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Trial record 9 of 19 for:    "Secondary Adrenal Insufficiency" | "Respiratory System Agents"

Safety Study to Assess the Potential for Adrenal Suppression Following Maximal Use Treatment With DSXS

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: NCT02933528
Recruitment Status : Completed
First Posted : October 14, 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 Maximal Use Treatment with DSXS .

Condition or disease Intervention/treatment Phase
Psoriasis Drug: DSXS Topical product Phase 2

Detailed Description:
Evaluate the potential of DSXS topical product to suppress HPA axis function in patients with moderate to severe scalp psoriasis. Evaluate the efficacy parameters and adverse event (AE) profiles of DSXS topical product administered to patients with moderate to severe scalp psoriasis.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 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 Maximal Use Treatment With DSXS in Patients With Moderate to Severe Scalp Psoriasis
Actual Study Start Date : July 11, 2016
Actual Primary Completion Date : August 11, 2017
Actual Study Completion Date : November 27, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Psoriasis

Arm Intervention/treatment
Experimental: Dsxs topical product
treatment with DSXS once daily for 28 days
Drug: DSXS Topical product
once daily for 28 days
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 stimulation



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Male or non-pregnant, non-lactating females 18 years of age or older.
  • IRE-approved, signed informed consent form that meets all criteria of current FDA regulations.

Exclusion Criteria:

  • Females who are pregnant, nursing, planning to become pregnant during the duration of the study, or if of child-bearing potential and sexually active and not prepared to use appropriate contraceptive methods to avoid pregnancy.

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): NCT02933528


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] December 27, 2016
Statistical Analysis Plan  [PDF] April 18, 2017


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Responsible Party: Taro Pharmaceuticals USA
ClinicalTrials.gov Identifier: NCT02933528     History of Changes
Other Study ID Numbers: DSXS 1538a
First Posted: October 14, 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