A Phase 2 interventional study of Nitric Oxide and Water in Tinea Pedis, sponsored by Nitric Solutions Inc.. Completed at 1 site in Canada. Open to participants aged 19 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-09-20.
Sponsored by Nitric Solutions Inc. · Phase 2, Interventional, and Treatment
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
74 studies on the registry are indexed under Tinea Pedis; 7 are open to participants now.
This study's enrollment of 20 is below the median of 120 across 68 interventional studies indexed under Tinea Pedis.
Browse Tinea Pedis studies →This is the only study on the registry with Nitric Solutions Inc. as lead sponsor.
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Exclusion Criteria:
Water, delivered as a footbath for 30 minutes, daily for 3 consecutive days.
Drug: Water
Nitric oxide delivered as a footbath for 30 minutes, daily for 3 consecutive days.
Drug: Nitric Oxide
Delivered as a footbath
Also known as: NORS
Delivered as a footbath
Also known as: Placebo
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.
Time frame: Day 1 and 31
| Milestone | Control | Nitric Oxide |
|---|---|---|
| Started | 7 | 13 |
| Completed | 7 | 13 |
| Not completed | 0 | 0 |
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.
| Participants | Control | Nitric Oxide |
|---|---|---|
| Number of Participants With Complete Cure: Post Treatment (Day 17) | 0 | 4 |
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.
| Participants | Control | Nitric Oxide |
|---|---|---|
| Number of Participants With Complete Cure: Post Treatment (Day 31) | 0 | 5 |
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.
| Participants | Control | Nitric Oxide |
|---|---|---|
| Number of Participants With Therapeutic Failure: Post Treatment (Day 17) | 2 | 0 |
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.
| Participants | Control | Nitric Oxide |
|---|---|---|
| Number of Participants withTherapeutic Failure: Post Treatment Day 31 AND a Post Treatment Clinical Symptom Severity Score (Day 31) of < 8. | 1 | 0 |
Number of moderate A/E possibly related to treatment
| Events | Control | Nitric Oxide |
|---|---|---|
| Incidence of Adverse Events | 0 | 3 |
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.
| Clinial symptom Severity Score | Control | Nitric Oxide |
|---|---|---|
| Change in Participants Clinical Symptom Severity Score Between Day 1 and Day 31 | -3.4 ± 8.6 | -18.8 ± 7.1 |
Collected over Thirty-one Days. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Control | 0/7 (0%) | 0/7 (0%) | 0/7 (0%) |
| Nitric Oxide | 0/13 (0%) | 0/13 (0%) | 3/13 (23.1%) |
| Event | Control | Nitric Oxide |
|---|---|---|
| Discomfort -warm/stingSkin and subcutaneous tissue disorders | 0/7 | 3/13 |
| Age, Continuous(years) | Control | Nitric Oxide | Total |
|---|---|---|---|
| Mean | 53.1 (35 to 79) | 53.2 (34 to 79) | 53.2 (34 to 79) |
| Sex: Female, Male(Participants) | Control | Nitric Oxide | Total |
|---|---|---|---|
| Female | 0 | 3 | 3 |
| Male | 7 | 10 | 17 |
| Region of Enrollment(participants) | Control | Nitric Oxide | Total |
|---|---|---|---|
| Canada | 7 | 13 | 20 |
Plan to share: Undecided
No publications or documents are linked to this record.
Ran from Aug 2016 to primary completion in Nov 2016, 3 months.
Results were first posted in Sep 2019, 2 years 10 months after primary completion.
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Studies of the drug tested here: Nitric Oxide