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This is a Phase 2, open label, maximal usage PK and safety study of ARQ-151 cream 0.3% in pediatric subjects (ages 2 to 5 years old) with plaque psoriasis:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ARQ-151 cream 0.3% | Experimental | Open label study of ARQ-151 cream 0.3% applied once daily for 4 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ARQ-151 cream 0.3% | Drug | ARQ-151 cream 0.3% applied to chronic plaque psoriasis lesions once a day for 4 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Plasma pharmacokinetic (PK) profile of ARQ-151 cream 0.3% and its major N-oxide metabolite | Plasma levels of circulating roflumilast and its major N-oxide metabolite | Week 4 |
| Incidence of adverse events | Number of participants with adverse events during treatment will be assessed | Week 4 |
| 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 | Week 4 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| David Berk, MD | Arcutis Biotherapeutics, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Arcutis Clinical Site 603 | Mountain Brook | Alabama | 35223 | United States | ||
| Arcutis Clinical Site 604 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40862624 | Derived | Hebert AA, Guide SV, Groysman V, Gonzalez ME, Blanco D, Laquer V, Seal MS, Thurston A, Krupa D, Snyder S, Burnett P, Chu DH, Berk DR, Higham RC. Early Evidence of Safety, Clinical Benefit, and Pharmacokinetics of Roflumilast Cream 0.3% Once Daily for Treatment of Mild or Moderate Plaque Psoriasis in Children Aged 2-11 Years. Pediatr Dermatol. 2026 Jan-Feb;43(1):105-108. doi: 10.1111/pde.70013. Epub 2025 Aug 27. |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Apr 14, 2026 | |
| Reset | May 1, 2026 |
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| Scottsdale |
| Arizona |
| 85255 |
| United States |
| Arcutis Clinical Site 609 | Fountain Valley | California | 92708 | United States |
| Arcutis Clinical Site 618 | Los Angeles | California | 90017 | United States |
| Arcutis Clinical Site 608 | Los Angeles | California | 90057 | United States |
| Arcutis Clinical Site 611 | Rancho Santa Margarita | California | 92688 | United States |
| Arcutis Clinical Site 610 | Boca Raton | Florida | 33428 | United States |
| Arcutis Clinical Site 602 | Coral Gables | Florida | 33146 | United States |
| Arcutis Clinical Site 613 | Delray Beach | Florida | 33484 | United States |
| Arcutis Clinical Study Site 628 | Miami | Florida | 33125 | United States |
| Arcutis Clinical Site 607 | Miami | Florida | 33155 | United States |
| Arcutis Clinical Site 627 | West Lafayette | Indiana | 47906 | United States |
| Arcutis Clinical Site 606 | Arlington | Texas | 76001 | United States |
| Arcutis Clinical Site 619 | Frisco | Texas | 75034 | United States |
| Arcutis Clinical Study Site 619 | Frisco | Texas | 75034 | United States |
| Arcutis Clinical Site 605 | Houston | Texas | 77030 | United States |
| Arcutis Clinical Site 621 | Toronto | Ontario | M5G 1X8 | Canada |
| Arcutis Clinical Site 630 | Santo Domingo | Dominican Republic |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Apr 14, 2026 | May 1, 2026 | |||
| May 5, 2026 | May 5, 2026 | 9 |
| ID | Term |
|---|---|
| D011565 | Psoriasis |
| ID | Term |
|---|---|
| D017444 | Skin Diseases, Papulosquamous |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| C424423 | Roflumilast |
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