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The purpose of this study is to investigate the pharmacokinetics and safety of OPA-15406 in adult subjects with atopic dermatitis
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | Matching placebo. |
|
| Tacrolimus | Active Comparator | Tacrolimus 0.1% ointment twice daily for 28 days. |
|
| OPA-15406 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| OPA-15406 | Drug | 0.3%, 1%, or 3% OPA-15406 topical ointment, applied twice daily for 28 days |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Number of subjects with AEs, SAEs, and % of clinically relevant changes from baseline in Draize Scale, physical examinations, vital signs, laboratory assessments, and electrocardiograms. | 28 days | |
| Measurement of drug levels in the blood of treated patients | 28 days |
| Measure | Description | Time Frame |
|---|---|---|
| Investigator's Global Assessment (IGA) of Disease Severity at Week 4 | 28 Days |
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Inclusion Criteria:
Exclusion Criteria:
-Use of systemic or topical therapy for contact or atopic dermatitis within 30 days of screening
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mobile | Alabama | 36608 | United States | |||
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| Tacrolimus |
| Drug |
0.1% concentration of tacrolimus. |
|
|
| Placebo | Drug |
|
| Hot Springs |
| Arizona |
| 71913 |
| United States |
| Irvine | California | 92697 | United States |
| Orange Park | Florida | 32073 | United States |
| Tampa | Florida | 33609 | United States |
| Carmel | Indiana | 46032 | United States |
| Berlin | New Jersey | 08009 | United States |
| High Point | North Carolina | 27262 | United States |
| Portland | Oregon | 97210 | United States |
| College Station | Texas | 77845 | United States |
| Dallas | Texas | 75230 | United States |
| San Antonio | Texas | 78229 | United States |
| 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 |
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| ID | Term |
|---|---|
| C000711049 | difamilast |
| D016559 | Tacrolimus |
| ID | Term |
|---|---|
| D018942 | Macrolides |
| D007783 | Lactones |
| D009930 | Organic Chemicals |
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