Recruiting

Sculptra 011611

Sponsor:

Galderma R&D

Code:

NCT07324564

Conditions

Gluteal Skin Irregularities

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Accepted

Interventions

Sculptra 016011

Study Details

Brief 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.

Conditions

Gluteal Skin Irregularities

Study ID

NCT07324564

Start date

Nov 24, 2025

Status verified date

Dec, 2025

Completion date

Apr, 2027

Anticipated

Primary completion date

Apr, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Accepted

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.

Study Design

Enrollment

125 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Treatment Group

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.

no intervention: Control Group

Participants will be randomized to not receive any intervention.

Interventions

Sculptra 016011

Freeze-dried powder for injection.

Primary outcome measure

  • Percentage of Responders Having At Least "Improved" in Both Buttocks at Maximal Contraction According to the Global Aesthetic Improvement Scale (GAIS), as Assessed Live by Blinded Evaluator, at Month 9 [ Time Frame: At Month 9 ]

Central Contacts and Locations

Central contacts

Clinical Project Manager

817-961-5000clinical.studies@galderma.com

Locations

Site 8688

Recruiting

Vancouver, British Columbia, Canada, V5Z 4E1

Site 7049

Recruiting

Vancouver, British Columbia, Canada, V6H 4E1

Site 8379

Recruiting

Burlington, Ontario, Canada, L7N 3N2

Site 8689

Recruiting

Toronto, Ontario, Canada, M5R3N8

Site 8162

Recruiting

Woodbridge, Ontario, Canada, L4L 8E2

Site 8690

Recruiting

Westmount, Quebec, Canada, H3Z 1C3

More Information

Sponsor

Galderma R&D

Last update posted

Jan 7, 2026

Last verified

Dec, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Galderma R&D on 2026-01-07.