A Multi-center Study to Evaluate the Efficacy and Safety of PEP005 (Ingenol Mebutate) Gel, When Used to Treat Actinic Keratoses on the Head (Face or Scalp)
- Conditions
- Actinic Keratosis
- Interventions
- Drug: PEP005 GelDrug: Vehicle gel
- Registration Number
- NCT00916006
- Lead Sponsor
- Peplin
- Brief Summary
This Phase III study is designed to assess the efficacy and safety of PEP005 Gel, 0.015% when applied to an area of skin containing 4-8 AK lesions on the face or scalp.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 269
-
Patient is male or female and at least 18 years of age
-
Female patients must be of either:
- Non-childbearing potential, post-menopausal
- Childbearing potential, provided there are negative serum and urine pregnancy test results prior to study treatment, to rule out pregnancy
- Cosmetic or therapeutic procedures within 2 weeks and 2cm 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 the selected treatment area
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description PEP005 gel PEP005 Gel PEP005 gel, 0.015% applied once daily for three consecutive days Vehicle gel Vehicle gel Vehicle gel applied once daily for three consecutive days
- Primary Outcome Measures
Name Time Method Patients With Complete Clearance of Actinic Keratosis (AK) Lesions. 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 (AK) baseline and 57 days Patients with partial clearance defined as ≥ 75% reduction in the number of actinic keratosis (AK) lesions identified at baseline in the treatment area
Trial Locations
- Locations (20)
Wake Research Associates
🇺🇸Raleigh, North Carolina, United States
Pedia Research LLC
🇺🇸Owensboro, Kentucky, United States
University of Miami, Skin Research Camp
🇺🇸Miami, Florida, United States
Skin Surgery Medical Group Inc.
🇺🇸San Diego, California, United States
Hamzavi Dermatology
🇺🇸Fort Gratiot, Michigan, United States
Minnesota Clinical Study Center
🇺🇸Fridley, Minnesota, United States
J & S Studies, Inc.
🇺🇸College Station, Texas, United States
Dermatology Associates of Tyler
🇺🇸Tyler, Texas, United States
St George Dematology and Skin Cancer Centre
🇦🇺Kogarah, New South Wales, Australia
Dermatology Research Center, Inc.
🇺🇸Salt Lake City, Utah, United States
Center for Clinical Studies
🇺🇸Webster, Texas, United States
Southderm Pty Ltd
🇦🇺Kogarah, New South Wales, Australia
Medaphase Inc
🇺🇸Newnan, Georgia, United States
Dermatology Specialists Inc
🇺🇸Oceanside, California, United States
Dermatology Research Associates
🇺🇸Nashville, Tennessee, United States
Atlanta Dermatology, Vein & Research Center, LLC
🇺🇸Alpharetta, Georgia, United States
Glazer Dermatology
🇺🇸Buffalo Grove, Illinois, United States
Dawes Fretein Clinical Research Group, LLC
🇺🇸Indianapolis, Indiana, United States
Conant Medical Group
🇺🇸San Francisco, California, United States
Virginia Clinical Research, Inc
🇺🇸Norfolk, Virginia, United States