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

NCT07368673 | Completed Phase 4 DMC

• 1 other identifier: UTF-8
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Vitiligo

Keywords

vitiligo, ruxolitinib, tacrolimus, janus kinase inhibitors, repigmentation

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (3)

group a

OTHER

ruxolitinib monotherapy

Drug: ruxolitinib cream

group b

OTHER

ruxolitinib with tacrolimus

Drug: ruxolitinib cream

group c

OTHER

ruxolitinib with corticosteriods

Drug: ruxolitinib cream

Interventions

ruxolitinib cream DRUG

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

group a; group b; group c

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Dow University of Health Sciences: lead

Study Sites (1)

Dow University of health sciences

Karachi, Sindh, Pakistan

Location

MeSH Terms

Conditions

Vitiligo

Condition Hierarchy (Ancestors)

Hypopigmentation; Pigmentation Disorders; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Dr Tayyaba iqbal, FCPS

  Dow University of Health Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: this is an open label study in which participants and investigators are aware of treatment allocation
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: DR tAYYABA iQBAL

Model Details: participants will be randomized into three parallel treatment arms recieving either topical ruxilitinib monotherapy or ruxolitinib in combination with topical tacrolimus or topical corticosteroids

Study Record Dates

• First Submitted: January 20, 2026
• First Posted: January 26, 2026
• Study Start: April 6, 2025
• Primary Completion: December 31, 2025
• Study Completion: January 5, 2026
• Last Updated: January 26, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)