A Study of Increasing Strengths, Safety and Efficacy of Two Formulas of LEO 43204 on the Face or the Chest in Patients With Actinic Keratosis

Exclusion Criteria

• •1. Location of the treatment area within 5 cm (2 inches) of:
• •1. an incompletely healed wound,
• •2. a suspected basal or squamous cell carcinoma.
• •2. Prior treatment with ingenol mebutate gel on the treatment area.
• •3. Lesions in the treatment areas that have:
• •1. atypical clinical appearance (e.g., hypertrophic, hyperkeratotic or cutaneous horns) and/or
• •2. recalcitrant disease (e.g., did not respond to cryotherapy on two previous occasions).
• •4. History or evidence of skin conditions other than the trial indication that would interfere with the evaluation of the trial medication (e.g., eczema, unstable psoriasis, xeroderma pigmentosum, Rosacea), at the investigator's discretion.
• •5. Use of cosmetic or therapeutic products and procedures which could interfere with the assessments of the treatment areas.
• •6. Any other disease or medical condition such as history or presence of cancer, cardiovascular, pulmonary, hepatic, renal, hematological, gastrointestinal, endocrine, immunological, or neurological disease or disorder, that, in the opinion of the investigator, makes the subject unsuitable to participate in the trial.
• •7. Any abnormal laboratory or ECG findings that are clinically significant and would impact the safety of the subjects or the interpretation of the study results, as determined by the investigator.
• •8. Anticipated need for hospitalisation or out-patient surgery during the first 15 days after the first trial medication application. Note that cosmetic/therapeutic procedures are not excluded if they fall outside of the criteria detailed in Prohibited Therapies or Medications.
• •9. Known sensitivity or allergy to any of the ingredients in the LEO 43204.
• •10. Presence of acute sunburn within the treatment areas.
• •11. Current enrolment or participation in an investigational clinical trial within 30 days of entry into this trial.
• •12. Subjects previously randomised in the trial (Part 1 or 2).
• •13. Female subjects who are breastfeeding.
• •14. In the opinion of the investigator, the subject is unlikely to comply with the Clinical Study Protocol (e.g., alcoholism, drug dependency or psychotic state).