The purpose of this study is to determine the fungicidal efficacy of nitric oxide releasing solution footbath and it's effect on the clinical signs and symptoms associated with Tinea Pedis
Study Type: Interventional Study Design: Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Sequential Assignment Masking: Double Blind (Subject \& Assessor) Primary Purpose: Treatment
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
20
Delivered as a footbath
Delivered as a footbath
Fairmont Medical Clinic
Vancouver, British Columbia, Canada
Number of Participants With Complete Cure: Post Treatment (Day 17)
Complete cure will be determined by negative fungal culture or negative microscopic evaluation via KOH preparation and a Clinical Symptom Severity Score of ≤ 8 (0-64) on Day 17. Improvement is expressed as a lower score.
Time frame: Day 17
Number of Participants With Complete Cure: Post Treatment (Day 31)
Complete cure will be determined by a minimum of a 12- point reduction on day 17 in the Clinical Symptom Severity Score (from \>20 to \<8) on a scale of 0-64. Improvement is expressed as a lower score.
Time frame: Day 31
Number of Participants With Therapeutic Failure: Post Treatment (Day 17)
Positive fungi colonization via mycological culture OR microscopic evaluation (KOH) AND a post treatment Clinical Symptom Severity Score of ≤ 8 (0-64) on Day 17. Improvement is expressed as a lower score.
Time frame: Day 17
Number of Participants withTherapeutic Failure: Post Treatment Day 31 AND a Post Treatment Clinical Symptom Severity Score (Day 31) of < 8.
Positive fungi colonization via mycological culture OR microscopic evaluation (KOH) AND a post treatment Clinical Symptom Severity Score of ≤ 8 (0-64) on Day 31. Improvement is expressed as a lower score.
Time frame: Day 31
Incidence of Adverse Events
Number of moderate A/E possibly related to treatment
Time frame: Duration of the study, 31 days for each participant.
Change in Participants Clinical Symptom Severity Score Between Day 1 and Day 31
Clinical Symptom Severity Score change in score on Day and Day 31 between all participants with an initial Clinical Symptom severity Score of \>20 (0-64 scale) in the two study groups. Increased improvement is expressed as largest negative change and a lower score.
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Time frame: Day 1 and 31