A Study to Determine the Optimal Tolerated Regime and Safety of PEP005 Topical Gel

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

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-01-31

Study Completion Date

2007-11-30

Brief Summary

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The purpose of this study is to determine the optimal tolerated regime of PEP005 for the treatment of actinic keratoses of the face or face and scalp.

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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 Keratoses

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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PEP005

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

1. Male patients at least 18 years of age.
2. Post-menopausal female patients i.e., no menses for at least 12 consecutive months, or without a uterus.
3. Four to eight clinically typical, visible and discrete AK lesions within a contiguous 25 cm2 treatment area on the face or face and scalp.

5\. Ability to follow study instructions and likely to complete all study requirements.

6\. Written informed consent has been obtained. 7. 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