Vitiligo
Conditions
Interventions
Group 1:1.5%(10%BSA) or placebo, a single dose of 3 mg/cm2 applied to designated areas on the back, upper limbs, lower limbs, and abdomen
Group 2:3%(10%BSA) or placebo, a single dose of 3 mg/cm2 applied to designated areas on the back, upper limbs, lower limbs, and abdomen
Group 3:3%(20%BSA) or placebo, a single dose of 3 mg/cm2 applied to designated areas on the back, upper limbs, lower limbs, and abdomen
Group 4:4.5%(20%BSA) or placebo, a single dose of 3 mg/cm2 applied to designated areas on the back, upper limbs, lower limbs, and abdomen
Group 5:4.5%(30%BSA) or placebo, a single dose of 3 mg/cm2 applied to designated areas on the back, upper limbs, lower limbs, and abdomen
Sponsors
Institute of dermatologyhinese academy of medical sciences
Eligibility
Sex/Gender
All
Age
18 Years to 45 Years
Inclusion criteria
Inclusion criteria: 1) Sign informed consent before the test, and fully understand the test content, process and possible adverse reactions; 2) Be able to complete the research according to the requirements of the test plan; 3) Adult male or female subjects aged 18-45 years (including boundary values); 4) Male weight =50kg, female weight =45kg, body mass index within the range of 19.0-26.0kg/m2 (including the critical value), body mass index (BMI) = weight (kg)/height 2 (m2); 5) Subjects (including male subjects) promised to have no pregnancy plans (including sperm and egg donation) from 2 weeks before screening to 3 months after administration, and to voluntarily use effective contraception.
Exclusion criteria
Exclusion criteria: 1) Has a history of cardiac, hepatic, neurological, respiratory, hematological, digestive, immunologic, renal or psychiatric diseases that, in the opinion of the investigator, may confound the results of the study or affect the absorption, distribution, metabolism and excretion of the drug or by the investigator Judged to be clinically significant medical history; 2) Those with any active tuberculosis (TB) disease; or those with evidence of latent infection (e.g., T-SPOT positive), or those with a history of tuberculosis; 3) Bacillus Calmette-Guérin vaccine within 12 months prior to dosing; or vaccination or exposure to other vaccines within 3 months prior to the first dose; or those who plan to be vaccinated during the trial; 4) Those with any active or recurrent viral infection, including herpes zoster, herpes simplex, syphilis, HIV, hepatitis B virus or hepatitis C virus; Those who are non-negative in serum virology during the screening period; 5) Patients with a history of clinically significant food and drug allergies or atopic allergic diseases (such as asthma, urticaria, eczematous dermatitis, etc.) or known allergies to the components and excipients of the trial drug or JAK inhibitors (such as tofacitinib, baricitinib, figotinib, etc.); 6) Those with a history of severe skin diseases (such as psoriasis, vitiligo, lupus erythematosus) or diseases known to change the appearance of the skin (such as diabetes, porphyria, etc.); 7) Have a family history of long QT syndrome (i.e.: delayed repolarization syndrome) (grandparents, parents, and siblings); 8) In the opinion of the investigator, the subject has skin lesions or abnormalities that may affect the evaluation of the study drug administration site; 9) Those who have undergone surgical procedures within 4 weeks prior to screening or plan to undergo surgical procedures during the study; 10) Those who have taken any medication or health products (including Chinese herbal medicines) within 14 days before screening; 11) Use of dermal topical medications at the study medication site within 21 days prior to dosing and skin tanning products within 14 days prior to dosing; 12) Use of any drug that inhibits or induces hepatic metabolism of the drug within 30 days prior to screening (such as: inducers—barbiturates, carbamazepine, phenytoin, glucocorticoids, omeprazole; Inhibitors - SSRI antidepressants, cimetidine, diltiazem, macrolides, nitroimidazoles, sedative-hypnotics, verapamil, fluoroquinolones, antihistamines); 13) Participation in any clinical trial within 3 months prior to screening; 14) Those who have donated blood or lost a large amount of blood (=200ml, except for blood loss during women's menstrual period), received blood transfusion or used blood products within 3 months before screening; 15) Pregnant or lactating women; 16) Those who have special dietary requirements and cannot comply with the uniform diet; 17) Excessive consumption of tea, coffee and/or caffeinated beverages (more than 8 cups, 1 cup = 250ml) per day; 18) Smokers or those who smoked more than 5 cigarettes per day in the 3 months prior to screening or those who cannot stop using any tobacco products during the trial; 19) Alcoholics or regular drinkers within 6 months prior to screening, i.e., those who consume more than 14 units of alcohol per week (1 unit = 360ml of beer or 45ml of spirits with 40% alcohol or 150ml of wine) or who cannot stop using any alcoholic products during the trial;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety Specifications; | — |
Secondary
| Measure | Time frame |
|---|---|
| PK parameters; | — |
Countries
China
Contacts
Public ContactLingjun Li
Institute of dermatologyhinese academy of medical sciences
Outcome results
None listed