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)

Completed · Phase 3

Conditions studied: Actinic Keratosis

In brief

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.

Key facts

Study ID

NCT00917306

Run by

Peplin

People needed

102

Starts

2009-06-01

Expected to finish

2009-09-01

Last updated by the study team

2015-04-15

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• Park Avenue Dermatology — Orange Park, Florida, United States
• Medaphase Inc — Newnan, Georgia, United States
• Gwinnett Clinical Research Centre — Snellville, Georgia, United States
• Michigan Center for Research Corp — Clinton Twp, Michigan, United States
• Henry Ford Health Systems — Detroit, Michigan, United States
• Dermatology Associates of Rochester — Rochester, New York, United States
• Oregon Health and Science University — Portland, Oregon, United States
• Dermatology Research Associates — Nashville, Tennessee, United States
• Dematology on Ward — Adelaide, South Australia, Australia
• Dermatology Institute of Victoria — Melbourne, Victoria, Australia
• St John of God Dermatology — Subiaco, Western Australia, Australia

Full record on ClinicalTrials.gov

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