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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Peplin
ClinicalTrials.gov Identifier:
NCT00742391
First received: August 25, 2008
Last updated: March 29, 2012
Last verified: March 2012
  Purpose

The purpose of this study is to determine whether topical application of PEP005 is effective for the treatment of actinic keratoses.


Condition Intervention Phase
Actinic Keratoses
Drug: PEP005 (ingenol mebutate) Gel
Drug: Vehicle gel
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: 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, 0.05% In Patients With Actinic Keratoses ON Non-head Locations (REGION-I)

Resource links provided by NLM:


Further study details as provided by Peplin:

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


Enrollment: 255
Study Start Date: September 2008
Study Completion Date: February 2009
Primary Completion Date: February 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
PEP005 (ingenol mebutate) Gel
Drug: PEP005 (ingenol mebutate) Gel
two day treatment
Placebo Comparator: 2
Vehicle gel
Drug: Vehicle gel
two day treatment

  Eligibility

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

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
  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: NCT00742391

Locations
United States, Arizona
Omni Dermatology Research
Mesa, Arizona, United States, 85206
United States, Colorado
Colorado Medical Research Center
Denver, Colorado, United States, 80210
United States, Florida
Advanced Dermatology and Cosmetic Research
Kissimmee, Florida, United States, 34741
Park Avenue Dermatology
Orange Park, Florida, United States, 32073
Advanced Dermatology & Cosmetic Surgery
Ormond Beach, Florida, United States, 32174
United States, Georgia
Medaphase Inc
Newnan, Georgia, United States, 30263
Gwinnett Clinical Research Centre
Snellville, Georgia, United States, 30078-3250
United States, Indiana
Dermatology Center of Indiana/Indiana Clinical Trials Center
Plainfield, Indiana, United States, 46168
United States, Michigan
Henry Ford Health Systems
Detroit, Michigan, United States, 48202
United States, New Jersey
Karen S. Harkaway, MD. LLC
South Delran, New Jersey, United States, 08075
United States, New Mexico
Academic Dermatology Associates
Albuquerque, New Mexico, United States, 87106
United States, New York
Dermatology Associates of Rochester
Rochester, New York, United States, 14623
United States, Ohio
University Hospitals Case Medical Center
Cleveland, Ohio, United States, 44121
United States, Oregon
Oregon Medical Research
Portland, Oregon, United States, 97223
Oregon Health and Science University
Portland, Oregon, United States, 97239-4501
United States, Tennessee
Dermatology East
Germantown, Tennessee, United States, 38138
Rivergate Dermatology and Skin Care Center
Goodlettsville, Tennessee, United States, 37072
United States, Texas
J & S Studies, Inc.
College Station, Texas, United States, 77845
Australia, Queensland
The Skin Centre
Benowa, Queensland, Australia, 4217
Australia, Western Australia
Burswood Dermatology
Victoria Park, Western Australia, Australia, 6100
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: NCT00742391     History of Changes
Other Study ID Numbers: PEP005-014
Study First Received: August 25, 2008
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 July 22, 2014