NCT05215054 (PLLA) is a NA clinical trial of Gana V® in Wrinkle, sponsored by GCS Co., Ltd.

Who is sponsoring NCT05215054?

NCT05215054 is sponsored by GCS Co., Ltd.

What drugs are being tested in NCT05215054?

Interventions in NCT05215054: Gana V®, Sculptra®.

Is NCT05215054 still recruiting?

NCT05215054 is currently completed. Last updated 20 January 2025.

Are results published for NCT05215054?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2025-01-20 · How we verify

NCT05215054: PLLA

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Clinical Study for the Evaluation of the Safety and Effectiveness of Use of a Poly-L Lactic Acid Injectable Filler for the Aesthetic Treatment of Nasolabial Folds

Completed NA Results posted Last updated 20 January 2025

What this trial tests

NA trial testing Gana V® in Wrinkle in 59 participants. Completed in 7 May 2024.

Timeline

7 March 2022

Primary endpoint
7 November 2022

7 May 2024

Quick facts

Lead sponsor	GCS Co., Ltd
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	59
Start date	7 March 2022
Primary completion	7 November 2022
Estimated completion	7 May 2024
Sites	1 location across France

Drugs / interventions tested

Gana V®
Sculptra®

Conditions studied

Wrinkle — all drugs for Wrinkle →

Sponsor

GCS Co., Ltd

Who can join

Adults 30 to 70, any sex, with Wrinkle. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Change From Baseline in the Nasolabial Folds Severity Score on the Wrinkle Severity Rating Scale (WSRS) 6 Months After Treatment Primary · Baseline and Month 6

The Wrinkle Severity Rating Scale is a scale for measurement of the nasolabial folds wrinkles severity. The scale ranges from Grade 1 (absent-better outcome) to Grade 5 (extreme-worse outcome) Change of grades was calculated as the value at 6 months minus the value at baseline. To observe an improvement of the nasolabial folds wrinkles, a decrease of the mean score was expected.

Group	Value	95% CI
Gana V	-0.3	-0.4 – -0.1
Sculptra	-0.2	-0.3 – -0.1
Gana V Versus Sculptra	-0.1	-0.2 – 0.1

Change From Baseline in the Nasolabial Folds Severity Score on the Wrinkle Severity Rating Scale (WSRS) Secondary · Baseline, Month 1^1/2, Month 3, Month 6, Month 9, Month 12, Month 18 and Month 24

The Wrinkle Severity Rating Scale is a scale for measurement of the nasolabial folds wrinkles severity. The scale ranges from Grade 1 (absent-better outcome) to Grade 5 (extreme-worse outcome) Change of grades was calculated as the value at month X minus the value at baseline. To observe an improvement of the nasolabial folds wrinkles, a decrease of the mean score was expected.

Change from baseline (D0 visit) to M11/2 visit

Group	Value	95% CI
Gana V Versus Sculptra	-0.1	± 0.3
Gana V	-0.1	± 0.3
Sculptra	-0.0	± 0.2

Change from baseline (D0 visit) to M3 visit

Group	Value	95% CI
Gana V Versus Sculptra	0.0	± 0.2
Gana V	-0.1	± 0.3
Sculptra	-0.1	± 0.3

Change from baseline (D0 visit) to M6 visit

Group	Value	95% CI
Gana V Versus Sculptra	-0.1	± 0.5
Gana V	-0.3	± 0.4
Sculptra	-0.2	± 0.4

Change from baseline (D0 0visit) to M9 visit

Group	Value	95% CI
Gana V Versus Sculptra	-0.2	± 0.6
Gana V	-0.4	± 0.5
Sculptra	-0.3	± 0.4

Change from baseline (D0 visit) to M12 visit

Group	Value	95% CI
Gana V Versus Sculptra	-0.1	± 0.5
Gana V	-0.4	± 0.6
Sculptra	-0.3	± 0.5

Change from baseline (D0 visit) to M18 visit

Group	Value	95% CI
Gana V Versus Sculptra	-0.1	± 0.3
Gana V	-0.3	± 0.5
Sculptra	-0.2	± 0.5

