A trial for comparing efficacy and safety of oral corticosteriod mini pulse versus oral tofacitinib in arresting disease progression and repigmentation of active vitiligo
- Conditions
- Health Condition 1: L80- Vitiligo
- Registration Number
- CTRI/2024/04/065014
- Lead Sponsor
- Research Cell, AIIMS Jodhpur
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
All consecutive patients with body weight >35 kg and age < 50 years, of either gender who are willing to participate and fulfill the following eligibility criteria for active vitiligo:
1.Subjects with non-segmental, unstable vitiligo with body surface area involved >2%
2.Disease activity in the past 3 months –
a.New lesions
b.Increase in the size of the older lesions
c.Depigmentation of previously repigmented lesions
Patient having any of the following criteria will be excluded from the study.
1.Segmental vitiligo
2.Pregnancy or lactation
3.Presence of any of the following: immunocompromised host, malignancy, co-morbidities like uncontrolled diabetes, renal disease, hepatitis.
4.Any known contraindication or hypersensitivity to any of the study molecules.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method A.Arrest of disease progression (clinical and dermoscopic assessment) <br/ ><br>1. No new lesions. <br/ ><br>2. No increase in the size of the older lesions. <br/ ><br>3. No depigmentation of previously repigmented lesions <br/ ><br> <br/ ><br>B.Improvement in the vitiligo signs of activity score37 (VSAS) score from baseline.Timepoint: 2, 4, 8, 12, 16, 20, 24 weeks
- Secondary Outcome Measures
Name Time Method A.Repigmentation : <br/ ><br>a. Objective - Investor global assessmen39 (IGA) and Vitiligo area scoring41(VASI) <br/ ><br>b. Subjective - Patient global assessment (PGA) on a scale of 0 to 10 39 <br/ ><br>B.Side effects will be noted <br/ ><br>C.Improvement in the Vitiligo Impact Scale 2240 (VIS-22) <br/ ><br>D.Serum IL-6 levels42Timepoint: 1. VIS at baseline and 24 weeks <br/ ><br>2. IL-6 levels at baseline and 24 weeks