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

Peking University

Status and phase

Enrolling

Phase 4

Conditions

Psoriasis

Treatments

Drug: Benvitimod

Study type

Interventional

Funder types

Other

Identifiers

NCT05064748

TJ202105BWMD

Details and patient eligibility

About

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.

Full 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.

Enrollment

2,000 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.