Change from baseline (D0 visit) to M24 visit

Group	Value	95% CI
Gana V Versus Sculptra	-0.1	± 0.3
Gana V	-0.2	± 0.5
Sculptra	-0.1	± 0.4

WSRS Responders Rate Secondary · Baseline, Month 1^1/2, Month 3, Month 6, Month 9, Month 12, Month 18 and Month 24

The Wrinkle Severity Rating Scale is a scale for measurement of the nasolabial folds wrinkles severity. The scale ranges from Grade 1 (absent-better outcome) to Grade 5 (extreme-worse outcome) Responders rate = percentage of participants with an improvement of at least one grade in WSRS compared to baseline score. An improvement represents a decrease in WSRS (from grade 5 to grade 4 for instance)

Responder rate from baseline (D0 visit) to M11/2 visit

Group	Value	95% CI
Gana V	5
Sculptra	2
Gana V	50
Sculptra	53

Responder rate from baseline (D0 visit) to M3 visit

Group	Value	95% CI
Gana V	6
Sculptra	6
Gana V	43
Sculptra	43

Responder rate from baseline (D0 visit) to M6 visit

Group	Value	95% CI
Gana V	14
Sculptra	11
Gana V	39
Sculptra	42

Responder rate from baseline (D0 visit) to M9 visit

Group	Value	95% CI
Gana V	20
Sculptra	13
Gana V	28
Sculptra	35

Responder rate from baseline (D0 visit) to M12 visit

Group	Value	95% CI
Gana V	16
Sculptra	13
Gana V	31
Sculptra	34

Responder rate from baseline (D0 visit) to M18 visit

Group	Value	95% CI
Gana V	12
Sculptra	9
Gana V	37
Sculptra	40

Responder rate from baseline (D0 visit) to M24 visit

Group	Value	95% CI
Gana V	10
Sculptra	6
Gana V	39
Sculptra	43

Global Aesthetic Improvement Scale (GAIS) Responder Rate Secondary · Month 1^1/2, Month 3, Month 6, Month 9, Month 12, Month 18 and Month 24

Percentage of participants with an improvement on GAIS. A responder is defined as a subject having "Improved", "Much improved" or "Very much improved" score according to GAIS.

Evaluated by the independent blind evaluator at M11/2

Group	Value	95% CI
Gana V	20
Sculptra	18
Gana V	35
Sculptra	37

Evaluated by the independent blind evaluator at M3

Group	Value	95% CI
Gana V	21
Sculptra	17
Gana V	28
Sculptra	32

Evaluated by the independent blind evaluator at M6

Group	Value	95% CI
Gana V	38
Sculptra	29
Gana V	15
Sculptra	24

Evaluated by the independent blind evaluator at M9

Group	Value	95% CI
Gana V	32
Sculptra	31
Gana V	16
Sculptra	17

Evaluated by the independent blind evaluator at M12

Group	Value	95% CI
Gana V	30
Sculptra	28
Gana V	16
Sculptra	18

Evaluated by the independent blind evaluator at M18

Group	Value	95% CI
Gana V	26
Sculptra	27
Gana V	23
Sculptra	22

Evaluated by the independent blind evaluator at M24

Group	Value	95% CI
Gana V	16
Sculptra	17
Gana V	33
Sculptra	32

Evaluated by the subjects at M11/2

Group	Value	95% CI
Gana V	27
Sculptra	27
Gana V	28
Sculptra	28

Change From Baseline in Nasolabial Folds Average Depth (mm) Secondary · Baseline, Month 1^1/2, Month 3, Month 6, Month 9, Month 12, Month 18 and Month 24

The average depth of the nasolabial folds wrinkles was calculated using a fringe projection system. An increase of the mean value means a positive outcome. Change was calculated as the value at each follow-up visit minus the value at baseline

Change from baseline (D0 visit) to M11/2 visit

Group	Value	95% CI
Gana V Versus Sculptra	0.004	± 0.019
Gana V	0.018	± 0.017
Sculptra	0.014	± 0.016

