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This study is to evaluate the safety, tolerability, and pharmacokinetics of YR001 topical ointment in adult patients with mild to moderate atopic dermatitis
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active dose | Experimental | The intervention is YR001 ointment on a range of body surface area for multiple topical administration |
|
| Placebo dose | Experimental | The intervention is Placebo on a range of body surface area for multiple topical administration |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| YR001 ointment | Drug | The intervention is YR001 ointment on a range of body surface area for multiple topical administration |
|
| Measure | Description | Time Frame |
|---|---|---|
| The primary endpoint will be safety. Specifically, the primary endpoint will be the incidence of treatment-related AEs (TRAEs) through Day 50. | incidence of treatment related AEs (TRAEs) | Day1-Day 50 |
| Measure | Description | Time Frame |
|---|---|---|
| all treatment-emergents AEs | number, severity, causality, and outcome of all treatment-emergetns AEs (TEAEs) | Day1-Day 50 |
| Efficacy of YR001 Ointment | Proportion of patients achieving ISGA 0 or 1 by visit |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Encore Medical Research -Boynton Beach | Boynton Beach | Florida | 33436 | United States | ||
| Encore Medical Research-Hollywood |
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| 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 |
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| Placebo | Other | The intervention is Placebo on a range of body surface area for multiple topical administration |
|
| Day1-Day50 |
| Hollywood |
| Florida |
| 33331 |
| United States |
| Encore Medical Research-Weston | Weston | Florida | 33331 | United States |
| DelRicht Research | Baton Rouge | Louisiana | 70809 | United States |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D017443 | Skin Diseases, Eczematous |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |