NCT05963204

A Study to Evaluate the Effects for Midface Improvement When Pairing a Biostimulator with a Skincare Regimen

A Randomized, Double-blinded, Split-face, Comparative Study to Evaluate the Synergistic Effects for Improving the Aging Midface When Pairing a Biostimulator with a Skincare Regimen

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 21 (actual)
• Sponsor: Galderma R&D · Industry
• Sex: All
• Age: 22 Years
• Healthy volunteers: Accepted

Summary

To assess skin structural change in midface after treatment with a biostimulator using Line-Field Optical Coherence Tomography

Detailed description

This is a randomized, double-blinded, split-face, comparative study. This study is designed to enroll and randomize approximately 20 subjects. All subjects are to have midface volume loss and contour deficiency and facial photodamage. Eligible subjects are randomized to receive study skincare products for pre-conditioning, 2 weeks before Baseline. All subjects receive biostimulator treatment at the midface by the Treating Investigator at Baseline. The method of injection is at the discretion of the Treating Investigator. A sufficient amount of product is injected to achieve optimal correction of the midface, in the opinion of the Treating Investigator. At the 6-week visit, after all study procedures for the visit are completed, treated subjects received a second biostimulator treatment to achieve optimal aesthetic improvement. At the 12-week and 18-week visits, similar study procedures are performed.

Conditions

• Photodamaged Skin
• Volume Deficiency of the Midface

Interventions

Type	Name	Description
COMBINATION_PRODUCT	Sculptra and Alastin Restorative Skin Complex	Biostimulator and cosmetics
COMBINATION_PRODUCT	Sculptra and CeraVe Daily Moisturizing Lotion	Biostimulator and cosmetics

Timeline

• Start date: 2023-07-07
• Primary completion: 2024-03-19
• Completion: 2024-03-19
• First posted: 2023-07-27
• Last updated: 2024-10-24

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study