Risk of Squamous Cell Carcinoma on Skin Areas Treated With Ingenol Mebutate Gel, 0.015% and Imiquimod Cream, 5%
Condition: Actinic Keratosis (AK)
MeSH terms: Keratosis, Actinic; Keratosis
Intervention: Ingenol Mebutate Gel, 0.015%; Imiquimod Cream, 5%
Intervention description: Ingenol mebutate gel 0.015 % (Picato®) applied on the selected treatment area. Retreatment if the treatment field is not completely cleared of AKs.; Imiquimod 5% cream applied to the selected treatment area. Retreatment if the treatment field is not completely cleared of AKs
Intervention MeSH terms: Imiquimod
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 485.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of the study is to compare the risk of developing squamous skin cancer (SCC) or
      other types of cancer after treatment of AKs with ingenol mebutate gel or imiquimod cream.
      Subjects will be randomised to treatment with ingenol mebutate or imiquimod and will receive
      a second treatment cycle with the same treatment if the first treatment does not clear all
      AKs. Subjects will be followed over a period of three year (36 months) after first treatment
    

Eligibility criteria:

        Inclusion Criteria:

          1. Signed Informed Consent Form (ICF) prior to any trial-related procedures

          2. Subjects with 5 to 9 clinically typical, visible and discrete AKs within a contiguous
             25 cm² treatment area on the face or scalp.

          3. Subject at least 18 years of age

          4. Female subjects must be of either:

               1. Non-childbearing potential, or,

               2. Childbearing potential, provided there is a confirmed negative urine pregnancy
                  test

          5. Female subjects of childbearing potential must be willing to use highly effective
             methods of contraception (Pearl index < 1%)

        Exclusion Criteria:

          1. Location of the selected treatment area:

               -  on the periorbital skin

               -  on the perioral skin/around the nostrils

               -  within 5 cm of an incompletely healed wound

               -  within 10 cm of a suspected BCC or SCC or other neoplasia

          2. Selected treatment area lesions that have atypical clinical appearance (e.g.,
             hypertrophic, hyperkeratotic or cutaneous horn).

          3. History of SCC, BCC, malignant melanoma or other neoplasia in the selected treatment
             area.

          4. History or evidence of skin conditions other than the trial indication that would
             interfere with evaluation of the trial medication in the selected treatment area

          5. Use of ingenol mebutate and/or imiquimod in and within 5 cm of the selected treatment
             area within 2 years prior to Screening (Visit 1)

          6. Organ transplant recipients

          7. Immunosuppressed subjects (for example HIV patients)

          8. Female subjects who are breastfeeding.

          9. Subjects who are institutionalised by court order or by the local authority

         10. 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)