a simultaneous treatment regimen compared to a sequential treatment regimen with ingenol mebutate gel 0.015% and 0.05% of two areas with actinic keratosis on face/scalp and trunk/extremities

Conditions: Actinic Keratosis

Summary: the purpose of this trial is to evaluate the safety of a simultaneous treatment regimen compared to a sequential treatment regimen when two separate areas with aks (one located on face/scalp and the other located on trunk/ extremities) are treated with ingenol mebutate gel


Eligibility criteria:
inclusion criteria: * subjects must provide informed consent * subjects with 4 to 8 clinically typical, visible and discrete aks within a contiguous 25 cm2 treatment area on face or scalp * subjects with 4 to 8 clinically typical, visible and discrete aks within a contiguous 25 cm2 treatment area on trunk or extremities * subjects 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 potential must be willing to use effective contraception at trial entry and until completion. exclusion criteria: * location of the selected treatment areas: * on the periorbital skin * 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 on face/scalp and on trunk/extremities * lesions in the selected treatment areas that have: * atypical clinical appearance (and/or, * recalcitrant disease * history or evidence of skin conditions other than the trial indication that would interfere with the evaluation of the trial medication * use of cosmetic or therapeutic products and procedures which could interfere with the assessments of the selected 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. * anticipated need for hospitalisation or out-patient surgery during the first 15 days after the first trial medication application. * known sensitivity or allergy to any of the ingredients in ingenol mebutate gel * presence of sunburn within the selected treatment areas * current enrolment or participation in an investigational clinical trial within 30 days of entry into this trial * subjects previously randomised in the trial * female subjects who are breastfeeding * in the opinion of the investigator, the subject is unlikely to comply with the clinical study protocol prohibited therapies and/or medications within 2 weeks prior to visit 1: * cosmetic or therapeutic procedures within 2 cm of the selected treatment areas * use of topical keratolytic therapeutic products within 2 cm of the selected treatment areas * use of topical medicated creams, ointments, lotions, gels, foams or sprays including topical steroids : within 2 cm of the selected treatment areas; artificial tanners: within 5 cm of the selected treatment areas prohibited therapies and/or medications: within 4 weeks prior to visit 1: * treatment with immunomodulators, cytotoxic drugs or interferon/interferon inducers * treatment with systemic medications that suppress the immune system * treatment/therapy with ultraviolet light a (uva) or ultraviolet light b (uvb) prohibited therapies and/or medications within 8 weeks prior to visit 1: - treatment with 5-fluorouracil (5-fu), imiquimod, topical diclofenac sodium, or photodynamic therapy within 2 cm of the selected treatment areas. prohibited therapies and/or medications within 6 months prior to visit 1: - use of systemic retinoids or biologic/monoclonal antibody therapies

Keywords: actinic keratosis ingenol mebutate gel