NCT07225348 Treatment of Perioral Wrinkles Using Topical Poly-L-lactic Acid and Microneedling Device
| NCT ID | NCT07225348 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Skincare Physicians of Chestnut Hill |
| Condition | Perioral Wrinkles |
| Study Type | INTERVENTIONAL |
| Enrollment | 26 participants |
| Start Date | 2025-11-07 |
| Primary Completion | 2026-06-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 26 participants in total. It began in 2025-11-07 with a primary completion date of 2026-06-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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
Eligibility 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
Contact & Investigator
Jessica G Labadie, MD
PRINCIPAL INVESTIGATOR
SkinCare Physicians
Frequently Asked Questions
Who can join the NCT07225348 clinical trial?
This trial is open to participants of all sexes, aged 40 Years or older, up to 70 Years, studying Perioral Wrinkles. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07225348 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT07225348 currently recruiting?
Yes, NCT07225348 is actively recruiting participants. Contact the research team at jlabadie@skincarephysicians.net for enrollment information.
Where is the NCT07225348 trial being conducted?
This trial is being conducted at Chestnut Hill, United States.
Who is sponsoring the NCT07225348 clinical trial?
NCT07225348 is sponsored by Skincare Physicians of Chestnut Hill. The principal investigator is Jessica G Labadie, MD at SkinCare Physicians. The trial plans to enroll 26 participants.