NCT04341363已完成不适用
Follicular Revival in Treatment-resistant Alopecia Areata: Evaluating Use of Micro-needling
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 8
- 试验地点
- 2
- 主要终点
- Total Area Hair Count
研究概览
简要总结
The intent of this study is to evaluate the efficacy of microneedling through use of a professional tattoo machine in hair regrowth in patients with androgenic alopecia (AGA) over up to 6 treatments (6 months).
详细描述
Proposed is an open label trial of tattoo machine microneedling in ten patients with androgenic alopecia. Ten healthy male patients older than 18 years will undergo 6 microneedling sessions. Over the course of six months, subjects will undergo up to six treatment sessions (one session every 30 day). Patients will be evaluated at 8 visits over 8 months with the first visit for screening purposes.
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
- Male
- 接受健康志愿者
- 是
入选标准
- •Symmetric hair loss from AGA
- •Hamilton-Norwood IIIa, III, III vertex, IV, Iva, V with low density hair coverage over majority of alopecic areas
- •No or minimal scalp hair regrowth on oral and/or topical minoxidil
排除标准
- •Any male with hair loss for other reasons
- •Unilateral or asymmetric hair loss
- •Hamilton-Norwood I, II, IIa, Va, IV, VII x
- •Patients without hair
- •Patients with the following who would make poor candidates for microneedling such as skin conditions, diabetes, or history of keloid formation
- •Anything additional existing comorbidities that in the opinion of the investigator may cause unnecessary risk for the patient to participate
结局指标
主要结局
Total Area Hair Count
时间窗: 6 months
Total number of hairs in an area of 1 cm\^2
次要结局
- Hair Shaft Diameter(6 months)
- Vellus Hairs(6 months)
- Terminal Hairs(6 months)
- SALT Score(6 months)
- Number of Follicular Units(6 months)
研究者
研究点 (2)
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