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

Plaque Psoriasis Clinical Trial

Official title:

Multi-Center, Double-Blind, Randomized, Vehicle-controlled, Parallel-Group Study Comparing NYC-0462 Ointment To a Vehicle Control

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00747032
• Other study ID #: NYC 0462-01-01
• Status: Withdrawn
• Phase: Phase 3
• First received: September 1, 2008
• Last updated: May 4, 2012
• Start date: September 2010
• Est. completion date: April 2011

Study information

• Verified date: May 2012
• Source: Nycomed
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: April 2011
• Est. primary completion date: February 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Plaque Psoriasis
• Psoriasis

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Fougera Pharmaceuticals Inc.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reduction in plaque elevation score		8 weeks	No
Secondary	Reduction in Investigator´s Global Evaluation, erythema and scaling scores		8 weeks	No