To Demonstrate the Superior Efficacy of NYC 0462 Ointment Over That of the Placebo in the Treatment of Plaque Psoriasis

May 4, 2012 updated by: Fougera Pharmaceuticals Inc.

Multi-Center, Double-Blind, Randomized, Vehicle-controlled, Parallel-Group Study Comparing NYC-0462 Ointment To a Vehicle Control

The aim of this trial is to assess the efficacy of NYC-0462 Ointment in the Treatment of Plaque Psoriasis.Treatment medication will be administered as follows: A thin layer of study product will be applied to the affected skin, excluding the face, once daily, at approximately the same time daily.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Phase 3

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Diagnosis of stable, symptomatic plaque psoriasis
  • Good health with the exception of psoriasis
  • % BSA and plaque elevation requirements

Exclusion Criteria:

  • Subjects who are pregnant, nursing or planning a pregnancy within the study participation period.
  • Subjects who have any systemic or dermatological disorders with the exception of psoriasis

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: 2
Placebo
Drug: Placebo
To assess the efficacy of NYC 0462 Ointment versus Placebo in the treatment of Plaque Psoriasis
Active Comparator: 1
NYC 0462 Ointment
Drug: NYC 0462 Ointment
To assess the efficacy of NYC 0462 Ointment versus Placebo in the treatment of Plaque Psoriasis

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Reduction in plaque elevation score
Time Frame: 8 weeks
8 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Reduction in Investigator´s Global Evaluation, erythema and scaling scores
Time Frame: 8 weeks
8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fougera Pharmaceuticals Inc.

Investigators

  • Study Chair: Kathleen Ocasio, Fougera Pharmaceuticals Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2010

Primary Completion (Anticipated)

February 1, 2011

Study Completion (Anticipated)

April 1, 2011

Study Registration Dates

First Submitted

September 1, 2008

First Submitted That Met QC Criteria

September 3, 2008

First Posted (Estimate)

September 4, 2008

Study Record Updates

Last Update Posted (Estimate)

May 7, 2012

Last Update Submitted That Met QC Criteria

May 4, 2012

Last Verified

May 1, 2012

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NYC 0462-01-01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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