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-IIb)
Phase 3
18 Years
N/A
18 Years
N/A
Not Enrolling
Both
Actinic Keratosis
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-IIb)
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:
Complete Clearance of Actinic Keratoses (AK) Lesions
Outcome Description:
Complete clearance of the treatment field
Outcome Time Frame:
baseline and 57 days
Safety Issue:
No
Authority:
United States: Food and Drug Administration
Study ID:
PEP005-025
NCT ID:
NCT00915551
Start Date:
June 2009
Completion Date:
September 2009
Related Keywords:
- Actinic Keratosis
- Peplin
- Actinic keratosis
- PEP005
- Keratosis
- Keratosis, Actinic
Name | Location |
|---|---|
| Mount Sinai School of Medicine | New York, New York 10029 |
| Academic Dermatology Associates | Albuquerque, New Mexico 87106 |
| North Florida Dermatology Associates, PA | Jacksonville, Florida 32204 |
| DermResearch, Inc. | Austin, Texas 78759 |
| Altman Dermatology Associates | Arlington Heights, Illinois 60004 |
| Premier Clinical Research | Spokane, Washington 99204 |
| Progressive Clinical Research | San Antonio, Texas 78229 |
| Burke Pharmaceutical Research | Hot Springs, Arizona 71913 |
| Skin Specialists, PC | Omaha, Nebraska |
| Center for Dermatology | Fremont, California 94538 |
| Laser Skin Surgery Center of Indiana | Carmel, Indiana 46032 |
| Deaconess Clinic, Inc | Evansville, Indiana 47713 |
| The Indiana Clinical Trials Center, PC | Plainfield, Indiana 46168 |
| Karl G. Heine Dermatology | Henderson, Nevada 89002 |
| Dermatology Associates of Rochester, PC | Rochester, New York 14623 |
| Dermatology, Laser Vein Specialists of the Carolinas | Charlotte, North Carolina 28207 |
| Oregon Medical Research Center, PC | Portland, Oregon 97223 |
| Suzanne Bruce and Associates, PA, The Center for Skin Research | Houston, Texas 77056 |
| The Education and Research Foundation | Lynchburg, Virginia 24501 |
