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OpenTrials
Completed

NCT Number: NCT02933866

Phase III Clinical Study 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

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Key information

Conditions

Scalp Psoriasis

Age range

18 year–65 year

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 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.

Who can participate

Healthy volunteers accepted: Yes

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

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.

Treatment and study plan

DSXS topical

Drug

topical treatment

Other names: Active

Vehicle topical

Drug

topical treatment

Other names: placebo

Primary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Sun Pharmaceutical Industries, Inc.

Industry

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2016
Study completion
2017
First posted
Oct 14, 2016
Registry last updated
Dec 6, 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.

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