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A multi-arm trial to evaluate the efficacy and safety of using gaseous nitric oxide to treat moderate to severe tinea pedis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | (1) 30min treatment |
|
| 2 | Experimental | (1) 60min treatment |
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| 3 | Experimental | (2) 30min treatments over two consecutive days. |
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| 4 | Experimental | (2) 60min treatments over two consecutive days. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 1% gaseous Nitric Oxide blended in Oxygen | Drug | 1% gaseous nitric oxide blended in oxygen applied for 30-60 minutes over 1-2 consecutive days. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Complete cure (negative KOH and culture and no signs or symptoms), Effective treatment (negative KOH and culture and at most mild erythema or scaling), Negative mycology (negative KOH and culture). | 29 days |
| Measure | Description | Time Frame |
|---|---|---|
| Determine the clinical and mycological effect of 1% gaseous nitric oxide (gNO) as a treatment for Tinea Pedis in the clinically evaluable population at the Test-of-Cure (TOC) evaluation (4 weeks post-treatment) according to the definitions below: | 29 days | |
| Determine the clinical and mycological effect of the topical application of 1% gNO as confirmed by pre treatment positive culture and clinical signs and symptoms compared to 2 weeks post treatment outcomes according to definitions below: |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mediprobe Research, Inc | London | Ontario | N5X 2P1 | Canada | ||
| Eureka Health Services |
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| 14 days |
| Determine the clinical and mycological effect of the topical application of 1% gNO as confirmed by pre treatment positive culture and clinical signs and symptoms compared to 1 week post treatment outcomes according to definitions below: | 7 days |
| Determine the safety of daily topical applications of 1% gNO as confirmed by methemoglobin levels and adverse events. | 29 days |
| Ramsbury Site |
| Nevis |
| Saint Kitts and Nevis |
| Diversified Healthcare Solutions | Basseterre | Saint Kitts | Saint Kitts and Nevis |
| Medical Associates | Basseterre | Saint Kitts | Saint Kitts and Nevis |
| ID | Term |
|---|---|
| D014008 | Tinea Pedis |
| ID | Term |
|---|---|
| D014005 | Tinea |
| D003881 | Dermatomycoses |
| D009181 | Mycoses |
| D001423 | Bacterial Infections and Mycoses |
| 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 |
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| ID | Term |
|---|---|
| D010100 | Oxygen |
| ID | Term |
|---|---|
| D018011 | Chalcogens |
| D004602 | Elements |
| D007287 | Inorganic Chemicals |
| D005740 | Gases |
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