Clinical Trial: Controlled Study of the Occurrence of Actinic Keratosis on the Face After Cryotherapy + ALA Photodynamic Therapy

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

Official Title: A Phase 2 Study Comparing the Occurrence of Actinic Keratoses on the Face in High-Risk Individuals After Cryotherapy + Photodynamic Therapy With Levulan Topical Solution +

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 face, following treatment with liquid nitrogen cryotherapy.

Detailed Summary:
Sponsor: DUSA Pharmaceuticals, Inc.

Current Primary Outcome: Total Number of AKs in Treatment Area [ Time Frame: Week 52 ]

proportion of subjects in each treatment group with a count of zero lesions in the Treatment Area, normalized based upon any lesions present at baseline.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Proportion of Subjects with 0 AKs [ Time Frame: Week 4 ]
    Normalized, based on number of lesions present at Baseline
  • Subject Satisfaction Score [ Time Frame: Week 52 ]

    Subject satisfaction score

    1. = Excellent (very satisfied)
    2. = Good (moderately satisfied)
    3. = Fair (slightly satisfied)
    4. = Poor (not satisfied at all)
  • Proportion of Subjects with 0 AKs [ Time Frame: Week 12 ]
    Normalized, based on number of lesions present at Baseline
  • Proportion of Subjects with 0 AKs [ Time Frame: Week 24 ]
    Normalized, based on number of lesions present at Baseline
  • Proportion of Subjects with 0 AKs [ Time Frame: Week 36 ]
    Normalized, based on number of lesions present at Baseline
  • Proportion of Subjects with 0 AKs [ Time Frame: Week 52 ]
    Normalized, based on number of lesions present at Baseline
  • Recurrence Rate [ Time Frame: Week 52 ]
    Recurrence rate of all lesions that were complete responses following on-study cryotherapy (at Visit 3/Baseline).
  • Recurrence Rate (Grade 1/2) [ Time Frame: Week 52 ]
    Recurrence rate of the subset of Grade 1 and Grade 2 lesions that were complete responses following on-study cryotherapy (at Visit 3/Baseline).
  • Duration of Response [ Time Frame: within 52 weeks after Baseline ]
    Duration of response is the elapsed number of weeks from the Baseline visit until a lesion recurred or Week 52, whichever comes first


Original Secondary Outcome: Same as current

Information By: DUSA Pharmaceuticals, Inc.

Dates:
Date Received: September 10, 2014
Date Started: September 2014
Date Completion:
Last Updated: September 22, 2016
Last Verified: September 2016