What side effects are associated with this type of intervention?

Common treatments for plaque psoriasis, such as Roflumilast (a PDE-4 inhibitor), generally have mild to moderate side effects. In clinical trials, Roflumilast has shown significant lesion improvement and pruritus management with no reported severe side effects. Other treatments like topical corticosteroids and vitamin D analogues (e.g., calcipotriol) can cause skin irritation, thinning, and potential systemic absorption leading to more serious effects if used extensively. Overall, PDE-4 inhibitors like Roflumilast are well-tolerated with a favorable safety profile.

What prior FDA approvals exist?

The FDA has approved several treatments for plaque psoriasis, including biologics and small molecule inhibitors. Among the small molecule inhibitors, Apremilast, another phosphodiesterase-4 (PDE-4) inhibitor, has been approved for the treatment of moderate-to-severe plaque psoriasis. Apremilast works by inhibiting PDE-4, which helps to reduce inflammation. This mechanism is similar to that of Roflumilast, the active ingredient in ARQ-151 cream, which is currently being studied for its efficacy and safety in treating plaque psoriasis.

What other types of research exist?

Promising novel alternatives to ARQ-151 cream for Plaque Psoriasis patients include biologic agents such as secukinumab and ustekinumab, which have shown efficacy in clinical trials. Additionally, newer agents like tralokinumab, abrocitinib, and upadacitinib, which are approved for other dermatological conditions, may also be considered as potential alternatives.

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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

No Placebo-Only Group

Pivotal Trial

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

This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 weeks for reporting.

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)

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

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

Do I qualify?Apply below to find out

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.