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| Name | Class |
|---|---|
| Dow Pharmaceutical Sciences | INDUSTRY |
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The purpose of this study is to assess the safety, tolerability and efficacy of KP-413 topical ointment compared with vehicle ointment in treating adult subjects with atopic dermatitis (AD).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 3% KP-413 Ointment | Experimental |
| |
| 1% KP-413 Ointment | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| KP-413 Ointment | Drug | Study drug ointment to be applied topically to the selected treatment areas on the head/neck and torso/limbs twice a day for 4 weeks. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Investigator's Global Severity Score(IGSS) | 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Plasma levels of KP-413 | 6 weeks | |
| Signs and Symptoms of AD | 4 weeks | |
| Subject's Numerical Rating Scale(NRS) of Pruritus Score |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Barry Calvarese, MS | Dow Pharmaceutical Sciences | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Michigan Center for Research Corp | Clinton Twp. | Michigan | 48038 | United States | ||
| Oregon Medical Research Center, PC |
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| 4 weeks |
| Percent of AD-affected body surface area (BSA) | 4 weeks |
| Portland |
| Oregon |
| 97223 |
| United States |
| DermResearch, Inc. | Austin | Texas | 78759 | United States |
| J & S Studies, Inc. | College Station | Texas | 77845 | United States |
| Dermatology Treatment & Research Center, PA | Dallas | Texas | 75230 | United States |
| The Education & Research Foundation, Inc | Lynchburg | Virginia | 24501-1604 | United States |
| 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 |
| 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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