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A Multicenter Study to Evaluate the Efficacy and Safety of PEP005 (Ingenol Mebutate) Gel When Used to Treat Actinic Keratoses (AKs) on the Non Head Locations

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00942604
Recruitment Status : Completed
First Posted : July 21, 2009
Results First Posted : March 19, 2012
Last Update Posted : March 6, 2015
Sponsor:
Information provided by (Responsible Party):
Peplin

Tracking Information
First Submitted Date  ICMJE July 19, 2009
First Posted Date  ICMJE July 21, 2009
Results First Submitted Date  ICMJE February 21, 2012
Results First Posted Date  ICMJE March 19, 2012
Last Update Posted Date March 6, 2015
Study Start Date  ICMJE July 2009
Actual Primary Completion Date October 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 21, 2012)
Proportion of Patients With Complete Clearance of Actinic Keratoses (AK) Lesions [ Time Frame: 57 days ]
Proportion of Patients with Complete Clearance of the treatment field defined as no clinically visible Actinic Keratoses (AK) lesions in the selected treatment area
Original Primary Outcome Measures  ICMJE
 (submitted: July 19, 2009)
Efficacy (complete clearance of AKs) [ Time Frame: 57 days ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 21, 2012)
Proportion of Patients With Partial Clearance of Actinic Keratoses (AK) Lesions [ Time Frame: 57 days ]
Proportion of patients with Partial Clearance defined as ≥ 75 % reduction in the number of Actinic Keratoses (AK) lesions identified at baseline in the treatment area
Original Secondary Outcome Measures  ICMJE
 (submitted: July 19, 2009)
Efficacy (partial clearance of AKs) [ Time Frame: 57 days ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Multicenter Study to Evaluate the Efficacy and Safety of PEP005 (Ingenol Mebutate) Gel When Used to Treat Actinic Keratoses (AKs) on the Non Head Locations
Official Title  ICMJE A Multi-center, Randomized, Parallel Group, Double-blind, Vehicle-controlled Study to Evaluate the Efficacy and Safety of PEP005 (Ingenol Mebutate) Gel, 0.05%, In Patients With Actinic Keratoses on Non-head Locations (REGION-Ib)
Brief Summary The purpose of this study is to determine whether topical application of PEP005 is effective for the treatment of actinic keratoses.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Actinic Keratoses
Intervention  ICMJE
  • Drug: PEP005 (ingenol mebutate) Gel
    two day treatment
  • Drug: Vehicle gel
    two day treatment
Study Arms  ICMJE
  • Active Comparator: PEP005 (ingenol mebutate) Gel
    PEP005 (ingenol mebutate) Gel 0.05% once daily for 2 consecutive days
    Intervention: Drug: PEP005 (ingenol mebutate) Gel
  • Placebo Comparator: Vehicle gel
    Vehicle gel once daily for 2 consecutive days
    Intervention: Drug: Vehicle gel
Publications * Lebwohl M, Swanson N, Anderson LL, Melgaard A, Xu Z, Berman B. Ingenol mebutate gel for actinic keratosis. N Engl J Med. 2012 Mar 15;366(11):1010-9. doi: 10.1056/NEJMoa1111170.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 6, 2010)
203
Original Estimated Enrollment  ICMJE
 (submitted: July 19, 2009)
200
Actual Study Completion Date  ICMJE October 2009
Actual Primary Completion Date October 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Must be male or female and at least 18 years of age.
  • Female patients must be of:
  • Non-childbearing potential;
  • Childbearing potential, provided negative serum and urine pregnancy test and using effective contraception.
  • 4 to 8 AK lesions on non-head locations.

Exclusion Criteria:

  • Cosmetic or therapeutic procedures within 2 weeks and within 2 cm of the selected treatment area.
  • Treatment with immunomodulators, or interferon/ interferon inducers or systemic medications that suppress the immune system within 4 weeks.
  • Treatment with 5-FU, imiquimod, diclofenac, or photodynamic therapy within 8 weeks and 2 cm of treatment area
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00942604
Other Study ID Numbers  ICMJE PEP005-028
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Peplin
Study Sponsor  ICMJE Peplin
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Peplin
Verification Date November 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP