NCT07368673

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 120 (actual)
• Sponsor: Dow University of Health Sciences · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

Vitiligo is an acquired autoimmune skin disorder characterized by selective destruction of melanocytes, resulting in depigmented macules and patches affecting the skin, hair, and mucosa. The condition affects approximately 0.5-2% of the global population and can occur in both genders equally. Beyond its cutaneous manifestations, vitiligo has a profound psychosocial impact, often leading to reduced self-esteem and impaired quality of life. The pathogenesis of vitiligo is multifactorial, involving genetic susceptibility, oxidative stress, immune dysregulation, and melanocyte apoptosis. Increased reactive oxygen species play a pivotal role in triggering melanocyte damage, particularly in genetically predisposed individuals. Conventional therapies, including topical corticosteroids, calcineurin inhibitors, and phototherapy, often yield variable results with frequent relapse. Ruxolitinib, a topical Janus kinase (JAK) inhibitor, represents a novel targeted therapy that modulates the JAK-STAT signaling pathway involved in inflammatory cytokine signaling. It has demonstrated promising efficacy and an acceptable safety profile in non-segmental vitiligo. While ruxolitinib monotherapy is effective, the potential synergistic benefits of combining it with other topical immunomodulators such as tacrolimus or topical corticosteroids remain insufficiently studied. This randomized controlled trial is designed to compare the clinical effectiveness of ruxolitinib monotherapy with its combination therapy using tacrolimus or topical corticosteroids. The study will be conducted in the outpatient dermatology department at Dow University of Health Sciences, Karachi, over a period of six months. A total of 120 adult patients aged 18-65 years with non-segmental vitiligo involving less than 10% body surface area will be enrolled. Participants will be randomly assigned into three groups: Group A: Topical ruxolitinib cream twice daily Group B: Tacrolimus 0.1% ointment in the morning plus ruxolitinib cream at night Group C: Topical fluticasone 0.05% cream in the morning plus ruxolitinib cream at night Clinical assessments will be performed at baseline and at weeks 4, 8, 16, and 24. Treatment efficacy will be evaluated using the Vitiligo Area Severity Index (VASI), Vitiligo European Task Force (VETF) staging, and Physician Global Assessment scores. Safety will be assessed by monitoring adverse effects throughout the study duration. The results of this study are expected to provide evidence regarding the comparative effectiveness and safety of combination topical therapy versus ruxolitinib monotherapy, potentially guiding improved treatment strategies for patients with vitiligo.

Conditions

• Vitiligo

Interventions

Type	Name	Description
DRUG	ruxolitinib cream	ruxolitinib cream applied topically twice daily to affected area for 24 weeks

Timeline

• Start date: 2025-04-06
• Primary completion: 2025-12-31
• Completion: 2026-01-05
• First posted: 2026-01-26
• Last updated: 2026-01-26

Locations

1 site across 1 country: Pakistan