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

Phase 3

Withdrawn

• Conditions: Plaque Psoriasis
• Interventions: Drug: NYC 0462 Ointment; Drug: Placebo

• Registration Number: NCT00747032
• Lead Sponsor: Fougera Pharmaceuticals Inc.

Brief Summary

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

Not available

Study Timeline

• Study First Submitted: 2008-09-01
• Study First Submitted QC: 2008-09-03
• Study First Posted: 2008-09-04
• Study Start: 2010-09
• Primary Completion: 2011-02
• Study Completion: 2011-04
• Status Verified: 2012-05
• Last Update Submitted: 2012-05-04
• Last Update Posted: 2012-05-07

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	NYC 0462 Ointment	NYC 0462 Ointment
2	Placebo	Placebo

Primary Outcome Measures

Name	Time	Method
Reduction in plaque elevation score	8 weeks

Secondary Outcome Measures

Name	Time	Method
Reduction in Investigator´s Global Evaluation, erythema and scaling scores	8 weeks