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:
NCT00942604
First received: July 19, 2009
Last updated: November 22, 2013
Last verified: November 2013
  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-Ib)

Resource links provided by NLM:


Further study details as provided by Peplin:

Primary Outcome Measures:
  • Proportion of Patients With Complete Clearance of Actinic Keratoses (AK) Lesions [ Time Frame: 57 days ] [ Designated as safety issue: No ]
    Proportion of Patients with Complete Clearance of the treatment field defined as no clinically visible Actinic Keratoses (AK) lesions in the selected treatment area


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


Enrollment: 203
Study Start Date: July 2009
Study Completion Date: October 2009
Primary Completion Date: October 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: PEP005 (ingenol mebutate) Gel
PEP005 (ingenol mebutate) Gel 0.05% once daily for 2 consecutive days
Drug: PEP005 (ingenol mebutate) Gel
two day treatment
Placebo Comparator: Vehicle gel
Vehicle gel once daily for 2 consecutive days
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: NCT00942604

Locations
United States, Arizona
Burke Pharmaceutical Research
Hot Springs, Arizona, United States, 71913
United States, California
Skin Surgery Medical Group Inc.
San Diego, California, United States, 92117
United States, Georgia
Atlanta Dermatology, Vein & Research Center, LLC
Alpharetta, Georgia, United States, 30022
United States, Illinois
Altman Dermatology Associates
Arlington Heights, Illinois, United States, 60005
Glazer Dermatology
Buffalo Grove, Illinois, United States, 60089
United States, Indiana
Deaconess Clinic Downtown
Evansville, Indiana, United States, 47713
Dawes Fretzin Clinical Research Group, LLC
Indianapolis, Indiana, United States, 46256
United States, Nebraska
Skin Specialists, PC
Omaha, Nebraska, United States, 68144
United States, Nevada
Karl G. Heine Dermatology
Henderson, Nevada, United States, 89002
United States, Ohio
Group Health Associates
Cincinnati, Ohio, United States, 45220
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
Dermatology Clinical Research Center of San Antonio
San Antonio, Texas, United States, 78229
Dermatology Associates of Tyler
Tyler, Texas, United States, 75703
United States, Utah
Dermatology Research Center, Inc.
Salt Lake City, Utah, United States, 84124
United States, Virginia
The Education and Research Foundation
Lynchburg, Virginia, United States, 24501
Virginia Clinical Research, Inc
Norfolk, Virginia, United States, 23507
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: NCT00942604     History of Changes
Other Study ID Numbers: PEP005-028
Study First Received: July 19, 2009
Results First Received: February 21, 2012
Last Updated: November 22, 2013
Health Authority: United States: Food and Drug 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 22, 2014