safety and efficacy of ingenol mebutate once daily for 2 or 3 consecutive days in subjects with actinic keratosis

Conditions: Actinic Keratosis

Summary: to identify the maximum tolerated dose levels of ingenol mebutate gel after once daily treatment for 2 or 3 consecutive days and to evaluate efficacy of ingenol mebutate gel in different doses after once daily treatment for 2 or 3 consecutive days compared to vehicle gel


Eligibility criteria:
inclusion criteria: * subjects must be competent to understand the nature of the trial and provide informed consent * part 1: subjects with 5 to 20 clinically typical, visible and discrete aks on the face part 2: subjects with 5 to 20 clinically typical, visible and discrete aks on either the face, the balding scalp (the balding part of the scalp should be at least 25 cm2) or a contiguous area of approximately 250 cm2 on the chest * subject at least 18 years of age * female subjects must be of either: 1. non-childbearing potential, i.e. post-menopausal or have a confirmed clinical history of sterility (e.g. the subject is without a uterus) or, 2. childbearing potential, provided there is a confirmed negative urine pregnancy test prior to trial treatment, to rule out pregnancy * female subjects of childbearing potential1 must be willing to use effective contraception at trial entry and until completion 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)