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

Completed · Phase 1

Conditions studied: Actinic Keratosis

In brief

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

Key facts

Study ID

NCT00850811

Run by

Peplin

People needed

30

Starts

2009-02-01

Expected to finish

2009-04-01

Last updated by the study team

2015-09-09

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• TKL Research, Inc. — Paramus, New Jersey, United States

Full record on ClinicalTrials.gov

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