Vitiligo
Conditions
Interventions
Group 1:1.5% (20% BSA) or placebo, D2-D6 applied twice daily, D1 and D7 administered as a single application in the morning only, applied at 3 mg/cm2 to delineated areas of the back, upper extremities
Group 2:3% (30% BSA) or placebo, D2-D6 applied twice daily, D1 and D7 administered as a single application in the morning only, applied at 3 mg/cm2 to delineated areas of the back, upper extremities,
Group 3:4.5% (30% BSA) or placebo, D2-D6 applied twice daily, D1 and D7 administered as a single application in the morning only, applied at 3 mg/cm2 to delineated areas of the back, upper extremities
Sponsors
Institute of dermatologyhinese academy of medical sciences
Eligibility
Sex/Gender
All
Age
18 Years to 45 Years
Inclusion criteria
Inclusion criteria: 1. Sign the informed consent form and fully understand the content, process and possible adverse effects of the trial before the trial; 2. Able to complete the study according to the requirements of the trial protocol; 3. Adult male or female subjects aged 18-45 years old (including borderline values); 4. Weighing >=50 kg for males and >=45 kg for females, with a body mass index (BMI) in the range of 19.0-26.0 kg/m2 (including the borderline value), and body mass index (BMI) = weight (kg)/height2 (m2); 5. Subjects (including male subjects) promise to have no pregnancy plan (including sperm and egg donation) from 2 weeks before screening to 3 months after drug administration, and voluntarily use effective contraception (non-pharmacological contraception during the trial).
Exclusion criteria
Exclusion criteria: 1. A history of clinically significant cardiac, hepatic, neurologic, respiratory, hematologic, gastrointestinal, immunologic, renal, or psychiatric disorders that, in the opinion of the investigator, may confound the results of the study or interfere with the absorption, distribution, metabolism, and excretion of the drug, or that, in the judgment of the investigator, are clinically significant; 2. People with any active tuberculosis (TB) disease; or evidence of latent infection (e.g., T-SPOT-positive) or a history of TB; 3. who have received BCG vaccine within 12 months prior to dosing; or who have received or been exposed to other vaccines within 3 months prior to the first dose; or who plan to receive the vaccine during the trial period 4. People with any active or recurrent viral infection, including herpes zoster, herpes simplex, syphilis, HIV, hepatitis B virus, or hepatitis C virus; and People whose screening serum virologic tests showed non-negativity; 5. Those with a history of clinically significant food or drug allergy or history of atopic allergic disease (e.g., asthma, urticaria, eczematous dermatitis, etc.) or known allergy to the components and excipients of the test drug or to JAK inhibitors (e.g., tofacitib, baricitinib, filgotinib, etc.); 6. Those with a history of severe skin disease (e.g., psoriasis, vitiligo, lupus erythematosus) or diseases known to alter the appearance of the skin (e.g., diabetes mellitus, porphyria, etc.); 7. A family history (grandparents, parents, and siblings) of long QT syndrome (i.e., repolarization delay syndrome); 8. Subjects who, in the opinion of the investigator, have a skin lesion or abnormality that may interfere with the assessment of the site of administration of the study medication 9. Who has undergone a surgical procedure within 4 weeks prior to screening or who is scheduled to undergo a surgical procedure during the study; 10. Who has taken any medications or supplements (including herbal remedies) within 14 days prior to screening; 11. Who have used a topical skin medication at the study site within 21 days prior to dosing and who have used a skin tanning product within 14 days prior to dosing 12. Use of any drug that inhibits or induces hepatic metabolism of a drug within 30 days prior to screening (e.g., inducers-barbiturates, carbamazepine, phenytoin, glucocorticosteroids, omeprazole; depressants-SSRI antidepressants, cimetidine, diltiazem, macrolides, nitroimidazoles, sedative-hypnotics, vera-pamil, fluoroquinolones); and Pamil, fluoroquinolones, antihistamines) in the 13. Participation in any clinical trial within 3 months prior to screening; 14. Donating blood or losing a large amount of blood (>=200 ml, except for blood loss during physiological period in women), receiving blood transfusion or using blood products within 3 months prior to the screening; 15. Women who are pregnant or breastfeeding; 16. Those who have special dietary requirements and cannot comply with the unified diet; 17. Those who consume excessive amounts of tea, coffee and/or caffeinated beverages (more than 8 cups, 1 cup = 250 ml) per day 18. Smokers or those who smoked more than 5 cigarettes per day in the 3 months prior to screening or those who were unable to stop using any tobacco-based products during the trial period 19. Alcoholics or those who regularly consumed alcohol in the 6 months prior to screening, i.e., more than 14 units of alcohol per week (1 unit = 360 ml of beer or 45 ml of spirits
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Local tolerability evaluation;Adverse events;Serious adverse events;Vital signs;Laboratory tests;physical examination;Electrocardiogram; | — |
Secondary
| Measure | Time frame |
|---|---|
| PK parameters; | — |
Countries
China
Contacts
Public ContactLingjun Li
Institute of dermatologyhinese academy of medical sciences
Outcome results
None listed