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A 12 Month, Long-term Follow-up Study of Patients With Actinic Keratosis on the Head (Face or Scalp) Who Have Completed Day 57 in Studies PEP005-016 or PEP005-025 (REGION IIa and IIb)

Phase 3
18 Years
Not Enrolling
Actinic Keratosis

Thank you

Trial Information

A 12 Month, Long-term Follow-up Study of Patients With Actinic Keratosis on the Head (Face or Scalp) Who Have Completed Day 57 in Studies PEP005-016 or PEP005-025 (REGION IIa and IIb)

A 12 month long-term follow-up study of patients who have achieved complete clearance of AK
lesions at the Day 57 in the Phase 3 studies PEP005-016 or PEP005-025.

Inclusion Criteria:

- 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

Exclusion Criteria:

- 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

- Early termination from study PEP005-016 or PEP005-025

Type of Study:


Study Design:

Time Perspective: Prospective

Outcome Measure:

Summarize treatment area recurrence of AK lesions, in the selected treatment area

Outcome Time Frame:

12 months

Safety Issue:



United States: Food and Drug Administration

Study ID:




Start Date:

August 2009

Completion Date:

October 2010

Related Keywords:

  • Actinic Keratosis
  • Peplin
  • Actinic keratosis
  • PEP005
  • Keratosis
  • Keratosis, Actinic



Mount Sinai School of Medicine New York, New York  10029
Dermatology Specialists Inc Vista, California  92083
Minnesota Clinical Study Center Fridley, Minnesota  55432
Academic Dermatology Associates Albuquerque, New Mexico  87106
Center For Clinical Studies Houston, Texas  77030
Virginia Clinical Research, Inc Norfolk, Virginia  23507
North Florida Dermatology Associates, PA Jacksonville, Florida  32204
Wake Research Associates Raleigh, North Carolina  27612
DermResearch, Inc. Austin, Texas  78759
Altman Dermatology Associates Arlington Heights, Illinois  60004
Dermatology Associates of Tyler Tyler, Texas  75703
Oregon Medical Research Centre9495 SW Locust St., Suite G Portland, Oregon  97223
Skin Surgery Medical Group Inc. 5222 Balboa Avenue Sixth Floor, San Diego, California  
Dermatology Research Associates Los Angeles, California  90045
Hamzavi Dermatology Fort Gratiot, Michigan  48059
Premier Clinical Research Spokane, Washington  99204
Glazer Dermatology Buffalo Grove, Illinois  60089
Medaphase Inc Newnan, Georgia  30263
Progressive Clinical Research San Antonio, Texas  78229
Burke Pharmaceutical Research Hot Springs, Arizona  71913
Dermatology Research Associates Nashville, Tennessee  37203
Suzanne Bruce and Associates, The Center for Skin Research Houston, Texas  77056
J & S Studies, Inc. College Station, Texas  77845
Skin Specialists, PC Omaha, Nebraska  
Center for Dermatology Fremont, California  94538
Laser Skin Surgery Center of Indiana Carmel, Indiana  46032
Deaconess Clinic, Inc Evansville, Indiana  47713
The Indiana Clinical Trials Center, PC Plainfield, Indiana  46168
Karl G. Heine Dermatology Henderson, Nevada  89002
Dermatology Associates of Rochester, PC Rochester, New York  14623
Dermatology, Laser Vein Specialists of the Carolinas Charlotte, North Carolina  28207
The Education and Research Foundation Lynchburg, Virginia  24501
Conant Medical Group San Francisco, California  94114
University of Miami, Skin Research Camp Miami, Florida  33136
Atlanta Dermatology, Vein & Research Center, LLC Alpharetta, Georgia  30022
Dawes Fretein Clinical Research Group, LLC Indianapolis, Indiana  46256
Pedia Research LLC Owensboro, Kentucky  42301
Dermatology Research Center, Inc. Salt Lake City, Utah  84124