Back to resultsEfficacy and Safety of Benvitimod Cream in the Retreatment of Mild to Moderate Psoriasis
Primary Purpose
Psoriasis
Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Benvitimod Cream
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Psoriasis focused on measuring Benvitimod Cream, Psoriasis, Retreatment
Eligibility Criteria
Inclusion Criteria:
- 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%.
- PGA ≥ 2.
- Capable of giving written informed consent.
Exclusion Criteria:
- 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.
- Alcoholic, or regular use of Chinese herbs or sedatives, sleeping pills, tranquilizers and other addictive drugs.
- Subjects who have other conditions that may interfere with the evaluation of the efficacy of psoriasis and/or other serious skin diseases other than psoriasis.
- Subjects who have serious diseases of the central nervous system, cardiovascular system, kidney, liver, digestive tract, respiratory system, metabolism and skeletal muscle system.
- Subjects who were considered unsuitable to participate in the study by the investigators.
- Received uv phototherapy, photochemotherapy, or systemic therapy (e.g., systemic glucocorticoid, methotrexate, retinoic acid, or cyclosporine) within 4 weeks prior to baseline visit.
- Received topical anti-psoriasis therapy (including topical glucocorticoids, retinoids, vitamin D analogues, or calcineurin inhibitors) within 2 weeks prior to baseline visit, except where the site of administration was not the target lesion after enrollment.
Sites / Locations
- Peking University People's HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Benvitimod Cream
Placebo
Arm Description
Benvitimod cream, 1%, applied twice daily for 12 weeks after enrolment.
Placebo, applied twice daily for 12 weeks after enrolment.
Outcomes
Primary Outcome Measures
Proportion of participants with ≥75% improvement in Psoriasis Area and Severity Index (PASI) score 12 weeks after retreatment with Benvitimod cream or placebo
The PASI scoring system is a widely-used standard clinical tool for assessing the severity of psoriasis that takes into account the overall severity of erythema (redness), induration (plaque thickness), and scale, and the extent of %Body Surface Area (BSA) affected with psoriasis. The 3 clinical signs are each graded on a 5-point scale (0 to 4) and the %BSA affected is scored on a 7-point scale (0 to 6) for each of the 4 specified body regions (head, upper extremities, trunk, and lower extremities). The individual scores are multiplied by a weighted factor for each body region; the sum of these scores gives the overall PASI score. Higher scores indicate more severe disease. PASI is a static assessment made without reference to previous scores.
Secondary Outcome Measures
Proportion of participants with ≥90% improvement in Psoriasis Area and Severity Index (PASI) score 12 weeks after retreatment with Benvitimod cream or placebo
The PASI scoring system is a widely-used standard clinical tool for assessing the severity of psoriasis that takes into account the overall severity of erythema (redness), induration (plaque thickness), and scale, and the extent of %Body Surface Area (BSA) affected with psoriasis. The 3 clinical signs are each graded on a 5-point scale (0 to 4) and the %BSA affected is scored on a 7-point scale (0 to 6) for each of the 4 specified body regions (head, upper extremities, trunk, and lower extremities). The individual scores are multiplied by a weighted factor for each body region; the sum of these scores gives the overall PASI score. Higher scores indicate more severe disease. PASI is a static assessment made without reference to previous scores.
Proportion of participants who Physician Global Assessment (PGA) score achieved 0 or 1 12 weeks after retreatment with Benvitimod cream or placebo
The PGA is a clinical tool for assessing the current state/severity of a participant's psoriasis at a given timepoint. It is a static 6-point (0-5) morphological assessment of overall disease severity, as determined by the investigator, using the clinical characteristics of erythema, scaling, and plaque thickness/elevation as guidelines. Higher PGA scores represent more severe disease.
Change of Psoriasis Area and Severity Index (PASI) score over time after retreatment with Benvitimod cream or placebo
The PASI scoring system is a widely-used standard clinical tool for assessing the severity of psoriasis that takes into account the overall severity of erythema (redness), induration (plaque thickness), and scale, and the extent of %Body Surface Area (BSA) affected with psoriasis. The 3 clinical signs are each graded on a 5-point scale (0 to 4) and the %BSA affected is scored on a 7-point scale (0 to 6) for each of the 4 specified body regions (head, upper extremities, trunk, and lower extremities). The individual scores are multiplied by a weighted factor for each body region; the sum of these scores gives the overall PASI score. Higher scores indicate more severe disease. PASI is a static assessment made without reference to previous scores.
