Status:
COMPLETED
A Study to Evaluate the Photoirritation Potential of PEP005 (Ingenol Mebutate) Gel, 0.01% in Healthy Volunteers
Lead Sponsor:
Peplin
Conditions:
Actinic Keratosis
Eligibility:
All Genders
18-65 years
Phase:
PHASE1
Brief Summary
This Phase 1 study is designed to determine the photoirritation potential of PEP005 Gel, 0.01% when application is followed by light exposure.
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
February 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2009
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT00850811
Start Date
February 1 2009
End Date
April 1 2009
Last Update
September 9 2015
Active Locations (1)
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1
TKL Research, Inc.
Paramus, New Jersey, United States, 07652