A Long Term Follow up Study of Patients Who Have Completed the PEP005-016 or PEP005-025 Studies

Completed

Conditions studied: Actinic Keratosis

In brief

This study is designed to follow up patients who have achieved complete clearance of AK lesions at the Day 57 visit having completed the PEP005-016 or PEP005-025 studies over a 12 month period to assess both recurrence of Actinic Keratosis (AK) lesions and long term safety in the selected treatment area.

Key facts

Study ID

NCT00953732

Run by

Peplin

People needed

117

Starts

2009-08-01

Expected to finish

2010-10-01

Last updated by the study team

2015-03-26

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patient must have achieved complete clearance of AK lesions (lesion count = 0) at Day 57 in one of the following Peplin AK clinical studies: PEP005-016 or PEP005-025
• Patient has provided informed consent documented by signing the Informed Consent Form (ICF) prior to any study-related procedures

You may not qualify if…

• 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 PEP005-016 or PEP005-025

Where it is running

• Burke Pharmaceutical Research — Hot Springs, Arizona, United States
• Center for Dermatology — Fremont, California, United States
• Dermatology Research Associates — Los Angeles, California, United States
• Dermatology Specialists Inc — Oceanside, California, United States
• Skin Surgery Medical Group Inc. — San Diego, California, United States
• Conant Medical Group — San Francisco, California, United States
• North Florida Dermatology Associates, PA — Jacksonville, Florida, United States
• University of Miami, Skin Research Camp — Miami, Florida, United States
• Atlanta Dermatology, Vein & Research Center, LLC — Alpharetta, Georgia, United States
• Medaphase Inc — Newnan, Georgia, United States
• Altman Dermatology Associates — Arlington Heights, Illinois, United States
• Glazer Dermatology — Buffalo Grove, Illinois, United States
• Laser Skin Surgery Center of Indiana — Carmel, Indiana, United States
• Deaconess Clinic, Inc — Evansville, Indiana, United States
• Dawes Fretein Clinical Research Group, LLC — Indianapolis, Indiana, United States
• The Indiana Clinical Trials Center, PC — Plainfield, Indiana, United States
• Pedia Research LLC — Owensboro, Kentucky, United States
• Hamzavi Dermatology — Fort Gratiot, Michigan, United States
• Minnesota Clinical Study Center — Fridley, Minnesota, United States
• Skin Specialists, PC — Omaha, Nebraska, United States
• Karl G. Heine Dermatology — Henderson, Nevada, United States
• Academic Dermatology Associates — Albuquerque, New Mexico, United States
• Mount Sinai School of Medicine — New York, New York, United States
• Dermatology Associates of Rochester, PC — Rochester, New York, United States
• Dermatology, Laser Vein Specialists of the Carolinas — Charlotte, North Carolina, United States

Full record on ClinicalTrials.gov

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