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

Conditions

• Perioral Wrinkles

Eligibility Criteria

Sex

ALL

Age

40 Years - 70 Years

Healthy Volunteers

Not accepted

Interventions

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

Study Details

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

Key Dates

Start date

Nov 7, 2025

Status verified

Dec 2025

Primary completion

Jun 1, 2026

Completion

Oct 1, 2026

Study Design

Enrollment

26 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Arm A
  Topical PLLA applied to perioral region first and then a microneedling treatment performed.
• Experimental: Arm B
  A microneedling treatment is first performed and then topical PLLA is applied.

Primary Outcome Measure

Global Aesthetic Improvement Scale (GAIS) [ Time Frame: 120 days ]

Central Contacts

• Jessica G Labadie, MD
  6176936125
  [email protected]
• Joaninha Barbosa, BS
  6177311600
  [email protected]

Locations (1)

Find similar trials in Chestnut Hill, MA