A Multi-center, Randomized, Parallel Group, Double-blind, Vehicle-controlled Study to Evaluate the Efficacy and Safety of PEP005 (Ingenol Mebutate) Gel, 0.015% In Patients With Actinic Keratoses ON the Head (Face or Scalp) (REGION-IIa)
18 Years
N/A
Both
Actinic Keratosis
Trial Information
A Multi-center, Randomized, Parallel Group, Double-blind, Vehicle-controlled Study to Evaluate the Efficacy and Safety of PEP005 (Ingenol Mebutate) Gel, 0.015% In Patients With Actinic Keratoses ON the Head (Face or Scalp) (REGION-IIa)
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
Outcome Measure:
Patients With Complete Clearance of Actinic Keratosis (AK) Lesions.
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:
PEP005-016
NCT ID:
NCT00916006
Start Date:
June 2009
Completion Date:
September 2009
Related Keywords:
- Actinic Keratosis
- Peplin
- Actinic keratosis
- PEP005
- Keratosis
- Keratosis, Actinic
Name | Location |
|---|---|
| Dermatology Specialists Inc | Vista, California 92083 |
| Minnesota Clinical Study Center | Fridley, Minnesota 55432 |
| Center For Clinical Studies | Houston, Texas 77030 |
| Virginia Clinical Research, Inc | Norfolk, Virginia 23507 |
| Wake Research Associates | Raleigh, North Carolina 27612 |
| Dermatology Associates of Tyler | Tyler, Texas 75703 |
| Skin Surgery Medical Group Inc. | 5222 Balboa Avenue Sixth Floor, San Diego, California |
| Dermatology Research Associates | Los Angeles, California 90045 |
| Hamzavi Dermatology | Fort Gratiot, Michigan 48059 |
| Glazer Dermatology | Buffalo Grove, Illinois 60089 |
| Medaphase Inc | Newnan, Georgia 30263 |
| Dermatology Research Associates | Nashville, Tennessee 37203 |
| J & S Studies, Inc. | College Station, Texas 77845 |
| Conant Medical Group | San Francisco, California 94114 |
| University of Miami, Skin Research Camp | Miami, Florida 33136 |
| Atlanta Dermatology, Vein & Research Center, LLC | Alpharetta, Georgia 30022 |
| Dawes Fretein Clinical Research Group, LLC | Indianapolis, Indiana 46256 |
| Pedia Research LLC | Owensboro, Kentucky 42301 |
| Dermatology Research Center, Inc. | Salt Lake City, Utah 84124 |
