Recruiting NCT07399028

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

No phase Interventional Volume Deficiency in the Mid-Face Skin Laxity Photo-aged Skin

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied: The protocol lists: Sculptra®.
Who it may be relevant to: Registry conditions: Volume Deficiency in the Mid-Face, Skin Laxity, Photo-aged Skin. Basic parameters: 45 years — 65 years · Female.
What needs checking: Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place: United States
Next step: Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Official title

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

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

Device Sculptra®
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.

Structural change in midface post-treatment with a biostimulator compared to pre-treatment assessed by standardized VISIA imaging and optical biopsy imaging [Time frame: 4 weeks, 8 weeks, 12 weeks, 16 weeks, and 20 weeks after baseline]

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.

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

United States · 1 center

NCT: NCT07399028 · GLI.04.US.SL.050