Short-incubation Levulan Photodynamic Therapy Versus Vehicle for Face/Scalp Actinic Keratosis (AK)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
DUSA Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:
NCT01475955
First received: November 15, 2011
Last updated: November 26, 2013
Last verified: November 2013
  Purpose

The purpose of this study is to determine if Levulan Photodynamic Therapy (PDT) is safe and effective in the treatment of actinic keratosis when applied to broad areas on the face and scalp for 1, 2 and 3 hours.


Condition Intervention Phase
Actinic Keratosis
Drug: Broad Area ALA 1-hour incubation
Drug: Broad Area ALA 2 hour incubation
Drug: broad area ALA 3-hour incubation
Drug: Spot ALA 2 hour incubation
Drug: Vehicle PDT
Device: Blue Light Treatment
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase II Study of Photodynamic Therapy With LEVULAN® Topical Solution + Blue Light Versus LEVULAN® Topical Solution Vehicle + Blue Light Using Spot and Broad Area Application and Incubation Times of 1, 2 and 3 Hours for the Treatment of Multiple Actinic Keratoses on the Face or Scalp

Resource links provided by NLM:


Further study details as provided by DUSA Pharmaceuticals, Inc.:

Primary Outcome Measures:
  • Complete Clearance Rate [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
    The proportion of subjects in each treatment group with a count of zero lesions in the Treatment Area


Secondary Outcome Measures:
  • Complete Clearance Rate [ Time Frame: Week 4 ] [ Designated as safety issue: No ]
    The proportion of subjects in each treatment group with a count of zero lesions in the Treatment Area

  • Complete Clearance Rate [ Time Frame: Week 8 ] [ Designated as safety issue: No ]
    The proportion of subjects in each treatment group with a count of zero lesions in the Treatment Area

  • Complete Clearance Rate [ Time Frame: Week 24 ] [ Designated as safety issue: No ]
    the proportion of subjects in each treatment group with a count of zero lesions in the Treatment Area

  • Partial Clearance Rate [ Time Frame: Baseline, Week 4 ] [ Designated as safety issue: No ]
    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, Week 8 ] [ Designated as safety issue: No ]
    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, Week 12 ] [ Designated as safety issue: No ]
    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 Week 24 ] [ Designated as safety issue: No ]
    proportion of subjects with 75% or more reduction in the AK count in the Treatment Area as compared to baseline.

  • AK Clearance Rate [ Time Frame: Baseline, Week 4 ] [ Designated as safety issue: No ]

    AK Clearance Rate (AKCR) for a subject is defined as:

    100% x [1 - (Number of AK lesions in the Treatment Area at follow-up visit/Number of AK lesions in the Treatment Area at Baseline)]


  • AK Clearance Rate [ Time Frame: Baseline, Week 8 ] [ Designated as safety issue: No ]

    AK Clearance Rate (AKCR) for a subject is defined as:

    100% x [1 - (Number of AK lesions in the Treatment Area at follow-up visit/Number of AK lesions in the Treatment Area at Baseline)]


  • AK Clearance Rate [ Time Frame: Baseline, Week 12 ] [ Designated as safety issue: No ]

    AK Clearance Rate (AKCR) for a subject is defined as:

    100% x [1 - (Number of AK lesions in the Treatment Area at follow-up visit/Number of AK lesions in the Treatment Area at Baseline)]


  • AK Clearance Rate [ Time Frame: Baseline, Week 24 ] [ Designated as safety issue: No ]

    AK Clearance Rate (AKCR) for a subject is defined as:

    100% x [1 - (Number of AK lesions in the Treatment Area at follow-up visit/Number of AK lesions in the Treatment Area at Baseline)]


  • Subject Satisfaction Score [ Time Frame: Week 24 ] [ Designated as safety issue: No ]

    0 = no improvement or worsening (not satisfied at all)

    1. = slight improvement (slightly satisfied)
    2. = moderate improvement (moderately satisfied)
    3. = excellent improvement (very satisfied)

