The purpose of this study is to evaluate the potential of DFD06 cream to suppress the HPA (hypothalamic-pituitary-adrenal) axis as compared to clobetasol propionate cream, 0.05% cream when applied twice daily for 15 days.
This was a 15-day, randomized, multicenter, comparator-controlled, open-label study. Approximately 50 subjects with moderate to severe plaque psoriasis were to be randomized to treatment with DFD-06 Cream or clobetasol propionate cream in a 1:1 ratio. Study products were applied twice daily for 15 days to all affected areas on the body excluding face, scalp, groin, axillae, and other intertriginous areas. Subject visits were scheduled at Screening, Baseline (Day 1), Day 8, Day 15, and Day 43 (if needed to confirm recovery). Clinical determinations of disease severity were conducted using the Investigator's Global Assessment (IGA) for overall severity at each visit.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
50
Advanced Research Associates
Glendale, Arizona, United States
Agave Clinical Research, LLC
Mesa, Arizona, United States
The Percentage of Subjects With HPA Axis Suppression.
HPA axis suppression as measured by serum cortisol levels post cosyntropin test (ACTH test)
Time frame: Day 15
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