<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03024060</url>
  </required_header>
  <id_info>
    <org_study_id>CP0114</org_study_id>
    <nct_id>NCT03024060</nct_id>
  </id_info>
  <brief_title>Phase 3 Study of Levulan With New Blue Light for AK on the Face or Scalp</brief_title>
  <official_title>A RANDOMIZED, VEHICLE-CONTROLLED PHASE 3 STUDY TO PROVE THE SAFETY AND EFFICACY OF LEVULAN KERASTICK (AMINOLEVULINIC ACID HCl) FOR TOPICAL SOLUTION, 20% AND 10 J/CM2 OF BLUE LIGHT DELIVERED AT 10 MW/CM2 OR 20 MW/CM2 BY A NEW LIGHT SOURCE FOR THE TREATMENT OF ACTINIC KERATOSES ON THE FACE OR SCALP</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>DUSA Pharmaceuticals, Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>DUSA Pharmaceuticals, Inc.</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
    <is_unapproved_device>Yes</is_unapproved_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to prove the safety and efficacy of Levulan Kerastick&#xD;
      (aminolevulinic acid HCl) for Topical Solution 20% followed by 10 J/cm2 of blue light&#xD;
      delivered at 10 mW/cm2 or 20 mW/cm2 in the treatment of multiple actinic keratosis on the&#xD;
      face or balding scalp (the Treatment Area), utilizing a 14-18 hour incubation period.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    Study withdrawn due to corporate business decision&#xD;
  </why_stopped>
  <start_date type="Anticipated">March 2017</start_date>
  <completion_date type="Anticipated">January 2018</completion_date>
  <primary_completion_date type="Anticipated">September 2017</primary_completion_date>
  <phase>Phase 3</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Participant, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Complete Clearance Rate</measure>
    <time_frame>Week 12</time_frame>
    <description>proportion of subjects in each treatment group with 100% clearance of Baseline target lesions</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Baseline AK Clearance Rate</measure>
    <time_frame>Baseline and Week 12</time_frame>
    <description>{1 - [(number of Baseline target AK lesions at follow-up)/(number of Baseline target AK lesions at Baseline)]} x 100</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Baseline AK Clearance Rate</measure>
    <time_frame>Baseline and Week 8</time_frame>
    <description>{1 - [(number of Baseline target AK lesions at follow-up)/(number of Baseline target AK lesions at Baseline)]} x 100</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Complete Clearance Rate</measure>
    <time_frame>Week 8</time_frame>
    <description>proportion of subjects in each treatment group with 100% clearance of Baseline target lesions</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Baseline AK Clearance Rate</measure>
    <time_frame>Baseline and Week 4</time_frame>
    <description>{1 - [(number of Baseline target AK lesions at follow-up)/(number of Baseline target AK lesions at Baseline)]} x 100&#xD;
= Excellent (very satisfied)&#xD;
= Good (moderately satisfied)&#xD;
= Fair (slightly satisfied)&#xD;
= Poor (not satisfied at all)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Complete Clearance Rate</measure>
    <time_frame>Week 4</time_frame>
    <description>proportion of subjects in each treatment group with 100% clearance of Baseline target lesions</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Hyperpigmentation</measure>
    <time_frame>Baseline</time_frame>
    <description>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</description>
  </other_outcome>
  <other_outcome>
    <measure>Hyperpigmentation</measure>
    <time_frame>14-18 hours after Baseline - prior to light treatment</time_frame>
    <description>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</description>
  </other_outcome>
  <other_outcome>
    <measure>Hyperpigmentation</measure>
    <time_frame>24 hours after PDT #1</time_frame>
    <description>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</description>
  </other_outcome>
  <other_outcome>
    <measure>Hyperpigmentation</measure>
    <time_frame>2 Weeks after PDT #1</time_frame>
    <description>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</description>
  </other_outcome>
  <other_outcome>
    <measure>Hyperpigmentation</measure>
    <time_frame>4 Weeks after PDT #1</time_frame>
    <description>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</description>
  </other_outcome>
  <other_outcome>
    <measure>Hyperpigmentation</measure>
    <time_frame>8 Weeks after PDT #1</time_frame>
    <description>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</description>
  </other_outcome>
  <other_outcome>
    <measure>Hyperpigmentation</measure>
    <time_frame>14-18 hours post Visit 6 (8 Weeks after PDT #1) prior to light treatment</time_frame>
    <description>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</description>
  </other_outcome>
  <other_outcome>
    <measure>Hyperpigmentation</measure>
    <time_frame>12 Weeks after PDT #1</time_frame>
    <description>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</description>
