A Long Term Follow up Study of Patients Who Have Completed the PEP005-020 Study

This study has been completed.

Sponsor:

Information provided by:

Peplin

ClinicalTrials.gov Identifier:

NCT00952783

First received: August 4, 2009

Last updated: October 6, 2010

Last verified: October 2010

History of Changes

Tracking Information
First Received Date ^ICMJE	August 4, 2009
Last Updated Date	October 6, 2010
Start Date ^ICMJE	July 2009
Primary Completion Date	October 2010 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: October 6, 2010)	Summarize treatment area recurrence of AK lesions in the selected treatment area [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Original Primary Outcome Measures ^ICMJE (submitted: August 4, 2009)	Summarize treatment area recurrence of Actinic Keratosis lesions, in the selected treatment area for patients who have completed Day 57 in study PEP005-020 [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
Change History	Complete list of historical versions of study NCT00952783 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: October 6, 2010)	Summarize long-term safety data (incidence of adverse events in the treatment area) [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
Original Secondary Outcome Measures ^ICMJE (submitted: August 4, 2009)	Summarize long-term safety data, in the selected treatment area, for patients who have completed Day 57 in study PEP005-020 [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
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 Completed the PEP005-020 Study
Official Title ^ICMJE	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
Brief Summary	This study is designed to follow up patients, who have achieved complete clearance of AK lesions (lesion count of 0) at Day 57 in the PEP005-020 study, over a 12 month period to assess both recurrence of Actinic Keratosis (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 have achieved complete clearance of AK lesions (lesion count of 0) at Day 57 in study PEP005-020
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	98
Completion Date	October 2010
Primary Completion Date	October 2010 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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
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, Australia

Administrative Information
NCT Number ^ICMJE	NCT00952783
Other Study ID Numbers ^ICMJE	PEP005-031
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
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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