Comparison of efficacy of 5-FU cream and methotrexate gel in acral vitiligo lesions
- Conditions
- Health Condition 1: L80- Vitiligo
- Registration Number
- CTRI/2023/07/055546
- Lead Sponsor
- All India Institute of Medical Sciences Bhubaneswar Odisha
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
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.
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Proportion of patients achieving 50% reduction in lesional vitiligo area & severity index (VASI) from baseline at five months.Timepoint: 5 months
- Secondary Outcome Measures
Name Time Method â?¢ Time to achieve a 50% reduction in lesional VASI from baseline. <br/ ><br>â?¢ Proportion of patients achieving 75% reduction in lesional VASI from baseline at five months. <br/ ><br>â?¢ Time to achieve a 75% reduction in VASI from baseline. <br/ ><br>â?¢ Patient satisfaction using Patientsâ?? global assessment score. <br/ ><br>â?¢ Adverse events, if any.Timepoint: 5 months