vitiligo
Conditions
Interventions
Case series:None
Sponsors
Boao Super Hospital
Eligibility
Sex/Gender
All
Age
15 Years to 66 Years
Inclusion criteria
Inclusion criteria: (1) Age >=12 years old, male or female; (2) In patients clinically diagnosed with non-segmental vitiligo who were treated with ruxolitinib phosphate cream, the area of depigmentation was consistent with facial BSA>=0.5%, F-VASI>=0.5, and the overall area was not more than 10 %BSA; (3) The informed consent form is signed by the patient and his/her guardian, unless waived by the Ethics Committee of his/her institution; (4) Ruxolitinib cream was used for >=21 weeks and was returned to the hospital for a 24- week (+/- 21 days) efficacy and safety assessment.
Exclusion criteria
Exclusion criteria: (1) The patient has other skin pigmentation disorders; (2) Patients received medications or treatments that affected efficacy evaluations during the treatment period, such as other JAK inhibitors, potent immunosuppressants, oral or topical corticosteroids, calcineurin inhibitors.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of patients achieving F-VASI 75 (>=75% improvement from baseline in facial vitiligo area score (F-VASI)) at Week 24.; | — |
Secondary
| Measure | Time frame |
|---|---|
| Proportion of patients achieving F-VASI 50 (F-VASI improvement >=50% from baseline), F-VASI 90 (F-VASI improvement >=90% from baseline), and T-VASI 50 (total vitiligo area score index [total Vitiligo Area Scoring Index, T-VASI] improvement >=50% from baseline) at Week 24;;The proportion of patients who achieved the VNS of vitiligo at week 24 was relatively insignificant or no longer significant.;Change from baseline in facial BSA at Week 24;Improvement from baseline in facial and systemic vitiligo area score index (F-VASI and T-VASI) at each visit;Change from baseline in facial and systemic BSA at each visit;Proportion of patients achieving F-VASI50, F-VASI75, F-VASI90, and T-VASI50, T-VASI75, T-VASI90 per visit;;The proportion of patients with vitiligo visualization scale (VNS) at 12th and 18th weeks was relatively insignificant or no longer significant;;Change from baseline in Dermatological Quality of Life Index (Dermatology Life Quality Index, DLQI[for adult]) or Child Dermatological Quality of Life Index (children's Dermatology Life Quality Index, CDLQI) at each visit.;Proportion of patients at each visit with physician's overall assessment of vitiligo-systemic (total Physician's Global Vitiligo Assessment, T-PhGVA), and physician's global assessment of vitiligo-facial (facial Physician' s Global Vitiligo Assessment, F-PhGVA), scored as clear and almost clear;;The proportion of patients with vitiligo improvement overall impression-face (facial Patient's Global Impression of Change-Vitiligo, F-PaGIC-V) and vitiligo improvement overall impression-whole body (total Patient' s Global Impression of Change-Vitiligo, T-PaGIC-V) scores of very significant improvement and significant improvement at each visit.; | — |
Countries
China
Contacts
Public ContactXuejun Zhang
Boao Super Hospital
Outcome results
None listed