Efficacy of Hair Transplantation Compared With Hypodermic Needle Irritation in Alopecia Areata
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 4
- 试验地点
- 1
- 主要终点
- Change in follicular growth
研究概览
简要总结
The purpose of this study is to look at the safety, as well as the efficacy of hair transplantation compared with irritation with hypodermic needles in the treatment of subjects with refractory alopecia areata.
With this study, the investigators hope to demonstrate that trauma is just as effective as hair transplant in the treatment of recalcitrant alopecia areata of the scalp.
详细描述
Alopecia areata is a recurrent, non-scarring type of hair loss that can affect any hair-bearing area. This disorder can present in many different manners. Though medically benign, alopecia areata can result in severe emotional and psychosocial stress in affected individuals. This disease can be treated by hair transplantation.
Hair transplantation is a procedure in which donor hair follicles are harvested from a section of a patient's scalp, and transplanted in another bald recipient area, at which time it will take root and continue to grow. Hairs generally continue to grow indefinitely
During this study, subjects with alopecia areata will have one area (or ½ of a large area) treated by hair transplant and another (or the other ½) treated by simple irritation with a large gauge sterile hypodermic needle.
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
- •Subject must have recalcitrant, quiescent, alopecia areata, non-responsive to treatment, for at least 6 months.
- •Subject must have one patch of alopecia areata greater than 5 cm diameter, of two patches of alopecia areata, each greater than 2.5 cm diameter.
排除标准
- •Subjects with active, progressive, alopecia areata.
- •Subjects who are actively experiencing significant spontaneous regrowth of terminal hair.
- •Subjects with autoimmune deficiency.
- •Subjects with a medical condition contraindicating use of anesthesia.
结局指标
主要结局
Change in follicular growth
时间窗: 36 weeks
The study will require 5 study visits: Day 0, Day 1, Week 2, Week 24, and Week 36.
次要结局
未报告次要终点