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This study is primarily designed to investigate whether treatment, once daily for up to three consecutive days, with PEP005 (ingenol mebutate) Gel, 0.05% will be safe and tolerable in patients with superficial Basal Cell Carcinoma (sBCC) lesions on the trunk and extremities.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 | Experimental | PEP005 0.05% gel applied and occluded with an aluminium disk for up to three consecutive days |
|
| Group 2 | Experimental | PEP005 0.05% Gel applied and occluded with an OpSite(TM) disk up to three consecutive days |
|
| Group 3 | Experimental | PEP005 0.05% applied with no occlusion for up to three consecutive days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PEP005 (ingenol mebutate) Gel, 0.05% | Drug | PEP005 (ingenol mebutate) Gel, 0.05% for up to three consecutive days |
|
| Measure | Description | Time Frame |
|---|---|---|
| Treatment related Adverse Events, Local Skin Responses; Pigmentation and scarring | Number of participants with treatment related Adverse Events, change from baseline in LSR and pigmentation and scarring. | 120 days |
| Measure | Description | Time Frame |
|---|---|---|
| Histological and clinical clearance of sBCC lesions. | Number of participants with histological and clinical clearance of sBCC lesions. | 120 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jacqueline Morley | Peplin Operations | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Southderm Pty Ltd | Kogarah | New South Wales | 2217 | Australia | ||
| St George Dermatology |
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| Label | URL |
|---|---|
| Therapeutic Goods Administration | View source |
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| Aluminium disk | Device |
|
| OpSite(TM) disk | Device |
|
| Kogarah |
| New South Wales |
| 2217 |
| Australia |
| The Skin Centre | Benowa | Queensland | 4217 | Australia |
| Specialist Connect | Woolloongabba | Queensland | 4102 | Australia |
| Dermatology Institute of Victoria | South Yarra | Victoria | 3141 | Australia |
| St John of God Dermatology | Subiaco | Western Australia | 6008 | Australia |
| Burswood Dermatology | Victoria Park | Western Australia | 6100 | Australia |
| ID | Term |
|---|---|
| C486592 | 3-ingenyl angelate |
| D005782 | Gels |
| ID | Term |
|---|---|
| D003102 | Colloids |
| D045424 | Complex Mixtures |
| D004304 | Dosage Forms |
| D004364 | Pharmaceutical Preparations |
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