A Multi-center, Open-label Study to Evaluate the Safety and Efficacy of PEP005 (Ingenol Mebutate) Gel, 0.05% in Patients With Actinic Keratoses on Non-head Locations (Trunk and Extremities)
Phase 3
18 Years
N/A
18 Years
N/A
Not Enrolling
Both
Actinic Keratosis
Both
Actinic Keratosis
Trial Information
A Multi-center, Open-label Study to Evaluate the Safety and Efficacy of PEP005 (Ingenol Mebutate) Gel, 0.05% in Patients With Actinic Keratoses on Non-head Locations (Trunk and Extremities)
Inclusion Criteria:
- 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.
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Safety (Incidence of treatment related AEs, local skin reactions and pigmentation and scarring)
Outcome Time Frame:
57 days
Safety Issue:
Yes
Authority:
United States: Food and Drug Administration
Study ID:
PEP005-020
NCT ID:
NCT00917306
Start Date:
June 2009
Completion Date:
September 2009
Related Keywords:
- Actinic Keratosis
- Peplin
- Actinic keratosis
- PEP005
- Keratosis
- Keratosis, Actinic
Name | Location |
|---|---|
| Henry Ford Health Systems | Detroit, Michigan 48202 |
| Oregon Health and Science University | Portland, Oregon 97201 |
| Park Avenue Dermatology | Orange Park, Florida 32073 |
| Dermatology Associates of Rochester | Rochester, New York 14623 |
| Gwinnett Clinical Research Centre | 2383 Pate St, Snellville, Georgia 30078-3250 |
| Medaphase Inc | Newnan, Georgia 30263 |
| Dermatology Research Associates | Nashville, Tennessee 37203 |
| Michigan Center for Research Corp | Clinton Twp, Michigan 48038 |
