This study is to evaluate the safety and efficacy of a topical lotion when applied once daily to adult participants with moderate to severe plaque psoriasis (defined as an Investigator's Global Assessment \[IGA\] score of 3 or 4).
The objective of the study is to evaluate the safety and efficacy of topical IDP-122 Lotion when applied once daily to adult participants with moderate to severe plaque psoriasis. The intent of the study is specifically to evaluate the safety and efficacy of a once daily application of IDP-122 Lotion in comparison with vehicle.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
213
Medicated topical lotion
Vehicle topical lotion with no active ingredient
Valeant Site 14
Santa Ana, California, United States
Valeant Site 02
Boynton Beach, Florida, United States
Valeant Site 10
Clearwater, Florida, United States
Percentage of Participants With Treatment Success at Week 8
Treatment success defined as at least a 2-grade improvement from Baseline in the IGA score and an IGA score equating to "clear" or "almost clear" at Week 8. The IGA score was based on a 5-point scale ranging from 0 to 4 (0=clear, 1=almost clear, 2=mild, 3=moderate, and 4=severe). The face, scalp, palms, soles, axillae, and intertriginous areas were excluded from this assessment.
Time frame: Week 8
Percentage of Participants With Treatment Success at Weeks 2, 4, 6, and 12
Treatment success defined as at least a 2-grade improvement from Baseline in the Investigator's Global Assessment (IGA) score and an IGA score equating to "clear" or "almost clear" at Weeks 2, 4, 6, and 12. The IGA score was based on a 5-point scale ranging from 0 to 4 (0=clear, 1=almost clear, 2=mild, 3=moderate, and 4=severe). The face, scalp, palms, soles, axillae, and intertriginous areas were excluded from this assessment.
Time frame: Weeks 2, 4, 6, and 12 (4-week follow-up)
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Valeant Site 1
Tampa, Florida, United States
Valeant Site 07
Plainfield, Indiana, United States
Valeant Site 15
Olathe, Kansas, United States
Valeant Site 08
Fridley, Minnesota, United States
Valeant Site 13
Omaha, Nebraska, United States
Valeant Site 04
New York, New York, United States
Valeant Site 12
Stony Brook, New York, United States
...and 5 more locations