Plaque psoriasis
Conditions
Interventions
Group A:0.5% Benvitimod cream
Group B:1.0% Benvitimod cream
Group C:1.0% Benvitimod cream
Sponsors
People's Hospital of Peking University
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. Male and female patients with Plaque Psoriasis aged 18 to 65 years, inclusive; 2. In good general health and free of any disease state or physical condition that might impair evaluation of plaque psoriasis; 3. A clinical diagnosis of stable plaque psoriasis representing a maximum of 10% of their total body surface area (excluding the face, groin, scalp, and genital regions); 4. Have a minimum of 1 plaque that is at least 2*2cm in size; 5. WOCBP using and willing to continue to use adequate contraceptive precautions for the duration of the study; 6. Willing and able to comply with the protocol and attend all study visits; 7. 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 within 36 weeks prior to the baseline visit; 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. 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; 13. Prolonged exposure to natural or artificial sources of ultraviolet (UV) radiation within 4 weeks prior to the baseline visit; 14. 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; 15. Alcohol abuse.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| PGA;PASI; | — |
Secondary
| Measure | Time frame |
|---|---|
| Photographs of Target Plaque; | — |
Countries
China
Contacts
Public ContactZhang jian-zhong
Outcome results
None listed