A Study to Determine the Optimal Tolerated Regime and Safety of PEP005 Topical Gel - Full Text View

Sponsored by:	Peplin
Information provided by:	Peplin
ClinicalTrials.gov Identifier:	NCT00427050

Purpose

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.

Condition	Intervention	Phase
Actinic Keratoses	Drug: PEP005	Phase II

Drug Information available for: 3-ingenyl angelate

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Dose Comparison, Parallel Assignment, Safety Study
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.

Further study details as provided by Peplin:

Primary Outcome Measures:

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 Outcome Measures:

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.

Estimated Enrollment:	50
Study Start Date:	January 2007
Study Completion Date:	November 2007
Primary Completion Date:	November 2007 (Final data collection date for primary outcome measure)

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Male patients at least 18 years of age.
Post-menopausal female patients i.e., no menses for at least 12 consecutive months, or without a uterus.
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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00427050

Locations

Australia, New South Wales
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, 2217
Skin and Cancer Foundation
277 Bourke St, Darlinghurst, New South Wales, Australia, 2010
Australia, Queensland
Siller Medical
Brisbane, Queensland, Australia
The Skin Centre
Benowa, Queensland, Australia, 4217
South East Dermatology
Belmont Specialist Centre, 1202 Creek Rd, Carina Heights, Queensland, Australia, 4152
New Zealand, Auckland
Auckland Dermatology
17 Gilgit Rd, Epsom, Auckland, New Zealand
New Zealand, Hamilton
Tristram Clinic
6 Knox Street, Hamilton, New Zealand
New Zealand, Tauranga
Skin Centre
171 Cameron Rd, PO Box 13509, Tauranga, New Zealand

Sponsors and Collaborators

Peplin

Investigators

Study Director:

Janelle Katsamas

Peplin Operations Pty Ltd

More Information

Sponsor website This link exits the ClinicalTrials.gov site

Central HREC This link exits the ClinicalTrials.gov site

Study ID Numbers:	PEP005-007
Study First Received:	January 24, 2007
Last Updated:	December 22, 2008
ClinicalTrials.gov Identifier:	NCT00427050
Health Authority:	Australia: Human Research Ethics Committee; Australia: Department of Health and Ageing Therapeutic Goods Administration

Keywords provided by Peplin:

Actinic Keratoses (AK)
PEP005
Topical
Dermatology

Study placed in the following topic categories:

Keratosis
Skin Diseases
Facies

Arnold-Chiari Malformation
Arnold-Chiari malformation
Tylosis

ClinicalTrials.gov processed this record on January 13, 2009