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: NCT00915551
Recruitment Status : Completed
First Posted : June 8, 2009
Results First Posted : March 16, 2012
Last Update Posted : March 6, 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 (Ingenol Mebutate) gel, 0.015% Drug: Vehicle Gel Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 278 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-IIb)
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

Arm Intervention/treatment
Experimental: PEP005 (Ingenol Mebutate) gel Drug: PEP005 (Ingenol Mebutate) gel, 0.015%
once daily for 3 consecutive days

Placebo Comparator: Vehicle gel Drug: Vehicle Gel
once daily for 3 consecutive days

Primary Outcome Measures :
  1. Complete Clearance of Actinic Keratoses (AK) Lesions [ Time Frame: baseline and 57 days ]
    Complete clearance of the treatment field

Secondary Outcome Measures :
  1. Partial Clearance of Actinic Keratoses (AK) [ Time Frame: baseline and 57 days ]
    Partial clearance defined as ≥ 75% reduction in the number of 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, Older Adult)
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): NCT00915551

  Hide Study Locations
United States, Arizona
Burke Pharmaceutical Research
Hot Springs, Arizona, United States, 71913
United States, California
Center for Dermatology
Fremont, California, United States, 94538
United States, Florida
North Florida Dermatology Associates, PA
Jacksonville, Florida, United States, 32204
United States, Illinois
Altman Dermatology Associates
Arlington Heights, Illinois, United States, 60005
United States, Indiana
Laser Skin Surgery Center of Indiana
Carmel, Indiana, United States, 46032
Deaconess Clinic, Inc
Evansville, Indiana, United States, 47713
The Indiana Clinical Trials Center, PC
Plainfield, Indiana, United States, 46168
United States, Nebraska
Skin Specialists, PC
Omaha, Nebraska, United States
United States, Nevada
Karl G. Heine Dermatology
Henderson, Nevada, United States, 89002
United States, New Mexico
Academic Dermatology Associates
Albuquerque, New Mexico, United States, 87106
United States, New York
Mount Sinai School of Medicine
New York, New York, United States, 10029-6574
Dermatology Associates of Rochester, PC
Rochester, New York, United States, 14623
United States, North Carolina
Dermatology, Laser Vein Specialists of the Carolinas
Charlotte, North Carolina, United States, 28207
United States, Oregon
Oregon Medical Research Center, PC
Portland, Oregon, United States, 97223
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
Progressive Clinical Research
San Antonio, Texas, United States, 78229
United States, Virginia
The Education and Research Foundation
Lynchburg, Virginia, United States, 24501
United States, Washington
Premier Clinical Research
Spokane, Washington, United States, 99204
Australia, Queensland
The Skin Centre
Benowa, Queensland, Australia, 4217
South East Dermatology, Belmont Specialist Centre
Carina Heights, Queensland, Australia, 4152
Sponsors and Collaborators

Additional Information:
Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Peplin Identifier: NCT00915551     History of Changes
Other Study ID Numbers: PEP005-025
First Posted: June 8, 2009    Key Record Dates
Results First Posted: March 16, 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