About this trial
This trial is a prospective, open-label, single-center, split face randomized controlled study comparing 1.5% topical Ruxolitinib cream twice daily (BD) to aqueous cream in treating non-segmental vitiligo (NSV) of the face and neck in patient previous failed to respond to topical tacrolimus 0.1%. Aqueous cream twice daily application will be used as control group treatment. Patients with stable NSV at least 0.5% of their total body surface area (BSA) on the face and neck, as determined by the fingertip method, are screened. Recruited subjects will be asked to review their impression of change of their lesion by the end of the study using a 7-point scale.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
18 - 85 year old
Have a clinical diagnosis of stable non-segmental vitiligo
Depigmentation including at least 0.5% of the BSA on the face and neck
Previously treated with topical tacrolimus 0.1% BD for at least 3 months without significant response
Disqualifiers
Patients who refuse to give consent
Presence of different vitiligo types or other skin depigmentation conditions like piebaldism or leprosy, etc.
History of using depigmentation treatments other than hydroquinone for vitiligo or pigmentation issues
Any skin condition affecting study participation, active skin infections one week before the study starts, issues impacting vitiligo evaluation, or serious health problems limiting involvement or increasing risk
Trial design
Crossover
Treatments tested in this trial
Ruxolitinib Cream 1.5%
Druga thin layer of the assigned topical to the selected lesions twice daily, maintaining at least an 8-hour interval between applications
Aqueous cream
Druga thin layer of the assigned topical to the selected lesions twice daily, maintaining at least an 8-hour interval between applications
Treatment groups
Trial outcomes
Primary outcomes
Degree of repigmentation at week 24 comparing to baseline
Comparing the degree of repigmentation of lesion site between baseline and week 24 with Physician global assessment of the degrees of repigmentation of the vitiligo lesions
Sponsors and contacts
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