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

This study has been completed.
Sponsor:
Information provided by:
Peplin
ClinicalTrials.gov Identifier:
NCT00952783
First received: August 4, 2009
Last updated: October 6, 2010
Last verified: October 2010
History of Changes
  Purpose

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 Phase
Actinic Keratosis
 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:

U.S. FDA Resources

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 ] [ Designated as safety issue: No ]

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

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)

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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

Criteria

Inclusion

  • 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

Exclusion

  • 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00952783

Locations
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
Peplin
  More Information

Additional Information:
Food and Drug Authority  This link exits the ClinicalTrials.gov site
Therapeutic Goods Administration  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Janelle Katsamas, Peplin
ClinicalTrials.gov Identifier: NCT00952783     History of Changes
Other Study ID Numbers: PEP005-031
Study First Received: August 4, 2009
Last Updated: October 6, 2010
Health Authority: United States: Food and Drug Administration
Australia: Department of Health and Ageing Therapeutic Goods 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 June 18, 2013