Back to resultsA Study to Determine the Optimal Tolerated Regime and Safety of PEP005 Topical Gel
Primary Purpose
Actinic Keratoses
Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
PEP005
Sponsored by
About this trial
This is an interventional treatment trial for Actinic Keratoses focused on measuring Actinic Keratoses (AK), PEP005, Topical, Dermatology
Eligibility Criteria
- Male patients at least 18 years of age.
- Post-menopausal female patients i.e., no menses for at least 12 consecutive months, or without a uterus.
- Four to eight clinically typical, visible and discrete AK lesions within a contiguous 25 cm2 treatment area on the face or face and scalp.
5. Ability to follow study instructions and likely to complete all study requirements.
6. Written informed consent has been obtained. 7. Agreement from the patient to allow photographs of the selected AK treatment area to be taken and used as part of the study data package.
Sites / Locations
- Skin and Cancer Foundation
- Southderm Pty Ltd
- St George Dermatology and Skin Cancer Centre
- South East Dermatology
- The Skin Centre
- Siller Medical
- Auckland Dermatology
- Tristram Clinic
- Skin Centre
Outcomes
Primary Outcome Measures
Optimal tolerated regime of PEP005 Topical Gel in patients, when administered as either two day or three day application schedules to a 25 cm2 contiguous AK treatment area on the face or face and scalp
Secondary Outcome Measures
Efficacy at 2 or 3day application PEP005 Topical Gel at the MTD of 0.025% in the Expanded Cohort, and at 2 lower concs of 0.0175% and 0.0125% at either a 2 or 3day application, when applied to 25cm2 AK treatment area on face or face/scalp.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00427050
Brief Title
A Study to Determine the Optimal Tolerated Regime and Safety of PEP005 Topical Gel
Official Title
An Open-label, Multi-centre, Dose-escalation, Cohort Study to Determine the Optimal Tolerated Regime and Safety of PEP005 Topical Gel When Applied to a 25 cm2 Contiguous Actinic Keratoses Treatment Area on the Face or Face and Scalp.
Study Type
Interventional
2. Study Status
Record Verification Date
December 2008
Overall Recruitment Status
Completed
Study Start Date
January 2007 (undefined)
Primary Completion Date
November 2007 (Actual)
Study Completion Date
November 2007 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Peplin
4. Oversight
5. Study Description
Brief Summary
The purpose of this study is to determine the optimal tolerated regime of PEP005 for the treatment of actinic keratoses of the face or face and scalp.
Detailed Description
Actinic keratoses (AK) is a common skin condition characterized by rough, scaly patches or sores on the top layer of the skin which if left untreated can progress to skin cancer. Current treatments can cause scarring and hypopigmentation, be inconvenient, or require long treatment duration. Non-invasive alternative therapy for treatment of AK lesions is thus being researched.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Actinic Keratoses
Keywords
Actinic Keratoses (AK), PEP005, Topical, Dermatology
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
PEP005
Primary Outcome Measure Information:
Title
Optimal tolerated regime of PEP005 Topical Gel in patients, when administered as either two day or three day application schedules to a 25 cm2 contiguous AK treatment area on the face or face and scalp
Secondary Outcome Measure Information:
Title
Efficacy at 2 or 3day application PEP005 Topical Gel at the MTD of 0.025% in the Expanded Cohort, and at 2 lower concs of 0.0175% and 0.0125% at either a 2 or 3day application, when applied to 25cm2 AK treatment area on face or face/scalp.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Male patients at least 18 years of age.
Post-menopausal female patients i.e., no menses for at least 12 consecutive months, or without a uterus.
Four to eight clinically typical, visible and discrete AK lesions within a contiguous 25 cm2 treatment area on the face or face and scalp.
5. Ability to follow study instructions and likely to complete all study requirements.
6. Written informed consent has been obtained. 7. Agreement from the patient to allow photographs of the selected AK treatment area to be taken and used as part of the study data package.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Janelle Katsamas
Organizational Affiliation
Peplin Operations Pty Ltd
Official's Role
Study Director
Facility Information:
Facility Name
Skin and Cancer Foundation
City
Darlinghurst
State/Province
New South Wales
ZIP/Postal Code
2010
Country
Australia
Facility Name
Southderm Pty Ltd
City
Kogarah
State/Province
New South Wales
Country
Australia
Facility Name
St George Dermatology and Skin Cancer Centre
City
Level 3, 22 Belgrave St, Kogarah
State/Province
New South Wales
ZIP/Postal Code
2217
Country
Australia
Facility Name
South East Dermatology
City
Belmont Specialist Centre, 1202 Creek Rd, Carina Heights
State/Province
Queensland
ZIP/Postal Code
4152
Country
Australia
Facility Name
The Skin Centre
City
Benowa
State/Province
Queensland
ZIP/Postal Code
4217
Country
Australia
Facility Name
Siller Medical
City
Brisbane
State/Province
Queensland
Country
Australia
Facility Name
Auckland Dermatology
City
Epsom
State/Province
Auckland
Country
New Zealand
Facility Name
Tristram Clinic
City
Hamilton
Country
New Zealand
Facility Name
Skin Centre
City
Tauranga
Country
New Zealand
12. IPD Sharing Statement
Links:
URL
http://www.bellberry.com.au
Description
Central HREC
Learn more about this trial
A Study to Determine the Optimal Tolerated Regime and Safety of PEP005 Topical Gel
We'll reach out to this number within 24 hrs