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

November 12, 2018 updated by: Taro Pharmaceuticals USA

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

371

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • Hawthorne, New York, United States, 10532
        • Taro Pharmaceuticals USA, Inc.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: DSXS topical
applied once daily for 28 days
Drug: DSXS topical
topical treatment
Other Names:
  • Active
Placebo Comparator: Vehicle topical
applied once daily for 28 days
Drug: Vehicle topical
topical treatment
Other Names:
  • placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Day 29

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Taro Pharmaceuticals USA

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 11, 2016

Primary Completion (Actual)

November 16, 2016

Study Completion (Actual)

September 29, 2017

Study Registration Dates

First Submitted

October 12, 2016

First Submitted That Met QC Criteria

October 12, 2016

First Posted (Estimate)

October 14, 2016

Study Record Updates

Last Update Posted (Actual)

December 6, 2018

Last Update Submitted That Met QC Criteria

November 12, 2018

Last Verified

November 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DSXS 1536

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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