Follicular Revival in Fibrosing Alopecia: Evaluating Use of Micro-needling
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 6
- 试验地点
- 2
- 主要终点
- Total Area Hair Count (Frontal)
研究概览
简要总结
To evaluate the efficacy microneedling via a professional tattoo machine in revitalizing hair follicles in patients with fibrosing alopecia.
详细描述
The investigators propose an open label trial of tattoo machine microneedling in ten patients with fibrosing alopecia (five patients with CCCA and five with FFA). Ten healthy female 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). Photographs will be taken at each session. Patients will be evaluated at 8 visits over 8 months with the first visit for screening purposes. Each visit will last about an hour. Approximately 30 minutes will be spent on consenting and time for patient to ask questions during the first visit. The remaining 30 minutes will be allotted for the investigator to determine if the patient meets criteria for trial enrollment. During the remaining visits, 20 minutes will be allotted for photography, 15-20 minutes for the procedure and 10-15 minutes for post-procedure patient assessment. Remaining 10 minutes on visits 2 and 8 will be used for biopsy.
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
- Female
- 接受健康志愿者
- 是
入选标准
- •Healthy Female
- •Diagnosing Fibrosing alopecia
排除标准
- •Any female with hair loss for other reasons
- •Patients with cardiac conditions or renal insufficiency
- •Pregnant patients
- •Patients containing the following who would make poor candidates for microneedling, such as skin conditions, diabetes, 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 (Frontal)
时间窗: 6 months
Total number of hairs over an area of 1cm\^2
Total Area Hair Count (Vertex)
时间窗: 6 months
Total number of hairs over an area of 1 cm\^2
次要结局
- Hair Shaft Diameters (Vertex)(6 months)
- Terminal Hairs (Frontal)(6 months)
- Number of Hair Follicles (Frontal)(6 months)
- Vellus Hairs (Frontal)(6 months)
- Vellus Hairs (Vertex)(6 months)
- Number of Hair Follicles (Vertex)(6 months)
- Terminal Hairs (Vertex)(6 months)
- Hair Shaft Diameters (Frontal)(6 months)