Recruiting

PLLA & Microneedling

Sponsor:

Skincare Physicians of Chestnut Hill

Code:

NCT07225348

Conditions

Perioral Wrinkles

Eligibility Criteria

Sex: All

Age: 40 - 70

Healthy Volunteers: Not accepted

Interventions

Poly-L-Lactic Acid

Microneedling

Study Details

Brief 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

Study ID

NCT07225348

Start date

Nov 7, 2025

Status verified date

Dec, 2025

Completion date

Oct 1, 2026

Anticipated

Primary completion date

Jun 1, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 40 - 70

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Males and non-pregnant, non-lactating females 40-70 years of age
  • Fitzpatrick Skin Type I-IV
  • Wrinkle severity graded by the investigator (1-3 on Lemperle scale)
  • Able to provide written informed consent, understand and be willing to comply with all study related procedures and follow-up visits
  • Signed informed consent obtained before any study-specific procedure is performed.

Exclusion Criteria:

  • Lesions suspicious for any malignancy, actinic keratosis, melasma, vitiligo, cutaneous papules/nodules or active inflammatory lesions in the area to be treated
  • Tenderness in the treatment rea
  • History of keloid formation or hypertrophic scarring
  • History of trauma or surgery to the treatment area
  • Scar present in the areas to be treated
  • Silicone or synthetic material injections in the areas to be treated
  • Injection of fat, collagen, hyaluronic acid or other dermal fillers in the areas to be treated within the previous 12 months
  • History of treatment with dermabrasion or laser in the areas to be treated within the previous 12 months
  • History of treatment with botulinum toxin injections in the areas to be treated within the prior 6 months
  • Active smokers (0.5 pack/day) or having quit within 3 months prior treatment
  • Active, chronic, or recurrent infection
  • History of compromised immune system or currently being treated with immunosuppressive agents
  • History of sensitivity to analgesic agents, Aquaphor, topical or local anesthetics
  • Excessive sun exposure and use of tanning beds or tanning creams within 30 days prior to treatment
  • Treatment with fish oil within 14 days prior to treatment
  • Treatment with aspirin or other blood thinning agents within 14 days prior to treatment
  • History or presence of any clinically significant bleeding disorder
  • Co-morbid condition that in the Investigator's opinion could limit ability to participate in the study or to comply with follow-up requirements
  • History of drug and/or alcohol abuse
  • Any issue that, at the discretion of the investigator, would interfere with assessment of safety or efficacy or compromise the subject's ability to safely undergo study procedures or give informed consent
  • Treatment with an investigational device or agent within 30 days before treatment or during the study period

Study Design

Enrollment

26 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

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.

Interventions

Poly-L-Lactic Acid

Topical PLLA diluted with 8cc of sterile water

Microneedling

Microneedling treatment of the perioral region

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Jessica G Labadie, MD

6176936125jlabadie@skincarephysicians.net

Joaninha Barbosa, BS

6177311600jdepina@skincarephysicians.net

Locations

SkinCare Physicians

Recruiting

Chestnut Hill, Massachusetts, United States, 02467

Contacts

Joaninha Barbosa, BS

6177311600jdepina@skincarephysicians.net

Jessica G Labadie, MD

6176936125jlabadie@skincarephysicians.net

Principal Investigator:

Jessica G Labadie, MD

More Information

Sponsor

Skincare Physicians of Chestnut Hill

Last update posted

Dec 5, 2025

Last verified

Dec, 2025

Keywords

  • perioral wrinkles
  • microneedling
  • poly-L-lactic acid

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Skincare Physicians of Chestnut Hill on 2025-12-05.