  </other_outcome>
  <other_outcome>
    <measure>Hypopigmentation</measure>
    <time_frame>Baseline</time_frame>
    <description>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</description>
  </other_outcome>
  <other_outcome>
    <measure>Hypopigmentation</measure>
    <time_frame>14-18 hours after Baseline - prior to light treatment</time_frame>
    <description>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</description>
  </other_outcome>
  <other_outcome>
    <measure>Hypopigmentation</measure>
    <time_frame>24 hours after PDT #1</time_frame>
    <description>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</description>
  </other_outcome>
  <other_outcome>
    <measure>Hypopigmentation</measure>
    <time_frame>2 Weeks after PDT #1</time_frame>
    <description>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</description>
  </other_outcome>
  <other_outcome>
    <measure>Hypopigmentation</measure>
    <time_frame>4 Weeks after PDT #1</time_frame>
    <description>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</description>
  </other_outcome>
  <other_outcome>
    <measure>Hypopigmentation</measure>
    <time_frame>8 Weeks after PDT #1</time_frame>
    <description>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</description>
  </other_outcome>
  <other_outcome>
    <measure>Hypopigmentation</measure>
    <time_frame>14-18 hours post Visit 6 (8 Weeks after PDT #1) prior to light treatment</time_frame>
    <description>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</description>
  </other_outcome>
  <other_outcome>
    <measure>Hypopigmentation</measure>
    <time_frame>12 Weeks after PDT #1</time_frame>
    <description>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</description>
  </other_outcome>
  <other_outcome>
    <measure>Erythema</measure>
    <time_frame>Baseline</time_frame>
    <description>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</description>
  </other_outcome>
  <other_outcome>
    <measure>Erythema</measure>
    <time_frame>14-18 hours after Baseline - prior to light treatment</time_frame>
    <description>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</description>
  </other_outcome>
  <other_outcome>
    <measure>Erythema</measure>
    <time_frame>5 minutes after PDT #1</time_frame>
    <description>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</description>
  </other_outcome>
  <other_outcome>
    <measure>Erythema</measure>
    <time_frame>24 hours after PDT #1</time_frame>
    <description>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</description>
  </other_outcome>
  <other_outcome>
    <measure>Erythema</measure>
    <time_frame>2 Weeks after PDT #1</time_frame>
    <description>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</description>
  </other_outcome>
  <other_outcome>
    <measure>Erythema</measure>
    <time_frame>4 Weeks after PDT #1</time_frame>
    <description>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</description>
  </other_outcome>
  <other_outcome>
    <measure>Erythema</measure>
    <time_frame>8 Weeks after PDT #1</time_frame>
    <description>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</description>
  </other_outcome>
  <other_outcome>
    <measure>Erythema</measure>
    <time_frame>14-18 hours post Visit 6 (8 Weeks after PDT #1) prior to light treatment</time_frame>
    <description>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</description>
  </other_outcome>
  <other_outcome>
    <measure>Erythema</measure>
    <time_frame>5 minutes after PDT #2</time_frame>
    <description>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</description>
  </other_outcome>
  <other_outcome>
    <measure>Erythema</measure>
    <time_frame>12 Weeks after PDT #1</time_frame>
    <description>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</description>
  </other_outcome>
  <other_outcome>
    <measure>Edema</measure>
    <time_frame>Baseline</time_frame>
    <description>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</description>
  </other_outcome>
  <other_outcome>
    <measure>Edema</measure>
    <time_frame>14-18 hours after Baseline - prior to light treatment</time_frame>
    <description>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</description>
  </other_outcome>
  <other_outcome>
    <measure>Edema</measure>
    <time_frame>5 minutes after PDT #1</time_frame>
    <description>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</description>
  </other_outcome>
  <other_outcome>
    <measure>Edema</measure>
    <time_frame>24 hours after PDT #1</time_frame>
    <description>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</description>
  </other_outcome>
  <other_outcome>
    <measure>Edema</measure>
    <time_frame>2 weeks after PDT #1</time_frame>
    <description>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</description>
  </other_outcome>
  <other_outcome>
    <measure>Edema</measure>
    <time_frame>4 Weeks after PDT #1</time_frame>
    <description>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</description>
