ingenol mebutate gel, 0.015% repeat use for multiple actinic keratoses on face and scalp

Conditions: Actinic Keratosis

Summary: the purpose of the study is to demonstrate that ingenol mebutate gel is efficacious in treating actinic keratoses (aks) present 8 weeks after initial field treatment or emerging in a previously cleared field.


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 the face or scalp * subject at least 18 years of age * female subjects must be of either: * non-childbearing potential, i.e. post-menopausal or have a confirmed clinical history of sterility (e.g. the subject is without a uterus) or, * childbearing potential, provided there is a confirmed negative urine pregnancy test prior to study treatment, to rule out pregnancy * female subjects of childbearing potential must be willing to consent to using highly effective methods of contraception exclusion criteria: * location of the selected treatment area: * on any location other than the face or scalp * 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 or scalp (previous treatment on trunk and extremities acceptable) * selected treatment area lesions that have atypical clinical appearance * history or evidence of skin conditions other than the trial indication that would interfere with evaluation of the trial medication in the selected treatment area * anticipated need for hospitalization or out-patient surgery prior to day 15 in the first treatment cycle * known sensitivity or allergy to any of the ingredients in ingenol mebutate gel * presence of sunburn within the selected treatment area * current enrollment or participation in a clinical trial within 30 days of entry into this study * subjects previously entered first treatment in the trial * female subjects who are breastfeeding * subjects who are institutionalised by court order or by the local authority * 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 day 1 * cosmetic or therapeutic procedures within 2 cm of the selected treatment area * use of keratolytic topical therapeutic products within 2 cm of the selected treatment area * use of topical medicated creams, ointments, lotions gels, foams or sprays within 2 cm of the selected treatment area; artificial tanners: within 5 cm of the selected treatment area prohibited therapies and/or medications: within 4 weeks prior to day 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 day 1 * treatment with 5-fluorouracil (5-fu), imiquimod, diclofenac sodium, or photodynamic therapy: within 2 cm of the selected treatment area prohibited therapies and/or medications within 6 months prior to day 1 * use of systemic retinoids or biologic/monoclonal antibody therapies