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A 12 Month, Long-term Follow-up Study of Patients With Actinic Keratosis on Non-head Locations (Trunk and Extremities) Who Have Completed Day 57 in Study PEP005-028 (REGION Ib)


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 Non-head Locations (Trunk and Extremities) Who Have Completed Day 57 in Study PEP005-028 (REGION Ib)

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 the following Peplin AK clinical Study:
PEP005-028

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 PEP005-028

Type of Study:

Observational

Study Design:

Observational Model: Case-Only, Time Perspective: Prospective

Outcome Measure:

Summarize treatment area recurrence of AK lesions, in the selected treatment area during a 12 month follow-up period for patients with complete clearance, who have completed Day 57 in Study PEP005-028.

Outcome Time Frame:

12 months

Safety Issue:

Yes

Authority:

United States: Food and Drug Administration

Study ID:

PEP005-032

NCT ID:

NCT00989313

Start Date:

September 2009

Completion Date:

October 2010

Related Keywords:

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

Name

Location

Virginia Clinical Research, IncNorfolk, Virginia  23507
Dawes Fretzin Clinical Research Group, LLCIndianapolis, Indiana  46256
Dermatology Clinical Research Center of San AntonioSan Antonio, Texas  78229
DermResearch, Inc.Austin, Texas  78759
Altman Dermatology AssociatesArlington Heights, Illinois  60004
Dermatology Associates of TylerTyler, Texas  75703
Dermatology Research Centre3920 South 1100 East Suite 210 & 310 Salt Lake City, Utah  84124
Skin Surgery Medical Group Inc.5222 Balboa Avenue Sixth Floor, San Diego, California  
Glazer DermatologyBuffalo Grove, Illinois  60089
Burke Pharmaceutical ResearchHot Springs, Arizona  71913
Skin Specialists, PCOmaha, Nebraska  
Karl G. Heine DermatologyHenderson, Nevada  89002
Suzanne Bruce and Associates, PA, The Center for Skin ResearchHouston, Texas  77056
The Education and Research FoundationLynchburg, Virginia  24501
Atlanta Dermatology, Vein & Research Center, LLCAlpharetta, Georgia  30022
Deaconess Clinic DowntownEvansville, Indiana  47713
Group Health AssociatesCincinnati, Ohio  45220