The objective of the trial is to investigate efficacy and safety of ingenol mebutate gel for actinic keratosis applied to large treatment areas once daily for three consecutive days on face, scalp or chest.

Inclusion Criteria:

Subjects with 5 to 20 clinically typical, visible and discrete, actinic keratosis (AKs) non-hyperkeratotic and non-hypertrophic AKs within a selected treatment area of sun-damaged skin on either:

• The full face
• The full balding scalp
• A contiguous area of approximately 250 cm2 on the chest

Exclusion Criteria:

• Location of the treatment area (full face, full balding scalp or chest) within 5 cm of an incompletely healed wound or within 5 cm of a suspected basal cell carcinoma (BCC) or squamous cell carcinoma (SCC).
• Previously assigned treatment in this clinical trial or previously participated in a clinical trial in the LEO clinical programme on ingenol mebutate gel for larger treatment areas.
• Treatment with ingenol mebutate gel in the selected treatment area within the last 12 months.
• Lesions in the treatment area that have: atypical clinical appearance (e.g. cutaneous horn) and/or, recalcitrant disease (e.g., did not respond to cryotherapy on two previous occasions).

14 Months

A total of 729 subjects were randomised to treatment, of whom 4 did not receive treatment with IMP. These 4 subjects (3 subjects from the active treatment group and 1 from the corresponding vehicle group) were excluded from the Full Analysis Set, which consisted of 725 subjects (549 subjects in the active treatment group and 176 in the corresponding vehicle group).

The Safety Analysis Set was the same as the Full Analysis Set.