Study to Determine the Safety of Two Applications of PEP005 Topical Gel to Actinic Keratoses

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

The purpose of this study is to determine whether topical application of PEP005 is safe for the treatment of 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