Buttocks Volume LossPLLANCT05363163

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

A study testing Gana X in people with Buttocks Volume Loss, run by GCS Co., Ltd at 1 site in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial 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. Read more about this study

Who is it for?: Ages 18 to 65 yearsHealthy volunteers can take part
Conditions the study is for: Buttocks Volume Loss
What is being tested?: Gana X
Type of treatment: Injection or infusion, Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 50 participants
Where: 1 siteFrance
Study dates: 2 May 2022to 4 Nov 2024
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 65 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

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.

Who cannot join

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

Show all 34Show fewer

Subject participation to another research on human beings or who is in an exclusion period of one.
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.
Subject with significant scarring, open wounds, lesions or tattoos in or near the area to be treated.
Subject having history of allergy or anaphylactic shock including hypersensitivity to Poly-l-lactic acid, to lidocaine or to one of the components of the tested devices or antiseptic solution.
Subject having received a dose of COVID-19 vaccine within the 14 days prior to injection visits or planning to receive a dose in the 14 days following injections.
Subject having received treatment on or near the buttocks (laser, dermabrasion, surgery, radiofrequency, cryolipolysis, buttocks electrostimulation, endermologie, liposuction, other energy-based treatment, surgery…) within the 12 months prior to screening visit.
Subject having received injection with a resorbable filling product in or near the buttocks within the 12 months prior to screening visit.
Subject having received at any time the following treatments in the area to be treated:
Buttocks implants;
Buttocks fillers (e.g., silicone, semi-permanent or permanent fillers or autologous fat injections);
Injections for the treatment of cellulitis.
Subject having started or changed her oral contraceptive or any other hormonal treatment during 12 weeks prior to screening visit.
Subject using medication such as aspirin, nonsteroidal anti-inflammatory drugs (NSAID) (ibuprofen, naproxen, …), antiplatelet agents, anticoagulants or other substances known to prolong bleeding time within 1 week prior to injection visits.
Subject undergoing a topical treatment on the test area or a systemic treatment:
Antihistamines during the 2 weeks prior to injections visits (D0 and touch-up visit).
Immunosuppressors and/or corticoids during the 4 weeks prior to injections visits (D0 and touch-up visit).
Retinoids during the 6 months prior to injections visits (D0 and touch-up visit).
Intensive exposure to sunlight or UV-rays within the month before injection visits and one month after.
Subject planning to loss or gain weight for the duration of the study.
Subject planning to change her/his life habits during the study

Trial locations and contacts

1 site in 1 country.

France1 site

Eurofins Dermscan Pharmascan
Villeurbanne, Auvergne-Rhône-Alpes, 69100

Other trials in France

About this study

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

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.

Read the 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
Being tested: Gana X

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Gana XDevice
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).

Study groups in NCT05363163
Study group	Role	What they receive
Gana X	Experimental	Participants will receive Gana X in both buttocks Receives: Device: Gana X

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: Baseline and Month 6

Secondary outcomes (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.
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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
Measured: 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
Measured: Day 0 to Month 24

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

2 May 20224 Nov 2024

First posted5 May 2022
Study start2 May 2022
Primary completion25 Apr 2023
Study completion4 Nov 2024

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Buttocks Volume LossStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Model description: All participants will receive the same medical device (Gana X)
Masking: None (open label)
Enrolment: 50 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05363163
Sponsor's protocol ID: 21E0805
Other IDs: 2021-A02728-33
Acronym: PLLA
Status last verified: Feb 2025
First submitted: 2 May 2022
Last updated: 7 Mar 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Study at a glance

From the registry record, last updated by the sponsor on 7 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Clinical Study for the Effectiveness of Use of an Injectable Medical Device GANA X® in the Treatment of Buttocks Volume Depression
ClinicalTrials.gov ID: NCT05363163
Acronym / sponsor ID: PLLA / 21E0805
Conditions: Buttocks Volume Loss
Study type: Interventional
Recruitment status: Completed
Enrolment: 50 participants (actual)
Lead sponsor: GCS Co., LtdIndustry (pharma, biotech, devices)
Collaborators: Eurofins Dermscan Pharmascan
Study start: 2 May 2022 (actual)
Primary completion: 25 Apr 2023 (actual)
Study completion: 4 Nov 2024 (actual)
First posted: 5 May 2022 (actual)
Results: Posted 7 Mar 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1
Model description: All participants will receive the same medical device (Gana X)

Arm	Type	Receives
Gana X	Experimental	Device: Gana XParticipants will receive Gana X in both buttocks

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (7 listed)

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.

Key exclusion criteria (34 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Gana XInjection 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).	Device	Gana X

Primary outcome

Change From Baseline in Buttocks Volume 6 Months After Treatment
Time frame: 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.

6 secondary outcomes

Change From Baseline in Buttocks Volume
Time frame: Baseline, Month 1^1/2, Month 9, Month 12, Month 18 and Month 24
Global Aesthetic Improvement Scale (GAIS) Responder Rate
Time frame: Month 1^1/2, Month 6, Month 9, Month 12, Month 18 and Month 24
Percentage of Satisfied Participants
Time frame: Month 1^1/2, Month 6, Month 9, Month 12, Month 18 and Month 24
Injector Satisfaction
Time frame: After initial injection (Day 0)
Collection of Injection Site Reactions
Time frame: Day 0, Month 1^1/2, Month 6, Month 9, Month 12, Month 18 and Month 24]
Collection of Adverse Events
Time frame: Day 0 to Month 24

Results and safety

Results posted to the registry on 7 Mar 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Gana X	50	37

Primary outcome: Change From Baseline in Buttocks Volume 6 Months After Treatment

Time frame: Baseline and Month 6. Mean (Standard Deviation). Unit: cm^3

Measure	Gana X n = 47
Value	22.21 (11.65)

Gana X: p <0.0001, t-test, 2 sided

Population analysed: Intent To Treat population - any subject included in the study with at least a post-basal value.

6 secondary outcomes are reported in the full results.

Adverse events

Time frame: 24 months. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Gana X	1 of 50 (2%)	31 of 50 (62%)	0 of 50

Limitations and caveats (from the sponsor): 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

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 7 Mar 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Gana X in people with Buttocks Volume Loss, run by GCS Co., Ltd at 1 site in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 34 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 7 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 7 Mar 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change From Baseline in Buttocks Volume 6 Months After Treatment (time frame: Baseline and Month 6). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05363163.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Mar 2025.