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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 52-week study period
Awards & highlights

Study Summary

This trial will evaluate the long-term safety and efficacy of difamilast ointment for treating atopic dermatitis in children.

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.Check my eligibility
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.See study design
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
Select...
My skin condition is mild or moderate and affects at least 3% of my body.
Select...
I have been diagnosed with atopic dermatitis.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~52 week study period
This trial's timeline: 3 weeks for screening, Varies for treatment, and 52 week study period for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Proportion of subjects who discontinue due to an AE over the study period
The incidence and severity of treatment-emergent adverse events (TEAEs), serious adverse events (SAEs), and their relationship to study drug

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
~340

Find a Location

Who is running the clinical trial?

Acrotech Biopharma Inc.Lead Sponsor
30 Previous Clinical Trials
4,679 Total Patients Enrolled
Uma S Atmuri, MPharm MSStudy DirectorAcrotech Biopharma Inc.

Media Library

Difamilast Ointment 1% (Phosphodiesterase 4 (PDE4) Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT05571943 — Phase 3
Atopic Dermatitis Research Study Groups: Difamilast Ointment 1%
Atopic Dermatitis Clinical Trial 2023: Difamilast Ointment 1% Highlights & Side Effects. Trial Name: NCT05571943 — Phase 3
Difamilast Ointment 1% (Phosphodiesterase 4 (PDE4) Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05571943 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any risks associated with using Difamilast Ointment 1%?

"Difamilast Ointment 1% is in Phase 3 of clinical trials, meaning that there is both safety and efficacy data available. Power rates the safety at a 3 out of 3."

Answered by AI

How many people are recruited for this test at most?

"The sponsor, Acrotech Biopharma Inc., needs to recruit 500 individuals that fit the bill for this experiment from various clinical trial sites including Palmetto Clinical Trial Services, LLC in Anderson, South carolina and International Clinical Research - Tennessee, LLC in Murfreesboro, Tennessee."

Answered by AI

Who else is applying?

What state do they live in?
Florida
What site did they apply to?
Skin Care Research
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
0
2
Recent research and studies
clinicaltrials.govStudy
A Open-label Study to Assess the Long-term Safety of Difamilast Ointment 1% in Mild to Moderate Atopic Dermatitis
2022. "A Open-label Study to Assess the Long-term Safety of Difamilast Ointment 1% in Mild to Moderate Atopic Dermatitis". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05571943.
All > Seborrheic Dermatitis > Atopic Dermatitis
~48 spots leftby Jul 2024
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