A Study to Examine the Safety and Toleration of PEP005 Topical Gel in Patients With Actinic Keratoses on the Top of the Hand - Full Text View

Purpose

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	Intervention	Phase
Actinic Keratosis	Drug: PEP005	Phase 2

Study Type:	Interventional
Study Design:	Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: 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

Resource links provided by NLM:

Drug Information available for: Ingenol mebutate

U.S. FDA Resources

Further study details as provided by Peplin:

Primary Outcome Measures:

Incidence of Adverse Events (AEs) and Serious Adverse Events (SAEs); and Local Skin Responses (LSR) [ Time Frame: 57 days ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

The complete clearance rate of AK lesions; partial clearance rate of AK lesions and baseline clearance rate of AK lesions. [ Time Frame: 57 days ] [ Designated as safety issue: No ]

Enrollment:	12
Study Start Date:	October 2007
Study Completion Date:	January 2008
Primary Completion Date:	January 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 1 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 Two day application, 0.05%

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00544297

Locations

United States, California
Skin Surgery Medical Group Inc
5222 Balboa Avenue Sixth Floor San Diego, California, United States, 92117
United States, Georgia
Gwinnett Clinical Research Centre
2383 Pate St, Snellville, Georgia, United States, 30078-3250
United States, Texas
Dermatology Associates of Tyler
1367 Dominion Plaza, Tyler, Texas, United States, 75703
Dermatology Clinical Research Centre of San Antonio
7810 Louis Pasteur Dr Suite 200 San Antonio, Texas, United States, 78229-3409

Sponsors and Collaborators

Peplin

Investigators

Study Director:

Janice Drew

Peplin

More Information

Additional Information:

Food and Drug Administration This link exits the ClinicalTrials.gov site

Human Research Ethics Committee This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Janice Drew, Peplin
ClinicalTrials.gov Identifier:	NCT00544297 History of Changes
Other Study ID Numbers:	PEP005-018
Study First Received:	October 14, 2007
Last Updated:	June 6, 2011
Health Authority:	United States: Food and Drug Administration

Keywords provided by Peplin:

Actinic Keratosis
Topical
Dermatology
Hand

Additional relevant MeSH terms:

Keratosis
Keratosis, Actinic
Skin Diseases
Precancerous Conditions
Neoplasms

ClinicalTrials.gov processed this record on May 19, 2013