Phase 2
N=20
Nitric Oxide Releasing Solution (NORS) Footbath to Treat Athlete's Foot
Tinea Pedis
Bottom Line
View on ClinicalTrials.gov: NCT02871011 ↗Enrolled (actual)
20
Serious AEs
0.0%
Results posted
Sep 2019
Primary outcome: Primary: Number of Participants With Complete Cure: Post Treatment (Day 17) — 0; 4 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Nitric Oxide (Drug); Water (Drug)
- Age
- Adult, Older Adult · 19+ yrs
- Sex
- All
- Sponsor
- Nitric Solutions Inc.
- Primary completion
- Nov 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Complete Cure: Post Treatment (Day 17) |
0; 4 | — |
| PRIMARY Number of Participants With Complete Cure: Post Treatment (Day 31) |
0; 5 | — |
| PRIMARY Number of Participants With Therapeutic Failure: Post Treatment (Day 17) |
2; 0 | — |
| PRIMARY Number of Participants withTherapeutic Failure: Post Treatment Day 31 AND a Post Treatment Clinical Symptom Severity Score (Day 31) of < 8. |
1; 0 | — |
| PRIMARY Incidence of Adverse Events |
0; 3 | — |
| SECONDARY Change in Participants Clinical Symptom Severity Score Between Day 1 and Day 31 |
-3.4; -18.8 | — |
Summary
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
Eligibility Criteria
Inclusion Criteria
- Positive clinical findings for moccasin, interdigital or bullous tinea pedis as determined by direct clinical examination
- Must have a clinical symptom severity score of at least 20 on a possible 64 point scale
- Written informed consent must be obtained from the subject.
- Must ≥ 19 years of age, for study sites located in British Columbia. For other locations the subject must be ≥ 18 years of age, unless local laws dictate otherwise.
- Must agree to avoid professional pedicures or application of any nail polish product or nail cosmetic to the toenails after the screening visit until the conclusion of the trial.
- Must agree to take measures to avoid pregnancy during the 31 day study period
Exclusion Criteria
- Has a diagnosis of either psoriasis or eczema, in or immediately around the area under evaluation.
- Has a visual diagnosis, by the investigator, of onychomycosis at a level, which in the opinion of the investigator could compromise the integrity of the study.
- Use of topical antifungals e.g. (clotrimazole, ketoconazole,miconazole, oxiconazole- (Oxistat®, Glaxo Smith Kline), sulconazole, naftifine (Naftin®, Merz), terconazole, econazole nitrate (Spectazole®, Ortho-McNeil), butoconazole ,Fluconazole, ciclopirox olamine-(Loprox®), tolnaftate, haloprogin), Zeasorb, antibacterials and corticosteroids in the preceding 5 days of screening visit (Day 1) on or immediately around the area under evaluation.
- Use of systemic corticosteroids in the preceding 7 days respectively, of screening visit (Day 1)
- Use of systemic antifungals in the preceding 7 days of screening visit (Day1) including - (terbinafine - (Lamisil®, Novartis), Itraconazole - (Sporanox®, Janssen), fluconazole- (Diflucan®, Pfizer), ketoconazole, miconazole, griseofulvin (GrisPEG®), butoconazole, terconazole, Potassium iodide)
- Has used any investigational drug(s) within 30 days preceding screening visit (Day 1)
- Is pregnant or is a nursing mother
- Is a woman of child bearing potential who is not using an adequate form of contraception (or abstinence)
- Is < 19 years of age, for study sites located in British Columbia. For other locations subject is < 18 years of age, unless local laws dictate otherwise.
- Suffers from a condition, which, in the opinion of the medical investigator, would compromise his/her safety and / or the quality of the data. Such conditions may include collagen vascular disease, diabetes mellitus, Cushing's Disease, hematological malignancy, chronic mucocutaneous candidiasis or atopy
Data sourced from ClinicalTrials.gov (NCT02871011). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.