Levulan PDT Versus Vehicle for Extremity Actinic Keratoses (AK)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
DUSA Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:
NCT01458587
First received: October 21, 2011
Last updated: March 12, 2013
Last verified: March 2013
  Purpose

The purpose of this study is to determine if Levulan PDT is safe and effective in the treatment of actinic keratoses on the upper arms and hands.


Condition Intervention Phase
Keratosis, Actinic
Drug: Aminolevulinic Acid PDT (ALA)
Drug: Vehicle PDT (VEH)
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 (PDT)With LEVULAN® Topical Solution + Blue Light Versus LEVULAN® Topical Solution Vehicle + Blue Light for the Treatment of Actinic Keratoses on the Upper Extremities

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Lesion Clearance Rate [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
    Clearance rate for all lesions


Secondary Outcome Measures:
  • Lesion Clearance Rate [ Time Frame: Week 8 ] [ Designated as safety issue: No ]
  • Complete Clearance Rate [ Time Frame: Week 8 ] [ Designated as safety issue: No ]
    proportion of subjects with a count of zero lesions in the treatment area

  • Complete Clearance Rate [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
    proportion of subjects with a count of zero lesions in the treatment area

  • Partial Clearance Rate [ Time Frame: Baseline and 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 and 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.

  • Subject Satisfaction Score [ Time Frame: Week 12 ] [ Designated as safety issue: No ]

    Subject satisfaction score

    1. = Excellent (very satisfied)
    2. = Good (moderately satisfied)
    3. = Fair (slightly satisfied)
    4. = Poor (not satisfied at all)

  • Hyperpigmentation at Baseline [ Time Frame: Baseline ] [ 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: 2 weeks 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 4 [ Time Frame: 8 weeks 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 5 [ Time Frame: 12 weeks 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

  • 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

  • Hypopigmentation at Visit 3 [ Time Frame: 2 Weeks 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

  • Hypopigmentation at Visit 4 [ Time Frame: 8 Weeks 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

  • Hypopigmentation at Visit 5 [ Time Frame: 12 Weeks 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

  • 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 3 [ Time Frame: 2 Weeks 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 4 [ Time Frame: 8 Weeks 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 5 [ Time Frame: 12 Weeks 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

  • 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 3 [ Time Frame: 2 Weeks 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 4 [ Time Frame: 8 Weeks 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 5 [ Time Frame: 12 Weeks 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

  • 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

  • Stinging/Burning During Light Treatment [ Time Frame: During 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

  • Stinging/Burning Post Light Treatment [ Time Frame: 5 minutes after 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

  • Stinging/Burning at Visit 3 [ Time Frame: 2 Weeks after 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

  • Stinging/Burning at Visit 4 [ Time Frame: 8 Weeks after 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

  • Stinging/Burning at Visit 5 [ Time Frame: 12 Weeks after 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

  • 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 3 [ Time Frame: 2 Weeks Post 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 4 [ Time Frame: 8 Weeks Post 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 5 [ Time Frame: 12 Weeks Post 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

  • 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 3 [ Time Frame: Week 2 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 4 [ Time Frame: 8 Weeks 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 5 [ Time Frame: 12 Weeks 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


Enrollment: 70
Study Start Date: November 2011
Study Completion Date: July 2012
Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: ALA Drug: Aminolevulinic Acid PDT (ALA)
20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light
Other Name: Levulan Kerastick
Placebo Comparator: Vehicle Drug: Vehicle PDT (VEH)
Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to upper extremities 3 hours prior to 10 J/cm2 blue light

  Eligibility

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

Inclusion Criteria:

  • At least 4 Grade 1/2 AKs on each upper extremity

Exclusion Criteria:

  • Pregnancy
  • history of cutaneous photosensitization, porphyria, hypersensitivity to porphyrins or photodermatosis
  • lesions suspicious for skin cancer (skin cancer not ruled out by biopsy) or untreated skin cancers within the Treatment Area
  • skin pathology or condition which could interfere with the evaluation of the test product or requires the use of interfering topical or systemic therapy
  • Subject is immunosuppressed
  • unsuccessful outcome from previous ALA-PDT therapy
  • 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)
  • 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: NCT01458587

Locations
United States, California
Therapeutics Clinical Research
San Diego, California, United States, 92123
United States, Florida
Park Avenue Dermatology, PA
Orange Park, Florida, United States, 32073
United States, Texas
DermResearch, Inc
Austin, Texas, United States, 78759
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: NCT01458587     History of Changes
Other Study ID Numbers: CP0106
Study First Received: October 21, 2011
Results First Received: December 21, 2012
Last Updated: March 12, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by DUSA Pharmaceuticals, Inc.:
Actinic keratosis

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

ClinicalTrials.gov processed this record on August 28, 2014