A Multi-center Study to Evaluate the Efficacy and Safety of PEP005 (Ingenol Mebutate) Gel, When Used to Treat Actinic Keratoses on the Head (Face or Scalp)

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: NCT00916006
Recruitment Status : Completed
First Posted : June 8, 2009
Results First Posted : March 21, 2012
Last Update Posted : April 2, 2015
Information provided by (Responsible Party):

Brief Summary:
This Phase III study is designed to assess the efficacy and safety of PEP005 Gel, 0.015% when applied to an area of skin containing 4-8 AK lesions on the face or scalp.

Condition or disease Intervention/treatment Phase
Actinic Keratosis Drug: PEP005 Gel Drug: Vehicle gel Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 269 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, 0.015% In Patients With Actinic Keratoses ON the Head (Face or Scalp) (REGION-IIa)
Study Start Date : June 2009
Actual Primary Completion Date : September 2009
Actual Study Completion Date : September 2009

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: PEP005 gel
PEP005 gel, 0.015% applied once daily for three consecutive days
Drug: PEP005 Gel
0.015%, three day treatment
Other Name: PEP005
Placebo Comparator: Vehicle gel
Vehicle gel applied once daily for three consecutive days
Drug: Vehicle gel
Vehicle gel, three day treatment
Other Name: Placebo

Primary Outcome Measures :
  1. Patients With Complete Clearance of Actinic Keratosis (AK) Lesions. [ 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 (AK) [ Time Frame: baseline and 57 days ]
    Patients with partial clearance defined as ≥ 75% reduction in the number of actinic keratosis (AK) lesions identified at baseline in the 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:

  • Patient is male or female and at least 18 years of age
  • Female patients must be of either:

    • Non-childbearing potential, post-menopausal
    • Childbearing potential, provided there are negative serum and urine pregnancy test results prior to study treatment, to rule out pregnancy

Exclusion Criteria:

  • Cosmetic or therapeutic procedures within 2 weeks and 2cm 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 the selected 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): NCT00916006

United States, California
Dermatology Research Associates
Los Angeles, California, United States, 90045
Dermatology Specialists Inc
Oceanside, California, United States, 92056
Skin Surgery Medical Group Inc.
San Diego, California, United States, 92117
Conant Medical Group
San Francisco, California, United States, 94114
United States, Florida
University of Miami, Skin Research Camp
Miami, Florida, United States, 33136
United States, Georgia
Atlanta Dermatology, Vein & Research Center, LLC
Alpharetta, Georgia, United States, 30022
Medaphase Inc
Newnan, Georgia, United States, 30263
United States, Illinois
Glazer Dermatology
Buffalo Grove, Illinois, United States, 60089
United States, Indiana
Dawes Fretein Clinical Research Group, LLC
Indianapolis, Indiana, United States, 46256
United States, Kentucky
Pedia Research LLC
Owensboro, Kentucky, United States, 42301
United States, Michigan
Hamzavi Dermatology
Fort Gratiot, Michigan, United States, 48059
United States, Minnesota
Minnesota Clinical Study Center
Fridley, Minnesota, United States, 55432
United States, North Carolina
Wake Research Associates
Raleigh, North Carolina, United States, 27612
United States, Tennessee
Dermatology Research Associates
Nashville, Tennessee, United States, 37203
United States, Texas
J & S Studies, Inc.
College Station, Texas, United States, 77845
Dermatology Associates of Tyler
Tyler, Texas, United States, 75703
Center for Clinical Studies
Webster, Texas, United States, 77598
United States, Utah
Dermatology Research Center, Inc.
Salt Lake City, Utah, United States, 84124
United States, Virginia
Virginia Clinical Research, Inc
Norfolk, Virginia, United States, 23507
Australia, New South Wales
Southderm Pty Ltd
Kogarah, New South Wales, Australia, 2217
St George Dematology and Skin Cancer Centre
Kogarah, New South Wales, Australia, 2217
Sponsors and Collaborators
Study Director: Eugene Bauer, MD Chief Medical Officer

Additional Information:
Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Peplin Identifier: NCT00916006     History of Changes
Other Study ID Numbers: PEP005-016
First Posted: June 8, 2009    Key Record Dates
Results First Posted: March 21, 2012
Last Update Posted: April 2, 2015
Last Verified: March 2015

Keywords provided by Peplin:
Actinic keratosis

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