VitiligoNCT07909668
Topical Ruxolitinib Versus Tacrolimus With Excimer Laser for Localized Vitiligo
A study testing Tacrolimus 0.1% ointment, Ruxolitinib 1.5% cream and 308-nm excimer laser in people with Vitiligo and Nonsegmental Vitiligo, run by Kafrelsheikh University at 1 site in Egypt.
Trial summary
This randomized comparative study will evaluate the efficacy and safety of topical ruxolitinib 1.5% cream compared with topical tacrolimus 0.1% ointment, each combined with 308-nm excimer laser therapy, in patients aged 12 years or older with stable localized non-segmental facial vitiligo. Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Vitiligo, Nonsegmental Vitiligo
- What is being tested?
- Tacrolimus 0.1% ointment, Ruxolitinib 1.5% cream and 308-nm excimer laser
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jul 2026to 1 Jan 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 12 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Stable localized non-segmental facial vitiligo.
- Age 12 years or older.
- Nonsmoker.
- No vitiligo treatment during the preceding 6 months.
- Selected lesion surface area less than 20 cm2.
Who cannot join
- Pregnancy or lactation.
- Vitiligo treatment within the previous 6 months.
- Diabetes mellitus.
- Collagen vascular disease or other autoimmune disease.
- Relevant systemic illness, other skin disease, drug allergy, or contraindication identified during screening.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Clinical and Histopathological Evaluation of Excimer Laser With Topical Ruxolitinib 1.5% or Tacrolimus 0.1% in Localized Vitiligo: A Randomized Comparative Study
This randomized comparative study will evaluate the efficacy and safety of topical ruxolitinib 1.5% cream compared with topical tacrolimus 0.1% ointment, each combined with 308-nm excimer laser therapy, in patients aged 12 years or older with stable localized non-segmental facial vitiligo. Forty participants will be randomly assigned in a 1:1 ratio to receive one of the topical treatments twice daily for 24 weeks plus excimer laser treatment. Clinical, dermoscopic, patient-reported, and histopathological outcomes will be assessed before and after treatment, with follow-up for recurrence.
Read the detailed description
Eligible participants with stable localized facial non-segmental vitiligo and selected lesions under 20 cm2 will receive either topical tacrolimus 0.1% ointment or topical ruxolitinib 1.5% cream twice daily for 24 weeks. Both groups will receive 10 sessions of 308-nm excimer laser therapy, administered twice weekly. Participants will attend every two weeks during treatment and monthly during a three-month post-treatment follow-up. Repigmentation will be assessed clinically by blinded physicians using the Physician Global Assessment, together with dermoscopic evaluation, participant satisfaction, photographs, and histopathological assessment.
- Conditions
- Vitiligo, Nonsegmental Vitiligo
- Being tested
- Tacrolimus 0.1% ointment, Ruxolitinib 1.5% cream, 308-nm excimer laser
- Keywords
- Localized vitiligo, Ruxolitinib, Tacrolimus, Excimer laser, Phototherapy, Physician Global Assessment
- Medical subject headings
- Vitiligo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tacrolimus 0.1% ointmentDrug
Topical application every 12 hours for 24 weeks.
Ruxolitinib 1.5% creamDrug
Topical application every 12 hours for 24 weeks
308-nm excimer laserDevice
10 treatment sessions, twice weekly, administered to both groups.
| Study group | Role | What they receive |
|---|---|---|
| Tacrolimus plus excimer laser | Active comparator | Tacrolimus 0.1% ointment applied twice daily for 24 weeks, plus 10 sessions of 308-nm excimer laser therapy administered twice weekly. Receives: Drug: Tacrolimus 0.1% ointment; Device: 308-nm excimer laser |
| Ruxolitinib plus excimer laser | Experimental | Ruxolitinib 1.5% cream twice daily for 24 weeks plus 10 sessions of 308-nm excimer laser therapy, twice weekly. Receives: Drug: Ruxolitinib 1.5% cream; Device: 308-nm excimer laser |
What is being measured
The primary outcome is the main question the study is designed to answer.
Degree of repigmentation by Physician Global Assessment (PGA)
Assessed at baseline and at week 24. Repigmentation categories are no change, mild (1%-25%), moderate (26%-50%), good (51%-75%), and excellent (>75%). Assessment is performed by two blinded clinicians by consensus
Measured: until week 24
Secondary outcomes (5)
Dermoscopic patterns and degree of repigmentation
Measured: until week 24
Vitiligo Extent Tensity Index score
Measured: until week 24
Patient satisfaction (A 5-point Likert scale)
Satisfaction-Based Scale (Direct measurement of satisfaction)
- 1 - Very Dissatisfied
- 2 - Dissatisfied
- 3 - Neutral (or Neither Satisfied nor Dissatisfied)
- 4 - Satisfied
- 5 - Very Satisfied
Measured: 6 months after treatment.
Recurrence of depigmentation
Measured: 3 months after treatment
Treatment safety/adverse events
Measured: 6 months after treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2026
- Study start1 Jul 2026
- Primary completion1 Dec 2026 (estimated)
- Study completion1 Jan 2027 (estimated)
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.
