vitiligo
Conditions
Interventions
Study Group:Home-use 308-nm LED phototherapy device combined with topical ruxolitinib cream
Control Group:topical ruxolitinib cream monotherapy
Sponsors
The First Affiliated Hospital of Guangzhou Medical University
Eligibility
Sex/Gender
All
Age
12 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Aged 12 years or older, with no gender restriction. 2. Clinically diagnosed with non-segmental vitiligo, with a total body depigmented area not exceeding 10% of the body surface area (BSA). For non-facial vitiligo lesions undergoing regular treatment with ruxolitinib cream, the affected BSA shall be >= 0.3% and the Vitiligo Area Scoring Index (VASI) shall be >= 0.3. 3 Exposed to ruxolitinib cream for no more than 3 consecutive days. 4. Agree to maintain no pregnancy/childbearing plans during the trial period and within 6 months following trial completion, and voluntarily implement effective contraceptive measures. 5. Possess the basic competence to operate a home-use phototherapy device and commit to regular treatment as required. 6. Provide voluntary written informed consent.
Exclusion criteria
Exclusion criteria: 1. Those with no willingness to receive treatment for non-facial vitiligo lesions. 2. Presence of other cutaneous depigmenting disorders, including but not limited to pityriasis alba, leprosy, post-inflammatory hypopigmentation, nevus anemicus, and tinea versicolor. 3. Presence of photosensitive diseases (e.g., systemic lupus erythematosus [SLE], dermatomyositis [DM]), ultraviolet (UV) hypersensitivity, or a personal or family history of skin malignancies (e.g., melanoma, basal cell carcinoma [BCC]). 4. Previous treatment with depigmenting therapies (e.g., monobenzone). 5. Receipt of other topical medications, including glucocorticoids, calcineurin inhibitors, etc., within 2 weeks prior to screening. 6. Receipt of any non-biologic agents in systemic pharmacotherapy within 4 weeks prior to screening, including but not limited to systemic glucocorticoids, methotrexate, cyclosporine, etc. 7. Receipt of any phototherapy, including narrowband ultraviolet B (NB-UVB), 308 nm excimer laser, etc., within 4 weeks prior to screening. 8. Anticipated use of therapies that may interfere with efficacy evaluation during screening and follow-up, such as oral Janus kinase (JAK) inhibitors, calcineurin inhibitors, etc.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Improvement rate of the non-facial Vitiligo Area Scoring Index at Week 24 compared with baseline; | — |
Secondary
| Measure | Time frame |
|---|---|
| Proportion of subjects with >=50% improvement in the non-facial Vitiligo Area Scoring Index at Week 24;Proportion of subjects with >=25% improvement in the non-facial Vitiligo Area Scoring Index at Week 24;Proportion of subjects with >=80% improvement in the non-facial Vitiligo Area Scoring Index at Week 24;Proportion of subjects with >=25% improvement in total Vitiligo Area Scoring Index at Week 24;Proportion of subjects with =50% improvement in total Vitiligo Area Scoring Index at Week 24;Proportion of subjects with >=80% improvement in total Vitiligo Area Scoring Index at Week 24;Proportion of subjects with >=25% improvement in facial Vitiligo Area Scoring Index at Week 24;Proportion of subjects with >=50% improvement in facial Vitiligo Area Scoring Index at Week 24;Proportion of subjects with >=80% improvement in facial Vitiligo Area Scoring Index at Week 24;Proportion of patients with Vitiligo Noticeability Scale score of 4 or 5 at week 24;Change in facial body surface area from baseline at week 24;Change in total body surface area from baseline at week 24;Change in trunk Vitiligo Area Scoring Index from baseline at week 24;Change in facial Vitiligo Area Scoring Index from baseline at week 24;Change in total Vitiligo Area Scoring Index from baseline at week 24;Change in Dermatology Life Quality Index score from baseline at week 24; | — |
Countries
China
Contacts
Public ContactLiu Zhongrong
The First Affiliated Hospital of Guangzhou Medical University
Outcome results
None listed