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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
N/A
Not Enrolling
Both
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
study)

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

Type of Study:

Observational

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:

No

Authority:

United States: Food and Drug Administration

Study ID:

PEP005-030

NCT ID:

NCT00953732

Start Date:

August 2009

Completion Date:

October 2010

Related Keywords:

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

Name

Location

Mount Sinai School of MedicineNew York, New York  10029
Dermatology Specialists IncVista, California  92083
Minnesota Clinical Study CenterFridley, Minnesota  55432
Academic Dermatology AssociatesAlbuquerque, New Mexico  87106
Center For Clinical StudiesHouston, Texas  77030
Virginia Clinical Research, IncNorfolk, Virginia  23507
North Florida Dermatology Associates, PAJacksonville, Florida  32204
Wake Research AssociatesRaleigh, North Carolina  27612
DermResearch, Inc.Austin, Texas  78759
Altman Dermatology AssociatesArlington Heights, Illinois  60004
Dermatology Associates of TylerTyler, Texas  75703
Oregon Medical ResearchCentre9495 SW Locust St., Suite G Portland, Oregon  97223
Skin Surgery Medical Group Inc.5222 Balboa Avenue Sixth Floor, San Diego, California  
Dermatology Research AssociatesLos Angeles, California  90045
Hamzavi DermatologyFort Gratiot, Michigan  48059
Premier Clinical ResearchSpokane, Washington  99204
Glazer DermatologyBuffalo Grove, Illinois  60089
Medaphase IncNewnan, Georgia  30263
Progressive Clinical ResearchSan Antonio, Texas  78229
Burke Pharmaceutical ResearchHot Springs, Arizona  71913
Dermatology Research AssociatesNashville, Tennessee  37203
Suzanne Bruce and Associates, The Center for Skin ResearchHouston, Texas  77056
J & S Studies, Inc.College Station, Texas  77845
Skin Specialists, PCOmaha, Nebraska  
Center for DermatologyFremont, California  94538
Laser Skin Surgery Center of IndianaCarmel, Indiana  46032
Deaconess Clinic, IncEvansville, Indiana  47713
The Indiana Clinical Trials Center, PCPlainfield, Indiana  46168
Karl G. Heine DermatologyHenderson, Nevada  89002
Dermatology Associates of Rochester, PCRochester, New York  14623
Dermatology, Laser Vein Specialists of the CarolinasCharlotte, North Carolina  28207
The Education and Research FoundationLynchburg, Virginia  24501
Conant Medical GroupSan Francisco, California  94114
University of Miami, Skin Research CampMiami, Florida  33136
Atlanta Dermatology, Vein & Research Center, LLCAlpharetta, Georgia  30022
Dawes Fretein Clinical Research Group, LLCIndianapolis, Indiana  46256
Pedia Research LLCOwensboro, Kentucky  42301
Dermatology Research Center, Inc.Salt Lake City, Utah  84124