- More trials run by Kafrelsheikh UniversityThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kafrelsheikh University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Noura Abdelmoneim Mohammed Elseessy, Kafrelsheikh University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07909668
- Sponsor's protocol ID
- KFSIRB200-1156
- Status last verified
- Oct 2026
- First submitted
- 18 Oct 2026
- Last updated
- 2 Nov 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical and Histopathological Evaluation of Excimer Laser With Topical Ruxolitinib 1.5% or Tacrolimus 0.1% in Localized Vitiligo: A Randomized Comparative Study
- ClinicalTrials.gov ID
- NCT07909668
- Acronym / sponsor ID
- KFSIRB200-1156
- Conditions
- Vitiligo, Nonsegmental Vitiligo
- Keywords
- Localized vitiligo, Ruxolitinib, Tacrolimus, Excimer laser, Phototherapy, Physician Global Assessment
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Kafrelsheikh UniversityUniversity, hospital or other
- Study start
- 1 Jul 2026 (actual)
- Primary completion
- 1 Dec 2026 (estimated)
- Study completion
- 1 Jan 2027 (estimated)
- First posted
- 2 Nov 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 comparative study will evaluate the efficacy and safety of topical ruxolitinib 1.5% cream compared with topical tacrolimus 0.1% ointment, each combined with 308-nm excimer laser therapy, in patients aged 12 years or older with stable localized non-segmental facial vitiligo. Forty participants will be randomly assigned in a 1:1 ratio to receive one of the topical treatments twice daily for 24 weeks plus excimer laser treatment. Clinical, dermoscopic, patient-reported, and histopathological outcomes will be assessed before and after treatment, with follow-up for recurrence.
Detailed description
Eligible participants with stable localized facial non-segmental vitiligo and selected lesions under 20 cm2 will receive either topical tacrolimus 0.1% ointment or topical ruxolitinib 1.5% cream twice daily for 24 weeks. Both groups will receive 10 sessions of 308-nm excimer laser therapy, administered twice weekly. Participants will attend every two weeks during treatment and monthly during a three-month post-treatment follow-up. Repigmentation will be assessed clinically by blinded physicians using the Physician Global Assessment, together with dermoscopic evaluation, participant satisfaction, photographs, and histopathological assessment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tacrolimus plus excimer laser | Active comparator | Drug: Tacrolimus 0.1% ointment, Device: 308-nm excimer laserTacrolimus 0.1% ointment applied twice daily for 24 weeks, plus 10 sessions of 308-nm excimer laser therapy administered twice weekly. |
| Ruxolitinib plus excimer laser | Experimental | Drug: Ruxolitinib 1.5% cream, Device: 308-nm excimer laserRuxolitinib 1.5% cream twice daily for 24 weeks plus 10 sessions of 308-nm excimer laser therapy, twice weekly. |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- Stable localized non-segmental facial vitiligo.
- Age 12 years or older.
- Nonsmoker.
- No vitiligo treatment during the preceding 6 months.
- Selected lesion surface area less than 20 cm2.
Key exclusion criteria (5 listed)
- Pregnancy or lactation.
- Vitiligo treatment within the previous 6 months.
- Diabetes mellitus.
- Collagen vascular disease or other autoimmune disease.
- Relevant systemic illness, other skin disease, drug allergy, or contraindication identified during screening.
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 |
|---|---|---|
| Tacrolimus 0.1% ointmentTopical application every 12 hours for 24 weeks. | Drug | Tacrolimus plus excimer laser |
| Ruxolitinib 1.5% creamTopical application every 12 hours for 24 weeks | Drug | Ruxolitinib plus excimer laser |
| 308-nm excimer laser10 treatment sessions, twice weekly, administered to both groups. | Device | Ruxolitinib plus excimer laser, Tacrolimus plus excimer laser |
Primary outcome
Degree of repigmentation by Physician Global Assessment (PGA)
Time frame: until week 24
Assessed at baseline and at week 24. Repigmentation categories are no change, mild (1%-25%), moderate (26%-50%), good (51%-75%), and excellent (>75%). Assessment is performed by two blinded clinicians by consensus
5 secondary outcomes
Dermoscopic patterns and degree of repigmentation
Time frame: until week 24
Vitiligo Extent Tensity Index score
Time frame: until week 24
Patient satisfaction (A 5-point Likert scale)
Time frame: 6 months after treatment.
Recurrence of depigmentation
Time frame: 3 months after treatment
Treatment safety/adverse events
Time frame: 6 months after treatment.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2026.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tacrolimus 0.1% ointment, Ruxolitinib 1.5% cream and 308-nm excimer laser in people with Vitiligo and Nonsegmental Vitiligo, run by Kafrelsheikh University at 1 site in Egypt.
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 5 inclusion and 5 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: enrolling by invitation, as of the sponsor's last update on 2 Nov 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 Egypt. 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.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
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?
Degree of repigmentation by Physician Global Assessment (PGA) (time frame: until 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 2 Nov 2026.