Health Condition 1: L80- Vitiligo
Conditions
Interventions
Intervention1: Oral tofacitinib: Oral tofacitinib 5 mg OD for 2 weeks followed by 5 mg BD till disease stabilization followed by tapering.
Control Intervention1: Oral corticosteroid mini pulse: Oral c
Sponsors
Research Cell, AIIMS Jodhpur
Eligibility
Inclusion criteria
Inclusion criteria: All consecutive patients with body weight >35 kg and age 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
Exclusion criteria
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| A.Arrest of disease progression (clinical and dermoscopic assessment) 1. No new lesions. 2. No increase in the size of the older lesions. 3. No depigmentation of previously repigmented lesions B.Improvement in the vitiligo signs of activity score37 (VSAS) score from baseline.Timepoint: 2, 4, 8, 12, 16, 20, 24 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| A.Repigmentation : a. Objective - Investor global assessmen39 (IGA) and Vitiligo area scoring41(VASI) b. Subjective - Patient global assessment (PGA) on a scale of 0 to 10 39 B.Side effects will be noted C.Improvement in the Vitiligo Impact Scale 2240 (VIS-22) D.Serum IL-6 levels42Timepoint: 1. VIS at baseline and 24 weeks 2. IL-6 levels at baseline and 24 weeks | — |
Countries
India
Contacts
Public ContactDr Prajakta Waghmare
All India Institute of Medical Sciences, Jodhpur
Outcome results
None listed