Vitiligo
Conditions
Interventions
Experimental Group:Ruxolitinib phosphate cream
Sponsors
Hangzhou Third People's Hospital
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, with no restriction on gender; 2. Study participants with a clinical diagnosis of stable vitiligo, presenting with facial lesions (no minimumrequirement for facial involvement area), and a total body depigmentation area of <=10% body surface area(BSA); 3. Study participants with stable vitiligo for whom the decision to receive "ruxolitinib phosphate creamcombined with phototherapy" has been made by the attending physician; 4. No contraindications to phototherapy, such as photosensitivity disorders or xeroderma pigmentosum; 5. Agree to have no plans for pregnancy/childbirth during the study period and for at least 4 weeks after thelast study treatment, and voluntarily use effective contraception; 6. Study participants voluntarily sign the written informed consent form and agree to attend scheduledfollow-up visits as required.
Exclusion criteria
Exclusion criteria: 1. Suffering from other depigmenting skin disorders that may interfere with efficacy assessment (e.g., pityriasisalba, leprosy, post-inflammatory hypopigmentation, progressive macular hypomelanosis, nevus anemicus,chemical leukoderma, tinea versicolor, etc.); 2. Participants with white hair involving >=1/3 of the depigmented lesion area, or with white hair within thedepigmented lesion area who are assessed as having a low likelihood of benefiting from the study basedon clinical experience; 3. Participation in another interventional clinical study; 4. Known history of allergy to ruxolitinib phosphate or any of its excipients; 5. Known end-stage renal disease (ESRD) or receiving renal replacement therapy (e.g., dialysis); 6. Pregnant or lactating females; 7. Other conditions deemed by the investigator to make the participant unsuitable for enrollment in thisstudy.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of participants achieving F-VASI 75 at Week 16; | — |
Secondary
| Measure | Time frame |
|---|---|
| Proportion of study participants achieving F-VASI 75;Proportion of study participants achieving F-VASI 50/90;Proportion of study participants achieving T-VASI 50/75/90;Proportion and distribution of study participants with a Vitiligo Visualization Scale (VNS) score of 4 (" less noticeable ") or 5 (" no longer noticeable ");Changes from baseline in BSA, F-BSA, T-BSA, F-VASI, and T-VASI scores;Change from baseline in the DLQI/CDLQI score; | — |
Countries
China
Contacts
Public ContactAie Xu
Hangzhou Third People's Hospital
Outcome results
None listed