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临床试验/NCT04338295
NCT04338295已完成不适用

Follicular Revival in Treatment-resistant Alopecia Areata: Evaluating Use of Micro-needling

Yale University2 个研究点 分布在 1 个国家目标入组 5 人开始时间: 2021年4月9日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
5
试验地点
2
主要终点
Target area hair count (TAHC)

研究概览

简要总结

The investigators propose to study the efficacy of micro-needling via the SOL Nova Device in generating hair growth in patients with Alopecia Areta (AA) who are either non-responsive or only partially responsive to combination oral JAK inhibitor plus oral minoxidil therapy.

详细描述

This will be a trial evaluating the efficacy of micro-needling via tattoo device in stimulating scalp hair growth in patients with AA refractory to combination JAK inhibitor and oral minoxidil treatment. Ten healthy subjects who are at least eighteen years of age who have experienced no or partial scalp hair regrowth after ≥three months of JAK inhibitor plus oral minoxidil treatment will be enrolled. Subjects will undergo a treatment session once every thirty days for a total of six sessions over six months and will complete a total of eight visits over eight months. Procedures and visits are not standard of care but conducted for research. 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
Device Feasibility
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

入选标准

  • Diagnosis of AA
  • SALT score ≥90%
  • No or minimal scalp hair regrowth after ≥three months of oral JAK inhibitor plus oral minoxidil treatment

排除标准

  • Known concomitant androgenetic or other form of alopecia (in addition to AA)
  • 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

Target area hair count (TAHC)

时间窗: 6 months

Total number of hairs in the area that undergoes microneedling

次要结局

  • Terminal hairs(6 months)
  • Vellus hairs(6 months)
  • Hair phase(6 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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