Vitiligo
Conditions
Interventions
Treatment group:Use 1.5% rapamycin phosphate cream for monotherapy twice daily (BID) until the 52nd week.
Sponsors
Children's Hospital of Fudan University
Eligibility
Sex/Gender
All
Age
12 Years to 18 Years
Inclusion criteria
Inclusion criteria: 1.At the time of signing the informed consent form, participants must be between 12 and 18 years of age (inclusive), regardless of gender. 2.Patients clinically diagnosed with non-segmental vitiligo who also have white patches on the face. The total area of depigmentation on the body does not exceed 10% of BSA. 3.The patient's guardian voluntarily signed the informed consent form, agreeing to periodic follow-up visits.
Exclusion criteria
Exclusion criteria: 1.Diagnosing other forms of vitiligo (such as segmental vitiligo). 2.Patients with other skin depigmentation disorders that may affect the assessment of treatment efficacy (such as piebaldism, pityriasis alba, leprosy, post-inflammatory hypopigmentation, progressive macular hypomelanosis, nevus anemic, chemical leukoderma, and tinea versicolor, etc.). 3.Past or current use of depigmentation treatments. 4.A history of failure of treatment with any systemic or topical JAK inhibitor for vitiligo or any other inflammatory disease. 5.Allergy to therapeutic drugs and excipients. 6.Participate in other clinical trials. 7.The researcher determined that the participant was not suitable for this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Week 24: Proportion of study participants with a >=75% improvement in the Facial Vitiligo Area Score Index (F-VASI) compared to baseline; | — |
Secondary
| Measure | Time frame |
|---|---|
| Proportion of patients who achieved a T-VASI score of 50/75/90 at 12 weeks,24 weeks, 36 weeks, and 52 weeks;Proportion of patients with a Visual Numeric Scale (VNS) score of 4 (relatively inconspicuous) or 5 (no longer visible) at 12, 24, 36, and 52 weeks, and the proportion of patients in each category;Proportion of patients who achieved an F-VASI score of 75 at 12 weeks, 36 weeks, and 52 weeks;Changes in F-BSA, T-BSA, F-VASI, and T-VASI scores at 12, 24, 36, and 52 weeks relative to baseline;Proportion of patients who achieved an F-VASI score of 50/90 at 12 weeks, 24 weeks, 36 weeks, and 52 weeks;Adverse Event;CDLQI scores at 12, 24, 36, and 52 weeks relative to baseline; | — |
Countries
China
Contacts
Public ContactLi Ming
Children's Hospital of Fudan University
Outcome results
None listed