Psoriasis Clinical Trial
Adrenal Suppression and Pharmacokinetics of Topicort® Spray, 0.25% in Pediatric Patients With Plaque Psoriasis
Summary
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.
Full Description
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.
Eligibility Criteria
Inclusion Criteria:
Patients aged 7 years and older must have provided written assent accompanied by written informed consent from patient's representative
Clinical diagnosis of stable plaque psoriasis with involvement of ≥ 10% body surface area (excluding face and scalp)
Physicians Global Assessment score of 3 or 4 at baseline
Exclusion Criteria:
Has other dermatological conditions that may interfere with clinical assessments
Allergy or sensitivity to corticosteroids or any drug hypersensitivity or intolerance that would compromise patient safety or study results
History of an adverse reaction to Cortrosynâ„¢ or similar test reagents
Chronic infectious disease, system or organ disorder or other medical condition that would place patient at undue risk by study participation
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There is 1 Location for this study
Hawthorne New York, 10532, United States
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