The purpose of this study is to determine the effect of Pandel® (hydrocortisone probutate cream) Cream 0.1% on the Hypothalamic Pituitary Adrenal (HPA) axis in pediatric and adult subjects with either psoriasis or atopic dermatitis involving greater than 20% body surface area.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
19
A thin coat of cream will be applied and rubbed into the affected areas, as well as normal skin, twice daily for 21 days
Christopher Huerter, MD
Omaha, Nebraska, United States
Oswald Mikell, MD
Hilton Head Island, South Carolina, United States
Michael Gold, MD
Nashville, Tennessee, United States
Post-injection Serum Cortisol Level
The number of subjects with a post-injection serum cortisol level less than or equal to 18 ug/dL on Day 22.
Time frame: 22 Days
Pre-injection Serum Cortisol Levels
The number of subjects with pre-injection serum cortisol levels less than or equal to 5 ug/dL Day 22.
Time frame: 22 Days
and the Number of Subjects With an Increment Between Basal and 30 Minutes Day 22 of at Least 7 ug/dL.
Time frame: 22 days
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