Back to resultsPhase III Clinical Study of Benvitimod Cream in the Treatment of Mild to Moderate Atopic Dermatitis
Primary Purpose
Atopic Dermatitis
Status
Recruiting
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
Benvitimod Cream
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Atopic Dermatitis focused on measuring Benvitimod Cream, Atopic Dermatitis, Topical Treatment
Eligibility Criteria
Inclusion Criteria:
- Age ≥ 18 years.
- Diagnosis of atopic dermatitis，course of disease ≥ 6 months，EASI ≤ 21 and 3% ≤ BSA ≤ 20%.
- IGA ≥ 3.
- Capable of giving written informed consent.
Exclusion Criteria:
- Skin lesions were limited to head, neck, hands and feet.
- ALT/AST ≥ 3 ULN、BUN/Cr ﹥ 1.5 ULN.
- Subjects with obvious cardiovascular, respiratory, gastrointestinal, liver, kidney, blood, neurological and psychological diseases that are unstable or not well controlled.
- Subjects have any systemic disease or other active skin disease that may affect the evaluation of the study results, or have scar, freckle, tattoo, etc. in the affected area that may affect the evaluation of skin lesions.
- Subjects with malignant neoplasms.
- Subjects with severe comorbid conditions may require systematic hormone therapy or other interventions, affect study participation or require frequent active monitoring (e.g., unstable chronic asthma).
- Subjects with definite skin infection with local bacteria, viruses and fungi.
- Subjects with mental illness or other reasons may interfere with participation in the study.
- Known to be allergic to any of the components of the drug.
- Severe hypersensitivity to food, drugs, insect venom, rubber, etc.
- Women who are pregnant, breast-feeding, or planning to become pregnant.
- Alcohol, drug abuse and known drug dependence.
Prior to enrollment, the following treatments were used within the specified time period:
- External medication used within 2 weeks (e.g. glucocorticoids, calcineurin inhibitors, tacrolimus, PDE-4 inhibitors, etc.)
- Systemic immunotherapy used within 4 weeks (e.g., glucocorticoids, methotrexate, JAK inhibitors, cyclosporine, etc.).
- Received biologics for atopic dermatitis (e.g., IL-4 inhibitors, IL-13 inhibitors, etc.) within 4 weeks (or 5 half-life, whichever is longer).
- Received uv therapy and photochemotherapy within 4 weeks.
- Participated in clinical trials of other drugs or medical devices within 4 weeks.
- The patients who were considered unsuitable to participate in the study by the investigators.
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 8 weeks after enrolment.
Placebo, applied twice daily for 8 weeks after enrolment.
Outcomes
Primary Outcome Measures
Proportion of participants with Investigator Global Assessment (IGA) of 0 (complete removal) or 1 (nearly complete removal) and a decrease of ≥2 points score from Baseline to Week 8
The IGA is a clinical tool for assessing the current state/severity of a participant's atopic dermatitis 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 and induration as guidelines. Higher IGA scores represent more severe disease.
Secondary Outcome Measures
Percentage decline in Eczema Area and Severity Index (EASI) score from Baseline to Week 8
The EASI scoring system is a widely-used standard clinical tool for assessing the severity of psoriasis that takes into account the overall severity of erythema, induration, excoriation, and lichenification, and the extent of %Body Surface Area (BSA) affected with atopic dermatitis.
The 3 clinical signs are each graded on a 7-point scale (0 to 6) and the %BSA affected is scored on a 4-point scale (0 to 3) 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 EASI score. Higher scores indicate more severe disease. EASI is a static assessment made without reference to previous scores.
Proportion of participants with ≥75% improvement in Eczema Area and Severity Index (EASI) score from Baseline to Week 8
The EASI scoring system is a widely-used standard clinical tool for assessing the severity of psoriasis that takes into account the overall severity of erythema, induration, excoriation, and lichenification, and the extent of %Body Surface Area (BSA) affected with atopic dermatitis.
The 3 clinical signs are each graded on a 7-point scale (0 to 6) and the %BSA affected is scored on a 4-point scale (0 to 3) 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 EASI score. Higher scores indicate more severe disease. EASI is a static assessment made without reference to previous scores.
