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

February 28, 2023 updated by: Taro Pharmaceuticals USA

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.

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 Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

129

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • Hawthorne, New York, United States, 10532
        • Taro Pharmaceuticals USA Inc.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

2 years to 17 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Topicort® Topical Spray, 0.25%
Topicort® (desoximetasone) Topical Spray, 0.25%, twice a day for 28 days
Drug: Topicort® (desoximetasone) Topical Spray, 0.25%
Topicort® (desoximetasone) Topical Spray, 0.25% applied to affected areas twice a day for 28 days
Other Names:
  • desoximetasone

What is the study measuring?

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
Time Frame: 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
28 days

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Taro Pharmaceuticals USA

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 23, 2015

Primary Completion (Actual)

November 22, 2019

Study Completion (Actual)

November 22, 2021

Study Registration Dates

First Submitted

December 28, 2014

First Submitted That Met QC Criteria

January 12, 2015

First Posted (Estimate)

January 16, 2015

Study Record Updates

Last Update Posted (Actual)

March 28, 2023

Last Update Submitted That Met QC Criteria

February 28, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DSXS-1303

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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