Safety and Efficacy of Ingenol Mebutate Gel 0.015% for Treatment of AK on the Face in Solid Organ Transplant Recipients

Inclusion criteria

• ✓. Adults at least 18 years old.
• ✓. Subject must be a solid organ transplant recipient at least one year from the date of transplantation.
• ✓. Subjects must be in stable health as confirmed by medical history, per investigator judgement.
• ✓. Subjects must be able to read, sign, and understand the informed consent.
• ✓. Subjects have at least 4 and no more than 20 clinically typical (non-hyperkeratotic/hypertrophic), visible actinic keratoses in a treatment area of approximately 100cm2 on the face. Treatment areas will include a single cheek (nasofacial sulcus to tragus, malar cheekbone to jawline and avoiding the lower eyelid and mouth); the forehead (hairline to eyebrows, extending laterally to the root of the helix).
• ✓. Subject must be willing to forego any other treatments on the face, including cryotherapy, tanning bed use and excessive sun exposure while in the study.
• ✓. Subject is willing and able to participate in the study and to comply with all study requirements including concomitant medication and other treatment restrictions.
• ✓. If subject is a female of childbearing potential she must have a negative urine pregnancy test result prior to study treatment initiation and must agree to use an approved method of birth control while enrolled in the study.