The purpose of this study is to evaluate the potential of DFD-06 to suppress the hypothalamic-pituitary-adrenal (HPA) axis when applied twice daily for 15 days.
This is a 15-day, single arm, multicenter, multi-dose, open-label, two stage, sequential study. In the first stage, subjects who are at least 12 years of age and not more than 16.9 years (16 years and 11 months) of age with moderate to severe plaque psoriasis will be treated with DFD-06 (at least 20 completed subjects). In the second stage subjects who are at least 6 years of age and not more than 11.9 years (11 years and 11 months) of age with moderate to severe plaque psoriasis will be treated with DFD-06 (at least 20 completed subjects). An attempt will be made to enroll subjects throughout the age range of each cohort including the lower age range. DFD-06 will be applied twice daily to all affected areas on the body excluding face, scalp, groin, axillae and other intertriginous areas. Subjects must have ≥10% Body Surface Area (BSA) treated to achieve maximal use exposure.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
22
Apply twice per day for 15 days
Site 104
Madera, California, United States
Site 108
Santa Ana, California, United States
Investigational Site 102
Hialeah, Florida, United States
Site 109
Hialeah, Florida, United States
Percentage of Subjects With HPA Axis Suppression at Day 15
The percentage of subjects with abnormal cortisol response for ACTH stimulation test at Day 15 (cortisol level ≤18 µg/dL at 30 minutes post stimulation) is the primary variable
Time frame: Day 15
Number of Participants With Improvement in IGA Grade From Baseline
Numbers of subjects with improvements by at least 1 pint in IGA grade will be provided as descriptive statistics.
Time frame: Baseline up to Day 15
Plasma Concentration of Clobetasol Propionate
Plasma concentrations of clobetasol propionate after multiple doses of DFD-06 under maximal use condition with the final-to-be-marketed formulation.
Time frame: Day 15 0 hour, 1 hour, 3 hours, 6 hours after application
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Site 107
Overland Park, Kansas, United States
Site 103
St Louis, Missouri, United States
Investigational Site 101
Lincoln, Nebraska, United States
Site 106
Greenville, South Carolina, United States
Site 105
Spokane, Washington, United States