Pharmacokinetic Study to Evaluate the Extent of Systemic Absorption of PEP005

Peplin8 enrolled

Overview

The purpose of this study is to determine the extent of systemic absorption of PEP005 when applied topically for the treatment of actinic keratoses.

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

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Actinic Keratoses

Interventions

PEP005DRUG

Eligibility

Sex: MALEMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Male patients at least 18 years of age. 2. A contiguous 100 cm2 treatment area containing at least 5 AK lesions, on the either the right or left extensor (dorsal aspect) forearm. 3. Written informed consent has been obtained. 4. Agreement from the patient to allow photographs of the selected AK treatment area to be taken and used as part of the study package.

Locations (1)

Siller Medical

Silverton Place, 101 Wickham Terrace, Brisbane, Queensland, Australia

Outcomes

Primary Outcomes

To evaluate the extent of systemic absorption of PEP005 when applied as 0.05% Topical Gel on two consecutive days (Day 1 and Day 2) to a 100 cm2 (5 cm x 20 cm) contiguous AK treatment area on the extensor (dorsal aspect) forearm.

Secondary Outcomes

To evaluate the safety and tolerability of two consecutive days of application of 0.05% PEP005 Topical Gel, when applied to a 100 cm2 (5 cm x 20 cm) contiguous AK treatment area on the extensor (dorsal aspect) forearm.

Data from ClinicalTrials.gov

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