MUSE Study of Levulan Kerastick

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 or a
screening lead level above 6μg/dl

- 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