Difamilast Ointment for Eczema

No longer recruiting at 65 trial locations

Overseen By Stephanie Magajna, MS

Age: Any Age

Sex: Any

Trial Phase: Phase 3

Sponsor: Acrotech Biopharma Inc.

Must not be taking: Biologics, Alternative therapies

Disqualifiers: Skin infection, Depression, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: Long-term

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests the long-term safety and effectiveness of difamilast ointment for treating eczema, specifically mild to moderate atopic dermatitis (AD). Participants will apply the ointment to affected skin areas twice a day to determine if it helps control symptoms over time. Individuals who have had eczema for at least three months and experience mild to moderate symptoms might be suitable for this study. The trial aims to understand if difamilast can prevent eczema symptoms from returning and ensure its long-term safety. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants a chance to contribute to the potential availability of a new treatment.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but it mentions that subjects using restricted medications, biologics, and alternative therapies are excluded. It's best to discuss your current medications with the trial team to see if they are allowed.

Is there any evidence suggesting that difamilast ointment is likely to be safe for humans?

Research shows that difamilast ointment is generally easy to use without causing problems. Studies have found that applying it twice a day to affected skin is safe for both infants and adults with eczema. In one study, Japanese infants aged 3 to 24 months experienced no major issues when using the ointment. Another study on adults found that difamilast was not only effective but also very safe. Participants did not experience significant side effects like nausea or diarrhea, which can occur with some other treatments. This suggests that difamilast ointment is safe for long-term use in treating mild to moderate eczema. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Unlike the standard eczema treatments, which often include corticosteroids and calcineurin inhibitors, Difamilast Ointment uses a new active ingredient that targets PDE4, an enzyme involved in inflammation. This unique mechanism of action could reduce inflammation and itching more effectively with potentially fewer side effects than current options. Researchers are excited about Difamilast because it offers a promising alternative for those who need relief without the typical drawbacks of long-term steroid use.

What evidence suggests that difamilast ointment might be an effective treatment for eczema?

Research has shown that difamilast ointment 1% effectively treats eczema. One study found it more effective than a placebo in improving skin conditions for individuals with atopic dermatitis, a common type of eczema. Other studies have confirmed its safety and effectiveness for both adults and children, with noticeable improvements when used twice daily. It has also produced good results in younger children, with lasting benefits over time. This makes difamilast a strong choice for managing mild to moderate eczema symptoms. ^{3 4 5 6 7}

Who Is on the Research Team?

Uma S Atmuri, MPharm MS

Principal Investigator

Acrotech Biopharma Inc.

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

I have been diagnosed with Alzheimer's disease for at least 3 months.

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

Subject is willing and able to comply with all study-related procedures, including, but not limited to, application of the study drug, and visit requirements

Exclusion Criteria

I experience mild depression and have had thoughts about suicide.

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

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

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants apply Difamilast ointment 1% to affected areas twice daily

Long-term

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Difamilast Ointment 1%

Trial Overview

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.

How Is the Trial Designed?

Group I: Difamilast Ointment 1% Experimental Treatment 1 Intervention

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

Who Is Running the Clinical Trial?

Acrotech Biopharma Inc.

Lead Sponsor

Trials

31

Recruited

5,200+

Published Research Related to This Trial

In two studies involving 631 adults with moderate to severe atopic dermatitis, tacrolimus ointment (0.03% or 0.1%) was found to be effective, significantly outperforming the vehicle in all measured efficacy parameters over 12 weeks.

While some patients experienced mild adverse events like skin burning and pruritus, these were generally brief and resolved quickly; importantly, tacrolimus ointment was deemed safe, with no significant laboratory changes and low systemic absorption.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Tacrolimus ointment for the treatment of atopic dermatitis in adult patients: part II, safety. Soter, NA., Fleischer, AB., Webster, GF., et al.[2022]

In a 3-week study involving 301 patients with eczematous dermatoses, once-daily applications of 0.05% diflorasone diacetate cream or ointment showed significant efficacy, with over 80% of patients rating their treatment as good or excellent.

The treatment was generally well-tolerated, with only 16 patients experiencing mild side effects like transient burning and stinging, indicating a favorable safety profile.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An evaluation of once-daily applications of diflorasone diacetate in eczematous dermatoses. Squires, DJ., Masson, EL.[2017]

Citations

1.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC11557786/

Cost-Effectiveness Study of Difamilast 1% for the Treatment of ...

The results suggest that difamilast 1% is a more cost-effective treatment option compared with delgocitinib 0.5% in Japanese adult patients with moderate-to- ...

2.

jaad.org

jaad.org/article/S0190-9622(21)02682-7/fulltext

Difamilast ointment in adult patients with atopic dermatitis

In this phase 3 trial, difamilast ointment 1% was significantly superior to vehicle for the primary endpoint of success rate in IGA score at ...

3.

sciencedirect.com

sciencedirect.com/science/article/abs/pii/S0022356524170450

Pharmacological Profile of Difamilast, a Novel Selective ...

In the phase 3 studies, difamilast ointment (0.3% and 1%) showed good efficacy and safety in both adult (Saeki, et al., 2022a) and pediatric patients (Saeki, et ...

4.

link.springer.com

link.springer.com/article/10.1007/s13555-025-01581-1

A Phase 3, Long-Term, Open-Label Study of Difamilast ...

Difamilast 0.3% or 1% ointment applied twice daily to Japanese infants with AD aged 3 to < 24 months for up to 52 weeks is shown to be effective ...

5.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC11393375/

An Interim Report of a Phase 3, Long-Term, Open-Label ...

Difamilast ointments applied twice daily to Japanese infants with AD aged 3 to < 24 months is effective and well tolerated as of the interim report in the ...

6.

clinicaltrials.gov

clinicaltrials.gov/study/NCT05571943

NCT05571943 | A Open-label Study to Assess the Long- ...

This is a Phase 3, open-label study to evaluate the long-term safety of difamilast ointment 1% in subjects ≥2 years of age with mild to moderate AD. The study ...

7.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/39075274/

An Interim Report of a Phase 3, Long-Term, Open-Label ...

Difamilast ointments applied twice daily to Japanese infants with AD aged 3 to < 24 months is effective and well tolerated as of the interim report in the ...