A Phase 2 Multi-centre, Parallel Group, Open Label Study to Evaluate the Safety and Efficacy of PEP005 (Ingenol Mebutate) Gel, 0.05%, When Administered for up to Three Consecutive Days to a Superficial Basal Cell Carcinoma (sBCC) on the Trunk or Extremities
- 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
- Ability to provide informed consent
- primary diagnosed and histologically confirmed sBCC located on the trunk or
extremities which is suitable for excision
- 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
- 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
- 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
- Females who are pregnant or are breastfeeding