Proportion of participants with ≥90% improvement in Eczema Area and Severity Index (EASI) score from Baseline to Week 8
The EASI scoring system is a widely-used standard clinical tool for assessing the severity of psoriasis that takes into account the overall severity of erythema, induration, excoriation, and lichenification, and the extent of %Body Surface Area (BSA) affected with atopic dermatitis.
The 3 clinical signs are each graded on a 7-point scale (0 to 6) and the %BSA affected is scored on a 4-point scale (0 to 3) 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 EASI score. Higher scores indicate more severe disease. EASI is a static assessment made without reference to previous scores.
Proportion of participants with ≥50% improvement in Eczema Area and Severity Index (EASI) score from Baseline to Week 8
The EASI scoring system is a widely-used standard clinical tool for assessing the severity of psoriasis that takes into account the overall severity of erythema, induration, excoriation, and lichenification, and the extent of %Body Surface Area (BSA) affected with atopic dermatitis.
The 3 clinical signs are each graded on a 7-point scale (0 to 6) and the %BSA affected is scored on a 4-point scale (0 to 3) 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 EASI score. Higher scores indicate more severe disease. EASI is a static assessment made without reference to previous scores.
Proportion of participants with ≥3 score improvement in Pruritus Visual Analogue Scale (VAS) from Baseline to Week 8
Pruritus Visual Analogue Scale (VAS) will be used to assess severity of pruritus.
Overall EASI improvement rate and its changes with time from Baseline to Week 8
The EASI scoring system is a widely-used standard clinical tool for assessing the severity of psoriasis that takes into account the overall severity of erythema, induration, excoriation, and lichenification, and the extent of %Body Surface Area (BSA) affected with atopic dermatitis.
The 3 clinical signs are each graded on a 7-point scale (0 to 6) and the %BSA affected is scored on a 4-point scale (0 to 3) 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 EASI score. Higher scores indicate more severe disease. EASI is a static assessment made without reference to previous scores.
The average IGA decrease and its changes with time from Baseline to Week 8
The IGA is a clinical tool for assessing the current state/severity of a participant's atopic dermatitis 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 and induration as guidelines. Higher IGA scores represent more severe disease.
The average DLQI decrease and its changes with time from Baseline to Week 8
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.
The average BSA decrease and its changes with time from Baseline to Week 8
The assessment of %BSA affected is an estimate of the percentage of total involved skin with atopic dermatitis. For the purpose of clinical estimation, the total palmar surface of the participant's palm and digits may be assumed to be approximately equivalent to 1% BSA. The %BSA affected by atopic dermatitis will be evaluated (from 0% to 100%). %BSA is a static assessment made without reference to previous scores.
The average Pruritus Visual Analogue Scale (VAS) decrease and its changes with time from Baseline to Week 8
Pruritus Visual Analogue Scale (VAS) will be used to assess severity of pruritus.
Proportion of participants with recurrence and the time of first recurrence of 1.0% Benvitimod cream
Recurrence definition: participants who have new lesions after discontinuation of Benvitimod cream, and IGA ≥2.
Proportion of participants of IGA = 0 or 1 was achieved after retreatment 8 weeks in recurrence subjects
Recurrence definition: participants who have new lesions after discontinuation of Benvitimod cream, and IGA ≥2.
Incidence of TEAE and SAE
TEAE definition: treatment emergent adverse event.
Number of recurrences in recurrence participants
Recurrence definition: participants who have new lesions after discontinuation of Benvitimod cream, and IGA ≥2.
Proportion of participants with ≥50% improvement in Eczema Area and Severity Index (EASI) score after retreatment 8 weeks in recurrence subjects
Recurrence definition: participants who have new lesions after discontinuation of Benvitimod cream, and IGA ≥2.
EASI score and IGA score decreased after retreatment 8 weeks in recurrence participants
The EASI scoring system is a widely-used standard clinical tool for assessing the severity of psoriasis that takes into account the overall severity of erythema, induration, excoriation, and lichenification, and the extent of %Body Surface Area (BSA) affected with atopic dermatitis.
The 3 clinical signs are each graded on a 7-point scale (0 to 6) and the %BSA affected is scored on a 4-point scale (0 to 3) 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 EASI score. Higher scores indicate more severe disease. EASI is a static assessment made without reference to previous scores.
