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

An Open-label, Multi-centre, Dose-escalation, Cohort Study to Determine the Optimal Tolerated Regime and Safety of PEP005 Topical Gel When Applied to a 25 cm2 Contiguous Actinic Keratoses Treatment Area on the Face or Face and Scalp.

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00427050

Enrollment

Registered

2007-01-26

Start date

2007-01-31

Completion date

2007-11-30

Last updated

2015-09-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Actinic Keratoses

Keywords

Actinic Keratoses (AK), PEP005, Topical, Dermatology

Brief summary

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.

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.

Interventions

DRUGPEP005

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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.	—

Countries

Australia, New Zealand

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026