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This is a multicenter, double-blind, vehicle-control study of 0.05% and 0.2% E6005 ointment. Pediatric subjects with atopic dermatitis (AD) will be grouped into two; an elder group (childhood - adolescent: 7 to 15 years of age) and a younger group (children: 2 to 6 years of age) according to the sequential cohorts by confirming the safety.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | E6005 0.2% ointment applied twice a day to eczema areas |
|
| 2 | Experimental | E6005 0.05% ointment applied twice a day to eczema areas |
|
| 3 | Placebo Comparator | Placebo ointment applied twice a day to eczema areas |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| E6005 0.05% | Drug |
| ||
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics of E6005 | The whole blood concentrations of E6005 and major metabolite will be evaluated at each visit | Up to 21 Days |
| Number of participants with adverse events as a measure of the safety and tolerability of E6005 | The safety variables include adverse events, clinical laboratory parameters, vital signs and ECG results. | Up to 21 Days |
| Measure | Description | Time Frame |
|---|---|---|
| Change from Baseline in severity score of targeted eczema | For targeted eczema defined at baseline, intensity of 4 symptoms (erythema, infiltration/papulation, excoriation, and lichenification) will be assessed using a 5-grade scoring method (0: clear, 1: almost clear, 2: mild, 3: moderate, 4: severe) (maximal score: 16). | Baseline and Day 15 |
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Inclusion Criteria
Exclusion Criteria
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chitose-shi | Hokkaido | Japan | ||||
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| ID | Term |
|---|---|
| D003876 | Dermatitis, Atopic |
| D003872 | Dermatitis |
| ID | Term |
|---|---|
| D012873 | Skin Diseases, Genetic |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D012871 | Skin Diseases |
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0.5 g placebo ointment |
|
| E6005 0.2% | Drug |
|
| Change from Baseline in severity assessment by Investigator's Global Assessment (IGA) for targeted eczema and whole application sites | Severity of AD dermal symptoms in targeted eczema and whole application sites wil be assessed based on a 6-grade scoring method (0: clear, 1: almost clear, 2: mild, 3: moderate, 4: severe, 5: most severe). | Baseline and Day 15 |
| Change from Baseline in intensity of pruritus | 1) Interview-based pruritus scores: Subjects or caregivers (who must not be changed throughout the study) will assess the intensity of pruritus day and night within 3 days before the visit. 2) Investigator-assessed pruritus: The investigator will assess pruritus conditions by grading into 5 levels (0: clear, 1: almost clear, 2: mild, 3: moderate, 4: severe) based on the comprehensive judgments of interview and scratching behaviors. | Baseline and Day 15 |
| Eniwa-shi |
| Hokkaido |
| Japan |
| Sapporo | Hokkaido | Japan |
| D017437 | Skin and Connective Tissue Diseases |
| D017443 | Skin Diseases, Eczematous |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |