A Prospective Study of the Efficacy of Radiofrequency Micro Needling for the Treatment of Melasma in Skin of Color.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Treatment efficacy as determined by change in mMASI scoring of melasma severity post-treatment.
研究概览
简要总结
The objective of this study is to test the effectiveness of radiofrequency microneedling (RFMN) as a treatment for melasma. The Investigator hypothesize that RFMN will be an effective treatment for melasma in skin of color patients.
详细描述
The target population is skin of color patients with melasma. Patients will receive 3 consecutive RFMN treatments over a period of three months. Baseline melasma severity will be measured by the modified Melasma Area and Severity Index (mMASI) score. Endpoints will be mMASI scores at 1 and 3 months post-procedure. Patient reported outcomes will be measured using the melasma quality of life (MelasQOL) validated patient questionnaire at screening and at both follow up visits. The long-term goal of future studies would be to provide melasma patients, particularly those with skin of color, with improved therapeutic options for the treatment of their melasma, as compared to current treatment options.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Males or females, at least 18 years of age
- •Fitzpatrick skin types IV-VI
- •Clinically diagnosed melasma
- •No topicals (retinol, vitamin C serum, etc) for 6 weeks before Visit 1 (with exception of sunscreen)
排除标准
- •is currently pregnant or planning to conceive during the study period
- •is using topical or oral therapy or other treatment for melasma
研究组 & 干预措施
Treatment
The target population is skin of color patients with melasma. Patients will receive 5 consecutive RFMN treatments over a period of 5 months.
干预措施: Radiofrequency microneedling (Device)
结局指标
主要结局
Treatment efficacy as determined by change in mMASI scoring of melasma severity post-treatment.
时间窗: 9 months
The primary endpoint is treatment efficacy as determined by change in mMASI scoring of melasma severity post-treatment.
次要结局
未报告次要终点
研究者
Shilpi Khetarpal
Principal Investigator
The Cleveland Clinic