non-segmental vitiligo
Conditions
Interventions
CKBA 0.5% group:Apply topically and externally twice daily for 24 weeks
CKBA 1.0% group:Apply topically and externally twice daily for 24 weeks
CKBA 1.5% group:Apply topically and externally twice daily for 24 weeks
Solvent group:Apply topically and externally twice daily for 24 weeks
Sponsors
Hangzhou Third People's Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. subjects with a clinical diagnosis of non-segmental vitiligo, with depigmentation of the face and neck >= 0.5% BSA, F-VASI >= 0.5, and depigmentation of the whole body (face and neck and non-face and neck) of not less than 3% and not more than 10% BSA; 2. subjects with vitiligo disease activity score (VIDA) need to fulfill VIDA < 4; 3. at the time of signing the informed consent form, the age is between 18 and 65 years old (including 18 and 65 years old), and the gender is not limited; 4. subjects agree not to use other vitiligo treatments than those permitted by the protocol from the screening visit to the final safety follow-up visit; 5. the subject must have given informed consent to the trial prior to the trial, be fully aware of the trial content, procedures and possible adverse effects, and have voluntarily signed a written informed consent form; 6. the subject is able to communicate well with the investigator and is able to complete the trial in accordance with the protocol.
Exclusion criteria
Exclusion criteria: 1. Complete depigmentation of the hair in the vitiligo area of the subject's face; 2. Subjects with a clinical diagnosis of segmental vitiligo or other skin depigmentation diseases (such as patchy albinism, pityriasis albicans, leprosy, post-inflammatory hypopigmentation, progressive maculohypopigmentation, chemical albinism, and tinea versicolor); 3. Subjects have previously received vitiligo depigmentation treatment (such as monophenazone); 4. Subjects suffer from other skin diseases that the investigator believes will interfere with the application of the trial drug or the evaluation of the study (e.g., psoriasis, seborrheic dermatitis, etc.); 5. Subjects have acute bacterial, fungal, or viral skin infections (e.g., herpes simplex, shingles, chickenpox) within 4 weeks prior to baseline; 6. Serious local infection (e.g., cellulitis, abscess) or systemic infection (e.g., pneumonia, sepsis) within 12 weeks prior to baseline, requiring intravenous anti-infective treatment or hospitalization due to infection; 7. Subject's medical history and symptoms suggest active tuberculosis at screening; 8. Subject has a severe active autoimmune disease; 9. Subjects with a history of malignancy, with the exception of the following adequately treated non-metastatic malignancies: basal cell skin cancer, cutaneous squamous cell carcinoma, or cervical cancer in situ that do not involve the vitiligo area. 10. Subjects with a history of depression, or subjects who are at risk of suicide in the clinical judgment of the investigator will be excluded; 11. The following cardiovascular and cerebrovascular diseases occurred within 6 months before screening: subjects have had moderate to severe congestive heart failure (New York Heart Association class III or IV), unstable angina, myocardial infarction, coronary artery stenting, cerebrovascular accident (cerebral infarction or cerebral hemorrhage), deep vein thrombosis, pulmonary embolism, etc., or poorly controlled hypertension (systolic blood pressure >=160 mmHg or diastolic blood pressure >=100 mmHg, confirmed by re-test); 12. Severe, progressive, or uncontrolled hepatic, renal, hematological, digestive, metabolic, endocrine, pulmonary, cardiovascular, or neurological disease; 13. Cannot be discontinued prior to the screening visit or anticipated need for the use of the following prohibited treatments/medications during the study: (1) Received local treatment for vitiligo within 2 weeks before screening, such as topical glucocorticoids, calcineurin inhibitors, vitamin D3 derivatives, phosphodiesterase 4 (PDE-4) inhibitors, and Janus kinase (JAK) inhibitors; (2) Received traditional Chinese medicine treatment for vitiligo within 2 weeks before screening; (3) Received melanocyte-stimulating hormone analogues within 4 weeks prior to screening, such as alfanotide; (4) Received systemic immunomodulatory drugs within 4 weeks before screening, such as oral glucocorticoids, methotrexate, cyclosporine, calcineurin inhibitors, and Janus kinase (JAK) inhibitors; (5) Received any other systemic therapy that may increase the skin's sensitivity to UV/visible light or affect skin pigmentation, such as tetracycline, psoralen, within 4 weeks prior to screening; (6) Received phototherapy/photochemotherapy (including psoralen and long-wave ultraviolet (PUVA) excimer laser, excimer light, or narrow-spectrum medium-wave ultraviolet (NB?UVB)) within 8 weeks prior to screening; (7) Use of any biologics for the treatment of vitiligo w
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Facial Vitiligo Area and Severity Index, F-VASI; | — |
Secondary
| Measure | Time frame |
|---|---|
| Total Vitiligo Area and Severity Index, T-VASI;Facial Body Surface Area, F-BSA;Total Body Surface Area, T-BSA;Photograph Global Vitiligo Assessment, PhGVA;Adverse Event;Pharmacokinetics; | — |
Countries
China
Contacts
Public ContactAie Xu
Hangzhou Third People's Hospital
Outcome results
None listed