Health Condition 1: L80- Vitiligo
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Patients 12 to 60 years of age having at least two comparable or symmetric or lesions suitable for intraindividual comparison vitiligo lesions. 2. Patients with localized vitiligo less than10% body surface area. 3. Stable vitiligo for at least 6 months prior to enrolment, defined by no new lesions or expansion of existing lesions. 4. Vitiligo Disease Activity score of 0 1, indicating stable or minimally active disease. 5. Patients who have not been on any biologic drug for 12 weeks, no phototherapy within 8 weeks, no immunomodulating treatment within 4 weeks and no topical treatments within 1 week. 6. Willingness to comply with study procedures and avoid other vitiligo treatments during the trial.
Exclusion criteria
Exclusion criteria: 1. Active or progressive vitiligo (VIDA score greater 1). 2. History of hypersensitivity to tacrolimus, laser therapy or excimer light. 3. Concomitant skin conditions (e.g., psoriasis, eczema) that could interfere with assessments. 4. Systemic immunosuppressive therapy within 4 weeks or topical treatments (including JAK inhibitor) within 4 weeks prior to enrolment. 5. Comorbidities such as active infection, malignancy, history of thromboembolic episodes, past or present smoker or severe hepatic/renal impairment. 6. Pregnancy, lactation or inadequate contraception in women of childbearing potential
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Global response in repigmentation, assessed using: Physician Global Assessment of Repigmentation (PhGA-R) Patient Global Assessment of Repigmentation (PtGA-R) Assessment Timeline: Week 8 and Week 16Timepoint: After week 16 | — |
Secondary
| Measure | Time frame |
|---|---|
| Patient satisfaction measured by Vitiligo Noticeability Scale (VNS) at Week 8 and Week 16 Time to onset of repigmentation, defined as gtreaterthen or equal 10% repigmentation of target lesions confirmed on two consecutive assessments Durability of repigmentation, including maintenance of response and relapse rates at Week 24 (8 weeks post-treatment)Timepoint: After week 16 | — |
Countries
India
Contacts
CUTIS Academy of Cutaneous Sciences