  • Hyperpigmentation at Baseline [ Time Frame: Baseline ] [ Designated as safety issue: Yes ]
    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 2 [ Time Frame: 24-48 Hours after PDT #1 ] [ Designated as safety issue: Yes ]
    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: Week 2 ] [ Designated as safety issue: Yes ]
    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: Week 4 ] [ Designated as safety issue: Yes ]
    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: Week 8 ] [ Designated as safety issue: Yes ]
    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 6 [ Time Frame: Week 12 ] [ Designated as safety issue: Yes ]
    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 7 [ Time Frame: Week 24 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    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 2 [ Time Frame: 24-48 Hours after PDT #1 ] [ Designated as safety issue: Yes ]
    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 3 [ Time Frame: Week 2 ] [ Designated as safety issue: Yes ]
    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: Week 4 ] [ Designated as safety issue: Yes ]
    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 5 [ Time Frame: Week 8 ] [ Designated as safety issue: Yes ]
    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 6 [ Time Frame: Week 12 ] [ Designated as safety issue: Yes ]
    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 7 [ Time Frame: Week 24 ] [ Designated as safety issue: Yes ]
    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

  • Erythema at Baseline [ Time Frame: Baseline ] [ Designated as safety issue: Yes ]
    Erythema Scale - Grade 0 = None Grade 1 = Minimal - barely perceptible erythema Grade 2 = Mild - predominantly minimal erythema (pink) in the treated area with or without a few isolated areas of more intense erythema Grade 3 = Moderate - predominantly moderate erythema (red) in the treated area with or without a few isolated areas of intense erythema (bright red) Grade 4 = Severe - predominantly intense erythema (bright red) in the treated area with or without a few isolated areas of very intense (fiery red) erythema

  • Erythema Post-Light Treatment [ Time Frame: 5 minutes after PDT #1 ] [ Designated as safety issue: Yes ]
    Erythema Scale - Grade 0 = None Grade 1 = Minimal - barely perceptible erythema Grade 2 = Mild - predominantly minimal erythema (pink) in the treated area with or without a few isolated areas of more intense erythema Grade 3 = Moderate - predominantly moderate erythema (red) in the treated area with or without a few isolated areas of intense erythema (bright red) Grade 4 = Severe - predominantly intense erythema (bright red) in the treated area with or without a few isolated areas of very intense (fiery red) erythema

  • Erythema at Visit 2 [ Time Frame: 24-48 hours after PDT #1 ] [ Designated as safety issue: Yes ]
    Erythema Scale - Grade 0 = None Grade 1 = Minimal - barely perceptible erythema Grade 2 = Mild - predominantly minimal erythema (pink) in the treated area with or without a few isolated areas of more intense erythema Grade 3 = Moderate - predominantly moderate erythema (red) in the treated area with or without a few isolated areas of intense erythema (bright red) Grade 4 = Severe - predominantly intense erythema (bright red) in the treated area with or without a few isolated areas of very intense (fiery red) erythema

  • Erythema at Visit 3 [ Time Frame: Week 2 ] [ Designated as safety issue: Yes ]
    Erythema Scale - Grade 0 = None Grade 1 = Minimal - barely perceptible erythema Grade 2 = Mild - predominantly minimal erythema (pink) in the treated area with or without a few isolated areas of more intense erythema Grade 3 = Moderate - predominantly moderate erythema (red) in the treated area with or without a few isolated areas of intense erythema (bright red) Grade 4 = Severe - predominantly intense erythema (bright red) in the treated area with or without a few isolated areas of very intense (fiery red) erythema

  • Erythema at Visit 4 [ Time Frame: Week 4 ] [ Designated as safety issue: Yes ]
    Erythema Scale - Grade 0 = None Grade 1 = Minimal - barely perceptible erythema Grade 2 = Mild - predominantly minimal erythema (pink) in the treated area with or without a few isolated areas of more intense erythema Grade 3 = Moderate - predominantly moderate erythema (red) in the treated area with or without a few isolated areas of intense erythema (bright red) Grade 4 = Severe - predominantly intense erythema (bright red) in the treated area with or without a few isolated areas of very intense (fiery red) erythema

  • Erythema at Visit 5 (Pre-drug) [ Time Frame: Week 8 pre-drug ] [ Designated as safety issue: Yes ]
    Erythema Scale - Grade 0 = None Grade 1 = Minimal - barely perceptible erythema Grade 2 = Mild - predominantly minimal erythema (pink) in the treated area with or without a few isolated areas of more intense erythema Grade 3 = Moderate - predominantly moderate erythema (red) in the treated area with or without a few isolated areas of intense erythema (bright red) Grade 4 = Severe - predominantly intense erythema (bright red) in the treated area with or without a few isolated areas of very intense (fiery red) erythema

