Skip to main content
OpenTrials
Completed

NCT Number: NCT02340169

Adrenal Suppression and Pharmacokinetics of Topicort® 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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Plaque Psoriasis

Age range

2 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Taro Pharmaceuticals USA Inc.

Hawthorne, New York, 10532, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Topicort® (desoximetasone) Topical Spray, 0.25%

Drug

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

Other names: desoximetasone

Primary outcomes

  1. 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

Secondary outcomes

  1. Adverse Event

    Time frame: 28 days

    The total number of subjects experiencing adverse events.

  2. Cpre-ss

    Time frame: 28 Days

    Concentration prior to dosing at steady state.

Sponsors and collaborators

Lead sponsor

Sun Pharmaceutical Industries, Inc.

Industry

Registry information

Official study 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.

Important dates

Study start
2015
Primary completion
2019
Study completion
2021
First posted
Jan 16, 2015
Registry last updated
Mar 28, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.