Non-segmental vitiligo
Conditions
Interventions
Monotherapy/combination therapy observation group:None
Sponsors
The First Hospital of China Medical University
Eligibility
Sex/Gender
All
Age
12 Years to No maximum
Inclusion criteria
Inclusion criteria: 1.Informed consent will be obtained from participants aged =12 years, regardless of gender; 2.Participants with a clinical diagnosis of non-segmental vitiligo with depigmented lesions on the face and total body vitiligo area not exceeding 10% of BSA; 3.Male and female participants must agree to have no reproductive plans during the study period and for at least 4 weeks after the last dose of study treatment, and to voluntarily use effective contraceptive measures to prevent pregnancy; 4.Participants must fully understand the study procedures, voluntarily participate in the trial, agree to comply with scheduled follow-up visits, and sign the ICF.
Exclusion criteria
Exclusion criteria: 1.Participants with a known history of hypersensitivity to the investigational product (ruxolitinib cream) or other Janus kinase (JAK) inhibitors; 2.Participants with more than one-third of white hair in depigmented lesions, or those judged to have low expected benefit based on clinical experience; 3.History of allergy or intolerance to phototherapy (e.g., narrow-band ultraviolet B, 308 nm excimer laser, home phototherapy) or photochemotherapy; absolute contraindications to phototherapy (including inherited photosensitive skin diseases such as xeroderma pigmentosum, erythropoietic protoporphyria, Cockayne syndrome, Bloom syndrome, albinism, history of malignant melanoma, and systemic lupus erythematosus); or relative contraindications to phototherapy that make trial participation inappropriate per investigator assessment (including cataracts, familial melanoma history, non-melanoma skin cancer, premalignant skin lesions, history of radiation or arsenic exposure, and oral cyclosporine use); 4.Participants with other types of vitiligo (e.g., segmental vitiligo), or other depigmenting skin disorders that may affect efficacy assessment (e.g., pityriasis alba, leprosy, post-inflammatory hypopigmentation, progressive macular hypomelanosis, nevus anemicus, chemical leukoderma, and tinea versicolor), or other skin conditions that may interfere with the study drug or phototherapy; 5.Participants with known end-stage renal disease (ESRD) or receiving renal replacement therapy (e.g., dialysis); 6.Participants with a history of JAK inhibitor treatment for vitiligo or other conditions who were judged by the investigator to have an inadequate response; 7.Participants with a past or current severe disorder of the respiratory, cardiovascular, cerebrovascular, hepatic, renal, gastrointestinal, musculoskeletal, genitourinary, immune, endocrine, metabolic, or neuropsychiatric system, who are deemed ineligible for trial participation by the investigator; 8.Participants who received investigational products or devices in other clinical trials within 3 months prior to screening; 9.Any other conditions where the investigator considers the participant ineligible.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Facial Vitiligo Area Scoring Index (F-VASI); | — |
Secondary
| Measure | Time frame |
|---|---|
| Proportion of participants discontinuing or withdrawing due to AEs during the study;Vitiligo Noticeability Scale,VNS;Laboratory examinations;Physical examination;Facial Vitiligo Area Scoring Index,F-VASI;Dermatology Life Quality Index,DLQI,Children's Dermatology Life Quality Index,CDLQI;Vital signs (pulse, axillary temperature, sitting blood pressure);All AEs, SAEs, and ADRs during the study will be collected, with special focus on application site acne, pruritus, and other AEs;Facial BodySurface Area,F-BSA,Total Body Surface Area,T-BSA,Facial Vitiligo Area Scoring Index,F-VASI,Total Vitiligo Area Scoring Index,T-VASI;Total Vitiligo Area Scoring Index,T-VASI;Facial Vitiligo Area Scoring Index,F-VASI; | — |
Countries
China
Contacts
Public ContactGao Xinghua
The First Hospital of China Medical University
Outcome results
None listed