Actively Recruiting
A Multi-center, Prospective Clinical Study to Assess Histological Changes From Treatment of Poly L-lactic Acid Biostimulator on Women at Various Menopausal Stages
Led by Galderma R&D · Updated on 2026-01-15
40
Participants Needed
2
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the effects of Poly L-lactic Acid (PLLA) biostimulator treatment on women at various menopausal stages who have moderate-to-severe cheek wrinkles. This randomized, prospective study aims to assess changes in protein expression in the skin after treatment, using punch biopsies taken at several follow-up visits compared to baseline. The study is sponsored by Galderma R&D and involves about 40 participants across two sites. Participants will receive Sculptra ae, a biostimulator device, applied to both cheeks in up to three treatments spaced four weeks apart. Initially, a punch biopsy is taken on one pre-auricular cheek side at baseline. After the first and second treatments, participants may receive a third optional treatment at week 8. At 12 weeks after the last Sculptra treatment, half of the subjects will have a second punch biopsy on the opposite cheek side, with the rest receiving this biopsy at 36 weeks post-treatment. Follow-up visits occur at 24 weeks after the final treatment. During the study, participants will be monitored through physical assessments, biopsy procedures, and self-assessment questionnaires measuring satisfaction at 12, 24, and 36 weeks after treatment. Researchers will analyze protein expression changes and track participant experiences. The study includes safety and adherence monitoring throughout the treatment and follow-up period, lasting up to 36 weeks after the last Sculptra treatment.
CONDITIONS
Brief Title
A Clinical Study to Assess Histological Changes From Treatment of Poly L-lactic Acid Biostimulator on Women at Various Menopausal Stages
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Subjects diagnosed with symmetrical, moderate-to-severe cheek wrinkles on each side of the face as assessed via the Galderma Cheek Wrinkles Scale.
- Subject with intent to undergo correction of cheek augmentation or contour deficiencies
- Subjects willing to have a 3-mm punch biopsy on each preauricular side
- Subjects willing to maintain the current lifestyle, daily routine (e.g., diet, exercise, sleep, etc.), and a stable Body Mass Index (BMI, �b1 5 kg/m2) throughout the study
- Ability of giving consent for participation in the study.
- Agreement to adhere to the procedures and requirements of the study and to report to the institute on the day(s) and at the time(s) scheduled for the assessments.
You will not qualify if you...
- Subjects with asymmetrical severity or unidentical cheek wrinkle score between 2 sides of the cheek.
- 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.
AI-Screening
AI-Powered Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 8 weeks
Participants receive up to three Sculptra treatments on both cheeks spaced 4 weeks apart, starting with a punch biopsy on one pre-auricular side at the baseline visit.
1 baseline visit and 2 to 3 treatment visits (in-person)
Duration - 36 weeks
Participants undergo punch biopsies and follow-up visits at 12, 24, and 36 weeks after the last Sculptra treatment to assess histological changes and satisfaction.
3 visits for biopsies occurring at 12, 24, and 36 weeks plus 1 follow-up visit at 24 weeks (in-person)
Trial Site Locations
Total: 2 locations
1
Miami Dermatology & Laser Institute
Miami, Florida, United States, 33133
Actively Recruiting
2
Day Dermatology & Aesthetics
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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