NCT00747032

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.

Trial Health

15
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Sep 2010

Shorter than P25 for phase_3

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 1, 2008

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 4, 2008

Completed
2 years until next milestone

Study Start

First participant enrolled

September 1, 2010

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2011

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2011

Completed
Last Updated

May 7, 2012

Status Verified

May 1, 2012

Enrollment Period

5 months

First QC Date

September 1, 2008

Last Update Submit

May 4, 2012

Conditions

Plaque Psoriasis

Outcome Measures

Primary Outcomes (1)

  • Reduction in plaque elevation score

    8 weeks

Secondary Outcomes (1)

  • Reduction in Investigator´s Global Evaluation, erythema and scaling scores

    8 weeks

Study Arms (2)

1

ACTIVE COMPARATOR

NYC 0462 Ointment

Drug: NYC 0462 Ointment

2

PLACEBO COMPARATOR

Placebo

Drug: Placebo

Interventions

NYC 0462 OintmentDRUG

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

1
PlaceboDRUG

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

2

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Officials

  • Kathleen Ocasio

    Fougera Pharmaceuticals Inc.

    STUDY CHAIR
0

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

September 1, 2008

First Posted

September 4, 2008

Study Start

September 1, 2010

Primary Completion

February 1, 2011

Study Completion

April 1, 2011

Last Updated

May 7, 2012

Record last verified: 2012-05