Difamilast Ointment 1% for Atopic Dermatitis

Phase-Based Progress Estimates
2
Effectiveness
3
Safety
Atopic DermatitisDifamilast - Drug
Eligibility
Any Age
All Sexes
What conditions do you have?
Select

Study Summary

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

Eligible Conditions
  • Atopic Dermatitis

Treatment Effectiveness

Effectiveness Progress

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

Study Objectives

2 Primary · 0 Secondary · Reporting Duration: 52-week study period

52 week study period
The incidence and severity of treatment-emergent adverse events (TEAEs), serious adverse events (SAEs), and their relationship to study drug
52-week study period
Proportion of subjects who discontinue due to an AE over the study period

Trial Safety

Safety Progress

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

Trial Design

1 Treatment Group

Difamilast Ointment 1%
1 of 1

Experimental Treatment

500 Total Participants · 1 Treatment Group

Primary Treatment: Difamilast Ointment 1% · No Placebo Group · Phase 3

Difamilast Ointment 1%
Drug
Experimental Group · 1 Intervention: Difamilast · Intervention Types: Drug

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 52-week study period

Who is running the clinical trial?

Acrotech Biopharma Inc.Lead Sponsor
29 Previous Clinical Trials
4,175 Total Patients Enrolled
Uma S Atmuri, MPharm MSStudy DirectorAcrotech Biopharma Inc.

Eligibility Criteria

Age Any Age · All Participants · 6 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
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 OR b.
You are at least 2 years of age and either male or female.
Subjects who have a diagnosis of AD based on the American Academy of Dermatology AD diagnostic criteria.