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
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
26
Topical PLLA diluted with 8cc of sterile water
Microneedling treatment of the perioral region
SkinCare Physicians
Chestnut Hill, Massachusetts, United States
RECRUITINGGlobal Aesthetic Improvement Scale (GAIS)
blinded in person GAIS scores
Time frame: 120 days
Lemperle Wrinkle Scale
three blinded raters, who will judge scores of pre- and post-treatment photographs using the Lemperle Wrinkle Scale
Time frame: 120 days
Lemperle Wrinkle Scale
treating investigator reported score using the Lemperle Wrinkle Scale
Time frame: 120 days
Canfield VISIA measurements
wrinkle severity scores as calculated by the computerized Canfield VISIA measurements
Time frame: 120 days
GAIS
subject and treating investigator reported score using the GAIS
Time frame: 120 days
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