[Trial of device that is not approved or cleared by the U.S. FDA]

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

Study Overview

• Status: Withheld
• Conditions: Gluteal Skin Irregularities
• Intervention / Treatment: Device: Sculptra 016011

• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • British Columbia
    • Vancouver, British Columbia, Canada, V5Z 4E1
      • Recruiting
      • Site 8688
    • Vancouver, British Columbia, Canada, V6H 4E1
      • Recruiting
      • Site 7049
  • Ontario
    • Burlington, Ontario, Canada, L7N 3N2
      • Recruiting
      • Site 8379
    • Toronto, Ontario, Canada, M5R3N8
      • Recruiting
      • Site 8689
    • Woodbridge, Ontario, Canada, L4L 8E2
      • Recruiting
      • Site 8162
  • Quebec
    • Westmount, Quebec, Canada, H3Z 1C3
      • Recruiting
      • Site 8690

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	Device: Sculptra 016011; Freeze-dried powder for injection.; Other Names: Poly L Lactic Acid (PLLA)
No Intervention: Control Group; Participants will be randomized to not receive any intervention.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Responder will be defined as participants achieving 'very much improved', 'much improved' or "Improved" on GAIS compared to baseline. The 7-graded GAIS will be used to assess the aesthetic improvement of gluteal skin irregularities by the Blinded Evaluator at maximal contraction by responding to the question: "How would you describe the aesthetic improvement today compared to the photograph taken at Baseline?" for each buttock separately by using the respective categorical scale as follows; Very Much Improved, Much Improved, Improved, No Change, Worse, Much Worse, Very Much Worse. In this outcome measure, percentage of participants who will achieve at least 'Improved' on the GAIS assessed by Blinded Evaluator at Month 9 will be reported.	At Month 9

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Responders Having At Least "Improved" in Appearance of Gluteal Skin Irregularities in Both Buttocks at Maximal Contraction According to GAIS, as Assessed Live by Blinded Evaluator, at Month 3, 6 and 12	Responder will be defined as participants achieving 'very much improved', 'much improved' or "Improved" on GAIS compared to baseline. The 7-graded GAIS will be used to assess the aesthetic improvement of gluteal skin irregularities by the Blinded Evaluator at maximal contraction by responding to the question: "How would you describe the aesthetic improvement today compared to the photograph taken at Baseline?" for each buttock separately by using the respective categorical scale as follows; Very Much Improved, Much Improved, Improved, No Change, Worse, Much Worse, Very Much Worse. In this outcome measure, percentage of participants who will achieve at least 'Improved' on the GAIS assessed by Blinded Evaluator at Months 3, 6 and 12 will be reported.	At Months 3, 6 and 12
Percentage of Responders Having at Least "Improved" in Appearance of Gluteal Skin Irregularities in Both Buttocks in Relaxed State According to GAIS, as Assessed Live by Blinded Evaluator, at Month 3, 6, 9 and 12	Responder will be defined as participants achieving 'very much improved', 'much improved' or "Improved" on GAIS compared to baseline. The 7-graded GAIS will be used to assess the aesthetic improvement of gluteal skin irregularities by the Blinded Evaluator in relaxed state by responding to the question: "How would you describe the aesthetic improvement today compared to the photograph taken at Baseline?" for each buttock separately by using the respective categorical scale as follows; Very Much Improved, Much Improved, Improved, No Change, Worse, Much Worse, Very Much Worse. In this outcome measure, percentage of participants who will achieve at least 'Improved' on the GAIS assessed by Blinded Evaluator at Months 3, 6, 9 and 12 will be reported.	At Months 3, 6, 9 and 12

Collaborators and Investigators

• Sponsor: [Redacted]

Study record dates

Study Major Dates

• Study Start: November 24, 2025
• Primary Completion: April 1, 2026
• Study Completion: April 1, 2027

Study Registration Dates

• First Submitted: December 23, 2025
• First Submitted That Met QC Criteria: December 23, 2025
• First Posted (Actual): January 7, 2026

Study Record Updates

• Last Update Posted (Actual): May 6, 2026
• Last Update Submitted That Met QC Criteria: May 4, 2026
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: 43CASA2406

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes