Ed Zimmerman, MD
Aesthetic Revolution Las Vegas, NV
Edward M. Zimmerman, MD, has degrees from Johns Hopkins, Georgetown, and the George Washington University School of Medicine. He is a Diplomate of the American Board of Family Practice and the American Board of Laser Surgery. Zimmerman is a Fellow of the American Society of Laser Surgery and Medicine since 1994; and a member of the American Academies of Cosmetic Surgery since 1998. Dr. Z serves as President and an Examiner for the American Board of Laser Surgery. He has served on the Board of Trustees of both the California and American Academies of Cosmetic Surgery. He is Treasurer and serves on the Board of Trustees of the Cosmetic Surgery Foundation. Dr. Z is an Adjunct Clinical Professor of Cosmetic Surgery at Touro University School of Osteopathic Medicine. He directs Aesthetic Revolution Las Vegas, a State Licensed, Nationally Accredited facility dedicated to the refinement and delivery of surgical and non-surgical aesthetic procedures.
Purpose: To demonstrate the safety and effectiveness of a Helium-Plasma Dermal System for use in dermal skin resurfacing.
Design: A prospective, multi-center, evaluator-blinded study of 55 subjects who received a procedure for the purpose of improving facial appearance by reducing facial wrinkles and rhytides. The study was conducted at four investigational centers in the United States. All study subjects were treated with a Helium-Plasma Dermal System. Each study subject received one procedure. Follow-up was at 1 day, at 6 (+2) days, at 10 (-1/+4) days, 30 (+7) days, 90 (+10) days, and 180 (+14) post-procedure.
Primary Effectiveness Endpoint was the proportion of subjects with at least one-point improvement from baseline in the Fitzpatrick Wrinkle and Elastosis Scale (FWS) at 90 days as determined by 2 out of 3 blinded Independent Photographic Reviewers. Additional Endpoints included: (1) Whether or not (yes/no) at least 2 out of 3 blinded Independent Photographic Reviewers (IPRs) correctly identify the 90-day image of a subject from the pair of Baseline and 90-day images. (2) Magnitude of improvement measured by the mean change in FWS from baseline to 90-day visit as determined by Investigators. (3) Subject modified Global Aesthetic Improvement Scale (GAIS) at 90-day visit. (4) Investigator modified GAIS at 90-day visit. (5) Subject satisfaction with procedure recorded at the 90-day visit.
Primary Safety Endpoint was the evaluation of adverse events up to the 90-day visit after treatment.
Findings: Primary endpoint met; 100% of subjects had at least one-point improvement; IPR Average Improvement in FWS was 3.6 points. Additional Endpoints: (1) 100% of subjects had correct identification of 90-day image by IPRs. (2) Investigator Average Improvement in FWS was 4.4 points at D90 and 4.4 points at D180. (3) 96.4% of subjects self-rated as Improved, Much Improved, or Very Much Improved at D90 and 98.1% of subjects also self-rated levels of improvement at D180. (4) 100% of investigators rated subjects as Improved, Much Improved, or Very Much Improved at D90 and 98.1% of investigators rated levels of improvement at D180. (5) Subject satisfaction at D90 was 96.4% were happy with the results of the procedure, 94.5% noted skin texture improvement and skin looks tighter, 92.7% noted fine lines and wrinkles improvement and skin feels tighter, and 90.9% noted skin seems more youthful.
Safety endpoint: Expected treatment effects that occurred in all subjects were erythema, crusting, and swelling. 54.55% of subjects experienced pain, 29.09% milia, 25.45% itching, 14.55% hypertrophic scarring, 10.91% post-inflammatory hyperpigmentation and telangiectasias, 5.45% temporary discoloration/hypopigmentation. Other adverse events were experienced in 3.64% or less.
Summary: This study demonstrated success for all effectiveness endpoints. Other than facelifts, phenol peels, dermabrasion and fully ablative laser resurfacing procedures, there are few treatment options for both physicians and patients to achieve the level of wrinkle improvement demonstrated in this study. The primary safety data from this study provides evidence of an acceptable risk profile for the Renuvion Dermal System for dermal resurfacing procedures. There were no serious adverse events reported in the study that were related to the study device or the study procedure.
Take Home Message
Helium Plasma is an efficacious and safe modality for facial skin resurfacing and rejuvenation of Fitzpatrick 1-3 skin types.