Clinical Trial

Treatment of Perioral Wrinkles Using Topical Poly-L-lactic Acid and Microneedling Device

Recruiting Phase 4
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Record status
This record was last updated December 5, 2025 (before its estimated June 1, 2026 completion). Its status may not reflect the trial's current state.
Summary
The first goal of this clinical trial is to learn if topical application of PLLA in conjunction with a microneedling treatment works to treat perioral wrinkles in adults. The second goal is to see whether the application of topical PLLA is more effective before or after a microneedling treatment. The main questions it aims to answer are: * Is PLLA present within the MN channels from in vivo biopsy samples? * Is it safe to combine topical PLLA and MN in the treatment of perioral wrinkles, as determined by the incidence and severity of adverse events in healthy subjects? * Does overall aesthetic and skin texture improve in combining microneedling with topical PLLA in the treatment of mild to moderate perioral wrinkles? * Is it the treatment of topical PLLA more effective when applied before or after a microneedling treatment. Researchers will compare the application of PLLA before a microneedling treatment to a microneedling treatment with PLLA application after to see which treatment method is more effective. Participants will: \- receive 2 treatments spaced 4-6 weeks apart of topical PLLA and microneedling
Protocol Amendment History 1 amendment
This ClinicalTrials.gov record has been amended once since 2025-11-04.
Status change: Not Yet Recruiting → Recruiting 2025-12-03
Trial Details
NCT Number NCT07225348
Lead Sponsor Skincare Physicians of Chestnut Hill
Collaborators: Galderma R&D
Conditions Perioral Wrinkles
Enrollment 26 participants
Start Date 2025-11-07
Primary Completion 2026-06-01 (estimated)
Study Completion 2026-10-01 (estimated)
Updated on ClinicalTrials.gov 2025-12-05