NCT05363163

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

Clinical Study for the Effectiveness of Use of an Injectable Medical Device GANA X® in the Treatment of Buttocks Volume Depression

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 50 (actual)
• Sponsor: GCS Co., Ltd · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

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.

Conditions

• Buttocks Volume Loss

Interventions

Type	Name	Description
DEVICE	Gana X	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).

Timeline

• Start date: 2022-05-02
• Primary completion: 2023-04-25
• Completion: 2024-11-04
• First posted: 2022-05-05
• Last updated: 2025-03-07
• Results posted: 2025-03-07

Locations

1 site across 1 country: France