Hawthorne, New York 10532


Purpose:

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.


Study summary:

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.


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 Cortrosyn™ 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


NCT ID:

NCT02340169


Primary Contact:

Study Director
Natalie Yantovskiy
Taro Pharmaceuticals USA Inc

Novum Pharmaceutical Research Services http://www.novumprs.com/contact
Phone: 412.363.3300


Backup Contact:

N/A


Location Contact:

Hawthorne, New York 10532
United States

Natalie Yantovskiy

Site Status: Recruiting


Data Source: ClinicalTrials.gov

Date Processed: November 20, 2017

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