Change of erythema (redness), induration (plaque thickness), and scale score in the skin lesions over time after retreatment with Benvitimod cream or placebo
Change of erythema (redness), induration (plaque thickness), and scale score in the skin lesions over time after retreatment with Benvitimod cream or placebo
Duration of remission after treatment response
Duration of remission after treatment response
The Dermatology Life Quality Index (DLQI) total and individual dimension scores
The DLQI is a simple dermatology-specific 10-question validated questionnaire to assess the impact of the disease on a participant's quality of life. DLQI scores range from 0 to 30, with a higher score indicating a more impaired quality of life.
European Questionnaires Five Dimensions Five Levels (EQ-5D-5L) scores
EQ-5D-5L is a standardized instrument for measuring generic health status. Rated level can be coded as a number 1, 2, 3, 4 or 5, which indicates having no problems for 1, having some problems for 2, having moderate problems for 3, having serious problems for 4 and having extreme problems for 5.
Incidence of AE during the study
AE definition: adverse event
Incidence of SAE during the study
SAE definition: serious adverse event
Incidence of ADR during the study
ADR definition: adverse reaction
Full Information
NCT ID
NCT05326659
First Posted
April 6, 2022
Last Updated
April 6, 2022
Sponsor
Peking University People's Hospital
Collaborators
Zhonghao Pharmaceutical
1. Study Identification
Unique Protocol Identification Number
NCT05326659
Brief Title
Efficacy and Safety of Benvitimod Cream in the Retreatment of Mild to Moderate Psoriasis
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
Study Type
Interventional
2. Study Status
Record Verification Date
April 2022
Overall Recruitment Status
Recruiting
Study Start Date
April 2022 (Anticipated)
Primary Completion Date
June 2023 (Anticipated)
Study Completion Date
August 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Peking University People's Hospital
Collaborators
Zhonghao Pharmaceutical
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Psoriasis
Keywords
Benvitimod Cream, Psoriasis, Retreatment
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
390 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Benvitimod Cream
Arm Type
Experimental
Arm Description
Benvitimod cream, 1%, applied twice daily for 12 weeks after enrolment.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo, applied twice daily for 12 weeks after enrolment.
Intervention Type
Drug
Intervention Name(s)
Benvitimod Cream
Intervention Description
Benvitimod cream, 1%, applied twice daily for 12 weeks after enrolment.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo, applied twice daily for 12 weeks after enrolment.
Primary Outcome Measure Information:
Title
Proportion of participants with ≥75% improvement in Psoriasis Area and Severity Index (PASI) score 12 weeks after retreatment with Benvitimod cream or placebo
Description
The PASI scoring system is a widely-used standard clinical tool for assessing the severity of psoriasis that takes into account the overall severity of erythema (redness), induration (plaque thickness), and scale, and the extent of %Body Surface Area (BSA) affected with psoriasis. The 3 clinical signs are each graded on a 5-point scale (0 to 4) and the %BSA affected is scored on a 7-point scale (0 to 6) for each of the 4 specified body regions (head, upper extremities, trunk, and lower extremities). The individual scores are multiplied by a weighted factor for each body region; the sum of these scores gives the overall PASI score. Higher scores indicate more severe disease. PASI is a static assessment made without reference to previous scores.
Time Frame
Week 12
Secondary Outcome Measure Information:
Title
Proportion of participants with ≥90% improvement in Psoriasis Area and Severity Index (PASI) score 12 weeks after retreatment with Benvitimod cream or placebo
Description
The PASI scoring system is a widely-used standard clinical tool for assessing the severity of psoriasis that takes into account the overall severity of erythema (redness), induration (plaque thickness), and scale, and the extent of %Body Surface Area (BSA) affected with psoriasis. The 3 clinical signs are each graded on a 5-point scale (0 to 4) and the %BSA affected is scored on a 7-point scale (0 to 6) for each of the 4 specified body regions (head, upper extremities, trunk, and lower extremities). The individual scores are multiplied by a weighted factor for each body region; the sum of these scores gives the overall PASI score. Higher scores indicate more severe disease. PASI is a static assessment made without reference to previous scores.
