A Open-label Study to Assess the Long-term Safety of Difamilast Ointment 1% in Mild to Moderate Atopic Dermatitis

A Multicenter, Open-label Study to Assess the Long-term Safety of Difamilast Ointment 1% in the Treatment of Children, Adolescents and Adults With Mild to Moderate Atopic Dermatitis

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05571943

Enrollment

542

Registered

2022-10-07

Start date

2022-09-15

Completion date

2024-07-31

Last updated

2024-08-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atopic Dermatitis

Brief summary

This is a Phase 3, open-label study to evaluate the long-term safety of difamilast ointment 1% in subjects ≥2 years of age with mild to moderate AD. The study will also evaluate the long-term efficacy of difamilast ointment 1%, including durability of response.

Interventions

DRUGDifamilast

Difamilast Ointment 1%

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

2 Years to No maximum

Healthy volunteers

Inclusion criteria

Important Inclusion Criteria: 1. Subjects who are male or female ≥2 years of age at Screening (Visit 1). 2. Subjects who have a diagnosis of AD based on the American Academy of Dermatology AD diagnostic criteria 3. Subjects who have had a diagnosis of AD for at least 3 months prior to Screening . 4. 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. IGA ≤ 3, with no minimum BSA and completed through Week 4/EOT Visit 6 of the study MEDI-MM36-301. 5. 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. Important

Exclusion criteria

1. Subjects who have an AD flare (defined as rapid intensification of AD) within 28 days prior to Screening or Baseline (except for those previously enrolled in Study MEDI-MM36-301) or history of consistent requirement for high-potency topical corticosteroids to manage AD signs and symptoms. 2. Subjects who have an active or acute skin infection (eg, herpes simplex, herpes zoster, or chicken pox), and/or clinically infected AD 3. Subjects with significant systemic or localized infection 4. Subjects with minimal/mild depression and suicidal ideation 5. Subjects using restricted medications, biologics and alternative therapies, or using investigational drug \-

Design outcomes

Primary

Measure	Time frame
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	52-week study period

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026