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

Actinic Keratoses Clinical Trial

Official title:

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00427050
• Other study ID #: PEP005-007
• Status: Completed
• Phase: Phase 2
• First received: January 24, 2007
• Last updated: September 11, 2015
• Start date: January 2007
• Est. completion date: November 2007

Study information

• Verified date: December 2008
• Source: Peplin
• Contact: n/a
• Is FDA regulated: No
• Health authority: Australia: Human Research Ethics CommitteeAustralia: Department of Health and Ageing Therapeutic Goods Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: November 2007
• Est. primary completion date: November 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Actinic Keratoses
• Keratosis
• Keratosis, Actinic

Intervention

Drug:
• PEP005

Locations

Country	Name	City	State
Australia	South East Dermatology	Belmont Specialist Centre, 1202 Creek Rd, Carina Heights	Queensland
Australia	The Skin Centre	Benowa	Queensland
Australia	Siller Medical	Brisbane	Queensland
Australia	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
New Zealand	Auckland Dermatology	Epsom	Auckland
New Zealand	Tristram Clinic	Hamilton
New Zealand	Skin Centre	Tauranga

Sponsors (1)

Lead Sponsor	Collaborator
Peplin

Countries where clinical trial is conducted

Australia,  New Zealand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.

External Links

•   Central HREC
•   Clinical Trials at LEO Pharma