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 :
July 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2009
Estimated Enrollment :
203 Patients enrolled
Trial Details
Trial ID
NCT00942604
Start Date
July 1 2009
End Date
October 1 2009
Last Update
March 6 2015
Active Locations (17)
Enter a location and click search to find clinical trials sorted by distance.
1
Burke Pharmaceutical Research
Hot Springs, Arizona, United States, 71913
2
Skin Surgery Medical Group Inc.
San Diego, California, United States, 92117
3
Atlanta Dermatology, Vein & Research Center, LLC
Alpharetta, Georgia, United States, 30022
4
Altman Dermatology Associates
Arlington Heights, Illinois, United States, 60005