Arlington Research Center, Inc. | Arlington, TX
Status and phase
Conditions
Treatments
About
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.
Enrollment
Sex
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Volunteers
Inclusion and exclusion criteria
Important Inclusion Criteria:
Important Exclusion Criteria:
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.
Subjects who have an active or acute skin infection (eg, herpes simplex, herpes zoster, or chicken pox), and/or clinically infected AD
Subjects with significant systemic or localized infection
Subjects with minimal/mild depression and suicidal ideation
Subjects using restricted medications, biologics and alternative therapies, or using investigational drug
Primary purpose
Allocation
Interventional model
Masking
542 participants in 1 patient group
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Central trial contact
Stephanie Magajna, MS
Data sourced from clinicaltrials.gov
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