A study to compare oral cyclosporine and oral corticosteroids in treatment of actively spreading vitiligo.
Not Applicable
Completed
- Conditions
- Health Condition 1: null- Unstable VitiligoHealth Condition 2: L80- Vitiligo
- Registration Number
- CTRI/2018/07/014732
- Lead Sponsor
- one
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 50
Inclusion Criteria
Consecutive patients with clinical diagnosis of vitiligo vulgaris and fulfilling the inclusion criteria listed below will be recruited for the study.
1. Patients with actively spreading vitiligo, defined as vitiligo disease activity score (VIDA) score of +4 with or without prior treatment history.
2. Patients of either sex with age 16-60 years.
Exclusion Criteria
1. Segmental Vitiligo.
2. Age < 16 years or > 60 years.
3. Leucoderma secondary to other causes.
4. Pregnancy/Lactation.
5. Patients with severe hepatic, renal or other systemic disorder.
•Pre existing malignancy.
•Immunosuppression.
•Hypertension.
•Hypocholesterolemia
•Aphakia/cataract
•History of spontaneous repigmentation of lesions.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1.To assess the cessation of disease activity by comparing change in VIDA score by two interventions. <br/ ><br>2.To assess the difference in extent of repigmentation in each group using Investigatorâ??s Assessment (IA) score and Vitiligo Area Scoring Index (VASI) . <br/ ><br>Timepoint: 6 months <br/ ><br>
- Secondary Outcome Measures
Name Time Method 1.Patientsâ?? assessment (PA) scores at baseline and thereafter at every follow-up visit. <br/ ><br>2.Quality of life assessment pre and post treatment. <br/ ><br>3.Pattern of spontaneous repigmentation attained, if any, post-treatment. <br/ ><br>4.Color matching of repigmented area. <br/ ><br>5.Number and extent of disease relapses during post-treatment follow up. <br/ ><br>6.Adverse effects. <br/ ><br>Timepoint: 6 months