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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00747032
Recruitment Status : Withdrawn (Study withdrawn due to business decisions. No subjects were treated.)
First Posted : September 4, 2008
Last Update Posted : May 7, 2012
Sponsor:
Information provided by:
Nycomed

Tracking Information
First Submitted Date  ICMJE September 1, 2008
First Posted Date  ICMJE September 4, 2008
Last Update Posted Date May 7, 2012
Study Start Date  ICMJE September 2010
Estimated Primary Completion Date February 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 3, 2008)
Reduction in plaque elevation score [ Time Frame: 8 weeks ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 3, 2008)
Reduction in Investigator´s Global Evaluation, erythema and scaling scores [ Time Frame: 8 weeks ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE To Demonstrate the Superior Efficacy of NYC 0462 Ointment Over That of the Placebo in the Treatment of Plaque Psoriasis
Official Title  ICMJE Multi-Center, Double-Blind, Randomized, Vehicle-controlled, Parallel-Group Study Comparing NYC-0462 Ointment To a Vehicle Control
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
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Plaque Psoriasis
Intervention  ICMJE
  • Drug: NYC 0462 Ointment
    To assess the efficacy of NYC 0462 Ointment versus Placebo in the treatment of Plaque Psoriasis
  • Drug: Placebo
    To assess the efficacy of NYC 0462 Ointment versus Placebo in the treatment of Plaque Psoriasis
Study Arms  ICMJE
  • Active Comparator: 1
    NYC 0462 Ointment
    Intervention: Drug: NYC 0462 Ointment
  • Placebo Comparator: 2
    Placebo
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Withdrawn
Actual Enrollment  ICMJE
 (submitted: May 4, 2012)
0
Original Estimated Enrollment  ICMJE
 (submitted: September 3, 2008)
300
Estimated Study Completion Date  ICMJE April 2011
Estimated Primary Completion Date February 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00747032
Other Study ID Numbers  ICMJE NYC 0462-01-01
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Kathleen Ocasio, Nycomed US Inc.
Study Sponsor  ICMJE Fougera Pharmaceuticals Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Kathleen Ocasio Fougera Pharmaceuticals Inc.
PRS Account Nycomed
Verification Date May 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP