Skip to main content
OpenTrials
Completed

NCT Number: NCT02618759

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Plaque Psoriasis

Age range

12 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Taro Pharmaceuticals USA Inc.

Hawthorne, New York, 10532, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

DSXS

Drug

active treatment

Other names: Active

Placebo

Drug

placebo treatment

Other names: vehicle

Primary outcomes

  1. Number of Patients in Each Treatment That Have Clinical Success Based on IGA at Day 28 ± 2

    Time frame: 28 Days

    The number of patients in each treatment group that have clinical success. Clinical Success is at least a 2-grade improvement from the baseline IGA score. The minimum IGA value is 0, and maximum value is 5. A higher number represents a more severe case of plaque psoriasis. Patients are required to have an IGA score of 2 or 3 at baseline, so all clinical success IGA scores will be either 0 or 1.

  2. Number of Patients in Each Treatment That Have Treatment Success Based on TLSS at Day 28 ± 2

    Time frame: 28 Days

    The number of patients in each treatment group that have Treatment Success for the Target Lesion based on the TLSS sub-scale scores. Treatment Success is defined as a score of 0 or 1 for each of the three signs and symptoms (erythema, scaling and plaque elevation) for the Target Lesion. Each score has a minimum value of 0 and maximum value of 5, where a higher value represents a more severe sign or symptom. To be considered for inclusion in the study, the Target Lesion must have a plaque elevation score of at least 2.

Secondary outcomes

  1. Number of Patients in Each Treatment That Have Clinical Success Based on IGA at Day 28 ± 2 (Patients With a Baseline IGA Score of 3)

    Time frame: 28 Days

    The number of patients in each treatment group that have clinical success. Clinical Success is defined as at least a 2-grade improvement from the baseline IGA score. This measure is limited to patients with a baseline IGA score of 3, so any IGA score of 0 or 1 at Day 28 ± 2 would be a treatment success.

  2. Number of Patients in Each Treatment That Have Treatment Success Based on TLSS at Day 28 ± 2 (Patients With a Baseline IGA Score of 3)

    Time frame: 28 Days

    The number of patients in each treatment group that have Treatment Success for the Target Lesion based on the TLSS sub-scale scores. Treatment Success is defined as a score of 0 or 1 for each of the three signs and symptoms (erythema, scaling and plaque elevation) for the Target Lesion. Each score has a minimum value of 0 and maximum value of 5, where a higher value represents a more severe sign or symptom. To be considered for inclusion in the study, the Target Lesion must have a plaque elevation score of at least 2. This measure is limited to patients with a baseline IGA score of 3.

  3. Number of Patients in Each Treatment That Have Clinical Success Based on IGA at Day 28 ± 2 (Patients With a Baseline IGA Score of 2)

    Time frame: 28 Days

    The number of patients in each treatment group that have clinical success. Clinical Success is defined as at least a 2-grade improvement from the baseline IGA score. This measure is limited to patients with a baseline IGA score of 2, so only an IGA score of 0 at Day 28 ± 2 would be a treatment success.

  4. Number of Patients in Each Treatment That Have Treatment Success Based on TLSS at Day 28 ± 2 (Patients With a Baseline IGA Score of 2)

    Time frame: 28 Days

    The number of patients in each treatment group that have Treatment Success for the Target Lesion based on the TLSS sub-scale scores. Treatment Success is defined as a score of 0 or 1 for each of the three signs and symptoms (erythema, scaling and plaque elevation) for the Target Lesion. Each score has a minimum value of 0 and maximum value of 5, where a higher value represents a more severe sign or symptom. To be considered for inclusion in the study, the Target Lesion must have a plaque elevation score of at least 2. This measure is limited to patients with a baseline IGA score of 2.

Sponsors and collaborators

Lead sponsor

Sun Pharmaceutical Industries, Inc.

Industry

Registry information

Official study title

A Randomized, Double-Blind, Placebo-Controlled, Parallel-Design, Multiple-Site Clinical Study to Evaluate the Efficacy and Safety of DSXS in Patients With Mild to Moderate Plaque Psoriasis

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Dec 1, 2015
Registry last updated
Dec 10, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.