A Study to Evaluate the Photoirritation Potential of PEP005 (Ingenol Mebutate) Gel, 0.01% in Healthy Volunteers

A 4-Day, Randomized, Controlled, Open Application Study to Evaluate the Photoirritation Potential of PEP005 (Ingenol Mebutate) Gel, 0.01% in Healthy Volunteers, Using a Phototoxicity Test Design

This Phase 1 study is designed to determine the photoirritation potential of PEP005 Gel, 0.01% when application is followed by light exposure.

Inclusion Criteria:

• healthy males or females;
• in the case of females of childbearing potential, must be using effective contraception and must provide a negative pregnancy test;
• must read, understand and provide signed informed consent.

Exclusion Criteria:

• are not willing to refrain from using topical/systemic analgesics within 72 hours prior to and during the study;
• are using systemic/locally-acting medications during the study and within 2 weeks prior to the beginning of the study;
• are using systemic/locally-acting anti-inflammatories during the study and within 72 hours prior to the beginning of the study;
• have participated in any clinical testing of an investigational drug within 28 days or any clinical patch application within 14 days prior to enrollment or are currently participating in any clinical testing.