PEP005 Gel - Evaluation of the Safety and Efficacy of Ingenol Mebutate Gel on a Superficial Basal Cell Carcinoma on the Trunk or Extremities

Inclusion criteria

• Must be male or female and at least 18 years of age
• Female patients must be of: non-childbearing potential or if of childbearing potential then have a negative serum and urine pregnancy test and using effective contraception
• Ability to provide informed consent
• primary diagnosed and histologically confirmed sBCC located on the trunk or extremities which is suitable for excision

Exclusion criteria

• location of the sBCC lesion within 10cm of an incompletely healed wound, on the hand or foot, on the breast of women, on the anogenital area.
• Undergone cosmetic or therapeutic procedures within 2cm of the selected treatment area in the 2 weeks prior to the screening visit.
• Use of acid-containing therapeutic products within 2 cm of the selected treatment area in the 2 weeks prior to the screening visit
• Use of topical moisturisers/creams/lotions (non-medicated/non-irritant salves are acceptable), artificial tanners or topical steroids: within 2 cm of the selected treatment area.
• Have received treatment with immunomodulators, or interferon/interferon inducers, systematic medications that suppress the immune system or UVB in the last 4 weeks
• Have undergone treatment with 5-FU, imiquimod, diclofenac or photodynamic therapy within 2 cm of the selected treatment area within 8 weeks prior to any screening visit.
• Use of systemic retinoids.
• Those who are currently participating in any other clinical trial
• Those known or suspected of not being able to comply with the requirements of the protocol
• Females who are pregnant or are breastfeeding