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Trial record 7 of 19 for:    "Secondary Adrenal Insufficiency" | "Respiratory System Agents"

An Open Label, Safety Study to Assess the Potential for Adrenal Suppression

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02932878
Recruitment Status : Completed
First Posted : October 13, 2016
Results First Posted : December 6, 2018
Last Update Posted : December 6, 2018
Sponsor:
Information provided by (Responsible Party):
Taro Pharmaceuticals USA

Brief Summary:
An Open Label, Safety Study to Assess the Potential for Adrenal Suppression Following Treatment with DSXS (Taro Pharmaceuticals U.S.A., Inc.) in Patients with Plaque Psoriasis

Condition or disease Intervention/treatment Phase
Plaque Psoriasis Drug: DSXS topical Phase 2

Detailed Description:

To evaluate the potential of DSXS to suppress HPA axis function in patients with mild to moderate plaque psoriasis.

To evaluate the efficacy parameters and adverse event (AE) profile of DSXS administered to patients with mild to moderate plaque psoriasis.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 16 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 Following Treatment With DSXS Topical Product in Patients With Plaque Psoriasis
Actual Study Start Date : September 2, 2016
Actual Primary Completion Date : April 10, 2017
Actual Study Completion Date : October 16, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Psoriasis

Arm Intervention/treatment
Experimental: DSXS topical
administered twice daily for 28 days
Drug: DSXS topical
topical treatment
Other Name: active




Primary Outcome Measures :
  1. Proportion of Patients in the Study With HPA Axis Suppression [ Time Frame: 28 Days ]
    Hypothalamic Pituitary Adrenal (HPA) Axis Response to Cosyntropin



Information from the National Library of Medicine

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Ages Eligible for Study:   2 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Male or non pregnant, non lactating females

Exclusion Criteria:

  • Patients under 2 years of age

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): NCT02932878


Locations
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United States, New York
Taro Pharmaceuticals USA Inc.
Hawthorne, New York, United States, 10532
Sponsors and Collaborators
Taro Pharmaceuticals USA
Investigators
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Study Chair: Novum Pharmaceutical Research Services http://www.novumprs.com/contact
  Study Documents (Full-Text)

Documents provided by Taro Pharmaceuticals USA:
Study Protocol  [PDF] September 13, 2016
Statistical Analysis Plan  [PDF] May 19, 2017


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Responsible Party: Taro Pharmaceuticals USA
ClinicalTrials.gov Identifier: NCT02932878     History of Changes
Other Study ID Numbers: DSXS 1503a
First Posted: October 13, 2016    Key Record Dates
Results First Posted: December 6, 2018
Last Update Posted: December 6, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Respiratory System Agents
Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases
Epinephrine
Racepinephrine
Epinephryl borate
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Adrenergic beta-Agonists
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Anti-Asthmatic Agents
Mydriatics
Sympathomimetics
Vasoconstrictor Agents