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

NCT02340169 | Completed Phase 4 Results

• 1 other identifier: DSXS-1303
• Study Type: interventional
• Target: 129
• Locations: 1 country
• Sites: 1

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.

Conditions

Plaque Psoriasis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Adverse Event

  28 days

• Cpre-ss

  28 Days

Study Arms (1)

Topicort® Topical Spray, 0.25%

EXPERIMENTAL

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

Drug: Topicort® (desoximetasone) Topical Spray, 0.25%

Interventions

Topicort® (desoximetasone) Topical Spray, 0.25% DRUG

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

Also known as: desoximetasone

Topicort® Topical Spray, 0.25%

Eligibility Criteria

• Age: 2 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Sun Pharmaceutical Industries, Inc.: lead

Study Sites (1)

Taro Pharmaceuticals USA Inc.

Hawthorne, New York, 10532, United States

Location

MeSH Terms

Interventions

Desoximetasone

Intervention Hierarchy (Ancestors)

Pregnadienediols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Dexamethasone; Steroids, Fluorinated

Results Point of Contact

• Title: Senior Director, Clinical Research
• Organization: Taro Pharmaceuticals

natalie.yantovskiy@taro.com

+1 914-345-9001

Study Officials

• Novum Pharmaceutical Research Services

  http://www.novumprs.com/contact

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 28, 2014
• First Posted: January 16, 2015
• Study Start: January 23, 2015
• Primary Completion: November 22, 2019
• Study Completion: November 22, 2021
• Last Updated: March 28, 2023
• Results First Posted: March 28, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)