临床试验/NCT02197455

NCT02197455已完成2 期

Tofacitnib for the Treatment of Alopecia Areata and Variants

Yale University1 个研究点分布在 1 个国家目标入组 30 人开始时间: 2014年7月最近更新: 2017年4月4日

适应症

干预措施

试验速览

阶段: 2 期
状态: 已完成
发起方: Yale University
入组人数: 30
试验地点: 1
主要终点: Mean Change in Severity of Alopecia Tool (SALT) Score

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

The purpose of this study is to investigate the ability of tofacitinib citrate, a Janus kinase inhibitor, to generate hair regrowth in patients with moderate to severe alopecia areata and its variants.

详细描述

This study is an open-label pilot study. Participants will be treated with oral tofacitinib for a maximum of 5 months. Participants will be evaluated at 3 months after completion of therapy to evaluate for durability of response, late response and/or late adverse effects.

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 90 Years（Adult, Older Adult）
性别: All
接受健康志愿者: 否

入选标准

•Age >= 18 years old
•Diagnosis of alopecia areata with >50% scalp involvement, alopecia totalis, or alopecia universalis
•Hair loss present for at least 6 months
•No treatment for alopecia areata in past 2 months
•No evidence of hair regrowth
•Females of childbearing potential must use birth control while taking the medication and there must be a negative pregnancy test documented prior to starting the medication

排除标准

•Age <18 years old
•Patients have received treatment known to affect alopecia areata within 2 months of enrolling in the study
•Patients with a history of malignancy (except history of successfully treated basal cell or squamous cell carcinoma of the skin)
•Patients known to be HIV or hepatitis B or C positive
•Patients with positive tuberculin skin test or positive QuantiFERON TB test
•Patients with leukopenia or anemia
•Patients with renal or hepatic impairment
•Patients with peptic ulcer disease
•Patients taking immunosuppressive medications, including but not limited to prednisone, methotrexate, mycophenolate mofetil, azathioprine, tacrolimus, cyclosporine, or TNH-alpha inhibitors
•Women of childbearing potential who are unable or unwilling to use birth control while taking the medication
•Women who are pregnant or nursing

研究组 & 干预措施

Tofacitinib Administration

Experimental

5 mg of Tofacitinib will be taken by mouth twice daily for 3 months.

干预措施: Tofacitinib Administration (Drug)

结局指标

主要结局

Mean Change in Severity of Alopecia Tool (SALT) Score

时间窗: 3 months

SALT score range is from 0 (no hair loss) to 100 (100% hair loss)

次要结局

Mean Change in Skindex 16 Scores(3 months)

研究者

发起方

Yale University

申办方类型

Other

责任方

Sponsor

研究点 (1)

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