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)
Phase 3
18 Years
N/A
18 Years
N/A
Not Enrolling
Both
Actinic Keratosis
Both
Actinic Keratosis
Trial Information
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)
Inclusion 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 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
Type of Study:
Observational
Study Design:
Observational Model: Case-Only, Time Perspective: Prospective
Outcome Measure:
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.
Outcome Time Frame:
12 months
Safety Issue:
Yes
Authority:
United States: Food and Drug Administration
Study ID:
PEP005-032
NCT ID:
NCT00989313
Start Date:
September 2009
Completion Date:
October 2010
Related Keywords:
- Actinic Keratosis
- Peplin
- Actinic keratosis
- PEP005
- Keratosis
- Keratosis, Actinic
Name | Location |
|---|---|
| Virginia Clinical Research, Inc | Norfolk, Virginia 23507 |
| Dawes Fretzin Clinical Research Group, LLC | Indianapolis, Indiana 46256 |
| Dermatology Clinical Research Center of San Antonio | San Antonio, Texas 78229 |
| DermResearch, Inc. | Austin, Texas 78759 |
| Altman Dermatology Associates | Arlington Heights, Illinois 60004 |
| Dermatology Associates of Tyler | Tyler, Texas 75703 |
| Dermatology Research Centre | 3920 South 1100 East Suite 210 & 310 Salt Lake City, Utah 84124 |
| Skin Surgery Medical Group Inc. | 5222 Balboa Avenue Sixth Floor, San Diego, California |
| Glazer Dermatology | Buffalo Grove, Illinois 60089 |
| Burke Pharmaceutical Research | Hot Springs, Arizona 71913 |
| Skin Specialists, PC | Omaha, Nebraska |
| Karl G. Heine Dermatology | Henderson, Nevada 89002 |
| Suzanne Bruce and Associates, PA, The Center for Skin Research | Houston, Texas 77056 |
| The Education and Research Foundation | Lynchburg, Virginia 24501 |
| Atlanta Dermatology, Vein & Research Center, LLC | Alpharetta, Georgia 30022 |
| Deaconess Clinic Downtown | Evansville, Indiana 47713 |
| Group Health Associates | Cincinnati, Ohio 45220 |
