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Clinical Study to Evaluate the Efficacy and Safety of DSXS in Patients With Mild to Moderate Plaque Psoriasis

NCT ID: NCT02618759

Last Updated: 2018-12-10

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

119 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-08-28

Study Completion Date

2017-08-25

Brief Summary

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The purpose of this study is to evaluate the therapeutic efficacy and safety of DSXS compared to a Placebo (vehicle) in patients with mild to moderate plaque psoriasis.

Detailed Description

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To evaluate the therapeutic efficacy and safety of dsxs topical spray, 0.15% (Taro Pharmaceuticals, U.S.A., Inc.) compared to a Placebo (vehicle) spray (Taro Pharmaceuticals, U.S.A., Inc.) in patients with mild to moderate plaque psoriasis.

Conditions

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Plaque Psoriasis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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DSXS1505

To evaluate the therapeutic efficacy and safety of DSXS topical spray, 0.15%.

Group Type EXPERIMENTAL

DSXS

Intervention Type DRUG

active treatment

Placebo

Intervention Type DRUG

placebo treatment

Placebo

Eligible patients will be randomized in a 1:1 ratio to Test or Placebo product.

Group Type PLACEBO_COMPARATOR

DSXS

Intervention Type DRUG

active treatment

Placebo

Intervention Type DRUG

placebo treatment

Interventions

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DSXS

active treatment

Intervention Type DRUG

Placebo

placebo treatment

Intervention Type DRUG

Other Intervention Names

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Active vehicle

Eligibility Criteria

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Inclusion Criteria

* male and non-pregnant females, 12 years of age or older, with a confirmed diagnosis of mild to moderate plaque psoriasis

Exclusion Criteria

* patient is\< 12 years old.
Minimum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sun Pharmaceutical Industries, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Novum Pharmaceutical Research Services

Role: STUDY_CHAIR

http://www.novumprs.com/contact

Locations

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Taro Pharmaceuticals USA Inc.

Hawthorne, New York, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

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DSXS 1505

Identifier Type: -

Identifier Source: org_study_id