To Demonstrate the Superior Efficacy of NYC 0462 Ointment... | NCT00747032

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

NCT00747032

Sponsor

Fougera Pharmaceuticals Inc.

Status

Withdrawn

Last Update Posted

May 7, 2012Estimated

Enrollment

0Actual

Phase

Phase 3

Conditions

Plaque Psoriasis

Interventions

NYC 0462 Ointment
Placebo

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2012

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Study withdrawn due to business decisions. No subjects were treated.

Expanded Access Info

Start Date

Sep 2010

Primary Completion Date

Feb 2011Estimated

Completion Date

Apr 2011Estimated

First Submitted Date

Sep 1, 2008

First Submission Date that Met QC Criteria

Sep 3, 2008

First Posted Date

Sep 4, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 4, 2012

Last Update Posted Date

May 7, 2012Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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 provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Active Comparator	NYC 0462 Ointment	Drug: NYC 0462 Ointment
2	Placebo Comparator	Placebo	Drug: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
NYC 0462 Ointment	Drug	To assess the efficacy of NYC 0462 Ointment versus Placebo in the treatment of Plaque Psoriasis	1

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Reduction in plaque elevation score		8 weeks

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided