Comparative Clinical Efficacy of Tofacitinib Versus Methotrexate in Severe Alopecia Areata, Alopecia Totalis, and Alopecia Universalis: A Randomized Controlled Trial
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 78
- 主要终点
- Change in Severity of Alopecia Tool (SALT) Score
研究概览
简要总结
This study will compare two oral medicines-tofacitinib and methotrexate-for treating severe alopecia areata, including alopecia totalis (loss of all scalp hair) and alopecia universalis (loss of scalp and body hair). Alopecia areata is an autoimmune condition that can cause significant hair loss and emotional distress.
Adults aged 18 to 60 years with severe disease will be enrolled at the Department of Dermatology, MTI-Hayatabad Medical Complex, Peshawar, after ethical approval and written informed consent. Participants will be randomly assigned to receive either tofacitinib 10 mg twice daily or methotrexate 0.2-0.4 mg/kg once weekly for 12 weeks.
The main outcome will be improvement in hair loss measured by the Severity of Alopecia Tool (SALT) score. Treatment will be considered effective if there is more than 50% improvement in SALT score from baseline at the end of 12 weeks. Safety will be monitored during follow-up visits. The findings may help guide treatment decisions for severe alopecia areata in our local population.
详细描述
This is a single-center, parallel-group, randomized controlled trial to compare the clinical efficacy of oral tofacitinib versus methotrexate in adults with severe alopecia areata, including alopecia totalis and alopecia universalis, conducted at the Department of Dermatology, MTI-Hayatabad Medical Complex, Peshawar.
After approvals from the Institutional Ethical Committee and CPSP-REU and after obtaining written informed consent, eligible participants aged 18-60 years with severe alopecia areata/totalis/universalis diagnosed by a consultant dermatologist will be enrolled using consecutive non-probability sampling. Patients already receiving systemic therapy for hair regrowth, pregnant women, and patients with renal, hepatic, or pulmonary disease (based on history and clinical assessment) will be excluded.
Baseline demographic and clinical data will be recorded, and baseline disease severity will be assessed using the Severity of Alopecia Tool (SALT) score. Participants will be randomized using blocked randomization into two treatment arms:
Arm A: Oral tofacitinib 10 mg twice daily for 12 weeks.
Arm B: Oral methotrexate 0.2-0.4 mg/kg once weekly for 12 weeks, with scheduled follow-up and laboratory monitoring for potential adverse effects as per institutional protocol.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
盲法说明
This is an open-label trial. Due to different dosing schedules and monitoring requirements for the two interventions, blinding of participants, treating clinicians, investigators, and outcome assessors will not be feasible.
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults aged 18-60 years.
- •Clinical diagnosis of severe alopecia areata, alopecia totalis, or alopecia universalis (as per protocol/operational definition), confirmed by a consultant dermatologist.
- •Either sex.
- •Able and willing to provide written informed consent.
排除标准
- •Currently receiving or recently used any systemic treatment intended for hair regrowth for alopecia areata (e.g., systemic corticosteroids, immunosuppressants, JAK inhibitors).
- •Pregnant women.
- •History or clinical evidence of renal, hepatic, or pulmonary disease.
- •Any condition that, in the investigator's judgment, makes participation unsafe or interferes with adherence to the study protocol.
研究组 & 干预措施
Tofacitinib 10 mg Twice Daily
Participants will receive oral tofacitinib 10 mg twice daily for 12 weeks. Clinical response will be assessed using the SALT score at baseline and at week 12. Efficacy is defined as >50% improvement in SALT score from baseline.
干预措施: Tofacitinib (Drug)
Methotrexate 0.2-0.4 mg/kg Weekly
Participants will receive oral methotrexate 0.2-0.4 mg/kg once weekly for 12 weeks with routine follow-up and laboratory monitoring for adverse effects as per institutional protocol. Clinical response will be assessed using the SALT score at baseline and at week 12. Efficacy is defined as >50% improvement in SALT score from baseline.
干预措施: Methotrexate (Drug)
结局指标
主要结局
Change in Severity of Alopecia Tool (SALT) Score
时间窗: Week 12
SALT score ranges from 0 to 100, with higher scores indicating greater scalp hair loss. The primary outcome is the change in SALT score from baseline to week 12, compared between the tofacitinib and methotrexate groups.
次要结局
未报告次要终点
研究者
Hira Rehman
PGR
Hayat Abad Medical Complex, Peshawar