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

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ClinicalTrials.gov Identifier: NCT02340169
Recruitment Status : Recruiting
First Posted : January 16, 2015
Last Update Posted : April 10, 2019
Sponsor:
Information provided by (Responsible Party):
Taro Pharmaceuticals USA

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.

Condition or disease Intervention/treatment Phase
Plaque Psoriasis Drug: Topicort® (desoximetasone) Topical Spray, 0.25% Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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.
Actual Study Start Date : January 23, 2015
Estimated Primary Completion Date : November 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Psoriasis

Arm Intervention/treatment
Experimental: Topicort® Topical Spray, 0.25%
Topicort® (desoximetasone) Topical Spray, 0.25%, twice a day for 28 days
Drug: Topicort® (desoximetasone) Topical Spray, 0.25%
Topicort® (desoximetasone) Topical Spray, 0.25% applied to affected areas twice a day for 28 days
Other Name: desoximetasone




Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. Evaluate efficacy parameters as measured by change from baseline in clinical signs and symptoms (erythema, scaling, plaque elevation) and the PGA score at baseline and end of treatment [ Time Frame: 28 days ]
  2. Evaluate pharmacokinetics as measured by Cmax-ss [ Time Frame: 28 days ]
    Evaluate pharmacokinetics as measured by the peak exposure at steady state (Cmax-ss)

  3. Evaluate pharmacokinetics as measured by Tmax-ss [ Time Frame: 28 days ]
    Evaluate pharmacokinetics as measured by the steady-state time to peak exposure (Tmax-ss)

  4. Evaluate pharmacokinetics as measured by Kel [ Time Frame: 28 days ]
    Evaluate pharmacokinetics as measured by the apparent elimination rate constant (Kel)

  5. Evaluate pharmacokinetics as measured by AUCss [ Time Frame: 28 days ]
    Evaluate pharmacokinetics as measured by steady-state area under the plasma concentration-time curve (AUCss)

  6. Evaluate pharmacokinetics as measured by T½ [ Time Frame: 28 days ]
    Evaluate pharmacokinetics as measured by the terminal half-life (T½) will be estimated as ln(2)/Kel

  7. Evaluate adverse event profile [ Time Frame: 28 days ]


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Ages Eligible for Study:   2 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02340169


Contacts
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Contact: Taro Pharmaceuticals U.S.A. Inc. +1 914-345-900

Locations
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United States, New York
Taro Pharmaceuticals USA Inc. Recruiting
Hawthorne, New York, United States, 10532
Contact: Natalie Yantovskiy         
Sponsors and Collaborators
Taro Pharmaceuticals USA
Investigators
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Study Chair: Novum Pharmaceutical Research Services http://www.novumprs.com/contact

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Responsible Party: Taro Pharmaceuticals USA
ClinicalTrials.gov Identifier: NCT02340169     History of Changes
Other Study ID Numbers: DSXS-1303
First Posted: January 16, 2015    Key Record Dates
Last Update Posted: April 10, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases
Desoximetasone
Physiological Effects of Drugs
Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists