Health Condition 1: L80- Vitiligo
Conditions
Interventions
Intervention1: Methotrexate 1% gel: Topical methotrexate 1% gel once daily will be applied over the patches of vitiligo after Fractional CO2 Laser.
Control Intervention1: 5-fluorouracil 5% cream: 5-fl
Sponsors
All India Institute of Medical Sciences Bhubaneswar Odisha
Eligibility
Inclusion criteria
Inclusion criteria: 1. Age >18 years 2. Patients with stable acral or acrofacial vitiligo and nonsegmental vitiligo having bilateral symmetrical lesions. 3. Two independent areas of size at least 1 x 1 cm or a single lesion with minimal size of at least 2 x 2 cm. 4. Patients who have not undergone any surgical management for the vitiligo.
Exclusion criteria
Exclusion criteria: 1. Patients with active vitiligo with signs of active vitiligo like confetti- like depigmentation, new lesions in the surrounding area, or the extension of existing lesions in the last 12 weeks. 2. History of keloidal tendency/hypertrophic or keloidal scarring 3. Collagen vascular disease and bleeding disorders 4. Any active bacterial, fungal or viral infection over the lesional site 5. Pregnant and lactating females 6. Age less than 18 years 7. Patients on anticoagulant therapy or aspirin 8. Patients with an unrealistic expectation
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of patients achieving 50% reduction in lesional vitiligo area & severity index (VASI) from baseline at five months.Timepoint: 5 months | — |
Secondary
| Measure | Time frame |
|---|---|
| â?¢ Time to achieve a 50% reduction in lesional VASI from baseline. â?¢ Proportion of patients achieving 75% reduction in lesional VASI from baseline at five months. â?¢ Time to achieve a 75% reduction in VASI from baseline. â?¢ Patient satisfaction using Patientsâ?? global assessment score. â?¢ Adverse events, if any.Timepoint: 5 months | — |
Countries
India
Contacts
Public ContactVishal Thakur
All India Institute of Medical Sciences, Bhubaneswar
Outcome results
None listed