h all b e 
d oc u m e nt e d a n d r e p ort e d t o t h e s p o ns or a n d t h e E C as s o o n as p ossi bl e.  
A c orr ectiv e acti o n will b e t a k e n: d oc u m e nti n g t h e d evi ati o n (s o urc e d oc u m e nt, l o g, C R F as r el e v a nt) 
i ncl u di n g its r e as o ns of occ urr e nc e a n d c orr ectiv e acti o ns t o b e t a k e n t o f urt h er a v oi d r e occ urr e nc e of it 
a n d pr o p erl y r e p orti n g. T h e i nv esti g at or as w ell as sit e p ers o n n el will b e tr ai n e d i n or d er t o a v oi d a ny 
m aj or pr ot oc ol d e vi ati o n i n t h e f ut ur e.  
F ail ur e t o c o m ply wit h t his cli nic al i nv esti g ati o n pl a n a n d/ or E C, C o m p et e nt A ut h oriti es, a ny l oc al 
r e q uir e m e nt will r es ult i n c orr ecti v e acti o ns a n d c o ul d r es ult i n t h e r e m ov al of t h e i nv esti g at or fr o m t h e 
st u dy. 
It is t h e r es p o nsi bilit y of t h e sit e t o us e c o nti n u o us vi gil a nc e t o i d e ntify a n d r e p ort d e vi ati o ns pr o m ptl y 
t o st u dy s p o ns or a n d t o E C (if r e q uir e d by l oc al r e g ul ati o n).  All d evi ati o ns m ust b e a d dr ess e d i n st u dy 
s o urc e d oc u m e nts.  T h e sit e PI/st u d y st aff is r es p o nsi bl e f or k n o wi n g a n d a d h eri n g t o t h eir E C 
r e q uir e m e nts.  
1 4. 4 
P U B LI C A TI O N A N D D A T A S H A RI N G P O LI C Y  
T h e I nt er n ati o n al C o m mitt e e of M e dic al J o ur n al E dit ors (I C MJ E) m e m b er j o ur n als h a v e a d o pt e d a 
cli nic al tri als r e gistr ati o n p olic y as a c o n diti o n f or p u blic ati o n. T h e I C MJ E d efi n es a cli nic al tri al as a ny 
r es e arc h pr oj ect t h at pr os p ecti v el y assi g ns h u m a n s u bj ects t o i nt erv e nti o n or c o nc urr e nt c o m p aris o n or 
c o ntr ol gr o u ps t o st u dy t h e c a us e -a n d -eff ect r el ati o ns hi p b et w e e n a m e dic al i nt er v e nti o n a n d a h e alt h 
o utc o m e. M e dic al i nt er v e nti o ns i ncl u d e dr u gs, s ur gic al pr oc e d ur es, d evic es, b e h avi or al tr e at m e nts, 
pr oc ess -of -c ar e c h a n g es, a n d t h e li k e.  H e alt h o utc o m es i ncl u d e a ny bi o m e dic al or h e alt h -r el at e d 
m e as ur es o bt ai n e d i n p ati e nts or p artici p a nts a n d a dv ers e e v e nts. T h e I C MJ E p olic y, a n d t h e  S ecti o n 8 0 1 
of t h e F o o d a n d Dr u g A d mi nistr ati o n A m e n d m e nts Act of 2 0 0 7, r e q uir es t h at all cli nic al tri als b e 
r e gist er e d i n a p u blic tri als r e gistr y s uc h as Cli nic al Tri als. g o v, w hic h is s p o ns or e d by t h e N ati o n al Li br ar y 
of M e dici n e. Ot h er bi o m e dic al j o ur n als ar e c o nsi d eri n g a d o pti n g si mil ar p olici es.  T h e D ecl a r ati o n of 
H elsi n ki c urr e nt r evisi o n ( 2 0 1 3) st at es t h at e v er y r es e arc h st u dy i nv olvi n g h u m a n s u bj ects m ust b e 
r e gist er e d i n a p u blicl y acc essi bl e d at a b as e b ef or e r ecr uit m e nt of t h e first s u bj ect (s ec. 3 5).  
T h e s p o ns or or its d esi g n e e will  r e gist er t h e VI 1 1 1 8  st u dy i nt o a p u blicl y acc essi bl e d at a b as e .  All  d at a 
g e n er at e d fr o m t his st u dy ar e t h e pr o p ert y of V e n us C o nc e pt Lt d a n d s h all b e h el d i n strict c o nfi d e nc e 
al o n g wit h all i nf or m ati o n f ur nis h e d by V e n us C o nc e pt Lt d . 
I n d e p e n d e nt a n al ysis a n d/ or p u blic ati o n of t h es e d at a by t h e I nv esti g at or or a ny m e m b er of his/ h er 
st aff ar e n ot p er mitt e d wit h o ut pri or writt e n c o ns e nt of V e n us C o nc e pt Lt d.  Writt e n p er missi o n t o t h e 
I nv esti g at or will b e c o nti n g e nt o n t h e r e vi e w by V e n us C o nc e pt Lt d of t h e st atistic al a n al ysis a n d 
m a n uscri p t a n d will pr o vi d e f or n o n discl os ur e of V e n us C o nc e pt Lt d c o nfi d e nti al or pr o pri et ary 
i nf or m ati o n. I n all c as es, t h e p arti es a gr e e t o s u b mit all m a n uscri pts or a bstr acts t o all ot h er p arti es at 
l e ast 6 0 d ays  pri or t o s u b missi o n. T his will e n a bl e all p arti e s t o pr ot ect pr o pri et ary i nf or m ati o n a n d t o 
pr o vi d e c o m m e nts b as e d o n i nf or m ati o n t h at m ay n ot y et b e av ail a bl e t o ot h er p arti es.  
T his p olicy mi g ht b e ov err ul e d by ot h er si g n e d a gr e e m e nts m a d e b et w e e n t h e s p o ns or a n d i nv esti g at ors 
at a l at er d at e.  

Cli nic al E v al u ati o n of t h e S af et y a n d P erf or m a nc e of F r acti o n al R a di ofr e q u e nc y f or t h e Tr e at m e nt a n d R e d ucti o n of Ac n e 
Sc arri n g  
V ersi o n 1. 0 
Pr ot oc ol # VI 1 1 1 8 
Oct o b er 9 , 2 0 1 8 
 
 
3 4  
1 5 
S T U D Y  A D MI NI S T R A TI O N  
 
1 5 . 1 
S T U D Y L E A D E R S HI P  
T h e st u dy will b e a d mi nist er e d by t h e s p o ns or , V e n us C o nc e pt Lt d. 
1 6 
C O N F LI C T O F I N T E R E S T  P O LI C Y  
T h e i n d e p e n d e nc e of t his st u dy fr o m a ny act u al or p erc ei v e d i nfl u e nc e, s uc h as by t h e d e vic e  i n d ustry, is 
critic al. T h er ef or e,  a ny act u al c o nflict of i nt er est of p ers o ns w h o h av e a r ol e i n t h e d esi g n, c o n d uct, 
a n al ysis, p u blic ati o n, or a ny as p ect of t his tri al will b e discl os e d a n d m a n a g e d.  F urt h er m or e, p ers o ns 
w h o h av e a p erc ei v e d c o nflict of i nt er est will b e r e q uir e d t o h a v e s uc h c o nflicts m a n a g e d i n a w ay t h at is 
a p pr o pri at e t o t h eir p artici p ati o n i n t h e tri al.  T h e s p o ns or will e ns ur e t h at  all st u dy gr o u p m e m b ers 
discl os e all c o nflicts of i nt er est a n d will est a blis h a m ec h a nis m f or t h e m a n a g e m e nt of all r e p ort e d 
d u aliti es of i nt er est.  
1 7  
LI T E R A T U R E R E F E R E N C E S  
1.  
O' D a ni el T G. M ulti m o d al m a n a g e m e nt of atr o p hic ac n e sc arri n g i n t h e a gi n g f ac e. A est h etic Pl ast 
S ur g. 2 0 1 1; 3 5( 6): 1 1 4 3 -5 0.  
2.  
Si m m o ns B, Griffit h R, F alt o -Aiz p ur u a L, N o uri K .  Us e of r a di ofr e q u e ncy i n c os m etic d er m at ol o gy: 
f oc us o n n o n a bl ati v e tr e at m e nt of ac n e sc ars. Cli nic al, C os m etic a n d I nv esti g ati o n al D er m at ol o gy. 
2 0 1 4: 7 3 3 5 — 3 3 9  
3.  
Alst er T S, L u pt o n J R. N o n a bl ati v e c ut a n e o us r e m o d eli n g usi n g r a di ofr e q u e ncy d evic es. Cli n 
D er m at ol. 2 0 0 7; 2 5: 4 8 7 -4 9 1.  
4.  
Al exi a d es -Ar m e n a k as M, D o v er J S, Ar n dt K A. U ni p ol ar v ers us bi p ol ar r a di ofr e q u e nc y tr e at m e nt of 
r hyti d es a n d l axit y usi n g a m o bil e p ai nl ess d eli v er y m et h o d. L as ers S ur g M e d. 2 0 0 8; 4 0( 7): 4 4 6-4 5 3  
5.  
D e F eli p e I, D el C u et o S R, P ér ez E, R e d o n d o P. A dv ers e r e acti o ns aft er n o n a bl ati v e r a di ofr e q u e nc y: 
f oll o w-u p of 2 9 0 p ati e nts. J C os m et D er m at ol. 2 0 0 7; 6( 3): 1 6 3 -1 6 6.  
6.  
O mi T, S at o S, K a mi n a k a C, Y a m a m ot o Y, K a w a n a S, et al. ( 2 0 1 4) A Hist ol o gic al St u dy o n t h e 
Tr e at m e nt of Ac n e Sc ars wit h Fr acti o n al R a di ofr e q u e nc y: Pr eli mi n ary Fi n di n gs. J Cli n Ex p D er m at ol 
R es 5: 2 0 3  
7.  
E. F or b at & F. Al -Ni ai mi  ( 2 0 1 6) Fr acti o n al r a di ofr e q u e nc y tr e at m e nt i n ac n e sc ars: Syst e m atic 
r e vi e w of c urr e nt evi d e nc e, J o ur n al of C os m etic a n d L as er T h er a py,1 8: 8,  4 4 2 -4 4 7  
 
 

Cli nic al E v al u ati o n of t h e S af et y a n d P erf or m a nc e of F r acti o n al R a di ofr e q u e nc y f or t h e Tr e at m e nt a n d R e d ucti o n of Ac n e 
Sc arri n g  
V ersi o n 1. 0 
Pr ot oc ol # VI 1 1 1 8 
Oct o b er 9 , 2 0 1 8 
 
 
3 5  
 
A P P E N DI X  I - A B B R E VI A TI O N S  
 
LI S T O F A B B R E VI A TI O N S 
 
A E  
A dv ers e E v e nt  
A N C O V A  
A n al ysis of C o v ari a nc e  
C R F  
C as e R e p ort F or m  
E C  
Et hics C o m mitt e e  
G AI S  
Gl o b al A est h etic I m pr ov e m e nt Sc al e  
G C P  
G o o d Cli nic al Pr actic e  
I C MJ E 
I nt er n ati o n al C o m mitt e e of M e dic al J o ur n al E dit ors 
I R B 
I nstit uti o n al R evi e w B o ar d 
I S O 1 4 15 5: 2 0 1 1  
I nt er n ati o n al Or g a niz ati o n f or St a n d ar diz ati o n G o o d Cli nic al Pr actic es f or Cli nic al 
I nv esti g ati o ns of M e dic al D e vic es 
M e d D R A  
M e dic al Dicti o n ary f or R e g ul at or y Activiti es  
PI  
Pri nci p al I nv esti g at or  
Q C  
Q u alit y C o ntr ol  
E C  
Et hics C o m mitt e e  
R F  
R a di o fr e q u e ncy 
S A E  
S eri o us A dv ers e Ev e nt  
S A P  
St atistic al a n d A n al y tic al Pl a n  
V A S  
Vis u al A n al o g Sc al e