NCT03583918

Efficacy of Micro-excisional Skin Removal by Micro-coring Device in Treatment of Wrinkles and Laxity of Face and Neck

A Prospective, Multi-center, Pilot Study to Evaluate the Efficacy of Micro-Excisional Skin Remodeling With Micro-Coring Device in the Treatment of Wrinkles and Skin Laxity of Face and Neck

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 50 (actual)
• Sponsor: Cytrellis Biosystems, Inc. · Industry
• Sex: All
• Age: 40 Years – 75 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

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.

Conditions

• Laxity; Skin

Interventions

Type	Name	Description
DEVICE	HighThroughput Micro Coring Device	Assess Safety and Efficacy for skin treatments through micro-excisional skin removal with micro-coring device

Timeline

• Start date: 2017-06-01
• Primary completion: 2018-06-13
• Completion: 2018-06-13
• First posted: 2018-07-12
• Last updated: 2018-07-12

Locations

5 sites across 1 country: United States

Regulatory

• FDA-regulated device study