  </other_outcome>
  <other_outcome>
    <measure>Edema</measure>
    <time_frame>8 Weeks after PDT #1</time_frame>
    <description>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</description>
  </other_outcome>
  <other_outcome>
    <measure>Edema</measure>
    <time_frame>14-18 hours after Visit 6 (8 Weeks after PDT #1) prior to light treatment</time_frame>
    <description>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</description>
  </other_outcome>
  <other_outcome>
    <measure>Edema</measure>
    <time_frame>5 minutes after PDT #2</time_frame>
    <description>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</description>
  </other_outcome>
  <other_outcome>
    <measure>Edema</measure>
    <time_frame>12 Weeks after PDT #1</time_frame>
    <description>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</description>
  </other_outcome>
  <other_outcome>
    <measure>Stinging/Burning</measure>
    <time_frame>Baseline</time_frame>
    <description>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</description>
  </other_outcome>
  <other_outcome>
    <measure>Stinging/Burning</measure>
    <time_frame>14-18 hours after Baseline - prior to light treatment</time_frame>
    <description>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</description>
  </other_outcome>
  <other_outcome>
    <measure>Stinging/Burning</measure>
    <time_frame>During PDT #1</time_frame>
    <description>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</description>
  </other_outcome>
  <other_outcome>
    <measure>Stinging/Burning</measure>
    <time_frame>5 minutes after PDT #1</time_frame>
    <description>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</description>
  </other_outcome>
  <other_outcome>
    <measure>Stinging/Burning</measure>
    <time_frame>2 Weeks after PDT #1</time_frame>
    <description>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</description>
  </other_outcome>
  <other_outcome>
    <measure>Stinging/Burning</measure>
    <time_frame>4 Weeks after PDT #1</time_frame>
    <description>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</description>
  </other_outcome>
  <other_outcome>
    <measure>Stinging/Burning</measure>
    <time_frame>14-18 hours after Visit 6 (8 Weeks after PDT #1) prior to light treatment</time_frame>
    <description>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</description>
  </other_outcome>
  <other_outcome>
    <measure>Stinging/Burning</measure>
    <time_frame>during PDT #2</time_frame>
    <description>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</description>
  </other_outcome>
  <other_outcome>
    <measure>Stinging/Burning</measure>
    <time_frame>5 minutes post PDT #2</time_frame>
    <description>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</description>
  </other_outcome>
  <other_outcome>
    <measure>Stinging/Burning</measure>
    <time_frame>12 Weeks after PDT #1</time_frame>
    <description>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</description>
  </other_outcome>
  <other_outcome>
    <measure>Scaling &amp; Dryness</measure>
    <time_frame>Baseline</time_frame>
    <description>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</description>
  </other_outcome>
  <other_outcome>
    <measure>Scaling &amp; Dryness</measure>
    <time_frame>14-18 hours after Baseline - prior to light treatment</time_frame>
    <description>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</description>
  </other_outcome>
  <other_outcome>
    <measure>Scaling &amp; Dryness</measure>
    <time_frame>24 hours after PDT #1</time_frame>
    <description>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</description>
  </other_outcome>
  <other_outcome>
    <measure>Scaling &amp; Dryness</measure>
    <time_frame>2 Weeks after PDT #1</time_frame>
    <description>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</description>
  </other_outcome>
  <other_outcome>
    <measure>Scaling &amp; Dryness</measure>
    <time_frame>4 Weeks after PDT #1</time_frame>
    <description>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</description>
  </other_outcome>
  <other_outcome>
    <measure>Scaling &amp; Dryness</measure>
    <time_frame>8 Weeks after PDT #1</time_frame>
    <description>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</description>
  </other_outcome>
  <other_outcome>
    <measure>Scaling &amp; Dryness</measure>
    <time_frame>14-18 hours after Visit 6 (8 Weeks after PDT #1) prior to light treatment</time_frame>
    <description>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</description>
  </other_outcome>
  <other_outcome>
    <measure>Scaling &amp; Dryness</measure>
    <time_frame>12 Weeks after PDT #1</time_frame>
    <description>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</description>
  </other_outcome>
  <other_outcome>
    <measure>Oozing/Vesiculation/Crusting</measure>
    <time_frame>Baseline</time_frame>
    <description>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</description>
  </other_outcome>
  <other_outcome>
    <measure>Oozing/Vesiculation/Crusting</measure>
    <time_frame>14-18 hours after Baseline - prior to light treatment</time_frame>
    <description>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</description>
  </other_outcome>
  <other_outcome>
    <measure>Oozing/Vesiculation/Crusting</measure>
    <time_frame>24 hours after PDT #1</time_frame>
    <description>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</description>
  </other_outcome>
  <other_outcome>
    <measure>Oozing/Vesiculation/Crusting</measure>
    <time_frame>2 Weeks after PDT #1</time_frame>
    <description>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</description>
  </other_outcome>
  <other_outcome>
    <measure>Oozing/Vesiculation/Crusting</measure>
    <time_frame>4 Weeks after PDT #1</time_frame>
    <description>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</description>
  </other_outcome>
  <other_outcome>
    <measure>Oozing/Vesiculation/Crusting</measure>
    <time_frame>8 Weeks after PDT #1</time_frame>
    <description>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</description>
  </other_outcome>
  <other_outcome>
    <measure>Oozing/Vesiculation/Crusting</measure>
    <time_frame>14-18 hours after Visit 6 (8 Weeks after PDT #1) prior to light treatment</time_frame>
    <description>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</description>
  </other_outcome>
  <other_outcome>
    <measure>Oozing/Vesiculation/Crusting</measure>
    <time_frame>12 Weeks after PDT #1</time_frame>
    <description>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</description>
  </other_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">0</enrollment>
  <condition>Actinic Keratosis</condition>
  <arm_group>
    <arm_group_label>ALA 20 mW</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>ALA + IBL 10J at 20 mW (8min 20 sec)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>ALA 10 mW</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>ALA + IBL 10J at 10 mW (16 min 40 sec)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Vehicle</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Vehicle (VEH) group will be randomized (1:1) to be balanced for the two active groups; receiving light treatment delivered at 20 mW/cm2 OR 10 mW/cm2. Subjects receiving VEH will be considered a single treatment group</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>ALA</intervention_name>
    <description>20% ALA applied to 4-15 lesions on the face or scalp 14-18 hours prior to 10 J/cm2 blue light</description>
    <arm_group_label>ALA 10 mW</arm_group_label>
    <arm_group_label>ALA 20 mW</arm_group_label>
    <other_name>Levulan Kerastick</other_name>
    <other_name>Aminolevulinic Acid</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Vehicle</intervention_name>
    <description>Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to 4-15 lesions on the face or scalp 14-18 hours prior to 10 J/cm2 blue light</description>
    <arm_group_label>Vehicle</arm_group_label>
    <other_name>Topical Solution Vehicle</other_name>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>IBL 20 mW</intervention_name>
    <description>10 J/cm2 blue light delivered at 20mW/cm2 for 8 minutes 20 seconds</description>
    <arm_group_label>ALA 20 mW</arm_group_label>
    <arm_group_label>Vehicle</arm_group_label>
    <other_name>Investigational Blue Light</other_name>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>IBL 10 mW</intervention_name>
    <description>10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds</description>
    <arm_group_label>ALA 10 mW</arm_group_label>
    <arm_group_label>Vehicle</arm_group_label>
    <other_name>Investigational Blue Light</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Four to fifteen Grade 1/2 actinic keratosis lesions (AKs) on the face OR balding scalp&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Pregnancy&#xD;
&#xD;
          -  grade 3 and/or atypical &gt;1cm AKs within Treatment Area and/or more than 15 AKs of any&#xD;
             Grade within the Treatment Area&#xD;
&#xD;
          -  history of cutaneous photosensitization, porphyria, hypersensitivity to porphyrins or&#xD;
             photodermatosis&#xD;
&#xD;
          -  lesions suspicious for skin cancer (skin cancer not ruled out by biopsy) or untreated&#xD;
             skin cancers within the Treatment Area&#xD;
&#xD;
          -  skin pathology or condition which could interfere with the evaluation of the test&#xD;
             product or requires the use of interfering topical or systemic therapy&#xD;
&#xD;
          -  Subject is immunosuppressed&#xD;
&#xD;
          -  unsuccessful outcome from previous ALA-PDT therapy&#xD;
&#xD;
          -  currently enrolled in an investigational drug or device study&#xD;
&#xD;
          -  has received an investigational drug or been treated with an investigational device&#xD;
             within 30 days prior to the initiation of treatment&#xD;
&#xD;
          -  known sensitivity to one or more of the vehicle components (ethyl alcohol, isopropyl&#xD;
             alcohol, laureth 4, polyethylene glycol)&#xD;
&#xD;
          -  has active herpes simplex infection in the Treatment Area OR a history of 2 or more&#xD;
             outbreaks within past 12 months, in the Treatment Area&#xD;
&#xD;
          -  use of the following topical preparations on the extremity to be treated:&#xD;
&#xD;
               -  Keratolytics including urea (greater than 5%), alpha hydroxyacids [e.g.glycolic&#xD;
                  acid, lactic acid, etc. greater than 5%], salicylic acid (greater than 2%) within&#xD;
                  2 days of initiation of treatment.&#xD;
&#xD;
               -  Curettage or Cryotherapy within 2 weeks of initiation of treatment&#xD;
&#xD;
               -  Retinoids, including tazarotene, adapalene, tretinoin, within 4 weeks of&#xD;
                  initiation of treatment.&#xD;
&#xD;
               -  Microdermabrasion, laser ablative treatments, ALA-PDT, chemical peels, 5-FU,&#xD;
                  diclofenac, ingenol mebutate, imiquimod or other topical treatments for AK within&#xD;
                  8 weeks of initiation of treatment.&#xD;
&#xD;
          -  use of systemic retinoid therapy within 6 months of initiation of treatment.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Stuart Marcus, MD, PhD</last_name>
    <role>Study Director</role>
    <affiliation>DUSA Pharmaceuticals, Inc.</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Therapeutics Clinical Research</name>
      <address>
        <city>San Diego</city>
        <state>California</state>
        <zip>92123</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Altman Dermatology Associates</name>
      <address>
        <city>Arlington Heights</city>
        <state>Illinois</state>
        <zip>60005</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Shideler Clinical Research Center</name>
      <address>
        <city>Carmel</city>
        <state>Indiana</state>
        <zip>46032</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Indiana Clinical Trials Center, PC</name>
      <address>
        <city>Plainfield</city>
        <state>Indiana</state>
        <zip>46168</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Minnesota Clinical Study Center</name>
      <address>
        <city>Fridley</city>
        <state>Minnesota</state>
        <zip>55432</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>DermResearch, Inc.</name>
      <address>
        <city>Austin</city>
        <state>Texas</state>
        <zip>78759</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Virginia Clinical Research, Inc.</name>
      <address>
        <city>Norfolk</city>
        <state>Virginia</state>
        <zip>23507</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>November 2017</verification_date>
  <study_first_submitted>January 13, 2017</study_first_submitted>
  <study_first_submitted_qc>January 13, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 18, 2017</study_first_posted>
  <last_update_submitted>November 3, 2017</last_update_submitted>
  <last_update_submitted_qc>November 3, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">November 7, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Actinic Keratosis</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Keratosis, Actinic</mesh_term>
    <mesh_term>Keratosis</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Aminolevulinic Acid</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03024060
org study id: CP0114
nct id: NCT03024060
lead sponsor: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: Yes
is unapproved device: Yes
The purpose of this study is to prove the safety and efficacy of Levulan Kerastick
      (aminolevulinic acid HCl) for Topical Solution 20% followed by 10 J/cm2 of blue light
      delivered at 10 mW/cm2 or 20 mW/cm2 in the treatment of multiple actinic keratosis on the
      face or balding scalp (the Treatment Area), utilizing a 14-18 hour incubation period.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Outcomes Assessor)
measure: Complete Clearance Rate
time frame: Week 12
description: proportion of subjects in each treatment group with 100% clearance of Baseline target lesions
measure: Baseline AK Clearance Rate
time frame: Baseline and Week 12
description: {1 - [(number of Baseline target AK lesions at follow-up)/(number of Baseline target AK lesions at Baseline)]} x 100
measure: Baseline AK Clearance Rate
time frame: Baseline and Week 8
description: {1 - [(number of Baseline target AK lesions at follow-up)/(number of Baseline target AK lesions at Baseline)]} x 100
measure: Complete Clearance Rate
time frame: Week 8
description: proportion of subjects in each treatment group with 100% clearance of Baseline target lesions
measure: Baseline AK Clearance Rate
time frame: Baseline and Week 4
description: {1 - [(number of Baseline target AK lesions at follow-up)/(number of Baseline target AK lesions at Baseline)]} x 100
= Excellent (very satisfied)
= Good (moderately satisfied)
= Fair (slightly satisfied)
= Poor (not satisfied at all)
