A Long Term Follow up Study of Patients Who Have Completed the PEP005-016 or PEP005-025 Studies
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)
1 other identifier
observational
117
2 countries
42
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Aug 2009
42 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2009
CompletedFirst Submitted
Initial submission to the registry
August 4, 2009
CompletedFirst Posted
Study publicly available on registry
August 6, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2010
CompletedMarch 26, 2015
March 1, 2015
1.2 years
August 4, 2009
March 25, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Summarize treatment area recurrence of AK lesions, in the selected treatment area
12 months
Secondary Outcomes (1)
Summarize long-term safety data(incidence of AEs in the treatment area)
12 months
Study Arms (1)
1
Interventions
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.
Eligibility Criteria
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.
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Peplinlead
- TKL Research, Inc.collaborator
Study Sites (42)
Burke Pharmaceutical Research
Hot Springs, Arizona, 71913, United States
Center for Dermatology
Fremont, California, 94538, United States
Dermatology Research Associates
Los Angeles, California, 90045, United States
Dermatology Specialists Inc
Oceanside, California, 92056, United States
Skin Surgery Medical Group Inc.
San Diego, California, 92117, United States
Conant Medical Group
San Francisco, California, 94114, United States
North Florida Dermatology Associates, PA
Jacksonville, Florida, 32204, United States
University of Miami, Skin Research Camp
Miami, Florida, 33136, United States
Atlanta Dermatology, Vein & Research Center, LLC
Alpharetta, Georgia, 30022, United States
Medaphase Inc
Newnan, Georgia, 30263, United States
Altman Dermatology Associates
Arlington Heights, Illinois, 60005, United States
Glazer Dermatology
Buffalo Grove, Illinois, 60089, United States
Laser Skin Surgery Center of Indiana
Carmel, Indiana, 46032, United States
Deaconess Clinic, Inc
Evansville, Indiana, 47713, United States
Dawes Fretein Clinical Research Group, LLC
Indianapolis, Indiana, 46256, United States
The Indiana Clinical Trials Center, PC
Plainfield, Indiana, 46168, United States
Pedia Research LLC
Owensboro, Kentucky, 42301, United States
Hamzavi Dermatology
Fort Gratiot, Michigan, 48059, United States
Minnesota Clinical Study Center
Fridley, Minnesota, 55432, United States
Skin Specialists, PC
Omaha, Nebraska, 68144, United States
Karl G. Heine Dermatology
Henderson, Nevada, 89002, United States
Academic Dermatology Associates
Albuquerque, New Mexico, 87106, United States
Mount Sinai School of Medicine
New York, New York, 10029-6574, United States
Dermatology Associates of Rochester, PC
Rochester, New York, 14623, United States
Dermatology, Laser Vein Specialists of the Carolinas
Charlotte, North Carolina, 28207, United States
Wake Research Associates
Raleigh, North Carolina, 27612, United States
Oregon Medical Research
Portland, Oregon, 97223, United States
Dermatology Research Associates
Nashville, Tennessee, 37203, United States
DermResearch, Inc.
Austin, Texas, 78759, United States
J & S Studies, Inc.
College Station, Texas, 77845, United States
Suzanne Bruce and Associates, The Center for Skin Research
Houston, Texas, 77056, United States
Progressive Clinical Research
San Antonio, Texas, 78229, United States
Dermatology Associates of Tyler
Tyler, Texas, 75703, United States
Center for Clinical Studies
Webster, Texas, 77598, United States
Dermatology Research Center, Inc.
Salt Lake City, Utah, 84124, United States
The Education and Research Foundation
Lynchburg, Virginia, 24501, United States
Virginia Clinical Research, Inc
Norfolk, Virginia, 23507, United States
Premier Clinical Research
Spokane, Washington, 99204, United States
Southderm Pty Ltd
Kogarah, New South Wales, 2217, Australia
St George Dematology and Skin Cancer Centre
Kogarah, New South Wales, 2217, Australia
The Skin Centre
Benowa, Queensland, 4217, Australia
South East Dermatology, Belmont Specialist Centre
Carina Heights, Queensland, 4152, Australia
Related Publications (1)
Lebwohl M, Shumack S, Stein Gold L, Melgaard A, Larsson T, Tyring SK. Long-term follow-up study of ingenol mebutate gel for the treatment of actinic keratoses. JAMA Dermatol. 2013 Jun;149(6):666-70. doi: 10.1001/jamadermatol.2013.2766.
PMID: 23553119DERIVED
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Eugene Bauer, MD
Chief Medical Officer
Study Design
- Study Type
- observational
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 4, 2009
First Posted
August 6, 2009
Study Start
August 1, 2009
Primary Completion
October 1, 2010
Study Completion
October 1, 2010
Last Updated
March 26, 2015
Record last verified: 2015-03