Treatment of Perioral Wrinkles Using Topical Poly-L-lactic Acid and Microneedling Device
Eligible age
40–70 yrs
Accepts
All genders
Locations
1 state
Healthy volunteers
No
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About this study
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
Sponsor: Skincare Physicians of Chestnut Hill
You may qualify if…
- ✓ 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.
You may not qualify if…
- ✕ 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
Where it's recruiting
Chestnut Hill
Source: ClinicalTrials.gov · NCT07225348 · last updated 2025-12-05