Adrenal Suppression and Pharmacokinetics of Topicort® Spray, 0.25% in Pediatric Patients With Plaque Psoriasis

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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An Open Label, Safety Study to Assess the Potential for Adrenal Suppression and Pharmacokinetics Following Maximal Use Treatment With Topicort® (Desoximetasone) Topical Spray, 0.25% in Pediatric Patients With Plaque Psoriasis.

Conditions
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Plaque Psoriasis

Intervention / Treatment
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* Drug: Topicort® (desoximetasone) Topical Spray, 0.25%


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 2 Years
Maximum Age: 17 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Topicort® Topical Spray, 0.25%<br>Topicort® (desoximetasone) Topical Spray, 0.25%, twice a day for 28 days | Drug: Topicort® (desoximetasone) Topical Spray, 0.25%<br>* Topicort® (desoximetasone) Topical Spray, 0.25% applied to affected areas twice a day for 28 days<br>* Other names: desoximetasone;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 28 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse Event | The total number of subjects experiencing adverse events. | 28 days | 
| Cpre-ss | Concentration prior to dosing at steady state. | 28 Days |