- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02871011
Nitric Oxide Releasing Solution (NORS) Footbath to Treat Athlete's Foot
August 20, 2019 updated by: Nitric Solutions Inc.
A Blinded Placebo Controlled Clinical Trial To Evaluate Fungicidal Activity With The Topical Application Of Nitric Oxide Releasing Solution (Nors) In Subjects With Moderate To Severe Tinea Pedis (Athlete's Foot)
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 Overview
Detailed Description
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
Enrollment (Actual)
20
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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British Columbia
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Vancouver, British Columbia, Canada, V5Z-16H
- Fairmont Medical Clinic
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
19 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: SINGLE_GROUP
- Masking: QUADRUPLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
PLACEBO_COMPARATOR: Control
Water, delivered as a footbath for 30 minutes, daily for 3 consecutive days.
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Delivered as a footbath
Other Names:
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EXPERIMENTAL: Nitric oxide
Nitric oxide delivered as a footbath for 30 minutes, daily for 3 consecutive days.
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Delivered as a footbath
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Participants With Complete Cure: Post Treatment (Day 17)
Time Frame: 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.
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Day 17
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Number of Participants With Complete Cure: Post Treatment (Day 31)
Time Frame: Day 31
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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
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Number of Participants With Therapeutic Failure: Post Treatment (Day 17)
Time Frame: Day 17
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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.
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Day 17
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Number of Participants withTherapeutic Failure: Post Treatment Day 31 AND a Post Treatment Clinical Symptom Severity Score (Day 31) of < 8.
Time Frame: Day 31
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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.
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Day 31
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Incidence of Adverse Events
Time Frame: Duration of the study, 31 days for each participant.
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Number of moderate A/E possibly related to treatment
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Duration of the study, 31 days for each participant.
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Participants Clinical Symptom Severity Score Between Day 1 and Day 31
Time Frame: Day 1 and 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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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Lisa Miller, M.D., Nitric Solutions Inc.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
August 13, 2016
Primary Completion (ACTUAL)
November 14, 2016
Study Completion (ACTUAL)
February 21, 2017
Study Registration Dates
First Submitted
August 4, 2016
First Submitted That Met QC Criteria
August 12, 2016
First Posted (ESTIMATE)
August 18, 2016
Study Record Updates
Last Update Posted (ACTUAL)
September 20, 2019
Last Update Submitted That Met QC Criteria
August 20, 2019
Last Verified
August 1, 2019
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Skin Diseases
- Infections
- Foot Diseases
- Bacterial Infections and Mycoses
- Skin Diseases, Infectious
- Mycoses
- Skin Manifestations
- Dermatomycoses
- Foot Dermatoses
- Pruritus
- Tinea
- Tinea Pedis
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Vasodilator Agents
- Autonomic Agents
- Peripheral Nervous System Agents
- Protective Agents
- Bronchodilator Agents
- Anti-Asthmatic Agents
- Respiratory System Agents
- Antioxidants
- Free Radical Scavengers
- Endothelium-Dependent Relaxing Factors
- Gasotransmitters
- Nitric Oxide
Other Study ID Numbers
- SAN-CPT-01
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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