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

NCT ID: NCT00747032

Last Updated: 2012-05-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE3

Study Classification

INTERVENTIONAL

Study Start Date

2010-09-30

Study Completion Date

2011-04-30

Brief Summary

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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.

Detailed Description

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Conditions

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Plaque Psoriasis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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1

NYC 0462 Ointment

Group Type ACTIVE_COMPARATOR

NYC 0462 Ointment

Intervention Type DRUG

To assess the efficacy of NYC 0462 Ointment versus Placebo in the treatment of Plaque Psoriasis

2

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

To assess the efficacy of NYC 0462 Ointment versus Placebo in the treatment of Plaque Psoriasis

Interventions

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NYC 0462 Ointment

To assess the efficacy of NYC 0462 Ointment versus Placebo in the treatment of Plaque Psoriasis

Intervention Type DRUG

Placebo

To assess the efficacy of NYC 0462 Ointment versus Placebo in the treatment of Plaque Psoriasis

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Fougera Pharmaceuticals Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Nycomed US Inc.

Principal Investigators

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Kathleen Ocasio

Role: STUDY_CHAIR

Fougera Pharmaceuticals Inc.

Other Identifiers

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NYC 0462-01-01

Identifier Type: -

Identifier Source: org_study_id

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