Change from baseline (D0 visit) to M3 visit

Group	Value	95% CI
Gana V Versus Sculptra	0.008	± 0.022
Gana V	0.029	± 0.025
Sculptra	0.021	± 0.017

Change from baseline (D0 visit) to M6 visit

Group	Value	95% CI
Gana V Versus Sculptra	0.005	± 0.026
Gana V	0.029	± 0.028
Sculptra	0.024	± 0.021

Change from baseline (D0 visit) to M9 visit

Group	Value	95% CI
Gana V Versus Sculptra	0.008	± 0.024
Gana V	0.031	± 0.028
Sculptra	0.023	± 0.021

Change from baseline (D0 visit) to M12 visit

Group	Value	95% CI
Gana V Versus Sculptra	0.008	± 0.027
Gana V	0.029	± 0.030
Sculptra	0.021	± 0.020

Change from baseline (D0 visit) to M18 visit

Group	Value	95% CI
Gana V Versus Sculptra	0.008	± 0.034
Gana V	0.029	± 0.027
Sculptra	0.020	± 0.027

Change from baseline (D0 visit) to M24 visit

Group	Value	95% CI
Gana V Versus Sculptra	-0.002	± 0.033
Gana V	0.016	± 0.022
Sculptra	0.016	± 0.031

Change From Baseline in Nasolabial Folds Volume Secondary · Baseline, Month 1^1/2, Month 3, Month 6, Month 9, Month 12, Month 18 and Month 24

The volume of the nasolabial folds wrinkles was calculated using a fringe projection system. A decrease of the volume means a positive outcome.

Change from baseline (D0 visit) to M11/2 visit

Group	Value	95% CI
Gana V Versus Sculptra	-0.606	± 1.707
Gana V	-1.444	± 1.692
Sculptra	-0.838	± 1.408

Change from baseline (D0 visit) to M3 visit

Group	Value	95% CI
Gana V Versus Sculptra	-0.840	± 1.914
Gana V	-2.458	± 2.271
Sculptra	-1.619	± 1.938

Change from baseline (D0 visit) to M6 visit

Group	Value	95% CI
Gana V Versus Sculptra	-0.782	± 1.918
Gana V	-2.591	± 2.038
Sculptra	-1.809	± 1.709

Change from baseline (D0 visit) to M9 visit

Group	Value	95% CI
Gana V Versus Sculptra	-1.041	± 1.919
Gana V	-2.719	± 2.059
Sculptra	-1.677	± 1.956

Change from baseline (D0 visit) to M12 visit

Group	Value	95% CI
Gana V Versus Sculptra	-0.832	± 1.985
Gana V	-2.281	± 2.232
Sculptra	-1.449	± 1.707

Change from baseline (D0 visit) to M18 visit

Group	Value	95% CI
Gana V Versus Sculptra	-0.909	± 2.383
Gana V	-2.351	± 2.305
Sculptra	-1.442	± 2.162

Change from baseline (D0 visit) to M24 visit

Group	Value	95% CI
Gana V Versus Sculptra	0.161	± 2.392
Gana V	-0.949	± 2.031
Sculptra	-0.939	± 2.496

Proportion of Satisfied Participants Secondary · Month 1^1/2, Month 3, Month 6, Month 9, Month 12, Month 18 and Month 24

