Background and Objectives: A novel helium plasma device was evaluated for efficacy and safety for dermal resurfacing (ClinicalTrials.gov Identifier: NCT03286283). The helium plasma device delivers energy in a controlled, bimodal fashion that when compared with the nitrogen plasma predicate device in a porcine animal model demonstrated a more limited depth of thermal effect but a greater skin tissue contraction. Study Design/Materials and Methods: Fifty-five eligible subjects seeking improvement in facial rhytids were enrolled for study at one of three investigational sites. Most subjects underwent full-face treatment. Power levels were limited to 20% at peri-oral and peri-orbital areas-a level that correlates to an energy density 40% lower than the highest setting on the predicate device. Three-month posttreatment Fitzpatrick Wrinkle and Elastosis Scale (FWS) scores were compared with baseline scores as determined by blinded independent photographic reviewers (IPRs) and study investigators. Results: Blinded IPRs observed a ≥1-point FWS improvement in 63.64% of subjects whereas study investigators noted a ≥1-point FWS improvement in 54 of 55 subjects (98.18%) of subjects. 90.9% of subjects indicated "improvement" in appearance utilizing the modified Global Aesthetic Improvement Scale. Subgroup analysis showed 1-point (±0.05) FWS improvement by IPRs and study investigators for Fitzpatrick Skin Types II and III, age≥62, two of three study sites, and post-treatment oral steroid use. Eighty Non-Serious Adverse Events in 39 subjects were reported, most of which resolved within 14 days or less. There were no Serious Adverse Events or Unanticipated Device Effects reported. Conclusion: At the modest power level studied, a significant improvement from a single pass helium plasma dermal resurfacing treatment was observable in most subjects by IPRs and investigators, and no serious adverse events were reported. The discrepancy between IPR and study investigator FWS improvement may be explained in part by the limitations of assessing two-dimensional photographs versus live in-person evaluation of subjects. Studies evaluating higher energy levels and/or multiple treatment passes are ongoing. Lasers Surg. Med.

Introduction: Nine experienced physician users of a novel helium plasma dermal resurfacing device for heating the skin at a controlled depth to achieve collagen coagulation, tissue contraction, and neocollagenesis convened to discuss their experiences and keys to success with their off-label use of this device with collectively more than 800 cases performed for facial skin renewal procedures. Methods: A round table discussion format was used to address a variety of topics including pretreatment considerations, optimum treatment parameters, posttreatment healing regimen, and avoidance and management of side effects and complications. All panelists consented to data collection, analysis, compilation, and publication. Results: Ideal candidates for the procedure were identified along with optimum treatment parameters and posttreatment care. Strategies for avoidance and management of complications and side effects were discussed. Conclusions: Consensus guidelines were developed for patient selection, pretreatment considerations, treatment parameters, posttreatment healing regimen, and avoidance and management of complications and side effects.

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