Ingenol Mebutate Gel, 0.015% Repeat Use for Multiple Actinic Keratoses on Face and Scalp
Condition: Actinic Keratosis
MeSH terms: Keratosis, Actinic; Keratosis
Intervention: Ingenol mebutate gel, 0.015%; Vehicle gel
Intervention description: Topical field treatment once daily for 3 consecutive days within a 25 cm2 treatment area on the face or scalp of AKs present or emerging after an initial treatment with ingenol mebutate gel, 0.015%; Topical field treatment once daily for 3 consecutive days within a 25 cm2 treatment area on the face or scalp of AKs present or emerging after an initial treatment with ingenol mebutate gel, 0.015%
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 463.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of the study is to demonstrate that ingenol mebutate gel is efficacious in
      treating Actinic Keratoses (AKs) present 8 weeks after initial field treatment or emerging in
      a previously cleared field.
    

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 the face or scalp

          -  Subject at least 18 years of age

          -  Female subjects must be of either:

               -  Non-childbearing potential, i.e. post-menopausal or have a confirmed clinical
                  history of sterility (e.g. the subject is without a uterus) or,

               -  Childbearing potential, provided there is a confirmed negative urine pregnancy
                  test prior to study treatment, to rule out pregnancy

          -  Female subjects of childbearing potential must be willing to consent to using highly
             effective methods of contraception

        Exclusion Criteria:

          -  Location of the selected treatment area:

               -  on any location other than the face or scalp

               -  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 or scalp (previous treatment on
             trunk and extremities acceptable)

          -  Selected treatment area lesions that have atypical clinical appearance

          -  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

          -  Anticipated need for hospitalization or out-patient surgery prior to Day 15 in the
             first treatment cycle

          -  Known sensitivity or allergy to any of the ingredients in ingenol mebutate gel

          -  Presence of sunburn within the selected treatment area

          -  Current enrollment or participation in a clinical trial within 30 days of entry into
             this study

          -  Subjects previously entered first treatment in the trial

          -  Female subjects who are breastfeeding

          -  Subjects who are institutionalised by court order or by the local authority

          -  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 Day 1

          -  Cosmetic or therapeutic procedures within 2 cm of the selected treatment area

          -  Use of keratolytic topical therapeutic products within 2 cm of the selected treatment
             area

          -  Use of topical medicated creams, ointments, lotions gels, foams or sprays within 2 cm
             of the selected treatment area; artificial tanners: within 5 cm of the selected
             treatment area

        Prohibited Therapies and/or Medications: within 4 weeks prior to Day 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 Day 1

          -  Treatment with 5-fluorouracil (5-FU), imiquimod, diclofenac sodium, or photodynamic
             therapy: within 2 cm of the selected treatment area

        Prohibited Therapies and/or Medications within 6 months prior to Day 1

          -  Use of systemic retinoids or biologic/monoclonal antibody therapies