The IGA is a clinical tool for assessing the current state/severity of a subject's atopic dermatitis at a given timepoint. It is a static 6-point morphological assessment of overall disease severity, as determined by the investigator, using
Incidence of AE/ADR at each visit during medication
AE definition: adverse event. ADR definition: adverse reaction.
Incidence of SAE and TEAE leading to discontinuation
SAE definition: serious adverse events. TEAE definition: treatment emergent adverse event.
Incidence of clinical abnormalities such as laboratory tests and electrocardiogram (ECG)
Incidence of clinical abnormalities such as laboratory tests and electrocardiogram (ECG)
Full Information
NCT ID
NCT05326672
First Posted
April 6, 2022
Last Updated
April 25, 2022
Sponsor
Peking University People's Hospital
Collaborators
Zhonghao Pharmaceutical
1. Study Identification
Unique Protocol Identification Number
NCT05326672
Brief Title
Phase III Clinical Study of Benvitimod Cream in the Treatment of Mild to Moderate Atopic Dermatitis
Official Title
A Randomized, Double-blind, Multicenter, Placebo-controlled Phase III Clinical Study to Evaluate the Efficacy and Safety of Benvitimod Cream in the Treatment of Mild to Moderate Atopic Dermatitis
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
December 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 randomized, double-blind, multicenter, placebo-controlled clinical Phase III study to evaluate the safety and efficacy of Benvitimod cream, 1% twice daily for the treatment of mild to moderate atopic dermatitis. Approximately 240 participants with mild to moderate atopic dermatitis 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 atopic dermatitis for 8 weeks.
Detailed Description
This is a randomized, double-blind, multicenter, placebo-controlled clinical Phase III study to evaluate the safety and efficacy of Benvitimod cream, 1% twice daily for the treatment of mild to moderate atopic dermatitis. Approximately 240 participants with mild to moderate atopic dermatitis 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 atopic dermatitis for 8 weeks. Participants who had completed the 8-week clinical trial and were well tolerant to the drug were followed up in one-arm, long-term intermittent administration (up to 52 weeks period). In the long-term medication phase, at each visit point: ① When IGA ≥ 2, Benvitimod cream was continued to be used, twice daily. ② When IGA < 2, the drug was stopped. In the long-term follow-up, the interval of visits was 4 weeks during the medication phase and 8 weeks during the discontinuation phase.
The primary objective is to evaluate the efficacy and safety of Benvitimod cream in the treatment of mild to moderate atopic dermatitis. The primary endpoint is the proportion of participants with Investigator Global Assessment (IGA) of 0 (complete removal) or 1 (nearly complete removal) and a decrease of ≥2 points score from baseline to week 8. The study is anticipated to last from April 2022 to August 2023 with 240 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
Atopic Dermatitis
Keywords
Benvitimod Cream, Atopic Dermatitis, Topical Treatment
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
240 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Benvitimod Cream
Arm Type
Experimental
Arm Description
Benvitimod cream, 1%, applied twice daily for 8 weeks after enrolment.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo, applied twice daily for 8 weeks after enrolment.
Intervention Type
Drug
Intervention Name(s)
Benvitimod Cream
Intervention Description
Benvitimod cream, 1%, applied twice daily for 8 weeks after enrolment.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo, applied twice daily for 8 weeks after enrolment.
Primary Outcome Measure Information:
Title
Proportion of participants with Investigator Global Assessment (IGA) of 0 (complete removal) or 1 (nearly complete removal) and a decrease of ≥2 points score from Baseline to Week 8
Description
The IGA is a clinical tool for assessing the current state/severity of a participant's atopic dermatitis 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 and induration as guidelines. Higher IGA scores represent more severe disease.
Time Frame
Week 8
Secondary Outcome Measure Information:
Title
Percentage decline in Eczema Area and Severity Index (EASI) score from Baseline to Week 8
Description
The EASI scoring system is a widely-used standard clinical tool for assessing the severity of psoriasis that takes into account the overall severity of erythema, induration, excoriation, and lichenification, and the extent of %Body Surface Area (BSA) affected with atopic dermatitis.
The 3 clinical signs are each graded on a 7-point scale (0 to 6) and the %BSA affected is scored on a 4-point scale (0 to 3) 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 EASI score. Higher scores indicate more severe disease. EASI is a static assessment made without reference to previous scores.
Time Frame
Week 8
Title
Proportion of participants with ≥75% improvement in Eczema Area and Severity Index (EASI) score from Baseline to Week 8
Description
The EASI scoring system is a widely-used standard clinical tool for assessing the severity of psoriasis that takes into account the overall severity of erythema, induration, excoriation, and lichenification, and the extent of %Body Surface Area (BSA) affected with atopic dermatitis.
The 3 clinical signs are each graded on a 7-point scale (0 to 6) and the %BSA affected is scored on a 4-point scale (0 to 3) 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 EASI score. Higher scores indicate more severe disease. EASI is a static assessment made without reference to previous scores.
Time Frame
Week 8
Title
Proportion of participants with ≥90% improvement in Eczema Area and Severity Index (EASI) score from Baseline to Week 8
Description
The EASI scoring system is a widely-used standard clinical tool for assessing the severity of psoriasis that takes into account the overall severity of erythema, induration, excoriation, and lichenification, and the extent of %Body Surface Area (BSA) affected with atopic dermatitis.
The 3 clinical signs are each graded on a 7-point scale (0 to 6) and the %BSA affected is scored on a 4-point scale (0 to 3) 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 EASI score. Higher scores indicate more severe disease. EASI is a static assessment made without reference to previous scores.
Time Frame
Week 8
Title
Proportion of participants with ≥50% improvement in Eczema Area and Severity Index (EASI) score from Baseline to Week 8
Description
The EASI scoring system is a widely-used standard clinical tool for assessing the severity of psoriasis that takes into account the overall severity of erythema, induration, excoriation, and lichenification, and the extent of %Body Surface Area (BSA) affected with atopic dermatitis.
The 3 clinical signs are each graded on a 7-point scale (0 to 6) and the %BSA affected is scored on a 4-point scale (0 to 3) 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 EASI score. Higher scores indicate more severe disease. EASI is a static assessment made without reference to previous scores.
Time Frame
Week 8
Title
Proportion of participants with ≥3 score improvement in Pruritus Visual Analogue Scale (VAS) from Baseline to Week 8
Description
Pruritus Visual Analogue Scale (VAS) will be used to assess severity of pruritus.
Time Frame
Week 8
Title
Overall EASI improvement rate and its changes with time from Baseline to Week 8
Description
The EASI scoring system is a widely-used standard clinical tool for assessing the severity of psoriasis that takes into account the overall severity of erythema, induration, excoriation, and lichenification, and the extent of %Body Surface Area (BSA) affected with atopic dermatitis.
The 3 clinical signs are each graded on a 7-point scale (0 to 6) and the %BSA affected is scored on a 4-point scale (0 to 3) 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 EASI score. Higher scores indicate more severe disease. EASI is a static assessment made without reference to previous scores.
Time Frame
Week 8
Title
The average IGA decrease and its changes with time from Baseline to Week 8
Description
The IGA is a clinical tool for assessing the current state/severity of a participant's atopic dermatitis 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 and induration as guidelines. Higher IGA scores represent more severe disease.
Time Frame
Week 8
Title
The average DLQI decrease and its changes with time from Baseline to Week 8
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 8
Title
The average BSA decrease and its changes with time from Baseline to Week 8
Description
The assessment of %BSA affected is an estimate of the percentage of total involved skin with atopic dermatitis. For the purpose of clinical estimation, the total palmar surface of the participant's palm and digits may be assumed to be approximately equivalent to 1% BSA. The %BSA affected by atopic dermatitis will be evaluated (from 0% to 100%). %BSA is a static assessment made without reference to previous scores.
Time Frame
Week 8
Title
The average Pruritus Visual Analogue Scale (VAS) decrease and its changes with time from Baseline to Week 8
Description
Pruritus Visual Analogue Scale (VAS) will be used to assess severity of pruritus.
Time Frame
Week 8
Title
Proportion of participants with recurrence and the time of first recurrence of 1.0% Benvitimod cream
Description
Recurrence definition: participants who have new lesions after discontinuation of Benvitimod cream, and IGA ≥2.
Time Frame
Week 52
Title
Proportion of participants of IGA = 0 or 1 was achieved after retreatment 8 weeks in recurrence subjects
Description
Recurrence definition: participants who have new lesions after discontinuation of Benvitimod cream, and IGA ≥2.
Time Frame
Week 52
Title
Incidence of TEAE and SAE
Description
TEAE definition: treatment emergent adverse event.
