An interventional study of Tacrolimus 0.1% ointment and Ruxolitinib 1.5% cream in Vitiligo and Nonsegmental Vitiligo, sponsored by Kafrelsheikh University. Enrolling by invitation at 1 site in Egypt. Open to participants aged 12 Years and older. Per ClinicalTrials.gov, last updated 2026-11-02.
Sponsored by Kafrelsheikh University · Not applicable, Interventional, and Treatment
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.
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.
343 studies on the registry are indexed under Vitiligo; 96 are open to participants now.
This study's planned enrollment of 40 is above the median of 36 across 265 interventional studies indexed under Vitiligo.
Browse Vitiligo studies →Kafrelsheikh University is the lead sponsor of 294 studies on the registry; 114 are open to participants now.
Of its 10 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Tacrolimus 0.1% ointment applied twice daily for 24 weeks, plus 10 sessions of 308-nm excimer laser therapy administered twice weekly.
Drug: Tacrolimus 0.1% ointment · Device: 308-nm excimer laser
Ruxolitinib 1.5% cream twice daily for 24 weeks plus 10 sessions of 308-nm excimer laser therapy, twice weekly.
Drug: Ruxolitinib 1.5% cream · Device: 308-nm excimer laser
Topical application every 12 hours for 24 weeks.
Topical application every 12 hours for 24 weeks
10 treatment sessions, twice weekly, administered to both groups.
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
Time frame: until week 24
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)
Satisfaction-Based Scale (Direct measurement of satisfaction) * 1 - Very Dissatisfied * 2 - Dissatisfied * 3 - Neutral (or Neither Satisfied nor Dissatisfied) * 4 - Satisfied * 5 - Very Satisfied
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.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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Studies of the drug tested here: Ruxolitinib