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| ID | Type | Description | Link |
|---|---|---|---|
| 2008-005654-21 | EudraCT Number |
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The study shall prove whether 6 consecutive doses of Bifonazole spray show comparable efficacy to a Terbinafine solution applied once.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1 | Experimental |
| |
| Arm 2 | Experimental |
| |
| Arm 3 | Placebo Comparator |
| |
| Arm 4 | Placebo Comparator |
| |
| Arm 5 | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bifonazole spray once daily | Drug | Application of one dose daily by means of an metered dose |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Assessment of erythema, scaling, vesiculation maceration, and pruritus based on a categorial scale (0=absent to 3 =severe), assessment of mycological cure based on cultures and microscopy | After 6 applications (7 and 42 days after start of treatment) | |
| Local side effects on the skin | From day 1 through day 42 |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical cure | After 6 applications (7 and 42 days after start of treatment) | |
| Mycological cure | After 6 applications (7 and 42 days after start of treatment) | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bayer Study Director | Bayer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Berlin | State of Berlin | 10437 | Germany | |||
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| Label | URL |
|---|---|
| Click here and search for websynopsis provided by the EMA | View source |
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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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| Bifonazole spray twice daily |
| Drug |
Application of two dose daily by means of an metered dose |
|
| Placebo | Drug | Application of one dose daily by means of an metered dose |
|
| Placebo | Drug | Application of one dose daily by means of an metered dose |
|
| Lamisil Once | Drug | One application of Lamisil Once |
|
| Rate of negative culture |
| After 6 applications (7 and 42 days after start of treatment) |
| Rate of microscopy negative | After 6 applications (7 and 42 days after start of treatment) |
| Rate of absence of itching and burning | After 6 applications (7 and 42 days after start of treatment) |
| Incidence and severity of Adverse Event | From visit 2 (day 3) till visit 7 (day 42) |
| Vital Signs | Visit 1 (day 1) and visit 7 (day 42) |
| Local side effects | From visit 2 (day 3) till visit 7 (day 42) |
| Berlin |
| State of Berlin |
| 13055 |
| Germany |
| Berlin | State of Berlin | 13187 | Germany |
| Berlin | State of Berlin | 13439 | 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 |