A Multi-center Study to Evaluate the Efficacy and Safety of PEP005 (Ingenol Mebutate) Gel, When Used to Treat Actinic Keratoses on the Head (Face or Scalp)

Completed · Phase 3 · Has a placebo group

Conditions studied: Actinic Keratosis

In brief

This Phase III study is designed to assess the efficacy and safety of PEP005 Gel, 0.015% when applied to an area of skin containing 4-8 AK lesions on the face or scalp.

Key facts

Study ID

NCT00916006

Run by

Peplin

People needed

269

Starts

2009-06-01

Expected to finish

2009-09-01

Last updated by the study team

2015-04-02

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 patients must be of either:
• Non-childbearing potential, post-menopausal
• Childbearing potential, provided there are negative serum and urine pregnancy test results prior to study treatment, to rule out pregnancy

You may not qualify if…

• Cosmetic or therapeutic procedures within 2 weeks and 2cm 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 the selected treatment area

Where it is running

• Dermatology Research Associates — Los Angeles, California, United States
• Dermatology Specialists Inc — Oceanside, California, United States
• Skin Surgery Medical Group Inc. — San Diego, California, United States
• Conant Medical Group — San Francisco, California, United States
• University of Miami, Skin Research Camp — Miami, Florida, United States
• Atlanta Dermatology, Vein & Research Center, LLC — Alpharetta, Georgia, United States
• Medaphase Inc — Newnan, Georgia, United States
• Glazer Dermatology — Buffalo Grove, Illinois, United States
• Dawes Fretein Clinical Research Group, LLC — Indianapolis, Indiana, United States
• Pedia Research LLC — Owensboro, Kentucky, United States
• Hamzavi Dermatology — Fort Gratiot, Michigan, United States
• Minnesota Clinical Study Center — Fridley, Minnesota, United States
• Wake Research Associates — Raleigh, North Carolina, United States
• Dermatology Research Associates — Nashville, Tennessee, United States
• J & S Studies, Inc. — College Station, Texas, United States
• Dermatology Associates of Tyler — Tyler, Texas, United States
• Center for Clinical Studies — Webster, Texas, United States
• Dermatology Research Center, Inc. — Salt Lake City, Utah, United States
• Virginia Clinical Research, Inc — Norfolk, Virginia, United States
• Southderm Pty Ltd — Kogarah, New South Wales, Australia
• St George Dematology and Skin Cancer Centre — Kogarah, New South Wales, Australia

Full record on ClinicalTrials.gov

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