PEP005 Gel - Biological Effects in Actinic Keratosis Assessed by Reflectance Confocal Microscopy

Inclusion Criteria

• Male or female subjects at least 18 years of age
• Subjects with AK lesions and subclinical AK lesions within a contiguous 25 cm2 area on the upper extremity
• Subjects must have a 25 cm2 area of normal skin on the inner upper arm
• Female subjects must be of either: • Non-childbearing potential, post-menopausal, or have a confirmed clinical history of sterility or • Childbearing potential, with a confirmed negative urine pregnancy test prior to exposure.
• Female subjects of childbearing potential must be willing to consent to using high effective methods of contraception
• Ability to follow trial instructions and likely to complete all trial requirements
• Obtained written informed consent prior to any trial-related procedures

Exclusion Criteria

• Location of the selected treatment areas: • Within 5 cm of an incompletely healed wound or infected area of the skin • Within 10 cm of a suspected basal cell carcinoma (BCC) or squamous cell carcinoma(SCC)
• History or evidence of skin conditions other than the trial indication that would interfere with evaluation of the investigational product
• 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 during the course of the trial, as determined by Investigator clinical judgment
• Anticipated need for in-patient hospitalisation or in-patient surgery during the trial 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
• Previous enrolment in this clinical trial
• Prohibited Therapies and/or Medications 2 weeks prior to the Screening visit within 2 cm of selected treatment area:•Cosmetic or therapeutic procedures •Use of acid-containing therapeutic products • Use of topical salves or topical steroids
• Prohibited Therapies and/or Medications: within 4 weeks prior to the Screening visit: • Treatment with immunomodulators, cytotoxic drugs or interferon/interferon inducers,systemic medications that suppress the immune system, or with UVB
• Prohibited Therapies and/or Medications: within 8 weeks prior to the Screening visit: • Treatment with 5-FU, imiquimod, diclofenac, or photodynamic therapy: within 2 cm of the selected treatment areas.
• Use of systemic retinoids