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

Inclusion Criteria:

* Four to fifteen AKs on the face
* histologically confirmed presence of abnormal architecture and satellite atypical keratinocytes in the epidermis, in clinically normal tissue samples of photodamaged skin adjacent to AKs
* at least one previously treated nonmelanoma skin cancer (NMSC) on the head and/or neck area within the past five years

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