Clinical Trial: Safety and Efficacy Study of Photodynamic Therapy With Levulan Kerastick + Blue Light for Actinic Keratoses on the Upper Extremities

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: A Phase 3 Study of Photodynamic Therapy With Levulan Kerastick Topical Solution + Blue Light Versus Topical Solution Vehicle + Blue Light for the Treatment of Actinic Keratoses

Brief Summary: The purpose of this study is to determine if Levulan Photodynamic Therapy (PDT) is safe and effective in the treatment of actinic keratoses on the upper arms and hands

Detailed Summary:
Sponsor: DUSA Pharmaceuticals, Inc.

Current Primary Outcome: Complete Clearance Rate [ Time Frame: Week 12 ]

proportion of subjects in each treatment group with a count of zero lesions in the Treatment Area


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • AK Clearance Rate [ Time Frame: Baseline and Week 12 ]
    {1 - [(number of AK lesions at follow-up)/(number of AK lesions at Baseline)]} x 100
  • AK Clearance Rate [ Time Frame: Baseline and Week 8 ]
    {1 - [(number of AK lesions at follow-up)/(number of AK lesions at Baseline)]} x 100
  • Complete Clearance Rate [ Time Frame: Week 8 ]
    proportion of subjects in each treatment group with a count of zero lesions in the Treatment Area
  • Subject Satisfaction Score [ Time Frame: Week 12 ]

    Subject satisfaction score

    1. = Excellent (very satisfied)
    2. = Good (moderately satisfied)
    3. = Fair (slightly satisfied)
    4. = Poor (not satisfied at all)


Original Secondary Outcome: Same as current

Information By: DUSA Pharmaceuticals, Inc.

Dates:
Date Received: May 7, 2014
Date Started: May 2014
Date Completion:
Last Updated: August 17, 2015
Last Verified: August 2015