Back to resultsA Study to Examine the Safety and Toleration of PEP005 Topical Gel in Patients With Actinic Keratoses on the Top of the Hand
Primary Purpose
Actinic Keratosis
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
PEP005 gel
Sponsored by
About this trial
This is an interventional treatment trial for Actinic Keratosis focused on measuring Actinic Keratosis, Topical, Dermatology, Hand
Eligibility Criteria
Inclusion Criteria:
- Male patients at least 18 years of age.
- Post-menopausal female patients
- 4 to 8 clinically typical, visible and discrete AK lesions within an area on the dorsum of one hand.
- 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 data package.
Sites / Locations
- Skin Surgery Medical Group Inc
- Gwinnett Clinical Research Centre
- Dermatology Clinical Research Centre of San Antonio
- Dermatology Associates of Tyler
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
PEP005 gel administration
Arm Description
0.05% PEP005 Topical Gel administered for two consecutive days to a 25cm2 contiguous AK treatment area on the top of the hand
Outcomes
Primary Outcome Measures
Incidence of Adverse Events (AEs) and Serious Adverse Events (SAEs); and Local Skin Responses (LSR)
Secondary Outcome Measures
The complete clearance rate of AK lesions; partial clearance rate of AK lesions and baseline clearance rate of AK lesions.
Full Information
NCT ID
NCT00544297
First Posted
October 14, 2007
Last Updated
March 13, 2015
Sponsor
Peplin
Collaborators
Omnicare Clinical Research
1. Study Identification
Unique Protocol Identification Number
NCT00544297
Brief Title
A Study to Examine the Safety and Toleration of PEP005 Topical Gel in Patients With Actinic Keratoses on the Top of the Hand
Official Title
A Multi-center, Open-label Study to Examine the Safety and Toleration of 0.05% PEP005 Topical Gel in Patients With Actinic Keratoses on the Dorsum of the Hand
Study Type
Interventional
2. Study Status
Record Verification Date
March 2015
Overall Recruitment Status
Completed
Study Start Date
October 2007 (undefined)
Primary Completion Date
January 2008 (Actual)
Study Completion Date
January 2008 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Peplin
Collaborators
Omnicare Clinical Research
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to examine the safety and toleration of PEP005 Topical Gel, administered on an actinic keratosis (AK) treatment area on the top of a hand.
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 Keratosis
Keywords
Actinic Keratosis, Topical, Dermatology, Hand
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
12 (Actual)
8. Arms, Groups, and Interventions
Arm Title
PEP005 gel administration
Arm Type
Experimental
Arm Description
0.05% PEP005 Topical Gel administered for two consecutive days to a 25cm2 contiguous AK treatment area on the top of the hand
Intervention Type
Drug
Intervention Name(s)
PEP005 gel
Other Intervention Name(s)
PEP005
Intervention Description
Two day application, 0.05%
Primary Outcome Measure Information:
Title
Incidence of Adverse Events (AEs) and Serious Adverse Events (SAEs); and Local Skin Responses (LSR)
Time Frame
57 days
Secondary Outcome Measure Information:
Title
The complete clearance rate of AK lesions; partial clearance rate of AK lesions and baseline clearance rate of AK lesions.
Time Frame
57 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Male patients at least 18 years of age.
Post-menopausal female patients
4 to 8 clinically typical, visible and discrete AK lesions within an area on the dorsum of one hand.
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 data package.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Arthur P Bertolino, MD
Organizational Affiliation
Chief Medical Officer and VP Medical Affairs
Official's Role
Study Director
Facility Information:
Facility Name
Skin Surgery Medical Group Inc
City
San Diego
State/Province
California
ZIP/Postal Code
92117
Country
United States
Facility Name
Gwinnett Clinical Research Centre
City
Snellville
State/Province
Georgia
ZIP/Postal Code
30078-3250
Country
United States
Facility Name
Dermatology Clinical Research Centre of San Antonio
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229-3409
Country
United States
Facility Name
Dermatology Associates of Tyler
City
Tyler
State/Province
Texas
ZIP/Postal Code
75703
Country
United States
12. IPD Sharing Statement
Links:
URL
http://www.fda.gov/
Description
Food and Drug Administration
URL
http://www.quorumreview.com
Description
Human Research Ethics Committee
Learn more about this trial
A Study to Examine the Safety and Toleration of PEP005 Topical Gel in Patients With Actinic Keratoses on the Top of the Hand
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