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Phosphodiesterase-4 (PDE4) Inhibitor
Topical Roflumilast for Plaque Psoriasis (DERMIS-OLE Trial)
Phase 3
Waitlist Available
Research Sponsored by Arcutis Biotherapeutics, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 24 weeks
Awards & highlights
Summary
This trial will test the safety and effectiveness of ARQ-151 cream, applied daily over several months, in people with chronic plaque psoriasis. The cream helps to calm the skin and prevent rapid skin cell growth.
Who is the study for?
This trial is for males and females aged 2 years and older with chronic plaque psoriasis. Participants must be able to consent or have a guardian's consent, not have serious health issues, avoid excessive sun exposure, and not abuse drugs or alcohol. Women of childbearing age must test negative for pregnancy and use contraception.
What is being tested?
The study tests the safety and effectiveness of ARQ-151 cream (topical roflumilast) applied daily for 24 weeks on individuals with chronic plaque psoriasis. It includes those who've completed a prior ARQ-151 study as well as treatment-naïve participants.
What are the potential side effects?
While specific side effects are not listed here, potential risks may include reactions at the application site or other adverse events that could arise from long-term topical medication use.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 24 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~24 weeks
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Occurrence of treatment emergent AEs (TEAEs)
Trial Design
1Treatment groups
Experimental Treatment
Group I: ARQ-151 Cream 0.3%Experimental Treatment1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Topical roflumilast
2020
Completed Phase 3
~340
Research Highlights
Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Plaque Psoriasis treatments often target specific pathways involved in the inflammatory process. Phosphodiesterase-4 (PDE-4) inhibitors like Roflumilast work by blocking the PDE-4 enzyme, which reduces the production of inflammatory cytokines, thereby decreasing inflammation and plaque formation.
Other common treatments include biologics such as anti-IL-17A monoclonal antibodies (e.g., Secukinumab and Ixekizumab) that inhibit specific interleukins involved in the inflammatory cascade, and TNF-alpha inhibitors (e.g., Adalimumab) that block tumor necrosis factor, a key inflammatory mediator. These treatments are crucial for Plaque Psoriasis patients as they directly target the underlying inflammatory mechanisms, leading to significant improvements in symptoms and quality of life.
New Topical Therapies for Psoriasis.A review of phosphodiesterase-inhibition and the potential role for phosphodiesterase 4-inhibitors in clinical dermatology.Phase II clinical trial of bexarotene gel 1% in psoriasis.
New Topical Therapies for Psoriasis.A review of phosphodiesterase-inhibition and the potential role for phosphodiesterase 4-inhibitors in clinical dermatology.Phase II clinical trial of bexarotene gel 1% in psoriasis.
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Who is running the clinical trial?
Arcutis Biotherapeutics, Inc.Lead Sponsor
21 Previous Clinical Trials
7,308 Total Patients Enrolled
David Berk, MDStudy DirectorArcutis Biotherapeutics, Inc.
21 Previous Clinical Trials
8,302 Total Patients Enrolled
Media Library
Research Study Groups:
This trial has the following groups:- Group 1: ARQ-151 Cream 0.3%
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