Health Condition 1: L80- Vitiligo
Conditions
Interventions
Intervention1: Apremilast: Apremilast 30 mg twice daily oral tablets
Control Intervention1: OMP: Betamethasone 2.5 mg on Saturdays and sundays
Sponsors
All India Institute of Medical Sciences
Eligibility
Inclusion criteria
Inclusion criteria: Patients >18 years of age with progressive non-segmental vitiligo (developing new lesions in the past 1 month and/or extension of pre-existing lesions in the past 1 month, VIDA score +4) affecting body surface area >2%.
Exclusion criteria
Exclusion criteria: 1. Patients with segmental or stable vitiligo 2. Patients with non-segmental vitiligo involving body surface area 3. Pregnant and lactating females 4. Patients with known contra-indications to corticosteroids, ie, patients with evidence of active infection; diabetes; hypertension. 5. Patient with a known hypersensitivity to apremilast 6. On topical treatment for last 2 weeks. 7. On systemic treatment and /or phototherapy for last 4 weeks.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Percentage of patients with no new lesions and no extension of pre-existing lesions at every visit, in both the groups 2. Comparison of mean number of new vitiligo lesions during the study period (intra- and inter group comparison) 3. Mean reduction in VIDA score (intra- and inter-group comparison)Timepoint: Baseline, 2 weeks, 4 weeks, 2 months, 3 months, 6 months | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Comparison of VESplus. 2. Comparison of VASI 3. Comparison of % re-pigmentation between the two groups 4. Quality of life as assessed by VIS-22 5. Change in Th1, Th2, Th17 and Treg cell markers in the lesional skin 6. Comparison of side-effects between the two treatment groups Timepoint: Baseline, 2 weeks, 4 weeks, 2 months, 3 months, 6 months | — |
Countries
India
Contacts
Public ContactSaurabh Bhatia
All India Institute of Medical Sciences
Outcome results
None listed