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).
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
33
Laser & Skin Center of Northern CA
Sacramento, California, United States
SkinCare Physicians
Chestnut Hill, Massachusetts, United States
Laser & Skin Surgery Center of NY
New York, New York, United States
Nashville Center for Laser & Facial Surgery
Nashville, Tennessee, United States
improvement in wrinkle appearance
One grade or better improvement in score on Wrinkle Severity Scale
Time frame: 60 and 90 days
improvement in skin laxity
One grade or better improvement in score on Laxity Scale
Time frame: up to 180 days
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Dr A Jay Burns Cosmetic Surgery
Dallas, Texas, United States