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
18 Years
N/A
Both
Actinic Keratosis
Trial Information
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
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.
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.
Type of Study:
Interventional
Study Design:
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Incidence of Adverse Events (AEs) and Serious Adverse Events (SAEs); and Local Skin Responses (LSR)
Outcome Time Frame:
57 days
Safety Issue:
Yes
Principal Investigator
Janice Drew
Investigator Role:
Study Director
Investigator Affiliation:
Peplin
Authority:
United States: Food and Drug Administration
Study ID:
PEP005-018
NCT ID:
NCT00544297
Start Date:
October 2007
Completion Date:
January 2008
Related Keywords:
- Actinic Keratosis
- Actinic Keratosis
- Topical
- Dermatology
- Hand
- Keratosis
- Keratosis, Actinic
Name | Location |
|---|---|
| Dermatology Associates of Tyler | Tyler, Texas 75703 |
| Skin Surgery Medical Group Inc | 5222 Balboa Avenue Sixth Floor San Diego, California 92117 |
| Gwinnett Clinical Research Centre | 2383 Pate St, Snellville, Georgia 30078-3250 |
| Dermatology Clinical Research Centre of San Antonio | 7810 Louis Pasteur Dr Suite 200 San Antonio, Texas 78229-3409 |
