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)
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 the Head (Face or Scalp) Who Have Completed Day 57 in Studies PEP005-016 or PEP005-025 (REGION IIa and IIb)
A 12 month long-term follow-up study of patients who have achieved complete clearance of AK
lesions at the Day 57 in the Phase 3 studies PEP005-016 or PEP005-025.
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Type of Study:
Observational
Study Design:
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:
PEP005-030
NCT ID:
NCT00953732
Start Date:
August 2009
Completion Date:
October 2010
Related Keywords:
- Actinic Keratosis
- Peplin
- Actinic keratosis
- PEP005
- Keratosis
- Keratosis, Actinic
Name | Location |
|---|---|
| Mount Sinai School of Medicine | New York, New York 10029 |
| Dermatology Specialists Inc | Vista, California 92083 |
| Minnesota Clinical Study Center | Fridley, Minnesota 55432 |
| Academic Dermatology Associates | Albuquerque, New Mexico 87106 |
| Center For Clinical Studies | Houston, Texas 77030 |
| Virginia Clinical Research, Inc | Norfolk, Virginia 23507 |
| North Florida Dermatology Associates, PA | Jacksonville, Florida 32204 |
| Wake Research Associates | Raleigh, North Carolina 27612 |
| DermResearch, Inc. | Austin, Texas 78759 |
| Altman Dermatology Associates | Arlington Heights, Illinois 60004 |
| Dermatology Associates of Tyler | Tyler, Texas 75703 |
| Oregon Medical Research | Centre9495 SW Locust St., Suite G Portland, Oregon 97223 |
| Skin Surgery Medical Group Inc. | 5222 Balboa Avenue Sixth Floor, San Diego, California |
| Dermatology Research Associates | Los Angeles, California 90045 |
| Hamzavi Dermatology | Fort Gratiot, Michigan 48059 |
| Premier Clinical Research | Spokane, Washington 99204 |
| Glazer Dermatology | Buffalo Grove, Illinois 60089 |
| Medaphase Inc | Newnan, Georgia 30263 |
| Progressive Clinical Research | San Antonio, Texas 78229 |
| Burke Pharmaceutical Research | Hot Springs, Arizona 71913 |
| Dermatology Research Associates | Nashville, Tennessee 37203 |
| Suzanne Bruce and Associates, The Center for Skin Research | Houston, Texas 77056 |
| J & S Studies, Inc. | College Station, Texas 77845 |
| Skin Specialists, PC | Omaha, Nebraska |
| Center for Dermatology | Fremont, California 94538 |
| Laser Skin Surgery Center of Indiana | Carmel, Indiana 46032 |
| Deaconess Clinic, Inc | Evansville, Indiana 47713 |
| The Indiana Clinical Trials Center, PC | Plainfield, Indiana 46168 |
| Karl G. Heine Dermatology | Henderson, Nevada 89002 |
| Dermatology Associates of Rochester, PC | Rochester, New York 14623 |
| Dermatology, Laser Vein Specialists of the Carolinas | Charlotte, North Carolina 28207 |
| The Education and Research Foundation | Lynchburg, Virginia 24501 |
| Conant Medical Group | San Francisco, California 94114 |
| University of Miami, Skin Research Camp | Miami, Florida 33136 |
| Atlanta Dermatology, Vein & Research Center, LLC | Alpharetta, Georgia 30022 |
| Dawes Fretein Clinical Research Group, LLC | Indianapolis, Indiana 46256 |
| Pedia Research LLC | Owensboro, Kentucky 42301 |
| Dermatology Research Center, Inc. | Salt Lake City, Utah 84124 |
