Vitiligo
Conditions
Interventions
Glucocorticoid–tofacitinib group:Prednisolone acetate + tofacitinib
Sponsors
Department of Dermatology, Huashan Hospital, Fudan University, Shanghai, China
Eligibility
Sex/Gender
All
Age
12 Years to 65 Years
Inclusion criteria
Inclusion criteria: Subjects aged 12–65 years with a clinical diagnosis of segmental vitiligo (SV) who meet at least one of the following criteria indicating a progressive disease stage: (1) Appearance of new lesions or enlargement of existing lesions within the past 6 months; (2) Clinical features such as confetti-like depigmentation, trichrome vitiligo, blurred lesion borders, inflammatory vitiligo, or hypopigmented macules; (3) Presence of the Koebner phenomenon (development of depigmented lesions at sites of physical, chemical, allergic, irritant, therapeutic, or inflammatory injury within 6 months); (4) Lesion area under natural light smaller than that under Wood’s lamp examination. Participants should be able to provide accurate responses based on their actual condition and must voluntarily sign the informed consent form.
Exclusion criteria
Exclusion criteria: Presence of other active dermatologic diseases that may interfere with study evaluation; History or current presence of infectious diseases, such as active hepatitis B or C infection, tuberculosis, herpes zoster, herpes simplex, HIV antibody positivity, or other active infections; Severe systemic diseases, including cardiovascular disorders, hepatic insufficiency, moderate to severe renal impairment, history of organ transplantation, malignancy, severe diabetes in elderly patients, or psychiatric disorders; Use of systemic glucocorticoids within the past month; Prior exposure to JAK inhibitors or other systemic immunosuppressive therapies; Pregnant or breastfeeding women; Known hypersensitivity to study medications (JAK inhibitors or systemic glucocorticoids); and inability to complete the study treatment and follow-up.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| T-VASI-50 response rate at week 24 of treatment; | — |
Secondary
| Measure | Time frame |
|---|---|
| Percentage change in F-VASI from baseline; | — |
Countries
China
Contacts
Public ContactZhang Chengfeng
Department of Dermatology, Huashan Hospital, Fudan University, Shanghai, China
Outcome results
None listed