This study will compare the efficacy and safety of DFD-06 Cream to Vehicle Cream for topical treatment of moderate to severe plaque psoriasis after 3, 7, and 14 days of treatment.
This study will be a multicenter (approximately 30 sites), randomized, vehicle-controlled, double-blind, and parallel group design. Approximately 264 subjects with moderate to severe plaque psoriasis will be randomized to treatment with DFD-06 Cream or Vehicle Cream. Subjects will use study product twice daily for 14 days. Subject visits are scheduled at Screening, Baseline (Day 1) and Days 4, 8, and 15. Clinical determinations of disease severity will be performed using the total sign score (TSS) for the target lesion and Investigator Global Assessment (IGA) for overall severity.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
265
Twice daily topical application for 14 days.
Twice daily topical application for 14 days.
Site 101
Birmingham, Alabama, United States
Efficacy (Percentage of Subjects With Treatment Success)
The primary efficacy endpoint is the percentage of subjects with treatment success (defined as IGA = 0 or 1 and at least a 2 grade reduction from Baseline) at the Day 15 visit. The primary analysis was done with multiple imputations. Results are combined analyses from 5 imputed data sets.
Time frame: Day 15 Visit
The Percent Change in Body Surface Area of Psoriasis
The percent change from baseline in Body Surface Area at Day 15. The analysis was done with multiple imputations. Results are combined analyses from 5 imputed data sets.
Time frame: From Baseline to Day 15
The Percentage of Subjects With Treatment Success at the Day 8 Visit.
The percentage of subjects with treatment success (defined as IGA = 0 or 1 and at least a 2 grade reduction from Baseline) at Day 8. The analysis was done with multiple imputations. Results are combined analyses from 5 imputed data sets.
Time frame: At Day 8 Visit
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Site 103
Mobile, Alabama, United States
Site 130
Mesa, Arizona, United States
Site 116
Phoenix, Arizona, United States
Site 125
Tucson, Arizona, United States
Site 120
North Hollywood, California, United States
Site 114
San Diego, California, United States
Site 127
Santa Monica, California, United States
Site 128
Clearwater, Florida, United States
Site 115
Miami, Florida, United States
...and 20 more locations