  • Erythema at Visit 5 (Post-light) [ Time Frame: Week 8 5 minutes post light treatment ] [ Designated as safety issue: Yes ]
    Erythema Scale - Grade 0 = None Grade 1 = Minimal - barely perceptible erythema Grade 2 = Mild - predominantly minimal erythema (pink) in the treated area with or without a few isolated areas of more intense erythema Grade 3 = Moderate - predominantly moderate erythema (red) in the treated area with or without a few isolated areas of intense erythema (bright red) Grade 4 = Severe - predominantly intense erythema (bright red) in the treated area with or without a few isolated areas of very intense (fiery red) erythema

  • Erythema at Visit 6 [ Time Frame: Week 12 ] [ Designated as safety issue: Yes ]
    Erythema Scale - Grade 0 = None Grade 1 = Minimal - barely perceptible erythema Grade 2 = Mild - predominantly minimal erythema (pink) in the treated area with or without a few isolated areas of more intense erythema Grade 3 = Moderate - predominantly moderate erythema (red) in the treated area with or without a few isolated areas of intense erythema (bright red) Grade 4 = Severe - predominantly intense erythema (bright red) in the treated area with or without a few isolated areas of very intense (fiery red) erythema

  • Erythema at Visit 7 [ Time Frame: Week 24 ] [ Designated as safety issue: Yes ]
    Erythema Scale - Grade 0 = None Grade 1 = Minimal - barely perceptible erythema Grade 2 = Mild - predominantly minimal erythema (pink) in the treated area with or without a few isolated areas of more intense erythema Grade 3 = Moderate - predominantly moderate erythema (red) in the treated area with or without a few isolated areas of intense erythema (bright red) Grade 4 = Severe - predominantly intense erythema (bright red) in the treated area with or without a few isolated areas of very intense (fiery red) erythema

  • Edema at Baseline [ Time Frame: Baseline ] [ Designated as safety issue: Yes ]
    EDEMA SCALE Grade 0 = None Grade 1 = Minimal - scant, rare edema Grade 2 = Mild - easily seen edema, minimally palpable, involving up to 1/3 of the treatment area Grade 3 = Moderate - easily seen edema and typically palpable, involving between 1/3 to 2/3 of the treatment area Grade 4 = Severe - easily seen edema, indurated in some areas, involving over 2/3 of the treatment area

  • Edema Post-Light Treatment [ Time Frame: 5 minutes after PDT #1 ] [ Designated as safety issue: Yes ]
    EDEMA SCALE Grade 0 = None Grade 1 = Minimal - scant, rare edema Grade 2 = Mild - easily seen edema, minimally palpable, involving up to 1/3 of the treatment area Grade 3 = Moderate - easily seen edema and typically palpable, involving between 1/3 to 2/3 of the treatment area Grade 4 = Severe - easily seen edema, indurated in some areas, involving over 2/3 of the treatment area

  • Edema at Visit 2 [ Time Frame: 24-48 hours post PDT#1 ] [ Designated as safety issue: Yes ]
    EDEMA SCALE Grade 0 = None Grade 1 = Minimal - scant, rare edema Grade 2 = Mild - easily seen edema, minimally palpable, involving up to 1/3 of the treatment area Grade 3 = Moderate - easily seen edema and typically palpable, involving between 1/3 to 2/3 of the treatment area Grade 4 = Severe - easily seen edema, indurated in some areas, involving over 2/3 of the treatment area

  • Edema at Visit 3 [ Time Frame: Week 2 ] [ Designated as safety issue: Yes ]
    EDEMA SCALE Grade 0 = None Grade 1 = Minimal - scant, rare edema Grade 2 = Mild - easily seen edema, minimally palpable, involving up to 1/3 of the treatment area Grade 3 = Moderate - easily seen edema and typically palpable, involving between 1/3 to 2/3 of the treatment area Grade 4 = Severe - easily seen edema, indurated in some areas, involving over 2/3 of the treatment area

  • Edema at Visit 4 [ Time Frame: Week 4 ] [ Designated as safety issue: Yes ]
    EDEMA SCALE Grade 0 = None Grade 1 = Minimal - scant, rare edema Grade 2 = Mild - easily seen edema, minimally palpable, involving up to 1/3 of the treatment area Grade 3 = Moderate - easily seen edema and typically palpable, involving between 1/3 to 2/3 of the treatment area Grade 4 = Severe - easily seen edema, indurated in some areas, involving over 2/3 of the treatment area

