Comparison of Tofacitinib versus betamethasone oral mini pulse in progressive vitiligo
Phase 2
- Conditions
- Health Condition 1: L80- Vitiligo
- Registration Number
- CTRI/2024/02/062634
- Lead Sponsor
- AIIMS, New Delhi
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
patients with rapidly progressive non segmental vitiligo with more than or equal to 5 new lesions in a month or more than or equal to 15 new lesions in 3 months
Exclusion Criteria
1. Patients with segmental or stable or slowly progressive vitiligo
2. Pregnant or lactating females
3. Patients with known contraindictions to oral steroids or tofacitinib
4. Patients on topical treatment for last 2 weeks or systemic treatment for 4 weeks
5. Patients with latent tuberculosis infection not willing to take isoniazid preventive treatment
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Proportion of patients with disease arrest (no new lesions and no progression of pre-existing patches) at every visit as confirmed on sequential photographsTimepoint: at 4, 8, 12, 16, 20 and 24 weeks (at every visit)
- Secondary Outcome Measures
Name Time Method Comparison of side effects profile in both groupsTimepoint: at every follow up visit;Mean number of new vitiligo lesions during the study period (intra- and inter group comparison)Timepoint: at every visit;Mean VDAS and VDIS scores during the study period (intra- and inter group comparison)Timepoint: at 3rd and 6th month visit;Mean VES (intra- and inter group comparison)Timepoint: at baseline, 3rd and 6th month visit;Mean VIS-22 scores (intra- and inter group comparison)Timepoint: at baseline, 3rd and 6th month visit;Mean VSAS score during the study period (intra- and inter group comparison)Timepoint: at every visit;Proportion of patients in different VIDA score categories (inter-group comparison)Timepoint: at every visit;Proportion of patients with a change of VIS-22 score more than 5 points (inter-group comparison)Timepoint: at 6th month visit;Proportion of patients with different GQ responses (inter-group comparison)Timepoint: at every follow up visit