Time Frame
Week 12
Title
Proportion of participants who Physician Global Assessment (PGA) score achieved 0 or 1 12 weeks after retreatment with Benvitimod cream or placebo
Description
The PGA is a clinical tool for assessing the current state/severity of a participant's psoriasis at a given timepoint. It is a static 6-point (0-5) morphological assessment of overall disease severity, as determined by the investigator, using the clinical characteristics of erythema, scaling, and plaque thickness/elevation as guidelines. Higher PGA scores represent more severe disease.
Time Frame
Week 12
Title
Change of Psoriasis Area and Severity Index (PASI) score over time after retreatment with Benvitimod cream or placebo
Description
The PASI scoring system is a widely-used standard clinical tool for assessing the severity of psoriasis that takes into account the overall severity of erythema (redness), induration (plaque thickness), and scale, and the extent of %Body Surface Area (BSA) affected with psoriasis. The 3 clinical signs are each graded on a 5-point scale (0 to 4) and the %BSA affected is scored on a 7-point scale (0 to 6) for each of the 4 specified body regions (head, upper extremities, trunk, and lower extremities). The individual scores are multiplied by a weighted factor for each body region; the sum of these scores gives the overall PASI score. Higher scores indicate more severe disease. PASI is a static assessment made without reference to previous scores.
Time Frame
Week 12
Title
Change of erythema (redness), induration (plaque thickness), and scale score in the skin lesions over time after retreatment with Benvitimod cream or placebo
Description
Change of erythema (redness), induration (plaque thickness), and scale score in the skin lesions over time after retreatment with Benvitimod cream or placebo
Time Frame
Week 12
Title
Duration of remission after treatment response
Description
Duration of remission after treatment response
Time Frame
Week 12
Title
The Dermatology Life Quality Index (DLQI) total and individual dimension scores
Description
The DLQI is a simple dermatology-specific 10-question validated questionnaire to assess the impact of the disease on a participant's quality of life. DLQI scores range from 0 to 30, with a higher score indicating a more impaired quality of life.
Time Frame
Week 12
Title
European Questionnaires Five Dimensions Five Levels (EQ-5D-5L) scores
Description
EQ-5D-5L is a standardized instrument for measuring generic health status. Rated level can be coded as a number 1, 2, 3, 4 or 5, which indicates having no problems for 1, having some problems for 2, having moderate problems for 3, having serious problems for 4 and having extreme problems for 5.
Time Frame
Week 12
Title
Incidence of AE during the study
Description
AE definition: adverse event
Time Frame
Week 16
Title
Incidence of SAE during the study
Description
SAE definition: serious adverse event
Time Frame
Week 16
Title
Incidence of ADR during the study
Description
ADR definition: adverse reaction
Time Frame
Week 16
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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%.
PGA ≥ 2.
Capable of giving written informed consent.
Exclusion Criteria:
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.
Alcoholic, or regular use of Chinese herbs or sedatives, sleeping pills, tranquilizers and other addictive drugs.
Subjects who have other conditions that may interfere with the evaluation of the efficacy of psoriasis and/or other serious skin diseases other than psoriasis.
Subjects who have serious diseases of the central nervous system, cardiovascular system, kidney, liver, digestive tract, respiratory system, metabolism and skeletal muscle system.
Subjects who were considered unsuitable to participate in the study by the investigators.
Received uv phototherapy, photochemotherapy, or systemic therapy (e.g., systemic glucocorticoid, methotrexate, retinoic acid, or cyclosporine) within 4 weeks prior to baseline visit.
Received topical anti-psoriasis therapy (including topical glucocorticoids, retinoids, vitamin D analogues, or calcineurin inhibitors) within 2 weeks prior to baseline visit, except where the site of administration was not the target lesion after enrollment.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jianzhong Zhang
Phone
010-88325472
Email
rmzjz@126.com
First Name & Middle Initial & Last Name or Official Title & Degree
Lin Cai
Phone
13611236310
Email
scailin66@hotmail.com
Facility Information:
Facility Name
Peking University People's Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100044
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lin Cai
Phone
13611236310
Email
scailin66@hotmail.com
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Efficacy and Safety of Benvitimod Cream in the Retreatment of Mild to Moderate Psoriasis
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