Ingenol Mebutate Compared to Cryotherapy for the Treatment of Skin Lesions

Inclusion Criteria:

- Male and female subjects between 18 and 89 years old.

- Have at least a total of 10 non-hypertrophic actinic keratoses (AKs) on the face and
scalp

- The subjects are in good health

- The subjects have the willingness and the ability to understand and provide informed
consent for the use of their tissue and are able to communicate with the investigator

Exclusion Criteria:

- Subjects under 18 years of age and over the age of 89

- Subjects who are pregnant or lactating

- Subjects with sensitivity to cold

- Subjects with use of topical medications such as corticosteroids, alpha-hydroxyacids
or retinoids 2 weeks before study entry

- Subjects who received previous treatment of target AKs

- Subjects whose target treatment area was within 5 cm of an incompletely healed wound
or within 10 cm of a suspected basal-cell or squamous-cell carcinoma

- Subjects with use of medications or other treatments that could interfere with
evaluation of the treatment area within 2 months before study entry (e.g., topical
medications, artificial tanners, immunosuppressive medications, immunomodulating
agents, cytotoxic drugs, ultraviolet B phototherapy, other therapies for actinic
keratoses, or oral retinoids)

- Subjects who are unable to understand the protocol or to give informed consent