Study to Determine the Safety of Two Applications of PEP005 Topical Gel to Actinic Keratoses

A Multi-center, Randomized, Double-blind, Parallel-group, Vehicle-controlled Study to Determine the Safety of PEP005 0.0025%, 0.01% and 0.05% Gel With Two Treatment Schedules, Day 1 & 2 or Day 1 & 8 Applications to Actinic Keratoses

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

Study Overview

• Status: Completed
• Conditions: Actinic Keratosis
• Intervention / Treatment: Drug: PEP005; Drug: PEP005; Drug: PEP005; Drug: PEP005; Drug: PEP005; Drug: PEP005; Drug: PEP005; Drug: PEP005

• Study Type: Interventional
• Enrollment: 60
• Phase: Phase 2

Contacts and Locations

Study Locations

• Australia
  • New South Wales
    • Sydney, New South Wales, Australia, 2050
      • Royal Prince Alfred Hospital
  • Queensland
    • Brisbane, Queensland, Australia, 4000
      • Siller Medical
  • Victoria
    • Melbourne, Victoria, Australia, 3168
      • Monash Medical Centre
    • Melbourne, Victoria, Australia, 3052
      • Skin and Cancer Foundation
  • Western Australia
    • Fremantle, Western Australia, Australia, 6160
      • Fremantle Dermatology
    • Fremantle, Western Australia, Australia, 6160
      • Private Dermaology Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Male or female patients
• At least five individual AK lesions on the arms, shoulders, chest, face and/or scalp

Exclusion Criteria:

• A cosmetic or therapeutic procedure:

  • within 10 cm of the selected AK lesions during the 3 months prior to study entry or
  • anywhere during the 4 weeks prior to study entry or anticipated treatment during the study

• Treatment with 5-fluorouracil, imiquimod, diclofenac or photodynamic therapy:

  • of lesions located within 10 cm of the selected AK lesions during the 3 months prior to study entry or
  • anywhere during the 4 weeks prior to study entry or anticipated treatment during the study
• Use of acid-containing products, topical retinoids or light chemical peels within 10 cm of the selected AK lesions during the 3 months prior to study entry, or anticipated treatment in this same area during the study
• Treatment with immuno-modulators, cytotoxic drugs, or interferon/interferon inducers during the 4 weeks prior to study entry or anticipated treatment during the study
• Treatment with psoralen plus UVA or use of UVB therapy during the 6 months prior to study entry or anticipated treatment during the study
• Use of systemic retinoids during the 6 months prior to study entry or anticipated treatment during the study
• Anticipated excessive or prolonged exposure to ultraviolet light or use of topical salves, creams or ointments to the selected AK lesions during the study
• Females of childbearing potential

