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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)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Peplin
ClinicalTrials.gov Identifier:
NCT00916006
First received: June 4, 2009
Last updated: March 29, 2012
Last verified: March 2012
History of Changes
  Purpose

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 Intervention Phase
Actinic Keratosis
 Drug: PEP005 Gel
Drug: Vehicle Gel
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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)

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Peplin:

Primary Outcome Measures:
  • Patients With Complete Clearance of Actinic Keratosis (AK) Lesions. [ Time Frame: 57 days ] [ Designated as safety issue: No ]
    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:
  • Patients With Partial Clearance of Actinic Keratosis (AK) [ Time Frame: baseline and 57 days ] [ Designated as safety issue: No ]
    Patients with partial clearance defined as ≥ 75% reduction in the number of actinic keratosis (AK) lesions identified at baseline in the treatment area


Enrollment: 269
Study Start Date: June 2009
Study Completion Date: September 2009
Primary Completion Date: September 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: PEP005 Gel
0.015%, three day treatment
Placebo Comparator: 2 Drug: Vehicle Gel
Three day treatment

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00916006

Locations
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
Peplin
  More Information

Additional Information:
Food and Drug Authority  This link exits the ClinicalTrials.gov site
Therapeutic Goods Administration  This link exits the ClinicalTrials.gov site

No publications provided by Peplin

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Peplin
ClinicalTrials.gov Identifier: NCT00916006     History of Changes
Other Study ID Numbers: PEP005-016
Study First Received: June 4, 2009
Results First Received: February 21, 2012
Last Updated: March 29, 2012
Health Authority: United States: Food and Drug Administration
Australia: Department of Health and Ageing Therapeutic Goods Administration

Keywords provided by Peplin:
Peplin
Actinic keratosis
PEP005

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

ClinicalTrials.gov processed this record on May 23, 2013