Safety and Efficacy of Ingenol Mebutate Gel 0.015% for Treatment of AK on the Face in Solid Organ Transplant Recipients
Condition: Actinic Keratosis
MeSH terms: Keratosis, Actinic; Keratosis
Intervention: ingenol mebutate gel 0.015%
Intervention description: ingenol mebutate gel 0.015% to be applied on treatment area
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 20.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Actinic Keratosis; lung transplant; kidney transplant

Summary:

      This is a single arm, open-label interventional study of ingenol mebutate 0.015% in solid
      organ transplant recipients. The investigators plan to treat 20 subjects, 10 kidney
      transplant recipients and 10 lung transplant recipients. The investigators have selected
      these two populations as the represent the spectrum of solid organ transplantation: kidney
      transplant recipients are the largest transplant population, but have lower levels of
      immunosuppression and skin cancer risk. Lung transplant recipients have the highest burden of
      skin cancer and actinic keratoses.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Adults at least 18 years old.

          2. Subject must be a solid organ transplant recipient at least one year from the date of
             transplantation.

          3. Subjects must be in stable health as confirmed by medical history, per investigator
             judgement.

          4. Subjects must be able to read, sign, and understand the informed consent.

          5. 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).

          6. 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.

          7. Subject is willing and able to participate in the study and to comply with all study
             requirements including concomitant medication and other treatment restrictions.

          8. 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:

          1. Subjects with an unstable medical condition as deemed by the clinical investigator.

          2. Subjects with a history of bone marrow or stem cell transplantation.

          3. Subjects with non-melanoma skin cancer on the face.

          4. Subjects with hyperkeratotic or hypertrophic AKs.

          5. 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.

          6. Women who are pregnant, lactating, or planning to become pregnant during the study
             period.

          7. Subjects who have previously been treated with ingenol mebutate in study area within
             the past 8 weeks.

          8. Subjects who have used any topical prescription medications for actinic keratosis on
             the study area within 8 weeks prior to study treatment initiation.

          9. Subjects who have used any topical prescription medications for other reason on the
             study area within 4 weeks prior to study treatment initiation.

         10. 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.

         11. 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.