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The safety and pharmacokinetics of topical application with E6005 ointment compared to vehicle will be evaluated in Japanese male patients with atopic dermatitis. Additionally, the efficacy of topical application with E6005 ointment will be explored in Japanese male patients with atopic dermatitis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental |
| |
| 2 | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| E6005 | Drug | Four Steps of Ointment Application: Step 1: 0.01% of E6005; Step 2: 0.03% of E6005; Step 3: 0.1% of E6005; Step 4: 0.2% of E6005. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetic parameter Cmax will be calculated | Until Day 13 | |
| Pharmacokinetic parameter tmax will be calculated | Until Day 13 | |
| Pharmacokinetic parameter AUC(0-t) will be calculated | Until Day 13 | |
| Pharmacokinetic parameter t1/2 will be calculated | Until Day 13 |
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Inclusion criteria;
Exclusion criteria;
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fukuoka | Japan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26581111 | Derived | Ohba F, Nomoto M, Hojo S, Akama H. Safety, tolerability and pharmacokinetics of a novel phosphodiesterase inhibitor, E6005 ointment, in healthy volunteers and in patients with atopic dermatitis. J Dermatolog Treat. 2016;27(3):241-6. doi: 10.3109/09546634.2015.1093587. Epub 2015 Nov 18. |
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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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| ID | Term |
|---|---|
| C583128 | methyl 4-(((3-(6,7-dimethoxy-2-(methylamino)quinazolin-4-yl)phenyl)amino)carbonyl)benzoate |
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| Placebo | Drug | Matching placebo for each step |
|
| D017437 | Skin and Connective Tissue Diseases |
| D017443 | Skin Diseases, Eczematous |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |