Skin changes after biostimulator (Sculptra) treatment seen with non-invasive imaging
Official title: A Single-center, Open-label Study to Characterize Human Skin Changes From Biostimulator Treatments Via Non-invasive Imaging
Run by Galderma R&D · NCT07399028 · Data updated 2026-11-12
We will try Sculptra injections in women aged 45–65 with moderate-to-severe cheek wrinkles to see how their skin changes over three treatments using non-invasive imaging.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 45 Years to 65 Years |
| Sex | Women only |
| Enrollment | 25 (estimated) |
| Sponsor | Galderma R&D Industry-sponsored |
| Locations | 1 site (New York, New York) |
| Status | Recruiting |
| Started | October 21, 2025 |
| Main results expected | September 2026 |
| Study ends | September 2026 |
| Registry record updated | February 10, 2026 |
| Trial ID | NCT07399028 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Women aged 45–65 with moderate-to-severe cheek wrinkles who are willing to receive three Sculptra treatments, follow the provided skincare regimen, and attend imaging and photo visits are ideal candidates.
✕Probably not a fit
People with known allergy to any ingredient in Sculptra, men, those outside the 45–65 age range, or those unwilling to follow the skincare or visit schedule are unlikely to benefit from this protocol.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
Adult female participants with moderate-to-severe cheek wrinkles will receive Sculptra injections planned as three treatments, with standardized photographs and non-invasive imaging taken at each visit. Participants will stop their current facial skincare and use provided cleanser, moisturizer, and sunscreen for the study duration to reduce variability. Imaging and photo documentation will be used to characterize changes in skin volume, texture, and laxity over time. The single-site study is sponsored by Galderma R&D and conducted at a clinic in New York City.
Why it matters
Potential benefit: If successful, the approach could improve understanding of how Sculptra changes cheek volume and appearance and help guide better treatment planning.
How similar studies have gone: Previous studies have shown Sculptra can restore facial volume and reduce wrinkles, although using detailed non-invasive imaging to characterize these changes is relatively novel.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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. Exclusion Criteria: * 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's running
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Luxurgery
New York, New York, United States Recruiting
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.