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The purpose of this study is to determine if the new ingenol derivative gels are as safe as and as well tolerated as ingenol mebutate gel when applied to AK lesions on the forearm for two consecutive days.
Various concentrations of new ingenol derivatives will be applied to AKs on the forearms. Reactions and safety will be compared to a US registered and marketed ingenol gel to ascertain if the new ingenol is at least as safe and as well tolerated as the registered ingenol.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ingenol mebutate gel 0.05% | Active Comparator | once daily for two consecutive days |
|
| Ingenol derivative concentration 1 | Experimental | once daily for two consecutive days |
|
| Ingenol derivative concentration 2 | Experimental | once daily for two consecutive days |
|
| Ingenol derivative concentration 3 | Experimental | once daily for two consecutive days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ingenol once daily for two consecutive days | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| Safety of a new ingenol derivative compared to ingenol mebutate gel applied topically once daily for two consecutive days to four separate treatment areas containing actinic keratosis on the forearm | Safety data to be collected via CRF entries of AEs/SAEs and photographs. | 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluate treatment responses on Actinic Keratosis of different concentrations of a new ingenol derivative gel compared to the ingenol mebutate gel as assessed by reduction in number of clinically visible selected AK lesions eight weeks after treatment | Assessed by Reflective Confocal Microscopy scoring of visible selected AK lesions | 8 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Hans P Soyer | Dermatology Department, Brisbane Public Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dermatology Department | Woolloongabba | Queensland | 4102 | Australia |
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| Label | URL |
|---|---|
| LEO Pharma | View source |
| Therapeutic Goods Administration | 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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| D017437 |
| Skin and Connective Tissue Diseases |