Maximal Use Systemic Exposure Study of Levulan Kerastick (MUSE 2)
Condition: Keratosis, Actinic
MeSH terms: Keratosis, Actinic; Keratosis
Intervention: Aminolevulinic Acid (ALA); BLU-U
Intervention description: 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light; 10 J/cm2 of 417 nm blue light delivered at 10 mW/cm2
Intervention MeSH terms: Aminolevulinic Acid
Phase: Phase 2
Study type: Interventional
Primary purpose: Other
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 14.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Actinic keratosis

Summary:

      The purpose of this study is to evaluate the potential for systemic exposure of
      aminolevulinic acid (ALA) and protoporphyrin IX (PpIX) when applied topically under
      occlusion, in a maximal use setting in patients with multiple actinic keratoses (AK)
      involving the upper extremities.
    

Eligibility criteria:

        Inclusion Criteria:

          -  At least 6 Grade 1/2 AKs on one upper extremity AND

          -  At least 12 Grade 1/2 AKs on the OTHER 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

          -  Body Mass Index (BMI) > 32.0 kg/m2

          -  skin pathology or condition which could interfere with the evaluation of the test
             product or requires the use of interfering topical or systemic therapy

          -  significant blood loss within 60 days or donated blood/plasma within 72 hours prior to
             Visit 2 (Baseline)

          -  tested positive at screening for human immunodeficiency virus (HIV) or was known to be
             seropositive for HIV

          -  a history of lead poisoning or a history of a significant exposure to lead

          -  tested positive at screening for hepatitis B surface antigen, hepatitis C antibody or
             had a history of a positive result

          -  positive drug screen at Screening

          -  Screening safety labs are clinically significant in the opinion of the investigator

          -  major surgery within 30 days prior to Visit 2 (Baseline) or plans to have surgery
             during the study

          -  Subject is immunosuppressed

          -  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 Visit 2 (Baseline)

          -  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

          -  use of systemic retinoid therapy within 6 months of initiation of treatment