Health Condition 1: L00-L99- Diseases of the skin and subcutaneous tissue
Conditions
Interventions
Intervention1: betamethasone oral mini pulse (2.5 mg twice a week) with topical treatment: Corticosteroids like betamethasone are used in achieving stabilization of disease arrest in vitiligo. Betamet
Fluocinolone acetonide 0.1% (once daily)for vitiligo patches on other sites of the body.
Control Intervention1: betamethasone oral mini pulse (5 mg twice a week) with topical treatment: Corticosteroid
Fluocinolone acetonide 0.1% for vitiligo patches on other sites of the body.
Control Intervention2: Topical treatment alone: Topical therapy for vitiligo in this study would i
Sponsors
Department of Dermatology and Venereology, All India Institute of Medical Sciences
Eligibility
Inclusion criteria
Inclusion criteria: This study will include patients between the ages of 18 and 65 with rapidly progressive vitiligo, which will be taken as the development of more than 5 new lesions in the past 1 month, or more than 15 new lesions in the past 3 months.
Exclusion criteria
Exclusion criteria: This study will exclude patients who have segmental vitiligo or stable/slowly progressive disease, pregnant and lactating females, patients who have known contraindications to corticosteroid use (such active infection, uncontrolled diabetes/hypertension), patients who are on phototherapy/systemic treatment for the last 4 weeks, and patients who are unwilling to adhere to monthly follow-up visits for 6 months.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of patients with disease arrest (no new lesion and no progression of pre-existing patches).Timepoint: 12 weeks and 24 weeks. | — |
Secondary
| Measure | Time frame |
|---|---|
| Proportion of patients with VDIS15 score corresponding to moderately improved which implies a score of more than 1 VDIS60 score corresponding to much improved for which to a score of more than 1.5 will be considered. Timepoint: Baseline, 12 weeks & 24 weeks;Mean number of new vitiligo lesions during the study period (intra- & inter group comparison) Timepoint: Baseline, 12 weeks & 24 weeks;Proportion of patients in different VIDA score categories (inter-group comparison). Timepoint: Baseline, 12 weeks & 24 weeks;Repigmentation outcomes: Mean percentage reduction in the TVASI & FVASI scores, proportion of patients with TVASI 50 & FVASI 75, & proportion of patients with different percentage repigmentation categories sites on Likert scale Timepoint: Baseline, 12 weeks & 24 weeks;Quality of life outcomes: Mean VIS-22 scores (intra- & inter group comparison), proportion of patients with a change of VIS-22 score more than 5 points (inter-group comparison), & proportion of patients with different GQ responses (inter-group comparison). Timepoint: Baseline, 12 weeks & 24 weeks;Proportion of patients with side effects Timepoint: Baseline, 12 weeks & 24 weeks;Longitudinal evolution of VSAS score during the study period (intra- & inter group comparison) & longitudinal evolution of VDAS & VDIS (15 & 60) scores during the study period (intra- & inter group comparison). Timepoint: Baseline, 12 weeks & 24 weeks | — |
Countries
India
Contacts
Public ContactVishal Gupta
All India Institute of Medical Sciences
Outcome results
None listed