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

• Status: Completed
• Trial end date: 2009-10-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Peplin

Criteria

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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