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

NCT ID: NCT02933866

Last Updated: 2018-12-06

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

371 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-03-11

Study Completion Date

2017-09-29

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Scalp Psoriasis

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

DSXS topical

applied once daily for 28 days

Group Type EXPERIMENTAL

DSXS topical

Intervention Type DRUG

topical treatment

Vehicle topical

applied once daily for 28 days

Group Type PLACEBO_COMPARATOR

Vehicle topical

Intervention Type DRUG

topical treatment

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

DSXS topical

topical treatment

Intervention Type DRUG

Vehicle topical

topical treatment

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Active placebo

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Sun Pharmaceutical Industries, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Novum Pharmaceutical Research Services

Role: STUDY_CHAIR

http://www.novumprs.com/contact

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Taro Pharmaceuticals USA, Inc.

Hawthorne, New York, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Provided Documents

Download supplemental materials such as informed consent forms, study protocols, or participant manuals.

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

DSXS 1536

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Sulodexide in Controlling the Recurrence of Psoriasis
NCT06982196 ENROLLING_BY_INVITATION PHASE3