A Long Term Follow up Study of Patients Who Have Complete Clearance of Their Actinic Keratosis (AK) Lesions at the Day 57 Visit in the PEP005-028 Study

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: NCT00989313
Recruitment Status : Completed
First Posted : October 5, 2009
Last Update Posted : March 26, 2015
Information provided by (Responsible Party):

Brief Summary:
This study is designed to follow up patients, who have participated in the PEP005-028 study and observed complete clearance of their Actinic Keratosis (AK) lesions, over a 12 month period to assess both recurrence of AK lesions and long term safety in the selected treatment area.

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

Study Type : Observational
Actual Enrollment : 43 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: A 12 Month, Long-term Follow-up Study of Patients With Actinic Keratosis on Non-head Locations (Trunk and Extremities) Who Have Completed Day 57 in Study PEP005-028 (REGION Ib)
Study Start Date : September 2009
Actual Primary Completion Date : October 2010
Actual Study Completion Date : October 2010

Resource links provided by the National Library of Medicine

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 during a 12 month follow-up period for patients with complete clearance, who have completed Day 57 in Study PEP005-028. [ Time Frame: 12 months ]

Secondary Outcome Measures :
  1. Summarize long-term safety data, in the selected treatment area over a 12 month follow-up period for patients with complete clearance, who have completed Day 57 in Study PEP005-028. [ Time Frame: 12 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients who achieved complete clearance of AK lesions at the Day 57 visit in the PEP005-028 study


  • Patient has provided informed consent documented by signing the Informed Consent Form (ICF) prior to any study-related procedures
  • Patient achieved complete clearance of AK lesions (lesion count of 0) in the selected treatment area at the Day 57 visit in the following Peplin AK clinical Study: PEP005-028


  • 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 PEP005-028

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): NCT00989313

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 Centre
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

Additional Information:
Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Peplin Identifier: NCT00989313     History of Changes
Other Study ID Numbers: PEP005-032
First Posted: October 5, 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