Clinical Trial: Levulan PDT Versus Vehicle for Extremity Actinic Keratoses (AK)

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

Official Title: A Phase II Study of Photodynamic Therapy (PDT)With LEVULAN® Topical Solution + Blue Light Versus LEVULAN® Topical Solution Vehicle + Blue Light for the Treatment of Actinic Clearance rate for all lesions



Original Primary Outcome: Baseline Lesion Clearance Rate (Grade 1/2 only) [ Time Frame: Week 12 ]

Clearance rate for Grade 1/2 lesions that were present at Baseline


Current Secondary Outcome:

  • Lesion Clearance Rate [ Time Frame: Week 8 ]
  • Complete Clearance Rate [ Time Frame: Week 8 ]
    proportion of subjects with a count of zero lesions in the treatment area
  • Complete Clearance Rate [ Time Frame: Week 12 ]
    proportion of subjects with a count of zero lesions in the treatment area
  • Partial Clearance Rate [ Time Frame: Baseline and Week 8 ]
    proportion of subjects with 75% or more reduction in the AK count in the Treatment Area as compared to baseline.
  • Partial Clearance Rate [ Time Frame: Baseline and Week 12 ]
    proportion of subjects with 75% or more reduction in the AK count in the Treatment Area as compared to baseline.
  • 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)
  • Hyperpigmentation at Baseline [ Time Frame: Baseline ]
    HYPERPIGMENTATION SCALE Grade 0 = No hyperpigmentation Grade 1 = Light hyperpigmentation involving small areas Grade 2 = Moderate hyperpigmentation involving small areas; light hyperpigmentation involving moderate areas Grade 3 = Moderate hyperpigmentation involving moderate sized areas; light hyperpigmentation involving large areas; small areas of marked hyperpigmentation Grade 4 = Marked hyperpigmentation involving moderate or large sized areas
  • Hyperpigmentation at Visit 3 [ Time Frame: 2 weeks after PDT #1 ]
    HYPERPIGMENTATION SCALE Grade 0 = No hyperpigmentation Grade 1 = Light hyperpigmentation involving small areas Grade 2 = Moderate hyperpigmentation involving small areas; light hyperpigmentation involving moderate areas Grade 3 = Moderate hyperpigmentation involving moderate sized areas; light hyperpigmentation involving large areas; small areas of marked hyperpigmentation Grade 4 = Marked hyperpigmentation involving moderate or large sized areas
  • Hyperpigmentation at Visit 4 [ Time Frame: 8 weeks after PDT #1 ]
    HYPERPIGMENTATION SCALE Grade 0 = No hyperpigmentation Grade 1 = Light hyperpigmentation involving small areas Grade 2 = Moderate hyperpigmentation involving small areas; light hyperpigmentation involving moderate areas Grade 3 = Moderate hyperpigmentation involving moderate sized areas; light hyperpigmentation involving large areas; small areas of marked hyperpigmentation Grade 4 = Marked hyperpigmentation involving moderate or large sized areas
  • Hyperpigmentation at Visit 5 [ Time Frame: 12 weeks after PDT #1 ]
    HYPERPIGMENTATION SCALE Grade 0 = No hyperpigmentation Grade 1 = Light hyperpigmentation involving small areas Grade 2 = Moderate hyperpigmentation involving small areas; light hyperpigmentation involving moderate areas Grade 3 = Moderate hyperpigmentation involving moderate sized areas; light hyperpigmentation involving large areas; small areas of marked hyperpigmentation Grade 4 = Marked hyperpigmentation involving moderate or large sized areas
  • Hypopigmentation at Baseline [ Time Frame: Baseline ]
    HYPOPIGMENTATION SCALE Grade 0 = No hypopigmentation Grade 1 = Light hypopigmentation involving small areas Grade 2 = Moderate hypopigmentation involving small areas; light hypopigmentation involving moderate areas Grade 3 = Moderate hypopigmentation involving moderate sized areas; light hypopigmentation involving large areas; small areas of marked hypopigmentation
  • Hypopigmentation at Visit 3 [ Time Frame: 2 Weeks after PDT #1 ]
    HYPOPIGMENTATION SCALE Grade 0 = No hypopigmentation Grade 1 = Light hypopigmentation involving small areas Grade 2 = Moderate hypopigmentation involving small areas; light hypopigmentation involving moderate areas Grade 3 = Moderate hypopigmentation involving moderate sized areas; light hypopigmentation involving large areas; small areas of marked hypopigmentation
  • Hypopigmentation at Visit 4 [ Time Frame: 8 Weeks after PDT #1 ]
    HYPOPIGMENTATION SCALE Grade 0 = No hypopigmentation Grade 1 = Light hypopigmentation involving small areas Grade 2 = Moderate hypopigmentation involving small areas; light hypopigmentation involving moderate areas Grade 3 = Moderate hypopigmentation involving moderate sized areas; light hypopigmentation involving large areas; small areas of marked hypopigmentation
  • Hypopigmentation at Visit 5 [ Time Frame: 12 Weeks after PDT #1 ]
    HYPOPIGMENTATION SCALE Grade 0 = No hypopigmentation Grade 1 = Light hypopig

    Original Secondary Outcome:

    • Baseline lesion clearance rate [ Time Frame: Week 12 ]
      Clearance rate for all lesions present at Baseline
    • Baseline lesion clearance rate (Grade 1/2 only) [ Time Frame: Week 8 ]
      Clearance rate for Grade 1/2 lesions present at Baseline
    • Baseline lesion clearance rate [ Time Frame: Week 8 ]
      Clearance rate for all lesions present at Baseline
    • Percent Change in Total AKs [ Time Frame: Baseline and Week 8 ]
    • Percent Change in Total AKs [ Time Frame: Baseline and Week 12 ]
    • Complete Clearance Rate [ Time Frame: Week 8 ]
      proportion of subjects with a count of zero lesions in the treatment area
    • Complete Clearance Rate [ Time Frame: Week 12 ]
      proportion of subjects with a count of zero lesions in the treatment area
    • Complete Clearance Rate (excluding Baseline Grade 3 lesions) [ Time Frame: Week 8 ]
      proportion of subjects with a count of zero lesions in the treatment area. Grade 3 lesions that were present at Baseline are excluded from this count if still present.
    • Complete Clearance Rate (excluding Baseline Grade 3 lesions) [ Time Frame: Week 12 ]
      proportion of subjects with a count of zero lesions in the treatment area. Grade 3 lesions that were present at Baseline are excluded from this count if still present.
    • Partial Clearance Rate [ Time Frame: Baseline and Week 8 ]
      proportion of subjects with 75% or more reduction in the AK count in the Treatment Area as compared to baseline.
    • Partial Clearance Rate [ Time Frame: Baseline and Week 12 ]
      proportion of subjects with 75% or more reduction in the AK count in the Treatment Area as compared to baseline.
    • 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)
    • Hyperpigmentation at Visit 3 [ Time Frame: 2 weeks after PDT #1 ]
      HYPERPIGMENTATION SCALE Grade 0 = No hyperpigmentation Grade 1 = Light hyperpigmentation involving small areas Grade 2 = Moderate hyperpigmentation involving small areas; light hyperpigmentation involving moderate areas Grade 3 = Moderate hyperpigmentation involving moderate sized areas; light hyperpigmentation involving large areas; small areas of marked hyperpigmentation Grade 4 = Marked hyperpigmentation involving moderate or large sized areas
    • Hyperpigmentation at Visit 4 [ Time Frame: 8 weeks after PDT #1 ]
      HYPERPIGMENTATION SCALE Grade 0 = No hyperpigmentation Grade 1 = Light hyperpigmentation involving small areas Grade 2 = Moderate hyperpigmentation involving small areas; light hyperpigmentation involving moderate areas Grade 3 = Moderate hyperpigmentation involving moderate sized areas; light hyperpigmentation involving large areas; small areas of marked hyperpigmentation Grade 4 = Marked hyperpigmentation involving moderate or large sized areas
    • Hyperpigmentation at Visit 5 [ Time Frame: 12 weeks after PDT #1 ]
      HYPERPIGMENTATION SCALE Grade 0 = No hyperpigmentation Grade 1 = Light hyperpigmentation involving small areas Grade 2 = Moderate hyperpigmentation involving small areas; light hyperpigmentation involving moderate areas Grade 3 = Moderate hyperpigmentation involving moderate sized areas; light hyperpigmentation involving large areas; small areas of marked hyperpigmentation Grade 4 = Marked hyperpigmentation involving moderate or large sized areas
    • Hypopigmentation at Visit 3 [ Time Frame: 2 Weeks after PDT #1 ]
      HYPOPIGMENTATION SCALE Grade 0 = No hypopigmentation Grade 1 = Light hypopigmentation involving small areas Grade 2 = Moderate hypopigmentation involving small areas; light hypopigmentation involving moderate areas Grade 3 = Moderate hypopigmentation involving moderate sized areas; light hypopigmentation involving large areas; small areas of marked hypopigmentation Grade 4 = Marked hypopigmentation involving moderate or large sized areas
    • Hypopigmentation at Visit 4 [ Time Frame: 8 Weeks after PDT #1 ]
      HYPOPIGMENTATION SCALE Grade 0 = No hypopigmentation Grade 1 = Light hypopigmentation involving small areas Grade 2 = Moderate hypopigmentation involving small areas; light h

      Information By: DUSA Pharmaceuticals, Inc.

      Dates:
      Date Received: October 21, 2011
      Date Started: November 2011
      Date Completion:
      Last Updated: March 12, 2013
      Last Verified: March 2013