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

Recruiting now · Not applicable

Conditions studied: Volume Deficiency in the Mid-Face, Skin Laxity, Photo-aged Skin

In brief

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

Key facts

Study ID

NCT07399028

Run by

Galderma R&D

People needed

25

Starts

2025-10-21

Expected to finish

2026-09-01

Last updated by the study team

2026-02-10

Who can join

Age: 45 and older, up to 65. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• Adult subjects aged 45-65 years old
• Females only
• Subject with moderate-to-severe cheek wrinkles on the GCWS
• Subject with intent to undergo correction of cheek wrinkles on both sides of the face
• Subject who in the opinion of the Investigator would need 3 treatments for optimal clinical outcomes
• Subject willing to be photographed at each visit.
• Subjects willing to stop using current facial skincare products for the duration of the study.
• Subject willing to replace the current facial skincare products with the provided facial skincare products, including cleanser, moisturizer and sunscreen, until study completion.
• Ability to read, understand and give consent for participation in the study.
• Agreement to adhere to the procedures and requirements of the study and to report to the site on the day(s) and at the time(s) scheduled for the assessments.

You may not qualify if…

• Subjects with a history of allergy or hypersensitivity to any ingredient of the treatment products.
• Previous tissue-augmenting therapy, contouring, or revitalization treatment in the face, except lips.
• Previous treatment/procedure in the face in the previous 6 months that, in the Investigator's opinion, would interfere with the study injections and/or study assessments or exposed the study subject to undue risk by study participation, or planning to undergo any of these procedures affecting the treatment area at any time during the study.
• Subjects with any medical condition that, in the opinion of the Investigator, would make the subject unsuitable for inclusion.

Where it is running

• Luxurgery — New York, New York, United States (enrolling)

Full record on ClinicalTrials.gov

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