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

NCT00852137 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 16

Last updated 2015-03-06

Study results available
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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 actinic keratoses

Conditions

  • Actinic Keratosis

Interventions

DRUG

PEP005 (ingenol mebutate) Gel, 0.05%

PEP005 (ingenol mebutate) Gel 0.05% once daily for 2 consecutive days

DRUG

Vehicle Gel

Vehicle Gel once daily for 2 consecutive days

Sponsors & Collaborators

  • Peplin

    lead INDUSTRY

Principal Investigators

  • Michael Jarratt, MD · Derm Research, PLLC

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-03-31
Primary Completion
2009-06-30
Completion
2009-06-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00852137 on ClinicalTrials.gov