Comparison of the efficacy and safety of oral methylprednisolone mini-pulse with oral tofacitinib and oral methylprednisolone mini-pulse with oral azathioprine in treatment of progressive non- segmental vitiligo: A Randomized Controlled Trial
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 142
- 试验地点
- 1
- 主要终点
- Reduction in Vitiligo Area Severity Index (VASI) by 75%
研究概览
简要总结
All patients aged 18 to 65 years diagnosed clinically with progressive non-segmental vitiligo 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 two groups.
Group A will be given oral methylprednisolone 32 mg on two consecutive days every week and oral tofacitinib 5 mg twice daily with supportive treatment (calcium and vitamin D) for 6 months.
Group B will be given oral methylprednisolone 32 mg on two consecutive days every week and oral azathioprine 50 mg twice daily with supportive treatment (calcium and vitamin D) for 6 months.
All patients will be followed every month for 6 months and response evaluation will be done by Vitiligo Area Severity Index (VASI). Endpoint of treatment will be complete repigmentation or 6 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 progressive non-segmental vitiligo with affected body surface area equals to or more than 5% 2.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.
结局指标
主要结局
Reduction in Vitiligo Area Severity Index (VASI) by 75%
时间窗: Reduction in Vitiligo Area Severity Index (VASI) by 75% which will be assessed monthly for 6 months
次要结局
- Reduction in Vitiligo Area Severity Index (VASI) by 50% and reduction in Vitiligo Area Severity Index (VASI) by 100%(Reduction in Vitiligo Area Severity Index (VASI) by 50% and reduction in Vitiligo Area Severity Index (VASI) by 100% which will be assessed monthly for 6 months)
研究者
Dr Satyendra Kumar Singh
Institute of Medical Sciences Banaras Hindu University