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
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
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
Parallel
Poly-L-Lactic Acid
DrugTopical PLLA diluted with 8cc of sterile water
Microneedling
DeviceMicroneedling treatment of the perioral region
Global Aesthetic Improvement Scale (GAIS)
blinded in person GAIS scores
Lemperle Wrinkle Scale
three blinded raters, who will judge scores of pre- and post-treatment photographs using the Lemperle Wrinkle Scale
Lemperle Wrinkle Scale
treating investigator reported score using the Lemperle Wrinkle Scale
Canfield VISIA measurements
wrinkle severity scores as calculated by the computerized Canfield VISIA measurements
GAIS
subject and treating investigator reported score using the GAIS
Incidence of Treatment-Emergent Adverse Events
the incidence and severity of systemic and cutaneous adverse events
Histologic endpoint
PLLA particles visualized within MN channels on H\&E with polariscopic examination
Molecular Endpoint
Molecular testing (Gene Markers)
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Skincare Physicians of Chestnut Hill
Lead sponsor
Galderma R&D
Collaborator
