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This study will evaluate the systemic exposure and characterize the plasma pharmacokinetic (PK) profile and assess the safety and tolerability of ARQ-154 foam 0.3%.
ARQ-154-127 is a Phase 1, open-label, single arm, maximum usage pharmacokinetic and safety study of roflumilast foam 0.3% in participants with scalp and body psoriasis.
The goal of the study is to:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ARQ-154 Foam 0.3% | Experimental | ARQ-154 foam 0.3% will be applied QD. Treatment duration will be up to 6 weeks, including 2 weeks under maximal usage conditions, followed by an optional 4 weeks under non-maximal usage conditions. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ARQ-154 Foam 0.3% | Drug | ARQ-154 Foam 0.3% |
|
| Measure | Description | Time Frame |
|---|---|---|
| Concentration of Roflumilast and Roflumilast N-Oxide from plasma | Assessment of steady-state trough plasma concentrations after 2 weeks of study drug administration. | 2 Weeks |
| Participant incidence of adverse events | Number of participants with adverse events during treatment will be assessed | 6 Weeks |
| Incidence of application site reactions | Number of participants that experience an application site skin reaction by investigator assessment and participant assessment will be assessed | 6 Weeks |
| The incidence of changes from Baseline in the total Children's Depression Inventory 2 (CDI-2)score. | The CDI-2 is an assessment instrument used to evaluate the severity of depressive symptoms in children. | 6 Weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Arcutis Clinical Study Site 106 | Bryant | Arkansas | 72022 | United States | ||
| Arcutis Clinical Study Site 107 |
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| Miami Lakes |
| Florida |
| 33014 |
| United States |
| Arcutis Clinical Study Site 108 | Meridian | Idaho | 83646 | United States |
| Arcutis Clinical Study Site 105 | West Lafayette | Indiana | 47906 | United States |
| Arcutis Clinical Study Site 104 | Arlington | Texas | 76011 | United States |
| ID | Term |
|---|---|
| D011565 | Psoriasis |
| ID | Term |
|---|---|
| D017444 | Skin Diseases, Papulosquamous |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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