This is a Phase 2, open label, maximal usage PK and safety study of ARQ-151 cream 0.3% in pediatric subjects (ages 6 to 11 years old) with plaque psoriasis:
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
20
ARQ-151 cream 0.3% applied to chronic plaque psoriasis lesions once a day for 4 weeks
Arcutis Clinical Site 503
Mountain Brook, Alabama, United States
Arcutis Clinical Site 504
Scottsdale, Arizona, United States
Plasma Concentration of ARQ-151 Cream 0.3%
Plasma levels of circulating roflumilast were determined at 2 points in the study.
Time frame: Predose on Days 14 and 28
Plasma Concentration of the Roflumilast Major N-oxide Metabolite
Plasma levels of circulating the roflumilast major N-oxide metabolite were determined at 2 points in the study.
Time frame: Predose on Days 14 and 28
Number of Participants With ≥1 Adverse Event (AE)
The number of participants with adverse events during the treatment period is reported. An AE is any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
Time frame: Up to 28 days
Number of Participants With Application Site Reactions
The number of subjects experiencing an application site skin reactions by investigator assessment is reported. The investigator assessed for erythema prior to that day's application of investigational product.
Time frame: Baseline (Day 1), Day 7, and Day 14
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Arcutis Clinical Site 509
Fountain Valley, California, United States
Arcutis Site 518
Los Angeles, California, United States
Arcutis Clinical Site 508
Los Angeles, California, United States
Arcutis Clinical Site 511
Rancho Santa Margarita, California, United States
Arcutis Clinical Site 510
Boca Raton, Florida, United States
Arcutis Clinical Site 502
Coral Gables, Florida, United States
Arcutis Clinical Site 513
Delray Beach, Florida, United States
Arcutis Clinical Site 501
Hialeah, Florida, United States
...and 7 more locations