125 Participants Needed

Sculptra for Cellulite

Recruiting at 5 trial locations
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

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

I have moderate to severe loose skin on my buttocks.
I am a woman aged 18 or older.
I plan to get treatment to improve my buttock skin quality.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive three subcutaneous injections of Sculptra 011611, spaced 1 month apart at Baseline, Month 1, and Month 2

2 months
3 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

10 months
Assessments at Months 3, 6, 9, and 12

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

Group I: Treatment GroupExperimental Treatment1 Intervention
Group II: Control GroupActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Galderma R&D

Lead Sponsor

Trials
303
Recruited
60,700+
Flemming Ørnskov profile image

Flemming Ørnskov

Galderma R&D

Chief Executive Officer since 2019

MD, MPH

Baldo Scassellati Sforzolini profile image

Baldo Scassellati Sforzolini

Galderma R&D

Chief Medical Officer

MD, PhD