What side effects are associated with this type of intervention?

Topical PDE4 inhibitors, such as ARQ-151 cream, have been studied for their safety and efficacy in treating atopic dermatitis. Common side effects reported include application site reactions such as burning, stinging, and itching. Other treatments for atopic dermatitis, like topical corticosteroids, can cause skin thinning, stretch marks, and systemic effects if used long-term. Calcineurin inhibitors (e.g., tacrolimus and pimecrolimus) may cause burning sensations and increased risk of skin infections. Systemic treatments, such as oral JAK inhibitors (e.g., upadacitinib), can lead to acne, upper respiratory infections, and headaches. It is important to discuss these potential side effects with a healthcare provider to determine the most appropriate treatment.

What prior FDA approvals exist?

The FDA has approved several treatments for Atopic Dermatitis, including topical PDE4 inhibitors like crisaborole ointment, 2%, which is used for mild-to-moderate cases. Crisaborole works by inhibiting phosphodiesterase 4 (PDE4), reducing inflammation. Other FDA-approved treatments include topical corticosteroids, topical calcineurin inhibitors like tacrolimus and pimecrolimus, and systemic treatments such as dupilumab, a monoclonal antibody for moderate-to-severe cases. These treatments aim to manage symptoms and reduce flare-ups in patients with Atopic Dermatitis.

What other types of research exist?

Promising novel alternatives to ARQ-151 cream for atopic dermatitis include: 1) Dupilumab, an anti-IL-4Rα monoclonal antibody, which has shown efficacy in both adults and pediatric patients with atopic dermatitis. 2) Upadacitinib, an oral JAK inhibitor, which has demonstrated significant improvement in Eczema Area and Severity Index (EASI) scores and pruritus reduction. 3) Crisaborole, a topical PDE4 inhibitor, which has shown antipruritic activity and efficacy in mild to moderate atopic dermatitis.

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Phosphodiesterase-4 (PDE4) Inhibitor

Roflumilast Cream for Eczema (INTEGUMENT-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

Females of childbearing potential (FOCBP) must have a negative urine pregnancy test at all study visits. In addition, sexually active FOCBP must agree to use at least one form of a highly effective or barrier method of contraception throughout the trial.

Must not have

Subjects who experienced a treatment-related AE or a serious AE (SAE) that precluded further treatment with ARQ-151 cream in the preceding study.

Subjects with known genetic dermatological conditions that overlap with AD.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 24 or 52 weeks

Awards & highlights

No Placebo-Only Group

Pivotal Trial

Summary

This trial is testing a special cream called ARQ-151 for people with eczema, a condition that makes their skin itchy and red. The cream is applied daily to see if it helps reduce these symptoms over time.

Who is the study for?

This trial is for individuals who have atopic dermatitis (eczema) and completed a previous related study. It's open to males and females aged 2 years and up, but only adults in Québec, Canada. Participants must be reliable in following the study plan. Women of childbearing age need a negative pregnancy test and must use effective contraception.

What is being tested?

The trial tests ARQ-151 cream (0.15% or 0.05%) applied daily for one year to see how safe it is and how well it works for managing eczema symptoms.

What are the potential side effects?

Potential side effects are not detailed here, but as with any topical cream, there could be risks of skin irritation, redness, itching or allergic reactions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am able to have children, will test for pregnancy, and agree to use birth control during the trial.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I had a serious side effect from ARQ-151 cream that stopped me from continuing its use.

Select...

I have a genetic skin condition that is similar to atopic dermatitis.

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I am not pregnant, trying to get pregnant, or breastfeeding.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 24 or 52 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~24 or 52 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 or 52 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

To assess long-term safety in a multicenter, open-label, single-arm, 52-week study in subjects with atopic dermatitis treated with ARQ-151 cream: AEs and SAEs

Secondary study objectives

EASI score over time

Validated Investigator Global Assessment-Atopic Dermatitis (vIGA-AD) score of 0 or 1 at each assessment

WI-NRS score over time

+1 more

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 0.15% or ARQ-151 Cream 0.05%Experimental Treatment1 Intervention

ARQ-151 Cream 0.15% or ARQ-151 Cream 0.05%

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

ARQ-151 Cream 0.15% or ARQ-151 Cream 0.05%

2021

Completed Phase 3

~1220

0 / 4Eligibility criteria met

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

Topical PDE4 inhibitors, such as ARQ-151 cream, work by inhibiting the enzyme phosphodiesterase 4, which reduces inflammation and pruritus by decreasing the production of pro-inflammatory cytokines. Topical corticosteroids reduce inflammation and immune responses by suppressing various inflammatory pathways. Calcineurin inhibitors, like tacrolimus and pimecrolimus, inhibit T-cell activation, thereby reducing inflammation and immune activity. Biologics, such as dupilumab, target specific immune pathways, like the IL-4 and IL-13 signaling, to reduce chronic inflammation. These treatments are crucial for AD patients as they help manage symptoms, reduce flare-ups, and improve the quality of life by addressing the underlying inflammatory processes of the disease.

The novel protease inhibitor SRD441 ointment is not effective in the treatment of adult subjects with atopic dermatitis: results of a randomized, vehicle-controlled study.