drugset / Trial / NCT03392168
Safety, Pharmacokinetics and Efficacy of ARQ-151 Cream in Adults With Mild to Moderate Chronic Plaque Psoriasis
RandomizedParallel-groupDouble-blindTreatment
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).
Timeline
- Start
- 2017-12-11
- Primary completion
- 2018-05-02
- Completion
- 2018-05-02
Publications
- Thurston AW Jr, Osborne DW, Snyder S, Higham RC, Burnett P, Berk DR. Pharmacokinetics of Roflumilast Cream in Chronic Plaque Psoriasis: Data from Phase I to Phase III Studies. Am J Clin Dermatol. 2023 Mar;24(2):315-324. doi: 10.1007/s40257-022-00741-9. Epub 2022 Nov 24.
- Papp KA, Gooderham M, Droege M, Merritt C, Osborne DW, Berk DR, Thurston AW, Smith VH, Welgus H. Roflumilast Cream Improves Signs and Symptoms of Plaque Psoriasis: Results from a Phase 1/2a Randomized, Controlled Study. J Drugs Dermatol. 2020 Aug 1;19(8):734-740. doi: 10.36849/JDD.2020.5370.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Roflumilast | Small molecule | 0.15 % | Topical |
| Subject | Roflumilast | Small molecule | 0.5 % | Topical |