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.
Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Maximum Tolerated Dose level (MTD) through incidence of treatment related AEs, local skin reactions and pigmentation and scarring.
United States: Food and Drug Administration
|Colorado Medical Research Center||Denver, Colorado 80210|
|Park Avenue Dermatology||Orange Park, Florida 32073|
|Dermatology Associates of Rochester||Rochester, New York 14623|
|Advanced Dermatology and Cosmetic Surgery||1120 Citrus Tower Blvd, Suite 330 Clermont, Florida 34711|
|Alta Dermatology||130 South 63rd St, Bldg 3, Suite 114, Mesa, Arizona 85206|
|Dermatology Specialists Inc.||2067 West Vista Way, Suite 250 Vista, California|
|Skin Surgery Medical Group Inc.||5222 Balboa Avenue Sixth Floor, San Diego, California|
|Minnesota Clinical Studies Center||7205 University Ave, FRIDLEY, Minnesota|
|Rivergate Dermatology and Skin Care Center||201 Bluebird Dr, Goodlettsville, Tennessee|