Health Condition 1: L80- Vitiligo
Conditions
Interventions
Intervention1: Non cultured epidermal cell suspension (NCES) plus placebo: NCES is a type of vitiligo surgery Placebo BD x 9 months
Control Intervention1: Non cultured epidermal cell suspension (NCES)
Sponsors
All India Institute of Medical Sciences
Eligibility
Inclusion criteria
Inclusion criteria: 1. Adult (18-65 years) patients with non-segmental (generalized, acrofacial, focal) slowly progressive vitiligo or clinically stable for less than 1 year (0-9 months) 2. Vitiligo patch of size 2.5-25 cm2, that is unresponsive or partially responsive to medical treatment x more than 3 months
Exclusion criteria
Exclusion criteria: 1. Patients with segmental vitiligo 2. Patients with vitiligo of clinical disease stability more than 1 year 3. Patients with rapidly progressive vitiligo (more than 5 patches in the last one month and/or more than 15 patches in last 3 months) 4. Patients with keloidal or bleeding tendency 5. Patients on topical treatment for last 2 weeks, and on phototherapy or systemic treatment for last 4 weeks 6. Patients with concomitant inflammatory skin diseases or autoimmune diseases requiring systemic immunosuppressive treatment 7. Patients with active or latent tuberculosis or other systemic infection or any other contra-indication to tofacitinib (as per investigators judgement) 8. Children, adults (more than 65 years), pregnant or lactating women with vitiligo 9. Women of child bearing potential not willing to observe sexual abstinence or use contraceptive during the period of oral treatment and 6 weeks beyond 10. Vitiligo patch less than 2.5cm2 or more than 25cm2 size 11. Patches on sites such as palms, soles, fingers and toes
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of patients with more than or equal to 75% repigmentation in the treated vitiligo patch at 6 months in both groupsTimepoint: Proportion of patients with more than or equal to 75% repigmentation in the treated vitiligo patch at 6 months in both groups | — |
Secondary
| Measure | Time frame |
|---|---|
| 1.Proportion of patients with 75% repigmentation in the treated vitiligo patch at 1 year, in both groups 2.Mean time to achieve 75% repigmentation in the treated vitiligo patch in both groups 3.Mean percentage repigmentation in the treated vitiligo patch at 6 months and 1 year, in both groups 4.Proportion of patients with residual achromic fissure in the treated vitiligo patch at 6 months, in both groups 5.Proportion of patients with a Vitiligo noticeability scale score of 4 or more in both groups 6. Comparison in the skin lesional and blood biomarkers with tofacitinib vs placebo priming 7.Proportion of patients with treatment-related adverse events in both groups 8. Proportion of patients with donor site depigmentation/Koebner phenomenon 9. Proportion of patients requiring rescue treatment in both groups Timepoint: 12 months | — |
Countries
India
Contacts
Public ContactVishal Gupta
All India Institute of Medical Sciences
Outcome results
None listed