A Multicenter Study to Evaluate the Efficacy and Safety of PEP005 (Ingenol Mebutate) Gel When Used to Treat Actinic Keratoses (AKs) on the Non Head Locations
- Conditions
- Actinic Keratoses
- Interventions
- Drug: Vehicle gelDrug: PEP005 (ingenol mebutate) Gel
- Registration Number
- NCT00742391
- Lead Sponsor
- Peplin
- Brief Summary
The purpose of this study is to determine whether topical application of PEP005 is effective for the treatment of actinic keratoses.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 255
- Must be male or female and at least 18 years of age.
- Female patients must be of:
- Non-childbearing potential;
- Childbearing potential, provided negative serum and urine pregnancy test and using effective contraception.
- 4 to 8 AK lesions on non-head locations.
- Cosmetic or therapeutic procedures within 2 weeks and within 2 cm of the selected treatment area.
- Treatment with immunomodulators, or interferon/ interferon inducers or systemic medications that suppress the immune system within 4 weeks.
- Treatment with 5-FU, imiquimod, diclofenac, or photodynamic therapy within 8 weeks and 2 cm of treatment area
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 2 Vehicle gel Vehicle gel 1 PEP005 (ingenol mebutate) Gel PEP005 (ingenol mebutate) Gel
- Primary Outcome Measures
Name Time Method Patients With Complete Clearance of Actinic Keratosis (AKs) 57 days Complete clearance rate of actinic keratosis (AK) lesions defined as the proportion of patients with no clinically visible AK lesions in the selected treatment area.
- Secondary Outcome Measures
Name Time Method Patients With Partial Clearance of Actinic Keratosis (AKs) baseline and 57 days Partial clearance rate of AK lesions defined as the proportion of patients with a 75% or greater reduction in the number of actinic keratosis (AK) lesions identified at baseline in the selected treatment area.
Trial Locations
- Locations (20)
Omni Dermatology Research
🇺🇸Mesa, Arizona, United States
Henry Ford Health Systems
🇺🇸Detroit, Michigan, United States
Advanced Dermatology and Cosmetic Research
🇺🇸Kissimmee, Florida, United States
Park Avenue Dermatology
🇺🇸Orange Park, Florida, United States
Medaphase Inc
🇺🇸Newnan, Georgia, United States
Advanced Dermatology & Cosmetic Surgery
🇺🇸Ormond Beach, Florida, United States
Gwinnett Clinical Research Centre
🇺🇸Snellville, Georgia, United States
Dermatology Center of Indiana/Indiana Clinical Trials Center
🇺🇸Plainfield, Indiana, United States
Karen S. Harkaway, MD. LLC
🇺🇸South Delran, New Jersey, United States
Academic Dermatology Associates
🇺🇸Albuquerque, New Mexico, United States
Dermatology Associates of Rochester
🇺🇸Rochester, New York, United States
University Hospitals Case Medical Center
🇺🇸Cleveland, Ohio, United States
Oregon Medical Research
🇺🇸Portland, Oregon, United States
Oregon Health and Science University
🇺🇸Portland, Oregon, United States
Dermatology East
🇺🇸Germantown, Tennessee, United States
Rivergate Dermatology and Skin Care Center
🇺🇸Goodlettsville, Tennessee, United States
J & S Studies, Inc.
🇺🇸College Station, Texas, United States
The Skin Centre
🇦🇺Benowa, Queensland, Australia
Burswood Dermatology
🇦🇺Victoria Park, Western Australia, Australia
Colorado Medical Research Center
🇺🇸Denver, Colorado, United States