Adrenal suppression effects of corticosteroids are among the most important safety concerns for this group of products. This study is designed to determine the adrenal effects of the investigational formulation of 122-0551 and characterize the steady state pharmacokinetics of the formulation.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
25
Applied twice daily for 2 weeks
Anaheim Clinical Trials
Anaheim, California, United States
Therapeutics Clinical Research
San Diego, California, United States
DermResearch, Inc.
Austin, Texas, United States
Hypothalamic-Pituitary-Adrenal (HPA) Axis Response
HPA axis response to stimulation by cosyntropin, dichotomized to "normal" and "abnormal". Laboratory evidence of abnormal HPA axis response is defined as a 30-minute post-stimulation serum cortisol level that is ≤ 18 μg/dL at the end of study.
Time frame: Day 15
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