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: NCT00942604
Recruitment Status : Completed
First Posted : July 21, 2009
Results First Posted : March 19, 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 : 203 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-Ib)
Study Start Date : July 2009
Actual Primary Completion Date : October 2009
Actual Study Completion Date : October 2009

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: PEP005 (ingenol mebutate) Gel
PEP005 (ingenol mebutate) Gel 0.05% once daily for 2 consecutive days
Drug: PEP005 (ingenol mebutate) Gel
two day treatment
Placebo Comparator: Vehicle gel
Vehicle gel once daily for 2 consecutive days
Drug: Vehicle gel
two day treatment

Primary Outcome Measures :
  1. Proportion of Patients With Complete Clearance of Actinic Keratoses (AK) Lesions [ Time Frame: 57 days ]
    Proportion of Patients with Complete Clearance of the treatment field defined as no clinically visible Actinic Keratoses (AK) lesions in the selected treatment area

Secondary Outcome Measures :
  1. Proportion of Patients With Partial Clearance of Actinic Keratoses (AK) Lesions [ Time Frame: 57 days ]
    Proportion of patients with Partial Clearance defined as ≥ 75 % reduction in the number of Actinic Keratoses (AK) lesions identified at baseline in the treatment area

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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): NCT00942604

United States, Arizona
Burke Pharmaceutical Research
Hot Springs, Arizona, United States, 71913
United States, California
Skin Surgery Medical Group Inc.
San Diego, California, United States, 92117
United States, Georgia
Atlanta Dermatology, Vein & Research Center, LLC
Alpharetta, Georgia, United States, 30022
United States, Illinois
Altman Dermatology Associates
Arlington Heights, Illinois, United States, 60005
Glazer Dermatology
Buffalo Grove, Illinois, United States, 60089
United States, Indiana
Deaconess Clinic Downtown
Evansville, Indiana, United States, 47713
Dawes Fretzin Clinical Research Group, LLC
Indianapolis, Indiana, United States, 46256
United States, Nebraska
Skin Specialists, PC
Omaha, Nebraska, United States, 68144
United States, Nevada
Karl G. Heine Dermatology
Henderson, Nevada, United States, 89002
United States, Ohio
Group Health Associates
Cincinnati, Ohio, United States, 45220
United States, Texas
DermResearch, Inc.
Austin, Texas, United States, 78759
Suzanne Bruce and Associates, PA, The Center for Skin Research
Houston, Texas, United States, 77056
Dermatology Clinical Research Center of San Antonio
San Antonio, Texas, United States, 78229
Dermatology Associates of Tyler
Tyler, Texas, United States, 75703
United States, Utah
Dermatology Research Center, Inc.
Salt Lake City, Utah, United States, 84124
United States, Virginia
The Education and Research Foundation
Lynchburg, Virginia, United States, 24501
Virginia Clinical Research, Inc
Norfolk, Virginia, United States, 23507
Sponsors and Collaborators

Additional Information:
Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Peplin Identifier: NCT00942604     History of Changes
Other Study ID Numbers: PEP005-028
First Posted: July 21, 2009    Key Record Dates
Results First Posted: March 19, 2012
Last Update Posted: March 6, 2015
Last Verified: November 2013

Keywords provided by Peplin:
Actinic keratosis

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