Finding studies
Finding studies
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Lead
Cytrellis Biosystems, Inc.
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.
Age
40–75
Sex
ALL
Healthy volunteers
Accepted
