Status:
COMPLETED
A Multi-center Study to Evaluate the Safety and Efficacy of PEP005 (Ingenol Mebutate) Gel, When Used to Treat Actinic Keratoses on Non-head Locations (Trunk and Extremities)
Lead Sponsor:
Peplin
Collaborating Sponsors:
TKL Research, Inc.
Conditions:
Actinic Keratosis
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
The open label study is designed to assess the safety and efficacy of 0.05% PEP005 Gel when applied to an area of skin containing 4-8 AK lesions on non-head locations.
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
June 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2009
Estimated Enrollment :
102 Patients enrolled
Trial Details
Trial ID
NCT00917306
Start Date
June 1 2009
End Date
September 1 2009
Last Update
April 15 2015
Active Locations (11)
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1
Park Avenue Dermatology
Orange Park, Florida, United States, 32073
2
Medaphase Inc
Newnan, Georgia, United States, 30263
3
Gwinnett Clinical Research Centre
Snellville, Georgia, United States, 30078-3250
4
Michigan Center for Research Corp
Clinton Twp, Michigan, United States, 48038