An open label, randomized, comparative, study to evaluate efficacy, safety and remission period of Topical Tacrolimus 0.1 percent ointment and Topical Tofacitinib 2 percent ointment in patients with focal vitiligo.
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- 1. Percentage of Patients with achievement of VASI-75 or complete re-pigmentation at the end of Week 12.
研究概览
简要总结
This is an open label, randomized, comparative, investigator initiated study to evaluate efficacy, safety and remission rate with Topical Tacrolimus 0.1% ointment vs Topical Tofacitinib 2% ointment in Indian patients with focal vitiligo.
This study is planned in 70 Indian patients. Each patient will undergo 12 weeks of treatment period and further 16 weeks of follow up. Efficacy assessment will be done at all visits till week 12 and safety assessment will be done through out the study duration.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Not Applicable
入排标准
- 年龄范围
- 2.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients eligible for enrolment in the study must meet all of the following criteria:
- •Male or female subjects aged between 02-65 years with focal vitiligo.
- •Patients with minimum of 2 lesions Excluding mucosal lesions with minimum patch size of 8 to 12 cm2 with involvement of less than 10% BSA, present on areas of face, trunk and upper limb.
- •No serious health conditions that may interfere with the study
- •The parent, guardian of child should give written Parental Consent form, Assent form, Informed Consent Form for participation in study.
排除标准
- •Patients meeting any of the following criteria must not be enrolled in the study:
- •History of skin disease or presence of skin condition that would interfere with the study assessments.
- •Any clinically significant medical condition that would, in the opinion of the investigator, put the subject at undue risk or interfere with interpretation of study results.
- •Known hypersensitivity to tacrolimus, tofacitinib or any of the excipients used in the formulation.
- •Subject who have taken any treatment for vitiligo (systemic, topical or phototherapy) for 14 days prior to being randomized.
结局指标
主要结局
1. Percentage of Patients with achievement of VASI-75 or complete re-pigmentation at the end of Week 12.
时间窗: 1. Upto 12 weeks | 2. From 12th week to 28th week | 3. From 12th week to 28th week
2. Percentage of patients who shows relapse after achieving VASI 75. (relapse of vitiligo is defined as appearance of new lesions or increase in extent of existing lesions)
时间窗: 1. Upto 12 weeks | 2. From 12th week to 28th week | 3. From 12th week to 28th week
3. Percentage of patients who show relapse within 16 weeks follow-up of achieving VASI 75.
时间窗: 1. Upto 12 weeks | 2. From 12th week to 28th week | 3. From 12th week to 28th week
次要结局
- 1. Incidence of Treatment Emergent Adverse Events till end of the study.(2. Evaluation of cutaneous tolerability in terms of redness, erythema, dryness, scaling, and burning/irritation sensation till end of the study.)