A Prospective Study Evaluating the Use of Helium Plasma for Dermal Resurfacing

Abstract

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.

Helium plasma dermal resurfacing: Consensus guidelines

“…Three helium PDR treatment paradigms are possible: single pass, multipass, and a mixture of single and multipass. Single‐pass treatment is similar to that of the predicate nitrogen PSR technology, where the desiccated outer layers of skin should be left in place during healing 6 . As the “old” treated skin desquamates the newly regenerated pink, “new” skin becomes apparent.…”

“…Depth of treatment will be affected by skin impedance and thickness, power, treatment speed, pulsing, and a number of passes. While the number of days required for complete re‐epithelialization may take longer with deeper treatments, single‐pass treatment at a lower power level (eg, 20%) should be achieved within 10 days after treatment 6 . Although pretreatments with either topical tretinoin 0.1% cream 26 or tripeptide/hexapeptide 19 are thought to be beneficial for expediting re‐epithelialization after full‐field ablative laser and ablative fractional CO 2 laser resurfacing, it is not yet clear whether these pretreatment skin preconditioning regimes have similar effects after helium PDR.…”

“…The multicenter study evaluated low energy (20% power, continuous helium gas flow at 4 L/min) single‐pass treatment with the majority of subjects undergoing full‐face treatment. Study results were very positive with most subjects achieving a Facial Wrinkle Scale score improvement of ≥1 at the 3‐month primary endpoint (98% per study investigators vs 64% per blinded independent photographic reviewers), 91% of subjects reporting at least “improved” self‐perception of improvement (modified Global Aesthetic Improvement Scale) at the 3‐month primary endpoint, and a greater percentage reporting maximum improvement (“very much improved”) at 6 months 6 …”

“…Plasma energy skin rejuvenation now has several treatment options including nitrogen plasma skin regeneration (PSR) 1‐3 and helium plasma dermal resurfacing (PDR) 4‐7 . Nitrogen PSR was Food and Drug Administration (FDA) approved for treatment of wrinkles and acne scarring as well as superficial precancerous skin lesions in 2006 (K060948).…”

“…Study results were very positive with most subjects achieving a Facial Wrinkle Scale score improvement of ≥1 at the 3-month primary endpoint (98% per study investigators vs 64% per blinded independent photographic reviewers), 91% of subjects reporting at least "improved" selfperception of improvement (modified Global Aesthetic Improvement Scale) at the 3-month primary endpoint, and a greater percentage reporting maximum improvement ("very much improved") at 6 months. 6 Numerous consensus guidelines have been developed for many available aesthetic procedures and technologies to ensure their safe use and optimized patient satisfaction. [8][9][10][11][12][13] The objective of the following discussion was to create treatment guidelines for the safe and effective use of this novel helium plasma energy skin rejuvenation device.…”