  • Edema at Visit 5 (Pre-drug) [ Time Frame: Week 8 pre-drug ] [ Designated as safety issue: Yes ]
    EDEMA SCALE Grade 0 = None Grade 1 = Minimal - scant, rare edema Grade 2 = Mild - easily seen edema, minimally palpable, involving up to 1/3 of the treatment area Grade 3 = Moderate - easily seen edema and typically palpable, involving between 1/3 to 2/3 of the treatment area Grade 4 = Severe - easily seen edema, indurated in some areas, involving over 2/3 of the treatment area

  • Edema Post PDT #2 [ Time Frame: 5 minutes post PDT #2 ] [ Designated as safety issue: Yes ]
    EDEMA SCALE Grade 0 = None Grade 1 = Minimal - scant, rare edema Grade 2 = Mild - easily seen edema, minimally palpable, involving up to 1/3 of the treatment area Grade 3 = Moderate - easily seen edema and typically palpable, involving between 1/3 to 2/3 of the treatment area Grade 4 = Severe - easily seen edema, indurated in some areas, involving over 2/3 of the treatment area

  • Edema at Week 12 [ Time Frame: Week 12 ] [ Designated as safety issue: Yes ]
    EDEMA SCALE Grade 0 = None Grade 1 = Minimal - scant, rare edema Grade 2 = Mild - easily seen edema, minimally palpable, involving up to 1/3 of the treatment area Grade 3 = Moderate - easily seen edema and typically palpable, involving between 1/3 to 2/3 of the treatment area Grade 4 = Severe - easily seen edema, indurated in some areas, involving over 2/3 of the treatment area

  • Edema at Week 24 [ Time Frame: Week 24 ] [ Designated as safety issue: Yes ]
    EDEMA SCALE Grade 0 = None Grade 1 = Minimal - scant, rare edema Grade 2 = Mild - easily seen edema, minimally palpable, involving up to 1/3 of the treatment area Grade 3 = Moderate - easily seen edema and typically palpable, involving between 1/3 to 2/3 of the treatment area Grade 4 = Severe - easily seen edema, indurated in some areas, involving over 2/3 of the treatment area

  • Stinging/Burning at Baseline [ Time Frame: Baseline ] [ Designated as safety issue: Yes ]
    STINGING AND BURNING SCALE Grade 0 = None Grade 1 = Minimal, barely perceptible -tolerable and little discomfort Grade 2 = Moderate - tolerable, but causes some discomfort Grade 3 = Severe - very uncomfortable or intolerable The most intense stinging/burning sensation during the 16 minute 40 second light treatment will be recorded.

  • Stinging/Burning During Light Treatment [ Time Frame: During PDT #1 (most intense sensation) ] [ Designated as safety issue: Yes ]
    STINGING AND BURNING SCALE Grade 0 = None Grade 1 = Minimal, barely perceptible -tolerable and little discomfort Grade 2 = Moderate - tolerable, but causes some discomfort Grade 3 = Severe - very uncomfortable or intolerable The most intense stinging/burning sensation during the 16 minute 40 second light treatment will be recorded.

  • Stinging/Burning Post Light-Treatment [ Time Frame: 5 minutes post PDT #1 ] [ Designated as safety issue: Yes ]
    STINGING AND BURNING SCALE Grade 0 = None Grade 1 = Minimal, barely perceptible -tolerable and little discomfort Grade 2 = Moderate - tolerable, but causes some discomfort Grade 3 = Severe - very uncomfortable or intolerable The most intense stinging/burning sensation during the 16 minute 40 second light treatment will be recorded.

  • Stinging/Burning at Visit 2 [ Time Frame: 24-48 hours post PDT #1 ] [ Designated as safety issue: Yes ]
    STINGING AND BURNING SCALE Grade 0 = None Grade 1 = Minimal, barely perceptible -tolerable and little discomfort Grade 2 = Moderate - tolerable, but causes some discomfort Grade 3 = Severe - very uncomfortable or intolerable The most intense stinging/burning sensation during the 16 minute 40 second light treatment will be recorded.

  • Stinging/Burning at Visit 3 [ Time Frame: Week 2 ] [ Designated as safety issue: Yes ]
    STINGING AND BURNING SCALE Grade 0 = None Grade 1 = Minimal, barely perceptible -tolerable and little discomfort Grade 2 = Moderate - tolerable, but causes some discomfort Grade 3 = Severe - very uncomfortable or intolerable The most intense stinging/burning sensation during the 16 minute 40 second light treatment will be recorded.

