To compare the efficacy and adverse effects of oral tofacitinib and oral methylprednisolone mini-pulse and combination of both in treatment of alopecia areata: A Randomized Controlled Trial.
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 219
- 试验地点
- 1
- 主要终点
- Reduction in severity of alopecia tool (SALT) score by 90%
研究概览
简要总结
All patients aged 18 to 65 years diagnosed clinically with alopecia areata coming to Dermatology OPD, SSH, BHU those who fulfill the inclusion criteria will be included in the study. All patients will be randomized equally in three groups.Group A will be giventofacitinib 5 mgBD with supportive treatment (proton pump inhibitor, calcium and vitamin D) for 4 months.
Group B will be given oral methylprednisolone 32 mg on two consecutive days per week with supportive treatment (proton pump inhibitor, calcium and vitamin D)for 4 months.
Group C will be given both tofacitinib 5 mg BD and oral methylprednisolone 32 mg on two consecutive days per week with supportive treatment (proton pump inhibitor, calcium and vitamin D) for 4 months.
All patients will be followed every month for 7 months and response evaluation will be done by severity of alopecia tool (SALT) score. End point of treatment will be complete regrowth of hair or 4 months of treatment whichever achieved first.
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 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Clinically diagnosed cases of alopecia areata with severity of alopecia tool (SALT) score of 10 % or over.
- •Age: 18 to 65 years
- •Patients not taking systemic drug in last 1 month and topical treatment in last 15 days.
- •All participants who give consent for the study.
排除标准
- •Patients having history or active tuberculosis.
- •Patients with Pregnancy and lactating mother.
- •Patients with uncontrolled renal, hepatic, hematological or heart disease.
- •Patients with diabetes mellitus and hypertension.
结局指标
主要结局
Reduction in severity of alopecia tool (SALT) score by 90%
时间窗: Reduction in severity of alopecia tool (SALT) score by 90% which will assessed monthly for 4 months.
次要结局
- Reduction in severity of alopecia tool (SALT) score by 50% & reduction in severity of alopecia tool (SALT) score by 100%(Reduction in severity of alopecia tool (SALT) score by 50% & reduction in severity of alopecia tool (SALT) score by 100% which will be assessed monthly for 4 months.)
研究者
Dr Satyendra Kumar Singh
Institute of Medical Sciences Banaras Hindu University