542 Participants Needed

Difamilast Ointment for Eczema

Recruiting at 64 trial locations
SM
Overseen ByStephanie Magajna, MS
Age: Any Age
Sex: Any
Trial Phase: Phase 3
Sponsor: Acrotech Biopharma Inc.
No Placebo GroupAll 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 DataThis treatment has passed at least one previous human trial

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.

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.12345

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.23467

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.12345

Research Team

US

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
See 2 more

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.
See 2 more

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 OverviewThe 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
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)

Find a Clinic Near You

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

References

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]
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]
Difamilast for the treatment of atopic dermatitis. [2023]
Difamilast ointment in adult patients with atopic dermatitis: A phase 3 randomized, double-blind, vehicle-controlled trial. [2022]
An evaluation of once-daily applications of diflorasone diacetate in eczematous dermatoses. [2017]
Difamilast Ointment in Japanese Adult and Pediatric Patients with Atopic Dermatitis: A Phase III, Long-Term, Open-Label Study. [2022]
Tacrolimus ointment for the treatment of atopic dermatitis in adult patients: part II, safety. [2022]