Study to Determine the Safety of Two Applications of PEP005 Topical Gel 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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
|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|
- Resolution of nodular basal cell carcinoma
|Study Start Date:||March 2005|
|Study Completion Date:||May 2006|
|Primary Completion Date:||May 2006 (Final data collection date for primary outcome measure)|
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.
|Australia, New South Wales|
|St George Dermatology & Skin Cancer Centre|
|Sydney, New South Wales, Australia, 2217|
|Southderm Pty Ltd|
|Sydney, New South Wales, Australia, 2010|
|South East Dermatology|
|Brisbane, Queensland, Australia, 4152|
|Brisbane, Queensland, Australia, 4000|
|The Skin Centre|
|Gold Coast, Queensland, Australia, 4217|
|13 Eleanor St|
|Footscray, Victoria, Australia, 3011|
|Skin and Cancer Foundation|
|Melbourne, Victoria, Australia, 3052|
|Monash Medical Centre|
|Melbourne, Victoria, Australia, 3168|
|Australia, Western Australia|
|Fremantle, Western Australia, Australia, 6160|
|St John of God Dermatology|
|Subiaco, Western Australia, Australia, 6008|
|Principal Investigator:||Greg Siller|