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Completed

NCT Number: NCT02413229

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

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.

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Key information

Conditions

Plaque Psoriasis

Age range

12 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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.

Treatment and study plan

DSXS1411

Drug

DSXS (Taro Pharmaceuticals Inc.)

Other names: Active

Placebo

Drug

Placebo (vehicle) (Taro Pharmaceuticals Inc.)

Other names: vehicle

Primary outcomes

  1. Clinical Response of Success

    Time frame: 28 Days

    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.

Sponsors and collaborators

Lead sponsor

Sun Pharmaceutical Industries, Inc.

Industry

Registry information

Official study 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

Important dates

Study start
2015
Primary completion
2015
Study completion
2016
First posted
Apr 9, 2015
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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