Evaluation of Safety and Efficacy of Micro-coring Device for Treatment of Facial Wrinkles and Ski… (NCT03228641) | Clinical Trial Compass
CompletedNot Applicable
Evaluation of Safety and Efficacy of Micro-coring Device for Treatment of Facial Wrinkles and Skin Laxity
United States45 participantsStarted 2016-06-01
Plain-language summary
A pilot study is designed to evaluate safety and efficacy of the Micro-Coring (MC) technology for treatment of facial wrinkles. MC device employs hollow coring needles that enable safe, rapid, and effective full-thickness small skin cores (200-500 microns in diameter) removal initiating a skin repair process through formation of new collagen and elastin fibers (skin rejuvenation).
Who can participate
Age range40 Years – 75 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Fitzpatrick Skin Type 1, 2, or 3 as assessed by Investigator
* One or more of the following conditions assessed by Investigator using provided Severity Scales:
* Nasolabial fold severity at rest ≥2 and ≤4;
* Marionette line prominence at rest ≥2 and ≤4;
* Oral commissure drooping at rest ≥2 and ≤4;
* Jawline sagging at rest ≥2 and ≤4 .
* Moderate-to-Severe wrinkles at rest at least in one of the following areas - the upper lip, chin and cheeks.
Exclusion Criteria:
* Lesions suspicious for any malignancy or the presence of actinic keratosis, melasma, vitiligo, cutaneous papules/nodules or active inflammatory lesions in the areas to be treated
* History of keloid formation or hypertrophic scarring
* History of trauma or surgery to the treatment areas in the past 6 months
* Scar present in the areas to be treated
* Silicone or synthetic material injections in the areas to be treated
* Injection of FDA-approved dermal fillers in the past two years
* Injection of fat in the past year
* History of treatment with dermabrasion, ablative laser, or radiofrequency in the past year
* History of treatment with non-ablative laser in the past 6 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 to treatment
* Active, chronic, or recurrent infection
* History of compromised immune system or currently being treated with immuno…