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临床试验/NCT04409041
NCT04409041已完成2 期

Oral Low-Dose Naltrexone in the Treatment of Lichen Planopilaris and Frontal Fibrosing Alopecia; an Uncontrolled Open-label Prospective Study

Washington University School of Medicine1 个研究点 分布在 1 个国家目标入组 43 人开始时间: 2019年9月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
2 期
状态
已完成
入组人数
43
试验地点
1
主要终点
Patient Reported Burning/Pain

研究概览

简要总结

Oral naltrexone was initially FDA approved to treat opioid use disorder and alcohol dependence at doses from 50-100mg/day. At lower doses of 1-5mg/day, naltrexone has been used off-label with success in treatment of several dermatologic conditions including the scarring hair loss disease lichen planopilaris. A recent case series of four patients with lichen planopilaris and a subtype, frontal fibrosing alopecia, treated with oral low-dose naltrexone at 3mg daily showed reduction of itch, clinical evidence of inflammation of the scalp, and of disease progression. There were no reported adverse events.

Based on the promising evidence, we propose using low-dose naltrexone at a daily dose of 3mg to treat lichen planopilaris and frontal fibrosing alopecia. The patients would be continued on their other medications for these conditions. The study would be open-label, so all participants would receive the low-dose naltrexone. Patients would be seen at 0,3,6 and 12 months to monitor their progress.

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

入选标准

  • Adults age 18 or greater
  • clinically or histologically confirmed diagnosis of lichen planopilaris or frontal fibrosing alopecia

排除标准

  • known allergy or hypersensitivity to naltrexone
  • patients with concurrent use of opioids
  • active depression, schizophrenia, and bipolar disorder

研究组 & 干预措施

Low-dose naltrexone group

Experimental

All participants were prescribed low-dose naltrexone at 3mg oral daily.

干预措施: Low-Dose Naltrexone (Drug)

结局指标

主要结局

Patient Reported Burning/Pain

时间窗: 12 months

Patient reported burning/pain on 0-10 scale. Higher values are worse. A change between two time points is reported at 12 months.

Change in Patient-Reported Itch

时间窗: 12 months

0-10 scale for itch. Lower scores are better outcome. A change between two time points is reported at 12 months.

Change in Investigator Rated Erythema

时间窗: 12 months

0-3 scale for erythema. Higher scores are worse. A change between two time points is reported at 12 months.

Change in Investigator Rated Scale

时间窗: 12 months

Investigator assessed outcome of scale on 0-3 scale. Higher numbers are worse. A change between two time points is reported at 12 months.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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