High energy, double pass helium plasma dermal resurfacing: A prospective, multicenter, single‐arm clinical study

Abstract

Background: A previous multi-center clinical study of low energy (20% power), single-pass helium plasma dermal resurfacing (HPDR) showed positive results but did not fully reveal the true potential of this novel technology. A second multi-center clinical study, reported herein, was therefore undertaken to evaluate efficacy and safety of high energy (40%), double pass HPDR for treatment of facial rhytids (ClinicalTrials.gov Identifier: NCT04185909). Methods: Fifty-five eligible subjects seeking improvement in facial rhytids were enrolled for study at one of four investigational sites. All subjects underwent fullface HPDR treatment. The forehead, nose, cheeks, and peri-oral treatment zones were treated at 40% power with two passes whereas the peri-orbital and jawline/ mandibular zones were treated at 20% power (up to 40% for jawline/mandibular zone) and one or two passes. Photographic images of the face were captured using the VISIA-CR system. Three-month posttreatment Fitzpatrick Wrinkle and Elastosis Scale (FWS) scores were compared to baseline scores as determined by blinded independent photographic reviewers (IPRs) and study investigators.Results: Blinded IPRs and study investigators observed a ≥1-point FWS improvement in 100% of subjects with mean change in IPR FWS from baseline to the 90-day visit of −3.6 (±1.2). 96.4% of subjects indicated "improvement" in appearance at the 90-day visit utilizing the modified Global Aesthetic Improvement Scale. Evaluation of VISIA-CR data revealed statistically significant improvements in wrinkles, brown spots, and pore counts. Overall, 269 Adverse Events in 55 subjects were reported; most were mild-moderate in severity (99.3%), anticipated (86.2%), and of relatively short duration with most having resolved within 30 days (60.6%) of treatment. Conclusion: Treatment of facial rhytids with high energy, double pass HPDR as detailed herein enables a marked improvement in FWS that parallels or surpasses competing technologies. VISIA-CR analysis demonstrates additional improvements in skin quality with statistically significant quantitative improvements in brown spots and enlarged pores as well as wrinkles. Effective rhytid effacement combines with high subject satisfaction and few unanticipated adverse events for a reasonable benefit-risk ratio.

Low‐intensity cold atmospheric plasma reduces wrinkles on photoaged skin through hormetic induction of extracellular matrix protein expression in dermal fibroblasts

“…This study evaluated the effects of LICAP on photoaginginduced wrinkles in an animal model and the expression profiles of extracellular matrix proteins in human dermal fibroblasts. LICAP was defined to distinguish the device from other conventional CAP devices that are designed to be used in a destructive manner, such as for skin resurfacing, [14][15][16] cancer therapy, 17 or tissue coagulation. 18 In this paper, the term LICAP indicates a physical plasma device that is designed to tune its plasma effluent intensity in a low range to enhance the tissue (or cell) regeneration without damaging its viability.…”

Skin Anti-Aging Efficacy of a Lactobacillus plantarum GT-17F Fermented Dendrobium officinale Ingredient: A Randomized, Double-Blind, Placebo-Controlled Clinical Study

“…Standard facial images were captured using the VISIA-CR 2.3 system equipped with Mirror Photo Tools image management software 7.5.6 (Canfield Scientific, Inc., Parsippany, NJ, USA) [28]. Images of the right side of the face were taken following a consistent protocol.…”

Helium Plasma Dermal Resurfacing With and Without Concurrent Aesthetic Surgery of the Face and Neck: A Retrospective Review

“… 14 A high-energy, double-pass multi-center study evaluating efficacy for wrinkle reduction and safety showed high patient satisfaction and marked improvement in Facial Wrinkle Scores (mean Independent Photographic Reviewer reduction of −3.6) along with mostly mild to moderate and mostly anticipated AEs that resolved in a reasonable time frame.15 Several hypertrophic scarring AEs were clustered at a single study site and were thought to be related to secondary wounding or to a variance in technique during energy delivery. 15 …”