Actively Recruiting
A 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
63 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
To assess protein expression stimulated by poly L-lactic acid (PLLA) via punch biopsy at each follow-up visits compared to Baseline.
CONDITIONS
Official 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...
- Diagnosed with symmetrical, moderate-to-severe cheek wrinkles on both sides using the Galderma Cheek Wrinkles Scale
- Intend to undergo correction of cheek augmentation or contour deficiencies
- Willing to have 3-mm punch biopsies on each pre-auricular side
- Willing to maintain current lifestyle, daily routine, and stable BMI (± 5 kg/m2) throughout the study
- Able to give consent for participation
- Agree to follow study procedures and attend scheduled assessments
You will not qualify if you...
- Asymmetrical severity or non-identical cheek wrinkle scores between the two cheeks
- History of allergy or hypersensitivity to any treatment product ingredients
- Prior tissue-augmenting, contouring, or revitalization treatments on the face except lips
- Face treatments or procedures in the past 6 months that might interfere with study injections or assessments
- Planning treatments affecting the study area during the study
- Any medical condition making participation unsuitable in the Investigator's opinion
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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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