Status:
COMPLETED
A Study to Evaluate the Pharmacokinetics of PEP005 (Ingenol Mebutate) Gel, 0.05%, When Applied in a Maximal Use Setting to the Dorsal Aspect of the Forearm in Patients With Actinic Keratosis
Lead Sponsor:
Peplin
Conditions:
Actinic Keratosis
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
This Phase II study is designed to evaluate the pharmacokinetics of PEP005 (ingenol mebutate) Gel, 0.05% when applied in a maximal use setting to the dorsal aspect of the forearm in patients with acti...
Eligibility Criteria
Inclusion
- Male or female;
- Multiple actinic keratosis (AK) lesions over a 100 cm\^2 area of skin located on the dorsal aspect of one forearm.
Exclusion
- Cosmetic or therapeutic procedures: within 2 weeks and within 2 cm of the selected treatment area(s);
- Treatment with immunomodulators, or interferon/interferon inducers or systemic medications that suppress the immune system: within 4 weeks;
- Treatment with 5-FU, imiquimod, diclofenac, or photodynamic therapy: within 8 weeks and within 2 cm of the selected treatment area(s).
Key Trial Info
Start Date :
March 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2009
Estimated Enrollment :
16 Patients enrolled
Trial Details
Trial ID
NCT00852137
Start Date
March 1 2009
End Date
June 1 2009
Last Update
March 6 2015
Active Locations (1)
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1
DermResearch, Inc.
Austin, Texas, United States, 78759