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

Sun Pharmaceutical Industries, Inc.151 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

151

Conditions

Plaque Psoriasis

Interventions

DSXS1411DRUG

DSXS (Taro Pharmaceuticals Inc.)

PlaceboDRUG

Placebo (vehicle) (Taro Pharmaceuticals Inc.)

Eligibility

Sex: ALLMin age: 12 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

Clinical Response of Success

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.

Time frame: 28 Days

Data from ClinicalTrials.gov

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