Pharmacokinetics of LEO 43204 Gel in Actinic Keratosis Administered Under Maximal Use Conditions

Inclusion Criteria

• •1. Subjects with 15 or more clinically typical, visible and discrete AKs on either:
• •* Full face (corresponding to a treatment area of at least 250 cm2). If subjects have a beard they must shave no later than the day before the first drug application.
• •* A contiguous area of approximately 250 cm2 on the arm between wrist and shoulder.
• •* Balding scalp (corresponding to a treatment area of approximately 250 cm2). Subjects with sparse hair on the scalp can be enrolled as long as LSR and AK assessments are not compromised.
• •2. Subject at least 18 years of age.
• •3. Female subjects of childbearing potential\* must be confirmed not pregnant by a negative urine pregnancy test prior to trial treatment.
• •4. Female subjects of childbearing potential must be willing to use effective contraception at trial entry and until completion.