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 ]
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
- = Excellent (very satisfied)
- = Good (moderately satisfied)
- = Fair (slightly satisfied)
- = 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
- = Excellent (very satisfied)
- = Good (moderately satisfied)
- = Fair (slightly satisfied)
- = 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
- Baseline lesion clearance rate [ Time Frame: Week 12 ]