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
| Tracking Information | |
|---|---|
| First Received Date ICMJE | October 1, 2009 |
| Last Updated Date | October 19, 2010 |
| Start Date ICMJE | September 2009 |
| Primary Completion Date | October 2010 (final data collection date for primary outcome measure) |
| Current Primary Outcome Measures ICMJE |
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 ] |
| Original Primary Outcome Measures ICMJE | Same as current |
| Change History | Complete list of historical versions of study NCT00989313 on ClinicalTrials.gov Archive Site |
| Current Secondary Outcome Measures ICMJE |
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 ] |
| Original Secondary Outcome Measures ICMJE | Same as current |
| Current Other Outcome Measures ICMJE | Not Provided |
| Original Other Outcome Measures ICMJE | Not Provided |
| Descriptive Information | |
| Brief Title ICMJE | 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 |
| Official Title ICMJE | 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) |
| Brief Summary | 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. |
| Detailed Description | Not Provided |
| Study Type ICMJE | Observational |
| Study Design ICMJE | Observational Model: Case-Only Time Perspective: Prospective |
| Target Follow-Up Duration | Not Provided |
| Biospecimen | Not Provided |
| 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 |
| Condition ICMJE | Actinic Keratosis |
| Intervention ICMJE | Not Provided |
| Study Group/Cohort (s) | 1 |
| Publications * | Not Provided |
|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
|
| Recruitment Information | |
| Recruitment Status ICMJE | Completed |
| Enrollment ICMJE | 43 |
| Completion Date | October 2010 |
| Primary Completion Date | October 2010 (final data collection date for primary outcome measure) |
| Eligibility Criteria ICMJE | Inclusion
Exclusion
|
| Gender | Both |
| Ages | 18 Years and older |
| Accepts Healthy Volunteers | No |
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects |
| Location Countries ICMJE | United States |
| Administrative Information | |
| NCT Number ICMJE | NCT00989313 |
| Other Study ID Numbers ICMJE | PEP005-032 |
| Has Data Monitoring Committee | No |
| Responsible Party | Janelle Katsamas, Peplin |
| Study Sponsor ICMJE | Peplin |
| Collaborators ICMJE | Not Provided |
| Investigators ICMJE | Not Provided |
| Information Provided By | Peplin |
| Verification Date | October 2010 |
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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