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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT00952783




Registration number
NCT00952783
Ethics application status
Date submitted
4/08/2009
Date registered
6/08/2009
Date last updated
26/03/2015

Titles & IDs
Public title
A Long Term Follow up Study of Patients Who Have Completed the PEP005-020 Study
Scientific title
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
Secondary ID [1] 0 0
PEP005-031
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Actinic Keratosis 0 0
Condition category
Condition code
Skin 0 0 0 0
Other skin conditions
Skin 0 0 0 0
Dermatological conditions

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Treatment: Drugs - Lesion count

1 -


Treatment: Drugs: 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.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Summarize treatment area recurrence of AK lesions in the selected treatment area
Timepoint [1] 0 0
12 months
Secondary outcome [1] 0 0
Summarize long-term safety data (incidence of adverse events in the treatment area)
Timepoint [1] 0 0
12 months

Eligibility
Key inclusion 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 study PEP005-020
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
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
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/07/2009
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/10/2010
Sample size
Target
Accrual to date
Final
98
Recruitment in Australia
Recruitment state(s)
SA,VIC,WA
Recruitment hospital [1] 0 0
Dematology on Ward - Adelaide
Recruitment hospital [2] 0 0
Dermatology Institute of Victoria - Melbourne
Recruitment hospital [3] 0 0
St John of God Dermatology - Subiaco
Recruitment postcode(s) [1] 0 0
5006 - Adelaide
Recruitment postcode(s) [2] 0 0
3141 - Melbourne
Recruitment postcode(s) [3] 0 0
6008 - Subiaco
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Florida
Country [2] 0 0
United States of America
State/province [2] 0 0
Georgia
Country [3] 0 0
United States of America
State/province [3] 0 0
Michigan
Country [4] 0 0
United States of America
State/province [4] 0 0
New York
Country [5] 0 0
United States of America
State/province [5] 0 0
Oregon
Country [6] 0 0
United States of America
State/province [6] 0 0
Tennessee

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Peplin
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT00952783
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT00952783