The objective of this study is to determine and compare the safety and efficacy of topical 146-9251 cream and vehicle cream applied twice daily for 6 weeks in subjects with moderate to severe ichthyosis vulgaris (IV).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
80
146-9251 cream contains an active drug and is applied topically.
Vehicle cream does not contain an active drug and is applied topically.
Crown investigative site 01
San Diego, California, United States
Crown Investigative site 07
Plainfield, Indiana, United States
Crown Investigative site 08
Metairie, Louisiana, United States
Crown Investigative site 02
Fridley, Minnesota, United States
Treatment Success
Number of participants that show at least a 2 level improvement of overall severity of disease (as measured by IGA score) at 6 weeks. The IGA score is a static evaluation of the overall or "average" degree of severity of a participant's disease, taking into account all of the participant's scaling, erythema, and fissuring in the Treatment Area. IGA was assessed using the following 5-point scale: clear (0), almost clear (1), mild (2), moderate (3), or severe (4).
Time frame: Day 43 (6 weeks)
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Crown Investigative site 04
Columbia, Missouri, United States
Crown Investigative Site 05
Albuquerque, New Mexico, United States
Crown Investigative site 06
High Point, North Carolina, United States