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

Overview

The purpose of this study is to determine whether topical application of PEP005 is effective for the treatment of actinic keratoses.

Full Title of Study: “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)”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Triple (Participant, Care Provider, Investigator)
  • Study Primary Completion Date: February 2009

Interventions

  • Drug: PEP005 (ingenol mebutate) Gel
    • two day treatment
  • Drug: Vehicle gel
    • two day treatment

Arms, Groups and Cohorts

  • Active Comparator: 1
    • PEP005 (ingenol mebutate) Gel
  • Placebo Comparator: 2
    • Vehicle gel

Clinical Trial Outcome Measures

Primary Measures

  • Patients With Complete Clearance of Actinic Keratosis (AKs)
    • Time Frame: 57 days
    • 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.

Secondary Measures

  • Patients With Partial Clearance of Actinic Keratosis (AKs)
    • Time Frame: baseline and 57 days
    • 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.

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Peplin
  • Provider of Information About this Clinical Study
    • Sponsor

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