💬In plain words
What the trial is, and whether it could suit you
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 micr
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📋 Eligibility rules (as published)
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
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