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

Actinic Keratosis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00544297
• Other study ID #: PEP005-018
• Status: Completed
• Phase: Phase 2
• First received: October 14, 2007
• Last updated: March 13, 2015
• Start date: October 2007
• Est. completion date: January 2008

Study information

• Verified date: March 2015
• Source: Peplin
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: January 2008
• Est. primary completion date: January 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Actinic Keratosis
• Keratosis
• Keratosis, Actinic

Intervention

Drug:
• PEP005 gel
Two day application, 0.05%

Locations

Country	Name	City	State
United States	Dermatology Clinical Research Centre of San Antonio	San Antonio	Texas
United States	Skin Surgery Medical Group Inc	San Diego	California
United States	Gwinnett Clinical Research Centre	Snellville	Georgia
United States	Dermatology Associates of Tyler	Tyler	Texas

Sponsors (2)

Lead Sponsor	Collaborator
Peplin	Omnicare Clinical Research

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of Adverse Events (AEs) and Serious Adverse Events (SAEs); and Local Skin Responses (LSR)		57 days	Yes
Secondary	The complete clearance rate of AK lesions; partial clearance rate of AK lesions and baseline clearance rate of AK lesions.		57 days	No

External Links

•   Clinical Trials at LEO Pharma
•   Food and Drug Administration
•   Human Research Ethics Committee