  • Stinging/Burning at Visit 4 [ Time Frame: Week 4 ] [ Designated as safety issue: Yes ]
    STINGING AND BURNING SCALE Grade 0 = None Grade 1 = Minimal, barely perceptible -tolerable and little discomfort Grade 2 = Moderate - tolerable, but causes some discomfort Grade 3 = Severe - very uncomfortable or intolerable The most intense stinging/burning sensation during the 16 minute 40 second light treatment will be recorded.

  • Stinging/Burning at Visit 5 (Pre-drug) [ Time Frame: Week 8 prior to drug ] [ Designated as safety issue: Yes ]
    STINGING AND BURNING SCALE Grade 0 = None Grade 1 = Minimal, barely perceptible -tolerable and little discomfort Grade 2 = Moderate - tolerable, but causes some discomfort Grade 3 = Severe - very uncomfortable or intolerable The most intense stinging/burning sensation during the 16 minute 40 second light treatment will be recorded.

  • Stinging/Burning at Visit 5 During PDT#2 [ Time Frame: during PDT #2 ] [ Designated as safety issue: Yes ]
    STINGING AND BURNING SCALE Grade 0 = None Grade 1 = Minimal, barely perceptible -tolerable and little discomfort Grade 2 = Moderate - tolerable, but causes some discomfort Grade 3 = Severe - very uncomfortable or intolerable The most intense stinging/burning sensation during the 16 minute 40 second light treatment will be recorded.

  • Stinging/Burning at Visit 5 Post PDT#2 [ Time Frame: 5 minutes post PDT #2 ] [ Designated as safety issue: Yes ]
    STINGING AND BURNING SCALE Grade 0 = None Grade 1 = Minimal, barely perceptible -tolerable and little discomfort Grade 2 = Moderate - tolerable, but causes some discomfort Grade 3 = Severe - very uncomfortable or intolerable The most intense stinging/burning sensation during the 16 minute 40 second light treatment will be recorded.

  • Stinging/Burning at Visit 6 [ Time Frame: Week 12 ] [ Designated as safety issue: Yes ]
    STINGING AND BURNING SCALE Grade 0 = None Grade 1 = Minimal, barely perceptible -tolerable and little discomfort Grade 2 = Moderate - tolerable, but causes some discomfort Grade 3 = Severe - very uncomfortable or intolerable The most intense stinging/burning sensation during the 16 minute 40 second light treatment will be recorded.

  • Stinging/Burning at Visit 7 [ Time Frame: Week 24 ] [ Designated as safety issue: Yes ]
    STINGING AND BURNING SCALE Grade 0 = None Grade 1 = Minimal, barely perceptible -tolerable and little discomfort Grade 2 = Moderate - tolerable, but causes some discomfort Grade 3 = Severe - very uncomfortable or intolerable The most intense stinging/burning sensation during the 16 minute 40 second light treatment will be recorded.

  • Scaling and Dryness at Baseline [ Time Frame: Baseline ] [ Designated as safety issue: Yes ]
    SCALING AND DRYNESS SCALE Grade 0 = None Grade 1 = Minimal - barely perceptible desquamation Grade 2 = Mild - limited areas of fine desquamation in up to 1/3 of the treatment area Grade 3 = Moderate - fine desquamation involving 1/3 to 2/3 of the treatment area or limited areas of coarser scaling Grade 4 = Severe - coarser scaling involving more than 2/3 of the treatment area or limited areas of very coarse scaling

  • Scaling and Dryness at Visit 2 [ Time Frame: 24-48 hours after PDT #1 ] [ Designated as safety issue: Yes ]
    SCALING AND DRYNESS SCALE Grade 0 = None Grade 1 = Minimal - barely perceptible desquamation Grade 2 = Mild - limited areas of fine desquamation in up to 1/3 of the treatment area Grade 3 = Moderate - fine desquamation involving 1/3 to 2/3 of the treatment area or limited areas of coarser scaling Grade 4 = Severe - coarser scaling involving more than 2/3 of the treatment area or limited areas of very coarse scaling

  • Scaling and Dryness at Visit 3 [ Time Frame: Week 2 ] [ Designated as safety issue: Yes ]
    SCALING AND DRYNESS SCALE Grade 0 = None Grade 1 = Minimal - barely perceptible desquamation Grade 2 = Mild - limited areas of fine desquamation in up to 1/3 of the treatment area Grade 3 = Moderate - fine desquamation involving 1/3 to 2/3 of the treatment area or limited areas of coarser scaling Grade 4 = Severe - coarser scaling involving more than 2/3 of the treatment area or limited areas of very coarse scaling

