PEP005 Gel - Biological Effects in Actinic Keratosis Assessed by Histology

Inclusion criteria

• Male or female patients at least 18 years of age
• Patients with AK lesions within a contiguous 25 cm2 area on the upper extremity
• Patients with a 25 cm2 area of normal skin on the upper inner arm
• Female subjects must be of either non-childbearing potential or childbearing potential, provided there is a confirmed negative urine pregnancy test prior to exposure, to rule out pregnancy
• Female subjects of childbearing potential must be willing to consent to using high effective methods of contraception
• Ability to follow study instructions and likely to complete all study requirements
• Obtained written informed consent prior to any study-related procedures

Exclusion criteria

• Location of the selected treatment areas within 5 cm of an incompletely healed wound within 10 cm of a suspected basal cell carcinoma (BCC) or squamous cell carcinoma (SCC)
• History or evidence of skin conditions other than the study indication that would interfere with evaluation of the study 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, as determined by Investigator clinical judgment.
• Anticipated need for in-patient hospitalisation or in-patient surgery during the study period.
• Current participation in any other interventional clinical trial
• Subjects who have received treatment with any non-marketed drug product within the last two months
• Subject known or, in the opinion of the investigator, is unlikely to comply with the Clinical Study Protocol
• Females who are pregnant, of child-bearing potential and wishing to become pregnant during the trial, or are breast feeding
• Undergone cosmetic or therapeutic procedures within 2 cm of the selected treatment areas in the 2 weeks prior to the screening visit
• Use of acid-containing therapeutic products within 2 cm of the selected treatment areas in the 2 weeks prior to the screening visit
• Use of topical salves/topical steroids: within 2 cm of the selected treatment areas in the 2 weeks prior to the screening visit
• Treatment with immunomodulators, cytotoxic drugs or interferon/interferon inducers, systemic medications that suppress the immune system or UVB in the last 4 weeks
• Treatment with 5-FU, imiquimod, diclofenac, or photodynamic therapy: within 2 cm of the selected treatment areas within 8 weeks prior to any screening visit
• Use of systemic retinoids