What side effects are associated with this type of intervention?

Common treatments for atopic dermatitis, such as PDE4 inhibitors like Difamilast and E6005, generally have mild side effects, including application site reactions like burning or stinging. Tacrolimus and pimecrolimus, which are calcineurin inhibitors, can also cause similar local reactions and, less commonly, systemic effects like headache or nasopharyngitis. Long-term safety data is still being evaluated for these treatments, but they are generally well-tolerated with proper use.

What prior FDA approvals exist?

The FDA has approved several treatments for Atopic Dermatitis, including PDE4 inhibitors like Crisaborole (Eucrisa), which is a topical ointment used for mild to moderate cases. Other notable treatments include topical corticosteroids, calcineurin inhibitors like Tacrolimus and Pimecrolimus, and biologics such as Dupilumab (Dupixent) for moderate to severe cases. These treatments aim to reduce inflammation and manage symptoms effectively.

What other types of research exist?

Promising novel alternatives to Difamilast Ointment 1% for Atopic Dermatitis patients include: 1) Crisaborole Ointment 2%, a non-steroidal PDE4 inhibitor, which has shown efficacy in reducing pruritus and improving AD symptoms. 2) Tacrolimus Ointment, which has demonstrated efficacy in vehicle-controlled studies for moderate-to-severe AD in children. 3) E6005, another topical PDE4 inhibitor, which has shown safety and efficacy in both children and adults with AD in clinical trials.

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Phosphodiesterase 4 (PDE4) Inhibitor

Difamilast Ointment for Eczema

Phase 3

Waitlist Available

Research Sponsored by Acrotech Biopharma Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Subjects who have an IGA of mild or moderate AD Severity and treatable body surface area (BSA) ≥3% at Baseline if not previously enrolled in study MEDI-MM36-301

Subjects who have a diagnosis of AD based on the American Academy of Dermatology AD diagnostic criteria

Must not have

Subjects using restricted medications, biologics and alternative therapies, or using investigational drug

Subjects who have an active or acute skin infection (eg, herpes simplex, herpes zoster, or chicken pox), and/or clinically infected AD

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

No Placebo-Only Group

Pivotal Trial

Summary

This trial is testing a medicated cream called difamilast ointment on people aged 2 and older who have mild to moderate atopic dermatitis. The cream aims to reduce skin inflammation and itching. The study will check if the cream is safe and effective over several months.

Who is the study for?

This trial is for individuals aged 2 years and older diagnosed with mild to moderate atopic dermatitis (AD), as defined by the American Academy of Dermatology. Participants must have had AD for at least three months, a treatable body surface area affected by AD of 3% or more, and be able to follow study procedures. Those with active skin infections, significant infections, using certain medications or therapies, or having severe depression are excluded.

What is being tested?

The study tests the long-term safety and effectiveness of Difamilast ointment 1% in treating atopic dermatitis. It's an open-label Phase 3 trial that also looks into how well responses last over time among participants who apply this medication regularly.

What are the potential side effects?

While specific side effects for Difamilast aren't listed here, common side effects from similar topical treatments can include skin irritation where the ointment is applied, itching, redness, and possible worsening of dermatitis symptoms.

Eligibility Criteria

Inclusion Criteria

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

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My skin condition is mild or moderate and affects at least 3% of my body.

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I have been diagnosed with atopic dermatitis.

Exclusion Criteria

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

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I am not using any restricted medications, biologics, alternative therapies, or investigational drugs.

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I do not have an active skin infection or infected atopic dermatitis.

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I am currently dealing with a serious infection.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

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: Difamilast Ointment 1%Experimental Treatment1 Intervention

A thin layer of Difamilast applied to affected areas twice daily (morning and evening, approximately 12 hours apart)

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Difamilast

2022

Completed Phase 3

~880

0 / 5Eligibility 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

Atopic Dermatitis (AD) treatments work by targeting the underlying inflammation and immune response. PDE4 inhibitors, like Difamilast Ointment 1%, reduce inflammation by inhibiting the enzyme phosphodiesterase 4, which decreases the production of pro-inflammatory cytokines. Topical corticosteroids suppress the immune response and inflammation by mimicking cortisol, a natural anti-inflammatory hormone. Calcineurin inhibitors, such as tacrolimus and pimecrolimus, block T-cell activation, reducing inflammation and immune activity. Biologics, like dupilumab, target specific molecules involved in the inflammatory pathway, such as interleukin-4 and interleukin-13, 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 root causes of the disease.

Effect of topical phosphodiesterase 4 inhibitor E6005 on Japanese children with atopic dermatitis: Results from a randomized, vehicle-controlled exploratory trial.