RecruitingPhase 4

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

United States26 participantsStarted 2025-11-07

Plain-language 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

Who can participate

Age range

40 Years – 70 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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 * Excessiv…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Global Aesthetic Improvement Scale (GAIS)

Timeframe: 120 days

Trial details

NCT IDNCT07225348

SponsorSkincare Physicians of Chestnut Hill

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-06-01

Contact for this trial

Jessica G Labadie, MD

6176936125 jlabadie@skincarephysicians.net

View on ClinicalTrials.gov More Perioral Wrinkles trials