Safety and Efficacy of Escalating Doses of LEO 43204 Applied Once Daily for Two Consecutive Days on Approximately 250 cm2 on Trunk and Extremities in Subjects With Actinic Keratosis

Inclusion Criteria:

- Part 1: Subjects with 5 to 20 clinically typical, visible and discrete AKs on the arm

- Part 2: Subjects with 5 to 20 clinically typical, visible and discrete AKs on the
extremities or trunk

Exclusion Criteria:

- Location of the treatment area

- within 5 cm of an incompletely healed wound

- within 5 cm of a suspected basal cell carcinoma (BCC) or squamous cell carcinoma
(SCC)

- Prior treatment with ingenol mebutate gel on 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)