To Determine the Maximum Tolerated Dose Level (MTD) of PEP005 Topical Gel in Patients With sBCC
- Registration Number
- NCT00432185
- Lead Sponsor
- Peplin
- Brief Summary
The purpose of this study is to determine maximum tolerated dose level (MTD) of PEP005 Topical Gel for the treatment of superficial basal cell carcinoma on the trunk
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 117
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description 1 PEP005 One day treatment 2 PEP005 Two day treatment
- Primary Outcome Measures
Name Time Method Maximum Tolerated Dose level (MTD) through incidence of treatment related AEs, local skin reactions and pigmentation and scarring. 85 days
- Secondary Outcome Measures
Name Time Method Efficacy (complete sBCC clearance rate and composite sBCC clearance rate) 85 days
Trial Locations
- Locations (9)
Alta Dermatology
🇺🇸Mesa, Arizona, United States
Dermatology Specialists Inc.
🇺🇸Oceanside, California, United States
Skin Surgery Medical Group Inc.
🇺🇸San Diego, California, United States
Colorado Medical Research Center
🇺🇸Denver, Colorado, United States
Advanced Dermatology and Cosmetic Surgery
🇺🇸Clermont, Florida, United States
Park Avenue Dermatology
🇺🇸Orange Park, Florida, United States
Minnesota Clinical Studies Center
🇺🇸Fridley, Minnesota, United States
Dermatology Associates of Rochester
🇺🇸Rochester, New York, United States
Rivergate Dermatology and Skin Care Center
🇺🇸Goodlettsville, Tennessee, United States
Alta Dermatology🇺🇸Mesa, Arizona, United States