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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control | Placebo Comparator | Water, delivered as a footbath for 30 minutes, daily for 3 consecutive days. |
|
| Nitric oxide | Experimental | Nitric oxide delivered as a footbath for 30 minutes, daily for 3 consecutive days. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nitric Oxide | Drug | Delivered as a footbath |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 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. | 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. | Day 31 |
| Incidence of Adverse Events | Number of moderate A/E possibly related to treatment | Duration of the study, 31 days for each participant. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Day 1 and 31 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Lisa Miller, M.D. | Nitric Solutions Inc. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fairmont Medical Clinic | Vancouver | British Columbia | V5Z-16H | Canada |
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| ID | Title | Description |
|---|---|---|
| FG000 | Control | Water, delivered as a footbath for 30 minutes, daily for 3 consecutive days. Water: Delivered as a footbath |
| FG001 | Nitric Oxide | Nitric oxide delivered as a footbath for 30 minutes, daily for 3 consecutive days. Nitric Oxide: Delivered as a footbath |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Control | Water, delivered as a footbath for 30 minutes, daily for 3 consecutive days. Water: Delivered as a footbath |
| BG001 | Nitric Oxide | Nitric oxide delivered as a footbath for 30 minutes, daily for 3 consecutive days. Nitric Oxide: Delivered as a footbath |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Randomized Treatment to Control of 2:1 |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Intent to treat enrollment was 20 individuals but per protocol only a total of 12 participants met the criteria for both a positive fungal culture and microscopic evaluation at baseline. | Posted | Count of Participants | Participants | Day 17 |
|
Thirty-one Days
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Control | Water, delivered as a footbath for 30 minutes, daily for 3 consecutive days. Water: Delivered as a footbath |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Discomfort -warm/sting | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr Chris Miller | SaNOtize Research & Development Corp. | 778-899-0607 | chris@sanotize.com |
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| ID | Term |
|---|---|
| D014008 | Tinea Pedis |
| D003881 | Dermatomycoses |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D009181 | Mycoses |
| D012871 | Skin Diseases |
| D005533 | Foot Dermatoses |
| D005534 | Foot Diseases |
| D011537 | Pruritus |
| ID | Term |
|---|---|
| D014005 | Tinea |
| D001423 | Bacterial Infections and Mycoses |
| D012874 | Skin Diseases, Infectious |
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| D009569 | Nitric Oxide |
| D014867 | Water |
| ID | Term |
|---|---|
| D026361 | Reactive Nitrogen Species |
| D005609 | Free Radicals |
| D007287 | Inorganic Chemicals |
| D009589 | Nitrogen Oxides |
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| Water | Drug | Delivered as a footbath |
|
|
| BG002 | Total | Total of all reporting groups |
| Mean |
| Full Range |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
Nitric oxide delivered as a footbath for 30 minutes, daily for 3 consecutive days.
Nitric Oxide: Delivered as a footbath
|
|
| Primary | 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. | Intent to treat enrollment was 20 individuals but per protocol only a total of 12 participants met the criteria for both a positive fungal culture and microscopic evaluation at baseline. | Posted | Count of Participants | Participants | Day 31 |
|
|
|
| Primary | 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. | Intent to treat enrollment was 20 individuals but per protocol only a total of 12 participants met the criteria for both a positive fungal culture and microscopic evaluation at baseline. | Posted | Count of Participants | Participants | Day 17 |
|
|
|
| Primary | 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. | Intent to treat enrollment was 20 individuals but per protocol only a total of 12 participants met the criteria for both a positive fungal culture and microscopic evaluation at baseline. | Posted | Count of Participants | Participants | Day 31 |
|
|
|
| Primary | Incidence of Adverse Events | Number of moderate A/E possibly related to treatment | Intent to treat enrollment was 20 individuals. | Posted | Number | Events | Duration of the study, 31 days for each participant. |
|
|
|
| Secondary | 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. | Intent to treat enrollment was 20 individuals. | Posted | Mean | Standard Deviation | Clinial symptom Severity Score | Day 1 and 31 |
|
|
|
| 0 |
| 7 |
| 0 |
| 7 |
| 0 |
| 7 |
| EG001 | Nitric Oxide | Nitric oxide delivered as a footbath for 30 minutes, daily for 3 consecutive days. Nitric Oxide: Delivered as a footbath | 0 | 13 | 0 | 13 | 3 | 13 |
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| D012877 | Skin Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D009140 | Musculoskeletal Diseases |
| D017672 |
| Nitrogen Compounds |
| D010087 | Oxides |
| D017601 | Oxygen Compounds |
| D009930 | Organic Chemicals |
| D006878 | Hydroxides |
| D000468 | Alkalies |
| D000838 | Anions |
| D007477 | Ions |
| D004573 | Electrolytes |