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

Primary Purpose

Actinic Keratosis

Status
Completed
Phase
Phase 2
Locations
Australia
Study Type
Interventional
Intervention
PEP005
PEP005
PEP005
PEP005
PEP005
PEP005
PEP005
PEP005
Sponsored by
Peplin
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Actinic Keratosis focused on measuring Actinic Keratosis, Solar Keratosis, AK, Sun spots, PEP005, Topical, Dermatology

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Royal Prince Alfred Hospital
  • Siller Medical
  • Skin and Cancer Foundation
  • Monash Medical Centre
  • Fremantle Dermatology
  • Private Dermaology Clinic

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm 8

Arm Type

Experimental

Experimental

Experimental

Placebo Comparator

Experimental

Experimental

Experimental

Placebo Comparator

Arm Label

1

2

3

4

5

6

7

8

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

To evaluate the efficacy of PEP005 0.0025%, 0.01% and 0.05% Topical Gel in treating Actinic Keratoses

Full Information

First Posted
April 11, 2005
Last Updated
March 24, 2015
Sponsor
Peplin
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1. Study Identification

Unique Protocol Identification Number
NCT00107965
Brief Title
Study to Determine the Safety of Two Applications of PEP005 Topical Gel to Actinic Keratoses
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
March 2015
Overall Recruitment Status
Completed
Study Start Date
March 2005 (undefined)
Primary Completion Date
September 2005 (Actual)
Study Completion Date
September 2005 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Peplin

4. Oversight

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Actinic Keratosis
Keywords
Actinic Keratosis, Solar Keratosis, AK, Sun spots, PEP005, Topical, Dermatology

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
60 (false)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Title
2
Arm Type
Experimental
Arm Title
3
Arm Type
Experimental
Arm Title
4
Arm Type
Placebo Comparator
Arm Title
5
Arm Type
Experimental
Arm Title
6
Arm Type
Experimental
Arm Title
7
Arm Type
Experimental
Arm Title
8
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
PEP005
Intervention Description
0.0025% PEP005 Topical Gel (Day 1,2 application)
Intervention Type
Drug
Intervention Name(s)
PEP005
Intervention Description
0.01% PEP005 Topical Gel (Day 1,2 application)
Intervention Type
Drug
Intervention Name(s)
PEP005
Intervention Description
0.05% PEP005 Topical Gel (Day 1,2 application)
Intervention Type
Drug
Intervention Name(s)
PEP005
Intervention Description
Vehicle Gel (Day 1,2 application)
Intervention Type
Drug
Intervention Name(s)
PEP005
Intervention Description
0.0025% PEP005 Topical Gel (Day 1,8 application)
Intervention Type
Drug
Intervention Name(s)
PEP005
Intervention Description
0.01% PEP005 Topical Gel (Day 1,8 application)
Intervention Type
Drug
Intervention Name(s)
PEP005
Intervention Description
0.05% PEP005 Topical Gel (Day 1,8 application)
Intervention Type
Drug
Intervention Name(s)
PEP005
Intervention Description
Vehicle Gel (Day 1,8 application)
Primary Outcome Measure Information:
Title
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
Time Frame
85 days
Secondary Outcome Measure Information:
Title
To evaluate the efficacy of PEP005 0.0025%, 0.01% and 0.05% Topical Gel in treating Actinic Keratoses
Time Frame
85 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Greg Siller
Official's Role
Principal Investigator
Facility Information:
Facility Name
Royal Prince Alfred Hospital
City
Sydney
State/Province
New South Wales
ZIP/Postal Code
2050
Country
Australia
Facility Name
Siller Medical
City
Brisbane
State/Province
Queensland
ZIP/Postal Code
4000
Country
Australia
Facility Name
Skin and Cancer Foundation
City
Melbourne
State/Province
Victoria
ZIP/Postal Code
3052
Country
Australia
Facility Name
Monash Medical Centre
City
Melbourne
State/Province
Victoria
ZIP/Postal Code
3168
Country
Australia
Facility Name
Fremantle Dermatology
City
Fremantle
State/Province
Western Australia
ZIP/Postal Code
6160
Country
Australia
Facility Name
Private Dermaology Clinic
City
Fremantle
State/Province
Western Australia
ZIP/Postal Code
6160
Country
Australia

12. IPD Sharing Statement

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

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