The objective of this study is to evaluate the potential of Topicort® (desoximetasone) Topical Spray, 0.25% to suppress hypothalmic pituitary adrenal axis function. The secondary objectives are to evaluate the efficacy parameters, pharmacokinetics and adverse event profile.
An open label, post marketing safety study to assess the potential of a TOPICORT® (desoximetasone) Topical Spray, 0.25% to suppress HPA axis function following twice daily dosing for 28 days.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
129
Topicort® (desoximetasone) Topical Spray, 0.25% applied to affected areas twice a day for 28 days
Taro Pharmaceuticals USA Inc.
Hawthorne, New York, United States
The Number of Participants With Hypothalmic Pituitary Adrenal Axis Function Suppression as Measured by Cortisol Response Test
A patient will be considered to have potential HPA axis suppression if they meet at least one of the criteria: * their 30 minute post injection cortisol level is not at least 7 mcg/100 ml greater than the basal level (\< basal + 7) * the post stimulation level is ≤ 18 mcg/100 ml
Time frame: 28 days
Adverse Event
The total number of subjects experiencing adverse events.
Time frame: 28 days
Cpre-ss
Concentration prior to dosing at steady state.
Time frame: 28 Days
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