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.

Exclusion Criteria

• Subjects with an unstable medical condition as deemed by the clinical investigator.
• Subjects with a history of bone marrow or stem cell transplantation.
• Subjects with non-melanoma skin cancer on the face.
• Subjects with hyperkeratotic or hypertrophic AKs.
• Subjects with any dermatologic disease in the treatment area that may be exacerbated by the treatment proposed or that might impair the evaluation of AKs.
• Women who are pregnant, lactating, or planning to become pregnant during the study period.
• Subjects who have previously been treated with ingenol mebutate in study area within the past 8 weeks.
• Subjects who have used any topical prescription medications for actinic keratosis on the study area within 8 weeks prior to study treatment initiation.
• Subjects who have used any topical prescription medications for other reason on the study area within 4 weeks prior to study treatment initiation.
• Subjects who are currently participating in another clinical study or have completed another clinical study with an investigational drug or device on the study area within 30 days prior to study treatment initiation.
• Subjects with known hypersensitivity to Picato gel or any of the inactive ingredients: isopropyl alcohol, hydroxyethyl cellulose, citric acid monohydrate, sodium citrate, or benzyl alcohol.