Phase IV Clinical Study of Benvitimod Cream in the Treatment of Mild to Moderate Psoriasis in Adults

NCT ID: NCT05064748

Last Updated: 2021-10-01

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 2000 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-06-01
• Study Completion Date: 2024-09-30

Brief Summary

This is a multi-center, prospective post-approval clinical Phase IV study to evaluate the safety and efficacy of Benvitimod cream, 1% twice daily for the treatment of mild to moderate stable psoriasis vulgaris in adults. Approximately 2000 adult participants with mild to moderate stable psoriasis vulgaris will be enrolled and they will use the Benvitimod cream at the skin with psoriasis for 12 weeks.

Detailed Description

This is a multi-center, prospective post-approval clinical Phase IV study to evaluate the safety and efficacy of Benvitimod cream, 1% twice daily for the treatment of mild to moderate stable psoriasis vulgaris in adults. Approximately 2000 adult participants with mild to moderate stable psoriasis vulgaris will be enrolled and they will apply the Benvitimod cream on the skin with plaque psoriasis for maximum 12 weeks. All participants will complete follow-up visits at 2 weeks, 4 weeks, 8 weeks, 12 weeks, 16 weeks and continuing up to one year.

Conditions

Psoriasis

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Treatment Cohort

Group Type: EXPERIMENTAL

Benvitimod

Intervention Type: DRUG

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

Interventions

Benvitimod

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

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Male and female participants ages at least 18 years.
• The participant with diagnosis of mild to moderate stable psoriasis vulgaris.
• BSA involvement <10%.
• Capable of giving written informed consent.

Exclusion Criteria

• Planned Ultraviolet (UV) light therapy or prolonged exposure to natural or artificial sources of UV radiation during the study period.
• Known allergies to the active ingredient or excipients of the drug.
• Pregnant females, lactating females.
• The patients who were considered unsuitable to participate in the study by the investigators.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Zhonghao Pharmaceutical

UNKNOWN

Sponsor Role: collaborator

Peking University People's Hospital

OTHER

Sponsor Role: lead

Responsible Party

Zhang jianzhong

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Peking University People's Hospital

Beijing, Beijing Municipality, China

Site Status: RECRUITING

Countries

China

Facility Contacts

Ping Liu

Role: primary

llppliuping@126.com

010 88325472

Other Identifiers

TJ202105BWMD

Identifier Type: -

Identifier Source: org_study_id