Phase III Clinical Study in Patients With Mild to Severe Scalp Psoriasis

Sun Pharmaceutical Industries, Inc.371 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

371

Conditions

Scalp Psoriasis

Interventions

DSXS topicalDRUG

topical treatment

Vehicle topicalDRUG

topical treatment

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

Taro Pharmaceuticals USA, Inc.

Hawthorne, New York, United States

Outcomes

Primary Outcomes

Proportion of Patients in Each Treatment Group Who Are Considered a Clinical Success

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

Time frame: Day 29

Data from ClinicalTrials.gov

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