Topical poly-L-lactic acid with microneedling for perioral wrinkles
Official title: Treatment of Perioral Wrinkles Using Topical Poly-L-lactic Acid and Microneedling Device
Run by Skincare Physicians of Chestnut Hill · NCT07225348 · Data updated 2026-11-12
This trial will test whether applying topical poly-L-lactic acid with microneedling helps reduce perioral wrinkles in adults aged 40–70.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Ages | 40 Years to 70 Years |
| Sex | All |
| Enrollment | 26 (estimated) |
| Sponsor | Skincare Physicians of Chestnut Hill Academic / other |
| Locations | 1 site (Chestnut Hill, Massachusetts) |
| Status | Recruiting |
| Started | November 7, 2025 |
| Main results expected | June 1, 2026 |
| Study ends | October 1, 2026 |
| Registry record updated | December 5, 2025 |
| Trial ID | NCT07225348 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are healthy adults 40–70 years old with mild to moderate perioral wrinkles (Lemperle grade 1–3), Fitzpatrick skin types I–IV, who are not pregnant or lactating and can attend in-person visits.
✕Probably not a fit
Patients with severe wrinkles, scars, recent dermal fillers or synthetic implants in the treatment area, a history of keloid formation, active skin disease at the site, or who are pregnant or breastfeeding are unlikely to benefit or be eligible.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This Phase 4 trial compares topical poly-L-lactic acid (PLLA) applied before versus after microneedling to treat mild-to-moderate perioral wrinkles. Participants (ages 40–70, Fitzpatrick I–IV) will receive microneedling combined with topical PLLA and undergo clinical assessments, skin texture evaluations, and in vivo biopsies to detect PLLA in microneedling channels. Safety will be tracked by recording the incidence and severity of adverse events, and aesthetic outcomes will be compared between application sequences to see which timing is more effective.
Why it matters
Potential benefit: If successful, the approach could improve perioral wrinkle appearance and skin texture using a minimally invasive topical adjunct to microneedling.
How similar studies have gone: Microneedling and injectable PLLA have prior evidence for improving skin texture and volume, but topical PLLA combined with microneedling is relatively novel and not well-established.
Who can join: the full rules
Show full inclusion / exclusion criteria
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
Where it's running
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SkinCare Physicians
Chestnut Hill, Massachusetts, United States Recruiting
Study contacts
- Principal investigator: Jessica G Labadie, MD — SkinCare Physicians
- Study coordinator: Jessica G Labadie, MD
- Email: jlabadie@skincarephysicians.net
- Phone: 6176936125
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.