Comparison of oral tofacitinib and oral corticosteroids in unstable vitiligo

Phase 3

• Conditions: Health Condition 1: L80- Vitiligo

• Registration Number: CTRI/2022/10/046826
• Lead Sponsor: Department of Dermatology, venereology, Leprology

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 21 November 2022

Recruitment & Eligibility

• Status: ot Yet Recruiting
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

Consecutive patients with a clinical diagnosis of non-segmental vitiligo

Patients with actively progressing vitiligo with or without prior treatment history

Body surface area >10%

Patients of either sex with age 18-60 years

Wash out period of 4 weeks if on prior topical or systemic therapy

Exclusion Criteria

Stable disease i.e., no koebnerisation, no new lesions or increase in size of lesions, well demarcated borders, no satellite or confetti lesions.

• Segmental vitiligo, focal or mucosal vitiligo

• Age < 18 years or > 60 years.

• Leukoderma secondary to other causes e.g., chemical leukoderma

• Pregnancy/Lactation.

• Patients with severe hepatic, renal or other systemic disorder

• Uncontrolled hypertension and diabetes mellitus

• Pre-existing malignancy.

• Immunosuppressed patients • Patients with concomitant infections like tuberculosis, systemic deep fungal infections, viral hepatitis, HIV, COVID-19 etc.

• Hematological abnormalities: Absolute lymphocyte count <500/mm3 or absolute neutrophil count (ANC) <1000/mm3 or hemoglobin <9 g/dL

• Known hypersensitivity to JAK-STAT inhibitors

• Patients who do not give consent for participation in the study

• Patients with unrealistic expectations

Study & Design

• Study Type: Interventional
• Study Design: Not specified