Percentage of participants with positive answers to an internal questionnaire

Are you satisfied with how your nasolabial fold looks? at M11/2

Group	Value	95% CI
Gana V	28
Sculptra	29
Gana V	27
Sculptra	26

Are you satisfied with how your nasolabial fold looks? at M3

Group	Value	95% CI
Gana V	34
Sculptra	33
Gana V	19
Sculptra	20

Are you satisfied with how your nasolabial fold looks? at M6

Group	Value	95% CI
Gana V	38
Sculptra	37
Gana V	15
Sculptra	16

Are you satisfied with how your nasolabial fold looks? at M9

Group	Value	95% CI
Gana V	32
Sculptra	29
Gana V	16
Sculptra	19

Are you satisfied with how your nasolabial fold looks? at M12

Group	Value	95% CI
Gana V	34
Sculptra	33
Gana V	13
Sculptra	14

Are you satisfied with how your nasolabial fold looks? at M18

Group	Value	95% CI
Gana V	32
Sculptra	29
Gana V	17
Sculptra	20

Are you satisfied with how your nasolabial fold looks? at M24

Group	Value	95% CI
Gana V	25
Sculptra	24
Gana V	24
Sculptra	25

The result is aesthetically satisfying at M11/2

Group	Value	95% CI
Gana V	29
Sculptra	28
Gana V	26
Sculptra	27

Injector Satisfaction Secondary · After initial injection (Day 0) and touch-up if applicable (Month 1^1/2)

Percentage of participants

Ease of injection after initial injection

Group	Value	95% CI
Gana V	32
Sculptra	29
Gana V	18
Sculptra	21
Gana V	5
Sculptra	5
Gana V	0
Sculptra	0

Ease of injection after touch-up

Group	Value	95% CI
Gana V	31
Sculptra	31
Gana V	15
Sculptra	13
Gana V	3
Sculptra	2
Gana V	3
Sculptra	6

Mouldability after initial injection

Group	Value	95% CI
Gana V	35
Sculptra	34
Gana V	20
Sculptra	19
Gana V	0
Sculptra	1
Gana V	0
Sculptra	1

Mouldability after touch-up

Group	Value	95% CI
Gana V	29
Sculptra	29
Gana V	17
Sculptra	22
Gana V	6
Sculptra	1
Gana V	0
Sculptra	0

Ease of product positioning after initial injection

Group	Value	95% CI
Gana V	27
Sculptra	26
Gana V	23
Sculptra	25
Gana V	5
Sculptra	4
Gana V	0
Sculptra	0

Ease of product positioning after touch-up

Group	Value	95% CI
Gana V	26
Sculptra	25
Gana V	23
Sculptra	25
Gana V	2
Sculptra	2
Gana V	1
Sculptra	0

Immediate result after initial injection

Group	Value	95% CI
Gana V	16
Sculptra	8
Gana V	31
Sculptra	32
Gana V	7
Sculptra	11
Gana V	1
Sculptra	4

Immediate result after touch-up

Group	Value	95% CI
Gana V	27
Sculptra	25
Gana V	24
Sculptra	25
Gana V	1
Sculptra	2
Gana V	0
Sculptra	0

Collection of Injection Site Reactions Secondary · Day 0, Month 1^1/2, Month 3, Month 6, Month 9, Month 12, Month 18 and Month 24

Proportion of subjects presenting at least one ISR of any severity

D0 after initial injection

Group	Value	95% CI
Gana V	3
Sculptra	6
Gana V	52
Sculptra	49

M11/2 before touch-up

Group	Value	95% CI
Gana V	50
Sculptra	54
Gana V	5
Sculptra	1

M11/2 after touch-up

Group	Value	95% CI
Gana V	1
Sculptra	5
Gana V	51
Sculptra	47

Group	Value	95% CI
Gana V	44
Sculptra	47
Gana V	5
Sculptra	2

Group	Value	95% CI
Gana V	49
Sculptra	51
Gana V	4
Sculptra	2

Group	Value	95% CI
Gana V	45
Sculptra	46
Gana V	3
Sculptra	2

M12

Group	Value	95% CI
Gana V	43
Sculptra	45
Gana V	4
Sculptra	2

M18

Group	Value	95% CI
Gana V	47
Sculptra	48
Gana V	2
Sculptra	1

Collection of Adverse Events Secondary · Day 0 to Month 24

Number of Adverse Events (AEs) Number of Adverse Device Effects (ADEs) Proportion of subjects with at least one AE Proportion of subject with at least one ADE

