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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00742391
Recruitment Status : Completed
First Posted : August 27, 2008
Results First Posted : March 21, 2012
Last Update Posted : March 6, 2015
Information provided by (Responsible Party):

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

Condition or disease Intervention/treatment Phase
Actinic Keratoses Drug: PEP005 (ingenol mebutate) Gel Drug: Vehicle gel Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 255 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
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)
Study Start Date : September 2008
Actual Primary Completion Date : February 2009
Actual Study Completion Date : February 2009

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: 1
PEP005 (ingenol mebutate) Gel
Drug: PEP005 (ingenol mebutate) Gel
two day treatment
Placebo Comparator: 2
Vehicle gel
Drug: Vehicle gel
two day treatment

Primary Outcome Measures :
  1. Patients With Complete Clearance of Actinic Keratosis (AKs) [ Time Frame: 57 days ]
    Complete clearance rate of actinic keratosis (AK) lesions defined as the proportion of patients with no clinically visible AK lesions in the selected treatment area.

Secondary Outcome Measures :
  1. Patients With Partial Clearance of Actinic Keratosis (AKs) [ Time Frame: baseline and 57 days ]
    Partial clearance rate of AK lesions defined as the proportion of patients with a 75% or greater reduction in the number of actinic keratosis (AK) lesions identified at baseline in the selected treatment area.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Must be male or female and at least 18 years of age.
  • Female patients must be of:
  • Non-childbearing potential;
  • Childbearing potential, provided negative serum and urine pregnancy test and using effective contraception.
  • 4 to 8 AK lesions on non-head locations.

Exclusion Criteria:

  • Cosmetic or therapeutic procedures within 2 weeks and within 2 cm of the selected treatment area.
  • 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 2 cm of treatment area

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00742391

United States, Arizona
Omni Dermatology Research
Mesa, Arizona, United States, 85206
United States, Colorado
Colorado Medical Research Center
Denver, Colorado, United States, 80210
United States, Florida
Advanced Dermatology and Cosmetic Research
Kissimmee, Florida, United States, 34741
Park Avenue Dermatology
Orange Park, Florida, United States, 32073
Advanced Dermatology & Cosmetic Surgery
Ormond Beach, Florida, United States, 32174
United States, Georgia
Medaphase Inc
Newnan, Georgia, United States, 30263
Gwinnett Clinical Research Centre
Snellville, Georgia, United States, 30078-3250
United States, Indiana
Dermatology Center of Indiana/Indiana Clinical Trials Center
Plainfield, Indiana, United States, 46168
United States, Michigan
Henry Ford Health Systems
Detroit, Michigan, United States, 48202
United States, New Jersey
Karen S. Harkaway, MD. LLC
South Delran, New Jersey, United States, 08075
United States, New Mexico
Academic Dermatology Associates
Albuquerque, New Mexico, United States, 87106
United States, New York
Dermatology Associates of Rochester
Rochester, New York, United States, 14623
United States, Ohio
University Hospitals Case Medical Center
Cleveland, Ohio, United States, 44121
United States, Oregon
Oregon Medical Research
Portland, Oregon, United States, 97223
Oregon Health and Science University
Portland, Oregon, United States, 97239-4501
United States, Tennessee
Dermatology East
Germantown, Tennessee, United States, 38138
Rivergate Dermatology and Skin Care Center
Goodlettsville, Tennessee, United States, 37072
United States, Texas
J & S Studies, Inc.
College Station, Texas, United States, 77845
Australia, Queensland
The Skin Centre
Benowa, Queensland, Australia, 4217
Australia, Western Australia
Burswood Dermatology
Victoria Park, Western Australia, Australia, 6100
Sponsors and Collaborators

Additional Information:
Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Peplin Identifier: NCT00742391     History of Changes
Other Study ID Numbers: PEP005-014
First Posted: August 27, 2008    Key Record Dates
Results First Posted: March 21, 2012
Last Update Posted: March 6, 2015
Last Verified: March 2012

Keywords provided by Peplin:
Actinic keratosis

Additional relevant MeSH terms:
Keratosis, Actinic
Skin Diseases
Precancerous Conditions