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A Long Term Follow up Study of Patients Who Have Completed the PEP005-020 Study

This study has been completed.
Information provided by (Responsible Party):
Peplin Identifier:
First received: August 4, 2009
Last updated: March 25, 2015
Last verified: March 2015
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 Intervention Phase
Actinic Keratosis Drug: Lesion count Phase 3

Study Type: Observational
Study Design: 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

Resource links provided by NLM:

Further study details as provided by Peplin:

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

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

Enrollment: 98
Study Start Date: July 2009
Study Completion Date: October 2010
Primary Completion Date: October 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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


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
  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 identifier: 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
  More Information

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
Study First Received: August 4, 2009
Last Updated: March 25, 2015

Keywords provided by Peplin:
Actinic keratosis

Additional relevant MeSH terms:
Keratosis, Actinic
Skin Diseases
Precancerous Conditions
Neoplasms processed this record on June 23, 2017