Basal Cell Carcinoma Clinical Trial
Official title:
A Multi-center, Randomized, Double-blind, Parallel-group, Vehicle-controlled Study to Determine the Safety of PEP005 0.0025%, 0.01% and 0.05% Gel With Two Treatment Schedules, Day 1 & 2 or Day 1 & 8 Applications to Nodular Basal Cell Carcinoma
The purpose of this study is to determine whether topical application of PEP005 is safe for the treatment of nodular basal cell carcinoma.
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.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
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