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

December 3, 2025 updated by: Jessica Labadie, Skincare Physicians of Chestnut Hill

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

26

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Massachusetts
      • Chestnut Hill, Massachusetts, United States, 02467
        • Recruiting
        • Skincare Physicians
        • Contact:
        • Contact:
        • Principal Investigator:
          • Jessica G Labadie, MD
        • Sub-Investigator:
          • Michael Kaminer, MD
        • Sub-Investigator:
          • Jeffrey S Dover, MD, FRCPC

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Arm A
Topical PLLA applied to perioral region first and then a microneedling treatment performed.
Drug: Poly-L-Lactic Acid
Topical PLLA diluted with 8cc of sterile water
Other Names:
  • Sculptra
Device: Microneedling
Microneedling treatment of the perioral region
Other Names:
  • Eclipse Skin Pen with glide OR MD needle Pen
Experimental: Arm B
A microneedling treatment is first performed and then topical PLLA is applied.
Drug: Poly-L-Lactic Acid
Topical PLLA diluted with 8cc of sterile water
Other Names:
  • Sculptra
Device: Microneedling
Microneedling treatment of the perioral region
Other Names:
  • Eclipse Skin Pen with glide OR MD needle Pen

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Global Aesthetic Improvement Scale (GAIS)
Time Frame: 120 days
blinded in person GAIS scores
120 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Lemperle Wrinkle Scale
Time Frame: 120 days
three blinded raters, who will judge scores of pre- and post-treatment photographs using the Lemperle Wrinkle Scale
120 days
Lemperle Wrinkle Scale
Time Frame: 120 days
treating investigator reported score using the Lemperle Wrinkle Scale
120 days
Canfield VISIA measurements
Time Frame: 120 days
wrinkle severity scores as calculated by the computerized Canfield VISIA measurements
120 days
GAIS
Time Frame: 120 days
subject and treating investigator reported score using the GAIS
120 days

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of Treatment-Emergent Adverse Events
Time Frame: 120 days
the incidence and severity of systemic and cutaneous adverse events
120 days
Histologic endpoint
Time Frame: 120 days
PLLA particles visualized within MN channels on H&E with polariscopic examination
120 days
Molecular Endpoint
Time Frame: 120 days
Molecular testing (Gene Markers)
120 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Skincare Physicians of Chestnut Hill

Collaborators

Galderma R&D

Investigators

  • Principal Investigator: Jessica G Labadie, MD, Skincare Physicians

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 7, 2025

Primary Completion (Estimated)

June 1, 2026

Study Completion (Estimated)

October 1, 2026

Study Registration Dates

First Submitted

November 3, 2025

First Submitted That Met QC Criteria

November 4, 2025

First Posted (Estimated)

November 6, 2025

Study Record Updates

Last Update Posted (Actual)

December 5, 2025

Last Update Submitted That Met QC Criteria

December 3, 2025

Last Verified

December 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SkincarePCH

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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