Sculptra for Cellulite
What You Need to Know Before You Apply
What is the purpose of this trial?
The main purpose of the study is to investigate the safety and effectiveness of Sculptra 011611 for improvement in appearance of gluteal skin irregularities.
Are You a Good Fit for This Trial?
This trial is for women aged 18 and older who have moderate to severe skin laxity in the buttocks, as judged by a specific visual scale. Participants should want to improve their skin quality and address irregularities in the buttock area.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive three subcutaneous injections of Sculptra 011611, spaced 1 month apart at Baseline, Month 1, and Month 2
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Sculptra 011611
Trial Overview
The study is testing Sculptra 011611's safety and effectiveness in improving the appearance of gluteal skin irregularities, commonly known as cellulite.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Active Control
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.
Participants will be randomized to not receive any intervention.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Galderma R&D
Lead Sponsor
Flemming Ørnskov
Galderma R&D
Chief Executive Officer since 2019
MD, MPH
Baldo Scassellati Sforzolini
Galderma R&D
Chief Medical Officer
MD, PhD
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