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Study to Evaluate Efficacy and Safety of the Topical Product in Patients With Mild to Severe Scalp Psoriasis

Primary Purpose

Scalp Psoriasis

Status
Completed
Phase
Phase 3
Locations
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 Scalp Psoriasis

Eligibility Criteria

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

Inclusion Criteria:

  • Patients with a clinical diagnosis of mild to severe plaque psoriasis of the scalp, defined by an Investigator's Global Assessment (IGA) score of at least 2 at baseline/randomization

Exclusion Criteria:

  • Patients whose scalp psoriasis necessitates systemic or other concomitant topical therapies during the study (concomitant treatment of body psoriasis with over the counter topical products including emollients, is allowed).
  • Patient has a scalp skin condition that would interfere with the diagnosis or assessment of plaque psoriasis of the scalp (e.g., seborrheic dermatitis, eczema, cutaneous T-cell lymphoma, or other forms of psoriasis including guttate, inverse, pustular or erythrodermic psoriasis)
  • Presence of pigmentation, extensive scarring, pigmented lesions, or sunburn in the treatment areas that could interfere with the rating of efficacy parameters, including planned extensive exposure to sunlight during the study.
  • History of psoriasis unresponsive to topical treatments.
  • Current immunosuppression or history of organ transplant.
  • Patients who have a history of or current diagnosis of glaucoma.
  • Patients who have had surgery on the eyes or eyelids within 1 month before baseline or plan to have eye or eyelid surgery during the study.
  • Patients with active infection (including but not limited to bacterial, fungal and viral infection) and/or open wounds on the entire head and neck area.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Placebo Comparator

    Arm Label

    DSXS 1535

    Placebo

    Arm Description

    DSXS 1535 topical product

    Vehicle

    Outcomes

    Primary Outcome Measures

    Clinical Success in Patients With Moderate and Severe Scalp Psoriasis
    IGA score of 0 (clear) or 1 (almost clear) with at least a 2 grades reduction from baseline
    Clinical Success in Patients With Mild to Severe Scalp Psoriasis
    IGA score of 0 (clear) or 1 (almost clear) with at least a 2 grades reduction from baseline

    Secondary Outcome Measures

    Clinical Success in Patients With Mild Scalp Psoriasis
    IGA score of 0 (clear) or 1 (almost clear) with at least a 2 grades reduction from baseline

    Full Information

    First Posted
    October 8, 2016
    Last Updated
    November 12, 2018
    Sponsor
    Taro Pharmaceuticals USA
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02932462
    Brief Title
    Study to Evaluate Efficacy and Safety of the Topical Product in Patients With Mild to Severe Scalp Psoriasis
    Official Title
    A Randomized, Double-Blind, Vehicle-Controlled, Parallel-Design, Multiple-Site, Phase III Clinical Study to Evaluate the Efficacy and Safety of DSXS 1535 in Patients With Mild to Severe Scalp Psoriasis
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    November 2018
    Overall Recruitment Status
    Completed
    Study Start Date
    March 2016 (Actual)
    Primary Completion Date
    December 1, 2016 (Actual)
    Study Completion Date
    September 29, 2017 (Actual)

    3. Sponsor/Collaborators

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

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    Yes
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    A Randomized Double-Blind, Vehicle-Controlled, Parallel Design, Multiple-Site, Phase III Clinical Study
    Detailed Description
    This randomized, double-blind, vehicle-controlled, parallel-group multiple-site study is designed to evaluate the therapeutic efficacy and safety of the investigational product, DSXS 1535 product, for the treatment of mild to severe scalp psoriasis

    6. Conditions and Keywords

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

    7. Study Design

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

    8. Arms, Groups, and Interventions

    Arm Title
    DSXS 1535
    Arm Type
    Experimental
    Arm Description
    DSXS 1535 topical product
    Arm Title
    Placebo
    Arm Type
    Placebo Comparator
    Arm Description
    Vehicle
    Intervention Type
    Drug
    Intervention Name(s)
    DSXS
    Other Intervention Name(s)
    DSXS 1535
    Intervention Description
    topical product
    Intervention Type
    Drug
    Intervention Name(s)
    Placebo
    Other Intervention Name(s)
    vehicle
    Intervention Description
    topical product
    Primary Outcome Measure Information:
    Title
    Clinical Success in Patients With Moderate and Severe Scalp Psoriasis
    Description
    IGA score of 0 (clear) or 1 (almost clear) with at least a 2 grades reduction from baseline
    Time Frame
    from baseline to study day 29
    Title
    Clinical Success in Patients With Mild to Severe Scalp Psoriasis
    Description
    IGA score of 0 (clear) or 1 (almost clear) with at least a 2 grades reduction from baseline
    Time Frame
    from baseline to study day 29
    Secondary Outcome Measure Information:
    Title
    Clinical Success in Patients With Mild Scalp Psoriasis
    Description
    IGA score of 0 (clear) or 1 (almost clear) with at least a 2 grades reduction from baseline
    Time Frame
    from baseline to study day 29

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    12 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Patients with a clinical diagnosis of mild to severe plaque psoriasis of the scalp, defined by an Investigator's Global Assessment (IGA) score of at least 2 at baseline/randomization Exclusion Criteria: Patients whose scalp psoriasis necessitates systemic or other concomitant topical therapies during the study (concomitant treatment of body psoriasis with over the counter topical products including emollients, is allowed). Patient has a scalp skin condition that would interfere with the diagnosis or assessment of plaque psoriasis of the scalp (e.g., seborrheic dermatitis, eczema, cutaneous T-cell lymphoma, or other forms of psoriasis including guttate, inverse, pustular or erythrodermic psoriasis) Presence of pigmentation, extensive scarring, pigmented lesions, or sunburn in the treatment areas that could interfere with the rating of efficacy parameters, including planned extensive exposure to sunlight during the study. History of psoriasis unresponsive to topical treatments. Current immunosuppression or history of organ transplant. Patients who have a history of or current diagnosis of glaucoma. Patients who have had surgery on the eyes or eyelids within 1 month before baseline or plan to have eye or eyelid surgery during the study. Patients with active infection (including but not limited to bacterial, fungal and viral infection) and/or open wounds on the entire head and neck area.
    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
    First Name & Middle Initial & Last Name & Degree
    Natalie Yantovskiy
    Organizational Affiliation
    Taro Pharmaceuticals USA Inc.
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    Study to Evaluate Efficacy and Safety of the Topical Product in Patients With Mild to Severe Scalp Psoriasis

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