Trial Outcomes & Findings for 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 (NCT NCT05363163)
NCT ID: NCT05363163
Last Updated: 2025-03-07
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
50 participants
Primary outcome timeframe
Baseline and Month 6
Results posted on
2025-03-07
Participant Flow
The clinical investigation was initiated on 2 May 2022 (first subject first visit). Subjects were recruited from one investigational center, in France. The last subject was screened on 7 November 2022 and the recruitment period lasted 189 days.
126 subjects were screened to randomize 50 subjects
Participant milestones
| Measure |
Gana X
Participants received Gana X in both buttocks using injection in the deep dermis and subcutaneous layer of the buttocks on D0 (initial injection) and 1 month and a half after initial injection if necessary (optional touch-up).
|
|---|---|
|
Overall Study
STARTED
|
50
|
|
Overall Study
COMPLETED
|
37
|
|
Overall Study
NOT COMPLETED
|
13
|
Reasons for withdrawal
| Measure |
Gana X
Participants received Gana X in both buttocks using injection in the deep dermis and subcutaneous layer of the buttocks on D0 (initial injection) and 1 month and a half after initial injection if necessary (optional touch-up).
|
|---|---|
|
Overall Study
Withdrawal by Subject
|
13
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Gana X
n=50 Participants
Participants received Gana X in both buttocks
|
|---|---|
|
Age, Continuous
|
35.06 years
STANDARD_DEVIATION 10.49 • n=50 Participants
|
|
Sex: Female, Male
Female
|
49 Participants
n=50 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=50 Participants
|
|
Region of Enrollment
France
|
50 participants
n=50 Participants
|
PRIMARY outcome
Timeframe: Baseline and Month 6Population: Intent To Treat population - any subject included in the study with at least a post-basal value.
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.
Outcome measures
| Measure |
Gana X
n=47 Participants
Participants received Gana X in both buttocks
|
|---|---|
|
Change From Baseline in Buttocks Volume 6 Months After Treatment
|
22.21 cm^3
Standard Deviation 11.65
|
SECONDARY outcome
Timeframe: Baseline, Month 1^1/2, Month 9, Month 12, Month 18 and Month 24Population: Intent To Treat population - any subject included in the study with at least a post-basal value.
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.
Outcome measures
| Measure |
Gana X
n=50 Participants
Participants received Gana X in both buttocks
|
|---|---|
|
Change From Baseline in Buttocks Volume
Change from baseline (D0 visit) to M11/2 visit
|
11.99 cm^3
Standard Deviation 7.73
|
|
Change From Baseline in Buttocks Volume
Change from baseline (D0 visit) to M9 visit
|
21.70 cm^3
Standard Deviation 12.14
|
|
Change From Baseline in Buttocks Volume
Change from baseline (D0 visit) to M12 visit
|
22.29 cm^3
Standard Deviation 13.38
|
|
Change From Baseline in Buttocks Volume
Change from baseline (D0 visit) to M18 visit
|
16.95 cm^3
Standard Deviation 11.60
|
|
Change From Baseline in Buttocks Volume
Change from baseline (D0 visit) to M24 visit
|
10.96 cm^3
Standard Deviation 10.21
|
SECONDARY outcome
Timeframe: Month 1^1/2, Month 6, Month 9, Month 12, Month 18 and Month 24Population: Intent To Treat population - any subject included in the study with at least a post-basal value.
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.
Outcome measures
| Measure |
Gana X
n=50 Participants
Participants received Gana X in both buttocks
|
|---|---|
|
Global Aesthetic Improvement Scale (GAIS) Responder Rate
Evaluated by the subject at M11/2 · Responder
|
27 Participants
|
|
Global Aesthetic Improvement Scale (GAIS) Responder Rate
Evaluated by the subject at M11/2 · Not Responder
|
22 Participants
|
|
Global Aesthetic Improvement Scale (GAIS) Responder Rate
Evaluated by the subject at M6 · Responder
|
42 Participants
|
|
Global Aesthetic Improvement Scale (GAIS) Responder Rate
Evaluated by the subject at M6 · Not Responder
|
5 Participants
|
|
Global Aesthetic Improvement Scale (GAIS) Responder Rate
Evaluated by the subject at M9 · Responder
|
32 Participants
|
|
Global Aesthetic Improvement Scale (GAIS) Responder Rate
Evaluated by the subject at M9 · Not Responder
|
6 Participants
|
|
Global Aesthetic Improvement Scale (GAIS) Responder Rate
Evaluated by the subject at M12 · Responder
|
33 Participants
|
|
Global Aesthetic Improvement Scale (GAIS) Responder Rate
Evaluated by the subject at M12 · Not Responder
|
5 Participants
|
|
Global Aesthetic Improvement Scale (GAIS) Responder Rate
Evaluated by the subject at M18 · Responder
|
29 Participants
|
|
Global Aesthetic Improvement Scale (GAIS) Responder Rate
Evaluated by the subject at M24 · Responder
|
28 Participants
|
|
Global Aesthetic Improvement Scale (GAIS) Responder Rate
Evaluated by the subject at M24 · Not Responder
|
9 Participants
|
|
Global Aesthetic Improvement Scale (GAIS) Responder Rate
Evaluated by the independent blind evaluator at M11/2 · Responder
|
36 Participants
|
|
Global Aesthetic Improvement Scale (GAIS) Responder Rate
Evaluated by the independent blind evaluator at M11/2 · Not Responder
|
14 Participants
|
|
Global Aesthetic Improvement Scale (GAIS) Responder Rate
Evaluated by the independent blind evaluator at M6 · Responder
|
46 Participants
|
|
Global Aesthetic Improvement Scale (GAIS) Responder Rate
Evaluated by the independent blind evaluator at M6 · Not Responder
|
1 Participants
|
|
Global Aesthetic Improvement Scale (GAIS) Responder Rate
Evaluated by the independent blind evaluator at M9 · Responder
|
38 Participants
|
|
Global Aesthetic Improvement Scale (GAIS) Responder Rate
Evaluated by the independent blind evaluator at M9 · Not Responder
|
2 Participants
|
|
Global Aesthetic Improvement Scale (GAIS) Responder Rate
Evaluated by the independent blind evaluator at M12 · Responder
|
37 Participants
|
|
Global Aesthetic Improvement Scale (GAIS) Responder Rate
Evaluated by the independent blind evaluator at M12 · Not Responder
|
2 Participants
|
|
Global Aesthetic Improvement Scale (GAIS) Responder Rate
Evaluated by the independent blind evaluator at M18 · Responder
|
26 Participants
|
|
Global Aesthetic Improvement Scale (GAIS) Responder Rate
Evaluated by the independent blind evaluator at M18 · Not Responder
|
9 Participants
|
|
Global Aesthetic Improvement Scale (GAIS) Responder Rate
Evaluated by the independent blind evaluator at M24 · Responder
|
26 Participants
|
|
Global Aesthetic Improvement Scale (GAIS) Responder Rate
Evaluated by the independent blind evaluator at M24 · Not Responder
|
11 Participants
|
|
Global Aesthetic Improvement Scale (GAIS) Responder Rate
Evaluated by the subject at M18 · Not Responder
|
7 Participants
|
SECONDARY outcome
Timeframe: Month 1^1/2, Month 6, Month 9, Month 12, Month 18 and Month 24Population: Intent To Treat population - any subject included in the study with at least a post-basal value
Percentage of participants with positive answers to an internal questionnaire
Outcome measures
| Measure |
Gana X
n=50 Participants
Participants received Gana X in both buttocks
|
|---|---|
|
Percentage of Satisfied Participants
Are you satisfied with how your buttocks looks at M11/2? · Satisfied
|
31 Participants
|
|
Percentage of Satisfied Participants
Are you satisfied with how your buttocks looks at M11/2? · Not satisfied
|
19 Participants
|
|
Percentage of Satisfied Participants
The result is natural at M12 · Satisfied
|
31 Participants
|
|
Percentage of Satisfied Participants
The result is natural at M12 · Not satisfied
|
7 Participants
|
|
Percentage of Satisfied Participants
The result is natural at M18 · Satisfied
|
35 Participants
|
|
Percentage of Satisfied Participants
The result is natural at M18 · Not satisfied
|
