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A Multi-center Study to Evaluate the Safety and Efficacy of PEP005 (Ingenol Mebutate) Gel, When Used to Treat Actinic Keratoses on Non-head Locations (Trunk and Extremities)

NCT00917306 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 102

Last updated 2015-04-15

No results posted yet for this study

Summary

The open label study is designed to assess the safety and efficacy of 0.05% PEP005 Gel when applied to an area of skin containing 4-8 AK lesions on non-head locations.

Conditions

  • Actinic Keratosis

Interventions

DRUG

PEP005 Gel

0.05% two day treatment

Sponsors & Collaborators

  • TKL Research, Inc.

    collaborator INDUSTRY

  • Peplin

    lead INDUSTRY

Principal Investigators

  • Eugene Bauer, MD · Chief Medical Officer

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-06-30
Primary Completion
2009-09-30
Completion
2009-09-30

Countries

  • United States
  • Australia

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 NCT00917306 on ClinicalTrials.gov