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

This study has been completed.
Sponsor:
Information provided by:
Peplin
ClinicalTrials.gov Identifier:
NCT00427050
First received: January 24, 2007
Last updated: December 22, 2008
Last verified: December 2008
  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 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: 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.

Resource links provided by NLM:


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
  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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
Australia, New South Wales
Skin and Cancer Foundation
277 Bourke St, 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
17 Gilgit Rd, Epsom, Auckland, New Zealand
Tristram Clinic
6 Knox Street, Hamilton, New Zealand
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

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00427050     History of Changes
Other Study ID Numbers: PEP005-007
Study First Received: January 24, 2007
Last Updated: December 22, 2008
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

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

ClinicalTrials.gov processed this record on August 20, 2014