A Multi-Center, Randomized, Double-Blind, Parallel-Group, Vehicle-Controlled Study to Determine the Safety of PEP005 0.0025%, 0.01% and 0.05% Gel With Two Treatment Schedules, Day 1 & 2 or Day 1 & 8 Applications to Actinic Keratoses

Inclusion Criteria:

- Male or female patients

- At least five individual AK lesions on the arms, shoulders, chest, face and/or scalp

Exclusion Criteria:

- A cosmetic or therapeutic procedure:

- within 10 cm of the selected AK lesions during the 3 months prior to study entry
or

- anywhere during the 4 weeks prior to study entry or anticipated treatment during
the study

- Treatment with 5-fluorouracil, imiquimod, diclofenac or photodynamic therapy:

- of lesions located within 10 cm of the selected AK lesions during the 3 months
prior to study entry or

- anywhere during the 4 weeks prior to study entry or anticipated treatment during
the study

- Use of acid-containing products, topical retinoids or light chemical peels within 10
cm of the selected AK lesions during the 3 months prior to study entry, or
anticipated treatment in this same area during the study

- Treatment with immuno-modulators, cytotoxic drugs, or interferon/interferon inducers
during the 4 weeks prior to study entry or anticipated treatment during the study

- Treatment with psoralen plus UVA or use of UVB therapy during the 6 months prior to
study entry or anticipated treatment during the study

- Use of systemic retinoids during the 6 months prior to study entry or anticipated
treatment during the study

- Anticipated excessive or prolonged exposure to ultraviolet light or use of topical
salves, creams or ointments to the selected AK lesions during the study

- Females of childbearing potential