Suspended

Efficacy and Safety of Benvitimod Cream in the Retreatment of Mild to Moderate Psoriasis: Retreatment, Multicenter, Randomized, Double-blind, Placebo-controlled Clinical Study

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What is being tested

Benvitimod Cream

+ Placebo

Drug
Who is being recruted

Psoriasis+1

+ Skin Diseases

+ Skin and Connective Tissue Diseases

From 18 to 65 Years
+16 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Placebo-Controlled
Interventional
Study Start: April 2022
See protocol details

Summary

Principal SponsorPeking University People's Hospital
Study ContactJianzhong ZhangMore contacts
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: April 1, 2022

Actual date on which the first participant was enrolled.

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. The primary objective is to evaluate the efficacy and safety of Benvitimod cream in the long-term (intermittent) treatment of mild to moderate psoriasis vulgaris. The primary endpoint is proportion of participants with ≥75% improvement in Psoriasis Area and Severity Index (PASI) score 12 weeks after retreatment with Benvitimod cream or placebo. The study is anticipated to last from April 2022 to August 2023 with 390 participants recruited form about 20 centers in China. All the related investigative organization and individuals will obey the Declaration of Helsinki and Chinese Good Clinical Practice standard. The study has been approved by Institutional Review Board (IRB) and Ethics Committee (EC) in Peking University People's Hospital.

Official TitleEfficacy and Safety of Benvitimod Cream in the Retreatment of Mild to Moderate Psoriasis: Retreatment, Multicenter, Randomized, Double-blind, Placebo-controlled Clinical Study
NCT05326659
Principal SponsorPeking University People's Hospital
Study ContactJianzhong ZhangMore contacts
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

390 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 65 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

PsoriasisSkin DiseasesSkin and Connective Tissue DiseasesSkin Diseases, Papulosquamous

Criteria

6 inclusion criteria required to participate
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%.
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10 exclusion criteria prevent from participating
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.
Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

50% chance of being blinded to the placebo group

Treatment Groups

Group I

Experimental
Benvitimod cream, 1%, applied twice daily for 12 weeks after enrolment.

Group II

Placebo
Placebo, applied twice daily for 12 weeks after enrolment.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Recruiting

Peking University People's Hospital

Beijing, ChinaOpen Peking University People's Hospital in Google Maps
SuspendedOne Study Center