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:
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
10
ARQ-151 cream 0.3% applied to chronic plaque psoriasis lesions once a day for 4 weeks
Arcutis Clinical Site 603
Mountain Brook, Alabama, United States
Arcutis Clinical Site 604
Scottsdale, Arizona, United States
Plasma Concentration of Roflumilast Following Daily Application of Roflumilast Cream 0.3%
The plasma concentration of roflumilast at Weeks 2 and 4 is reported.
Time frame: Weeks 2 and 4: 1 hour predose
Plasma Concentration of Major N-oxide Metabolite Following Daily Application of Roflumilast Cream 0.3%
The plasma concentration of the major N-oxide metabolite of roflumilast at Weeks 2 and 4 is reported.
Time frame: Weeks 2 and 4: 1 hour predose
Number of Participants With an Adverse Event (AE)
The number of participants with an AE during the treatment period is reported. An AE is any untoward medical
Time frame: Up to 4 weeks
Number of Participants With Application Site Reactions
The number of subjects that experience an application site skin reaction by investigator assessment or application site reactions reported as AEs is reported.
Time frame: Up to 4 weeks
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Arcutis Clinical Site 609
Fountain Valley, California, United States
Arcutis Clinical Site 618
Los Angeles, California, United States
Arcutis Clinical Site 608
Los Angeles, California, United States
Arcutis Clinical Site 611
Rancho Santa Margarita, California, United States
Arcutis Clinical Site 610
Boca Raton, Florida, United States
Arcutis Clinical Site 602
Coral Gables, Florida, United States
Arcutis Clinical Site 613
Delray Beach, Florida, United States
Arcutis Clinical Study Site 628
Miami, Florida, United States
...and 8 more locations