Efficacy and Safety of Benvitimod Cream in the Retreatment of Mild to Moderate Psoriasis

• Status: Recruiting
• Trial end date: 2023-08-01
• Target enrollment: 0
• Participant gender: All

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 moderate stable psoriasis vulgaris in adults. Approximately 390 participants with mild to moderate stable psoriasis vulgaris will be enrolled and randomly divided into two groups in a 2:1 ratio. They will use either the Benvitimod cream or placebo at the skin with psoriasis vulgaris for 12 weeks.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Peking University People's Hospital
• Collaborator: Zhonghao Pharmaceutical

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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.