Psoriasis
Conditions
Interventions
Investigational Group:Benvitimod Cream
Placebo group:Vertical
Sponsors
Peking University People's Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. Age 18-65 years; 2. Patients who used to be treated with Benvitimod cream and had discontinued medication are again diagnosed as suitable for treatment with Benvitimod cream; 3. The participant with the diagnosis of mild to moderate stable psoriasis vulgaris: (1) BSA = 2; 4. Capable of giving written informed consent.
Exclusion criteria
Exclusion criteria: 1. ALT/AST > 3*ULN, BUN/Cr > 1.5*ULN; 2. Skin lesions were limited to headface and skin folds; 3. Women who are pregnant, breast-feeding, or planning to become pregnant; 4. Known to be allergic to active ingredients or any of the components of the drug; 5. Alcoholic, or regular use of Chinese herbs or sedatives, sleeping pills, tranquilizers and other addictive drugs; 6. Subjects who have other conditions that may interfere with the evaluation of the efficacy of psoriasis and/or other serious skin diseases other than psoriasis; 7. Subjects who have serious diseases of the central nervous system, cardiovascular system, kidney, liver, digestive tract, respiratory system, metabolism and skeletal muscle system; 8. Subjects who were considered unsuitable to participate in the study by the investigators; 9. Received uv phototherapy, photochemotherapy, or systemic therapy (e.g., systemic glucocorticoid, methotrexate, retinoic acid, or cyclosporine) within 4 weeks prior to baseline visit; 10. Received topical anti-psoriasis therapy (including topical glucocorticoids, retinoids, vitamin D analogues, or calcineurin inhibitors) within 2 weeks prior to baseline visit, except where the site of administration was not the target lesion after enrollment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of participants with =75% improvement in Psoriasis Area and Severity Index (PASI) score 12 weeks after retreatment with Benvitimod cream or placebo; | — |
Secondary
| Measure | Time frame |
|---|---|
| Proportion of participants with =90% improvement in Psoriasis Area and Severity Index (PASI) score 12 weeks after retreatment with Benvitimod cream or placebo;Proportion of participants who Physician Global Assessment (PGA) score achieved 0 or 1 12 weeks after retreatment with Benvitimod cream or placebo;Change of Psoriasis Area and Severity Index (PASI) score over time after retreatment with Benvitimod cream or placebo;Change of erythema (redness), induration (plaque thickness), and scale score in the skin lesions over time after retreatment with Benvitimod cream or placebo;Change of erythema (redness), induration (plaque thickness), and scale score in the skin lesions over time after retreatment with Benvitimod cream or placebo;Duration of remission after treatment response;The Dermatology Life Quality Index (DLQI) total and individual dimension scores;European Questionnaires Five Dimensions Five Levels (EQ-5D-5L) scores;Incidence of AE (Adverse Events) during the study;Incidence of SAE (Severe Adverse Events) during the study;Incidence of ADR (Adverse Drug Reaction) during the study; | — |
Countries
China
Contacts
Public ContactShen Juan
Guangdong Zhonghao Pharmaceutical Co., Ltd.
Outcome results
None listed