A Multi-center, Prospective Clinical Study to Assess Histological Changes From Treatment of Poly L-lactic Acid Biostimulator on Women at Various Menopausal Stages
Galderma R&D
Summary
To assess protein expression stimulated by poly L-lactic acid (PLLA) via punch biopsy at each follow-up visits compared to Baseline.
Description
This is a randomized, prospective study. This study will enroll approximately 40 subjects across two sites. All subjects have moderate-to-severe cheek wrinkles on both cheeks. Eligible subjects will first receive punch biopsy on one pre-auricular side according to a pre-determined randomization, followed by a first Sculptra treatment on both cheeks starting at the pre-auricular areas first at Baseline visit. Subjects will receive second Sculptra treatment at Week 4, and an optional third treatment at Week 8. At 12 weeks since last Sculptra treatment, half of the subjects will receive a second…
Eligibility
- Age range
- 22+ years
- Sex
- Female
- Healthy volunteers
- No
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 proced…
Interventions
- DeviceSculptra®
Biostimulator
Locations (2)
- Miami Dermatology & Laser InstituteMiami, Florida
- Day Dermatology & AestheticsNew York, New York