Psoriasis
Conditions
Interventions
Group 1 :CKBA ointment or vehicle topical administration, QD
Group 2:CKBA ointment or vehicle topical administration BID
Group 3:CKBA ointment or vehicle topical administration QD
Group 4:CKBA ointment or vehicle topical administration BID
Group 5:CKBA ointment or vehicle topical administration QD
Group 6:CKBA ointment or vehicle topical administration BID
Sponsors
Peking University People's Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Patients >= 18 years and = 6 months; 3. Mild to moderate plaque psoriasis conforms to the PASI score < 10 in the screening period and before randomization, the psoriasis lesions involve BSA < 10% and PGA score is 2 or 3, and the diameter of the target lesions should be at least 2 cm; 4. The researcher thinks that the subject is suitable for local treatment of psoriasis (whether it is initial treatment or previous treatment); 5. Avoid excessive exposure to sunlight, artificial sunbathing or other ultraviolet light sources during the research; 6. The screening period and random pre-pregnancy test for women with fertility potential must be negative; 7. Fully understand the content of the experiment, voluntarily participate in the experiment, and sign the informed consent.
Exclusion criteria
Exclusion criteria: 1. Psoriasis diagnosed at the time of screening is not chronic plaque psoriasis (such as arthropathy psoriasis, pustular psoriasis, erythrodermic psoriasis and guttate psoriasis); 2. Suffering from drug-induced psoriasis (induced by drugs such as beta blockers, calcium channel inhibitors or lithium); 3. Serious infection or systemic infection occurred within 8 weeks before baseline, requiring intravenous anti-infection treatment or hospitalization due to infection; 4. There are other skin diseases and problems (such as skin bacteria, fungi, virus infection, seborrheic dermatitis, eczema, etc.) that researchers think will hinder the evaluation of psoriasis; 5. The subject has severe active autoimmune diseases; 6. Any organ system has a history or symptoms of malignant tumor within 5 years before screening, whether it has been treated or not, and whether there are signs of recurrence or metastasis. Except for non-metastatic skin carcinoma in situ or cervical basal cell or squamous cell carcinoma in situ after proper treatment or resection; 7. Subjects who have a history of depression, or who are clinically judged to be at risk of suicide by researchers, will be excluded; 8. Blood donation or blood loss >= 400 mL within 8 weeks before baseline and/or blood donation plan during the study period; 9. The following cardiovascular and cerebrovascular diseases occurred within 12 months before the screening: the subject had moderate to severe congestive heart failure (Grade III or IV of new york Heart Association), unstable angina pectoris, myocardial infarction, coronary stent implantation, cerebrovascular accident (cerebral infarction or cerebral hemorrhage), deep vein thrombosis, pulmonary embolism, etc., or hypertension (systolic blood pressure >= 160 mmHg or diastolic blood pressure >= 100 mmHg) which was poorly controlled during the screening period, after retest. 10. Severe, progressive or uncontrolled diseases of kidney, liver, blood, digestion, metabolism, endocrine, lung, cardiovascular or nervous system; 11. Allergic to the pharmaceutical ingredients or auxiliary materials in this study; 12. The following prohibited treatments/drugs cannot be stopped before the screening visit or are expected to be used during the study: (1) using any biological agent 12 weeks or 5 half-lives (whichever is longer) before screening; (2) Anti-IL-17, anti-IL-17 receptor and anti-IL-12/IL-23 drugs were used before screening; (3) Received small molecular targeted drugs such as Janus kinase (JAK) inhibitor and phosphodiesterase 4 inhibitor within 4 weeks before screening; (4) Phototherapy/photochemotherapy (including psoralen and ultraviolet-aradiation (PUVA) light therapy, UVB (ultravioletBradiation) or systemic therapy (e.g.Methyldipterin, cyclosporine, cyclophosphamide, acitacin, oral/injectable (e.g. intra-articular, intramuscular or intravenous), glucocorticoids, etc.); (5) Received local treatment for psoriasis within 2 weeks before screening, such as local glucocorticoid, vitamin D3 derivatives and retinoids; (6) Received traditional Chinese medicine treatment for psoriasis within 2 weeks before screening; 13. Have participated in (have been randomized) clinical trials of any drug within 3 months before the baseline or within 5 half-lives of the study drug (whichever is longer); 14. Vaccinated with live vaccine or attenuated live vaccine within 12 weeks before baseline, or planned to vaccinate with live vaccine or attenuated live va
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| laboratory parameters;12-lead electrocardiogram;vital signs;physical examination;adverse event;serious adverse event;evaluation of contact dermatitis with extradermal medication; | — |
Secondary
| Measure | Time frame |
|---|---|
| pharmacokinetic parameters;CKBA metabolites;Physician global assessment, PGA;Body surface area, BSA; | — |
Countries
China
Contacts
Public ContactJianzhong Zhong
Jiangsu BCY Pharm Co., Ltd.
Outcome results
None listed