Comparison of oral tofacitinib and oral corticosteroids in unstable vitiligo

A randomised control study to compare the efficacy of oral tofacitinib versus oral corticosteroids as mini pulse therapy in the treatment of patients with unstable vitiligo

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2022/10/046826

Enrollment

Registered

2022-10-27

Start date

Unknown

Completion date

Unknown

Last updated

2022-11-21

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

Conditions

Health Condition 1: L80- Vitiligo

Interventions

Intervention1: Oral tofacitinib: Oral tofacitinib will be administered to the intervention group at a dose of 5 mg twice a day for 6 months Control Intervention1: Oral corticosteroids: Oral dexamethas

Eligibility

Inclusion criteria

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

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 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 • Known hypersensitivity to JAK-STAT inhibitors • Patients who do not give consent for participation in the study • Patients with unrealistic expectations

Design outcomes

Primary

Measure	Time frame
The proportion of patients showing 50% improvement in VES score from baseline at 24 weeks in both groupsTimepoint: 24 weeks	—

Secondary

Measure	Time frame
Adverse effects of treatments in both groupsTimepoint: 9 months;Number of patients maintaining disease stabilisation at 9 months in both groups.Timepoint: 9 months;Pattern of repigmentation if any and colour matchTimepoint: 9 months;Proportion of patients showing disease stabilisation for a minimum of 12 weeks on serial photographic assessment at 24 weeksTimepoint: 24 weeks;To assess change in quality of life of patients in both groups after treatmentTimepoint: 9 months	—

Measure

Time frame

Adverse effects of treatments in both groupsTimepoint: 9 months;Number of patients maintaining disease stabilisation at 9 months in both groups.Timepoint: 9 months;Pattern of repigmentation if any and colour matchTimepoint: 9 months;Proportion of patients showing disease stabilisation for a minimum of 12 weeks on serial photographic assessment at 24 weeksTimepoint: 24 weeks;To assess change in quality of life of patients in both groups after treatmentTimepoint: 9 months

—

Countries

India

Contacts

Public ContactVinay K

PGIMER, Chandigarh

vinay.keshavmurthy@gmail.com08872993222

Outcome results

None listed

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