This is a multi-center, single arm, evaluator-blind prospective study of up to 55 study subjects who are seeking a procedure to reduce the appearance of wrinkles and rhytides.
This is a multi-center, single arm, evaluator-blind prospective study of up to 55 study subjects who are seeking a procedure to reduce the appearance of wrinkles and rhytides. All study subjects will be treated with the Renuvion Dermal System. The study population will consist of males and females, 30 years of age or older, requesting a procedure for the purpose of improving facial appearance by reducing facial wrinkles and rhytides. Those subjects who meet eligibility criteria and agree to provide written informed consent will be invited to participate.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
55
The Renuvion® Dermal System consists of an electrosurgical generator unit, a handpiece with detachable standoffs, and a supply of helium gas. Radio Frequency (RF) energy is delivered to the handpiece by the electrosurgical generator unit and used to energize an electrode. When helium gas is passed over the energized electrode, a helium plasma is generated which allows for conduction of the RF energy from the electrode to the subject in the form of a precise helium plasma beam.
Michael Lin, MD
Sherman Oaks, California, United States
Contemporary Plastic Surgery
Jacksonville, Florida, United States
Holcomb-Kreithen Plastic Surgery and MedSpa, PLLC
Sarasota, Florida, United States
Aesthetic Revolution Las Vegas
Las Vegas, Nevada, United States
Independent Photo Reviewer Fitzpatrick Wrinkle and Elastosis Scale (FWS)
The FWS is a clinically validated assessment tool used to assess skin wrinkle severity and elastosis on a scale from 1 through 9, where the lower the value, the better the outcome. Three Independent Photographic Reviewers were blinded to the study subject's visit (Day 90 follow-up visit) and performed photographic assessments of each subject's wrinkle depth in the treated zones.
Time frame: 90-day
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