At a glance
ClinicalIndex Comparison Record- ✓Adult male and female participants aged ≥18 years
- ✓Cohort 1: At least 25 cm² of chronic plaque psoriasis (excluding face, scalp, intertriginous areas, palms and soles)
- ✓Cohort 2: 0.5-5% total BSA of chronic plaque psoriasis with at least one target plaque ≥9 cm² and TPSS ≥4 (excluding face, scalp, intertriginous areas, palms and soles)
- ✓In good health based on medical history, physical examination, ECG, serum chemistry, hematology, and urinalysis
- ✕Non-plaque forms of psoriasis (erythrodermic, guttate, pustular or palmo-plantar) or drug-induced psoriasis
- ✕Skin conditions other than psoriasis that would interfere with evaluation of study medication
- ✕Pregnant or lactating women or planning to become pregnant during study and/or within 28 days after last dose
- ✕Known allergies to excipients in ARQ-151 cream
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 2 clinical trial evaluating ARQ-151 cream 0.5%, ARQ-151 cream 0.15%, and 1 other intervention for Psoriasis. Completed, enrolled 91 participants across 8 sites in 2 countries.
Detailed Summary
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).
Study Details
Timeline
Interventions
0.5% active concentration
0.15% active concentration
Vehicle cream