NCT05363163: PLLA

Clinical Study for the Evaluation of the Effectiveness of Use of a Poly-L Lactic Acid Injectable Filler for the Aesthetic Treatment of Buttocks Volume Depression

Completed NA Results posted Last updated 7 March 2025

What this trial tests

NA trial testing Gana X in Buttocks Volume Loss in 50 participants. Completed in 4 November 2024.

Timeline

2 May 2022

Primary endpoint
25 April 2023

4 November 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	50
Start date	2 May 2022
Primary completion	25 April 2023
Estimated completion	4 November 2024
Sites	1 location across France

Drugs / interventions tested

• Gana X

Conditions studied

• Buttocks Volume Loss — all drugs for Buttocks Volume Loss →

Sponsor

GCS Co., Ltd

Who can join

Adults 18 to 65, any sex, with Buttocks Volume Loss. 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 Buttocks Volume 6 Months After Treatment Primary · Baseline and Month 6

This will be assessed using 3D acquisitions of the buttocks analysed on a computer software to evaluate the decrease of the buttocks hollow. To observe an improvement, an increase of the mean change from baseline value was expected.

Group	Value	95% CI
Gana X	22.21	± 11.65

Change From Baseline in Buttocks Volume Secondary · Baseline, Month 1^1/2, Month 9, Month 12, Month 18 and Month 24

This will be assessed using 3D acquisitions of the buttocks analysed on a computer software to evaluate the decrease of the buttocks hollow. To observe an improvement, an increase of the mean change from baseline value was expected.

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

Group	Value	95% CI
Gana X	11.99	± 7.73

Change from baseline (D0 visit) to M9 visit

Group	Value	95% CI
Gana X	21.70	± 12.14

Change from baseline (D0 visit) to M12 visit

Group	Value	95% CI
Gana X	22.29	± 13.38

Change from baseline (D0 visit) to M18 visit

Group	Value	95% CI
Gana X	16.95	± 11.60

Change from baseline (D0 visit) to M24 visit

Group	Value	95% CI
Gana X	10.96	± 10.21

Global Aesthetic Improvement Scale (GAIS) Responder Rate Secondary · Month 1^1/2, 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 X	36
Gana X	14

Evaluated by the independent blind evaluator at M6

Group	Value	95% CI
Gana X	46
Gana X	1

Evaluated by the independent blind evaluator at M9

Group	Value	95% CI
Gana X	38
Gana X	2

Evaluated by the independent blind evaluator at M12

Group	Value	95% CI
Gana X	37
Gana X	2

Evaluated by the independent blind evaluator at M18

Group	Value	95% CI
Gana X	26
Gana X	9

Evaluated by the independent blind evaluator at M24

Group	Value	95% CI
Gana X	26
Gana X	11

Evaluated by the subject at M11/2

Group	Value	95% CI
Gana X	27
Gana X	22

Evaluated by the subject at M6

Group	Value	95% CI
Gana X	42
Gana X	5

Percentage of Satisfied Participants Secondary · Month 1^1/2, 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 buttocks looks at M11/2?

Group	Value	95% CI
Gana X	31
Gana X	19

Are you satisfied with how your buttocks looks at M6?

Group	Value	95% CI
Gana X	39
Gana X	8

Are you satisfied with how your buttocks looks at M9?

Group	Value	95% CI
Gana X	33
Gana X	7

Are you satisfied with how your buttocks looks at M12?

Group	Value	95% CI
Gana X	33
Gana X	6

Are you satisfied with how your buttocks looks at M18?

Group	Value	95% CI
Gana X	31
Gana X	5

Are you satisfied with how your buttocks looks at M24?

Group	Value	95% CI
Gana X	32
Gana X	5

The result is aesthetically satisfying at M11/2

Group	Value	95% CI
Gana X	33
Gana X	17

The result is aesthetically satisfying at M6

Group	Value	95% CI
Gana X	40
Gana X	7

Injector Satisfaction Secondary · After initial injection (Day 0)

The investigator who will inject the product will complete a questionnaire for each participant.

Ease of injection

Group	Value	95% CI
Gana X	34
Gana X	13
Gana X	2
Gana X	1

Mouldability

Group	Value	95% CI
Gana X	28
Gana X	21
Gana X	1
Gana X	0

Ease of product positioning

Group	Value	95% CI
Gana X	29
Gana X	14
Gana X	7
Gana X	0

Immediate result

Group	Value	95% CI
Gana X	22
Gana X	18
Gana X	9
Gana X	1

Result after massage

Group	Value	95% CI
Gana X	23
Gana X	23
Gana X	4
Gana X	0

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

Injection site reactions are usual signs reported after injection and consist on the evaluation of the following signs : Redness / Erythema, Pain / Tenderness, Induration / Firmness, Swelling / Edema, Lumps / Bumps, Bruising, Itching, Coloration, Pigmentation / Discoloration. Data presented are a percentage of subjects presenting at least one ISR of any severity evaluated by the investigator

D0 after initial injection

Group	Value	95% CI
Gana X	32
Gana X	18

M11/2 before touch-up

Group	Value	95% CI
Gana X	2
Gana X	48

M11/2 after touch-up

Group	Value	95% CI
Gana X	40
Gana X	5

M6

Group	Value	95% CI
Gana X	7
Gana X	40

M9

Group	Value	95% CI
Gana X	4
Gana X	36

M12

Group	Value	95% CI
Gana X	6
Gana X	33

M18

Group	Value	95% CI
Gana X	9
Gana X	27

M24

Group	Value	95% CI
Gana X	6
Gana X	31

Collection of Adverse Events Secondary · Day 0 to Month 24

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

Subjects with at least one AE:

Group	Value	95% CI
Gana X	39
Gana X	11

Subjects with at least one SAE:

Group	Value	95% CI
Gana X	1
Gana X	49

subjects with at least one ADE:

Group	Value	95% CI
Gana X	28
Gana X	22

Subjects with at least one SADE:

Group	Value	95% CI
Gana X	0
Gana X	50

Adverse events — posted to ClinicalTrials.gov

Time frame: 24 months. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Gana X

Serious: 1/50 (2%)

Deaths: 0/50

Serious adverse events (1 terms)

Reaction	System	Gana X
Depression	Psychiatric disorders	—

Other adverse events (5 terms — click to expand)

Reaction	System	Gana X
Headache	Nervous system disorders	—
Pain	General disorders	—
Lump/nodule	Product Issues	—
Dysmenorrhea	General disorders	—
Angina	Infections and infestations	—

Most-reported serious reactions: Depression.

Data from ClinicalTrials.gov NCT05363163 adverse events section.

Sponsor's own description

The purpose of this study is to assess the effectiveness and safety of Gana X, a Poly L-lactic acid filler for the aesthetic treatment of buttocks.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.