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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. Identifier: NCT02932891
Recruitment Status : Completed
First Posted : October 13, 2016
Results First Posted : December 7, 2018
Last Update Posted : December 7, 2018
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 in Patients with Atopic Dermatitis

Condition or disease Intervention/treatment Phase
Atopic Dermatitis Drug: DSXS topical Phase 2

Detailed Description:
To evaluate the potential of DSXS topical product to suppress HPA axis function in patients with moderate to severe atopic dermatitis.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 28 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 Atopic Dermatitis
Actual Study Start Date : August 2016
Actual Primary Completion Date : April 14, 2017
Actual Study Completion Date : December 12, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eczema

Arm Intervention/treatment
Experimental: DSXS topical
active treatment
Drug: DSXS topical
topical treatment
Other Name: active

Primary Outcome Measures :
  1. The Number of Patients in the Study With HPA Axis Suppression [ Time Frame: 29 Days ]
    Hypothalamic Pituitary Adrenal (HPA) Axis Response to a stimulator

Information from the National Library of Medicine

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Ages Eligible for Study:   6 Months to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • Parent/legal guardian has signed informed consent form, which 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 identifier (NCT number): NCT02932891

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United States, New York
Taro Pharmaceuticals USA Inc.
Hawthorne, New York, United States, 10532
Sponsors and Collaborators
Taro Pharmaceuticals USA
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Study Chair: Novum Pharmaceutical Research Services
  Study Documents (Full-Text)

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

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Responsible Party: Taro Pharmaceuticals USA Identifier: NCT02932891     History of Changes
Other Study ID Numbers: DSXS 1502a
First Posted: October 13, 2016    Key Record Dates
Results First Posted: December 7, 2018
Last Update Posted: December 7, 2018
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Dermatitis, Atopic
Skin Diseases
Skin Diseases, Genetic
Genetic Diseases, Inborn
Skin Diseases, Eczematous
Hypersensitivity, Immediate
Immune System Diseases
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
Respiratory System Agents
Vasoconstrictor Agents