PLLA (Sculptra) effects on cheek skin across menopausal stages
A Multi-center, Prospective Clinical Study to Assess Histological Changes From Treatment of Poly L-lactic Acid Biostimulator on Women at Various Menopausal Stages
This study will test whether PLLA (Sculptra) injections change skin protein levels and improve cheek wrinkles in menopausal women.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 22 Years and up |
| Sex | Female |
| Sponsor | Galderma R&D Industry-sponsored |
| Locations | 2 sites (Miami, Florida and 1 other locations) |
| Trial ID | NCT07342400 on ClinicalTrials.gov |
What this trial studies
This randomized, prospective trial will enroll about 40 women with symmetrical moderate-to-severe cheek wrinkles at two U.S. dermatology sites. Participants receive a baseline 3-mm punch biopsy on one preauricular side, then Sculptra injections to both cheeks at baseline and week 4 with an optional third treatment at week 8. According to randomization, the opposite-side biopsy is taken either 12 or 36 weeks after the last Sculptra treatment, and protein expression will be compared to baseline. The study links histological changes to treatment timing and menopausal stage while tracking clinical appearance and safety.
Who should consider this trial
Good fit: Ideal candidates are menopausal women with symmetrical moderate-to-severe cheek wrinkles who are willing to have small punch biopsies, receive Sculptra injections, and attend scheduled follow-up visits.
Not a fit: Patients with asymmetrical cheek severity, known allergy to the product, prior tissue-augmenting therapy, or unwillingness to undergo biopsies or follow-up visits are unlikely to receive benefit from this protocol.
Why it matters
Potential benefit: If successful, the results could clarify how PLLA stimulates skin proteins and help optimize timing or patient selection to improve cheek appearance.
How similar studies have performed: Previous clinical and histologic work with PLLA has demonstrated collagen and tissue stimulation and cosmetic improvement, although randomized biopsy-based timing comparisons are limited.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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, ± 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. Exclusion Criteria: * 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.
Where this trial is running
Miami, Florida and 1 other locations
- Miami Dermatology & Laser Institute — Miami, Florida, United States (Recruiting)
- Day Dermatology & Aesthetics — New York, New York, United States (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.