Overview

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

Status:
Completed
Trial end date:
2009-04-01
Target enrollment:
0
Participant gender:
All
Summary
This Phase 1 study is designed to determine the photoallergic potential of PEP005 Gel, 0.01% and it's vehicle on normal skin.
Phase:
Phase 1
Accepts Healthy Volunteers?
Accepts Healthy Volunteers
Details
Lead Sponsor:
Peplin
Criteria
Inclusion Criteria:

- are healthy males or females;

- in the case of females of childbearing potential, are using an acceptable form of
birth control and provide a negative urine pregnancy test;

- 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.