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

NCT05363163 | Completed Results

• 2 other identifiers: 21E08052021-A02728-33
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Buttocks Volume Loss

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline and Month 6

Secondary Outcomes (6)

• Change From Baseline in Buttocks Volume

  Baseline, Month 1^1/2, Month 9, Month 12, Month 18 and Month 24

• Global Aesthetic Improvement Scale (GAIS) Responder Rate

  Month 1^1/2, Month 6, Month 9, Month 12, Month 18 and Month 24

• Percentage of Satisfied Participants

  Month 1^1/2, Month 6, Month 9, Month 12, Month 18 and Month 24

• Injector Satisfaction

  After initial injection (Day 0)

• Collection of Injection Site Reactions

  Day 0, Month 1^1/2, Month 6, Month 9, Month 12, Month 18 and Month 24]

Study Arms (1)

Gana X

EXPERIMENTAL

Participants will receive Gana X in both buttocks

Device: Gana X

Interventions

Gana X DEVICE

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).

Gana X

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subject with mild to moderate buttock volume depression and/or seeking buttocks volume augmentation based on investigator evaluation.
• Subject wiling to abstain from other body contouring procedures during the whole study period.
• Subject psychologically able to understand the study related information and to give a written informed consent.
• Subject having given freely and expressly his/her informed consent.
• Subject willing to have photographs taken.
• Subject affiliated to a health social security system.
• Female of childbearing potential should use a contraceptive regimen recognized as effective since at least 12 weeks before screening visit and during the whole study period.

You may not qualify if:

• Pregnant or nursing woman or having given birth within the last year or planning a pregnancy during the study.
• Excessive subcutaneous fat in the area to be treated.
• Excessive skin laxity on the area to be treated.
• Severe buttocks ptosis.
• Subject who had been deprived of their freedom by administrative or legal decision or who is under guardianship.
• Subject in a social or sanitary establishment
• Subject having already received 4500 euros indemnities for participation in research involving human beings in the 12 previous months or exceeding these 4500 euros with his participation in the present study.
• Subject suspected to be non-compliant according to the investigator's judgment.
• Subject suffering from a severe or progressive disease or any other pathology that may interfere with the evaluation of the study results.
• Subject with known history of or suffering from autoimmune disease and/or immune deficiency.
• Subject with a history of cellulitis, streptococcal disease, such as acute rheumatic fever or recurrent sore throats and in case of acute rheumatic fever with heart complications.
• Subject suffering from inflammatory and/or infectious cutaneous disorders in or near the studied zones (e.g. acne, chronic eczema, atopic dermatitis…).
• Subject with an abscess, unhealed wound, or a cancerous or precancerous lesion on the studied zone.
• Subject prone to develop inflammatory skin conditions or having tendency to bleeding disorders.
• Subject with a tendency to develop keloids or hypertrophic scarring.

Sponsors & Collaborators

• GCS Co., Ltd: lead
• Eurofins Dermscan Pharmascan: collaborator

Study Sites (1)

Eurofins Dermscan Pharmascan

Villeurbanne, Auvergne-Rhône-Alpes, 69100, France

Location

Limitations and Caveats

The number of injections sessions was quite low in this clinical investigation and is thus not representative of the usual medical practice. However, in most of the publications presenting efficacy and safety of PLLA in Buttocks, 1 to 3 sessions were done

Results Point of Contact

• Title: Florence REBER
• Organization: Eurofins Dermscan Pharmascan

Florence.Reber@cpt.eurofinseu.com

0472823656

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: Participants and investigators assessors will know which filler was used.
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: All participants will receive the same medical device (Gana X)

Study Record Dates

• First Submitted: May 2, 2022
• First Posted: May 5, 2022
• Study Start: May 2, 2022
• Primary Completion: April 25, 2023
• Study Completion: November 4, 2024
• Last Updated: March 7, 2025
• Results First Posted: March 7, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)