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

Sponsored by:	Nycomed US Inc.
Information provided by:	Nycomed
ClinicalTrials.gov Identifier:	NCT00747032

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 III

MedlinePlus related topics: Psoriasis

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Efficacy Study
Official Title:	Multi-Center, Double-Blind, Randomized, Vehicle-Controlled, Parallel-Group Study Comparing NYC-0462 Ointment To a Vehicle Control

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 ]

Estimated Enrollment:	300
Study Start Date:	November 2008
Estimated Study Completion Date:	November 2009
Estimated Primary Completion Date:	September 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator NYC 0462 Ointment	Drug: NYC 0462 Ointment To assess the efficacy of NYC 0462 Ointment versus Placebo in the treatment of Plaque Psoriasis
2: Placebo Comparator 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

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

Contacts

Contact: Kathleen Ocasio

+16314547677 ext 2089

kathleen.ocasio@nycomedus.com

Sponsors and Collaborators

Nycomed US Inc.

Investigators

Study Chair:

Kathleen Ocasio

Nycomed US Inc.

More Information

Responsible Party:	Nycomed US Inc. ( Kathleen Ocasio )
Study ID Numbers:	NYC 0462-01-01
Study First Received:	September 1, 2008
Last Updated:	September 22, 2008
ClinicalTrials.gov Identifier:	NCT00747032
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Skin Diseases
Psoriasis
Skin Diseases, Papulosquamous

ClinicalTrials.gov processed this record on January 14, 2009