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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02340169
Other study ID # DSXS-1303
Secondary ID
Status Completed
Phase Phase 4
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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