Safety and Dose Finding Study of New Vehicle Formulations Containing Ingenol Mebutate to Treat Actinic Keratosis on the Forearm

Exclusion Criteria

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