measure: Complete Clearance Rate
time frame: Week 4
description: proportion of subjects in each treatment group with 100% clearance of Baseline target lesions
measure: Hyperpigmentation
time frame: Baseline
description: 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
measure: Hyperpigmentation
time frame: 14-18 hours after Baseline - prior to light treatment
description: 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
measure: Hyperpigmentation
time frame: 24 hours after PDT #1
description: 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
measure: Hyperpigmentation
time frame: 2 Weeks after PDT #1
description: 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
measure: Hyperpigmentation
time frame: 4 Weeks after PDT #1
description: 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
measure: Hyperpigmentation
time frame: 8 Weeks after PDT #1
description: 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
measure: Hyperpigmentation
time frame: 14-18 hours post Visit 6 (8 Weeks after PDT #1) prior to light treatment
description: 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
measure: Hyperpigmentation
time frame: 12 Weeks after PDT #1
description: 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
measure: Hypopigmentation
time frame: Baseline
description: 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
measure: Hypopigmentation
time frame: 14-18 hours after Baseline - prior to light treatment
description: 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
measure: Hypopigmentation
time frame: 24 hours after PDT #1
description: 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
measure: Hypopigmentation
time frame: 2 Weeks after PDT #1
description: 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
measure: Hypopigmentation
time frame: 4 Weeks after PDT #1
description: 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
measure: Hypopigmentation
time frame: 8 Weeks after PDT #1
description: 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
measure: Hypopigmentation
time frame: 14-18 hours post Visit 6 (8 Weeks after PDT #1) prior to light treatment
description: 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
measure: Hypopigmentation
time frame: 12 Weeks after PDT #1
description: 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
measure: Erythema
time frame: Baseline
description: 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
measure: Erythema
time frame: 14-18 hours after Baseline - prior to light treatment
description: 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
measure: Erythema
time frame: 5 minutes after PDT #1
description: 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
measure: Erythema
time frame: 24 hours after PDT #1
description: 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
measure: Erythema
time frame: 2 Weeks after PDT #1
description: 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
measure: Erythema
time frame: 4 Weeks after PDT #1
description: 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
measure: Erythema
time frame: 8 Weeks after PDT #1
description: 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
measure: Erythema
time frame: 14-18 hours post Visit 6 (8 Weeks after PDT #1) prior to light treatment
description: 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
measure: Erythema
time frame: 5 minutes after PDT #2
description: 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
measure: Erythema
time frame: 12 Weeks after PDT #1
description: 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
measure: Edema
time frame: Baseline
description: 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
measure: Edema
time frame: 14-18 hours after Baseline - prior to light treatment
description: 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
measure: Edema
time frame: 5 minutes after PDT #1
description: 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
measure: Edema
time frame: 24 hours after PDT #1
description: 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
measure: Edema
time frame: 2 weeks after PDT #1
description: 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
measure: Edema
time frame: 4 Weeks after PDT #1
description: 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
measure: Edema
time frame: 8 Weeks after PDT #1
description: 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
measure: Edema
time frame: 14-18 hours after Visit 6 (8 Weeks after PDT #1) prior to light treatment
description: 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
measure: Edema
time frame: 5 minutes after PDT #2
description: 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
measure: Edema
time frame: 12 Weeks after PDT #1
description: 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
measure: Stinging/Burning
time frame: Baseline
description: 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
measure: Stinging/Burning
time frame: 14-18 hours after Baseline - prior to light treatment
description: 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
measure: Stinging/Burning
time frame: During PDT #1
description: 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
measure: Stinging/Burning
time frame: 5 minutes after PDT #1
description: 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
measure: Stinging/Burning
time frame: 2 Weeks after PDT #1
description: 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
measure: Stinging/Burning
time frame: 4 Weeks after PDT #1
description: 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
measure: Stinging/Burning
time frame: 14-18 hours after Visit 6 (8 Weeks after PDT #1) prior to light treatment
description: 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
measure: Stinging/Burning
time frame: during PDT #2
description: 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
measure: Stinging/Burning
time frame: 5 minutes post PDT #2
description: 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
measure: Stinging/Burning
time frame: 12 Weeks after PDT #1
description: 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
measure: Scaling & Dryness
time frame: Baseline
description: 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
measure: Scaling & Dryness
time frame: 14-18 hours after Baseline - prior to light treatment
description: 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
measure: Scaling & Dryness
time frame: 24 hours after PDT #1
description: 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
measure: Scaling & Dryness
time frame: 2 Weeks after PDT #1
description: 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
measure: Scaling & Dryness
time frame: 4 Weeks after PDT #1
description: 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
measure: Scaling & Dryness
time frame: 8 Weeks after PDT #1
description: 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
measure: Scaling & Dryness
time frame: 14-18 hours after Visit 6 (8 Weeks after PDT #1) prior to light treatment
description: 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
measure: Scaling & Dryness
time frame: 12 Weeks after PDT #1
description: 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
measure: Oozing/Vesiculation/Crusting
time frame: Baseline
description: 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
measure: Oozing/Vesiculation/Crusting
time frame: 14-18 hours after Baseline - prior to light treatment
description: 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
measure: Oozing/Vesiculation/Crusting
time frame: 24 hours after PDT #1
description: 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
measure: Oozing/Vesiculation/Crusting
time frame: 2 Weeks after PDT #1
description: 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
measure: Oozing/Vesiculation/Crusting
time frame: 4 Weeks after PDT #1
description: 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
measure: Oozing/Vesiculation/Crusting
time frame: 8 Weeks after PDT #1
description: 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
measure: Oozing/Vesiculation/Crusting
time frame: 14-18 hours after Visit 6 (8 Weeks after PDT #1) prior to light treatment
description: 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
measure: Oozing/Vesiculation/Crusting
time frame: 12 Weeks after PDT #1
description: 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
arm group label: ALA 20 mW
arm group type: Experimental
description: ALA + IBL 10J at 20 mW (8min 20 sec)
arm group label: ALA 10 mW
arm group type: Experimental
description: ALA + IBL 10J at 10 mW (16 min 40 sec)
arm group label: Vehicle
arm group type: Placebo Comparator
description: Vehicle (VEH) group will be randomized (1:1) to be balanced for the two active groups; receiving light treatment delivered at 20 mW/cm2 OR 10 mW/cm2. Subjects receiving VEH will be considered a single treatment group
intervention type: Drug
intervention name: ALA
description: 20% ALA applied to 4-15 lesions on the face or scalp 14-18 hours prior to 10 J/cm2 blue light
arm group label: ALA 10 mW
arm group label: ALA 20 mW
other name: Levulan Kerastick
other name: Aminolevulinic Acid
intervention type: Drug
intervention name: Vehicle
description: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to 4-15 lesions on the face or scalp 14-18 hours prior to 10 J/cm2 blue light
arm group label: Vehicle
other name: Topical Solution Vehicle
intervention type: Device
intervention name: IBL 20 mW
description: 10 J/cm2 blue light delivered at 20mW/cm2 for 8 minutes 20 seconds
arm group label: ALA 20 mW
arm group label: Vehicle
other name: Investigational Blue Light
intervention type: Device
intervention name: IBL 10 mW
description: 10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds
arm group label: ALA 10 mW
arm group label: Vehicle
other name: Investigational Blue Light
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Stuart Marcus, MD, PhD
role: Study Director
affiliation: DUSA Pharmaceuticals, Inc.
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: United States
responsible party type: Sponsor
mesh term: Keratosis, Actinic
mesh term: Keratosis
mesh term: Aminolevulinic Acid
sharing ipd: No