Study to Determine the Safety of PEP005 0.025% and 0.05% Topical Gel in Patients With Actinic Keratoses

Inclusion Criteria

• •Inclusion
• •1. Male patients at least 18 years of age.
• •2. Post-menopausal female patients i.e., no menses for at least 12 consecutive months, or without a uterus.
• •3. 4 to 8 clinically typical, visible and discrete AK lesions within a contiguous 25 cm2 treatment area on the arm, shoulder, chest, back or scalp.
• •4. Screening laboratory values within the reference ranges as defined by the central laboratory or "out of range" test results that are clinically acceptable to the Investigator.
• •5. Ability to follow study instructions and likely to complete all study requirements.
• •6. Written informed consent has been obtained.
• •7. Written Authorization for Use and Release of Health and Research Study Information has been obtained.
• •8. Agreement from the patient to allow photographs of the selected AK treatment area to be taken and used as part of the study data package.
• •Exclusion
• •1. Females of child bearing potential (a female is considered of childbearing potential unless she is postmenopausal, i.e., no menses for at least 12 consecutive months, or is without a uterus).
• •2. Location of the selected AK treatment area:
• •1. anywhere on the face
• •2. within 5 cm of an incompletely healed wound
• •3. on the breast area of women
• •4. on the dorsum of the hand
• •3. AK lesions that have atypical clinical appearance e.g. hypertrophic, hyperkeratotic, recalcitrant disease (had cryosurgery on 2 previous occasions), cutaneous horns within the selected AK treatment area.
• •4. Presence of suspected basal cell carcinoma (BCC) or squamous cell carcinoma (SCC) within the selected AK treatment area or within 10 cm of the selected AK treatment area.
• •5. Presence of known or suspected metastatic disease.
• •6. History or evidence of skin conditions other than AK that would interfere with evaluation of the study drug (e.g. eczema, unstable psoriasis, xeroderma pigmentosa).
• •7. Known sensitivity to any of the ingredients in the study drug.
• •8. A cosmetic or therapeutic procedure (e.g. use of liquid nitrogen, surgical excision, curettage, dermabrasion, medium or greater depth chemical peel, laser resurfacing):
• •* within 2 cm of the selected AK treatment area during the 4 weeks prior to screening visit
• •9. Treatment with 5-fluorouracil, imiquimod, diclofenac, masoprocol or photodynamic therapy:
• •* within 2 cm of the selected AK treatment area during the 24 months prior to screening visit or
• •* anywhere during the 4 weeks prior to screening visit
• •10. Treatment with other immunomodulators (e.g. vinblastine, podophyllin, colhamin, camptothecin), cytotoxic drugs (e.g. cyclophosphamide, azathiopine, chlorambucil, nitrogen mustard, methotrexate), or interferon/ interferon inducers:
• •* within 4 weeks prior to screening visit
• •11. Use of acid-containing therapeutic products (e.g. salicylic acids or fruit acids, such as alpha and beta hydroxy acids and glycolic acids), topical retinoids or light chemical peels:
• •* within 2 cm of the selected AK treatment area during the 4 weeks prior to screening visit
• •12. Treatment with psoralen plus UVA (PUVA) or use of UVB therapy:
• •* anywhere during the 6 months prior to screening visit
• •13. Use of systemic retinoids (e.g. isotretinoin, acitretin, bexarotene):
• •* within 6 months prior to screening visit
• •14. Anticipated excessive or prolonged exposure to ultraviolet light (e.g. sunlight, tanning beds).
• •15. Use of topical salves, artificial tanners or topical steroids:
• •* On the selected AK treatment area during the 4 weeks prior to screening visit