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

NCT00942604

Run by

Peplin

People needed

203

Starts

2009-07-01

Expected to finish

2009-10-01

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

• Burke Pharmaceutical Research — Hot Springs, Arizona, United States
• Skin Surgery Medical Group Inc. — San Diego, California, United States
• Atlanta Dermatology, Vein & Research Center, LLC — Alpharetta, Georgia, United States
• Altman Dermatology Associates — Arlington Heights, Illinois, United States
• Glazer Dermatology — Buffalo Grove, Illinois, United States
• Deaconess Clinic Downtown — Evansville, Indiana, United States
• Dawes Fretzin Clinical Research Group, LLC — Indianapolis, Indiana, United States
• Skin Specialists, PC — Omaha, Nebraska, United States
• Karl G. Heine Dermatology — Henderson, Nevada, United States
• Group Health Associates — Cincinnati, Ohio, United States
• DermResearch, Inc. — Austin, Texas, United States
• Suzanne Bruce and Associates, PA, The Center for Skin Research — Houston, Texas, United States
• Dermatology Clinical Research Center of San Antonio — San Antonio, Texas, United States
• Dermatology Associates of Tyler — Tyler, Texas, United States
• Dermatology Research Center, Inc. — Salt Lake City, Utah, United States
• The Education and Research Foundation — Lynchburg, Virginia, United States
• Virginia Clinical Research, Inc — Norfolk, Virginia, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.