Ingenol Mebutate Gel, 0.015% Repeat Use for Multiple Actinic Keratoses on Face and Scalp

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