Time Frame
Week 52
Title
Number of recurrences in recurrence participants
Description
Recurrence definition: participants who have new lesions after discontinuation of Benvitimod cream, and IGA ≥2.
Time Frame
Week 52
Title
Proportion of participants with ≥50% improvement in Eczema Area and Severity Index (EASI) score after retreatment 8 weeks in recurrence subjects
Description
Recurrence definition: participants who have new lesions after discontinuation of Benvitimod cream, and IGA ≥2.
Time Frame
Week 52
Title
EASI score and IGA score decreased after retreatment 8 weeks in recurrence participants
Description
The EASI scoring system is a widely-used standard clinical tool for assessing the severity of psoriasis that takes into account the overall severity of erythema, induration, excoriation, and lichenification, and the extent of %Body Surface Area (BSA) affected with atopic dermatitis.
The 3 clinical signs are each graded on a 7-point scale (0 to 6) and the %BSA affected is scored on a 4-point scale (0 to 3) 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 EASI score. Higher scores indicate more severe disease. EASI is a static assessment made without reference to previous scores.
The IGA is a clinical tool for assessing the current state/severity of a subject's atopic dermatitis at a given timepoint. It is a static 6-point morphological assessment of overall disease severity, as determined by the investigator, using
Time Frame
Week 52
Title
Incidence of AE/ADR at each visit during medication
Description
AE definition: adverse event. ADR definition: adverse reaction.
Time Frame
Week 52
Title
Incidence of SAE and TEAE leading to discontinuation
Description
SAE definition: serious adverse events. TEAE definition: treatment emergent adverse event.
Time Frame
Week 52
Title
Incidence of clinical abnormalities such as laboratory tests and electrocardiogram (ECG)
Description
Incidence of clinical abnormalities such as laboratory tests and electrocardiogram (ECG)
Time Frame
Week 52
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age ≥ 18 years.
Diagnosis of atopic dermatitis，course of disease ≥ 6 months，EASI ≤ 21 and 3% ≤ BSA ≤ 20%.
IGA ≥ 3.
Capable of giving written informed consent.
Exclusion Criteria:
Skin lesions were limited to head, neck, hands and feet.
ALT/AST ≥ 3 ULN、BUN/Cr ﹥ 1.5 ULN.
Subjects with obvious cardiovascular, respiratory, gastrointestinal, liver, kidney, blood, neurological and psychological diseases that are unstable or not well controlled.
Subjects have any systemic disease or other active skin disease that may affect the evaluation of the study results, or have scar, freckle, tattoo, etc. in the affected area that may affect the evaluation of skin lesions.
Subjects with malignant neoplasms.
Subjects with severe comorbid conditions may require systematic hormone therapy or other interventions, affect study participation or require frequent active monitoring (e.g., unstable chronic asthma).
Subjects with definite skin infection with local bacteria, viruses and fungi.
Subjects with mental illness or other reasons may interfere with participation in the study.
Known to be allergic to any of the components of the drug.
Severe hypersensitivity to food, drugs, insect venom, rubber, etc.
Women who are pregnant, breast-feeding, or planning to become pregnant.
Alcohol, drug abuse and known drug dependence.
Prior to enrollment, the following treatments were used within the specified time period:
External medication used within 2 weeks (e.g. glucocorticoids, calcineurin inhibitors, tacrolimus, PDE-4 inhibitors, etc.)
Systemic immunotherapy used within 4 weeks (e.g., glucocorticoids, methotrexate, JAK inhibitors, cyclosporine, etc.).
Received biologics for atopic dermatitis (e.g., IL-4 inhibitors, IL-13 inhibitors, etc.) within 4 weeks (or 5 half-life, whichever is longer).
Received uv therapy and photochemotherapy within 4 weeks.
Participated in clinical trials of other drugs or medical devices within 4 weeks.
The patients who were considered unsuitable to participate in the study by the investigators.
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
Yan Zhao
Phone
18500291610
Email
zhaoyan377@hotmail.com
Facility Information:
Facility Name
Peking University People's Hospital
City
Beijing
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yan Zhao
Phone
18500291610
Email
zhaoyan377@hotmail.com
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Phase III Clinical Study of Benvitimod Cream in the Treatment of Mild to Moderate Atopic Dermatitis
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