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

8

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 1	Drug: PEP005; 0.0025% PEP005 Topical Gel (Day 1,2 application); Drug: PEP005; 0.01% PEP005 Topical Gel (Day 1,2 application); Drug: PEP005; 0.05% PEP005 Topical Gel (Day 1,2 application); Drug: PEP005; Vehicle Gel (Day 1,2 application); Drug: PEP005; 0.0025% PEP005 Topical Gel (Day 1,8 application); Drug: PEP005; 0.01% PEP005 Topical Gel (Day 1,8 application); Drug: PEP005; 0.05% PEP005 Topical Gel (Day 1,8 application); Drug: PEP005; Vehicle Gel (Day 1,8 application)
Experimental: 2	Drug: PEP005; 0.0025% PEP005 Topical Gel (Day 1,2 application); Drug: PEP005; 0.01% PEP005 Topical Gel (Day 1,2 application); Drug: PEP005; 0.05% PEP005 Topical Gel (Day 1,2 application); Drug: PEP005; Vehicle Gel (Day 1,2 application); Drug: PEP005; 0.0025% PEP005 Topical Gel (Day 1,8 application); Drug: PEP005; 0.01% PEP005 Topical Gel (Day 1,8 application); Drug: PEP005; 0.05% PEP005 Topical Gel (Day 1,8 application); Drug: PEP005; Vehicle Gel (Day 1,8 application)
Experimental: 3	Drug: PEP005; 0.0025% PEP005 Topical Gel (Day 1,2 application); Drug: PEP005; 0.01% PEP005 Topical Gel (Day 1,2 application); Drug: PEP005; 0.05% PEP005 Topical Gel (Day 1,2 application); Drug: PEP005; Vehicle Gel (Day 1,2 application); Drug: PEP005; 0.0025% PEP005 Topical Gel (Day 1,8 application); Drug: PEP005; 0.01% PEP005 Topical Gel (Day 1,8 application); Drug: PEP005; 0.05% PEP005 Topical Gel (Day 1,8 application); Drug: PEP005; Vehicle Gel (Day 1,8 application)
Placebo Comparator: 4	Drug: PEP005; 0.0025% PEP005 Topical Gel (Day 1,2 application); Drug: PEP005; 0.01% PEP005 Topical Gel (Day 1,2 application); Drug: PEP005; 0.05% PEP005 Topical Gel (Day 1,2 application); Drug: PEP005; Vehicle Gel (Day 1,2 application); Drug: PEP005; 0.0025% PEP005 Topical Gel (Day 1,8 application); Drug: PEP005; 0.01% PEP005 Topical Gel (Day 1,8 application); Drug: PEP005; 0.05% PEP005 Topical Gel (Day 1,8 application); Drug: PEP005; Vehicle Gel (Day 1,8 application)
Experimental: 5	Drug: PEP005; 0.0025% PEP005 Topical Gel (Day 1,2 application); Drug: PEP005; 0.01% PEP005 Topical Gel (Day 1,2 application); Drug: PEP005; 0.05% PEP005 Topical Gel (Day 1,2 application); Drug: PEP005; Vehicle Gel (Day 1,2 application); Drug: PEP005; 0.0025% PEP005 Topical Gel (Day 1,8 application); Drug: PEP005; 0.01% PEP005 Topical Gel (Day 1,8 application); Drug: PEP005; 0.05% PEP005 Topical Gel (Day 1,8 application); Drug: PEP005; Vehicle Gel (Day 1,8 application)
Experimental: 6	Drug: PEP005; 0.0025% PEP005 Topical Gel (Day 1,2 application); Drug: PEP005; 0.01% PEP005 Topical Gel (Day 1,2 application); Drug: PEP005; 0.05% PEP005 Topical Gel (Day 1,2 application); Drug: PEP005; Vehicle Gel (Day 1,2 application); Drug: PEP005; 0.0025% PEP005 Topical Gel (Day 1,8 application); Drug: PEP005; 0.01% PEP005 Topical Gel (Day 1,8 application); Drug: PEP005; 0.05% PEP005 Topical Gel (Day 1,8 application); Drug: PEP005; Vehicle Gel (Day 1,8 application)
Experimental: 7	Drug: PEP005; 0.0025% PEP005 Topical Gel (Day 1,2 application); Drug: PEP005; 0.01% PEP005 Topical Gel (Day 1,2 application); Drug: PEP005; 0.05% PEP005 Topical Gel (Day 1,2 application); Drug: PEP005; Vehicle Gel (Day 1,2 application); Drug: PEP005; 0.0025% PEP005 Topical Gel (Day 1,8 application); Drug: PEP005; 0.01% PEP005 Topical Gel (Day 1,8 application); Drug: PEP005; 0.05% PEP005 Topical Gel (Day 1,8 application); Drug: PEP005; Vehicle Gel (Day 1,8 application)
Placebo Comparator: 8	Drug: PEP005; 0.0025% PEP005 Topical Gel (Day 1,2 application); Drug: PEP005; 0.01% PEP005 Topical Gel (Day 1,2 application); Drug: PEP005; 0.05% PEP005 Topical Gel (Day 1,2 application); Drug: PEP005; Vehicle Gel (Day 1,2 application); Drug: PEP005; 0.0025% PEP005 Topical Gel (Day 1,8 application); Drug: PEP005; 0.01% PEP005 Topical Gel (Day 1,8 application); Drug: PEP005; 0.05% PEP005 Topical Gel (Day 1,8 application); Drug: PEP005; Vehicle Gel (Day 1,8 application)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
To determine the safety of PEP005 Topical Gel at 0.0025%, 0.01%, and 0.05% administered as two applications to patients with actinic keratosis (AKs) on the arms, shoulders, chest, face, and/or scalp	85 days

Secondary Outcome Measures

Outcome Measure	Time Frame
To evaluate the efficacy of PEP005 0.0025%, 0.01% and 0.05% Topical Gel in treating Actinic Keratoses	85 days

Collaborators and Investigators

• Sponsor: Peplin

Study record dates

Study Major Dates

• Study Start: March 1, 2005
• Primary Completion (Actual): September 1, 2005
• Study Completion (Actual): September 1, 2005

Study Registration Dates

• First Submitted: April 11, 2005
• First Submitted That Met QC Criteria: April 11, 2005
• First Posted (Estimate): April 12, 2005

Study Record Updates

• Last Update Posted (Estimate): March 25, 2015
• Last Update Submitted That Met QC Criteria: March 24, 2015
• Last Verified: March 1, 2015

More Information

Terms related to this study

• Keywords: Actinic Keratosis; Dermatology; Topical; Solar Keratosis; AK; PEP005; Sun spots
• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Precancerous Conditions; Keratosis, Actinic; Keratosis
• Other Study ID Numbers: PEP005-001; 2005/145