Controlled Study of the Occurrence of Actinic Keratosis on the Face After Cryotherapy + Aminolevulinic Acid (ALA) Photodynamic Therapy

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
• •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)
• •has an active herpes simplex infection OR a history of 2 or more outbreaks within the past 12 months, on the face
• •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
• •* Retinoids, including tazarotene, adapalene, tretinoin, within 4 weeks
• •* Microdermabrasion, laser ablative treatments, ALA-PDT, chemical peels, 5-fluorouracil (5-FU), diclofenac, ingenol mebutate, imiquimod or other topical treatments for AK within 8 weeks
• •use of systemic retinoid therapy within 6 months