Safety and Effectiveness of Sculptra 011611 for Improvement in Appearance of Gluteal Skin Irregularities

Galderma

Status: Enrolling

Conditions: Gluteal Skin Irregularities

Treatments: Device: Sculptra 016011

Study type: Interventional

Funder types: Industry

Identifiers

NCT07324564

43CASA2406

Details and patient eligibility

About

The main purpose of the study is to investigate the safety and effectiveness of Sculptra 011611 for improvement in appearance of gluteal skin irregularities.

Enrollment: 125 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• 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 criteria

• 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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125 participants in 2 patient groups

Treatment Group

Experimental group

Description:

Participants will receive three subcutaneous injection of single regimen of Sculptra 011611. A single regimen consists of up to three injection sessions spaced 1 month (+2 weeks) apart at Baseline, Month 1 and Month 2.

Treatment:

Device: Sculptra 016011

Control Group

No Intervention group

Description:

Participants will be randomized to not receive any intervention.