This is a prospective, multi-center, pilot study evaluating effectiveness of micro-excisional skin remodeling by micro-coring skin in subjects meeting the Inclusion Criteria. Subjects will undergo bilateral treatment on the face and neck (upper and lower cheek, upper and lower lip, periocular and perioral areas, submandibular and middle neck, etc). The exact treatment area(s), choice of treatment density are left to the Investigator's discretion and subject's consent. Up to 3 treatments are allowed with a minimum of 30-day between the consecutive treatments.
The study will enroll up to 50 subjects at 6-8 investigational sites. It will evaluating effectiveness of a micro-coring device for micro-excisional skin remodeling in subjects with moderate to severe wrinkles of face and neck who meet the Inclusion/Exclusion Criteria. The choice of treatment density is at the investigator's discretion with the subject's consent. Up to 3 treatments may be performed with a minimum of 30-day interval between the consecutive treatments. Subjects will undergo bilateral micro-coring of skin on the face and upper neck, including but not limited to upper and lower cheek, upper and lower lip, periocular and perioral areas, submandibular and upper neck. The exact area(s) of treatment are left to the Investigator's discretion and subject's consent. The subjects will be evaluated at each visit and following data will be collected: * The incidence and severity of systemic and local adverse events. * Wrinkle severity score assessed using the Lemperle Wrinkle Severity Scale. * Changes in skin laxity assessed by Laxity Scale. * Canfield Image Analyses. * Needle and/or punch biopsy (in some subjects). * Overall aesthetic improvement using the following scales: * Subject and PI Global Aesthetic Improvement Scale (GAIS) * Subject Satisfaction Scale * Rhytides and Laxity Scale * Lower face assessment * Investigator evaluation of device usability and functionality. Data Analysis: Analyses will be conducted per measurement tools listed. Statistical analysis will include but will not be limited to T tests, univariate and multivariate analysis.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
50
Assess Safety and Efficacy for skin treatments through micro-excisional skin removal with micro-coring device
Laser and Skin Surgery Center of Northern California
Sacramento, California, United States
Miami Dermatology and Laser Institute
Miami, Florida, United States
Laser and Skin Surgery Center of New York
New York, New York, United States
The Practice of Brian S. Biesman, M.D
Nashville, Tennessee, United States
Dr A Jay Burns Cosmetic Surgery
Dallas, Texas, United States
Assess wrinkle reduction for moderate to severe wrinkles at 90 days post treatment based on the Lemperle Wrinkle Scale
Assess wrinkle reduction in wrinkle severity score from the baseline assessed by Independent Reviewer(s) using the Lemperle Wrinkle Severity Scale. No wrinkles = 0; Just perceptible wrinkles = 1; Shallow wrinkles = 2; Moderately deep wrinkles = 3; Deep wrinkles, well-defined edges = 4; Very deep wrinkles, redundant fold = 5
Time frame: 90-day post-treatment
Assess skin laxity Improvement at 90 days post treatment
Improvement in skin laxity score from the baseline assessed by Independent Reviewer using Laxity Scale and supplemented by the Canfield Image Analyses. Global Aesthetic Improvement Scale: 3 Very Much Improved; 2 Much Improved; 1 Improved; 0 No Change; - 1 Worse; - 2 Much Worse; -3 Very Much Worse.
Time frame: 90-day post-treatment
Assess skin for new collagenases
Histological changes in treated skin when compared to untreated skin consistent with new collagenases
Time frame: 60, 90, 180-day post treatment
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