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A study to compare oral cyclosporine and oral corticosteroids in treatment of actively spreading vitiligo.

A randomized study to compare the efficacy of oral cyclosporine versus oral corticosteroids as mini pulse in treatment of patients with unstable vitiligo.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2018/07/014732
Enrollment
50
Registered
2018-07-04
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: null- Unstable Vitiligo Health Condition 2: L80- Vitiligo

Interventions

Intervention1: Cyclosporine: Group B patients will receive low dose Cyclosporine A 3 mg/kg/day in two divided doses for a total duration of 4 months. Estimation of blood levels of cyclosporine will be

Sponsors

None
Lead Sponsor

Eligibility

Inclusion criteria

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

Exclusion criteria: 1. Segmental Vitiligo. 2. Age 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.

Design outcomes

Primary

MeasureTime frame
1. To assess the cessation of disease activity by comparing change in VIDA score by two interventions. 2. To assess the difference in extent of repigmentation in each group using Investigatorâ??s Assessment (IA) score and Vitiligo Area Scoring Index (VASI) . Timepoint: 6 months

Secondary

MeasureTime frame
1. Patientsâ?? assessment (PA) scores at baseline and thereafter at every follow-up visit. 2. Quality of life assessment pre and post treatment. 3. Pattern of spontaneous repigmentation attained, if any, post-treatment. 4. Color matching of repigmented area. 5. Number and extent of disease relapses during post-treatment follow up. 6. Adverse effects. Timepoint: 6 months

Countries

India

Contacts

Public ContactHitaishi Mehta

Post Graduate Institute of Medical Education & Research, Chandigarh

drsen_2000@yahoo.com

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026