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
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 Areas (Trunk and Extremities) Who Have Completed Day 57 in Study PEP005-020
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 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
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
Outcome Time Frame:
12 months
Safety Issue:
No
Authority:
United States: Food and Drug Administration
Study ID:
PEP005-031
NCT ID:
NCT00952783
Start Date:
July 2009
Completion Date:
October 2010
Related Keywords:
- Actinic Keratosis
- Peplin
- Actinic keratosis
- PEP005
- Keratosis
- Keratosis, Actinic
Name | Location |
|---|---|
| Henry Ford Health Systems | Detroit, Michigan 48202 |
| Oregon Health and Science University | Portland, Oregon 97201 |
| Park Avenue Dermatology | Orange Park, Florida 32073 |
| Dermatology Associates of Rochester | Rochester, New York 14623 |
| Gwinnett Clinical Research Centre | 2383 Pate St, Snellville, Georgia 30078-3250 |
| Medaphase Inc | Newnan, Georgia 30263 |
| Dermatology Research Associates | Nashville, Tennessee 37203 |
| Michigan Center for Research Corp | Clinton Twp, Michigan 48038 |
