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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-10-31

Study Completion Date

2008-01-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Actinic Keratosis

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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

Group Type EXPERIMENTAL

PEP005 gel

Intervention Type DRUG

Two day application, 0.05%

Interventions

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PEP005 gel

Two day application, 0.05%

Intervention Type DRUG

Other Intervention Names

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PEP005

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No