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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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00942604
First Posted: July 21, 2009
Last Update Posted: March 6, 2015
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.
Information provided by (Responsible Party):
Peplin
July 19, 2009
July 21, 2009
February 21, 2012
March 19, 2012
March 6, 2015
July 2009
October 2009   (Final data collection date for primary outcome measure)
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
Efficacy (complete clearance of AKs) [ Time Frame: 57 days ]
Complete list of historical versions of study NCT00942604 on ClinicalTrials.gov Archive Site
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
Efficacy (partial clearance of AKs) [ Time Frame: 57 days ]
Not Provided
Not Provided
 
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
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)
The purpose of this study is to determine whether topical application of PEP005 is effective for the treatment of actinic keratoses.
Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Actinic Keratoses
  • Drug: PEP005 (ingenol mebutate) Gel
    two day treatment
  • Drug: Vehicle gel
    two day treatment
  • 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
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.
 
Completed
203
October 2009
October 2009   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00942604
PEP005-028
No
Not Provided
Not Provided
Peplin
Peplin
Not Provided
Not Provided
Peplin
November 2013

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