A Prospective, Multi-center, Randomized Pilot Study for the Safety and Efficacy of a GEN II Micro-coring Device for the Treatment of Wrinkles and Skin Laxity in the Pre-auricular Area and Mid to Lower Face
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Wrinkle
- Sponsor
- Cytrellis Biosystems, Inc.
- Enrollment
- 33
- Locations
- 5
- Primary Endpoint
- improvement in wrinkle appearance
- Status
- Completed
- Last Updated
- 7 years ago
Overview
Brief 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).
Detailed Description
This is a prospective, multi-center, randomized, single blind, bilateral paired study evaluating the safety, tolerability and preliminary effectiveness of a micro-coring device for removal of excess skin using 2 needle gauges (22G, 24G,) at densities (percent of skin removed per 1cm2) of 2.5-10% in subjects with mid- and lower- face skin laxity manifested by moderate-to-severe mid and lower cheek wrinkles, deepening of the nasolabial folds at rest; prominence of marionette lines at rest; downturn of the oral commissures at rest, sagging of the skin at the jawline at rest. Subjects are blinded to needle gauge and density. There will be two cohorts of subjects: one group of subjects will receive a single treatment and the second - multiple treatments. All subjects will be followed for 180 days with several intermediate visits at 3, 7, 30, 60, and 90-days.
Investigators
Eligibility Criteria
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
Outcomes
Primary Outcomes
improvement in wrinkle appearance
Time Frame: 60 and 90 days
One grade or better improvement in score on Wrinkle Severity Scale
Secondary Outcomes
- improvement in skin laxity(up to 180 days)