Superficial Basal Cell Carcinoma Clinical Trial
Official title:
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.
The purpose of this study is to determine maximum tolerated dose level (MTD) of PEP005 Topical Gel for the treatment of superficial basal cell carcinoma 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.
;
Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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