Difamilast Ointment for Eczema

Recruiting at 64 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

542 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

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 Difamilast Ointment safe for humans?

Difamilast Ointment has been shown to be safe and well-tolerated in both adults and children with atopic dermatitis, a type of eczema. Clinical trials have not reported any major safety concerns, and it has been approved for use in Japan for patients aged 2 years and older. ^{1 2 3 4 5}

How is Difamilast ointment different from other eczema drugs?

Difamilast ointment is unique because it is a phosphodiesterase 4 inhibitor, which helps reduce inflammation and itching in eczema. It has a rapid onset of action, showing significant improvement within one week, and is approved for both adults and children in Japan. ^{1 2 5 6 7}

What data supports the effectiveness of the drug Difamilast Ointment 1% for eczema?

Research shows that Difamilast Ointment, a drug used for atopic dermatitis (a type of eczema), is effective and safe. Studies found it reduces symptoms like itching and inflammation quickly, with improvements seen within a week, and it is well-tolerated by both adults and children. ^{1 2 5 6 7}

Research Team

Uma S Atmuri, MPharm MS

Principal Investigator

Acrotech Biopharma Inc.

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

References

1. England pubmed.ncbi.nlm.nih.gov

Phase 2, randomized, double-blind, placebo-controlled, 4-week study to evaluate the safety and efficacy of OPA- 15406 (difamilast), a new topical selective phosphodiesterase type-4 inhibitor, in Japanese pediatric patients aged 2-14 years with atopic dermatitis. [2020]

2. England pubmed.ncbi.nlm.nih.gov

Clinical efficacy and safety of topical difamilast in the treatment of patients with atopic dermatitis: a systematic review and meta-analysis of randomized controlled trials. [2022]

3. England pubmed.ncbi.nlm.nih.gov

Difamilast for the treatment of atopic dermatitis. [2023]

4. United States pubmed.ncbi.nlm.nih.gov

Difamilast ointment in adult patients with atopic dermatitis: A phase 3 randomized, double-blind, vehicle-controlled trial. [2022]

5. England pubmed.ncbi.nlm.nih.gov

An evaluation of once-daily applications of diflorasone diacetate in eczematous dermatoses. [2017]

6. Switzerland pubmed.ncbi.nlm.nih.gov

Difamilast Ointment in Japanese Adult and Pediatric Patients with Atopic Dermatitis: A Phase III, Long-Term, Open-Label Study. [2022]

7. United States pubmed.ncbi.nlm.nih.gov

Tacrolimus ointment for the treatment of atopic dermatitis in adult patients: part II, safety. [2022]