Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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:
NCT00942604
First received: July 19, 2009
Last updated: November 22, 2013
Last verified: November 2013

July 19, 2009
November 22, 2013
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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
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 ] [ 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-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
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: 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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00942604
PEP005-028
No
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