A Long Term Follow up Study of Patients Who Have Completed the PEP005-020 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: NCT00952783
Recruitment Status : Completed
First Posted : August 6, 2009
Last Update Posted : March 26, 2015
Information provided by (Responsible Party):

Brief Summary:
This study is designed to follow up patients, who have achieved complete clearance of AK lesions (lesion count of 0) at Day 57 in the PEP005-020 study, 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

Study Type : Observational
Actual Enrollment : 98 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 Areas (Trunk and Extremities) Who Have Completed Day 57 in Study PEP005-020
Study Start Date : July 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 over a 12 month period 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 adverse events in the treatment area) [ Time Frame: 12 months ]

Information from the National Library of Medicine

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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
Patients who have achieved complete clearance of AK lesions (lesion count of 0) at Day 57 in study PEP005-020


  • 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 study PEP005-020


  • 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 PEP005-020

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): NCT00952783

United States, Florida
Park Avenue Dermatology
Orange Park, Florida, United States, 32073
United States, Georgia
Medaphase Inc
Newnan, Georgia, United States, 30263
Gwinnett Clinical Research Centre
Snellville, Georgia, United States, 30078-3250
United States, Michigan
Michigan Center for Research Corp
Clinton Twp, Michigan, United States, 48038
Henry Ford Health Systems
Detroit, Michigan, United States, 48202
United States, New York
Dermatology Associates of Rochester
Rochester, New York, United States, 14623
United States, Oregon
Oregon Health and Science University
Portland, Oregon, United States, 97239-4501
United States, Tennessee
Dermatology Research Associates
Nashville, Tennessee, United States, 37203
Australia, South Australia
Dematology on Ward
Adelaide, South Australia, Australia, 5006
Australia, Victoria
Dermatology Institute of Victoria
Melbourne, Victoria, Australia, 3141
Australia, Western Australia
St John of God Dermatology
Subiaco, Western Australia, Australia, 6008
Sponsors and Collaborators

Additional Information:
Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Peplin Identifier: NCT00952783     History of Changes
Other Study ID Numbers: PEP005-031
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