Proportion of subjects with at least one AE : With

Group	Value	95% CI
Gana V Versus Sculptra	43
Gana V	43
Sculptra	43

Proportion of subjects with at least one AE : Without

Group	Value	95% CI
Gana V Versus Sculptra	12
Gana V	12
Sculptra	12

Proportion of subjects with at least one SAE : With

Group	Value	95% CI
Gana V Versus Sculptra	1
Gana V	1
Sculptra	1

Proportion of subjects with at least one SAE : Without

Group	Value	95% CI
Gana V Versus Sculptra	54
Gana V	54
Sculptra	54

Proportion of subjects with at least one ADE : With

Group	Value	95% CI
Gana V Versus Sculptra	18
Gana V	17
Sculptra	14

Proportion of subjects with at least one ADE : Without

Group	Value	95% CI
Gana V Versus Sculptra	37
Gana V	38
Sculptra	41

proportion of subects with at least one SADE : With

Group	Value	95% CI
Gana V Versus Sculptra	0
Gana V	0
Sculptra	0

proportion of subects with at least one SADE : Without

Group	Value	95% CI
Gana V Versus Sculptra	55
Gana V	55
Sculptra	55

Adverse events — posted to ClinicalTrials.gov

Time frame: 24 months. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Gana V

Serious: 1/55 (2%)

Deaths: 0/55

Sculptra

Serious: 1/55 (2%)

Deaths: 0/55

Serious adverse events (1 terms)

Reaction	System	Gana V	Sculptra
Femoral fracture	Musculoskeletal and connective tissue disorders	—	—

Other adverse events (8 terms — click to expand)

Reaction	System	Gana V	Sculptra
General disorders and administration site conditions	General disorders	—	—
Infection	Infections and infestations	—	—
Headache / Migraine	Nervous system disorders	—	—
Muskulokeletal disorders	Musculoskeletal and connective tissue disorders	—	—
Gastrointestinal disorders	Gastrointestinal disorders	—	—
Acne, seborrheic dermatitis, burn	Skin and subcutaneous tissue disorders	—	—
Eye disorder	Eye disorders	—	—
Pneumonia / Tracheitis	Respiratory, thoracic and mediastinal disorders	—	—

Most-reported serious reactions: Femoral fracture.

Data from ClinicalTrials.gov NCT05215054 adverse events section.

Sponsor's own description

The purpose of this study is to assess the effectiveness and safety of Gana V, a Poly L-lactic acid filler for the aesthetic treatment of nasolabial folds, in comparison with Sculptra.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

Safety and Efficacy of Poly-L-Lactic Acid Filler (Gana V vs. Sculptra) Injection for Correction of the Nasolabial Fold: A Double-Blind, Non-Inferiority, Randomized, Split-Face Controlled Trial.
Han WY, Kim HJ, Kwon R, Kang SM, et al · · 2023 · cited 8× · PMID 37626137 · DOI 10.1007/s00266-023-03600-y
Final Report on the Safety and Efficacy of Poly-L-Lactic Acid Filler (Gana V) Injection for the Correction of Nasolabial Fold: A Double-Blind, Non-Inferiority, Randomized, Split-Face Controlled Trial.
Kim H, Kim HJ, Han WY, Yon DK. · · 2026 · PMID 40897963 · DOI 10.1007/s00266-025-05190-3
Letter to the Editor on: "Safety and Efficacy of Poly-L-Lactic Acid Filler (Gana V vs. Sculptra) Injection for Correction of the Nasolabial Fold: A Double-Blind, Non-Inferiority, Randomized, Split-Face Controlled Trial".
Fabi S, Bråsäter D. · · 2025 · PMID 37993537 · DOI 10.1007/s00266-023-03736-x

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Other GCS Co., Ltd trials

Trials by the same sponsor.

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Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT05215054 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by GCS Co., Ltd
Last refreshed: 20 January 2025

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05215054.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing

NCT05215054: PLLA

Quick facts

Drugs / interventions tested

Conditions studied

Sponsor

Who can join

Results — posted to ClinicalTrials.gov

Adverse events — posted to ClinicalTrials.gov

Serious adverse events (1 terms)

Sponsor's own description

Publications & conference data

Related trials

Other recruiting trials for Wrinkle

Other GCS Co., Ltd trials

Verify against primary sources