Ingenol Mebutate Gel, 0.015% Repeat Use for Multiple Actinic Keratoses on Face and Scalp

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