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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00427050
Recruitment Status : Completed
First Posted : January 26, 2007
Last Update Posted : September 14, 2015
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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.

Condition or disease Intervention/treatment Phase
Actinic Keratoses Drug: PEP005 Phase 2

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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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.
Study Start Date : January 2007
Actual Primary Completion Date : November 2007
Actual Study Completion Date : November 2007

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  1. 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 :
  1. 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.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
  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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00427050

Australia, New South Wales
Skin and Cancer Foundation
Darlinghurst, New South Wales, Australia, 2010
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
Australia, Queensland
South East Dermatology
Belmont Specialist Centre, 1202 Creek Rd, Carina Heights, Queensland, Australia, 4152
The Skin Centre
Benowa, Queensland, Australia, 4217
Siller Medical
Brisbane, Queensland, Australia
New Zealand
Auckland Dermatology
Epsom, Auckland, New Zealand
Tristram Clinic
Hamilton, New Zealand
Skin Centre
Tauranga, New Zealand
Sponsors and Collaborators
Study Director: Janelle Katsamas Peplin Operations Pty Ltd

Additional Information: Identifier: NCT00427050     History of Changes
Other Study ID Numbers: PEP005-007
First Posted: January 26, 2007    Key Record Dates
Last Update Posted: September 14, 2015
Last Verified: December 2008

Keywords provided by Peplin:
Actinic Keratoses (AK)

Additional relevant MeSH terms:
Keratosis, Actinic
Skin Diseases
Precancerous Conditions