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

Completed
Conditions
Actinic Keratosis
Interventions
Drug: Lesion count
Registration Number
NCT00952783
Lead Sponsor
Peplin
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 available

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
98
Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

Study Type
OBSERVATIONAL
Study Design
Not specified
Arm && Interventions
GroupInterventionDescription
1Lesion count-
Primary Outcome Measures
NameTimeMethod
Summarize treatment area recurrence of AK lesions in the selected treatment area12 months
Secondary Outcome Measures
NameTimeMethod
Summarize long-term safety data (incidence of adverse events in the treatment area)12 months

Trial Locations

Locations (11)

Park Avenue Dermatology

🇺🇸

Orange Park, Florida, United States

Medaphase Inc

🇺🇸

Newnan, Georgia, United States

Gwinnett Clinical Research Centre

🇺🇸

Snellville, Georgia, United States

Michigan Center for Research Corp

🇺🇸

Clinton Twp, Michigan, United States

Henry Ford Health Systems

🇺🇸

Detroit, Michigan, United States

Dermatology Associates of Rochester

🇺🇸

Rochester, New York, United States

Oregon Health and Science University

🇺🇸

Portland, Oregon, United States

Dermatology Research Associates

🇺🇸

Nashville, Tennessee, United States

Dematology on Ward

🇦🇺

Adelaide, South Australia, Australia

Dermatology Institute of Victoria

🇦🇺

Melbourne, Victoria, Australia

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Park Avenue Dermatology
🇺🇸Orange Park, Florida, United States

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