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 (Ingenol Mebutate) gel, 0.015%Drug: Vehicle Gel
- Registration Number
- NCT00915551
- 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
- 278
-
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 (Ingenol Mebutate) gel PEP005 (Ingenol Mebutate) gel, 0.015% - Vehicle gel Vehicle Gel -
- Primary Outcome Measures
Name Time Method Complete Clearance of Actinic Keratoses (AK) Lesions baseline and 57 days Complete clearance of the treatment field
- Secondary Outcome Measures
Name Time Method Partial Clearance of Actinic Keratoses (AK) baseline and 57 days Partial clearance defined as ≥ 75% reduction in the number of AK lesions identified at baseline in the treatment area
Trial Locations
- Locations (21)
Karl G. Heine Dermatology
🇺🇸Henderson, Nevada, United States
Center for Dermatology
🇺🇸Fremont, California, United States
Altman Dermatology Associates
🇺🇸Arlington Heights, Illinois, United States
Academic Dermatology Associates
🇺🇸Albuquerque, New Mexico, United States
Laser Skin Surgery Center of Indiana
🇺🇸Carmel, Indiana, United States
Mount Sinai School of Medicine
🇺🇸New York, New York, United States
Progressive Clinical Research
🇺🇸San Antonio, Texas, United States
DermResearch, Inc.
🇺🇸Austin, Texas, United States
Oregon Medical Research Center, PC
🇺🇸Portland, Oregon, United States
North Florida Dermatology Associates, PA
🇺🇸Jacksonville, Florida, United States
Burke Pharmaceutical Research
🇺🇸Hot Springs, Arizona, United States
The Indiana Clinical Trials Center, PC
🇺🇸Plainfield, Indiana, United States
Dermatology, Laser Vein Specialists of the Carolinas
🇺🇸Charlotte, North Carolina, United States
South East Dermatology, Belmont Specialist Centre
🇦🇺Carina Heights, Queensland, Australia
The Skin Centre
🇦🇺Benowa, Queensland, Australia
Suzanne Bruce and Associates, PA, The Center for Skin Research
🇺🇸Houston, Texas, United States
Deaconess Clinic, Inc
🇺🇸Evansville, Indiana, United States
Skin Specialists, PC
🇺🇸Omaha, Nebraska, United States
Dermatology Associates of Rochester, PC
🇺🇸Rochester, New York, United States
The Education and Research Foundation
🇺🇸Lynchburg, Virginia, United States
Premier Clinical Research
🇺🇸Spokane, Washington, United States