A Multicenter Study to Evaluate the Efficacy and Safety of PEP005 (Ingenol Mebutate) Gel When Used to Treat Actinic Keratoses (AKs) on the Non Head Locations

A Multi-center, Randomized, Parallel Group, Double-blind, Vehicle-controlled Study to Evaluate the Efficacy and Safety of PEP005 (Ingenol Mebutate) Gel, 0.05% In Patients With Actinic Keratoses ON Non-head Locations (REGION-I)

The purpose of this study is to determine whether topical application of PEP005 is effective for the treatment of actinic keratoses.

Inclusion Criteria:

• Must be male or female and at least 18 years of age.
• Female patients must be of:
• Non-childbearing potential;
• Childbearing potential, provided negative serum and urine pregnancy test and using effective contraception.
• 4 to 8 AK lesions on non-head locations.

Exclusion Criteria:

• Cosmetic or therapeutic procedures within 2 weeks and within 2 cm of the selected treatment area.
• Treatment with immunomodulators, or interferon/ interferon inducers or systemic medications that suppress the immune system within 4 weeks.
• Treatment with 5-FU, imiquimod, diclofenac, or photodynamic therapy within 8 weeks and 2 cm of treatment area