Plaque Psoriasis
Conditions
Interventions
1:0.5% Benvitimod cream
2:1.0% Benvitimod cream
3:1.5% Benvitimod cream
Sponsors
People's hospital, Peking University
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: Healthy male and female patients with Psoriasis aged 18 to 65 years, inclusive 1. In good general health and free of any disease state or physical condition that might impair evaluation of plaque psoriasis; 2. A clinical diagnosis of stable plaque psoriasis for >6 months representing a maximum of 10% of BSA and a minimum of 2% BSA of their total body surface area (excluding the face, groin, scalp, and genital regions); 3. Willing and able to comply with the protocol and attend all study visits; 4. Provide written informed consent prior to the initiation of any study-related procedures.
Exclusion criteria
Exclusion criteria: 1. Other concomitant serious illness or medical condition (e.g., human immunodeficiency virus, renal insufficiency, clinically significant abnormal laboratory values) that could put a patient at risk during the study; 2. History of neurological/psychiatric disorders, including psychotic disorders or dementia, or any other reason that would interfere with the patient's participation in the trial; 3. Pregnancy or lactation; 4. Known or suspected hypersensitivity to any of the constituents of the investigational product; 5. Treatment with other investigational drug within 3 months of day 0 or current participation in another clinical trial; 6. Spontaneously improving or rapidly deteriorating plaque psoriasis; 7. Any other skin diseases that might interfere with the clinical assessment of plaque psoriasis and/or put the patient at risk; 8. Pustular, erythrodermic, or other non-plaque forms of psoriasis; 9. Guttate psoriasis as the dominant form of psoriasis; 10. Use of any psoriasis vaccine or previous participation in an investigational study of any psoriasis vaccine; 11. Systemic immunomodulatory therapy known to affect psoriasis and decreases immune cell populations (e.g., alefacept) within 36 weeks prior to the baseline visit; 12. Systemic immunomodulatory therapy known to affect psoriasis and that does not typically decrease immune cell populations (e.g., etanercept) within 12 weeks prior to the baseline visit; 13. Any phototherapy (including laser), photo-chemotherapy, or systemic psoriasis therapy (such as systemic corticosteroids, methotrexate, retinoids, or cyclosporine) within 4 weeks prior to the baseline visit; 14. Prolonged exposure to natural or artificial sources of ultraviolet (UV) radiation within 4 weeks prior to the baseline visit or intention to have such exposure during the study, thought by the investigator likely to modify the patient's psoriasis; 15. Topical anti-psoriatic therapy (including topical retinoids and vitamin D analogs) on the areas to be treated within 2 weeks prior to the baseline visit; 16. Alcohol abuse in the last 2 years as defined by consumption of >14 standard drinks of alcohol per week; 17. Use of lithium within 2 weeks prior to the screening visit; 18. Use of beta-blockers (e.g., propranolol) within 2 weeks prior to the screening visit unless on a stable dose for >3 months.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Adverse Events;PASI;Hematology;Clinical Chemistry;PGA;Photographs of Target Plaques;Urine routine test;Vital Signs;ECGs; | — |
Countries
China
Contacts
Public ContactZHANG Jian-zhong
Outcome results
None listed