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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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ClinicalTrials.gov Identifier: NCT00544297
Recruitment Status : Completed
First Posted : October 16, 2007
Last Update Posted : April 2, 2015
Sponsor:
Collaborator:
Omnicare Clinical Research
Information provided by (Responsible Party):
Peplin

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.

Condition or disease Intervention/treatment Phase
Actinic Keratosis Drug: PEP005 gel Phase 2

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : October 2007
Actual Primary Completion Date : January 2008
Actual Study Completion Date : January 2008

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: PEP005 gel administration
0.05% PEP005 Topical Gel administered for two consecutive days to a 25cm2 contiguous AK treatment area on the top of the hand
Drug: PEP005 gel
Two day application, 0.05%
Other Name: PEP005



Primary Outcome Measures :
  1. Incidence of Adverse Events (AEs) and Serious Adverse Events (SAEs); and Local Skin Responses (LSR) [ Time Frame: 57 days ]

Secondary Outcome Measures :
  1. The complete clearance rate of AK lesions; partial clearance rate of AK lesions and baseline clearance rate of AK lesions. [ Time Frame: 57 days ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00544297


Locations
United States, California
Skin Surgery Medical Group Inc
San Diego, California, United States, 92117
United States, Georgia
Gwinnett Clinical Research Centre
Snellville, Georgia, United States, 30078-3250
United States, Texas
Dermatology Clinical Research Centre of San Antonio
San Antonio, Texas, United States, 78229-3409
Dermatology Associates of Tyler
Tyler, Texas, United States, 75703
Sponsors and Collaborators
Peplin
Omnicare Clinical Research
Investigators
Study Director: Arthur P Bertolino, MD Chief Medical Officer and VP Medical Affairs

Additional Information:
Responsible Party: Peplin
ClinicalTrials.gov Identifier: NCT00544297     History of Changes
Other Study ID Numbers: PEP005-018
First Posted: October 16, 2007    Key Record Dates
Last Update Posted: April 2, 2015
Last Verified: March 2015

Keywords provided by Peplin:
Actinic Keratosis
Topical
Dermatology
Hand

Additional relevant MeSH terms:
Keratosis
Keratosis, Actinic
Skin Diseases
Precancerous Conditions
Neoplasms