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Completed Phase 3 Interventional Results available

A Multicenter Study to Evaluate the Efficacy and Safety of PEP005 (Ingenol Mebutate) Gel When Used to Treat Actinic Keratoses (AKs) on the Non Head Locations

ClinicalTrials.gov ID: NCT00742391

Public ClinicalTrials.gov record NCT00742391. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Oct 22, 2026, 1:51 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

A Multi-center, Randomized, Parallel Group, Double-blind, Vehicle-controlled Study to Evaluate the Efficacy and Safety of PEP005 (Ingenol Mebutate) Gel, 0.05% In Patients With Actinic Keratoses ON Non-head Locations (REGION-I)

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

The purpose of this study is to determine whether topical application of PEP005 is effective for the treatment of actinic keratoses.

Study identification

NCT ID
NCT00742391
Recruitment status
Completed
Study type
Interventional
Phase
Phase 3
Lead sponsor
Peplin
Industry
Enrollment
255 participants

Conditions and interventions

Eligibility (public fields only)

Age range
18 Years and older
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Sep 2008 (Type not available)
Primary completion
Feb 2009 (Actual)
Completion
Feb 2009 (Actual)
Last update posted
Mar 6, 2015

2008 – 2009

United States locations

U.S. sites
18
U.S. states
13
U.S. cities
17
Facility City State ZIP Site status
Omni Dermatology Research Mesa Arizona 85206 —
Colorado Medical Research Center Denver Colorado 80210 —
Advanced Dermatology and Cosmetic Research Kissimmee Florida 34741 —
Park Avenue Dermatology Orange Park Florida 32073 —
Advanced Dermatology & Cosmetic Surgery Ormond Beach Florida 32174 —
Medaphase Inc Newnan Georgia 30263 —
Gwinnett Clinical Research Centre Snellville Georgia 30078-3250 —
Dermatology Center of Indiana/Indiana Clinical Trials Center Plainfield Indiana 46168 —
Henry Ford Health Systems Detroit Michigan 48202 —
Karen S. Harkaway, MD. LLC South Delran New Jersey 08075 —
Academic Dermatology Associates Albuquerque New Mexico 87106 —
Dermatology Associates of Rochester Rochester New York 14623 —
University Hospitals Case Medical Center Cleveland Ohio 44121 —
Oregon Medical Research Portland Oregon 97223 —
Oregon Health and Science University Portland Oregon 97239-4501 —
Dermatology East Germantown Tennessee 38138 —
Rivergate Dermatology and Skin Care Center Goodlettsville Tennessee 37072 —
J & S Studies, Inc. College Station Texas 77845 —

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 2 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT00742391, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Mar 6, 2015 · Synced Oct 22, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT00742391 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →