Maloney McKenzie E, Iglesia Sofia, Kononov Tatiana, Zahr Alisar S, Gold Michael H
Medical College of Georgia, Augusta University, Augusta, Georgia, USA.
Revision Skincare, Irving, Texas, USA.
J Cosmet Dermatol. 2024 Dec;23(12):4077-4084. doi: 10.1111/jocd.16622. Epub 2024 Oct 10.
Radiofrequency (RF) microneedling produces patient discomfort which deters patients from completing the recommended treatment series.
The primary objective was to determine the tolerability, safety, and efficacy of a neurocosmetic postprocedure cream post-RF microneedling in reducing patient discomfort and enhancing recovery across the length of the study and, secondarily, to evaluate against a leading comparator. The third objective was to evaluate the efficacy of the neurocosmetic on self-perceived improvement and objective grading.
An Institutional Review Board (IRB) approved, fourteen-day, randomized, single-center, double-blind, controlled clinical case study was conducted with 11 healthy female subjects, 6 randomized to the neurocosmetic and 5 to the comparator cell. Following a 7-day washout period, subjects received RF microneedling (face and neck) and applied the postprocedure cream twice daily for 7 days. Objective and subjective tolerability, self-assessments, and clinical photography were performed immediately postprocedure, 24 h, three and seven days following the procedure.
The neurocosmetic was tolerable and safe. Erythema and stinging immediately decreased postprocedure, postneurocosmetic application. After 24 h, 83% favorably agreed the neurocosmetic "reduced irritation on the skin post-procedure," and after 7 days, 100% favorably agreed "experience with the product was positive and I would be interested in returning for a second treatment." The neurocosmetic reduced skin tone redness in the face and neck faster and to a greater degree when measured against a comparator.
The neurocosmetic postprocedure cream improved patient discomfort and enhanced recovery when used immediately post-RF microneedling and after 7 days.
Pro00064211.
射频微针治疗会给患者带来不适,这使得患者不愿完成推荐的治疗疗程。
主要目的是确定一种神经美容术后乳膏在射频微针治疗后减轻患者不适并促进恢复方面的耐受性、安全性和有效性,次要目的是与一种领先的对照产品进行评估比较。第三个目的是评估该神经美容产品在自我感觉改善和客观分级方面的有效性。
进行了一项经机构审查委员会(IRB)批准的、为期14天的、随机、单中心、双盲、对照临床病例研究,共有11名健康女性受试者,6名随机分配至神经美容产品组,5名分配至对照产品组。经过7天的洗脱期后,受试者接受射频微针治疗(面部和颈部),并在术后每天两次涂抹术后乳膏,持续7天。在术后即刻、术后24小时、术后三天和七天进行客观和主观耐受性评估、自我评估以及临床拍照。
该神经美容产品耐受性良好且安全。在使用神经美容产品后,术后即刻的红斑和刺痛感立即减轻。24小时后,83%的受试者积极认可该神经美容产品“减轻了术后皮肤刺激”,7天后,100%的受试者积极认可“对该产品的体验良好,我有兴趣再次接受治疗”。与对照产品相比,该神经美容产品能更快且更显著地减轻面部和颈部的肤色发红。
射频微针治疗后立即使用并持续7天,该神经美容术后乳膏可改善患者不适并促进恢复。
IRB方案编号:Pro00064211。