1 Participants
|
|
Percentage of Satisfied Participants
The result is natural at M24 · Satisfied
|
35 Participants
|
|
Percentage of Satisfied Participants
The result is natural at M24 · Not satisfied
|
2 Participants
|
|
Percentage of Satisfied Participants
The buttocks volume are restored at M11/2 · Satisfied
|
31 Participants
|
|
Percentage of Satisfied Participants
The buttocks volume are restored at M11/2 · Not satisfied
|
18 Participants
|
|
Percentage of Satisfied Participants
The buttocks volume are restored at M6 · Satisfied
|
39 Participants
|
|
Percentage of Satisfied Participants
The buttocks volume are restored at M6 · Not satisfied
|
8 Participants
|
|
Percentage of Satisfied Participants
The buttocks volume are restored at M9 · Satisfied
|
30 Participants
|
|
Percentage of Satisfied Participants
The buttocks volume are restored at M9 · Not satisfied
|
10 Participants
|
|
Percentage of Satisfied Participants
The buttocks volume are restored at M18 · Satisfied
|
28 Participants
|
|
Percentage of Satisfied Participants
The buttocks volume are restored at M18 · Not satisfied
|
8 Participants
|
|
Percentage of Satisfied Participants
The buttocks volume are restored at M24 · Satisfied
|
29 Participants
|
|
Percentage of Satisfied Participants
The buttocks volume are restored at M24 · Not satisfied
|
8 Participants
|
|
Percentage of Satisfied Participants
The buttocks skin laxity is improved at M11/2 · Satisfied
|
30 Participants
|
|
Percentage of Satisfied Participants
The buttocks skin laxity is improved at M11/2 · Not satisfied
|
20 Participants
|
|
Percentage of Satisfied Participants
Are you satisfied with how your buttocks looks at M6? · Satisfied
|
39 Participants
|
|
Percentage of Satisfied Participants
Are you satisfied with how your buttocks looks at M6? · Not satisfied
|
8 Participants
|
|
Percentage of Satisfied Participants
Are you satisfied with how your buttocks looks at M9? · Satisfied
|
33 Participants
|
|
Percentage of Satisfied Participants
Are you satisfied with how your buttocks looks at M9? · Not satisfied
|
7 Participants
|
|
Percentage of Satisfied Participants
Are you satisfied with how your buttocks looks at M12? · Satisfied
|
33 Participants
|
|
Percentage of Satisfied Participants
Are you satisfied with how your buttocks looks at M12? · Not satisfied
|
6 Participants
|
|
Percentage of Satisfied Participants
Are you satisfied with how your buttocks looks at M18? · Satisfied
|
31 Participants
|
|
Percentage of Satisfied Participants
Are you satisfied with how your buttocks looks at M18? · Not satisfied
|
5 Participants
|
|
Percentage of Satisfied Participants
Are you satisfied with how your buttocks looks at M24? · Satisfied
|
32 Participants
|
|
Percentage of Satisfied Participants
Are you satisfied with how your buttocks looks at M24? · Not satisfied
|
5 Participants
|
|
Percentage of Satisfied Participants
The result is aesthetically satisfying at M11/2 · Satisfied
|
33 Participants
|
|
Percentage of Satisfied Participants
The result is aesthetically satisfying at M11/2 · Not satisfied
|
17 Participants
|
|
Percentage of Satisfied Participants
The result is aesthetically satisfying at M6 · Satisfied
|
40 Participants
|
|
Percentage of Satisfied Participants
The result is aesthetically satisfying at M6 · Not satisfied
|
7 Participants
|
|
Percentage of Satisfied Participants
The result is aesthetically satisfying at M9 · Satisfied
|
32 Participants
|
|
Percentage of Satisfied Participants
The result is aesthetically satisfying at M9 · Not satisfied
|
8 Participants
|
|
Percentage of Satisfied Participants
The result is aesthetically satisfying at M12 · Satisfied
|
32 Participants
|
|
Percentage of Satisfied Participants
The result is aesthetically satisfying at M12 · Not satisfied
|
6 Participants
|
|
Percentage of Satisfied Participants
The result is aesthetically satisfying at M18 · Satisfied
|
30 Participants
|
|
Percentage of Satisfied Participants
The result is aesthetically satisfying at M18 · Not satisfied
|
6 Participants
|
|
Percentage of Satisfied Participants
The result is aesthetically satisfying at M24 · Satisfied
|
32 Participants
|
|
Percentage of Satisfied Participants
The result is aesthetically satisfying at M24 · Not satisfied
|
5 Participants
|
|
Percentage of Satisfied Participants
The result is natural at M11/2 · Satisfied
|
41 Participants
|
