Safety and Efficacy of Ingenol Mebutate Once Daily for 2 or 3 Consecutive Days in Subjects With Actinic Keratosis

Exclusion Criteria

• •Location of the treatment area (full face, full balding scalp or chest)
• •* within 5 cm of an incompletely healed wound,
• •* within 10 cm of a suspected basal cell carcinoma (BCC) or squamous cell carcinoma (SCC
• •Prior treatment with ingenol mebutate gel within the treatment area
• •Lesions in the treatment areas that have:
• •* atypical clinical appearance (e.g., hypertrophic, hyperkeratotic or cutaneous horns) and/or,
• •* recalcitrant disease (e.g., did not respond to cryotherapy on two previous occasions
• •History or evidence of skin conditions other than the trial indication that would interfere with the evaluation of the trial medication (e.g., eczema, unstable psoriasis, xeroderma pigmentosum)
• •Use of cosmetic or therapeutic products and procedures which could interfere with the assessments of the treatment areas.
• •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 and efficacy during the course of the trial, as determined by the investigator's clinical judgment
• •Any abnormal laboratory tests that are medically significant and would impact the safety of the subjects or the interpretation of the trial results, as determined by the investigator's judgment
• •Anticipated need for hospitalisation or out-patient surgery during the first 15 days after the first trial medication application. Note that cosmetic/therapeutic procedures are not excluded if they fall outside of the criteria detailed in Prohibited Therapies or Medications
• •Known sensitivity or allergy to any of the ingredients in ingenol mebutate gel
• •Presence of acute sunburn within the treatment areas
• •Current enrolment or participation in an investigational clinical trial within 30 days of entry into this trial.
• •Subjects previously assigned to treatment in Part 1 or rand
• •Female subjects who are breastfeeding.
• •In the opinion of the investigator, the subject is unlikely to comply with the Clinical Study Protocol (e.g. alcoholism, drug dependency or psychotic state)