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

Primary Purpose

Plaque Psoriasis

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Topicort® (desoximetasone) Topical Spray, 0.25%
Sponsored by
Taro Pharmaceuticals USA
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Plaque Psoriasis

Eligibility Criteria

2 Years - 17 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Taro Pharmaceuticals USA Inc.

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Topicort® Topical Spray, 0.25%

Arm Description

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Adverse Event
The total number of subjects experiencing adverse events.
Cpre-ss
Concentration prior to dosing at steady state.

Full Information

First Posted
December 28, 2014
Last Updated
February 28, 2023
Sponsor
Taro Pharmaceuticals USA
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1. Study Identification

Unique Protocol Identification Number
NCT02340169
Brief Title
Adrenal Suppression and Pharmacokinetics of Topicort® Spray, 0.25% in Pediatric Patients With Plaque Psoriasis
Official Title
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.
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Completed
Study Start Date
January 23, 2015 (Actual)
Primary Completion Date
November 22, 2019 (Actual)
Study Completion Date
November 22, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Taro Pharmaceuticals USA

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Plaque Psoriasis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
129 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Topicort® Topical Spray, 0.25%
Arm Type
Experimental
Arm Description
Topicort® (desoximetasone) Topical Spray, 0.25%, twice a day for 28 days
Intervention Type
Drug
Intervention Name(s)
Topicort® (desoximetasone) Topical Spray, 0.25%
Other Intervention Name(s)
desoximetasone
Intervention Description
Topicort® (desoximetasone) Topical Spray, 0.25% applied to affected areas twice a day for 28 days
Primary Outcome Measure Information:
Title
The Number of Participants With Hypothalmic Pituitary Adrenal Axis Function Suppression as Measured by Cortisol Response Test
Description
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
Time Frame
28 days
Secondary Outcome Measure Information:
Title
Adverse Event
Description
The total number of subjects experiencing adverse events.
Time Frame
28 days
Title
Cpre-ss
Description
Concentration prior to dosing at steady state.
Time Frame
28 Days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
2 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
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 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Novum Pharmaceutical Research Services
Organizational Affiliation
http://www.novumprs.com/contact
Official's Role
Study Chair
Facility Information:
Facility Name
Taro Pharmaceuticals USA Inc.
City
Hawthorne
State/Province
New York
ZIP/Postal Code
10532
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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