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
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)
1 other identifier
observational
43
1 country
17
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Sep 2009
17 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
September 1, 2009
CompletedFirst Submitted
Initial submission to the registry
October 1, 2009
CompletedFirst Posted
Study publicly available on registry
October 5, 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
1.1 years
October 1, 2009
March 25, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (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.
12 months
Secondary Outcomes (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.
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
Patients who achieved complete clearance of AK lesions at the Day 57 visit in the PEP005-028 study
You may qualify if:
- 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
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 PEP005-028
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Peplinlead
Study Sites (17)
Burke Pharmaceutical Research
Hot Springs, Arizona, 71913, United States
Skin Surgery Medical Group Inc.
San Diego, California, 92117, United States
Atlanta Dermatology, Vein & Research Center, LLC
Alpharetta, Georgia, 30022, United States
Altman Dermatology Associates
Arlington Heights, Illinois, 60005, United States
Glazer Dermatology
Buffalo Grove, Illinois, 60089, United States
Deaconess Clinic Downtown
Evansville, Indiana, 47713, United States
Dawes Fretzin Clinical Research Group, LLC
Indianapolis, Indiana, 46256, United States
Skin Specialists, PC
Omaha, Nebraska, 68144, United States
Karl G. Heine Dermatology
Henderson, Nevada, 89002, United States
Group Health Associates
Cincinnati, Ohio, 45220, United States
DermResearch, Inc.
Austin, Texas, 78759, United States
Suzanne Bruce and Associates, PA, The Center for Skin Research
Houston, Texas, 77056, United States
Dermatology Clinical Research Center of San Antonio
San Antonio, Texas, 78229, United States
Dermatology Associates of Tyler
Tyler, Texas, 75703, United States
Dermatology Research Centre
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
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 Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 1, 2009
First Posted
October 5, 2009
Study Start
September 1, 2009
Primary Completion
October 1, 2010
Study Completion
October 1, 2010
Last Updated
March 26, 2015
Record last verified: 2015-03