Status:
COMPLETED
A Multicenter Study to Evaluate the Efficacy and Safety of PEP005 (Ingenol Mebutate) Gel When Used to Treat Actinic Keratoses (AKs) on the Non Head Locations
Lead Sponsor:
Peplin
Conditions:
Actinic Keratoses
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
The purpose of this study is to determine whether topical application of PEP005 is effective for the treatment of actinic keratoses.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2009
Estimated Enrollment :
255 Patients enrolled
Trial Details
Trial ID
NCT00742391
Start Date
September 1 2008
End Date
February 1 2009
Last Update
March 6 2015
Active Locations (20)
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1
Omni Dermatology Research
Mesa, Arizona, United States, 85206
2
Colorado Medical Research Center
Denver, Colorado, United States, 80210
3
Advanced Dermatology and Cosmetic Research
Kissimmee, Florida, United States, 34741
4
Park Avenue Dermatology
Orange Park, Florida, United States, 32073