Actively Recruiting
A Single-center, Open-label Study to Characterize Human Skin Changes From Biostimulator Treatments Via Non-invasive Imaging
Led by Galderma R&D · Updated on 2026-02-10
25
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating skin changes in adult women with moderate-to-severe cheek wrinkles using non-invasive imaging methods. The goal is to study the effects of treatments aimed at improving volume deficiency, skin laxity, and photo-aged skin in the mid-face area. This is an open-label, single-center study sponsored by Galderma R&D involving women aged 45 to 65 years. Participants will receive three treatments of Sculptra injections into the cheeks, spaced four weeks apart. Each treatment involves subdermal injections using a 25 G needle, with up to 18 mL total per session. The injections target the subcutaneous and supraperiosteal regions evenly across both cheeks. The study focuses on monitoring structural skin changes following these biostimulator treatments. During the study, participants will undergo standardized VISIA imaging and optical biopsy imaging at multiple time points: 4, 8, 12, 16, and 20 weeks after baseline. Researchers will assess changes in the midface structure compared to before treatment. Participants must adhere to a skincare regimen provided by the study and allow photographs at each visit. Safety and response will be monitored throughout the study period, which runs until September 2026.
CONDITIONS
Brief Title
A Study to Characterize Human Skin Changes From Biostimulator Treatments Via Non-invasive Imaging
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adult females aged 45 to 65 years
- Moderate-to-severe cheek wrinkles on the GCWS
- Intent to correct cheek wrinkles on both sides of the face
- Investigator agrees that 3 treatments are needed for optimal results
- Willingness to be photographed at each visit
- Willingness to stop current facial skincare products during the study
- Willingness to use provided facial skincare products including cleanser, moisturizer, and sunscreen
- Ability to understand and consent to study participation
- Agreement to follow study procedures and attend scheduled assessments
You will not qualify if you...
- History of allergy or hypersensitivity to any ingredient of the treatment products
- Previous facial tissue-augmenting, contouring, or revitalization treatments except lips
- Facial treatments or procedures within 6 months that could interfere with study injections or assessments
- Planning any facial procedures affecting the treatment area during the study
- Any medical condition making participation unsuitable as judged by the Investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 12 weeks
Participants receive 3 Sculptra treatments to the cheeks to correct fine lines and wrinkles, with treatments spaced four weeks apart.
3 treatment visits spaced 4 weeks apart
Duration - 8 weeks
Participants are monitored for structural changes in the midface using non-invasive imaging over time after treatment.
5 imaging assessment visits at 4, 8, 12, 16, and 20 weeks after baseline
Trial Site Locations
Total: 1 location
1
Luxurgery
New York, New York, United States, 10021
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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