|
Percentage of Satisfied Participants
The result is natural at M11/2 · Not satisfied
|
9 Participants
|
|
Percentage of Satisfied Participants
The result is natural at M6 · Satisfied
|
44 Participants
|
|
Percentage of Satisfied Participants
The result is natural at M6 · Not satisfied
|
3 Participants
|
|
Percentage of Satisfied Participants
The result is natural at M9 · Satisfied
|
37 Participants
|
|
Percentage of Satisfied Participants
The result is natural at M9 · Not satisfied
|
3 Participants
|
|
Percentage of Satisfied Participants
The buttocks volume are restored at M12 · Satisfied
|
31 Participants
|
|
Percentage of Satisfied Participants
The buttocks volume are restored at M12 · Not satisfied
|
7 Participants
|
|
Percentage of Satisfied Participants
The buttocks skin laxity is improved at M6 · Satisfied
|
33 Participants
|
|
Percentage of Satisfied Participants
The buttocks skin laxity is improved at M6 · Not satisfied
|
14 Participants
|
|
Percentage of Satisfied Participants
The buttocks skin laxity is improved at M9 · Satisfied
|
29 Participants
|
|
Percentage of Satisfied Participants
The buttocks skin laxity is improved at M9 · Not satisfied
|
11 Participants
|
|
Percentage of Satisfied Participants
The buttocks skin laxity is improved at M12 · Satisfied
|
31 Participants
|
|
Percentage of Satisfied Participants
The buttocks skin laxity is improved at M12 · Not satisfied
|
7 Participants
|
|
Percentage of Satisfied Participants
The buttocks skin laxity is improved at M18 · Satisfied
|
27 Participants
|
|
Percentage of Satisfied Participants
The buttocks skin laxity is improved at M18 · Not satisfied
|
9 Participants
|
|
Percentage of Satisfied Participants
The buttocks skin laxity is improved at M24 · Satisfied
|
30 Participants
|
|
Percentage of Satisfied Participants
The buttocks skin laxity is improved at M24 · Not satisfied
|
7 Participants
|
SECONDARY outcome
Timeframe: After initial injection (Day 0)Population: Intent To Treat population - any subject included in the study with at least a post-basal value
The investigator who will inject the product will complete a questionnaire for each participant.
Outcome measures
| Measure |
Gana X
n=50 Participants
Participants received Gana X in both buttocks
|
|---|---|
|
Injector Satisfaction
Result after massage · Somewhat dissatisfied
|
0 Participants
|
|
Injector Satisfaction
Result after massage · Dissatisfied
|
0 Participants
|
|
Injector Satisfaction
Result after massage · Very dissatisfied
|
0 Participants
|
|
Injector Satisfaction
Ease of injection · Very satisfied
|
34 Participants
|
|
Injector Satisfaction
Ease of injection · satisfied
|
13 Participants
|
|
Injector Satisfaction
Ease of injection · Somewhat satisfied
|
2 Participants
|
|
Injector Satisfaction
Ease of injection · Somewhat dissatisfied
|
1 Participants
|
|
Injector Satisfaction
Ease of injection · Dissatisfied
|
0 Participants
|
|
Injector Satisfaction
Ease of injection · Very dissatisfied
|
0 Participants
|
|
Injector Satisfaction
Mouldability · Very satisfied
|
28 Participants
|
|
Injector Satisfaction
Mouldability · satisfied
|
21 Participants
|
|
Injector Satisfaction
Mouldability · Somewhat satisfied
|
1 Participants
|
|
Injector Satisfaction
Mouldability · Somewhat dissatisfied
|
0 Participants
|
|
Injector Satisfaction
Mouldability · Dissatisfied
|
0 Participants
|
|
Injector Satisfaction
Mouldability · Very dissatisfied
|
0 Participants
|
|
Injector Satisfaction
Ease of product positioning · Very satisfied
|
29 Participants
|
|
Injector Satisfaction
Ease of product positioning · satisfied
|
14 Participants
|
|
Injector Satisfaction
Ease of product positioning · Somewhat satisfied
|
7 Participants
|
|
Injector Satisfaction
Ease of product positioning · Somewhat dissatisfied
|
0 Participants
|
|
Injector Satisfaction
Ease of product positioning · Dissatisfied
|
0 Participants
|
|
Injector Satisfaction
Ease of product positioning · Very dissatisfied
|
0 Participants
|
|
Injector Satisfaction
Immediate result · Very satisfied
|
22 Participants
|
|
Injector Satisfaction
Immediate result · satisfied
|
18 Participants
|
|
Injector Satisfaction
Immediate result · Somewhat satisfied
|
9 Participants
|
|
Injector Satisfaction
Immediate result · Somewhat dissatisfied
|
1 Participants
|
|
Injector Satisfaction
Immediate result · Dissatisfied
|
0 Participants
|
|
Injector Satisfaction
Immediate result · Very dissatisfied
|
0 Participants
|
|
Injector Satisfaction
Result after massage · Very satisfied
|
23 Participants
|
|
Injector Satisfaction
Result after massage · satisfied
|
23 Participants
|
|
Injector Satisfaction
Result after massage · Somewhat satisfied
|
4 Participants
|
SECONDARY outcome
Timeframe: Day 0, Month 1^1/2, Month 6, Month 9, Month 12, Month 18 and Month 24]Population: Safety population - any subject having used the investigational device
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
Outcome measures
| Measure |
Gana X
n=50 Participants
Participants received Gana X in both buttocks
|
|---|---|
|
Collection of Injection Site Reactions
D0 after initial injection · At least one sign
|
32 Participants
|
|
Collection of Injection Site Reactions
D0 after initial injection · No sign
|
18 Participants
|
|
Collection of Injection Site Reactions
M6 · No sign
|
40 Participants
|
|
Collection of Injection Site Reactions
M9 · At least one sign
|
4 Participants
|
|
Collection of Injection Site Reactions
M9 · No sign
|
36 Participants
|
|
Collection of Injection Site Reactions
M18 · At least one sign
|
9 Participants
|
|
Collection of Injection Site Reactions
M18 · No sign
|
27 Participants
|
|
Collection of Injection Site Reactions
M24 · At least one sign
|
6 Participants
|
|
Collection of Injection Site Reactions
M11/2 before touch-up · At least one sign
|
2 Participants
|
|
Collection of Injection Site Reactions
M11/2 before touch-up · No sign
|
48 Participants
|
|
Collection of Injection Site Reactions
M11/2 after touch-up · At least one sign
|
40 Participants
|
|
Collection of Injection Site Reactions
M11/2 after touch-up · No sign
|
5 Participants
|
|
Collection of Injection Site Reactions
M6 · At least one sign
|
7 Participants
|
|
Collection of Injection Site Reactions
M12 · At least one sign
|
6 Participants
|
|
Collection of Injection Site Reactions
M12 · No sign
|
33 Participants
|
|
Collection of Injection Site Reactions
M24 · No sign
|
31 Participants
|
SECONDARY outcome
Timeframe: Day 0 to Month 24Population: Safety population - any subject having used the investigational device
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
Outcome measures
| Measure |
Gana X
n=50 Participants
Participants received Gana X in both buttocks
|
|---|---|
|
Collection of Adverse Events
Subjects with at least one AE: · With
|
39 Participants
|
|
Collection of Adverse Events
Subjects with at least one SAE: · Without
|
49 Participants
|
|
Collection of Adverse Events
subjects with at least one ADE: · With
|
28 Participants
|
|
Collection of Adverse Events
subjects with at least one ADE: · Without
|
22 Participants
|
|
Collection of Adverse Events
Subjects with at least one SADE: · With
|
0 Participants
|
|
Collection of Adverse Events
Subjects with at least one SADE: · Without
|
50 Participants
|
|
Collection of Adverse Events
Subjects with at least one AE: · Without
|
11 Participants
|
|
Collection of Adverse Events
Subjects with at least one SAE: · With
|
1 Participants
|
Adverse Events
Gana X
Serious events: 1 serious events
Other events: 31 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Gana X
n=50 participants at risk
Participants received Gana X in both buttocks
|
|---|---|
|
Psychiatric disorders
Depression
|
2.0%
1/50 • 24 months
Definitions from MDCG were used as the study was done on a medical device
|
Other adverse events
| Measure |
Gana X
n=50 participants at risk
Participants received Gana X in both buttocks
|
|---|---|
|
Nervous system disorders
Headache
|
36.0%
18/50 • Number of events 67 • 24 months
Definitions from MDCG were used as the study was done on a medical device
|
|
Infections and infestations
Angina
|
6.0%
3/50 • Number of events 3 • 24 months
Definitions from MDCG were used as the study was done on a medical device
|
|
General disorders
Dysmenorrhea
|
8.0%
4/50 • Number of events 15 • 24 months
Definitions from MDCG were used as the study was done on a medical device
|
|
Product Issues
Lump/nodule
|
16.0%
8/50 • Number of events 9 • 24 months
Definitions from MDCG were used as the study was done on a medical device
|
|
General disorders
Pain
|
34.0%
17/50 • Number of events 25 • 24 months
Definitions from MDCG were used as the study was done on a medical device
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place