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