Difamilast Ointment for Dermatitis

Phase-Based Progress Estimates
Dermatitis+3 More
Difamilast - Drug
Any Age
All Sexes
What conditions do you have?

Study Summary

This is a Phase 3 Double Blind multi-center study conducted at 40 investigational sites in United States to assess the efficacy and safety of Difamilast Ointment 1% in subjects ≥2 years of age with mild to moderate atopic dermatitis.

Eligible Conditions
  • Dermatitis

Treatment Effectiveness

Effectiveness Progress

2 of 3
This is further along than 85% of similar trials

Study Objectives

1 Primary · 1 Secondary · Reporting Duration: Baseline, Day 15, Day 22 and Day 29

Day 29
To further characterize the efficacy of Difamilast ointment 1% compared to vehicle control in subjects with mild to moderate AD
Baseline, Day 29
To evaluate the efficacy of twice-daily topical application of Difamilast ointment 1% compared to vehicle control in subjects ≥2 years of age with mild to moderate AD

Trial Safety

Safety Progress

3 of 3
This is further along than 85% of similar trials

Trial Design

2 Treatment Groups

Difamilast Ointment
1 of 2
Vehicle Controlled
1 of 2

Active Control

Non-Treatment Group

336 Total Participants · 2 Treatment Groups

Primary Treatment: Difamilast Ointment · Has Placebo Group · Phase 3

Difamilast Ointment
ActiveComparator Group · 1 Intervention: Difamilast · Intervention Types: Drug
Vehicle Controlled
PlaceboComparator Group · 1 Intervention: Placebo · Intervention Types: Drug

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: baseline, day 15, day 22 and day 29

Who is running the clinical trial?

Acrotech Biopharma Inc.Lead Sponsor
29 Previous Clinical Trials
4,339 Total Patients Enrolled
1 Trials studying Dermatitis
500 Patients Enrolled for Dermatitis
Uma Srinivas Atmuri, MPharm MSStudy DirectorAcrotech Biopharma Inc.

Eligibility Criteria

Age Any Age · All Participants · 7 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You are male or female at least 2 years of age.
Subjects and/or their parent(s)/legal guardian(s) (if subject is under the legal age of consent) must provide written informed consent prior to the conduct of any study-related procedures.
Subjects who have a diagnosis of AD based on the American Academy of Dermatology AD diagnostic criteria.
Subjects who have AD involvement ≥5% to ≤40% of treatable BSA excluding scalp.
Subjects who have an AD Severity of mild (2) or moderate (3) as measured by the IGA of AD Severity score at screening and baseline visit.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 28th, 2021

Last Reviewed: November 24th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.