Maximal Use Systemic Exposure (MUSE) Study of Levulan Kerastick

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