Ruxolitinib Cream Combined With Corticosteroids for Progressive Non-Segmental Vitiligo: A Multicenter Real-World Study

Trial details

Who runs it

ShanShan Li

Trial code

NCT07673640

Record updated

8 September 2026

Original description

This study is a prospective, multicenter, real-world observational study to assess the clinical efficacy and safety of topical 1.5% Ruxolitinib phosphate cream used in combination with systemic corticosteroids in a real-world clinical setting. The study plans to observe patients aged 12 years and older with active, progressive non-segmental vitiligo involving the face. All treatments are prescribed based on standard routine clinical care and medical practice guidelines. Participants will apply Ruxolitinib cream twice daily to affected skin areas for up to 24 weeks alongside a standard corticosteroid regimen. The primary goal of the study is to evaluate how many patients achieve a 75% or greater improvement in their facial vitiligo patches after 12 weeks of combined treatment. Safety and side effects will also be closely monitored throughout the 24-week period.Read full original descriptionShow less

Efficacy and Safety of Ruxolitinib Phosphate Cream Combined With Corticosteroids in Patients With Progressive Non-Segmental Vitiligo: A Multicenter Real-World Study

This study is a prospective, multicenter, real-world observational study to assess the clinical efficacy and safety of topical 1.5% Ruxolitinib phosphate cream used in combination with systemic corticosteroids in a real-world clinical setting. The study plans to observe patients aged 12 years and older with active, progressive non-segmental vitiligo involving the face. All treatments are prescribed based on standard routine clinical care and medical practice guidelines. Participants will apply Ruxolitinib cream twice daily to affected skin areas for up to 24 weeks alongside a standard corticosteroid regimen. The primary goal of the study is to evaluate how many patients achieve a 75% or greater improvement in their facial vitiligo patches after 12 weeks of combined treatment. Safety and side effects will also be closely monitored throughout the 24-week period.

Inclusion: Age ≥ 12 years at the time of signing informed consent; Clinical diagnosis of non-segmental vitiligo with facial involvement, and total body surface area (BSA) depigmentation ≤ 10%; Diagnosed with progressive/active vitiligo meeting at least one of the following: Vitiligo Disease Activity (VIDA) score ≥ 3; Clinical signs including trichrome vitiligo, confetti-like depigmentation, or Koebner phenomenon; The extent of lesions under Wood's lamp is larger than that visible to the naked eye; Agrees to have no pregnancy plans and uses effective contraception during the study and up to 4 weeks after the last dose; Voluntarily signs the informed consent form and agrees to regular follow-up visits.

Exclusion: Contraindications to systemic corticosteroid use; Concurrent participation in other clinical studies; Co-existing skin depigmentation disorders affecting efficacy evaluation (e.g., pityriasis alba, leprosy, post-inflammatory hypopigmentation, progressive macular hypomelanosis, nevus anemicus, chemical leukoderma, tinea versicolor); Known hypersensitivity or allergy to the study medications or excipients; Known end-stage renal disease (ESRD) or currently undergoing renal replacement therapy (e.g., dialysis); Any other condition which, in the investigator's judgment, makes the patient unsuitable for the study; Diagnosis of other clinical forms of vitiligo (e.g., segmental vitiligo); Clinically diagnosed with stable vitiligo; Leukoderma lesions with more than 1/3 white hair, or lesions accompanied by white hair where the investigator assesses the probability of benefit from participating is low based on clinical experience.

ClinicalTrials.gov NCT07673640