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

Completed · Phase 2

Conditions studied: Actinic Keratosis

In brief

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 actinic keratoses

Key facts

Study ID

NCT00852137

Run by

Peplin

People needed

16

Starts

2009-03-01

Expected to finish

2009-06-01

Last updated by the study team

2015-03-06

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Male or female;
• Multiple actinic keratosis (AK) lesions over a 100 cm\^2 area of skin located on the dorsal aspect of one forearm.

You may not qualify if…

• 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).

Where it is running

• DermResearch, Inc. — Austin, Texas, United States

Full record on ClinicalTrials.gov

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