A Multi-center Study to Evaluate the Safety and Efficacy of PEP005 (Ingenol Mebutate) Gel, When Used to Treat Actinic Keratoses on Non-head Locations (Trunk and Extremities)
- Conditions
- Actinic Keratosis
- Interventions
- Drug: PEP005 Gel
- Registration Number
- NCT00917306
- Lead Sponsor
- Peplin
- Brief Summary
The open label study is designed to assess the safety and efficacy of 0.05% PEP005 Gel when applied to an area of skin containing 4-8 AK lesions on non-head locations.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 102
-
Patient is male or female and at least 18 years of age.
-
Female patient must be of either:
- Non-childbearing potential, post-menopausal, or there is a confirmed clinical history of sterility (e.g., the patient is without a uterus)
- Childbearing potential, provided there are negative urine pregnancy test results prior to study treatment, to rule out pregnancy
Exclusion Criteria
- Cosmetic or therapeutic procedures within two weeks and within 2 cm of the selected treatment area.
- Treatment with immunomodulators, 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.
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description PEP005 gel PEP005 Gel PEP005 gel, 0.05% administered once daily for 2 consecutive days
- Primary Outcome Measures
Name Time Method Safety (Incidence of treatment related AEs, local skin reactions and pigmentation and scarring) 57 days
- Secondary Outcome Measures
Name Time Method Efficacy (complete and partial clearance of AK lesions) 57 days
Trial Locations
- Locations (11)
Henry Ford Health Systems
🇺🇸Detroit, Michigan, United States
Dermatology Research Associates
🇺🇸Nashville, Tennessee, United States
Dematology on Ward
🇦🇺Adelaide, South Australia, Australia
Dermatology Institute of Victoria
🇦🇺Melbourne, Victoria, Australia
Park Avenue Dermatology
🇺🇸Orange Park, Florida, United States
Medaphase Inc
🇺🇸Newnan, Georgia, United States
Gwinnett Clinical Research Centre
🇺🇸Snellville, Georgia, United States
Michigan Center for Research Corp
🇺🇸Clinton Twp, Michigan, United States
Dermatology Associates of Rochester
🇺🇸Rochester, New York, United States
Oregon Health and Science University
🇺🇸Portland, Oregon, United States
St John of God Dermatology
🇦🇺Subiaco, Western Australia, Australia