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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.
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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PEP005 | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Janelle Katsamas | Peplin Operations Pty Ltd | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Skin and Cancer Foundation | Darlinghurst | New South Wales | 2010 | Australia | ||
| Southderm Pty Ltd |
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| Label | URL |
|---|---|
| Central HREC | View source |
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| ID | Term |
|---|---|
| D055623 | Keratosis, Actinic |
| ID | Term |
|---|---|
| D011230 | Precancerous Conditions |
| D009369 | Neoplasms |
| D007642 | Keratosis |
| D012871 | Skin Diseases |
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| ID | Term |
|---|---|
| C486592 | 3-ingenyl angelate |
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| Kogarah |
| New South Wales |
| Australia |
| St George Dermatology and Skin Cancer Centre | Level 3, 22 Belgrave St, Kogarah | New South Wales | 2217 | Australia |
| South East Dermatology | Belmont Specialist Centre, 1202 Creek Rd, Carina Heights | Queensland | 4152 | Australia |
| The Skin Centre | Benowa | Queensland | 4217 | Australia |
| Siller Medical | Brisbane | Queensland | Australia |
| Auckland Dermatology | Epsom | Auckland | New Zealand |
| Tristram Clinic | Hamilton | New Zealand |
| Skin Centre | Tauranga | New Zealand |
| D017437 |
| Skin and Connective Tissue Diseases |