A Long Term Follow up Study of Patients Who Have Completed the PEP005-016 or PEP005-025 Studies
This study has been completed.
Sponsor:
Peplin
Information provided by:
Peplin
ClinicalTrials.gov Identifier:
NCT00953732
First received: August 4, 2009
Last updated: October 6, 2010
Last verified: October 2010
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Purpose
This study is designed to follow up patients who have achieved complete clearance of AK lesions at the Day 57 visit having completed the PEP005-016 or PEP005-025 studies over a 12 month period to assess both recurrence of Actinic Keratosis (AK) lesions and long term safety in the selected treatment area.
| Study Type: | Observational |
| Study Design: | Time Perspective: Prospective |
| Official Title: | 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) |
Resource links provided by NLM:
Further study details as provided by Peplin:
Primary Outcome Measures:
- Summarize treatment area recurrence of AK lesions, in the selected treatment area [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Summarize long-term safety data(incidence of AEs in the treatment area) [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
| Enrollment: | 117 |
| Study Start Date: | August 2009 |
| Study Completion Date: | October 2010 |
| Primary Completion Date: | October 2010 (Final data collection date for primary outcome measure) |
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Study Population
All patients must have achieved complete clearance of AK lesions at Day 57 visit in either study PEP005-016 or PEP005-025 will be offered participation in this study.
Criteria
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00953732
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Hide Study LocationsLocations
| United States, Arizona | |
| Burke Pharmaceutical Research | |
| Hot Springs, Arizona, United States, 71913 | |
| United States, California | |
| Center for Dermatology | |
| Fremont, California, United States, 94538 | |
| Dermatology Research Associates | |
| Los Angeles, California, United States, 90045 | |
| Dermatology Specialists Inc | |
| Oceanside, California, United States, 92056 | |
| Skin Surgery Medical Group Inc. | |
| San Diego, California, United States, 92117 | |
| Conant Medical Group | |
| San Francisco, California, United States, 94114 | |
| United States, Florida | |
| North Florida Dermatology Associates, PA | |
| Jacksonville, Florida, United States, 32204 | |
| University of Miami, Skin Research Camp | |
| Miami, Florida, United States, 33136 | |
| United States, Georgia | |
| Atlanta Dermatology, Vein & Research Center, LLC | |
| Alpharetta, Georgia, United States, 30022 | |
| Medaphase Inc | |
| Newnan, Georgia, United States, 30263 | |
| United States, Illinois | |
| Altman Dermatology Associates | |
| Arlington Heights, Illinois, United States, 60005 | |
| Glazer Dermatology | |
| Buffalo Grove, Illinois, United States, 60089 | |
| United States, Indiana | |
| Laser Skin Surgery Center of Indiana | |
| Carmel, Indiana, United States, 46032 | |
| Deaconess Clinic, Inc | |
| Evansville, Indiana, United States, 47713 | |
| Dawes Fretein Clinical Research Group, LLC | |
| Indianapolis, Indiana, United States, 46256 | |
| The Indiana Clinical Trials Center, PC | |
| Plainfield, Indiana, United States, 46168 | |
| United States, Kentucky | |
| Pedia Research LLC | |
| Owensboro, Kentucky, United States, 42301 | |
| United States, Michigan | |
| Hamzavi Dermatology | |
| Fort Gratiot, Michigan, United States, 48059 | |
| United States, Minnesota | |
| Minnesota Clinical Study Center | |
| Fridley, Minnesota, United States, 55432 | |
| United States, Nebraska | |
| Skin Specialists, PC | |
| Omaha, Nebraska, United States | |
| United States, Nevada | |
| Karl G. Heine Dermatology | |
| Henderson, Nevada, United States, 89002 | |
| United States, New Mexico | |
| Academic Dermatology Associates | |
| Albuquerque, New Mexico, United States, 87106 | |
| United States, New York | |
| Mount Sinai School of Medicine | |
| New York, New York, United States, 10029-6574 | |
| Dermatology Associates of Rochester, PC | |
| Rochester, New York, United States, 14623 | |
| United States, North Carolina | |
| Dermatology, Laser Vein Specialists of the Carolinas | |
| Charlotte, North Carolina, United States, 28207 | |
| Wake Research Associates | |
| Raleigh, North Carolina, United States, 27612 | |
| United States, Oregon | |
| Oregon Medical Research | |
| Portland, Oregon, United States, 97223 | |
| United States, Tennessee | |
| Dermatology Research Associates | |
| Nashville, Tennessee, United States, 37203 | |
| United States, Texas | |
| DermResearch, Inc. | |
| Austin, Texas, United States, 78759 | |
| J & S Studies, Inc. | |
| College Station, Texas, United States, 77845 | |
| Suzanne Bruce and Associates, The Center for Skin Research | |
| Houston, Texas, United States, 77056 | |
| Progressive Clinical Research | |
| San Antonio, Texas, United States, 78229 | |
| Dermatology Associates of Tyler | |
| Tyler, Texas, United States, 75703 | |
| Center for Clinical Studies | |
| Webster, Texas, United States, 77598 | |
| United States, Utah | |
| Dermatology Research Center, Inc. | |
| Salt Lake City, Utah, United States, 84124 | |
| United States, Virginia | |
| The Education and Research Foundation | |
| Lynchburg, Virginia, United States, 24501 | |
| Virginia Clinical Research, Inc | |
| Norfolk, Virginia, United States, 23507 | |
| United States, Washington | |
| Premier Clinical Research | |
| Spokane, Washington, United States, 99204 | |
| Australia, New South Wales | |
| Southderm Pty Ltd | |
| Kogarah, New South Wales, Australia, 2217 | |
| St George Dematology and Skin Cancer Centre | |
| Kogarah, New South Wales, Australia, 2217 | |
| Australia, Queensland | |
| The Skin Centre | |
| Benowa, Queensland, Australia, 4217 | |
| South East Dermatology, Belmont Specialist Centre | |
| Carina Heights, Queensland, Australia, 4152 | |
Sponsors and Collaborators
Peplin
More Information
Additional Information:
No publications provided
| Responsible Party: | Joseph Suttner, Director, Clinical Development, Peplin |
| ClinicalTrials.gov Identifier: | NCT00953732 History of Changes |
| Other Study ID Numbers: | PEP005-030 |
| Study First Received: | August 4, 2009 |
| Last Updated: | October 6, 2010 |
| Health Authority: | United States: Food and Drug Administration Australia: Department of Health and Ageing Therapeutic Goods Administration |
Keywords provided by Peplin:
|
Peplin Actinic keratosis PEP005 |
Additional relevant MeSH terms:
|
Keratosis Keratosis, Actinic Skin Diseases Precancerous Conditions Neoplasms |
ClinicalTrials.gov processed this record on June 17, 2013