ITEM TYPE:
Journal Article
AUTHORS:
J. David Holcomb, MD, Michael Kelly, MD, FACS, Tiffani K. Hamilton, MD, and Joseph B. DeLozier III, MD, FACS
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.
APYX® MEDICAL DISCLOSURES:
FINANCIAL & CONTENT DISCLOSURE
The authors declared no potential conflicts of interest with respect to the research, authorship, and publication of this article. No funding was received for this article. Drs DiBernardo, Bharti, and Kortesis are paid consultants for Apyx Medical, and Dr Duncan is a member of Apyx Medical’s Medical Advisory Board. The opinions contained herein are those of the authors and do not necessarily represent the official position or policies of Apyx Medical, Inc.
MANUFACTURING DISCLOSURE
Apyx Medical manufactures and owns the Renuvion®/J-Plasma® technology discussed in this article.
INDICATIONS FOR USE & INTENDED USE DISCLOSURES
- Renuvion Dermal Handpiece is indicated for dermatological procedures for the treatment of moderate to severe wrinkles and rhytides, limited to patients with Fitzpatrick skin types I, II, or III.
- Apyx Medical wants to present to you with current scientific discourse. Specific usage outside of the cleared indications may not be safe or effective.
RISKS
- Risks associated with the use of the Renuvion Dermal System include but are not limited to hypertrophic scarring, milia/acne, telangiectasia (spider veins), skin discoloration/ hypopigmentation, dormant infection reactivation, infection, bruising or bleeding. Warning: Application of more than one treatment pass in the perioral area, on the forehead, and along the jawline has been associated with hypertrophic scarring.
As with any procedure, individual results may vary. As with all energy devices there are inherent risks associated with its use, refer to the IFU for further information.
