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