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Phase III Clinical Study in Patients With Mild to Severe Scalp Psoriasis

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: NCT02933866
Recruitment Status : Completed
First Posted : October 14, 2016
Results First Posted : December 6, 2018
Last Update Posted : December 6, 2018
Sponsor:
Information provided by (Responsible Party):
Taro Pharmaceuticals USA

Study Description
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Brief Summary:
A Randomized, Double-Blind, Vehicle-Controlled, Parallel-Design, Multiple-Site, Phase III Clinical Study to Evaluate the Efficacy and Safety of DSXS topical product in Patients with Mild to Severe Scalp Psoriasis

Condition or disease Intervention/treatment Phase
Scalp Psoriasis Drug: DSXS topical Drug: Vehicle topical Phase 3

Detailed Description:
To evaluate the therapeutic efficacy and safety of DSXS topical product (Taro Pharmaceuticals, U.S.A., Inc.) compared to a Vehicle topical product (Taro Pharmaceuticals, U.S.A., Inc.) in patients with mild to severe scalp psoriasis.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 371 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Double-Blind, Vehicle-Controlled, Parallel-Design, Multiple-Site, Phase III Clinical Study to Evaluate the Efficacy and Safety of DSXS Topical Product in Patients With Mild to Severe Scalp Psoriasis
Actual Study Start Date : March 11, 2016
Actual Primary Completion Date : November 16, 2016
Actual Study Completion Date : September 29, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Psoriasis

Arms and Interventions
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Arm Intervention/treatment
Experimental: DSXS topical
applied once daily for 28 days
 Drug: DSXS topical
topical treatment
Other Name: Active
Placebo Comparator: Vehicle topical
applied once daily for 28 days
 Drug: Vehicle topical
topical treatment
Other Name: placebo


Outcome Measures
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Primary Outcome Measures :
  1. Proportion of Patients in Each Treatment Group Who Are Considered a Clinical Success [ Time Frame: Day 29 ]
    Clinical Success is defined by an IGA score of 0 (clear) or I (almost clear) with at least a 2 grades reduction from baseline at Day 29 ± 2


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Male or non-pregnant, non-lactating females 18 years of age and older.

Exclusion Criteria:

  • Females who are pregnant, lactating or likely to become pregnant during the study.
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): NCT02933866


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
  Study Documents (Full-Text)

Documents provided by Taro Pharmaceuticals USA:
Study Protocol  [PDF] June 7, 2016
Statistical Analysis Plan  [PDF] October 11, 2016

More Information
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Responsible Party: Taro Pharmaceuticals USA
ClinicalTrials.gov Identifier: NCT02933866    
Other Study ID Numbers: DSXS 1536
First Posted: October 14, 2016    Key Record Dates
Results First Posted: December 6, 2018
Last Update Posted: December 6, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases