Short-incubation Levulan Photodynamic Therapy Versus Vehicle for Face/Scalp Actinic Keratosis (AK)
Condition: Actinic Keratosis
MeSH terms: Keratosis, Actinic; Keratosis
Intervention: Broad Area ALA 1-hour incubation; Broad Area ALA 2 hour incubation; broad area ALA 3-hour incubation; Spot ALA 2 hour incubation; Vehicle PDT; Blue Light Treatment
Intervention description: 20% ALA, broad area, 1 hour incubation; 20% ALA broad area 2-hour incubation; 20% ALA broad area 3 hour incubation; 20% ALA spot 2 hour incubation; Levulan Kerastick containing vehicle ingredients only.VEH group will be randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment. Subjects receiving VEH will be considered a single treatment group.; 10 J/cm2 blue light delivered at 10 mW/cm2
Intervention MeSH terms: Aminolevulinic Acid
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Enrollment: 235.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

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

Eligibility criteria:

        Inclusion Criteria:

          -  6-20 Grade 1/2 AKs on the face or scalp

          -  a history of AK therapy within the treatment area at least twice in the two years
             prior to study entry

        Exclusion Criteria:

          -  Pregnancy

          -  Grade 3 AKs or atypical AKs (e.g., AK > 1 cm2 in size) within the Treatment Area

          -  lesions suspicious for skin cancer (skin cancer not ruled out by biopsy) or untreated
             skin cancers within the Treatment Area

          -  plans to be exposed to artificial tanning devices or excessive sunlight during the
             trial

          -  Subject is immunosuppressed

          -  unsuccessful outcome from previous ALA-PDT therapy

          -  history of cutaneous photosensitization, porphyria, hypersensitivity to porphyrins or
             photodermatosis

          -  skin pathology or condition which could interfere with the evaluation of the test
             product or requires the use of interfering topical or systemic therapy

          -  skin pathology or condition that could interfere with the evaluation of the test
             product or requires the use of interfering topical or systemic therapy

          -  any condition which would make it unsafe for the subject to participate in this
             research study

          -  currently enrolled in an investigational drug or device study

          -  has received an investigational drug or been treated with an investigational device
             within 30 days prior to the initiation of treatment

          -  known sensitivity to one or more of the vehicle components (ethyl alcohol, isopropyl
             alcohol, laureth 4, polyethylene glycol)

          -  Subject has;

               -  an active herpes simplex infection OR

               -  a history of 2 or more outbreaks within the past 12 months, in the Treatment Area

          -  use of the following topical preparations on the extremities to be treated:

               -  Keratolytics including urea (greater than 5%), alpha hydroxyacids [e.g.glycolic
                  acid, lactic acid, etc. greater than 5%], salicylic acid (greater than 2%) within
                  2 days of initiation of treatment.

               -  Cryotherapy within 2 weeks of initiation of treatment

               -  Retinoids, including tazarotene, adapalene, tretinoin, retinol, within 4 weeks of
                  initiation of treatment.

               -  Microdermabrasion, laser ablative treatments, ALA-PDT, chemical peels, 5-FU,
                  diclofenac, imiquimod or other topical treatments for AK within 8 weeks of
                  initiation of treatment.

               -  Two or more ALA PDT treatments in the past 6 months

          -  use of systemic retinoid therapy within 6 months of initiation of treatment.