VitiligoPhase 4NCT07368673
Comparative Effectiveness of Ruxolitinib Monotherapy Versus Its Combination With Tacrolimus and Corticosteroids in the Management of Vitiligo: A Randomized Controlled Trial
A Phase 4 study testing ruxolitinib cream in people with Vitiligo, run by Dow University of Health Sciences at 1 site in Pakistan.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Vitiligo
- What is being tested?
- ruxolitinib cream
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 sitePakistan
- Study dates
- 6 Apr 2025to 5 Jan 2026
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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
- Being tested
- ruxolitinib cream
- Keywords
- vitiligo, ruxolitinib, tacrolimus, janus kinase inhibitors, repigmentation
- Medical subject headings
- Vitiligo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ruxolitinib creamDrug
ruxolitinib cream applied topically twice daily to affected area for 24 weeks
| Study group | Role | What they receive |
|---|---|---|
| group a | Other | ruxolitinib monotherapy Receives: Drug: ruxolitinib cream |
| group b | Other | ruxolitinib with tacrolimus Receives: Drug: ruxolitinib cream |
| group c | Other | ruxolitinib with corticosteriods Receives: Drug: ruxolitinib cream |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: baseline to week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2026
- Study start6 Apr 2025
- Primary completion31 Dec 2025
- Study completion5 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for VitiligoStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- participants will be randomized into three parallel treatment arms recieving either topical ruxilitinib monotherapy or ruxolitinib in combination with topical tacrolimus or topical corticosteroids
- Masking
- None (open label)
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dow University of Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tayyaba Iqbal, Dow University of Health Sciences
- Investigators
- Dr Tayyaba iqbal, FCPS, Principal investigator, Dow University of Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07368673
- Sponsor's protocol ID
- UTF-8
- Status last verified
- Jan 2026
- First submitted
- 20 Jan 2026
- Last updated
- 26 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: individual participant data will not be shared due to ethical, institutional and confidentiality considerations
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Effectiveness of Ruxolitinib Monotherapy Versus Its Combination With Tacrolimus and Corticosteroids in the Management of Vitiligo: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07368673
- Acronym / sponsor ID
- UTF-8
- Conditions
- Vitiligo
- Keywords
- vitiligo, ruxolitinib, tacrolimus, janus kinase inhibitors, repigmentation
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Dow University of Health SciencesUniversity, hospital or other
- Study start
- 6 Apr 2025 (actual)
- Primary completion
- 31 Dec 2025 (actual)
- Study completion
- 5 Jan 2026 (actual)
- First posted
- 26 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- participants will be randomized into three parallel treatment arms recieving either topical ruxilitinib monotherapy or ruxolitinib in combination with topical tacrolimus or topical corticosteroids
| Arm | Type | Receives |
|---|---|---|
| group a | Other | Drug: ruxolitinib creamruxolitinib monotherapy |
| group b | Other | Drug: ruxolitinib creamruxolitinib with tacrolimus |
| group c | Other | Drug: ruxolitinib creamruxolitinib with corticosteriods |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ruxolitinib creamruxolitinib cream applied topically twice daily to affected area for 24 weeks | Drug | group a, group b, group c |
Primary outcome
change in VASI score
Time frame: baseline to week 24
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jan 2026.
- Individual participant dataSharing planned: No. individual participant data will not be shared due to ethical, institutional and confidentiality considerations
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dr Tayyaba iqbal, FCPS principal investigator
Dow University of Health Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing ruxolitinib cream in people with Vitiligo, run by Dow University of Health Sciences at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change in VASI score (time frame: baseline to week 24). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jan 2026.