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

Completed · Phase 3

Conditions studied: Actinic Keratoses

In brief

The purpose of this study is to determine whether topical application of PEP005 is effective for the treatment of actinic keratoses.

Key facts

Study ID

NCT00742391

Run by

Peplin

People needed

255

Starts

2008-09-01

Expected to finish

2009-02-01

Last updated by the study team

2015-03-06

Who can join

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

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• Omni Dermatology Research — Mesa, Arizona, United States
• Colorado Medical Research Center — Denver, Colorado, United States
• Advanced Dermatology and Cosmetic Research — Kissimmee, Florida, United States
• Park Avenue Dermatology — Orange Park, Florida, United States
• Advanced Dermatology & Cosmetic Surgery — Ormond Beach, Florida, United States
• Medaphase Inc — Newnan, Georgia, United States
• Gwinnett Clinical Research Centre — Snellville, Georgia, United States
• Dermatology Center of Indiana/Indiana Clinical Trials Center — Plainfield, Indiana, United States
• Henry Ford Health Systems — Detroit, Michigan, United States
• Karen S. Harkaway, MD. LLC — South Delran, New Jersey, United States
• Academic Dermatology Associates — Albuquerque, New Mexico, United States
• Dermatology Associates of Rochester — Rochester, New York, United States
• University Hospitals Case Medical Center — Cleveland, Ohio, United States
• Oregon Medical Research — Portland, Oregon, United States
• Oregon Health and Science University — Portland, Oregon, United States
• Dermatology East — Germantown, Tennessee, United States
• Rivergate Dermatology and Skin Care Center — Goodlettsville, Tennessee, United States
• J & S Studies, Inc. — College Station, Texas, United States
• The Skin Centre — Benowa, Queensland, Australia
• Burswood Dermatology — Victoria Park, Western Australia, Australia

Full record on ClinicalTrials.gov

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