Vitiligo
Conditions
Interventions
1.5% Ruxolitinib Phosphate Cream Combined with Phototherapy Treatment Group:None
Sponsors
The Affiliated Hospital of Southwest Medical University
Eligibility
Sex/Gender
All
Age
12 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Aged >=12 years at the time of signing the informed consent form, regardless of gender; 2. Study participants with a clinical diagnosis of stable non-segmental vitiligo involving facial lesions, with a total body surface area (BSA) of depigmented lesions <=10%; 3. No contraindications to phototherapy such as allergic diseases or xeroderma pigmentosum; 4. Agree to have no pregnancy plans during the study period and for at least 4 weeks after the last study treatment, and voluntarily adopt effective contraceptive measures; 5. Study participants shall voluntarily sign a written informed consent form and agree to regular follow-up visits.
Exclusion criteria
Exclusion criteria: 1. Clinically diagnosed with progressive non-segmental vitiligo; 2. History of known hypersensitivity to the investigational product of this trial (ruxolitinib phosphate cream) or other similar active medicinal agents (other Janus kinase (JAK) inhibitors); 3. Lesions with white hair accounting for more than one-third of the vitiligo area, or vitiligo lesions accompanied by white hair for whom the likelihood of clinical benefit from trial participation is deemed low based on clinical experience; 4. History of hypersensitivity or intolerance to phototherapy (e.g., narrowband ultraviolet B, 308 nm excimer laser, home phototherapy, etc.) or photochemotherapy; or presence of absolute contraindications to phototherapy, including hereditary photosensitive dermatoses (xeroderma pigmentosum, congenital erythropoietic protoporphyria, Cockayne syndrome, Bloom syndrome, etc.), albinism, history of malignant melanoma, systemic lupus erythematosus, etc.; or presence of relative contraindications to phototherapy judged by the investigator to render trial participation inappropriate, such as cataract, family history of melanoma, non-melanoma skin cancer, precancerous skin lesions, prior radiotherapy or arsenic exposure, concomitant oral cyclosporine, etc.; 5. Other subtypes of vitiligo (e.g., segmental vitiligo), or concomitant depigmenting skin disorders other than vitiligo that may interfere with efficacy assessment (e.g., pityriasis alba, l5eprosy, post-inflammatory hypopigmentation, progressive macular hypomelanosis, nevus anemicus, chemical leukoderma, tinea versicolor, etc.); or concomitant dermatoses other than vitiligo that interfere with the use of the investigational drug or phototherapy; 6. Study participants with known end-stage renal disease (ESRD) or receiving renal replacement therapy (e.g., dialysis); 7. Prior treatment with JAK inhibitors for vitiligo or other diseases with unsatisfactory efficacy as assessed by the investigator; 8. Current or prior severe disorders involving the respiratory, cardiovascular and cerebrovascular, hepatic, renal, gastrointestinal, musculoskeletal, urogenital, immune, endocrine, metabolic, psychiatric and neurological systems, which are considered by the investigator to preclude trial participation; 9. Participation in another clinical trial of an investigational drug/device with exposure to the investigational product within 3 months prior to screening; 10. Other conditions for which the investigator deems the study participant unsuitable for enrollment in this trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The proportion of study participants achieving a >=75% improvement from baseline in the Facial Vitiligo Area Scoring Index (F-VASI) at Week 24.; | — |
Secondary
| Measure | Time frame |
|---|---|
| Change from baseline in BSA, F-BSA, T-BSA, F-VASI and T-VASI scores;Proportion of study participants achieving F-VASI 75;Change from baseline in DLQI and CDLQI scores;Proportion of study participants achieving F-VASI 50 or F-VASI 90;Proportion of study participants achieving T-VASI 50, T-VASI 75 or T-VASI 90;Proportion and distribution of study participants with a score of 4 (barely noticeable) or 5 (no longer noticeable) on the Vitiligo Noticeability Scale (VNS); | — |
Countries
China
Contacts
Public ContactHe Yuanmin
The Affiliated Hospital of Southwest Medical University
Outcome results
None listed