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A Phase 1/2a Single Dose and 28-day Parallel Group, Double Blind, Vehicle-Controlled Study of the Safety, Pharmacokinetics and Efficacy of ARQ-151 Cream 0.5% and 0.15% in Adults With Mild to Moderate Chronic Plaque Psoriasis
This study assessed the safety and pharmacokinetics (PK) of a single dose application of ARQ-151 cream 0.5% to 25 cm\^2 of psoriatic plaque(s) (Cohort 1). The study also assessed the safety, PK and efficacy of ARQ-151 cream 0.5% vs vehicle and ARQ-151 cream 0.15% vs vehicle applied once a day for 28 days to individuals with 0.5% to 5.0% body surface area (BSA) of chronic plaque psoriasis (Cohort 2).
There were 2 cohorts of participants. Cohort 1 was a single dose study of ARQ-151 0.5% cream applied to 25 cm\^2 of psoriatic plaque(s) in 8 psoriasis participants. Cohort 2 was a parallel group, double blind, vehicle controlled study in which ARQ-151 cream 0.5%, ARQ-151 cream 0.15% or vehicle cream was applied once a day for 28 days to participants with between 0.5% to 5.0% BSA of chronic plaque psoriasis. Participants were adult (≥18 years old) males or females with chronic plaque psoriasis.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
Mosaic Dermatology
Santa Monica, California, United States
Dr. Chih-ho Hong Medical Inc.
Surrey, British Columbia, Canada
Lynderm Research Inc.
Markham, Ontario, Canada
Research by ICLS
Oakville, Ontario, Canada
SKiN Centre for Dermatology
Peterborough, Ontario, Canada
The Centre for Dermatology
Richmond Hill, Ontario, Canada
K. Papp Clinical Research Inc.
Waterloo, Ontario, Canada
XLR8 Medical Research Inc.
Windsor, Ontario, Canada
Start Date
December 11, 2017
Primary Completion Date
May 2, 2018
Completion Date
May 2, 2018
Last Updated
August 4, 2022
91
ACTUAL participants
ARQ-151 cream 0.5%
DRUG
ARQ-151 cream 0.15%
DRUG
ARQ-151 vehicle cream
DRUG
Lead Sponsor
Arcutis Biotherapeutics, Inc.
NCT07449234
NCT07116967
NCT07250802
Data Source & Attribution
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