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| ID | Type | Description | Link |
|---|---|---|---|
| 2013-003899-12 | EudraCT Number |
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The purpose of this study is to investigate the effectiveness and safety of 2 concentrations of OPA-15406 compared to vehicle in participants with atopic dermatitis (AD).
AD is a disease mainly characterized by pruritic eczema, and those with the disease experience repeated exacerbations and remissions. Therapeutic guidelines for the disease, currently being developed in many countries, all recognize AD as chronic eczema that is accompanied by the physiological dysfunction of the skin and in which inflammation is caused by various nonspecific stimuli or specific allergens. OPA 15406 is a type-4 phosphodiesterase (PDE4) inhibitor. PDE4 inhibitors are thought to be useful for allergic inflammatory diseases. This is a Phase 2 dose ranging study to evaluate the efficacy of two concentrations of OPA 15406 ointment compared to vehicle, when administered topically twice daily in participants with mild to moderate AD.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 0.3% OPA-15406 | Experimental | OPA-15406 0.3% ointment was applied topically twice daily (BID) to the selected treatment area(s) at approximately 12-hour intervals for 8 weeks. |
|
| 1% OPA-15406 | Experimental | OPA-15406 1% ointment was applied topically BID to the selected treatment area(s) at approximately 12-hour intervals for 8 weeks. |
|
| Vehicle Ointment | Placebo Comparator | OPA-15406 1%-matching placebo (vehicle ointment) was applied topically BID to the selected treatment area(s) at approximately 12-hour intervals for 8 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| OPA-15406 | Drug | OPA-15406 topical ointment |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Success in the Overall Investigator's Global Assessment of Disease Severity (IGA) Score at Week 4 [Using Non-responder Imputation or Last Observation Carried Forward (LOCF)] | The IGA evaluation was performed by a certified rater. The IGA score, used to assess the overall disease severity, consists of a 6-point severity scale from clear to very severe disease (0 = clear, 1 = almost clear, 2 = mild disease, 3 = moderate disease, 4 = severe disease, and 5 = very severe disease). The IGA uses clinical characteristics of erythema, infiltration, papulation, oozing, and crusting as guidelines for the overall severity assessment. The IGA assessment was performed for the overall selected treatment area(s): overall percentage body surface area to be treated and additionally for the target lesion. Success was defined as a score of 0 or 1 with at least a 2-grade reduction from Baseline. Participants without IGA score at Week 4 were treated as non-responders. In the sensitivity analysis, missing IGA score at Week 4 was imputed using LOCF method first and the success was defined based on the imputed IGA score. | Week 4 |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Overall IGA Score at Week 4 [Using Mixed Model Repeated Measures (MMRM) Analysis] | The IGA evaluation was performed by a certified rater. The IGA allows for an assessment of overall disease severity at a given time point, and it consists of a 6-point severity scale from clear to very severe disease (0 = clear, 1 = almost clear, 2 = mild disease, 3 = moderate disease, 4 = severe disease, and 5 = very severe disease). The IGA uses clinical characteristics of erythema, infiltration, papulation, oozing, and crusting as guidelines for the overall severity assessment. The IGA assessment was performed for the overall selected treatment area(s): overall percentage body surface area to be treated and additionally for the target lesion. A negative change from Baseline indicates improvement in overall IGA score. |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Success in the Overall IGA Score at Week 8 (Using Non-responder Imputation or LOCF Imputation) | IGA evaluation was performed by a certified rater. The IGA consists of a 6-point severity scale from clear to very severe disease (0 = clear, 1 = almost clear, 2 = mild disease, 3 = moderate disease, 4 = severe disease, and 5 = very severe disease). The IGA uses clinical characteristics of erythema, infiltration, papulation, oozing, and crusting as guidelines for the overall severity assessment. The IGA assessment was performed for the overall selected treatment area(s): overall percentage body surface area to be treated and additionally for the target lesion. Success was defined as a score of 0 or 1 with at least a 2-grade reduction from Baseline. In the primary analysis, participants without IGA score available at Week 8 were treated as non-responders. In the sensitivity analysis, the missing IGA score at Week 8 was imputed using LOCF method first and the success was defined based on the imputed IGA score. |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Los Angeles | California | 90045 | United States | |||
Anonymized Individual participant data (IPD) that underlie the results of this study will be shared with researchers to achieve aims pre-specified in a methodologically sound research proposal. Small studies with less than 25 participants are excluded from data sharing.
Data will be available after marketing approval in global markets, or beginning 1-3 years following article publication. There is no end date to the availability of the data.
Otsuka will share data on the Vivli data sharing platform which can be found here: https://vivli.org/ourmember/Otsuka/
Participants with mild/moderate atopic dermatitis were randomized in 1:1:1 ratio to receive OPA 15406 (3% w/w, 1% w/w) and matching placebo. Participants had screening evaluations between 30 and 2 days before entering the 8-week treatment phase.
Participants took part in the study at 30 investigative sites in Australia, Poland, and the United States from 20 June 2014 to 28 January 2015.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | 0.3% OPA-15406 | OPA-15406 0.3% ointment was applied topically twice daily (BID) to the selected treatment area(s) at approximately 12-hour intervals for 8 weeks. |
| FG001 | 1% OPA-15406 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
Not provided
Not provided
| Vehicle ointment |
| Drug |
OPA-15406 1%-matching placebo topical ointment |
|
| Baseline, Week 4 |
| Change From Baseline in Overall IGA Score at Week 4 [Using Last Observation Carried Forward (LOCF) Analysis] | The IGA allows for an assessment of overall disease severity at a given time point, and it consists of a 6-point severity scale from clear to very severe disease (0 = clear, 1 = almost clear, 2 = mild disease, 3 = moderate disease, 4 = severe disease, and 5 = very severe disease). The IGA uses clinical characteristics of erythema, infiltration, papulation, oozing, and crusting as guidelines for the overall severity assessment. Missing overall IGA scores at Week 4 were imputed using LOCF method. A negative change from Baseline indicates improvement in overall IGA score. | Baseline, Week 4 |
| Percentage of Participants With Adverse Events (AEs) | An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. An serious adverse event (SAE) was defined as any event which resulted in death, was life-threatening, was a persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions, required in-patient hospitalization or prolonged hospitalization, was a congenital anomaly/birth defect, or was another medically significant event. | From signing of informed consent through Week 8 |
| Week 8 |
| Change From Baseline in Eczema Area and Severity Index (EASI) Score (Using MMRM Analysis) | The EASI evaluation assesses the extent of disease at 4 body sites and measures 4 clinical signs: (1) erythema, (2) induration/papulation, (3) excoriation, and (4) lichenification, each on a scale from 0 (no disease) to 3 (very severe). The EASI scale allows for a maximum score of 72. The EASI assessment was performed on overall body. A negative change from Baseline indicates improvement in EASI score. | Baseline, Weeks 4 and 8 |
| Change From Baseline in EASI Score (Using LOCF Analysis) | The EASI evaluation assesses the extent of disease at 4 body sites and measures 4 clinical signs: (1) erythema, (2) induration/papulation, (3) excoriation, and (4) lichenification, each on a scale from 0 (no disease) to 3 (very severe). The EASI scale allows for a maximum score of 72. The EASI assessment was performed on overall body. A negative change from Baseline indicates improvement in EASI score. | Baseline, Weeks 4 and 8 |
| Change From Baseline in Visual Analog Scale (VAS) Score for Pruritus (Using MMRM Analysis) | At each evaluation, the participants were asked to record their current pruritus intensity over their body overall, not just within the selected treatment areas[s] (i.e., intensity over the last 24 hours) on a horizontal 100-mm line marked as "No itch" on the left end and "Worst imaginable itch" on the right end. The VAS assessment was performed on the overall impression of itch on the body and not just for the selected treatment area(s) or for the target lesion. A negative change from Baseline indicates improvement in VAS score. | Baseline, Weeks 4 and 8 |
| Change From Baseline in VAS for Pruritus (Using LOCF Analysis) | At each evaluation, the participants were asked to record their current pruritus intensity over their body overall, not just within the selected treatment areas[s] (i.e., intensity over the last 24 hours) on a horizontal 100-mm line marked as "No itch" on the left end and "Worst imaginable itch" on the right end. The VAS assessment was performed on the overall impression of itch on the body and not just for the selected treatment area(s) or for the target lesion. A negative change from Baseline indicates improvement in VAS score. | Baseline, Weeks 4 and 8 |
| San Diego |
| California |
| 92123 |
| United States |
| Denver | Colorado | 80220 | United States |
| Orange Park | Florida | 32065 | United States |
| Tampa | Florida | 33613 | United States |
| West Palm Beach | Florida | 33401 | United States |
| Arlington Heights | Illinois | 60005 | United States |
| Carmel | Indiana | 46032 | United States |
| Ann Arbor | Michigan | 48109 | United States |
| Verona | New Jersey | 07044 | United States |
| Albuquerque | New Mexico | 87106 | United States |
| Stony Brook | New York | 11790 | United States |
| High Point | North Carolina | 27262 | United States |
| Portland | Oregon | 97239-4501 | United States |
| Austin | Texas | 78759 | United States |
| College Station | Texas | 77845 | United States |
| Houston | Texas | 77065 | United States |
| San Antonio | Texas | 78229 | United States |
| Norfolk | Virginia | 23507 | United States |
| Spokane | Washington | 99204 | United States |
| Phillip | Australian Capital Territory | Australia |
| Kogarah | New South Wales | Australia |
| Woolloongabba | Queensland | Australia |
| Hectorville | South Australia | 5073 | Australia |
| Fremantle | Western Australia | Australia |
| Katowice | Poland |
| Krakow | Poland |
| Lodz | Poland |
| Warsaw | Poland |
| Wroclaw | Poland |
OPA-15406 1% ointment was applied topically BID to the selected treatment area(s) at approximately 12-hour intervals for 8 weeks.
