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
March 25, 2015 updated by: Peplin
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)
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.
Study Overview
Study Type
Observational
Enrollment (Actual)
43
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Arizona
-
Hot Springs, Arizona, United States, 71913
- Burke Pharmaceutical Research
-
-
California
-
San Diego, California, United States, 92117
- Skin Surgery Medical Group Inc.
-
-
Georgia
-
Alpharetta, Georgia, United States, 30022
- Atlanta Dermatology, Vein & Research Center, LLC
-
-
Illinois
-
Arlington Heights, Illinois, United States, 60005
- Altman Dermatology Associates
-
Buffalo Grove, Illinois, United States, 60089
- Glazer Dermatology
-
-
Indiana
-
Evansville, Indiana, United States, 47713
- Deaconess Clinic Downtown
-
Indianapolis, Indiana, United States, 46256
- Dawes Fretzin Clinical Research Group, LLC
-
-
Nebraska
-
Omaha, Nebraska, United States, 68144
- Skin Specialists, PC
-
-
Nevada
-
Henderson, Nevada, United States, 89002
- Karl G. Heine Dermatology
-
-
Ohio
-
Cincinnati, Ohio, United States, 45220
- Group Health Associates
-
-
Texas
-
Austin, Texas, United States, 78759
- Dermresearch, Inc.
-
Houston, Texas, United States, 77056
- Suzanne Bruce and Associates, PA, The Center for Skin Research
-
San Antonio, Texas, United States, 78229
- Dermatology Clinical Research Center of San Antonio
-
Tyler, Texas, United States, 75703
- Dermatology Associates of Tyler
-
-
Utah
-
Salt Lake City, Utah, United States, 84124
- Dermatology Research Centre
-
-
Virginia
-
Lynchburg, Virginia, United States, 24501
- The Education and Research Foundation
-
Norfolk, Virginia, United States, 23507
- Virginia Clinical Research, Inc
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Patients who achieved complete clearance of AK lesions at the Day 57 visit in the PEP005-028 study
Description
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 the following Peplin AK clinical Study: PEP005-028
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 PEP005-028
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
1
|
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.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
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.
Time Frame: 12 months
|
12 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
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.
Time Frame: 12 months
|
12 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2009
Primary Completion (ACTUAL)
October 1, 2010
Study Completion (ACTUAL)
October 1, 2010
Study Registration Dates
First Submitted
October 1, 2009
First Submitted That Met QC Criteria
October 2, 2009
First Posted (ESTIMATE)
October 5, 2009
Study Record Updates
Last Update Posted (ESTIMATE)
March 26, 2015
Last Update Submitted That Met QC Criteria
March 25, 2015
Last Verified
March 1, 2015
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- PEP005-032
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.