Tolerability and Pharmacokinetics of Ingenol Mebutate 0.05% Gel Applied to Treatment Areas up to 100cm(2) on the Forearm(s) of Patients with Actinic Keratosis.

ABSTRACT:

Objective

To determine safety, tolerability, and systemic absorption of ingenol mebutate 0.05% gel applied for two consecutive days to treatment areas up to 100cm(2) on the forearm(s) of patients with actinic keratosis.

Design and setting

Two studies are reported: a Phase 1, multicenter, open-label, dose-area escalation cohort study (http://www.clinicaltrials.gov/ct2/show/NCT00659893) and a Phase 2, double-blind, vehicle-controlled pharmacokinetic study (http://clinical trials.gov/ct2/show/NCT00852137).

Participants

The Phase 1 study included male patients (n=65), mean age 68.1 years; the Phase 2 study included both male and female patients (n=16), mean age 63.3 years.

Measurements

In the Phase 1 study, patients assigned to escalating dose-area cohorts were eva

SUBMITTER: Anderson L 

PROVIDER: S-EPMC4285446 | biostudies-literature | 2014 Dec

REPOSITORIES: biostudies-literature