RecruitingNot ApplicableNCT07324564
Safety and Effectiveness of Sculptra 011611 for Improvement in Appearance of Gluteal Skin Irregularities
A Randomized, Evaluator-blinded, No-treatment Controlled, Multicenter Study to Evaluate the Effectiveness and Safety of Sculptra 011611 for Improvement in Appearance of Gluteal Skin Irregularities
Sponsor
Galderma R&D
Enrollment
125 participants
Start Date
Nov 24, 2025
Study Type
INTERVENTIONAL
Conditions
Summary
The main purpose of the study is to investigate the safety and effectiveness of Sculptra 011611 for improvement in appearance of gluteal skin irregularities.
Eligibility
Sex: FEMALEMin Age: 18 Years
Inclusion Criteria3
- Participant with moderate to severe skin laxity in the buttocks when standing with the buttocks in repose as evaluated using the Buttocks' Skin Laxity Visual Scale (SLVS) by the Blinded Evaluator and Treating Investigator at the Baseline visit.
- Women 18 years of age and older.
- Has intent to undergo treatment to improve skin quality and skin irregularities in the buttock area.
Exclusion Criteria7
- Previous surgery in or near the treatment area.
- Previous treatment/procedure in or near the treatment area OR is planning to undergo any procedures affecting the treatment area, at any time during the study.
- Presence of any disease or lesions near or on the area to be treated.
- Evidence of scar-related disease or delayed healing activity within 1 year prior to the Baseline visit, or participants susceptible to keloid formation, hyperpigmentation or hypertrophic scarring from injectable procedures.
- Skin coloring/bleaching/tattoo/stretch marks in the treatment area, which, in the Treating Investigator's opinion, would interfere with the study injections and/or study assessment.
- An underlying known disease, a surgical or medical condition that would expose the participant to undue risk.
- Treatment with chemotherapy, immunosuppressive agents, topical and systemic prescription retinoids, topical and systemic corticosteroids within 3 months before treatment.
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Interventions
DEVICESculptra 016011
Freeze-dried powder for injection.
Locations(6)
View Full Details on ClinicalTrials.gov
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NCT07324564