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

Plaque Psoriasis Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02340169
• Other study ID #: DSXS-1303
• Status: Completed
• Phase: Phase 4
• Start date: January 23, 2015
• Est. completion date: November 22, 2021

Study information

• Verified date: February 2023
• Source: Taro Pharmaceuticals USA
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 129
• Est. completion date: November 22, 2021
• Est. primary completion date: November 22, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 2 Years to 17 Years

Eligibility

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

Related Conditions & MeSH terms

• Plaque Psoriasis
• Psoriasis

Intervention

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

Locations

Country	Name	City	State
United States	Taro Pharmaceuticals USA Inc.	Hawthorne	New York

Sponsors (1)

Lead Sponsor	Collaborator
Taro Pharmaceuticals USA

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Adverse Event	The total number of subjects experiencing adverse events.	28 days
Secondary	Cpre-ss	Concentration prior to dosing at steady state.	28 Days