Study to Determine the Safety of Two Applications of PEP005 Topical Gel to Nodular Basal Cell Carcinoma
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00108121|
Recruitment Status : Completed
First Posted : April 15, 2005
Last Update Posted : January 19, 2015
|Condition or disease||Intervention/treatment||Phase|
|Basal Cell Carcinoma||Drug: PEP005||Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Enrollment :||60 participants|
|Intervention Model:||Parallel Assignment|
|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|
|Study Start Date :||March 2005|
|Actual Primary Completion Date :||May 2006|
|Actual Study Completion Date :||May 2006|
- Resolution of nodular basal cell carcinoma
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00108121
|Australia, New South Wales|
|Southderm Pty Ltd|
|Sydney, New South Wales, Australia, 2010|
|St George Dermatology & Skin Cancer Centre|
|Sydney, New South Wales, Australia, 2217|
|Brisbane, Queensland, Australia, 4000|
|South East Dermatology|
|Brisbane, Queensland, Australia, 4152|
|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|