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| ID | Type | Description | Link |
|---|---|---|---|
| EudraCT: 2009-012063-33 |
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The aim of this study is to determine the efficacy, safety and tolerability of either a once or twice daily topical application of LAS41007 compared to a twice daily application of LAS106521 in the treatment of actinic keratosis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LAS41007 o.d. | Experimental | Once daily |
|
| LAS41007 b.i.d. | Experimental | Twice daily |
|
| LAS106521 | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LAS41007 o.d. | Drug | Once daily, topical application |
| |
| LAS41007 b.i.d. |
| Measure | Description | Time Frame |
|---|---|---|
| Histological clearance of one pre-selected target lesion | Day 120 | |
| Complete clinical clearance of all target lesions in the treatment areas | Day 120 |
| Measure | Description | Time Frame |
|---|---|---|
| Physician's Global Tolerability Assessment (PGT) | Day 120 |
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Inclusion Criteria:
Exclusion Criteria:
Have evidence of clinically significant or unstable medical conditions such as:
Suffer from paresthesia in the treatment areas
Show Cornu cutaneum of the skin and/or hypertrophic AK lesions in the treatment areas
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| Name | Affiliation | Role |
|---|---|---|
| Christoph Willers, MD, MBA | Almirall Hermal GmbH | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Investigational Site | Hamburg | Germany |
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| Label | URL |
|---|---|
| Almirall Corporate Website | 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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| Drug |
Twice daily, topical application |
|
| LAS106521 | Drug | Twice daily, topical application |
|
| D017437 |
| Skin and Connective Tissue Diseases |