A Multi-center, Randomized, Parallel Group, Double-blind, Vehicle-controlled Study to Evaluate the Efficacy and Safety of PEP005 (Ingenol Mebutate) Gel, 0.05% In Patients With Actinic Keratoses ON Non-head Locations (REGION-I)
18 Years
N/A
Both
Actinic Keratoses
Trial Information
A Multi-center, Randomized, Parallel Group, Double-blind, Vehicle-controlled Study to Evaluate the Efficacy and Safety of PEP005 (Ingenol Mebutate) Gel, 0.05% In Patients With Actinic Keratoses ON Non-head Locations (REGION-I)
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
Outcome Measure:
Patients With Complete Clearance of Actinic Keratosis (AKs)
Outcome Description:
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.
Outcome Time Frame:
57 days
Safety Issue:
No
Authority:
United States: Food and Drug Administration
Study ID:
PEP005-014
NCT ID:
NCT00742391
Start Date:
September 2008
Completion Date:
February 2009
Related Keywords:
- Actinic Keratoses
- Peplin
- Actinic keratosis
- PEP005
- Keratosis
- Keratosis, Actinic
Name | Location |
|---|---|
| Henry Ford Health Systems | Detroit, Michigan 48202 |
| Oregon Health and Science University | Portland, Oregon 97201 |
| Colorado Medical Research Center | Denver, Colorado 80210 |
| Academic Dermatology Associates | Albuquerque, New Mexico 87106 |
| Park Avenue Dermatology | Orange Park, Florida 32073 |
| University Hospitals Case Medical Center | Cleveland, Ohio 44106 |
| Dermatology Associates of Rochester | Rochester, New York 14623 |
| Oregon Medical Research | Centre9495 SW Locust St., Suite G Portland, Oregon 97223 |
| Rivergate Dermatology and Skin Care Center | 201 Bluebird Dr, Goodlettsville, Tennessee |
| Gwinnett Clinical Research Centre | 2383 Pate St, Snellville, Georgia 30078-3250 |
| Medaphase Inc | Newnan, Georgia 30263 |
| Omni Dermatology Research | Mesa, Arizona 85206 |
| Advanced Dermatology and Cosmetic Research | Kissimmee, Florida 34741 |
| Advanced Dermatology & Cosmetic Surgery | Ormond Beach, Florida 32174 |
| Dermatology Center of Indiana/Indiana Clinical Trials Center | Plainfield, Indiana 46168 |
| Karen S. Harkaway, MD. LLC | South Delran, New Jersey 08075 |
| Dermatology East | Germantown, Tennessee 38138 |
| J & S Studies, Inc. | College Station, Texas 77845 |
