NCT07225348

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

• Status: Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 26 (estimated)
• Sponsor: Skincare Physicians of Chestnut Hill · Academic / Other
• Sex: All
• Age: 40 Years – 70 Years
• Healthy volunteers: Not accepted

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

Conditions

• Perioral Wrinkles

Interventions

Type	Name	Description
DRUG	Poly-L-Lactic Acid	Topical PLLA diluted with 8cc of sterile water
DEVICE	Microneedling	Microneedling treatment of the perioral region

Timeline

• Start date: 2025-11-07
• Primary completion: 2026-06-01
• Completion: 2026-10-01
• First posted: 2025-11-06
• Last updated: 2025-12-05

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study