To compare the efficacy and safety of low dose tofacitinib versus oral corticosteroid (dexamethasone) mini pulse along with topical PUVAsol in stabilization and repigmentation of cutaneous lesions in rapidly progressive vitiligo. An open label active controlled randomized study.
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- To evaluate the number of patients achieving the arrest of progression of the disease i.e decrease of VIDA score by 1 point in low dose tofacitinib (Group A) and oral corticosteroid (dexamethasone) mini pulse (Group B.
研究概览
简要总结
An open-label two-arm randomized prospective non inferior active controlled study with intention to treat to compare the efficacy and safety of low dose tofacitinib versus oral corticosteroid (dexamethasone) mini pulse along with topical PUVAsol in the stabilization and repigmentation of rapidly progressive vitiligo with Body surface area less than 5 percent.Vitiligo patient with active disease VIDA 4 and having vitiligo for more than 6 months adult of age group 18-60 years old of any sex, presenting to the Dermatology OPD and providing written informed consent. Patients unwilling to give written informed consent to participate in the study,with other major dermatological ailments (Immunobullous disease, SLE, Connective tissue diseases, Autoimmune diseases,Vasculitis),with underlying hepatic, renal diseases, coronary artery disease (CAD) or any major contraindications to the use of tofacitinib,Pregnant, lactating female will be excluded.Participants will be randomised using computer generated random number.Primary objectives are to evaluate the number of patients achieving the arrest of progression of the disease ,decrease of VIDA score by 1 point in low dose tofacitinib (Group A) and oral corticosteroid (dexamethasone) mini pulse (Group B) at 16 weeks.To evaluate number of patients achieving more than 50 percent of repigmentation in each group at 16 weeks.Secondary objectives are to evaluate the percentage of patients maintaining arrest of the disease in each group at 24 weeks.To compare the patients achieving arrest of progression and repigmentation between the groups A and B at 16 and 24 weeks.To evaluate change in mean VASI and mean Physician global assessment scores from baseline to end of 16 weeks and end of 24 weeks within and between groups A and B.To analyse patient global assessment using patient satisfaction score and Patient reported outcome measures (PROM) VitiQoL at 16 and 24 weeks within and between group A and group B.
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 60.00 Year(s)(—)
- 性别
- All
入选标准
- •Diagnosis: Vitiligo patient with active disease i.e. VIDA 4+
- •Patients having vitiligo for more than 6 months.
- •Body surface area (BSA) involvement is less than 5 %
- •Participants must be adult of age group 18-60 years old
- •Presenting to the Dermatology OPD.
排除标准
- •Patients unwilling to give written informed consent to participate in the study.
- •Patients of vitiligo with other major dermatological ailments ( Immunobullous disease, SLE, Connective tissue diseases, Autoimmune diseases, Vasculitis).
- •Patients with underlying hepatic, renal diseases, coronary artery disease (CAD)
- •Patients with any major contraindications to the use of tofacitinib.
- •Pregnant, lactating female.
结局指标
主要结局
To evaluate the number of patients achieving the arrest of progression of the disease i.e decrease of VIDA score by 1 point in low dose tofacitinib (Group A) and oral corticosteroid (dexamethasone) mini pulse (Group B.
时间窗: 16 weeks
2. To evaluate number of patients achieving more than 50 percent of repigmentation in each group.
时间窗: 16 weeks
次要结局
- 1. To evaluate the percentage of patients maintaining arrest of the disease in each group at 24 weeks.(2. To compare the patients achieving arrest of progression and repigmentation between the groups A and B at 16 and 24 weeks.)
研究者
Dr Alka Yadav
All India Institute of Medical Science,AIIMS Rajkot
