Clinical Study to Evaluate the Efficacy and Safety of Desoximetasone (DSXS) With Atopic Dermatitis
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.
1 other identifier
interventional
124
1 country
1
Brief Summary
Efficacy and Safety of DSXS (Taro Pharmaceuticals, U.S.A., Inc.) in Patients with Moderate to Severe Atopic Dermatitis
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Sep 2015
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 4, 2015
CompletedFirst Submitted
Initial submission to the registry
November 1, 2015
CompletedFirst Posted
Study publicly available on registry
November 3, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 17, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
August 29, 2017
CompletedResults Posted
Study results publicly available
December 7, 2018
CompletedDecember 7, 2018
December 1, 2018
1.4 years
November 1, 2015
November 12, 2018
December 5, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
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
28 days
Secondary Outcomes (1)
Change From Baseline in %BSA Affected at Day 28 ± 2
28 days
Study Arms (2)
DSXS topical product
EXPERIMENTALDSXS Active treatment
Placebo topical product
PLACEBO COMPARATORPlacebo treatment
Interventions
Eligibility Criteria
You may qualify if:
- \- male and non-pregnant females, age 6 months or older, with a confirmed diagnosis of moderate to severe atopic dermatitis (AD)
You may not qualify if:
- \- Lacks stable diagnosis of atopic dermatitis or has been diagnosed with mild atopic dermatitis.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Taro Pharmaceuticals USA Inc.
Hawthorne, New York, 10532, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Natalie Yantovskiy
- Organization
- Taro Pharmaceuticals U.S.A. Inc
Study Officials
- STUDY CHAIR
Novum Pharmaceutical Research Services
http://www.novumprs.com/contact
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 1, 2015
First Posted
November 3, 2015
Study Start
September 4, 2015
Primary Completion
January 17, 2017
Study Completion
August 29, 2017
Last Updated
December 7, 2018
Results First Posted
December 7, 2018
Record last verified: 2018-12
Data Sharing
- IPD Sharing
- Will not share