  • Scaling and Dryness at Visit 4 [ Time Frame: Week 4 ] [ Designated as safety issue: Yes ]
    SCALING AND DRYNESS SCALE Grade 0 = None Grade 1 = Minimal - barely perceptible desquamation Grade 2 = Mild - limited areas of fine desquamation in up to 1/3 of the treatment area Grade 3 = Moderate - fine desquamation involving 1/3 to 2/3 of the treatment area or limited areas of coarser scaling Grade 4 = Severe - coarser scaling involving more than 2/3 of the treatment area or limited areas of very coarse scaling

  • Scaling and Dryness at Visit 5 [ Time Frame: Week 8 ] [ Designated as safety issue: Yes ]
    SCALING AND DRYNESS SCALE Grade 0 = None Grade 1 = Minimal - barely perceptible desquamation Grade 2 = Mild - limited areas of fine desquamation in up to 1/3 of the treatment area Grade 3 = Moderate - fine desquamation involving 1/3 to 2/3 of the treatment area or limited areas of coarser scaling Grade 4 = Severe - coarser scaling involving more than 2/3 of the treatment area or limited areas of very coarse scaling

  • Scaling and Dryness at Visit 6 [ Time Frame: Week 12 ] [ Designated as safety issue: Yes ]
    SCALING AND DRYNESS SCALE Grade 0 = None Grade 1 = Minimal - barely perceptible desquamation Grade 2 = Mild - limited areas of fine desquamation in up to 1/3 of the treatment area Grade 3 = Moderate - fine desquamation involving 1/3 to 2/3 of the treatment area or limited areas of coarser scaling Grade 4 = Severe - coarser scaling involving more than 2/3 of the treatment area or limited areas of very coarse scaling

  • Scaling and Dryness at Visit 7 [ Time Frame: Week 24 ] [ Designated as safety issue: Yes ]
    SCALING AND DRYNESS SCALE Grade 0 = None Grade 1 = Minimal - barely perceptible desquamation Grade 2 = Mild - limited areas of fine desquamation in up to 1/3 of the treatment area Grade 3 = Moderate - fine desquamation involving 1/3 to 2/3 of the treatment area or limited areas of coarser scaling Grade 4 = Severe - coarser scaling involving more than 2/3 of the treatment area or limited areas of very coarse scaling

  • Oozing/Vesiculation/Crusting at Baseline [ Time Frame: Baseline ] [ Designated as safety issue: Yes ]
    OOZING/VESICULATION/CRUSTING Grade 0 = None Grade 1 = Minimal - a single area of oozing, vesiculation or crusting 3 mm diameter or less in size Grade 2 = Mild - two to four areas of oozing, vesiculation or crusting 3 mm diameter or less in size OR a single area larger than 3 mm diameter in size Grade 3 = Moderate - more than a single area of oozing, vesiculation or crusting larger than 3 mm diameter in size or more than four areas of 3 mm diameter or less in size Grade 4 = Severe - any degree of oozing, vesiculation or crusting greater than (3) above

  • Oozing/Vesiculation/Crusting at Visit 2 [ Time Frame: 24-48 hours after PDT #1 ] [ Designated as safety issue: Yes ]
    OOZING/VESICULATION/CRUSTING Grade 0 = None Grade 1 = Minimal - a single area of oozing, vesiculation or crusting 3 mm diameter or less in size Grade 2 = Mild - two to four areas of oozing, vesiculation or crusting 3 mm diameter or less in size OR a single area larger than 3 mm diameter in size Grade 3 = Moderate - more than a single area of oozing, vesiculation or crusting larger than 3 mm diameter in size or more than four areas of 3 mm diameter or less in size Grade 4 = Severe - any degree of oozing, vesiculation or crusting greater than (3) above

  • Oozing/Vesiculation/Crusting at Visit 3 [ Time Frame: Week 2 ] [ Designated as safety issue: Yes ]
    OOZING/VESICULATION/CRUSTING Grade 0 = None Grade 1 = Minimal - a single area of oozing, vesiculation or crusting 3 mm diameter or less in size Grade 2 = Mild - two to four areas of oozing, vesiculation or crusting 3 mm diameter or less in size OR a single area larger than 3 mm diameter in size Grade 3 = Moderate - more than a single area of oozing, vesiculation or crusting larger than 3 mm diameter in size or more than four areas of 3 mm diameter or less in size Grade 4 = Severe - any degree of oozing, vesiculation or crusting greater than (3) above

  • Oozing/Vesiculation/Crusting at Visit 4 [ Time Frame: Week 4 ] [ Designated as safety issue: Yes ]
    OOZING/VESICULATION/CRUSTING Grade 0 = None Grade 1 = Minimal - a single area of oozing, vesiculation or crusting 3 mm diameter or less in size Grade 2 = Mild - two to four areas of oozing, vesiculation or crusting 3 mm diameter or less in size OR a single area larger than 3 mm diameter in size Grade 3 = Moderate - more than a single area of oozing, vesiculation or crusting larger than 3 mm diameter in size or more than four areas of 3 mm diameter or less in size Grade 4 = Severe - any degree of oozing, vesiculation or crusting greater than (3) above

  • Oozing/Vesiculation/Crusting at Visit 5 [ Time Frame: Week 8 ] [ Designated as safety issue: Yes ]
    OOZING/VESICULATION/CRUSTING Grade 0 = None Grade 1 = Minimal - a single area of oozing, vesiculation or crusting 3 mm diameter or less in size Grade 2 = Mild - two to four areas of oozing, vesiculation or crusting 3 mm diameter or less in size OR a single area larger than 3 mm diameter in size Grade 3 = Moderate - more than a single area of oozing, vesiculation or crusting larger than 3 mm diameter in size or more than four areas of 3 mm diameter or less in size Grade 4 = Severe - any degree of oozing, vesiculation or crusting greater than (3) above

  • Oozing/Vesiculation/Crusting at Visit 6 [ Time Frame: Week 12 ] [ Designated as safety issue: Yes ]
    OOZING/VESICULATION/CRUSTING Grade 0 = None Grade 1 = Minimal - a single area of oozing, vesiculation or crusting 3 mm diameter or less in size Grade 2 = Mild - two to four areas of oozing, vesiculation or crusting 3 mm diameter or less in size OR a single area larger than 3 mm diameter in size Grade 3 = Moderate - more than a single area of oozing, vesiculation or crusting larger than 3 mm diameter in size or more than four areas of 3 mm diameter or less in size Grade 4 = Severe - any degree of oozing, vesiculation or crusting greater than (3) above

  • Oozing/Vesiculation/Crusting at Visit 7 [ Time Frame: Week 24 ] [ Designated as safety issue: Yes ]
    OOZING/VESICULATION/CRUSTING Grade 0 = None Grade 1 = Minimal - a single area of oozing, vesiculation or crusting 3 mm diameter or less in size Grade 2 = Mild - two to four areas of oozing, vesiculation or crusting 3 mm diameter or less in size OR a single area larger than 3 mm diameter in size Grade 3 = Moderate - more than a single area of oozing, vesiculation or crusting larger than 3 mm diameter in size or more than four areas of 3 mm diameter or less in size Grade 4 = Severe - any degree of oozing, vesiculation or crusting greater than (3) above


Enrollment: 235
Study Start Date: December 2011
Study Completion Date: November 2012
Primary Completion Date: November 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Broad Area ALA 1-hour incubation
Broad Area ALA 1-hour incubation
Drug: Broad Area ALA 1-hour incubation
20% ALA, broad area, 1 hour incubation
Other Name: Levulan
Device: Blue Light Treatment
10 J/cm2 blue light delivered at 10 mW/cm2
Other Name: BLU-U
Experimental: Broad Area ALA 2-hour incubation
Broad Area ALA 2-hour incubation
Drug: Broad Area ALA 2 hour incubation
20% ALA broad area 2-hour incubation
Other Name: Levulan
Device: Blue Light Treatment
10 J/cm2 blue light delivered at 10 mW/cm2
Other Name: BLU-U
Experimental: Broad Area ALA 3-hour incubation
Broad Area ALA 3-hour incubation
Drug: broad area ALA 3-hour incubation
20% ALA broad area 3 hour incubation
Other Name: Levulan
Device: Blue Light Treatment
10 J/cm2 blue light delivered at 10 mW/cm2
Other Name: BLU-U
Experimental: Spot ALA 2-hour incubation
Spot ALA 2-hour incubation
Drug: Spot ALA 2 hour incubation
20% ALA spot 2 hour incubation
Other Name: Levulan
Device: Blue Light Treatment
10 J/cm2 blue light delivered at 10 mW/cm2
Other Name: BLU-U
Placebo Comparator: Vehicle PDT
VEH group will be randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment. Subjects receiving VEH will be considered a single treatment group.
Drug: Vehicle PDT
Levulan Kerastick containing vehicle ingredients only.VEH group will be randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment. Subjects receiving VEH will be considered a single treatment group.
Device: Blue Light Treatment
10 J/cm2 blue light delivered at 10 mW/cm2
Other Name: BLU-U

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 6-20 Grade 1/2 AKs on the face or scalp
  • a history of AK therapy within the treatment area at least twice in the two years prior to study entry

Exclusion Criteria:

  • Pregnancy
  • Grade 3 AKs or atypical AKs (e.g., AK > 1 cm2 in size) within the Treatment Area
  • lesions suspicious for skin cancer (skin cancer not ruled out by biopsy) or untreated skin cancers within the Treatment Area
  • plans to be exposed to artificial tanning devices or excessive sunlight during the trial
  • Subject is immunosuppressed
  • unsuccessful outcome from previous ALA-PDT therapy
  • history of cutaneous photosensitization, porphyria, hypersensitivity to porphyrins or photodermatosis
  • skin pathology or condition which could interfere with the evaluation of the test product or requires the use of interfering topical or systemic therapy
  • skin pathology or condition that could interfere with the evaluation of the test product or requires the use of interfering topical or systemic therapy
  • any condition which would make it unsafe for the subject to participate in this research study
  • currently enrolled in an investigational drug or device study
  • has received an investigational drug or been treated with an investigational device within 30 days prior to the initiation of treatment
  • known sensitivity to one or more of the vehicle components (ethyl alcohol, isopropyl alcohol, laureth 4, polyethylene glycol)
  • Subject has;

    • an active herpes simplex infection OR
    • a history of 2 or more outbreaks within the past 12 months, in the Treatment Area
  • use of the following topical preparations on the extremities to be treated:

    • Keratolytics including urea (greater than 5%), alpha hydroxyacids [e.g.glycolic acid, lactic acid, etc. greater than 5%], salicylic acid (greater than 2%) within 2 days of initiation of treatment.
    • Cryotherapy within 2 weeks of initiation of treatment
    • Retinoids, including tazarotene, adapalene, tretinoin, retinol, within 4 weeks of initiation of treatment.
    • Microdermabrasion, laser ablative treatments, ALA-PDT, chemical peels, 5-FU, diclofenac, imiquimod or other topical treatments for AK within 8 weeks of initiation of treatment.
    • Two or more ALA PDT treatments in the past 6 months
  • use of systemic retinoid therapy within 6 months of initiation of treatment.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01475955

Locations
United States, California
UCSD Dermatology Perlman Ambulatory Clinic
La Jolla, California, United States, 92037
Dermatology Research Associates
Los Angeles, California, United States, 90045
Therapeutics Clinical Research
San Diego, California, United States, 92123
United States, Idaho
Northwest Clinical Trials, Inc.
Boise, Idaho, United States, 83704
United States, Illinois
Altman Dermatology Associates
Arlington Heights, Illinois, United States, 60005
United States, Indiana
The Indiana Clinical Trials Center, PC
Plainfield, Indiana, United States, 46168
United States, Minnesota
Minnesota Clinical Study Center
Fridley, Minnesota, United States, 55432
United States, Ohio
Dermatology Research Center of Cincinnati
Cincinnati, Ohio, United States, 45220
United States, Oregon
Oregon Medical Research Center, PC
Portland, Oregon, United States, 97223
United States, Tennessee
Tennessee Clinical Research Center
Nashville, Tennessee, United States, 37215
United States, Texas
DermResearch, Inc.
Austin, Texas, United States, 78759
Suzanne Bruce and Associates, P.A.,The Center for Skin Research
Houston, Texas, United States, 77056
United States, Virginia
Virginia Clinical Research Inc
Norfolk, Virginia, United States, 23507
Sponsors and Collaborators
DUSA Pharmaceuticals, Inc.
Investigators
Study Director: Stuart Marcus, MD, PhD DUSA Pharmaceuticals, Inc.
  More Information

No publications provided

Responsible Party: DUSA Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT01475955     History of Changes
Other Study ID Numbers: CP0105
Study First Received: November 15, 2011
Results First Received: September 20, 2013
Last Updated: November 26, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Keratosis
Keratosis, Actinic
Skin Diseases
Precancerous Conditions
Neoplasms
Aminolevulinic Acid
Photosensitizing Agents
Radiation-Sensitizing Agents
Physiological Effects of Drugs
Pharmacologic Actions
Dermatologic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on July 20, 2014