Non-segmental vitiligo
Conditions
Interventions
Ruxolitinib Phosphate Cream combined with phototherapy group:None
Ruxolitinib phosphate cream monotherapy group:None
The group treated with ruxolitinib phosphate cream combined with total glucosides of paeony:None
Sponsors
China-Japan Friendship Hospital
Eligibility
Sex/Gender
All
Age
12 Years to No maximum
Inclusion criteria
Inclusion criteria: 1.When signing the informed consent form, the age shall be 12 years old and above, with no gender restriction. 2.Study participants with a clinical diagnosis of non-segmental vitiligo accompanied by facial involvement, with an overall total body depigmented area not exceeding 10% BSA. 3.Agree to have no fertility plans during the trial and within 4 weeks after the last administration, and voluntarily take effective contraceptive measures. 4.The study participants voluntarily signed informed consent and agreed to regular follow-up.
Exclusion criteria
Exclusion criteria: 1.Suffering from other skin depigmentation diseases that affect the judgment of therapeutic efficacy (such as pityriasis alba, leprosy, post-inflammatory hypopigmentation, progressive macular hypomelanosis, nevus anemicus, chemical leukoderma, tinea versicolor, etc.); 2.Patients with more than one-third of white hair in the leukoplakia area, or those with white hair in the leukoplakia area and who are assessed to have a low possibility of benefiting from the study based on clinical diagnosis and treatment experience. 3.People with contraindications to phototherapy, such as photosensitive diseases and xeroderma pigmentosum. 4.Patients with known end-stage renal disease (ESRD) or those undergoing renal replacement therapy (such as dialysis); 5.Currently participating in other clinical studies. 6.People who are allergic to or have contraindications to therapeutic drugs and excipients; 7.The researcher determined that they were not suitable for this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The rate of change from baseline in the whole body vitiligo area score index (T-VASI) at week 24; | — |
Secondary
| Measure | Time frame |
|---|---|
| The rate of change in T-VASI score from baseline to 12 weeks, 36 weeks and 52 weeks;Proportion of study participants achieving F-VASI 50/75/90 at 12, 24, 36, and 52 weeks;Proportion of study participants achieving T-VASI 50/75/90 at 12, 24, 36, and 52 weeks;The rate of change in F-BSA, T-BSA, and F-VASI scores from baseline to 12 weeks, 24 weeks, 36 weeks, and 52 weeks were compared;The Vitiligo Visualization Scale (VNS) score was 4 at 12, 24, 36, and 52 weeks (vs Not evident) or score 5 (no longer evident) and study participation in each category Proportion of persons;The rate of change from baseline in DLQI/CDLQ score at 12, 24, 36, and 52 weeks; | — |
Countries
China
Contacts
Public ContactCui Yong
China-Japan Friendship Hospital
Outcome results
None listed