NCT03228641

Evaluation of Safety and Efficacy of Micro-coring Device for Treatment of Facial Wrinkles and Skin Laxity

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 45 (actual)
• Sponsor: Cytrellis Biosystems, Inc. · Industry
• Sex: All
• Age: 40 Years – 75 Years
• Healthy volunteers: Accepted

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.

Conditions

• Wrinkle
• Facial and Neck Skin Laxity

Interventions

Type	Name	Description
DEVICE	micro-excisional skin removal with coring needle

Timeline

• Start date: 2016-06-01
• Primary completion: 2017-08-31
• Completion: 2017-08-31
• First posted: 2017-07-25
• Last updated: 2026-03-25

Locations

6 sites across 1 country: United States

Regulatory

• FDA-regulated device study