Trial Information

An Open-label, Multi-center, Dose-escalation, Cohort Study to Determine the Maximum Tolerated Dose and Safety of PEP005 Topical Gel Given as Either a Single Application (on Day 1) or as Two Applications (on Day 1 and Day 8) to a Superficial Basal Cell Carcinoma (sBCC) on the Trunk.

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 Opeation Pty Ltd.

The proposed study follows a previously conducted 12 week study in sBCC, PEP005-003. This
was a two dose schedule evaluating doses up to 0.05%. Histological clearance rate at the
end of study was 71% for the 0.05% concentration on the Day 1, Day 2 schedule compared with
0% in the vehicle group.

The proposed study aims to determine the maximum tolerated dose level (MTD) of PEP005
Topical Gel, in patients, when administered either as a single application or as two
applications to a selected superficial basal cell carcinoma lesion with a 3 month follow up.