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A Randomized Double Blind Vehicle Controlled Dose Ranging Parallel Design Multiple Site Clinical Study

Primary Purpose

Plaque Psoriasis

Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
DSXS1411
Placebo
Sponsored by
Taro Pharmaceuticals USA
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Plaque Psoriasis

Eligibility Criteria

12 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Male or non-pregnant, non-lactating females age 12 and older.
  • Clinical diagnosis of moderate to severe scalp psoriasis, defined by a Investigator's Global Assessment score of at least 3 at screening.

Exclusion Criteria:

  • Under 12 years of age.
  • Patients whose scalp and/or non-scalp psoriasis necessitates systemic or other concomitant topical therapies during the study.
  • Has a scalp skin condition that would interfere with the diagnosis or assessment of plaque psoriasis of the scalp.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Placebo Comparator

    Arm Label

    DSXS1411

    Placebo

    Arm Description

    DSXS applied once a day for a total of 28 days.

    Placebo (vehicle) applied once a day for a total of 28 days.

    Outcomes

    Primary Outcome Measures

    Clinical Response of Success
    The proportion of patients in each treatment group that have clinical success at Day 28, which is defined by a Investigator's Global Assessment score of 0 or 1.

    Secondary Outcome Measures

    Full Information

    First Posted
    April 6, 2015
    Last Updated
    November 12, 2018
    Sponsor
    Taro Pharmaceuticals USA
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02413229
    Brief Title
    A Randomized Double Blind Vehicle Controlled Dose Ranging Parallel Design Multiple Site Clinical Study
    Official Title
    A Randomized Double Blind Vehicle Controlled Dose Ranging Multiple Site Phase 2 Clinical Study to Evaluate the Efficacy and Safety of DSXS in Patients With Moderate to Severe Scalp Psoriasis
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    November 2018
    Overall Recruitment Status
    Completed
    Study Start Date
    April 2015 (Actual)
    Primary Completion Date
    September 14, 2015 (Actual)
    Study Completion Date
    January 29, 2016 (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
    The objectives of this study are to evaluate the therapeutic efficacy and safety of DSXS and a Placebo in patients with moderate to severe scalp psoriasis.
    Detailed Description
    This randomized, double-blind, vehicle-controlled, dose-ranging, parallel-group multi-site study is designed to evaluate the therapeutic efficacy and safety of the investigational product, DSXS, for the treatment of moderate to severe scalp psoriasis at different application times up to 30 minutes.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Plaque Psoriasis

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantInvestigator
    Allocation
    Randomized
    Enrollment
    151 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    DSXS1411
    Arm Type
    Experimental
    Arm Description
    DSXS applied once a day for a total of 28 days.
    Arm Title
    Placebo
    Arm Type
    Placebo Comparator
    Arm Description
    Placebo (vehicle) applied once a day for a total of 28 days.
    Intervention Type
    Drug
    Intervention Name(s)
    DSXS1411
    Other Intervention Name(s)
    Active
    Intervention Description
    DSXS (Taro Pharmaceuticals Inc.)
    Intervention Type
    Drug
    Intervention Name(s)
    Placebo
    Other Intervention Name(s)
    vehicle
    Intervention Description
    Placebo (vehicle) (Taro Pharmaceuticals Inc.)
    Primary Outcome Measure Information:
    Title
    Clinical Response of Success
    Description
    The proportion of patients in each treatment group that have clinical success at Day 28, which is defined by a Investigator's Global Assessment score of 0 or 1.
    Time Frame
    28 Days

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    12 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Male or non-pregnant, non-lactating females age 12 and older. Clinical diagnosis of moderate to severe scalp psoriasis, defined by a Investigator's Global Assessment score of at least 3 at screening. Exclusion Criteria: Under 12 years of age. Patients whose scalp and/or non-scalp psoriasis necessitates systemic or other concomitant topical therapies during the study. Has a scalp skin condition that would interfere with the diagnosis or assessment of plaque psoriasis of the scalp.
    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

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    A Randomized Double Blind Vehicle Controlled Dose Ranging Parallel Design Multiple Site Clinical Study

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