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Clinical Trial Summary

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


Clinical Trial 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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05963204
Study type Interventional
Source Galderma R&D
Contact
Status Active, not recruiting
Phase N/A
Start date July 7, 2023
Completion date August 31, 2024

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