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

Peplin50 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Actinic Keratoses

Interventions

PEP005DRUG

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (9)

Skin and Cancer Foundation

Darlinghurst, New South Wales, Australia

Southderm Pty Ltd

Kogarah, New South Wales, Australia

St George Dermatology and Skin Cancer Centre

Level 3, 22 Belgrave St, Kogarah, New South Wales, Australia

South East Dermatology

Outcomes

Primary Outcomes

Optimal tolerated regime of PEP005 Topical Gel in patients, when administered as either two day or three day application schedules to a 25 cm2 contiguous AK treatment area on the face or face and scalp

Secondary Outcomes

Efficacy at 2 or 3day application PEP005 Topical Gel at the MTD of 0.025% in the Expanded Cohort, and at 2 lower concs of 0.0175% and 0.0125% at either a 2 or 3day application, when applied to 25cm2 AK treatment area on face or face/scalp.

Data from ClinicalTrials.gov

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