Status:
UNKNOWN
Efficacy and Safety of Benvitimod Cream in the Retreatment of Mild to Moderate Psoriasis
Lead Sponsor:
Peking University People's Hospital
Collaborating Sponsors:
Zhonghao Pharmaceutical
Conditions:
Psoriasis
Eligibility:
All Genders
18-65 years
Phase:
NA
Brief Summary
This is a retreatment, multicenter, randomized, double-blind, placebo-controlled clinical study to evaluate the safety and efficacy of Benvitimod cream, 1% twice daily for the retreatment of mild to m...
Detailed Description
This is a retreatment, multicenter, randomized, double-blind, placebo-controlled clinical study to evaluate the safety and efficacy of Benvitimod cream, 1% twice daily for the retreatment of mild to m...
Eligibility Criteria
Inclusion
- Age 18\~65 years.
- Patients who were treated with Benvitimod cream and have discontinued medication were again diagnosed as suitable for treatment with Benvitimod cream.
- The participant with diagnosis of mild to moderate stable psoriasis vulgaris:
- BSA \< 10%.
- PGA ≥ 2.
- Capable of giving written informed consent.
Exclusion
- ALT/AST \> 3 ULN, BUN/Cr \> 1.5 ULN.
- Skin lesions were limited to head，face and skin folds.
- Women who are pregnant, breast-feeding, or planning to become pregnant.
- Known to be allergic to active ingredients or any of the components of the drug.
- Alcoholic, or regular use of Chinese herbs or sedatives, sleeping pills, tranquilizers and other addictive drugs.
- 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.
- Subjects who have serious diseases of the central nervous system, cardiovascular system, kidney, liver, digestive tract, respiratory system, metabolism and skeletal muscle system.
- Subjects who were considered unsuitable to participate in the study by the investigators.
- Received uv phototherapy, photochemotherapy, or systemic therapy (e.g., systemic glucocorticoid, methotrexate, retinoic acid, or cyclosporine) within 4 weeks prior to baseline visit.
- 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.
Key Trial Info
Start Date :
April 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 1 2023
Estimated Enrollment :
390 Patients enrolled
Trial Details
Trial ID
NCT05326659
Start Date
April 1 2022
End Date
August 1 2023
Last Update
April 13 2022
Active Locations (1)
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1
Peking University People's Hospital
Beijing, Beijing Municipality, China, 100044