A Study to Determine the Optimal Tolerated Regime and Safety of PEP005 Topical Gel
This study has been completed.
Sponsor:
Peplin
Information provided by:
Peplin
ClinicalTrials.gov Identifier:
NCT00427050
First received: January 24, 2007
Last updated: December 22, 2008
Last verified: December 2008
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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) |
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 | |
| 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 June 18, 2013