NCT05064761

Safety and Effectiveness of Poly-l-lactic Acid (PLLA) for the Improvement in Appearance of Cellulite

A Pilot Study to Evaluate Safety and Effectiveness of Poly-l-lactic Acid (PLLA) for the Improvement in Appearance of Cellulite

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 29 (actual)
• Sponsor: Galderma R&D · Industry
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

This pilot study has been designed to evaluate the safety and effectiveness of PLLA as a single regimen for the improvement in appearance of cellulite after changes in reconstitution procedure.

Detailed description

Cellulite is a topographic and localized skin condition that is commonly found on the posterolateral thighs, buttocks, and abdomen. It is often identified by a dimpled or orange-peel appearance of the skin's surface. The presence of visible cellulite is associated with histologic changes in the dermis, adipose tissue, and septae. Based on the theory that a stronger skin structure, with a decrease in skin laxity and increase in dermal thickness, could reduce the appearance of cellulite, the Sponsor intends to investigate the safety and effectiveness of PLLA for the improvement in appearance of cellulite in the posterior thighs.

Conditions

• Cellulite

Interventions

Type	Name	Description
DEVICE	Sculptra new dilution	Treatment to improve appearance of cellulite.

Timeline

• Start date: 2021-11-19
• Primary completion: 2022-12-21
• Completion: 2023-02-27
• First posted: 2021-10-01
• Last updated: 2024-09-26
• Results posted: 2024-09-26

Locations

1 site across 1 country: Canada