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| ID | Type | Description | Link |
|---|---|---|---|
| 2009-016627-56 | EudraCT Number |
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The aim of this study is to determine the efficacy and safety of once daily topical application of the combinational cream LAS41003 compared to the corresponding mono-substances in the treatment of candida infections in intertriginous areas at the trunk.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LAS41003 | Experimental |
| |
| LAS189962 | Active Comparator |
| |
| LAS189961 | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LAS41003 | Drug | Once daily, topically |
| |
| LAS189962 |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical efficacy and mycological culture | Clinical assesment scores and mycological status of candida (mycological culture) | Day 14 |
| Measure | Description | Time Frame |
|---|---|---|
| Physical examination, AEs | Physician assesmentes of sign and symptoms (erythema, papules, pustules and maceration) Percentage of local skin reactions, AEs | 14 Days |
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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 #5 | Augsburg | 86179 | Germany | |||
| Investigational Site #4 |
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| Label | URL |
|---|---|
| Almirall Corporate Website | View source |
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| ID | Term |
|---|---|
| D002177 | Candidiasis |
| ID | Term |
|---|---|
| D009181 | Mycoses |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
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| ID | Term |
|---|---|
| C034213 | octenidine |
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| Drug |
Once daily, topically |
|
| LAS189961 | Drug | Once daily, topically |
|
| Bad Saarow |
| 15526 |
| Germany |
| Investigational Site #2 | Berlin | 10961 | Germany |
| Investigational Site #6 | Dülmen | 48249 | Germany |
| Investigational Site #1 | Hamburg | 20095 | Germany |
| Investigational Site #3 | Vechta | 49377 | Germany |