Holcomb-Kreithen Plastic Surgery and MedSpa, Sarasota, Florida, USA.
Contemporary Plastic Surgery, Jacksonville, Florida, USA.
Lasers Surg Med. 2022 Jul;54(5):648-662. doi: 10.1002/lsm.23524. Epub 2022 Feb 16.
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).
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.
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.
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.
先前的一项低能量（20%功率）单次氦等离子体皮肤表面重建术（HPDR）多中心临床研究显示出积极的结果，但并未充分揭示这项新技术的真正潜力。因此，本文报告了第二项多中心临床研究，评估高能（40%）、双次 HPDR 治疗面部皱纹的疗效和安全性（ClinicalTrials.gov 标识符：NCT04185909）。
在四个研究地点之一，招募了 55 名寻求改善面部皱纹的合格受试者进行研究。所有受试者均接受全脸 HPDR 治疗。额部、鼻部、面颊部和口周治疗区以 40%的功率进行两次通过，而眶周和下颌线/下颌区则以 20%的功率（对于下颌线/下颌区最高可达 40%）和一次或两次通过进行治疗。使用 VISIA-CR 系统拍摄面部照片。由盲法独立照片评估员（IPR）和研究调查员根据基线评分比较治疗后 3 个月的 Fitzpatrick 皱纹和弹性量表（FWS）评分。
盲法 IPR 和研究调查员观察到 100%的受试者的 FWS 改善≥1 分，平均 IPR FWS 从基线到 90 天随访的变化为-3.6（±1.2）。96.4%的受试者在 90 天随访时利用改良的全球美学改善量表表示“改善”外观。VISIA-CR 数据评估显示皱纹、棕色斑点和毛孔计数均有统计学显著改善。总体而言，55 名受试者共报告了 269 例不良事件；大多数为轻度至中度（99.3%），预期（86.2%），相对短暂，大多数在治疗后 30 天（60.6%）内解决。
如本文所述，高能、双次 HPDR 治疗面部皱纹可显著改善 FWS，与竞争技术相当或超过竞争技术。VISIA-CR 分析显示皮肤质量的额外改善，棕色斑点和扩大毛孔以及皱纹的定量改善具有统计学意义。有效的皱纹消除与高满意度和较少意外不良事件相结合，具有合理的收益风险比。
