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

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.

Study Overview

• Status: Completed
• Conditions: Vitiligo
• Intervention / Treatment: Drug: ruxolitinib cream

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.

• Study Type: Interventional
• Enrollment (Actual): 120
• Phase: Phase 4

Contacts and Locations

Study Locations

• Pakistan
  • Sindh
    • Karachi, Sindh, Pakistan
      • Dow University of Health Sciences

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• adult aged 18 to 65 years male or female patients non-segmental vitiligo vitiligo involving less then 10% body surface area willingness to provide written informed consent

Exclusion Criteria:

• pregnant or lactating females known hypersentivity to ruxolitinib, tacrolimus or topical corticosteriods current use of systemic immunosuppressive therapy use of biologic therapy or phototherapy within the previous 12 weeks

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: group a; ruxolitinib monotherapy	Drug: ruxolitinib cream; ruxolitinib cream applied topically twice daily to affected area for 24 weeks
Other: group b; ruxolitinib with tacrolimus	Drug: ruxolitinib cream; ruxolitinib cream applied topically twice daily to affected area for 24 weeks
Other: group c; ruxolitinib with corticosteriods	Drug: ruxolitinib cream; ruxolitinib cream applied topically twice daily to affected area for 24 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
change in VASI score	the VASI will be used to assess the extent and degree of depigmentation. change in total VASI score from base line will be calculated to evaluate treatment efficacy	baseline to week 24

Collaborators and Investigators

• Sponsor: Dow University of Health Sciences
• Investigators: Principal Investigator: Dr Tayyaba iqbal, FCPS, Dow University of Health Sciences

Study record dates

Study Major Dates

• Study Start (Actual): April 6, 2025
• Primary Completion (Actual): December 31, 2025
• Study Completion (Actual): January 5, 2026

Study Registration Dates

• First Submitted: January 20, 2026
• First Submitted That Met QC Criteria: January 20, 2026
• First Posted (Actual): January 26, 2026

Study Record Updates

• Last Update Posted (Actual): January 26, 2026
• Last Update Submitted That Met QC Criteria: January 20, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: vitiligo, ruxolitinib, tacrolimus, janus kinase inhibitors, repigmentation
• Additional Relevant MeSH Terms: Skin Diseases; Hypopigmentation; Pigmentation Disorders; Skin and Connective Tissue Diseases; Vitiligo
• Other Study ID Numbers: UTF-8

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: individual participant data will not be shared due to ethical, institutional and confidentiality considerations

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No