Hawthorne, New York 10532

  • Atopic Dermatitis

Purpose:

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


Study summary:

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


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.


Study is Available At:


Original ID:

DSXS 1504


NCT ID:

NCT02595073


Secondary ID:


Study Acronym:


Brief Title:

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


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.


Overall Status:

Completed


Study Phase:

Phase 3


Genders:

N/A


Minimum Age:

6 Months


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Taro Pharmaceuticals USA


Oversight Authority:

United States: Food and Drug Administration


Reasons Why Stopped:


Study Type:

Interventional


Study Design:


Number of Arms:

2


Number of Groups:

0


Total Enrollment:

124


Enrollment Type:

Actual


Overall Contact Information

Official Name:Novum Pharmaceutical Research Services
Study Chair
http://www.novumprs.com/contact

Study Dates

Start Date:September 4, 2015
Completion Date:August 29, 2017
Completion Type:Actual
Primary Completion Date:January 17, 2017
Primary Completion Type:Actual
Verification Date:December 2018
Last Changed Date:December 5, 2018
First Received Date:November 1, 2015
First Results Date:November 12, 2018

Study Outcomes

Outcome Type:Primary Outcome
Measure:The Number of Patients in Each Treatment Group That Have Clinical Success
Time Frame:28 days
Safety Issues:False
Description: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
Outcome Type:Secondary Outcome
Measure:Change From Baseline in %BSA Affected at Day 28 ± 2
Time Frame:28 days
Safety Issues:False
Description:The change in %BSA Affected from Visit 1 Baseline (Day 1) to Visit 4 End of Treatment (Day 28 ± 2)

Study Interventions

Intervention Type:Drug
Name:DSXS
Description:Active treatment
Arm Name:DSXS topical product
Other Name:Active
Intervention Type:Drug
Name:Placebo
Description:Placebo treatment
Arm Name:Placebo topical product
Other Name:vehicle

Study Arms

Study Arm Type:Experimental
Arm Name:DSXS topical product
Description:DSXS Active treatment
Study Arm Type:Placebo Comparator
Arm Name:Placebo topical product
Description:Placebo treatment

Study Agencies

Agency Class:Industry
Agency Type:Lead Sponsor
Agency Name:Taro Pharmaceuticals USA

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: April 03, 2020

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