Clinical Study for the Safety and Effectiveness of Use of an Injectable Medical Device GANA V® for Facial Aesthetic Treatment
Phase: NA
Conditions: Wrinkle
Sponsor: GCS Co., Ltd

GCS Co., Ltd. 
GANA V® 
CIP #21E0787 
Final version 5.0 
Date: 27/06/2022 
Confidential 
Page 1/6 
 
OVERALL SYNOPSIS OF THE CLINICAL INVESTIGATION # 21E0787 
ANSM registration #: 
2021-A02451-40 
Clinical investigation plan #: 
21E0787 
Title of the clinical investigation: 
Clinical study for the safety and effectiveness of use of an 
injectable medical device GANA V® for facial aesthetic treatment 
Sponsor: 
GCS Co., Ltd. 
1008 Ho, Sunil Technopia Bldg,  
555 Dunchon-daero 
Jungwon-gu, Seongnam-si, Gyeonggi-do 
KOREA 
Development phase 
Post market study 
Interventional 
Device used according to Instruction For Use (IFU) 
Objectives: 
The primary objective is to evaluate the effectiveness of Gana V® in 
comparison with Sculptra® in the correction of Nasolabial Folds 
(NLFs) 6 months after treatment initiation.  
 
The secondary objectives of the study are: 
- 
To evaluate the effectiveness of Gana V® in comparison with 
Sculptra® in the correction of Nasolabial Folds (NLFs) 11/2, 3, 
9, 12, 18 and 24 months after treatment initiation.  
- 
To evaluate the effectiveness of Gana V® in comparison with 
Sculptra® on the global aesthetic improvement 11/2, 3, 6, 9, 
12, 18 and 24 months after treatment initiation.  
- 
To evaluate the effectiveness of Gana V® in comparison with 
Sculptra® in reducing NLFs depth and volume 11/2, 3, 6, 9, 
12, 18 and 24 months after treatment initiation. 
- 
To evaluate the subject satisfaction with Gana V® in 
comparison with Sculptra® 11/2, 3, 6, 9, 12, 18 and 24 months 
after treatment initiation. 
- 
To evaluate the injector satisfaction with Gana V® in 
comparison with Sculptra® after initial injection and touch-up 
injection if applicable.  
- 
To evaluate the safety of Gana V® in comparison with 
Sculptra®. 
Design: 
The study will be: 
• double-blinded,  
• randomized, 
• within-subjects: each subject testing both devices,  
• versus comparator, 
• single centre. 
Planned Sample Size: 
55 subjects randomized. 
Number of investigational study 
sites: 
1 site (France) 
Inclusion criteria: 
1. Healthy Subject 
2. Sex: male or female 
3. Age: between 30 and 70 years. 
4. Subject with moderate to severe nasolabial folds as determined 
by a Wrinkle Severity Rating Scale (WSRS) score of 3 or 4 on 
both folds at the pre-treatment evaluation. 

GCS Co., Ltd. 
GANA V® 
CIP #21E0787 
Final version 5.0 
Date: 27/06/2022 
Confidential 
Page 2/6 
 
5. Subject wiling to abstain from other facial procedures (i.e., dermal 
fillers, toxin treatments, laser, microdermal abrasion, chemical 
peels, non-invasive skin-tightening) during the whole study 
period. 
6. Subject, psychologically able to understand the study related 
information and to give a written informed consent. 
7. Subject having given freely and expressly his/her informed 
consent. 
8. Subject willing to have photographs of the face taken. 
9. Subject affiliated to a health social security system. 
10. Female of childbearing potential should use a contraceptive 
regimen recognized as effective since at least 12 weeks before 
screening visit and during the whole study period. 
Exclusion criteria: 
1. Pregnant or nursing woman or planning a pregnancy during the 
study. 
2. Subject with a scar, moles, pigment disorders or anything on 
the face which might interfere with the evaluation.  
3. Subject who had been deprived of their freedom by 
administrative or legal decision or who is under guardianship. 
4. Subject in a social or sanitary establishment 
5. Subject participation to another research on human beings or 
who is in an exclusion period of one. 
6. Subject 
having 
received 
4500 
euros 
indemnities 
for 
participation in research involving human beings in the 12 
previous months, including participation in the present study. 
7. Subject suspected to be non-compliant according to the 
investigator’s judgment. 
8. Subject suffering from a severe or progressive disease or any 
other pathology that may interfere with the evaluation of the 
study results. 
9. Subject with known history of or suffering from autoimmune 
disease and/or immune deficiency. 
10. Subject 
suffering 
from 
inflammatory 
and/or 
infectious 
cutaneous disorders in or near the studied zones (e.g. acne, 
mycosis, papilloma, chronic eczema, atopic dermatitis…). 
Subject with labial herpes in the last 2 years is not eligible even 
if asymptomatic at time of screening visit. 
11. Subject with an abscess, unhealed wound, or a cancerous or 
precancerous lesion on the studied zone. 
12. Subject prone to develop inflammatory skin conditions or 
having tendency to bleeding disorders. 
13. Subject with a tendency to develop keloids or hypertrophic 
scarring. 
14. Subject having history of allergy or anaphylactic shock 
including hypersensitivity to Poly-l-lactic acid, to lidocaine or to 
one of the components of the tested devices or antiseptic 
solution. 
15. Subject 
having 
received 
treatment 
with 
a 
laser, 
a 
dermabrasion, a surgery, a deep chemical peeling or other 
ablative procedure on the face within the past 12 months prior 
to screening visit. 
16. Subject having received injection with a resorbable filling 
product in the face area within the past 12 months prior to 
screening visit. 
17. Subject having received at any time injection with a slowly 
resorbable 
filling 
product 
(polylactic 
acid, 
calcium 
hydroxyapatite, combinations of hyaluronic acid (HA) and 
hypromellose, HA and dextran microbeads or HA and 

