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

Primary Purpose

Atopic Dermatitis

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
DSXS
Placebo
Sponsored by
Taro Pharmaceuticals USA
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Atopic Dermatitis

Eligibility Criteria

6 Months - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Taro Pharmaceuticals USA Inc.

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

DSXS topical product

Placebo topical product

Arm Description

DSXS Active treatment

Placebo treatment

Outcomes

Primary Outcome Measures

The Number of Patients in Each Treatment Group That Have Clinical Success
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

Change From Baseline in %BSA Affected at Day 28 ± 2
The change in %BSA Affected from Visit 1 Baseline (Day 1) to Visit 4 End of Treatment (Day 28 ± 2)

Full Information

First Posted
November 1, 2015
Last Updated
December 5, 2018
Sponsor
Taro Pharmaceuticals USA
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1. Study Identification

Unique Protocol Identification Number
NCT02595073
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.
Study Type
Interventional

2. Study Status

Record Verification Date
December 2018
Overall Recruitment Status
Completed
Study Start Date
September 4, 2015 (Actual)
Primary Completion Date
January 17, 2017 (Actual)
Study Completion Date
August 29, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Taro Pharmaceuticals USA

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atopic Dermatitis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
124 (Actual)

8. Arms, Groups, and Interventions

Arm Title
DSXS topical product
Arm Type
Experimental
Arm Description
DSXS Active treatment
Arm Title
Placebo topical product
Arm Type
Placebo Comparator
Arm Description
Placebo treatment
Intervention Type
Drug
Intervention Name(s)
DSXS
Other Intervention Name(s)
Active
Intervention Description
Active treatment
Intervention Type
Drug
Intervention Name(s)
Placebo
Other Intervention Name(s)
vehicle
Intervention Description
Placebo treatment
Primary Outcome Measure Information:
Title
The Number of Patients in Each Treatment Group That Have Clinical Success
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/edema
Time Frame
28 days
Secondary Outcome Measure Information:
Title
Change From Baseline in %BSA Affected at Day 28 ± 2
Description
The change in %BSA Affected from Visit 1 Baseline (Day 1) to Visit 4 End of Treatment (Day 28 ± 2)
Time Frame
28 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Months
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Novum Pharmaceutical Research Services
Organizational Affiliation
http://www.novumprs.com/contact
Official's Role
Study Chair
Facility Information:
Facility Name
Taro Pharmaceuticals USA Inc.
City
Hawthorne
State/Province
New York
ZIP/Postal Code
10532
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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