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This study will assess the safety and tolerability of ARQ-151 cream 0.05% applied once a day for 4 weeks in infants with atopic dermatitis (eczema).
This study is an open label safety study in which ARQ-151 cream 0.05% is applied once a day for 4 weeks in infants with atopic dermatitis (eczema).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ARQ-151 roflumilast cream 0.05% (open label) | Experimental | This single study arm is open label in which ARQ-151 cream 0.05% is applied daily for 4 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ARQ-151 cream 0.05% | Drug | ARQ-151 Cream 0.05% is applied once daily for 4 weeks in infants with atopic dermatitis (eczema). |
|
| Measure | Description | Time Frame |
|---|---|---|
| Subject incidence of adverse events | Number of participants with adverse events during treatment will be assessed | 4 weeks |
| Subject incidence of serious adverse events | Number of participants with serious adverse events during treatment will be assessed | 4 weeks |
| Incidence of application site reactions | Number of subjects that experience an application site skin reaction by investigator assessment and application site reactions reported as adverse events will be assessed | 4 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Arcutis Clinical Study Site 208 | Birmingham | Alabama | 35244 | United States | ||
| Arcutis Clinical Study Site 221 |
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Single arm open label study.
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| Bryant |
| Arkansas |
| 72022 |
| United States |
| Arcutis Clinical Study Site 214 | Fountain Valley | California | 92708 | United States |
| Arcutis Clinical Study Site 209 | Rancho Santa Margarita | California | 92688 | United States |
| Arcutis Clinical Study Site 207 | Coral Gables | Florida | 33146 | United States |
| Arcutis Clinical Study Site 217 | Delray Beach | Florida | 33484 | United States |
| Arcutis Clinical Study Site 213 | Jacksonville | Florida | 32256 | United States |
| Arcutis Clinical Study Site 223 | Boise | Idaho | 83706 | United States |
| Arcutis Clinical Study Site 219 | West Lafayette | Indiana | 47906 | United States |
| Arcutis Clinical Study Site 212 | Minneapolis | Minnesota | 55112 | United States |
| Arcutis Clinical Study Site 211 | Portsmouth | New Hampshire | 03801 | United States |
| Arcutis Clinical Study Site 220 | Mason | Ohio | 45040 | United States |
| Arcutis Clinical Study Site 206 | Portland | Oregon | 97239 | United States |
| Arcutis Clinical Study Site 222 | Summerville | South Carolina | 29486 | United States |
| Arcutis Clinical Study Site 210 | Bellaire | Texas | 77401 | United States |
| Arcutis Clinical Study Site 224 | Fort Worth | Texas | 76244 | United States |
| Arcutis Clinical Study Site 202 | San Antonio | Texas | 78218 | United States |
| Arcutis Clinical Study Site 203 | Winnipeg | Manitoba | R3J0S9 | Canada |
| Arcutis Clinical Study Site 204 | Halifax | Nova Scotia | B3K 5R3 | Canada |
| Arcutis Clinical Study Site 216 | Waterloo | Ontario | N2J1C4 | Canada |
| Arcutis Clinical Study Site 225 | Saskatoon | Saskatchewan | S7K2C1 | Canada |
| Arcutis Clinical Study Site 201 | Santo Domingo | 10306 | Dominican Republic |
| 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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