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:
NCT00915551
First received: June 4, 2009
Last updated: November 22, 2013
Last verified: November 2013
  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 (Ingenol Mebutate) gel, 0.015%
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-IIb)

Resource links provided by NLM:


Further study details as provided by Peplin:

Primary Outcome Measures:
  • Complete Clearance of Actinic Keratoses (AK) Lesions [ Time Frame: baseline and 57 days ] [ Designated as safety issue: No ]
    Complete clearance of the treatment field


Secondary Outcome Measures:
  • Partial Clearance of Actinic Keratoses (AK) [ Time Frame: baseline and 57 days ] [ Designated as safety issue: No ]
    Partial clearance defined as ≥ 75% reduction in the number of AK lesions identified at baseline in the treatment area


Enrollment: 278
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: 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

  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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00915551

  Hide Study Locations
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
Peplin
  More Information

Additional Information:
No publications provided by Peplin

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Peplin
ClinicalTrials.gov Identifier: NCT00915551     History of Changes
Other Study ID Numbers: PEP005-025
Study First Received: June 4, 2009
Results First Received: February 21, 2012
Last Updated: November 22, 2013
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 September 18, 2014