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.
A screening visit will allow to inform and preselect the participants. On D0, baseline scoring, fringe projection acquisitions and photographs will be done before injection. Eligible participants will receive a first injection of the product. 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 (M1 and a half), clinical scoring, fringe projection acquisitions and photographs will be done before touch-up (if applicable). Participant'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 participant opinion. Investigator evaluator will collect AEs and ISRs before and after touch-up if applicable. Six (M6), nine (M9), twelve (M12), eighteen (M18) and twenty-four (M24) months after initial injection, clinical scoring, fringe projection acquisitions and photographs will be done. Participant's treatment satisfaction will be collected. Investigator evaluator will collect AEs and ISRs.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
50
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).
Eurofins Dermscan Pharmascan
Villeurbanne, Auvergne-Rhône-Alpes, France
Change From Baseline in Buttocks Volume 6 Months After Treatment
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.
Time frame: Baseline and Month 6
Change From Baseline in Buttocks Volume
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.
Time frame: Baseline, Month 1^1/2, Month 9, Month 12, Month 18 and Month 24
Global Aesthetic Improvement Scale (GAIS) Responder Rate
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.
Time frame: Month 1^1/2, Month 6, Month 9, Month 12, Month 18 and Month 24
Percentage of Satisfied Participants
Percentage of participants with positive answers to an internal questionnaire
Time frame: Month 1^1/2, Month 6, Month 9, Month 12, Month 18 and Month 24
Injector Satisfaction
The investigator who will inject the product will complete a questionnaire for each participant.
Time frame: After initial injection (Day 0)
Collection of Injection Site Reactions
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
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Time frame: Day 0, Month 1^1/2, Month 6, Month 9, Month 12, Month 18 and Month 24]
Collection of Adverse Events
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
Time frame: Day 0 to Month 24