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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
542
Difamilast Ointment 1%
The incidence and severity of treatment-emergent adverse events (TEAEs), serious adverse events (SAEs), and their relationship to study drug
Time frame: 52 week study period
Proportion of subjects who discontinue due to an AE over the study period
Time frame: 52-week study period
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Qualmedica Research, LLC
Birmingham, Alabama, United States
AllerVie Health
Birmingham, Alabama, United States
Elite Clinical Studies, LLC
Phoenix, Arizona, United States
NEA Baptist Clinic-Dermatology
Jonesboro, Arkansas, United States
First OC Dermatology
Fountain Valley, California, United States
Center for Dermatology Clinical Research, Inc.
Fremont, California, United States
Southern CA Dermatology Skin and Laser
Laguna Niguel, California, United States
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Lancaster, California, United States
Dermatology Research Associates
Los Angeles, California, United States
Clinical Trials Research Institute
Thousand Oaks, California, United States
...and 53 more locations