RecruitingPhase 4NCT07225348

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


Sponsor

Skincare Physicians of Chestnut Hill

Enrollment

26 participants

Start Date

Nov 7, 2025

Study Type

INTERVENTIONAL

Conditions

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


Eligibility

Min Age: 40 YearsMax Age: 70 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a medical device called Microneedling and a drug called Poly-L-Lactic Acid for people with perioral wrinkles. The study is currently recruiting participants at 1 location.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGPoly-L-Lactic Acid

Topical PLLA diluted with 8cc of sterile water

DEVICEMicroneedling

Microneedling treatment of the perioral region


Locations(1)

SkinCare Physicians

Chestnut Hill, Massachusetts, United States

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NCT07225348


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