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

Phase 4

Completed

• Conditions: Plaque Psoriasis
• Interventions: Drug: Topicort® (desoximetasone) Topical Spray, 0.25%

• Registration Number: NCT02340169
• Lead Sponsor: Taro Pharmaceuticals USA

Brief 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.

Detailed 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.

Study Timeline

• Study First Submitted: 2014-12-28
• Study First Submitted QC: 2015-01-12
• Study First Posted: 2015-01-16
• Study Start: 2015-01-23
• Primary Completion: 2019-11-22
• Study Completion: 2021-11-22
• Results First Submitted: 2022-12-02
• Status Verified: 2023-02
• Results First Submitted QC: 2023-02-28
• Last Update Submitted: 2023-02-28
• Results First Posted: 2023-03-28
• Last Update Posted: 2023-03-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 129

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Topicort® Topical Spray, 0.25%	Topicort® (desoximetasone) Topical Spray, 0.25%	Topicort® (desoximetasone) Topical Spray, 0.25%, twice a day for 28 days

Primary Outcome Measures

Name	Time	Method
The Number of Participants With Hypothalmic Pituitary Adrenal Axis Function Suppression as Measured by Cortisol Response Test	28 days	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

Secondary Outcome Measures

Name	Time	Method
Adverse Event	28 days	The total number of subjects experiencing adverse events.
Cpre-ss	28 Days	Concentration prior to dosing at steady state.

Trial Locations

Locations (1)

Taro Pharmaceuticals USA Inc.; 🇺🇸 Hawthorne, New York, United States