To evaluate the efficacy and safety of 5-fluorouracil 5% cream versus tacrolimus 0.1% ointment versus stand alone with microneedling device in clinically stable vitiligo patients
Phase 2
- Registration Number
- CTRI/2023/11/059621
- Lead Sponsor
- Dr Sushnitha Johnson
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
1.All patients aged from 18 to 50 years with localized & stable vitiligo for a year willing to come for regular follow up. 2.No history of topical application for 2 weeks, oral medication for 4 weeks, phototherapy and excimer laser for 8 weeks when enrolled in the study. 3.Patients with 3 or more stable vitiligo patches
Exclusion Criteria
1.Pregnant or lactating women
2.Presence of Bleeding /coagulation disorders
3.Past history of keloidal tendency
4.Patients with active infections
5.Patients with known allergy to 5-fluorouracil, tacrolimus
6.Immunosuppressed patients
7.Any concomitant skin conditions over the vitiligo patch
8.Mucosal and palmoplantar vitiligo
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To evaluate the efficacy of microneedling combined with 5-fluorouracil 5% cream versus the efficacy of microneedling combined with tacrolimus 0.1% ointment versus microneedling alone in clinically stable vitiligo patientTimepoint: one year
- Secondary Outcome Measures
Name Time Method To evaluate the safety of microneedling combined with 5-fluorouracil 5% cream versus the safety of microneedling combined with tacrolimus 0.1% ointment versus microneedling alone in clinically stable vitiligo patientsTimepoint: one year