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

Peplin

Status and phase

Completed

Phase 3

Conditions

Actinic Keratoses

Treatments

Drug: Vehicle gel

Drug: PEP005 (ingenol mebutate) Gel

Study type

Interventional

Funder types

Industry

Identifiers

PEP005-014

Details and patient eligibility

About

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

Enrollment

255 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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