The purpose of this study is to investigate the pharmacokinetics and safety of OPA-15406 in adult subjects with atopic dermatitis
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
92
0.3%, 1%, or 3% OPA-15406 topical ointment, applied twice daily for 28 days
0.1% concentration of tacrolimus.
Unnamed facility
Mobile, Alabama, United States
Unnamed facility
Hot Springs, Arizona, United States
Unnamed facility
Irvine, California, United States
Unnamed facility
Orange Park, Florida, United States
Number of subjects with AEs, SAEs, and % of clinically relevant changes from baseline in Draize Scale, physical examinations, vital signs, laboratory assessments, and electrocardiograms.
Time frame: 28 days
Measurement of drug levels in the blood of treated patients
Time frame: 28 days
Investigator's Global Assessment (IGA) of Disease Severity at Week 4
Time frame: 28 Days
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Unnamed facility
Tampa, Florida, United States
Unnamed facility
Carmel, Indiana, United States
Unnamed facility
Berlin, New Jersey, United States
Unnamed facility
High Point, North Carolina, United States
Unnamed facility
Portland, Oregon, United States
Unnamed facility
College Station, Texas, United States
...and 2 more locations