A comparative study to evaluate the safety and efficacy of oral tofacitinib and oral azathioprine in unstable vitiligo:A one year hospital based randomised control trial at a tertiary care hospital
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 19
- 试验地点
- 1
- 主要终点
- To evaluate the efficacy of oral tofacitinib and oral azathioprine in unstable vitiligo
研究概览
简要总结
All patients diagnosed with unstable non-segmental vitiligo aged 18-60 years attending dermatology out patient departmentatKLE’s Dr. Prabhakar Kore hospital and MRC, Belagavi will be recruited after taking written informed consent.
All patients in study will undergo a detailed history taking, general physical, systemic and dermatological examination. Data will be collected by a single examiner and recorded in case record proforma.
The treatment plan will be discussed with patients, along with the anticipated outcomes, length of treatment, follow-ups, side effects to be reported, and treatment prognosis.
Patients will be randomly divided into two equal groups, namely Group A and Group B.
Complete hemogram, liver function test, Renal function test, Lipid profile, Hepatitis B, Hepatitis C, Mantoux test will be done at Baseline.
Patients of Group A will be given oral tofacitinib 5mg BD daily and those of the Group B will be given oral azathioprine 50 mg twice daily.
Complete hemogram, liver function test, Renal function test , Lipid profile repeated monthly once for the rest 3 months .
Digital photographs will be taken using identical camera settings, patient positioning and room lighting at baseline and at every followup.
The treatment duration in both groups is 3 months with follow-up at 1st month , 2nd month and 3rd month.
Digital photographs will be taken at each visit.
Side effects if any will be noted at each follow up.
After 3 months, the digital photographs will be compared with baseline.
Patient’s assessment of improvement will be recorded by visual analog scale.
Physician’s assessment of improvement will also be recorded by VASI.
The efficacy of the treatment will be calculated based on percent of regimentation.
The safety of the treatment will be assessed by the side effects associated with the treatment.
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
- •1.Patients with clinical signs of unstable vitiligo 2.Patients who have not taken any systemic treatment in last 1 month , topical treatment in last 2 weeks and excimer laser in last 8 weeks
- •When body surface area more than 10% involved 5.Patient willing to participate in the study.
排除标准
- •1.Patient with exclusive segmental and mucosal vitiligo
- •Pregnancy and lactation
- •Patients with active TB infection or any contact with TB patient
- •Patients with chronic liver disease , cirrhosis, HIV/AIDS, renal dysfunction , malignancies 5.Patients on drugs interacting with azathioprine / tofacitinib 6.Patient with history of hypersensitivity to tofacitinib / azathioprine.
结局指标
主要结局
To evaluate the efficacy of oral tofacitinib and oral azathioprine in unstable vitiligo
时间窗: one year
次要结局
- To evaluate the safety of oral tofacitinib & oral azathioprine in unstable vitiligo(One year)
研究者
Dr Aishwarya Acharya
Jawaharlal Nehru Medical College, Belgavi