A Long Term Follow up Study of Patients Who Have Completed the PEP005-016 or PEP005-025 Studies

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: NCT00953732
Recruitment Status : Completed
First Posted : August 6, 2009
Last Update Posted : March 26, 2015
TKL Research, Inc.
Information provided by (Responsible Party):

Brief Summary:
This study is designed to follow up patients who have achieved complete clearance of AK lesions at the Day 57 visit having completed the PEP005-016 or PEP005-025 studies over a 12 month period to assess both recurrence of Actinic Keratosis (AK) lesions and long term safety in the selected treatment area.

Condition or disease Intervention/treatment
Actinic Keratosis Drug: Lesion count

Detailed Description:
A 12 month long-term follow-up study of patients who have achieved complete clearance of AK lesions at the Day 57 in the Phase 3 studies PEP005-016 or PEP005-025.

Study Type : Observational
Actual Enrollment : 117 participants
Time Perspective: Prospective
Official Title: A 12 Month, Long-term Follow-up Study of Patients With Actinic Keratosis on the Head (Face or Scalp) Who Have Completed Day 57 in Studies PEP005-016 or PEP005-025 (REGION IIa and IIb)
Study Start Date : August 2009
Actual Primary Completion Date : October 2010
Actual Study Completion Date : October 2010

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Group/Cohort Intervention/treatment
1 Drug: Lesion count
Lesion count in area treated by study drug in a prior study. No drug will be applied during this long-term follow up study. Drug was applied during the primary study.
Other Name: AK lesion recurrence

Primary Outcome Measures :
  1. Summarize treatment area recurrence of AK lesions, in the selected treatment area [ Time Frame: 12 months ]

Secondary Outcome Measures :
  1. Summarize long-term safety data(incidence of AEs in the treatment area) [ Time Frame: 12 months ]

Information from the National Library of Medicine

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, Learn About Clinical Studies.

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
All patients must have achieved complete clearance of AK lesions at Day 57 visit in either study PEP005-016 or PEP005-025 will be offered participation in this study.

Inclusion Criteria:

  • Patient must have achieved complete clearance of AK lesions (lesion count = 0) at Day 57 in one of the following Peplin AK clinical studies: PEP005-016 or PEP005-025
  • Patient has provided informed consent documented by signing the Informed Consent Form (ICF) prior to any study-related procedures

Exclusion Criteria:

  • Concurrent participation in another research study which would involve the selected treatment area (except for any post-study follow-up visits for previous Peplin AK study)
  • Early termination from study PEP005-016 or PEP005-025

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): NCT00953732

  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
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
North Florida Dermatology Associates, PA
Jacksonville, Florida, United States, 32204
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
Altman Dermatology Associates
Arlington Heights, Illinois, United States, 60005
Glazer Dermatology
Buffalo Grove, Illinois, United States, 60089
United States, Indiana
Laser Skin Surgery Center of Indiana
Carmel, Indiana, United States, 46032
Deaconess Clinic, Inc
Evansville, Indiana, United States, 47713
Dawes Fretein Clinical Research Group, LLC
Indianapolis, Indiana, United States, 46256
The Indiana Clinical Trials Center, PC
Plainfield, Indiana, United States, 46168
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, Nebraska
Skin Specialists, PC
Omaha, Nebraska, United States, 68144
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
Wake Research Associates
Raleigh, North Carolina, United States, 27612
United States, Oregon
Oregon Medical Research
Portland, Oregon, United States, 97223
United States, Tennessee
Dermatology Research Associates
Nashville, Tennessee, United States, 37203
United States, Texas
DermResearch, Inc.
Austin, Texas, United States, 78759
J & S Studies, Inc.
College Station, Texas, United States, 77845
Suzanne Bruce and Associates, The Center for Skin Research
Houston, Texas, United States, 77056
Progressive Clinical Research
San Antonio, Texas, United States, 78229
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
The Education and Research Foundation
Lynchburg, Virginia, United States, 24501
Virginia Clinical Research, Inc
Norfolk, Virginia, United States, 23507
United States, Washington
Premier Clinical Research
Spokane, Washington, United States, 99204
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
Australia, Queensland
The Skin Centre
Benowa, Queensland, Australia, 4217
South East Dermatology, Belmont Specialist Centre
Carina Heights, Queensland, Australia, 4152
Sponsors and Collaborators
TKL Research, Inc.
Study Director: Eugene Bauer, MD Chief Medical Officer

Additional Information:
Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Peplin Identifier: NCT00953732     History of Changes
Other Study ID Numbers: PEP005-030
First Posted: August 6, 2009    Key Record Dates
Last Update Posted: March 26, 2015
Last Verified: March 2015

Keywords provided by Peplin:
Actinic keratosis

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