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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
153
Off-white ointment containing active ingredient, petrolatum and other ingredients
Matching Difamilast (Study drug) ointment without active ingradient
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
The proportion of subjects achieving success on the the 5-point Investigator Global Assessment (IGA) of AD Severity score at Day 29, and the success is defined as as a score of Clear (0) or Almost clear (1), with at least a 2-grade improvement from Baseline on the 5-point IGA of AD Severity score at Day 29
Time frame: Baseline, Day 29
To further characterize the efficacy of Difamilast ointment 1% compared to vehicle control in subjects with mild to moderate AD
The proportion of subjects achieving an IGA of AD Severity score of Clear (0) or Almost clear (1) at Day 29; the proportion of subjects achieving success on the 5-point IGA of AD Severity score at Day 22; the proportion of subjects achieving success on the 5-point IGA of AD Severity score at Day 15 The proportion of subjects achieving success on the 5-point IGA of AD Severity score at Day 22 The proportion of subjects achieving success on the 5-point IGA of AD Severity score at Day 15
Time frame: Baseline, Day 15, Day 22 and Day 29
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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
Antelope Valley Clinical Trials
Lancaster, California, United States
Dermatology Research Associates
Los Angeles, California, United States
Shahram Jacobs, MD Inc.
Sherman Oaks, California, United States
Clinical Trials Research Institute
Thousand Oaks, California, United States
IMMUNOe Research Centers
Centennial, Colorado, United States
...and 29 more locations