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Protocol Summary for OEF0701

Protocol Summary
Protocol Id: OEF0701
Secondary Ids:
Title: A Study to Evaluate the Efficacy and Tolerability of Clobetasol Propionate vs. Vehicle in the Treatment of Mild to Moderate Plaque-Type Psoriasis
Phase: phase 4
Acronym:
FDA Regulated Intervention?: No
Section 801 Clinical Trial?:
Delayed Posting:
IND/IDE Protocol?: no
Study Type: Interventional
Oversight Authority:
  • Canada: Ethics Review Committee
Collaborators:
  • GlaxoSmithKline
  • GSK
Brief Summary: The purpose of the study is to compare the efficacy and safety of Clobetasol propionate to that of its Vehicle in the treatment of mild to moderate plaque-type psoriasis.
Detailed Description: The purpose of the study is to compare the efficacy and safety of Clobetasol propionate to that of its Vehicle in the treatment of mild to moderate plaque-type psoriasis. This is a multi-center, double blind, randomized, parallel designed study which consists of 2 weeks of treatment and a follow-up visit 2 weeks later.
Record Verification Date: July 2011
Status: Completed
Why Study Stopped:
Study Start Date: November 2007
Study Completion Date: January 2008
Study Completion Date Type: Actual
Primary Completion Date: December 2007
Primary Completion Date Type: Actual
Primary Purpose: treatment
Allocation: Randomized
Masking: Double Blind
Masked Subject: yes
Masked Caregiver: no
Masked Investigator: yes
Masked Assessor: no
Study Design (Assignment): Parallel Assignment
Study Classification (Endpoint): Safety/Efficacy Study
Primary Outcomes:
  • Target Lesion Global Improvement score All visits
Secondary Outcomes:
  • Pruritus, erythema, scaling, plaque thickness score at Week 2 All visits
Conditions:
  • Psoriasis
Keywords:
  • Psoriasis
  • Plaque Type Psoriasis
Eligibility Criteria: Click to view inclusion/exclusion criteria
Gender: Both
Minimum Age: 12 Year
Maximum Age:
Enrollment: 58
Enrollment Type: Actual
Healthy Volunteers?: none
Central Contact: Call Center
Central Contact Phone: 877-379-3718
Central Contact Email: GSKClinicalSupportHD@gsk.com
Backup Central Contact:
Backup Central Contact Phone:
Backup Central Contact Email:
Overall Study Official: GSK Clinical Trials
Overall Study Official Affiliation: GlaxoSmithKline
Overall Study Official Role: Study Director
Responsible Party Name/Official Title: Cheri Hudson; Clinical Disclosure Advisor
Responsible Party Organization: GSK Clinical Disclosure
Location and Contact Information: Click to view location information