GCS Co., Ltd. 
GANA V® 
CIP #21E0787 
Final version 5.0 
Date: 27/06/2022 
Confidential 
Page 3/6 
 
TriCalcium Phosphate (TCP), …) or with a non-resorbable 
filling product (polyacrylamide, silicone, combination of 
methacrylic polymers and collagen, polymer particles, …) on 
the face. 
18. Subject having received at any time a treatment with tensor 
threads on the face. 
19. Subject having started or changed her oral contraceptive or any 
other hormonal treatment during 12 weeks prior to screening 
visit. 
20. Subject using medication such as aspirin, nonsteroidal anti-
inflammatory 
drugs 
(NSAID) 
(ibuprofen, 
naproxen, 
…), 
antiplatelet agents, anticoagulants or other substances known to 
prolong bleeding time within 1 week prior to injection visits. 
21. Subject undergoing a topical treatment on the test area or a 
systemic treatment: 
• 
Antihistamines during the 2 weeks prior to screening visit. 
• 
Immunosuppressors and/or corticoids during the 4 weeks 
prior to screening visit. 
• 
Retinoids during the 6 months prior to screening visit. 
22. Intensive exposure to sunlight or UV-rays within the previous 
month before and after injection visits. 
Investigational device: 
Name / code 
Classification 
Composition 
 
Galenic form 
Administration route 
 
Gana V® 
Class III medical device 
Poly-L-Lactic Acid (210mg), Sodium Carboxymethyl Cellulose, 
Mannitol. 
Sterile freeze-dried preparation (powder) 
Injection in the deep dermis and subcutaneous layer 
Comparator: 
Name / code 
Classification 
Composition 
 
Galenic form 
Administration route 
 
Sculptra® 
Class III medical device 
Poly-L-Lactic Acid (150mg), Sodium Carboxymethyl Cellulose, 
Mannitol. 
Sterile freeze-dried preparation (powder) 
Injection in the deep dermis and subcutaneous layer 
Endpoints: 
Primary effectiveness endpoint: 
Mean change in NLFs severity from baseline to 6 months after 
treatment initiation, as assessed by an independent blinded live 
evaluator using the validated 5-point Wrinkles Severity Rating Scale 
(WSRS). 
 
Secondary effectiveness endpoints: 
- 
Mean WSRS change from baseline to 11/2, 3, 9, 12, 18 and 
24 months after treatment initiation as assessed by a blinded 
live independent evaluator. 
- 
WSRS responder rates 11/2, 3, 6, 9, 12, 18 and 24 months 
after treatment initiation as assessed by a blinded live 
independent evaluator. A responder is defined as a subject 
with at least 1-point improvement from baseline on the 
WSRS. 
- 
Global Aesthetic Improvement Scale (GAIS) responder rates 
11/2, 3, 6, 9, 12, 18 and 24 months after treatment initiation 
as assessed by subjects and a blinded live independent 
evaluator. A responder is defined as a subject having 

GCS Co., Ltd. 
GANA V® 
CIP #21E0787 
Final version 5.0 
Date: 27/06/2022 
Confidential 
Page 4/6 
 
“Improved”, “Much improved” or “Very much improved” score 
according to GAIS.  
- 
Mean change in NLF depth and volume from baseline to 11/2, 
3, 6, 9, 12, 18 and 24 months after treatment initiation using 
fringe projection system. 
- 
Proportion of satisfied subjects 11/2, 3, 6, 9, 12, 18 and 24 
months after treatment initiation using a questionnaire. 
- 
Injector’s satisfaction regarding injection quality after initial 
and touch-up injection using a questionnaire. 
Secondary safety endpoints: 
Investigational devices safety will be assessed by collection of 
Injection Site Reactions (ISRs) and Adverse Events (AEs) throughout 
the study by the investigator. Subjects will record ISRs and AEs in 
their subject diaries. 
Study Procedures: 
A screening visit will allow to inform and preselect the subjects. 
 
On D0, baseline scoring (WSRS), fringe projection acquisitions and 
photographs will be done before injection. Eligible subjects will 
receive a first injection of the investigational devices according to the 
randomization list. Immediately after injection, injector’s treatment 
satisfaction will be collected. Investigator evaluator will collect 
Adverse Events (AEs) and Injection Site Reactions (ISRs) 
immediately after injection.   
 
A month and a half after initial injection (M11/2), WSRS and GAIS 
scoring, fringe projection acquisitions and photographs will be done 
before touch-up (if applicable). Subject’s treatment satisfaction and 
injector’s treatment satisfaction (if applicable) will be collected. A 
touch-up injection will be made if necessary, according to injector and 
subject opinion. Investigator evaluator will collect AEs and ISRs 
before and after touch-up if applicable.  
 
Three (M3), six (M6), nine (M9), twelve (M12), eighteen (M18) and 
twenty-four (M24) months after initial injection, effectiveness scoring 
(WSRS and GAIS scales), fringe projection acquisitions and 
photographs will be done. Subject’s treatment satisfaction will be 
collected. Investigator evaluator will collect AEs and ISRs 
Statistical methods: 
For the primary evaluation criterion: 
The parameter Wrinkle Severity Rating Scale (WSRS) with the 5 
level scores (at D0 before injection and M6) will be summarized using 
statistics for quantitative variable (N, mean, median, standard 
deviation, first and third quartile, minimum and maximum value) for 
each timepoint as well as for the change from baseline (M6-D0bef) 
by product. 
Inferential analysis for the primary endpoint: 
The non-inferiority of Gana V® versus Sculptra® will be demonstrated 
if the upper-limit of the two-sided 95% CI of the (M6-D0bef) mean 
difference is inferior or equal to 0.5.  
 
For the secondary evaluation criteria: 
 
All the variables will be described using adapted statistics according 
to their type (quantitative data or qualitative data). 
For quantitative data a Wilcoxon or paired t test will be applied to 
assess the change from baseline and to compare the products. 

GCS Co., Ltd. 
GANA V® 
CIP #21E0787 
Final version 5.0 
Date: 27/06/2022 
Confidential 
Page 5/6 
 
For qualitative data a McNemar’s test will be applied to compare the 
proportion of improvement or satisfaction between the products. 
 
The bilateral approach will be used with a significance level of 0.05. 
Foreseen study duration: 
Clinical investigation beginning: Q1 2022 
Clinical investigation end: Q2 2024 
Clinical investigation global duration: 28 months 
Duration by subject: 24 months + screening period 
 
 

GCS Co., Ltd. 
GANA V® 
CIP #21E0787 
Final version 5.0 
Date: 27/06/2022 
Confidential 
Page 6/6 
 
FLOW-CHART 
Procedure 
Visit 1 
Screenin
g 
Visit 2 
Day 0 
Visit 3 
M11/2 
Visit 4 
M3 
Visit 5 
M6 
Visit 6 
M9 
Visit 7 
M12 
Visit 8 
M18 
Visit 9 
M24 
Days 
D-x 
D0 
D40 
±2 
D90 
±2 
D180 
±4 
D270 
±4 
D365 
±7 
D540 
±14 
D730 
±14 
Informed 
consent 
form 
signature 

 
 
 
 
 
 
 
 
Medical examination 

 
 
 
 
 
 
 
 
Medical history and 
previous and concomitant 
treatments collection 

 
 
 
 
 
 
 
 
Checking of the inclusion 
and exclusion criteria 

 
 
 
 
 
 
 
 
Pregnancy test 

b
 
 
 
 
 
 
 
Confirmation of eligibility 

b
 
 
 
 
 
 
 
Randomization 

 
 
 
 
 
 
 
 
WSRS live assessment 
by a blinded evaluator 
 
b 
b 






Macrophotographs 
 
b
b






Fringe projection 
acquisitions (2 areas) 
 
b
b






Injection + anaesthesia (if 
necessary) 
 

Touch 
up 






GAIS live assessment by 
a blinded evaluator 
 
 
b 
 
 
 
 
 
 
GAIS assessment by the 
subjects 
 
 
b






Subjective evaluation 
questionnaire for subjects 
 
 
b






ISR assessor  
 
a 
b + a 
 
 
 
 
 
 
ISR subjects 
 
completed each day during 4 
weeks after injection and touch up 
if applicable at home by the 
subject 
 
 
 
 
 
Subjective evaluation 
questionnaire for injector 
 
a 
a 
 
 
 
 
 
 
AE and concomitant 
treatments and 
procedures collection 
 
 
 
 
 
 
 
 
 
Study end 









Keys:b: Before injection; a: After injection