Comparative Effectiveness of Ruxolitinib Monotherapy Versus Its Combination With Tacrolimus and Corticosteroids in the Management of Vitiligo: A Randomized Controlled Trial

Sponsor
Dow University of Health Sciences
Study ID
NCT07368673
Phase
PHASE4
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Accepted

Interventions

  • ruxolitinib cream — DRUG
    ruxolitinib cream applied topically twice daily to affected area for 24 weeks

Study Details

this randomized controlled trial aims to compare the effectiveness and safety of ruxolitinib monotherapy versus its combination with topical tacrolimus or topical corticosteroids in patients with non-segmental vitiligo involving less than 10% body surface area. A total of 120 adult patients will be randomized into three treatment groups and followed for 24 weeks. Treatment response will be evaluated using validated scoring systems including the Vitiligo Area Severity Index (VASI), Vitiligo European Task Force (VETF) staging, and Physician Global Assessment. The findings may help optimize topical treatment strategies for vitiligo.

Key Dates

Start date
Apr 6, 2025
Status verified
Jan 2026
Primary completion
Dec 31, 2025
Completion
Jan 5, 2026

Study Design

Enrollment
120 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Other: group a
    ruxolitinib monotherapy
  • Other: group b
    ruxolitinib with tacrolimus
  • Other: group c
    ruxolitinib with corticosteriods

Primary Outcome Measure

change in VASI score [ Time Frame: baseline to week 24 ]

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