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

NCT07225348 · Status: RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 26

Last updated 2025-12-05

No results posted yet for this study

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

DRUG

Poly-L-Lactic Acid

Topical PLLA diluted with 8cc of sterile water

DEVICE

Microneedling

Microneedling treatment of the perioral region

Sponsors & Collaborators

  • Galderma R&D

    collaborator INDUSTRY

  • Skincare Physicians of Chestnut Hill

    lead OTHER

Principal Investigators

  • Jessica G Labadie, MD · SkinCare Physicians

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
40 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-11-07
Primary Completion
2026-06-01
Completion
2026-10-01
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07225348 on ClinicalTrials.gov