This study will compare the safety and efficacy of three test article foams (PDI-192 0.1% Foam, PDI-192 0.15% Foam, and Vehicle Foam) such that a final commercial product may be selected for future development.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
151
UCSD - Rady Children's Hospital
San Diego, California, United States
Northwestern University
Chicago, Illinois, United States
Sneeze, Wheeze & Itch Associates, LLC
Normal, Illinois, United States
Minnesota Clinical Study Center
"Treatment Success" based on change in Investigator's Global Assessment (IGA)
Success rate, based on IGA score. Success rate is defined as the percentage of subjects who achieve "Clear" (score = 0) or "Almost Clear" (score = 1) and at least a 2-grade improvement from Baseline on the IGA score at Day 29. IGA is a measure of overall severity of atopic dermatitis using a 5-point ordinal scale from 0 = clear to 4 = severe.
Time frame: Baseline and Day 29
Change in Pruritis Severity at Day 29
Change from Baseline in the severity of pruritus (itching) at Day 29. Pruritis severity is based on a periodic subject assessment using a 4-point ordinal scale from 0 = none to 3 = severe.
Time frame: Baseline and Day 29
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Fridley, Minnesota, United States
Academic Dermatology Associates
Albuquerque, New Mexico, United States
Dermatology Consulting Services
High Point, North Carolina, United States
DermResearch, Inc.
Austin, Texas, United States
UT Houston Health Science Center
Houston, Texas, United States
Virginia Clinical Research, Inc.
Norfolk, Virginia, United States