RecruitingNot ApplicableNCT07399028

A Study to Characterize Human Skin Changes From Biostimulator Treatments Via Non-invasive Imaging

A Single-center, Open-label Study to Characterize Human Skin Changes From Biostimulator Treatments Via Non-invasive Imaging

Sponsor

Galderma R&D

Enrollment

25 participants

Start Date

Oct 21, 2025

Study Type

INTERVENTIONAL

Conditions

Photo-aged Skin Skin Laxity Volume Deficiency in the Mid-Face

Summary

Adult subjects with moderate-to-severe cheek wrinkles will be treated with Sculptra for correction of fine lines and wrinkles in the cheek area.

Eligibility

Sex: FEMALEMin Age: 45 YearsMax Age: 65 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a medical device called Sculptra® for people with photo-aged skin, skin laxity, and other related conditions. The study is currently recruiting participants at 1 location. People eligible for this study include women aged 45 Years to 65 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICESculptra®

Sculptra injection will be performed to the cheeks using 25 G needle size. Injections will be performed subdermally, i.e., in the subcutaneous and supraperiosteal region. A maximum of 18 mL (2 vials) of Sculptra will be administered per treatment session with a maximum of 9 mL (1 vial) per cheek, evenly distributed within the treatment area.