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-Ib)
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-Ib)
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:
Proportion of Patients With Complete Clearance of Actinic Keratoses (AK) Lesions
Outcome Description:
Proportion of Patients with Complete Clearance of the treatment field defined as no clinically visible Actinic Keratoses (AK) lesions in the selected treatment area
Outcome Time Frame:
57 days
Safety Issue:
No
Authority:
United States: Food and Drug Administration
Study ID:
PEP005-028
NCT ID:
NCT00942604
Start Date:
July 2009
Completion Date:
October 2009
Related Keywords:
- Actinic Keratoses
- Peplin
- Actinic keratosis
- PEP005
- Keratosis
- Keratosis, Actinic
Name | Location |
|---|---|
| Virginia Clinical Research, Inc | Norfolk, Virginia 23507 |
| Dawes Fretzin Clinical Research Group, LLC | Indianapolis, Indiana 46256 |
| Dermatology Clinical Research Center of San Antonio | San Antonio, Texas 78229 |
| DermResearch, Inc. | Austin, Texas 78759 |
| Altman Dermatology Associates | Arlington Heights, Illinois 60004 |
| Dermatology Associates of Tyler | Tyler, Texas 75703 |
| Skin Surgery Medical Group Inc. | 5222 Balboa Avenue Sixth Floor, San Diego, California |
| Glazer Dermatology | Buffalo Grove, Illinois 60089 |
| Burke Pharmaceutical Research | Hot Springs, Arizona 71913 |
| Skin Specialists, PC | Omaha, Nebraska |
| Karl G. Heine Dermatology | Henderson, Nevada 89002 |
| Suzanne Bruce and Associates, PA, The Center for Skin Research | Houston, Texas 77056 |
| The Education and Research Foundation | Lynchburg, Virginia 24501 |
| Atlanta Dermatology, Vein & Research Center, LLC | Alpharetta, Georgia 30022 |
| Dermatology Research Center, Inc. | Salt Lake City, Utah 84124 |
| Deaconess Clinic Downtown | Evansville, Indiana 47713 |
| Group Health Associates | Cincinnati, Ohio 45220 |
