Medical Affairs & Clinical Development, Crown Laboratories, Dallas, Texas, USA.
Department of Plastic Surgery, UT Southwestern Medical Center, Dallas, Texas, USA.
J Cosmet Dermatol. 2023 Jan;22(1):206-213. doi: 10.1111/jocd.14985. Epub 2022 Jun 2.
OBJECTIVES: A microneedling pen has been cleared by the US Food and Drug Administration, indicated for improving the appearance of adult facial acne scars. The objective of this study was to assess the device's effectiveness for treating wrinkles of the face area. MATERIALS AND METHODS: Healthy adults seeking to improve the appearance of face wrinkles were enrolled (N = 35), receiving four monthly microneedling procedures by a trained aesthetician who treated the face skin per manufacturer instructions. Wrinkle assessments were performed by two trained blinded raters by comparing baseline images of each subject with images obtained at 90 days post-procedure. Subsequently, the two raters were unblinded for the Clinician's Global Aesthetic Improvement Scale (CGAIS) assessment. Subjects completed the Subject's Global Aesthetic Improvement Scale (SGAIS) and a Satisfaction Questionnaire at 30 and 90 days post-treatment. RESULTS: The study was completed by 32 subjects with a mean (SD) age of 56.3 (5.0) years. Wrinkle assessments demonstrated significant improvement in the face areas (p < 0.001). The SGAIS scores showed significant improvements after 30 and 90 days post-treatment (for each, p < 0.001). The CGAIS scores also showed significant improvements at 90 days post-treatment (p < 0.001). Most subjects reported some level of improvement in their appearance at 30 days (73.3%) and 90 days (68.8%) post-treatment. The satisfaction questionnaire showed high levels of improvement in wrinkles (93.8%), satisfaction with the treatment procedure (87.5%) and would recommend microneedling to friends and family members (80.6%) on the face and neck. CONCLUSION: Microneedling is a viable, minimally invasive option for treating wrinkles of the face. CLINICALTRIALS: gov Identifier: NCT03803059.
目的:美国食品和药物管理局已批准使用微针笔,用于改善成人面部痤疮疤痕的外观。本研究的目的是评估该设备对面部皱纹的治疗效果。
材料和方法:寻求改善面部皱纹外观的健康成年人(N=35)参与了这项研究,他们接受了由经过培训的美容师进行的四次每月微针治疗,治疗师按照制造商的说明对面部皮肤进行治疗。两名经过培训的盲评者通过比较每位受试者的基线图像和治疗后 90 天获得的图像来进行皱纹评估。随后,两名盲评者对临床医生整体美学改善量表(CGAIS)进行了评估。受试者在治疗后 30 和 90 天分别完成了受试者整体美学改善量表(SGAIS)和满意度问卷。
结果:32 名平均(标准差)年龄为 56.3(5.0)岁的受试者完成了这项研究。面部区域的皱纹评估显示出显著改善(p<0.001)。SGAIS 评分在治疗后 30 和 90 天均显示出显著改善(每次,p<0.001)。CGAIS 评分在治疗后 90 天也显示出显著改善(p<0.001)。大多数受试者在治疗后 30 天(73.3%)和 90 天(68.8%)报告自己的外观有所改善。满意度问卷显示,皱纹(93.8%)、对治疗过程的满意度(87.5%)和向朋友和家人推荐微针治疗面部和颈部(80.6%)的满意度都很高。
结论:微针是治疗面部皱纹的一种可行的微创选择。
临床试验:gov 标识符:NCT03803059。
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