Dermatology Research News Brief Summary:
This study is designed to assess the safety and pharmacokinetics (PK) of a single dose application of ARQ-151 cream 0.5% to 25 cm2 of psoriatic plaque(s) (Cohort 1). The study will also assess the safety, PK and efficacy of different doses and multiple applications of ARQ-151 cream 0.5% vs placebo and ARQ-151 cream 0.15% vs placebo 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).
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Psoriasis | Drug: ARQ-151 cream 0.5% Drug: ARQ-151 cream 0.15% Drug: ARQ-151 cream placebo | Phase 1 Phase 2 |
There are 2 cohorts of subjects. Cohort 1 is a single dose study of ARQ-151 0.5% cream applied to 25 cm2 of psoriatic plaque(s) in up to 8 psoriasis subjects. Cohort 2 is a parallel group, double blind, vehicle controlled study in which ARQ-151 cream 0.5%, ARQ-151 cream 0.15% or vehicle cream is applied once a day for 28 days to subjects with between 0.5% to 5.0% BSA of chronic plaque psoriasis. Including both Cohorts, a total of up to 92 subjects will be enrolled at 8 study sites in Canada and the US. Subjects will be adult (≥18 years old) males or females with chronic plaque psoriasis.
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 92 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Double (Participant, Investigator) |
| Masking Description: | Cohort 1 is open label. Cohort 2 is double blind. |
| Primary Purpose: | Treatment |
| Official Title: | 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 |
| Actual Study Start Date : | December 11, 2017 |
| Estimated Primary Completion Date : | May 2018 |
| Estimated Study Completion Date : | June 2018 |
Resource links provided by the National Library of Medicine 
MedlinePlus related topics: Psoriasis
