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The aim of this study is to determine the efficacy, safety and tolerability of LAS41007 compared to a marketed reference product as well as to vehicle (topical application, twice daily, indication mild to moderate AK).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LAS41007 | Experimental | All patients will be instructed to apply the IMP twice daily, once in the morning and once in the evening. Per application, not more than 1.5 g of the IMP should be applied, which is sufficient to cover a total area of 75 cm2 (corresponding to 3 single TAs, each with a size of 25 cm²) in maximum. The IMPs will be applied for 90 days in maximum. |
|
| LASW1510 | Active Comparator | All patients will be instructed to apply the IMP twice daily, once in the morning and once in the evening. Per application, not more than 1.5 g of the IMP should be applied, which is sufficient to cover a total area of 75 cm2 (corresponding to 3 single TAs, each with a size of 25 cm²) in maximum. The IMPs will be applied for 90 days in maximum. |
|
| vehicle | Placebo Comparator | All patients will be instructed to apply the IMP twice daily, once in the morning and once in the evening. Per application, not more than 1.5 g of the IMP should be applied, which is sufficient to cover a total area of 75 cm2 (corresponding to 3 single TAs, each with a size of 25 cm²) in maximum. The IMPs will be applied for 90 days in maximum. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LAS41007 | Drug | Topical gel, to be applied twice daily (mornings and evenings), for up to 90 days. Generally 0.5 g gel (pea-sized amount of gel) per application will be sufficient to cover an overall area of 25 cm². |
| Measure | Description | Time Frame |
|---|---|---|
| superiority of LAS41007 compared to vehicle | superiority of LAS41007 compared to comparator each assessed by histology to evaluate the histological clearance of one pre-selected target lesion | Day 1 |
| superiority of LAS41007 compared to vehicle | superiority of LAS41007 compared to comparator each assessed by histology to evaluate the histological clearance of one pre-selected target lesion | Day 150 |
| Measure | Description | Time Frame |
|---|---|---|
| superiority of LAS41007 compared to vehicle | improved clinical efficacy of LAS41007 compared to comparator with respect to clinical efficacy | Day 1 |
| superiority of LAS41007 compared to vehicle |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Dr. Estrella Estrella Garcia, PhD | Almirall, S.A. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Almirall Investigational Site | Vechta | 49377 | Germany |
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| LASW1510 | Drug | Topical gel, to be applied twice daily (mornings and evenings), for up to 90 days. Generally 0.5 g gel (pea-sized amount of gel) per application will be sufficient to cover an overall area of 25 cm². |
|
| vehicle of LAS41007 | Drug | Topical gel, to be applied twice daily (mornings and evenings), for up to 90 days. Generally 0.5 g gel (pea-sized amount of gel) per application will be sufficient to cover an overall area of 25 cm². |
|
improved clinical efficacy of LAS41007 compared to comparator with respect to clinical efficacy
| Day 21 |
| superiority of LAS41007 compared to vehicle | improved clinical efficacy of LAS41007 compared to comparator with respect to clinical efficacy | Day 56 |
| superiority of LAS41007 compared to vehicle | improved clinical efficacy of LAS41007 compared to comparator with respect to clinical efficacy | Day 90 |
| superiority of LAS41007 compared to vehicle | improved clinical efficacy of LAS41007 compared to comparator with respect to clinical efficacy | Day 150 |
| ID | Term |
|---|---|
| D055623 | Keratosis, Actinic |
| ID | Term |
|---|---|
| D011230 | Precancerous Conditions |
| D009369 | Neoplasms |
| D007642 | Keratosis |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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