Status:
COMPLETED
Safety and Toleration of PEP005 Topical Gel When Applied to a Treatment Area of up to 100cm2
Lead Sponsor:
Peplin
Conditions:
Actinic Keratosis
Eligibility:
MALE
18+ years
Phase:
PHASE1
Brief Summary
Study Hypothesis: Safety and Tolerability will differ when treating multiple contiguous 25 cm2 treatment areas, as compared to individual 25 cm2 treatment areas.
Eligibility Criteria
Inclusion
- Must be male and at least 18 years of age.
- A 100 cm2 contiguous treatment area on each of the right and left extensor (dorsal aspect) forearms, each containing a minimum of 5 AK lesions.
Exclusion
- Cosmetic or therapeutic procedures (e.g., use of liquid nitrogen, surgical excision, curettage, dermabrasion, medium or greater depth chemical peel, laser resurfacing): within 2 weeks and within 2 cm of the selected treatment area(s).
- 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 within 2 cm of the selected treatment area(s).
Key Trial Info
Start Date :
April 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2008
Estimated Enrollment :
64 Patients enrolled
Trial Details
Trial ID
NCT00659893
Start Date
April 1 2008
End Date
November 1 2008
Last Update
September 14 2015
Active Locations (13)
Enter a location and click search to find clinical trials sorted by distance.
1
Radiant Research
Tucson, Arizona, United States, 85710
2
Skin Surgery Medical Group Inc.
San Diego, California, United States, 92117
3
Park Avenue Dermatology
Orange Park, Florida, United States, 32073
4
Advanced Dermatology and Cosmetic Surgery
Ormond Beach, Florida, United States, 32174