Safety and Efficacy Study of Photodynamic Therapy With Levulan Kerastick + Blue Light for Actinic Keratoses on the Upper Extremities
Condition: Actinic Keratosis
MeSH terms: Keratosis, Actinic; Keratosis
Intervention: Aminolevulinic Acid (ALA); Topical Solution Vehicle; Blue Light Photodynamic Therapy Illuminator (BLU-U)
Intervention description: 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light; Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to upper extremities 3 hours prior to 10 J/cm2 blue light; 10 J/cm2 blue light delivered at 10mW/cm2
Intervention MeSH terms: Aminolevulinic Acid
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Enrollment: 269.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Actinic Keratosis

Summary:

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

Eligibility criteria:

        Inclusion Criteria:

          -  Four to fifteen Grade 1/2 actinic keratosis lesions (AKs) on one upper extremity

        Exclusion Criteria:

          -  Pregnancy

          -  grade 3 and/or atypical >1cm AKs within Treatment Area

          -  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 extremity 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, within 4 weeks of
                  initiation of treatment.

               -  Microdermabrasion, laser ablative treatments, ALA-PDT, chemical peels, 5-FU,
                  diclofenac, ingenol mebutate, imiquimod or other topical treatments for AK within
                  8 weeks of initiation of treatment.

          -  use of systemic retinoid therapy within 6 months of initiation of treatment.