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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00952783
Other study ID # PEP005-031
Secondary ID
Status Completed
Phase Phase 3
First received August 4, 2009
Last updated March 25, 2015
Start date July 2009
Est. completion date October 2010

Study information

Verified date March 2015
Source Peplin
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug AdministrationAustralia: Department of Health and Ageing Therapeutic Goods Administration
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 98
Est. completion date October 2010
Est. primary completion date October 2010
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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

Study Design

Observational Model: Case-Only, Time Perspective: Prospective


Related Conditions & MeSH terms


Intervention

Drug:
Lesion count
Lesion count in area treated by study drug in a prior study over a 12 month period No drug will be applied during this long-term follow up study. Drug was applied during the primary study.

Locations

Country Name City State
Australia Dematology on Ward Adelaide South Australia
Australia Dermatology Institute of Victoria Melbourne Victoria
Australia St John of God Dermatology Subiaco Western Australia
United States Michigan Center for Research Corp Clinton Twp Michigan
United States Henry Ford Health Systems Detroit Michigan
United States Dermatology Research Associates Nashville Tennessee
United States Medaphase Inc Newnan Georgia
United States Park Avenue Dermatology Orange Park Florida
United States Oregon Health and Science University Portland Oregon
United States Dermatology Associates of Rochester Rochester New York
United States Gwinnett Clinical Research Centre Snellville Georgia

Sponsors (1)

Lead Sponsor Collaborator
Peplin

Countries where clinical trial is conducted

United States,  Australia, 

Outcome

Type Measure Description Time frame Safety issue
Primary Summarize treatment area recurrence of AK lesions in the selected treatment area 12 months No
Secondary Summarize long-term safety data (incidence of adverse events in the treatment area) 12 months Yes
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