Carcinoma, Squamous Cell Clinical Trial
Official title:
Multi-centre, Open-label Study to Determine the Safety and Efficacy of PEP005 0.05% Topical Gel in Patients With Cutaneous Squamous Cell Carcinoma In Situ (SCCIS, Bowen's Disease)
The purpose of this study is to determine whether the topical application of PEP005 is safe and effective for the treatment of cutaneous squamous cell carcinoma in situ (SCCIS, Bowen's disease).
Squamous cell carcinomas (SCCs) are a common skin problem largely caused by long term sun
exposure. Current treatments include surgery, curettage/desiccation and some topical
pharmaceutical therapies, which are often cosmetically disfiguring. Non-invasive alternative
therapy for treatment of SCC 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, three well-controlled studies with
PEP005 gel in humans have been completed. In the first and second completed studies, sixteen
(1st study) and sixty-four (2nd study) patients received one or two applications of PEP005
0.0025% or 0.01% or 0.05% or vehicle gel to actinic keratoses. In the third completed study,
sixty patients received two applications of PEP005 0.0025% or 0.01% or 0.05% or vehicle gel
to superficial basal cell carcinomas. Results from all studies show good tolerance and
evidence of activity.
The current study is designed to evaluate the efficacy and safety of two applications of
0.05% PEP005 gel in patients with SCCIS on the extremities, trunk or face. Approximately 24
patients are planned to be included from multiple Australian centers. 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 2-3 months.
;
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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