Evaluate Efficacy and safety of 2 percent topical tofacitinib versus 0.05 percent topical betamethasone valerate in treatment of vitiligo among patients attending tertiary care hospital bhavnagar a simple randomized controlled study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- TO COMPARE VASI(vitiligo area scoring index)
研究概览
简要总结
Evaluate Efficacy and safety of topical tofacitinib versus topical betamethasone in treatment of vitiligo among patients attending tertiary care hospital bhavnagar- a Simple randomized controlled, study
Aim : To assess efficacy of 2% topical tofacitinib ointment With 0.05% topical betamethasone valerate cream in terms of VASI ,VNS and Percentage repigmentation in treatment of vitiligo.
Objective :
Primary:
1.To compare the efficacy of 2% topical tofacitinib ointment with 0.05% topical betamethasone valerate in treatment of vitiligo using vitiligo area scoring index (VASI) and Vitiligo Noticeability Scale (VNS).
- To assess the side effects of 2% topical tofacitinib ointment in treatment of vitiligo.
3. To assess the side effects of 0.05% topical betamethasone cream in treatment of vitiligo.
METHODOlOGY
-Permission of ethics committee and CTRI will be taken
-Clinically diagnosed patients of vitiligo will be assessed for eligibility and will be included according to inclusion and exclusion criteria in the study after the consent is given
-Relevant history of the patient will be taken with the help of data collection tool
-Patient will be randomized into group A and group B
With Simple randomization method,vitiligo area scoring index(VASI)
will be calculated (BASELINE,1MONTH,2MONTH)
-Group A- 2% Topical tofacitinib ointment local application twice a day for 2 months
Group B- 0.05% Topical betamethasone valerate cream local application twice a day for 2 months
Vitiligo Noticeability Scale (VNS) and Percentage repigmentation will be evaluated)
-Data will be collected and entered in excel sheet.
Appropriate statistical test will be applied and analysis will be done.
研究设计
- 研究类型
- Interventional
- 分配方式
- Other
- 盲法
- None
入排标准
- 年龄范围
- 2.00 Year(s) 至 80.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients of age more than 2 yrs of either gender presenting with less than five depigmented patches with size not exceeding 10 × 10 CM.
排除标准
- •Patient of vitiligo who have taken treatment in past 3 months.
- •Patient of vitiligo with any other dermatology disorder.
- •Patient of vitiligo with site involving mucosal, genital, perianal regions and face lesion.
结局指标
主要结局
TO COMPARE VASI(vitiligo area scoring index)
时间窗: outcome will be assessed at baseline,1 month,2 month
次要结局
- Vitiligo Noticeability Scale (VNS) and Percentage repigmentation(2 MONTHS)
研究者
Dr nirbhay damor
Government medical college,bhavnagar