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A study comparing various oral immunosupressant medications-oral minipulse steroids, azathioprine and tofacitinib in treatment of childhood vitiligo

A Randomised Three Arm Prospective study comparing oral minipulse dexamethasone, azathioprine and tofacitinib in the treatment of Unstable childhood vitiligo - NIL

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/06/088298
Enrollment
45
Registered
2025-06-05
Start date
Unknown
Completion date
Unknown
Last updated
2025-06-24

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: orally 6 months 5mg once a day(weight less than 20 kg) 5mg twice a day(weight more than 20 kg) Intervention2: Oral azathioprine: 6 months 2 mg/kg per day orally Contro

Sponsors

PGIMER Chandigarh
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Arm1-Oral minipulse dexamethasone 2.5 mg on two days a week orally for 6 months Arm 2- Azathioprine 2mg/kg/day orally once a day for 6 months Arm3- Tofacitinib 5 mg once daily if weight 20 kg for 6 months

Exclusion criteria

Exclusion criteria: Age more than 18 years. Age less than 6 years Weight less than 20 kg (for tofacitinib) Leucoderma secondary to other causes Patients with severe hepatic, renal or other systemic disorder Pre-existing malignancy History of tuberculosis in past Patients with known hypersensitivity to the drug

Design outcomes

Primary

MeasureTime frame
To assess stabilisation of disease activityTimepoint: To assess stabilisation of disease activity at 4 weeks, 8 weeks, 12 weeks, 16 weeks, 20 weeks, 24 weeks and 36 weeks

Secondary

MeasureTime frame
assess repigmentation in addition that is the proportion of patients achieving 50 % reduction in VES score from baseline.Timepoint: at 6 months

Countries

India

Contacts

Public ContactM Sendhil Kumaran

PGIMER Chandigarh

drsen2017@gmail.com01722745078

Outcome results

None listed

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