Topical Tofacitinib for the Treatment of Alopecia Areata and Its Variants
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Percent Change in Severity of Alopecia Tool (SALT) Score
研究概览
简要总结
The purpose of the study is to investigate the use of topical tofacitinib to promote hair regrowth in patients with alopecia areata, alopecia totalis, and alopecia universalis.
详细描述
This will be an open label clinical trial. We plan to treat 10 adults with AA (with at least 2 patches of alopecia involving the scalp), AT or AU with tofacitinib ointment for a maximum of 6 months. During treatment, patients will be evaluated every 4 weeks and effectiveness of the medication will be measured by changes in hair growth. Laboratory evaluation will be performed before and during treatment in order to monitor for adverse effects of the medication.
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
- 否
入选标准
- •Diagnosis of AA with at least 2 patches of alopecia involving the scalp, AT or AU
- •Stable hair loss present for 6 months or longer
- •No treatment for alopecia areata in the past 1 month
- •No evidence of spontaneous hair regrowth
排除标准
- •Patients have received treatment known to affect alopecia areata within 1 month of enrolling in the study
- •Patients whose current episode of AT or AU is more than 5 years
- •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 taking immunosuppressive medications, including but not limited to prednisone, methotrexate, mycophenolate mofetil, azathioprine, tacrolimus, cyclosporine, or TNF-α inhibitors
- •Women who are pregnant or nursing
研究组 & 干预措施
Tofacitinib ointment
Patients with AA (with at least 2 patches of alopecia involving the scalp), AT or AU will be treated with tofacitinib ointment for a maximum of 6 months. During treatment, patients will be evaluated every 4 weeks and effectiveness of the medication will be measured by changes in hair growth.
干预措施: Tofacitinib ointment (Drug)
结局指标
主要结局
Percent Change in Severity of Alopecia Tool (SALT) Score
时间窗: 6 Months
SALT score range is from 0 (no hair loss) to 100 (100% hair loss). A positive percent change from baseline corresponds to a reduction in SALT score, and in this study study will be measured between baseline and 6 months.
次要结局
- Treatment Response Assessed as the Number of Participants With Hair Regrowth(6 Months)