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Protocol Summary for 114569

Protocol Summary
Protocol Id: 114569
Secondary Ids:
  • U0280-402
Title: A Study to Evaluate Safety and Efficacy of Clobetasol Propionate for Treatment of Plaque-Type Psoriasis in Adult Subjects.
Phase: phase 4
Acronym:
FDA Regulated Intervention?: Yes
Section 801 Clinical Trial?: Yes
Delayed Posting: No
IND/IDE Protocol?: no
Study Type: Interventional
Oversight Authority:
  • United States: Institutional Review Board
Collaborators:
  • GSK
Brief Summary: The purpose of the study is to determine the efficacy and safety of two different forms of a topical steroid (clobetasol propionate) in patients with plaque-type psoriasis.
Detailed Description: This study is being conducted to obtain efficacy and tolerability data for two clobetasol propionate therapies in the treatment of plaque-type psoriasis. Subjects will be randomized to only one of the two therapies for treatment throughout the study.
Record Verification Date: February 2012
Status: Completed
Why Study Stopped:
Study Start Date: March 2009
Study Completion Date: August 2009
Study Completion Date Type: Actual
Primary Completion Date: June 2009
Primary Completion Date Type: Actual
Primary Purpose: treatment
Allocation: Randomized
Masking: Single Blind
Masked Subject: no
Masked Caregiver: no
Masked Investigator: yes
Masked Assessor: no
Study Design (Assignment): Parallel Assignment
Study Classification (Endpoint): Safety/Efficacy Study
Primary Outcomes:
  • At least a one grade improvement for the target psoriasis lesion on the elbow or knee (Psoriasis Grading Scale) Baseline to day 15
Secondary Outcomes:
  • Dermatology Quality of Life - Work and School Baseline, Days 3, 8, 15
  • Total Dermatology Life Quality Index (DLQI) Score Baseline, Days 3, 8, 15
  • Dermatology Life Quality Index (DLQI) Categories Days 3, 8, 15
  • Median change in Psoriasis Grading Scale Baseline, Days 3, 8, 15
  • At least 1 grade improvement Psoriasis Grading Scale Baseline, days 3 and 8
  • Dermatology Quality of Life - Personal Relationships Baseline, Days 3, 8, 15
  • At least a 3 grade improvement in the Psoriasis Global Assessment Baseline, days 3, 8, 15
  • Dermatology Quality of Life - Symptoms and Feelings Baseline, Days 3, 8, 15
  • Dermatology Quality of Life - Leisure Baseline, Days 3, 8, 15
  • Dermatology Quality of Life - Treatment Baseline, Days 3, 8, 15
  • At least a 3 grade improvement in Subject's Global Assessment Baseline, days 3, 8, 15
  • At least 1 grade improvement in Subject’s Global Assessment Baseline, days 3, 8, 15
  • At least a 2 grade improvement Psoriasis Grading Scale Baseline, days 3, 8, 15
  • At least 1 grade improvement in the Psoriasis Global Assessment Baseline, days 3, 8, 15
  • Dermatology Quality of Life - Daily Activities Baseline, Days 3, 8, 15
  • At least a 3 grade improvement Psoriasis Grading Scale Baseline, days 3, 8, 15
  • At least a 2 grade improvement in the Psoriasis Global Assessment Baseline, days 3, 8, 15
  • At least a 2 grade improvement in Subject's Global Assessment Baseline, days 3, 8, 15
Conditions:
  • Psoriasis
Keywords:
  • Psoriasis
Eligibility Criteria: Click to view inclusion/exclusion criteria
Gender: Both
Minimum Age: 18 Year
Maximum Age:
Enrollment: 34
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