Ignite Creation Date:
2025-12-24 @ 2:43 PM
Ignite Modification Date:
2025-12-26 @ 1:22 PM
Study NCT ID:
NCT05326659
Status:
UNKNOWN
Last Update Posted:
2022-04-13
First Post:
2022-04-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy and Safety of Benvitimod Cream in the Retreatment of Mild to Moderate Psoriasis
Sponsor:
Peking University People's Hospital
Organization:
Study Overview
Official Title:
Efficacy and Safety of Benvitimod Cream in the Retreatment of Mild to Moderate Psoriasis: Retreatment, Multicenter, Randomized, Double-blind, Placebo-controlled Clinical Study
Status:
UNKNOWN
Status Verified Date:
2022-04
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 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.
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 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.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: