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

Phase 2

Completed

• Conditions: Actinic Keratosis
• Interventions: Drug: PEP005 gel

• Registration Number: NCT00544297
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2007-10
• Study First Submitted: 2007-10-14
• Study First Submitted QC: 2007-10-15
• Study First Posted: 2007-10-16
• Primary Completion: 2008-01
• Study Completion: 2008-01
• Disposition First Submitted: 2010-07-13
• Disposition First Submitted QC: 2010-07-13
• Disposition First Posted: 2010-07-15
• Status Verified: 2015-03
• Last Update Submitted: 2015-03-13
• Last Update Posted: 2015-04-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 12

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.

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
PEP005 gel administration	PEP005 gel	0.05% PEP005 Topical Gel administered for two consecutive days to a 25cm2 contiguous AK treatment area on the top of the hand

Primary Outcome Measures

Name	Time	Method
Incidence of Adverse Events (AEs) and Serious Adverse Events (SAEs); and Local Skin Responses (LSR)	57 days

Secondary Outcome Measures

Name	Time	Method
The complete clearance rate of AK lesions; partial clearance rate of AK lesions and baseline clearance rate of AK lesions.	57 days

Trial Locations

Locations (4)

Skin Surgery Medical Group Inc; 🇺🇸 San Diego, California, United States

Gwinnett Clinical Research Centre; 🇺🇸 Snellville, Georgia, United States

Dermatology Clinical Research Centre of San Antonio; 🇺🇸 San Antonio, Texas, United States

Dermatology Associates of Tyler; 🇺🇸 Tyler, Texas, United States