Back to resultsPharmacokinetic Study to Evaluate the Extent of Systemic Absorption of PEP005
Primary Purpose
Actinic Keratoses
Status
Completed
Phase
Phase 1
Locations
Australia
Study Type
Interventional
Intervention
PEP005
Sponsored by
About this trial
This is an interventional treatment trial for Actinic Keratoses focused on measuring Pharmacokinetic study, Actinic Keratosis, Topical, Dermatology
Eligibility Criteria
Inclusion Criteria:
- Male patients at least 18 years of age.
- A contiguous 100 cm2 treatment area containing at least 5 AK lesions, on the either the right or left extensor (dorsal aspect) forearm.
- Written informed consent has been obtained.
- Agreement from the patient to allow photographs of the selected AK treatment area to be taken and used as part of the study package.
Sites / Locations
- Siller Medical
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
1
Arm Description
Two days consecutive days of application of 0.05% PEP005 Topical Gel to a 100cm2 contiguous AK treatment area of the arm.
Outcomes
Primary Outcome Measures
To evaluate the extent of systemic absorption of PEP005 when applied as 0.05% Topical Gel on two consecutive days (Day 1 and Day 2) to a 100 cm2 (5 cm x 20 cm) contiguous AK treatment area on the extensor (dorsal aspect) forearm.
Secondary Outcome Measures
To evaluate the safety and tolerability of two consecutive days of application of 0.05% PEP005 Topical Gel, when applied to a 100 cm2 (5 cm x 20 cm) contiguous AK treatment area on the extensor (dorsal aspect) forearm.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00544258
Brief Title
Pharmacokinetic Study to Evaluate the Extent of Systemic Absorption of PEP005
Official Title
A Phase I, Pharmacokinetic Study to Evaluate the Extent of Systemic Absorption of PEP005, When Applied as 0.05% PEP005 Topical Gel to a 100 cm2 (5 cm x 20 cm) Contiguous Actinic Keratosis(AK) Treatment Area on the Extensor (Dorsal Aspect) Forearm.
Study Type
Interventional
2. Study Status
Record Verification Date
May 2008
Overall Recruitment Status
Completed
Study Start Date
October 2007 (undefined)
Primary Completion Date
May 2008 (Actual)
Study Completion Date
May 2008 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Peplin
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to determine the extent of systemic absorption of PEP005 when applied topically for the treatment of actinic keratoses.
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
Pharmacokinetic study, Actinic Keratosis, Topical, Dermatology
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
8 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
Two days consecutive days of application of 0.05% PEP005 Topical Gel to a 100cm2 contiguous AK treatment area of the arm.
Intervention Type
Drug
Intervention Name(s)
PEP005
Primary Outcome Measure Information:
Title
To evaluate the extent of systemic absorption of PEP005 when applied as 0.05% Topical Gel on two consecutive days (Day 1 and Day 2) to a 100 cm2 (5 cm x 20 cm) contiguous AK treatment area on the extensor (dorsal aspect) forearm.
Secondary Outcome Measure Information:
Title
To evaluate the safety and tolerability of two consecutive days of application of 0.05% PEP005 Topical Gel, when applied to a 100 cm2 (5 cm x 20 cm) contiguous AK treatment area on the extensor (dorsal aspect) forearm.
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Male patients at least 18 years of age.
A contiguous 100 cm2 treatment area containing at least 5 AK lesions, on the either the right or left extensor (dorsal aspect) forearm.
Written informed consent has been obtained.
Agreement from the patient to allow photographs of the selected AK treatment area to be taken and used as part of the study package.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Janelle Katsamas
Organizational Affiliation
Peplin
Official's Role
Study Director
Facility Information:
Facility Name
Siller Medical
City
Silverton Place, 101 Wickham Terrace, Brisbane
State/Province
Queensland
ZIP/Postal Code
4000
Country
Australia
12. IPD Sharing Statement
Links:
URL
http://www.qimr.edu.au/
Description
Queensland Institute of Medical Research
URL
http://www.qpharm.com.au/
Description
Q-Pharm Ltd
Learn more about this trial
Pharmacokinetic Study to Evaluate the Extent of Systemic Absorption of PEP005
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