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| ID | Type | Description | Link |
|---|---|---|---|
| 2009-016626-14 | EudraCT Number |
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The aim of this study is to determine the efficacy and safety of a topical application of the combinational cream LAS41003 compared to application of its mono-substances after once daily treatment in patients with inflammatory tinea pedis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LAS41003 | Experimental | Once daily |
|
| LAS189962 | Active Comparator | Once daily |
|
| LAS189961 | Active Comparator | Once daily |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LAS41003 | Drug | Once daily |
| |
| LAS189961 |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical assessment scores and mycological status of fungi (KOH test and mycological culture) | 2 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Physicians assessment of signs and symptoms (erythema, scaling, vesicles, pustules, crusting, fissuring and maceration) | Percentage of locla skin reactions, AEs | 2 weeks |
| Local skin reactions, AEs |
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Inclusion Criteria:
Exclusion Criteria:
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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 #2 | Berlin | 10961 | Germany | |||
| Investigational Site #1 |
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| ID | Term |
|---|---|
| D014008 | Tinea Pedis |
| ID | Term |
|---|---|
| D014005 | Tinea |
| D003881 | Dermatomycoses |
| D009181 | Mycoses |
| D001423 | Bacterial Infections and Mycoses |
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| ID | Term |
|---|---|
| C034213 | octenidine |
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| Drug |
Once daily |
|
| LAS189962 | Drug | Once daily |
|
| 2 weeks |
| Hamburg |
| 20095 |
| Germany |
| D007239 |
| Infections |
| D012874 | Skin Diseases, Infectious |
| D005533 | Foot Dermatoses |
| D005534 | Foot Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D011537 | Pruritus |
| D012877 | Skin Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |