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: * Evaluate the systemic exposure and characterize the plasma pharmacokinetic (PK) profile of ARQ-154 foam 0.3%. * Assess the safety and tolerability of ARQ-154 foam 0.3%
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
16
ARQ-154 Foam 0.3%
Arcutis Clinical Study Site 106
Bryant, Arkansas, United States
RECRUITINGArcutis Clinical Study Site 107
Miami Lakes, Florida, United States
RECRUITINGArcutis Clinical Study Site 108
Meridian, Idaho, United States
Concentration of Roflumilast and Roflumilast N-Oxide from plasma
Assessment of steady-state trough plasma concentrations after 2 weeks of study drug administration.
Time frame: 2 Weeks
Participant incidence of adverse events
Number of participants with adverse events during treatment will be assessed
Time frame: 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
Time frame: 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.
Time frame: 6 Weeks
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Arcutis Clinical Study Site 105
West Lafayette, Indiana, United States
RECRUITINGArcutis Clinical Study Site 104
Arlington, Texas, United States
RECRUITING