Study to Evaluate Effect of Pandel Cream 0.1% on HPA Axis in Pediatric and Adult Population
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 Design:||Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||An Open -Label Study to Evaluate the Effect of Pandel Cream 0.1% on the Hypothalamic Pituitary Adrenal Axis in the Pediatric and Adult Population|
- Post-injection serum cortisol level [ Time Frame: 22 Days ] [ Designated as safety issue: Yes ]The number of subjects with a post-injection serum cortisol level exceeding 18 ug/dL on Day 22.
- Pre-injection serum cortisol levels [ Time Frame: 22 Days ] [ Designated as safety issue: Yes ]The number of subjects with pre-injection serum cortisol levels exceeding 5 ug/dL Day 22 and the number of subjects with an increment between basal and 30 minutes Day 22 of at least 7 ug/dL.
|Study Start Date:||June 2004|
|Estimated Study Completion Date:||December 2011|
|Estimated Primary Completion Date:||December 2011 (Final data collection date for primary outcome measure)|
Drug: Pandel Cream 0.1%
|United States, Nebraska|
|Christopher Huerter, MD|
|Omaha, Nebraska, United States, 68130|
|United States, South Carolina|
|Oswald Mikell, MD|
|Hilton Head Island, South Carolina, United States, 29926|
|United States, Tennessee|
|Michael Gold, MD|
|Nashville, Tennessee, United States, 37215|
|Study Director:||Ron Trancik||Fougera Pharmaceuticals Inc.|