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Clinical Study to Evaluate the Efficacy and Safety of Desoximetasone (DSXS) With Atopic Dermatitis

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: NCT02595073
Recruitment Status : Completed
First Posted : November 3, 2015
Results First Posted : December 7, 2018
Last Update Posted : December 7, 2018
Sponsor:
Information provided by (Responsible Party):
Taro Pharmaceuticals USA

Study Description
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Brief Summary:
Efficacy and Safety of DSXS (Taro Pharmaceuticals, U.S.A., Inc.) in Patients with Moderate to Severe Atopic Dermatitis

Condition or disease Intervention/treatment Phase
Atopic Dermatitis Drug: DSXS Drug: Placebo Phase 3

Detailed Description:
A Randomized, Double-Blind, Placebo-Controlled, Parallel-Design, Multiple-Site Clinical Study to Evaluate the Efficacy and Safety of DSXS (Taro Pharmaceuticals, U.S.A., Inc.) in Patients with Moderate to Severe Atopic Dermatitis
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 124 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Double-Blind, Placebo-Controlled, Parallel-Design, Multiple-Site Clinical Study to Evaluate the Efficacy and Safety of DSXS in Patients With Moderate to Severe Atopic Dermatitis.
Actual Study Start Date : September 4, 2015
Actual Primary Completion Date : January 17, 2017
Actual Study Completion Date : August 29, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eczema

Arms and Interventions
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Arm Intervention/treatment
Experimental: DSXS topical product
DSXS Active treatment
 Drug: DSXS
Active treatment
Other Name: Active
Placebo Comparator: Placebo topical product
Placebo treatment
 Drug: Placebo
Placebo treatment
Other Name: vehicle


Outcome Measures
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Primary Outcome Measures :
  1. The Number of Patients in Each Treatment Group That Have Clinical Success [ Time Frame: 28 days ]
    Clinical Success defined using the following scores at Visit 4 (Day 28 ± 2): At least a 2-grade improvement from the baseline IGA score (i.e., clear [0] or almost clear [1]) AND A score of clear or mild (0 or 1) for both erythema and induration/papulation/edema


Secondary Outcome Measures :
  1. Change From Baseline in %BSA Affected at Day 28 ± 2 [ Time Frame: 28 days ]
    The change in %BSA Affected from Visit 1 Baseline (Day 1) to Visit 4 End of Treatment (Day 28 ± 2)


Eligibility Criteria
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Ages Eligible for Study:   6 Months and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

- male and non-pregnant females, age 6 months or older, with a confirmed diagnosis of moderate to severe atopic dermatitis (AD)

Exclusion Criteria:

- Lacks stable diagnosis of atopic dermatitis or has been diagnosed with mild atopic dermatitis.

Contacts and Locations
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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): NCT02595073


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
More Information
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Responsible Party: Taro Pharmaceuticals USA
ClinicalTrials.gov Identifier: NCT02595073    
Other Study ID Numbers: DSXS 1504
First Posted: November 3, 2015    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
Dermatitis
Eczema
Skin Diseases
Skin Diseases, Genetic
 Genetic Diseases, Inborn
Skin Diseases, Eczematous
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases