A multi-arm trial to evaluate the efficacy and safety of using gaseous nitric oxide to treat moderate to severe tinea pedis.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
92
1% gaseous nitric oxide blended in oxygen applied for 30-60 minutes over 1-2 consecutive days.
Mediprobe Research, Inc
London, Ontario, Canada
Eureka Health Services
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
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).
Time frame: 29 days
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:
Time frame: 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:
Time frame: 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:
Time frame: 7 days
Determine the safety of daily topical applications of 1% gNO as confirmed by methemoglobin levels and adverse events.
Time frame: 29 days
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