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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:
Information provided by (Responsible Party):
Peplin
ClinicalTrials.gov Identifier:
NCT00742391
First received: August 25, 2008
Last updated: March 29, 2012
Last verified: March 2012

August 25, 2008
March 29, 2012
September 2008
February 2009   (final data collection date for primary outcome measure)
Patients With Complete Clearance of Actinic Keratosis (AKs) [ Time Frame: 57 days ] [ Designated as safety issue: No ]
Complete clearance rate of actinic keratosis (AK) lesions defined as the proportion of patients with no clinically visible AK lesions in the selected treatment area.
Efficacy (complete clearance of AKs) [ Time Frame: 57 days ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00742391 on ClinicalTrials.gov Archive Site
Patients With Partial Clearance of Actinic Keratosis (AKs) [ Time Frame: baseline and 57 days ] [ Designated as safety issue: No ]
Partial clearance rate of AK lesions defined as the proportion of patients with a 75% or greater reduction in the number of actinic keratosis (AK) lesions identified at baseline in the selected treatment area.
Efficacy (partial clearance of AKs) [ Time Frame: 57 days ] [ Designated as safety issue: No ]
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-I)

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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Actinic Keratoses
  • Drug: PEP005 (ingenol mebutate) Gel
    two day treatment
  • Drug: Vehicle gel
    two day treatment
  • Active Comparator: 1
    PEP005 (ingenol mebutate) Gel
    Intervention: Drug: PEP005 (ingenol mebutate) Gel
  • Placebo Comparator: 2
    Vehicle gel
    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
255
February 2009
February 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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Australia
 
NCT00742391
PEP005-014
No
Peplin
Peplin
Not Provided
Not Provided
Peplin
March 2012

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