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Clinical Trial of Poly-L-lactic Acid (Sculptra Aesthetic) for the Treatment of Cellulite of the Buttocks and Thighs

Cellulite Clinical Trial

Official title:
A Randomized Single Center, Double Blinded, Split-body Clinical Trial of Poly-L-lactic Acid (Sculptra Aesthetic) for the Treatment of Cellulite of the Buttocks and Thighs

Clinical Trial Summary

clinical trial is to assess the safety, efficacy and patient satisfaction associated with the treatment of cellulite of the buttocks and thighs with injectable poly-L-lactic acid (PLLA), or Sculptra® Aesthetic

Clinical Trial Description

Enrolled subjects will be randomized to 2 treatment groups: "Right side treated" and "Left side treated". All subjects will receive three, single-sided injections of Sculptra Aesthetic, performed 1 month apart. Treatments will be provided to one side randomly assigned to either "right side" or "left side". The non-treatment side will receive bacteriostatic water, injected in the same manner as Sculptra Aesthetic. Up to four (4) vials of Sculptra Aesthetic, diluted at 16 mL, will be used per treatment session. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04830722
Study type Interventional
Source Goldman, Butterwick, Fitzpatrick and Groff
Contact Sherif Research Director, MD
Phone 8586571004
Email SMikhail@clderm.com
Status Recruiting
Phase N/A
Start date April 9, 2021
Completion date June 1, 2022
View Details
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