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

This study has been withdrawn prior to enrollment.
(Study withdrawn due to business decisions. No subjects were treated.)
Sponsor:
Information provided by:
Nycomed
ClinicalTrials.gov Identifier:
NCT00747032
First received: September 1, 2008
Last updated: May 4, 2012
Last verified: May 2012
  Purpose

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.


Condition Intervention Phase
Plaque Psoriasis
Drug: NYC 0462 Ointment
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Multi-Center, Double-Blind, Randomized, Vehicle-controlled, Parallel-Group Study Comparing NYC-0462 Ointment To a Vehicle Control

Resource links provided by NLM:


Further study details as provided by Nycomed:

Primary Outcome Measures:
  • Reduction in plaque elevation score [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Reduction in Investigator´s Global Evaluation, erythema and scaling scores [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]

Enrollment: 0
Study Start Date: September 2010
Estimated Study Completion Date: April 2011
Estimated Primary Completion Date: February 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
Placebo Comparator: 2
Placebo
Drug: Placebo
To assess the efficacy of NYC 0462 Ointment versus Placebo in the treatment of Plaque Psoriasis

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00747032

Sponsors and Collaborators
Fougera Pharmaceuticals Inc.
Investigators
Study Chair: Kathleen Ocasio Fougera Pharmaceuticals Inc.
  More Information

No publications provided

Responsible Party: Kathleen Ocasio, Nycomed US Inc.
ClinicalTrials.gov Identifier: NCT00747032     History of Changes
Other Study ID Numbers: NYC 0462-01-01
Study First Received: September 1, 2008
Last Updated: May 4, 2012
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases

ClinicalTrials.gov processed this record on August 19, 2014