Clinical Evaluation of Efficacy and Safety of Tofacitinib Film Forming Topical Lotion 2% Versus Momate® Lotion (Mometasone Furoate Topical Solution 0.1% w v) in the Management of Patients with Alopecia Areata - An Open Label, Comparative, Active Controlled, Randomized, Parallel, Prospective, Multi-Center Clinical Study
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 180
- 试验地点
- 6
- 主要终点
- - Change in SALT score
研究概览
简要总结
This is an Open Label, Comparative, Active Controlled, Randomized, Parallel, Prospective, Multi-Center Clinical Study. The primary objective of this trial is to evaluate the clinical efficacy of Tofacitinib film forming topical lotion 2% as compared to Momate® Lotion (Mometasone Furoate Topical Solution USP 0.1% w/v) in the management of patients with alopecia areata. The secondary objective of this trial is to assess the safety of Tofacitinib film forming topical lotion 2% as compared to Momate® Lotion (Mometasone Furoate Topical Solution USP 0.1% w/v) in the management of patients with alopecia areata.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 50.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients aged 18 – 50 years of either gender with clinical diagnosis of alopecia areata.
- •Patients in good health with no evidence of systemic illness.
- •Willing to report response to treatment as per protocol during the study period.
- •Willing to give written informed consent.
排除标准
- •Any subject who is currently experiencing significant spontaneous regrowth of terminal hair.
- •Any subject treated with a topical, intralesional or systemic agent likely to cause regrowth in alopecia areata within the past month.
- •Patients who concomitantly using systemic drugs (steroids, cytotoxic agents (methotrexate, azathioprine), vasodilators, antihypertensive agents, anticonvulsant drugs, beta-adrenergic receptor blockers, diuretics, spironolactone, diazoxide, cyclosporine, or ketoconazole.
- •Patients with H / O Tuberculosis or any serious illness.
- •H/ o hypersensitivity to study medication.
- •Participating in other clinical trials.
结局指标
主要结局
- Change in SALT score
时间窗: Week 4, week 8 and week 12 (end of study)
- Percent scalp hair regrowth based on extent of absolute hair loss (percent scalp hair regrowth based on extent of absolute hair loss. (percent scalp hair regrowth based on SALT score).
时间窗: Week 4, week 8 and week 12 (end of study)
次要结局
- Treatment Emergent Adverse Events (TEAEs)(Week 4, Week 8 and Week 12)
研究者
Dr Shoba jagdish chandra
Hetero Healthcare Limited