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
Interventional
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
To determine the photoirritation potential of PEP005 Gel, when application is followed by light exposure.
4 days
Yes
Jonothan S Dosik, MD
Principal Investigator
TKL Research
United States: Food and Drug Administration
PEP005-023
NCT00850811
February 2009
April 2009
Name | Location |
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TKL Research, Inc. | Paramus, New Jersey 07652 |