Vitiligo
Conditions
Interventions
Progressive stage group:The topical regimen of lucotinib phosphate cream was the same as that of the stable periodic group, and combined with oral administration of compound glycyrrhizin
1. adult: 50m
2. minors: weight>60kg, 50mg, TID
Body weight<60kg, 25mg, TID. Treatment course: 24 weeks
Stable stage group:Rutinib phosphate cream, topical rutinib phosphate cream, twice a day (bid), for 24 weeks.
Sponsors
Huashan Hospital, Fudan University
Eligibility
Sex/Gender
All
Age
12 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. At the time of signing the informed consent form, participants shall be aged 12 years or older with no restriction on gender; 2. participants who were clinically diagnosed as segmental vitiligo with facial and neck involvement, and the total body involvement surface area (BSA) was no more than 10%; 3. Participants shall have no plan to conceive from the signing of the informed consent form until 4 weeks after the last administration of the investigational product, and shall voluntarily adopt effective contraceptive measures throughout this period; 4. Participants shall fully understand the trial content, voluntarily participate in the trial, agree to regular follow-up, and sign the informed consent form.
Exclusion criteria
Exclusion criteria: 1. Participants with a known history of allergy to the investigational products (Ruxolitinib Phosphate Cream, Compound Glycyrrhizin Tablets) or other similar active drugs (other Janus kinase (JAK) inhibitors); 2. Participants diagnosed with other types of vitiligo (e.g., non-segmental vitiligo, mixed vitiligo), or those complicated with other depigmentary skin disorders that may interfere with efficacy evaluation (e.g., pityriasis alba, leprosy, post-inflammatory hypopigmentation, progressive macular hypomelanosis, nevus anemicus, chemical leukoderma, tinea versicolor), or other skin diseases affecting the assessment of study medication efficacy; 3. Participants with known end-stage renal disease (ESRD) or receiving renal replacement therapy (e.g., dialysis); 4. Participants who have previously received JAK inhibitor therapy for vitiligo or other diseases and were assessed by the investigator as having poor therapeutic response; 5. Participants with a previous or current severe disease involving the respiratory, cardiovascular and cerebrovascular, hepatic, renal, gastrointestinal, musculoskeletal, urogenital, immune, endocrine, metabolic, psychiatric or neurological systems, who are deemed ineligible for this trial by the investigator; 6. Participants who have enrolled in other clinical trials of drugs or medical devices and used investigational products within 3 months prior to screening; 7. Participants with any other conditions that, in the opinion of the investigator, make them unsuitable for participation in this trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Facial and Neck Vitiligo Area Scoring Index; | — |
Secondary
| Measure | Time frame |
|---|---|
| Facial and Neck Vitiligo Area Scoring Index;Dermatology Life Quality Index (DLQI) Questionnaire;Vitiligo Impact Disease Assessment;Vitiligo Noticeability Scale (VNS) score;BSA (Face and Neck); | — |
Countries
China
Contacts
Public ContactLeihong Xiang
Huashan Hospital, Fudan University
Outcome results
None listed