Basal cell carcinomas (BCCs) are a common skin problem largely caused by long term sun exposure. Current treatments include surgery, curettage/desiccation and simple excision, which are often cosmetically disfiguring. Non-invasive alternative therapy for treatment of BCC lesions is thus being researched.~Sap from the plant Euphorbia peplus has been used for many years in Australia as a folk remedy to treat a number of skin conditions. The active component of Euphorbia peplus has been isolated and made into a gel applied directly to the skin by Peplin Ltd. To date, only one well-controlled study with PEP005 gel in humans has been completed. Sixteen patients received a single application of PEP005 0.01% or vehicle gel to actinic keratoses on the chest, shoulders, back and/or arms. Results show good tolerance and evidence of activity.~The current study is designed to evaluate the safety of two applications of PEP005 gel in patients with nBCC (nodular basal cell carcinoma) on the arms, shoulders, chest, face and/or scalp, testing three concentrations according to two treatment regimens. Approximately 60 patients are planned to be included from multiple Australian centers.~Efficacy and cosmetic outcome will be assessed and a recommended treatment regimen will be determined. Assignment to treatment is random and patients and medical staff will be blinded as to the treatment.~Patients will have two visits for treatment application and will return for check-up visits the day after the first application and several times thereafter for approximately 3 months.
The purpose of this study is to determine whether topical application of PEP005 is safe for the treatment of nodular basal cell carcinoma.