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
This study has been completed.
Sponsor:
Peplin
Information provided by:
Peplin
ClinicalTrials.gov Identifier:
NCT00989313
First received: October 1, 2009
Last updated: October 19, 2010
Last verified: October 2010
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Purpose
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 Type: | Observational |
| Study Design: | Observational Model: Case-Only Time Perspective: Prospective |
| Official Title: | 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) |
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 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 ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- 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 ] [ Designated as safety issue: Yes ]
| Enrollment: | 43 |
| Study Start Date: | September 2009 |
| Study Completion Date: | October 2010 |
| Primary Completion Date: | October 2010 (Final data collection date for primary outcome measure) |
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
Patients who achieved complete clearance of AK lesions at the Day 57 visit in the PEP005-028 study
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00989313
Locations
| United States, Arizona | |
| Burke Pharmaceutical Research | |
| Hot Springs, Arizona, United States, 71913 | |
| United States, California | |
| Skin Surgery Medical Group Inc. | |
| San Diego, California, United States, 92117 | |
| United States, Georgia | |
| Atlanta Dermatology, Vein & Research Center, LLC | |
| Alpharetta, Georgia, United States, 30022 | |
| United States, Illinois | |
| Altman Dermatology Associates | |
| Arlington Heights, Illinois, United States, 60005 | |
| Glazer Dermatology | |
| Buffalo Grove, Illinois, United States, 60089 | |
| United States, Indiana | |
| Deaconess Clinic Downtown | |
| Evansville, Indiana, United States, 47713 | |
| Dawes Fretzin Clinical Research Group, LLC | |
| Indianapolis, Indiana, United States, 46256 | |
| United States, Nebraska | |
| Skin Specialists, PC | |
| Omaha, Nebraska, United States, 68144 | |
| United States, Nevada | |
| Karl G. Heine Dermatology | |
| Henderson, Nevada, United States, 89002 | |
| United States, Ohio | |
| Group Health Associates | |
| Cincinnati, Ohio, United States, 45220 | |
| United States, Texas | |
| DermResearch, Inc. | |
| Austin, Texas, United States, 78759 | |
| Suzanne Bruce and Associates, PA, The Center for Skin Research | |
| Houston, Texas, United States, 77056 | |
| Dermatology Clinical Research Center of San Antonio | |
| San Antonio, Texas, United States, 78229 | |
| Dermatology Associates of Tyler | |
| Tyler, Texas, United States, 75703 | |
| United States, Utah | |
| Dermatology Research Centre | |
| 3920 South 1100 East Suite 210 & 310 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 | |
Sponsors and Collaborators
Peplin
More Information
Additional Information:
No publications provided
| Responsible Party: | Janelle Katsamas, Peplin |
| ClinicalTrials.gov Identifier: | NCT00989313 History of Changes |
| Other Study ID Numbers: | PEP005-032 |
| Study First Received: | October 1, 2009 |
| Last Updated: | October 19, 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 18, 2013