Efficacy of 2 percent Tofacitinib ointment versus 0.1 percent Tacrolimus ointment in patients of vitiligo - A hospital based double blinded randomised controlled trial
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 84
- 试验地点
- 1
- 主要终点
- Number and percentage of patients achieving treatment success which is defined by Vitiligo noticebility scale grade more than 3 or more than 50% repigmentation in vitiligo patch in both groups after 24 weeks of treatment.
研究概览
简要总结
This study recruits a total of 84 patients willing to participate in the study after taking written informed consent and divides them into two groups each having a total of 42 participants randomly. One group will be recieving topical 2% tofacitinib ointment + momatasone cream( standard therapy for vitiligo) for 8 weeks followed by only tofacitinib ointment application twice daily for the next 16 weeks. Similarly other group will be applying 0.1 % tacrolimus in place of tofacitinib initialy once daily for 8 weeks followed by twice daily for next 16 weeks. Each participant will be followed up regularly at 4 weeks interval for clinical assesment which will be recorded and to note adverse effect if any to given therapy. At the end of 24 weeks outcomes will be compared in terms of number and percentage of patients achieving treatment success using vitiligo noticebility scale( patient based score) and percentage repigmentation( physician based score) in each group.
Randomization will be done by using a randomization chart generated by a medical personal outside of the department of dermatology and venereology who will be alloting the patients into either group based on the number given to each patient in the sequence of their enrollement into the study. This person will be distributing medication to each patient on the basis of the randomization chart at a regular interval of 4 weeks in the form of packed tubes labeled as A,B OR C and only this person will be aware of the content of each tube keeping the patient and the investigator blinded.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 80.00 Year(s)（—）
- 性别
- All
入选标准
- •vitiligo patients with affected total body surface area less than 5 percent, who are equal to or older than 18 years of age not taking any systemic treatment from past 3 months.
排除标准
- •vitiligo patients who have only mucosal involvement, or TBSA more than 5 percent, or those requiring systemic treatment, or pregnancy or lactation, or younger than 18 years of age, or having known hypersensitivity to momatasone cream, tacrolimus ointment or tofacitinib ointment not consenting to the study.
结局指标
主要结局
Number and percentage of patients achieving treatment success which is defined by Vitiligo noticebility scale grade more than 3 or more than 50% repigmentation in vitiligo patch in both groups after 24 weeks of treatment.
时间窗: 24 weeks
次要结局
- 1. Number and percentage of patients achieving treatment success which is Vitiligo noticebility scale grade more than or equal to 3 or more than 50% repigmentation as per various types of vitiligo at the end of 24 weeks.
研究者
Dr Kavita Swami
All India Institute of Medical Sciences Gorakhpur