Protocol Summary for OEF0701
| 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: |
|
| Collaborators: |
|
| 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: |
|
| Secondary Outcomes: |
|
| Conditions: |
|
| Keywords: |
|
| Eligibility Criteria: |
Click to view inclusion/exclusion criteria
Inclusion 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
|

Click to view inclusion/exclusion criteria