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 full-face 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.

Keywords: facial rejuvenation; helium plasma; helium plasma dermal resurfacing; radiofrequency; rhytid; skin rejuvenation; skin resurfacing; wrinkle.

© 2022 The Authors. Lasers in Surgery and Medicine published by Wiley Periodicals LLC.

Figures

Figure 1

HPDR facial treatment zones. The face of each subject was divided into six zones: forehead, periorbital, nose, cheeks, perioral, and jawline/mandibular border. HPDR, helium plasma dermal resurfacing

Figure 2

Mild wrinkle improvement after HPDR treatment in a 68‐year‐old female, Fitzpatrick Skin Scale III. Before (A, B), 3‐month (C, D), and 6‐month (E, F) VISIA‐CR photographs (front, left oblique). Double pass, 40% power all zones except periorbital (single pass, 20% power) and jawline/mandibular border (single pass). Baseline IPR FWS 6.3 (blinded reviewer average) with 3‐month IPR FWS net change −0.7. Significant improvement of dyschromia and photodamage along with modest improvement of skin texture with reduction of facial lines evident at Month 3 that is further improved at month 6. FWS, Fitzpatrick Wrinkle and Elastosis Scale; HPDR, helium plasma dermal resurfacing; IPR, independent photographic reviewers

Figure 3

Moderate wrinkle improvement after HPDR treatment in a 49‐year‐old female, Fitzpatrick Skin Scale II. Before (A, B), 3‐month (C, D), and 6‐month (E, F) VISIA‐CR photographs (front, left oblique). Double pass, 40% power all zones except periorbital (double pass, 20% power) and jawline/mandibular border (double pass, 20% power). Baseline IPR FWS 7.7 (blinded reviewer average) with 3‐month IPR FWS net change −3.7. Significant improvement of dyschromia and photodamage along with marked improvement of skin texture with reduction of facial lines evident at Months 3 and 6. Mild erythema in discrete areas continuing to resolve and some previously darker toned areas of peri‐orbital and cheek skin remain evident by month 6 with no intervention other than sunblock (see Methods). FWS, Fitzpatrick Wrinkle and Elastosis Scale; HPDR, helium plasma dermal resurfacing; IPR, independent photographic reviewers

Figure 4

Marked wrinkle improvement after HPDR treatment in a 69‐year‐old female, Fitzpatrick Skin Scale II. Before (A, B), 3‐month (C, D), and 6‐month (E, F) VISIA‐CR photographs (front, left oblique). Double pass, 40% power all zones except periorbital (double pass, 20% power) and jawline/mandibular border (single pass). Baseline IPR FWS 8.7 (blinded reviewer average) with 3‐month IPR FWS net change −5.3. Significant improvement of dyschromia and photodamage along with marked improvement of skin texture with reduction of facial lines evident at Months 3 and 6. Mild erythema of cheek areas and linear redness of upper forehead lines at Month 3 that is continuing to improve at Month 6. FWS, Fitzpatrick Wrinkle and Elastosis Scale; HPDR, helium plasma dermal resurfacing; IPR, independent photographic reviewers

Figure 5

Marked wrinkle improvement with mild severity AE (focal hypertrophic scar left lateral upper lip and melolabial fold) after HPDR treatment in a 67‐year‐old female, Fitzpatrick Skin Scale II. Before (A, B), 3‐month (C, D), and 6‐month (E, F) VISIA‐CR photographs (front, left oblique). Double pass, 40% power all zones except periorbital (single pass, 20% power) and jawline/mandibular border (single pass). Baseline IPR FWS 9.0 (blinded reviewer average) with 3‐month IPR FWS net change −5.0. Significant improvement of dyschromia and photodamage along with marked improvement of skin texture with reduction of facial lines evident at Months 3 and 6. Slightly visible and just palpable raised hypertrophic scar (mild severity) left lateral upper lip and melolabial fold evident by month 3 that is much improved by month 6 after several triamcinolone (10 mg/ml) injections. Mild erythema of left lower cheek with several telangiectasias present at month 3 improved by Month 6. FWS, Fitzpatrick Wrinkle and Elastosis Scale; HPDR, helium plasma dermal resurfacing; IPR, independent photographic reviewers

Figure 6

Healing progression after HPDR treatment in a 53‐year‐old female, Fitzpatrick Skin Scale II. An additional 7 days (17 days total) was required for completion of re‐epithelialization. Before (A), 6 (B), 10 (C), and 30 days (D) posttreatment. Incomplete re‐epithelialization is an event at Day 10 (C) in the peri‐oral area as well as other focal areas (left lateral brow, medial left upper eyelid) but complete by Day 30 posttreatment (D). HPDR, helium plasma dermal resurfacing