Health Condition 1: O- Medical and Surgical Health Condition 2: L80- Vitiligo
Conditions
Interventions
Intervention1: Non-cultured epidermal suspension (NCES) and Tofacitinib: NCES is a type of vitiligo surgery
Tofacitinib is a JAK-inhibitor oral drug
Tofacitinib dose is 5mg BD x 9 months
Control Inter
Sponsors
All India Institute of Medical Sciences
Eligibility
Inclusion criteria
Inclusion criteria: Adult ( >18 years) patients with non-segmental (generalized, acrofacial, focal) vitiligo clinically stable for <1 (3-12 months) year (VIDA Score +1 or +2)
Exclusion criteria
Exclusion criteria: 1. Children, pregnant or lactating women with vitiligo 2. Patients with segmental vitiligo 3. Patients with vitiligo of clinical disease stability >1 year (VIDA score 0 or -1) 4. Patients with vitiligo of clinical disease stability 5. Patients with keloidal or bleeding tendency 6. Patients on topical treatment for last 2 weeks, and on phototherapy/systemic treatment for last 4 weeks 7. Patients with active tuberculosis / other systemic infection or any other contra-indication to tofacitinib 8. Patients with latent tuberculosis, who refuse prophylactic anti-tubercular treatment (Patients who have evidence of latent TB may be enrolled if they complete at least 4 weeks of appropriate treatment prior to randomization and agree to complete the remainder of treatment while in the trial) 9. Vitiligo patch 100cm2
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1.Proportion of patients with 80% repigmentation in the treated vitiligo patch at 6 months & 1 year, in both groups 2.Mean percentage repigmentation in the treated vitiligo patch at 6 months & 1 year, in both groups Timepoint: 0.5, 1 year | — |
Secondary
| Measure | Time frame |
|---|---|
| -Timepoint: - | — |
Countries
India
Contacts
Public ContactVishal Gupta
AIIMS, New Delhi
Outcome results
None listed