| FG002 | Vehicle Ointment | OPA-15406 1%-matching placebo (vehicle ointment) was applied topically BID to the selected treatment area(s) at approximately 12-hour intervals for 8 weeks. |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Efficacy Sample included all participants who were randomized and received at least one dose of investigational medicinal product (IMP).
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 0.3% OPA-15406 | OPA-15406 0.3% ointment was applied topically BID to the selected treatment area(s) at approximately 12-hour intervals for 8 weeks. |
| BG001 | 1% OPA-15406 | OPA-15406 1% ointment was applied topically BID to the selected treatment area(s) at approximately 12-hour intervals for 8 weeks. |
| BG002 | Vehicle Ointment | OPA-15406 1%-matching placebo (vehicle ointment) was applied topically BID to the selected treatment area(s) at approximately 12-hour intervals for 8 weeks. |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
|
| 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 | Percentage of Participants With Success in the Overall Investigator's Global Assessment of Disease Severity (IGA) Score at Week 4 [Using Non-responder Imputation or Last Observation Carried Forward (LOCF)] | The IGA evaluation was performed by a certified rater. The IGA score, used to assess the overall disease severity, consists of a 6-point severity scale from clear to very severe disease (0 = clear, 1 = almost clear, 2 = mild disease, 3 = moderate disease, 4 = severe disease, and 5 = very severe disease). The IGA uses clinical characteristics of erythema, infiltration, papulation, oozing, and crusting as guidelines for the overall severity assessment. The IGA assessment was performed for the overall selected treatment area(s): overall percentage body surface area to be treated and additionally for the target lesion. Success was defined as a score of 0 or 1 with at least a 2-grade reduction from Baseline. Participants without IGA score at Week 4 were treated as non-responders. In the sensitivity analysis, missing IGA score at Week 4 was imputed using LOCF method first and the success was defined based on the imputed IGA score. | Efficacy Sample included all participants who were randomized and received at least one dose of IMP. Number analyzed is the number of participants meeting responder criteria defined as an IGA score of 0 or 1 and at least 2-grade reduction from Baseline. | Posted | Number | percentage of participants | Week 4 |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Overall IGA Score at Week 4 [Using Mixed Model Repeated Measures (MMRM) Analysis] | The IGA evaluation was performed by a certified rater. The IGA allows for an assessment of overall disease severity at a given time point, and it consists of a 6-point severity scale from clear to very severe disease (0 = clear, 1 = almost clear, 2 = mild disease, 3 = moderate disease, 4 = severe disease, and 5 = very severe disease). The IGA uses clinical characteristics of erythema, infiltration, papulation, oozing, and crusting as guidelines for the overall severity assessment. The IGA assessment was performed for the overall selected treatment area(s): overall percentage body surface area to be treated and additionally for the target lesion. A negative change from Baseline indicates improvement in overall IGA score. | Efficacy Sample included all randomized participants who received at least one dose of study treatment. Overall number analyzed is the number of participants with non-missing assessment at a specific visit. | Posted | Least Squares Mean | Standard Error | score on a scale | Baseline, Week 4 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Overall IGA Score at Week 4 [Using Last Observation Carried Forward (LOCF) Analysis] | The IGA allows for an assessment of overall disease severity at a given time point, and it consists of a 6-point severity scale from clear to very severe disease (0 = clear, 1 = almost clear, 2 = mild disease, 3 = moderate disease, 4 = severe disease, and 5 = very severe disease). The IGA uses clinical characteristics of erythema, infiltration, papulation, oozing, and crusting as guidelines for the overall severity assessment. Missing overall IGA scores at Week 4 were imputed using LOCF method. A negative change from Baseline indicates improvement in overall IGA score. | Efficacy Sample included all participants who were randomized and received at least one dose of IMP. Overall number analyzed is the number of participants with non-missing assessment at a specific visit. | Posted | Least Squares Mean | Standard Error | score on a scale | Baseline, Week 4 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Adverse Events (AEs) | An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. An serious adverse event (SAE) was defined as any event which resulted in death, was life-threatening, was a persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions, required in-patient hospitalization or prolonged hospitalization, was a congenital anomaly/birth defect, or was another medically significant event. | Safety Sample included all participants who received at least one dose of IMP. | Posted | Number | percentage of participants | From signing of informed consent through Week 8 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Percentage of Participants With Success in the Overall IGA Score at Week 8 (Using Non-responder Imputation or LOCF Imputation) | IGA evaluation was performed by a certified rater. The IGA consists of a 6-point severity scale from clear to very severe disease (0 = clear, 1 = almost clear, 2 = mild disease, 3 = moderate disease, 4 = severe disease, and 5 = very severe disease). The IGA uses clinical characteristics of erythema, infiltration, papulation, oozing, and crusting as guidelines for the overall severity assessment. The IGA assessment was performed for the overall selected treatment area(s): overall percentage body surface area to be treated and additionally for the target lesion. Success was defined as a score of 0 or 1 with at least a 2-grade reduction from Baseline. In the primary analysis, participants without IGA score available at Week 8 were treated as non-responders. In the sensitivity analysis, the missing IGA score at Week 8 was imputed using LOCF method first and the success was defined based on the imputed IGA score. | Efficacy Sample included all participants who were randomized and received at least one dose of IMP. Number analyzed is the number of participants meeting responder criteria defined as an IGA score of 0 or 1 and at least 2-grade reduction from Baseline. | Posted | Number | percentage of participants | Week 8 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Change From Baseline in Eczema Area and Severity Index (EASI) Score (Using MMRM Analysis) | The EASI evaluation assesses the extent of disease at 4 body sites and measures 4 clinical signs: (1) erythema, (2) induration/papulation, (3) excoriation, and (4) lichenification, each on a scale from 0 (no disease) to 3 (very severe). The EASI scale allows for a maximum score of 72. The EASI assessment was performed on overall body. A negative change from Baseline indicates improvement in EASI score. | Efficacy Sample included all participants who were randomized and received at least one dose of IMP. Number analyzed is the number of participants with non-missing assessment at a specific visit. | Posted | Least Squares Mean | Standard Error | score on a scale | Baseline, Weeks 4 and 8 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Change From Baseline in EASI Score (Using LOCF Analysis) | The EASI evaluation assesses the extent of disease at 4 body sites and measures 4 clinical signs: (1) erythema, (2) induration/papulation, (3) excoriation, and (4) lichenification, each on a scale from 0 (no disease) to 3 (very severe). The EASI scale allows for a maximum score of 72. The EASI assessment was performed on overall body. A negative change from Baseline indicates improvement in EASI score. | Efficacy Sample included all participants who were randomized and received at least one dose of IMP. Number analyzed is the number of participants with non-missing assessment at a specific visit. | Posted | Least Squares Mean | Standard Error | score on a scale | Baseline, Weeks 4 and 8 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Change From Baseline in Visual Analog Scale (VAS) Score for Pruritus (Using MMRM Analysis) | At each evaluation, the participants were asked to record their current pruritus intensity over their body overall, not just within the selected treatment areas[s] (i.e., intensity over the last 24 hours) on a horizontal 100-mm line marked as "No itch" on the left end and "Worst imaginable itch" on the right end. The VAS assessment was performed on the overall impression of itch on the body and not just for the selected treatment area(s) or for the target lesion. A negative change from Baseline indicates improvement in VAS score. | Efficacy Sample included all participants who were randomized and received at least one dose of IMP. Number analyzed is the number of participants with non-missing assessment at a specific visit. | Posted | Least Squares Mean | Standard Error | units on scale | Baseline, Weeks 4 and 8 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Change From Baseline in VAS for Pruritus (Using LOCF Analysis) | At each evaluation, the participants were asked to record their current pruritus intensity over their body overall, not just within the selected treatment areas[s] (i.e., intensity over the last 24 hours) on a horizontal 100-mm line marked as "No itch" on the left end and "Worst imaginable itch" on the right end. The VAS assessment was performed on the overall impression of itch on the body and not just for the selected treatment area(s) or for the target lesion. A negative change from Baseline indicates improvement in VAS score. | Efficacy Sample included all participants who were randomized and received at least one dose of IMP. Number analyzed is the number of participants with non-missing assessment at a specific visit. | Posted | Least Squares Mean | Standard Error | units on a scale | Baseline, Weeks 4 and 8 |
|
From signing the informed consent until the end of the Treatment Period (Up to Week 8)
Safety Sample included all participants who received at least one dose of IMP.
Not provided
| 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 | OPA-15406 0.3% ointment was applied topically BID to the selected treatment area(s) at approximately 12-hour intervals for 8 weeks. | 0 | 41 | 2 | 41 | 22 | 41 |
| EG001 | 1% OPA-15406 | OPA-15406 1% ointment was applied topically BID to the selected treatment area(s) at approximately 12-hour intervals for 8 weeks. | 0 | 43 | 2 | 43 | 13 | 43 |
| EG002 | Vehicle Ointment | OPA-15406 1%-matching placebo (vehicle ointment) was applied topically BID to the selected treatment area(s) at approximately 12-hour intervals for 8 weeks. | 0 | 37 | 0 | 37 | 16 | 37 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Giardiasis | Infections and infestations | MedDra 17.0 | Non-systematic Assessment |
| |
| Liver function test abnormal | Investigations | MedDra 17.0 | Non-systematic Assessment |
| |
| Multiple sclerosis | Nervous system disorders | MedDra 17.0 | Non-systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDra 17.0 | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Toothache | Gastrointestinal disorders | MedDra 17.0 | Non-systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDra 17.0 | Non-systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDra 17.0 | Non-systematic Assessment |
| |
| Excoriation | Injury, poisoning and procedural complications | MedDra 17.0 | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MedDra 17.0 | Non-systematic Assessment |
| |
| Dermatitis atopic | Skin and subcutaneous tissue disorders | MedDra 17.0 | Non-systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDra 17.0 | Non-systematic Assessment |
|
A disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 90 days from the time submitted to the sponsor for review. The sponsor cannot require changes to the communication and cannot extend the embargo.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Global Clinical Development | Otsuka Pharmaceutical Development & Commercialization, Inc. | 1-609-524-6788 | clinicaltransparency@otsuka-us.com |
| ID | Term |
|---|---|
| D003876 | Dermatitis, Atopic |
| D004485 | Eczema |
| ID | Term |
|---|---|
| D012873 | Skin Diseases, Genetic |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D003872 | Dermatitis |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D017443 | Skin Diseases, Eczematous |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C000711049 | difamilast |
Not provided
Not provided
Not provided
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| LOCF |
|
|
| 0.0165 |
P-value was derived using CMH test stratified by age group (< 18 or ≥ 18) and region. |
| Mean Difference |
| 18.23 |
| 2-Sided |
| 95 |
| 4.99 |
| 31.46 |
| Superiority or Other (legacy) |
| Cochran-Mantel-Haenszel | 0.0617 | P-value was derived using CMH test stratified by age group (< 18 or ≥ 18) and region. | Mean Difference | 12.30 | 2-Sided | 95 | 0.06 | 24.53 | Superiority or Other (legacy) |
| OG002 | Vehicle Ointment | OPA-15406 1%-matching placebo (vehicle ointment) was applied topically BID to the selected treatment area(s) at approximately 12-hour intervals for 8 weeks. |
|
|
|
OPA-15406 1%-matching placebo (vehicle ointment) was applied topically BID to the selected treatment area(s) at approximately 12-hour intervals for 8 weeks. |
|
|
|
|
|
OPA-15406 1% ointment was applied topically BID to the selected treatment area(s) at approximately 12-hour intervals for 8 weeks. |
| OG002 | Vehicle Ointment | OPA-15406 1%-matching placebo (vehicle ointment) was applied topically BID to the selected treatment area(s) at approximately 12-hour intervals for 8 weeks. |
|
|
|
|
|
|
|
|
|
OPA-15406 1%-matching placebo (vehicle ointment) was applied topically BID to the selected treatment area(s) at approximately 12-hour intervals for 8 weeks. |
|
|
|
OPA-15406 1%-matching placebo (vehicle ointment) was applied topically BID to the selected treatment area(s) at approximately 12-hour intervals for 8 weeks.
|
|
|