Clinical trial NCT05064748: Phase IV Clinical Study of Benvitimod Cream in the Treatment of Mild to Moderate Psoriasis in Adults
Official title: A Multi-center, Open-Label, Extension Study to Evaluate the Safety and Efficacy of Benvitimod Cream in the Treatment of Mild to Moderate Psoriasis in Adults
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Psoriasis
Keywords: Benvitimod Cream
Psoriasis
Topical Treatment
Lead sponsor: Peking University People's Hospital
Sponsor class: OTHER
Collaborators: name: Zhonghao Pharmaceutical
First posted: 2021-10-01
Enrollment: 2000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Change in Psoriasis Area and Severity Index (PASI) from Baseline to Week 12
timeFrame: Week 12
measure: Percentage decline in Physician Global Assessment (PGA) score at Week 12
timeFrame: Week 12
Secondary outcomes:
measure: Change in Psoriasis Area and Severity Index (PASI) from Baseline to Week 8
timeFrame: Week 8
measure: Proportion of participants with ≥90% improvement in Psoriasis Area and Severity Index (PASI) score from Baseline to Week 8
timeFrame: Week 8
measure: Proportion of participants with ≥75% improvement in Psoriasis Area and Severity Index (PASI) score from Baseline to Week 8
timeFrame: Week 8
measure: Proportion of participants with ≥50% improvement in Psoriasis Area and Severity Index (PASI) score from Baseline to Week 8
timeFrame: Week 8
measure: Change in percent of total body surface area (%BSA) affected from Baseline to Week 8
timeFrame: Week 8
measure: Proportion of participants with ≥90% improvement in Psoriasis Area and Severity Index (PASI) score from Baseline to Week 12
timeFrame: Week 12
measure: Proportion of participants with ≥75% improvement in Psoriasis Area and Severity Index (PASI) score from Baseline to Week 12
timeFrame: Week 12
measure: Proportion of participants with ≥50% improvement in Psoriasis Area and Severity Index (PASI) score from Baseline to Week 12
timeFrame: Week 12
measure: Change in percent of total body surface area (%BSA) affected from Baseline to Week 12
timeFrame: Week 12
measure: Change of Psoriasis Area and Severity Index (PASI) score over time from Baseline to Week 12.
timeFrame: Week 12
measure: The Dermatology Life Quality Index (DLQI) total and individual dimension scores.
timeFrame: Week 16
measure: European Questionnaires Five Dimensions Five Levels (EQ-5D-5L) scores.
timeFrame: Week 16
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University People's Hospital
state: Beijing
Study officials:
References: