Psoriasis Clinical Trial
The Safety, Efficacy and Pharmacokinetics of ARQ-151 Cream in Subjects With Chronic Plaque Psoriasis
Summary
This is a parallel group, double blind, vehicle-controlled study in which roflumilast (ARQ-151) cream 0.3%, roflumilast cream 0.15%, or vehicle cream is applied once daily (QD) for 84 days to subjects with chronic plaque psoriasis involving between 2 and 20% body surface area.
Eligibility Criteria
Inclusion Criteria:
Participants legally competent to sign and give informed consent
Males and females ages 18 years and older (inclusive)
Clinical diagnosis of psoriasis vulgaris of at least 6 months duration as determined by the Investigator
Females of childbearing potential (FOCBP) must have a negative urine pregnancy test at Screening (Visit 1) and Baseline (Visit 2). In addition, sexually active FOCBP must agree to use at least one form of highly effective contraception throughout the trial.
In good health as judged by the Investigator, based on medical history, physical examination, serum chemistry labs, hematology values, and urinalysis.
Subjects are considered reliable and capable of adhering to the Protocol and visit schedule, according to the judgment of the Investigator.
Exclusion Criteria:
Planned excessive exposure of treated area(s) to either natural or artificial sunlight or tanning bed.
Females who are pregnant, wishing to become pregnant during the study, or are breast-feeding.
Previous treatment with roflumilast cream or its active ingredient
Subjects with any serious medical condition or laboratory abnormality that would prevent study participation or place the subject at significant risk, as determined by the Investigator.
Subjects with a history of chronic alcohol or drug abuse within 6 months of initiation of study medication.
Subjects who are unable to communicate, read or understand the local language, or who display another condition, which in the Investigator's opinion, makes them unsuitable for clinical study participation.
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There are 30 Locations for this study
Beverly Hills California, 90212, United States
Northridge California, 91324, United States
San Diego California, 92123, United States
Santa Monica California, 90403, United States
Miami Florida, 33144, United States
Sanford Florida, 32771, United States
Louisville Kentucky, 40217, United States
Clinton Township Michigan, 48038, United States
Detroit Michigan, 48202, United States
Fridley Minnesota, 55432, United States
New York New York, 10029, United States
High Point North Carolina, 27262, United States
Bexley Ohio, 43209, United States
Pittsburgh Pennsylvania, 15213, United States
College Station Texas, 77845, United States
Houston Texas, 77004, United States
Houston Texas, 77056, United States
San Antonio Texas, 78213, United States
Webster Texas, 77598, United States
Norfolk Virginia, 23502, United States
Surrey British Columbia, V3R 6, Canada
Surrey British Columbia, V3V 0, Canada
Winnipeg Manitoba, R3M 3, Canada
Ajax Ontario, L1S 7, Canada
London Ontario, N6H 5, Canada
Markham Ontario, L3P 1, Canada
Oakville Ontario, L6J 7, Canada
Peterborough Ontario, K9J 5, Canada
Waterloo Ontario, N2J 1, Canada
Windsor Ontario, N8W 1, Canada
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