A Sequential Treatment Regimen of Cryotherapy and Picato® for the Treatment of Actinic Keratosis on the Face and Scalp

Inclusion Criteria: * Subjects must be competent to understand the nature of the trial and provide informed consent. * Subjects with 4 to 8 clinically typical, visible and discrete AKs within a contiguous 25 cm2 treatment area on the face or scalp. * Subject at least 18 years of age. * Female subjects must be of either: * Non-childbearing potential, i.e. post-menopausal or have a confirmed clinical history of sterility (e.g. the subject is without a uterus) or, * Childbearing potential, provided there is a confirmed negative urine pregnancy test prior to study treatment, to rule out pregnancy. * Female subjects of childbearing potential must be willing to use effective contraception. Exclusion Criteria: * Location of the selected treatment area: * on any location other than the face or scalp * within 5 cm of an incompletely healed wound * within 10 cm of a suspected basal cell carcinoma (BCC) or SCC * Prior treatment with PEP005 Gel on face or scalp. * Selected treatment area lesions that have: * atypical clinical appearance and/or * recalcitrant disease * History or evidence of skin conditions other than the trial indication that would interfere with evaluation of the trial medication * Clinical diagnosis/history or evidence of any medical condition that would expose a subject to an undue risk of a significant AE or interfere with assessments of safety and efficacy. * Any abnormal vital signs measurements that are medically significant or would impact the safety of the subject or the interpretation of the trial results. * Anticipated need for hospitalization or out-patient surgery during the first 15 days after the first trial medication application. * Known sensitivity or allergy to any of the ingredients in PEP005 Gel * Recent excessive exposure to ultraviolet light * Current enrolment or participation in a clinical trial within 30 days of entry into this study * Subjects previously randomised in the trial * Female subjects who are breastfeeding Prohibited Therapies and/or Medications within 2 weeks prior to Visit 1 * Cosmetic or therapeutic procedures within 2 cm of the selected treatment area * Use of acid-containing therapeutic products within 2 cm of the selected treatment area * Use of topical medicated creams, ointments, lotions, gels, foams or sprays Prohibited Therapies and/or Medications: within 4 weeks prior to visit 1: * Treatment with immunomodulators, cytotoxic drugs or inter-feron /interferon inducers * Treatment with systemic medications that suppress the immune system * Treatment/therapy with ultraviolet light A (UVA) or ultraviolet light B (UVB). Prohibited Therapies and/or Medications within 8 weeks prior to visit 1: * Treatment with 5-FU, imiquimod, diclofenac sodium, or photodynamic therapy: within 2 cm of the selected treatment area. Prohibited Therapies and/or Medications within 6 months prior to visit 1 * Use of systemic retinoids or biologic / mono-clonal antibody therapies