Histological Confirmation of Clinical Clearance of Actinic Keratoses Following Treatment With Ingenol Mebutate Gel, 0.05%

Inclusion criteria

• Must be male or female and at least 18 years of age.
• Female patients must be on non-childbearing potential or if of childbearing potential then negative serum and urine pregnancy test and using effective contraception
• Ability to provide informed consent
• Subjects must have 5-9 clinically typical, visible and discrete AK lesions within a contiguous 25cm2 treatment area on the trunk and extremities except the back of the hand
• AK should be confirmed by histopathology of one of the AK's prior to inclusion

Exclusion criteria

• location of the selected treatment area within 5cm of an incompletely healed wound or within 10cm of a suspected basal cell carcinoma or squamous cell carcinoma
• undergone Cosmetic or therapeutic procedures
• use of acid-containing therapeutic products within 2cm of the selected treatment area in the 2 weeks prior to Visit 1
• use of topical creams/lotions, artificial tanners or topical steroids within 2cm of the selected treatment areas in the 2 weeks prior to visit 1.
• treatment with immunomodulators, or interferon/interferon inducers or systemic medications that suppress the immune system within 4 weeks of visit 1
• treatment with 5-FU, imiquimod, diclofenac, ingenol mebutate of photodynamic therapy within 2cm of the treatment area in the 8 weeks prior to visit 1
• use of systemic retinoids
• those who are currently participating in any other interventional clinical trial
• females who are pregnant or are breastfeeding
• those known or suspected of not being able to comply with the requirements of the protocol or provide consent