A Simultaneous Treatment Regimen Compared to a Sequential Treatment Regimen With Ingenol Mebutate Gel 0.015% and 0.05% of Two Areas With Actinic Keratosis on Face/Scalp and Trunk/Extremities
Condition: Actinic Keratosis
MeSH terms: Keratosis, Actinic; Keratosis
Intervention: Ingenol mebutate gel 0.05 %; Ingenol mebutate gel 0.015 %
Intervention description: Ingenol mebutate gel 0.05 % (Picato®) on trunk/extremities either applied simultaneously or sequentially; Ingenol mebutate gel 0.015 % (Picato®) on face/scalp either applied simultaneously or sequentially
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 200.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Actinic Keratosis; Ingenol mebutate gel

Summary:

      The purpose of this trial is to evaluate the safety of a simultaneous treatment regimen
      compared to a sequential treatment regimen when two separate areas with AKs (one located on
      face/scalp and the other located on trunk/ extremities) are treated with ingenol mebutate gel
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects must provide informed consent

          -  Subjects with 4 to 8 clinically typical, visible and discrete AKs within a contiguous
             25 cm2 treatment area on face or scalp

          -  Subjects with 4 to 8 clinically typical, visible and discrete AKs within a contiguous
             25 cm2 treatment area on trunk or extremities

          -  Subjects at least 18 years of age

          -  Female subjects must be of either:

               1. Non-childbearing potential, i.e. post-menopausal or have a confirmed clinical
                  history of sterility (e.g. the subject is without a uterus) or,

               2. Childbearing potential, provided there is a confirmed negative urine pregnancy
                  test prior to trial treatment, to rule out pregnancy.

          -  Female subjects of childbearing potential must be willing to use effective
             contraception at trial entry and until completion.

        Exclusion Criteria:

          -  Location of the selected treatment areas:

               -  on the periorbital skin

               -  within 5 cm of an incompletely healed wound

               -  within 10 cm of a suspected basal cell carcinoma (BCC) or squamous cell carcinoma
                  (SCC)

          -  Prior treatment with ingenol mebutate gel on face/scalp and on trunk/extremities

          -  Lesions in the selected treatment areas that have:

               -  atypical clinical appearance (and/or,

               -  recalcitrant disease

          -  History or evidence of skin conditions other than the trial indication that would
             interfere with the evaluation of the trial medication

          -  Use of cosmetic or therapeutic products and procedures which could interfere with the
             assessments of the selected treatment areas

          -  Clinical diagnosis/history or evidence of any medical condition that would expose a
             subject to an undue risk of a significant AE or interfere with assessments of safety
             and efficacy during the course of the trial, as determined by the investigator's
             clinical judgment.

          -  Anticipated need for hospitalisation or out-patient surgery during the first 15 days
             after the first trial medication application.

          -  Known sensitivity or allergy to any of the ingredients in ingenol mebutate gel

          -  Presence of sunburn within the selected treatment areas

          -  Current enrolment or participation in an investigational clinical trial within 30 days
             of entry into this trial

          -  Subjects previously randomised in the trial

          -  Female subjects who are breastfeeding

          -  In the opinion of the investigator, the subject is unlikely to comply with the
             Clinical Study Protocol

        Prohibited Therapies and/or Medications within 2 weeks prior to Visit 1:

          -  Cosmetic or therapeutic procedures within 2 cm of the selected treatment areas

          -  Use of topical keratolytic therapeutic products within 2 cm of the selected treatment
             areas

          -  Use of topical medicated creams, ointments, lotions, gels, foams or sprays including
             topical steroids : within 2 cm of the selected treatment areas; artificial tanners:
             within 5 cm of the selected treatment areas

        Prohibited Therapies and/or Medications: within 4 weeks prior to Visit 1:

          -  Treatment with immunomodulators, cytotoxic drugs or interferon/interferon inducers

          -  Treatment with systemic medications that suppress the immune system

          -  Treatment/therapy with ultraviolet light A (UVA) or ultraviolet light B (UVB)

        Prohibited Therapies and/or Medications within 8 weeks prior to Visit 1:

        - Treatment with 5-fluorouracil (5-FU), imiquimod, topical diclofenac sodium, or
        photodynamic therapy within 2 cm of the selected treatment areas.

        Prohibited Therapies and/or Medications within 6 months prior to Visit 1:

        - Use of systemic retinoids or biologic/monoclonal antibody therapies