Safety and Efficacy of Ingenol Mebutate 0.05% Gel When Used After Cryotherapy in the Hypertrophic Actinic Keratoses
Condition: Actinic Keratoses
MeSH terms: Keratosis, Actinic; Keratosis
Intervention: Ingenol Mebutate; Cryotherapy
Intervention description: Ingenol mebutate 0.05% gel; 1-2 sprays, 5 seconds each, with a 5 second interval
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Enrollment: 16.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Actinic

Summary:

      Sequential therapy with cryosurgery and ingenol mebutate may optimize the treatment of
      hypertrophic AKs and also treat non-hypertrophic AKs in this anatomic location. Furthermore,
      use of ingenol mebutate will also be evaluated for potential treatment of subclinical
      lesions.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Adults at least 18 years old.

          -  Subjects must be in good general health as confirmed by the medical history.

          -  Subjects must be able to read, sign, and understand the informed consent

          -  Prior to cryosurgery, subjects have at least 3 hypertrophic actinic keratoses on each
             dorsal hand.

          -  Subject must be willing to forego any other treatments on the dorsum of the hands,
             including tanning bed use and excessive sun exposure while in the study.

          -  Subject is willing and able to participate in the study as an outpatient, making
             frequent visits to the study center during the treatment and follow-up periods 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 a history of melanoma anywhere on the body.

          -  Subjects with an unstable medical condition as deemed by the clinical investigator.

          -  Subjects with non-melanoma skin cancer on the dorsum of the hands.

          -  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.

          -  Subjects who have previously been treated with ingenol mebutate: on the dorsum of the
             hands in the past 6 months; or outside of the study area within the past 30 days.

          -  Women who are pregnant, lactating, or planning to become pregnant during the study
             period.

          -  Subjects who have experienced a clinically important medical event within 90 days of
             the visit (e.g., stroke, myocardial infarction, etc).

          -  Subjects who have active chemical dependency or alcoholism as assessed by the
             investigator.

          -  Subjects who have known allergies to any excipient in the study gel.

          -  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 who have received any of the following within 90 days prior to study
             treatment initiation:

               -  interferon or interferon inducers

               -  cytotoxic drugs

               -  immunomodulators or immunosuppressive therapies (inhaled/ intranasal steroids are
                  permitted)

               -  oral or parenteral corticosteroids

               -  topical corticosteroids if greater than 2 gm/day

               -  any dermatologic procedures or surgeries on the study area (including any AK
                  treatments)

          -  Subjects who have used any topical prescription medications on the study area within
             30 days prior to study treatment initiation.