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To demonstrate the superiority of the investigational medicinal product (IMP; 0.3% OPA-15406 ointment, 1% OPA-15406 ointment, or vehicle) to the vehicle when administered twice daily for 4 weeks using success rate in Investigator's Global Assessment (IGA) at Week 4 as the primary endpoint in pediatric patients with Atopic Dermatitis (AD).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 0.3% OPA-15406 | Experimental | Twice daily |
|
| 1% OPA-15406 | Experimental | Twice daily |
|
| Placebo | Placebo Comparator | Twice daily |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 0.3% OPA-15406 | Drug | Twice daily |
| |
| 1% OPA-15406 |
| Measure | Description | Time Frame |
|---|---|---|
| Responder Rate of Investigator's Global Assesment (IGA) of Disease Severity | The investigator or subinvestigator assessed the skin symptoms using IGA. The investigator or subinvestigator scored the severity (0 = clear, 1 = almost clear, 2 =mild, 3 = moderate, 4 = severe/very severe) of the overall symptoms of the treatment area (erythema, infiltration, papules, effusion and scab formation) from baseline to Week 4. Incidence of success in IGA is defined as the rate of subjects whose IGA score is 0 (clear) or 1 (almost clear) and has improved by at least 2 grades (responders) from baseline. | At Week 4 |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Eczema Area and Severity Index (EASI) Score | The investigator or sub investigator assessed the symptoms of AD using EASI. EASI's minimum and maximum scores are 0 and 72 scores respectively. The higher the EASI score is, the more severe the symptoms of AD, and a negative change from the baseline means improvement and a positive change means worsening. The investigator or sub investigator scored the severity (0-3 points) and affected BSA (%) based on the 4 symptoms (erythema, infiltration/papules, excoriation, and lichenification) on the 4 body regions (face, neck and head ; upper limbs ;trunk; and lower limbs). Number of participants analyzed represents number of participants with data at both Baseline and Week4. Participants who have no data were excluded. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Osamu Sato | Otsuka Pharmaceutical Co., Ltd. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kato Dermatology Clinic | Sapporo | Japan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34289086 | Derived | Saeki H, Baba N, Ito K, Yokota D, Tsubouchi H. Difamilast, a selective phosphodiesterase 4 inhibitor, ointment in paediatric patients with atopic dermatitis: a phase III randomized double-blind, vehicle-controlled trial. Br J Dermatol. 2022 Jan;186(1):40-49. doi: 10.1111/bjd.20655. Epub 2021 Nov 1. |
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| ID | Title | Description |
|---|---|---|
| FG000 | 0.3% OPA-15406 | Subjects were treated with assigned 0.3% OPA-15406 ointment twice daily. |
| FG001 | 1% OPA-15406 | Subjects were treated with assigned 1% OPA-15406 ointment twice daily. |
| FG002 | Placebo | Subjects were treated with assigned 0% OPA-15406 ointment twice daily. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 0.3% OPA-15406 | Subjects were treated with assigned 0.3% OPA-15406 ointment twice daily. |
| BG001 | 1% OPA-15406 | Subjects were treated with assigned 1% OPA-15406 ointment twice daily. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Responder Rate of Investigator's Global Assesment (IGA) of Disease Severity | The investigator or subinvestigator assessed the skin symptoms using IGA. The investigator or subinvestigator scored the severity (0 = clear, 1 = almost clear, 2 =mild, 3 = moderate, 4 = severe/very severe) of the overall symptoms of the treatment area (erythema, infiltration, papules, effusion and scab formation) from baseline to Week 4. Incidence of success in IGA is defined as the rate of subjects whose IGA score is 0 (clear) or 1 (almost clear) and has improved by at least 2 grades (responders) from baseline. | Posted | Number | 95% Confidence Interval | percentage of participants | At Week 4 |
|
Treatment period (4 weeks)
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 0.3% OPA-15406 | Subjects were treated with assigned 0.3% OPA-15406 ointment twice daily. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Impetigo | Infections and infestations | MedDRA Ver. 22.1 | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Director of Clinical Trials | Otsuka Pharmaceutical Co., LTD. | +81-3-6361-7366 | CL_OPCJ_RDA_Team@otsuka.jp |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| SAP | No | Yes | No | Statistical Analysis Plan | Jan 30, 2020 | Jan 5, 2021 | SAP_000.pdf |
| Prot | Yes | No | No | Study Protocol | Feb 1, 2019 | Jan 5, 2021 | Prot_001.pdf |
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| ID | Term |
|---|---|
| D003876 | Dermatitis, Atopic |
| ID | Term |
|---|---|
| D012873 | Skin Diseases, Genetic |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D003872 | Dermatitis |
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| ID | Term |
|---|---|
| C000711049 | difamilast |
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| Drug |
Twice daily |
|
| Placebos | Drug | Twice daily |
|
| Baseline, Week 4 |
| Change From Baseline in Verbal Rating Scale (VRS) for Pruritus Score | The investigator or subinvestigator evaluated the pruritus intensity based on VRS. The subjects aged 7 to 14 years old evaluated the pruritus intensity according to the following criteria. The subjects recorded the level of pruritus and the time and date of evaluation in a pruritus diary. 0 : None
| Baseline, Week 4 |
| Physician Decision |
|
| Withdrawal by Subject |
|
| Withdrawal by parent/guardian |
|
| BG002 | Placebo | Subjects were treated with assigned 0% OPA-15406 ointment twice daily. |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
Subjects were treated with assigned 1% OPA-15406 ointment twice daily. |
| OG002 | Placebo | Subjects were treated with assigned 0% OPA-15406 ointment twice daily. |
|
|
| Secondary | Change From Baseline in Eczema Area and Severity Index (EASI) Score | The investigator or sub investigator assessed the symptoms of AD using EASI. EASI's minimum and maximum scores are 0 and 72 scores respectively. The higher the EASI score is, the more severe the symptoms of AD, and a negative change from the baseline means improvement and a positive change means worsening. The investigator or sub investigator scored the severity (0-3 points) and affected BSA (%) based on the 4 symptoms (erythema, infiltration/papules, excoriation, and lichenification) on the 4 body regions (face, neck and head ; upper limbs ;trunk; and lower limbs). Number of participants analyzed represents number of participants with data at both Baseline and Week4. Participants who have no data were excluded. | Posted | Mean | Standard Error | score on a scale | Baseline, Week 4 |
|
|
|
| Secondary | Change From Baseline in Verbal Rating Scale (VRS) for Pruritus Score | The investigator or subinvestigator evaluated the pruritus intensity based on VRS. The subjects aged 7 to 14 years old evaluated the pruritus intensity according to the following criteria. The subjects recorded the level of pruritus and the time and date of evaluation in a pruritus diary. 0 : None
| Posted | Mean | Standard Error | score on a scale | Baseline, Week 4 |
|
|
|
| 0 |
| 83 |
| 0 |
| 83 |
| 11 |
| 83 |
| EG001 | 1% OPA-15406 | Subjects were treated with assigned 1% OPA-15406 ointment twice daily. | 0 | 85 | 0 | 85 | 9 | 85 |
| EG002 | Placebo | Subjects were treated with assigned 0% OPA-15406 ointment twice daily. | 0 | 83 | 0 | 83 | 7 | 83 |
| Nasopharyngitis | Infections and infestations | MedDRA Ver. 22.1 | Non-systematic Assessment |
|
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| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D017443 | Skin Diseases, Eczematous |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |