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

Peplin

Status and phase

Completed

Phase 2

Conditions

Actinic Keratosis

Treatments

Drug: PEP005 (ingenol mebutate) Gel, 0.05%

Drug: Vehicle Gel

Study type

Interventional

Funder types

Industry

Identifiers

NCT00852137

PEP005-017

Details and patient eligibility

About

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

Enrollment

16 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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 criteria

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).