Tinea PedisPhase 2NCT02871011
Nitric Oxide Releasing Solution (NORS) Footbath to Treat Athlete's Foot
A Phase 2 study testing Nitric Oxide and Water in people with Tinea Pedis, run by Nitric Solutions Inc. at 1 site in Canada.
Trial 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 Read more about this study
- Who is it for?
- Ages 19 years and olderHealthy volunteers can take part
- Conditions the study is for
- Tinea Pedis
- What is being tested?
- Nitric Oxide and Water
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteCanada
- Study dates
- 13 Aug 2016to 21 Feb 2017
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
Read the 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
- Conditions
- Tinea Pedis
- Being tested
- Nitric Oxide, Water
- Keywords
- Tinea Bronchodilator Agents, Tinea Pedis, Nitric Oxide, Dermatomycoses, Endothelium-Dependent Relaxing Factors, Infectious, Infection, Mycoses, Skin Diseases, Foot Dermatoses, Foot Diseases, Pruritus, Skin Manifestations Signs and Symptoms
- Medical subject headings
- Tinea Pedis, Dermatomycoses, Communicable Diseases, Infections, Mycoses, Skin Diseases, Foot Dermatoses, Foot Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nitric OxideDrug
Also called NORS
Delivered as a footbath
WaterDrug
Also called Placebo
Delivered as a footbath
| Study group | Role | What they receive |
|---|---|---|
| Control | Placebo comparator | Water, delivered as a footbath for 30 minutes, daily for 3 consecutive days. Receives: Drug: Water |
| Nitric oxide | Experimental | Nitric oxide delivered as a footbath for 30 minutes, daily for 3 consecutive days. Receives: Drug: Nitric Oxide |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Day 31
Incidence of Adverse Events
Number of moderate A/E possibly related to treatment
Measured: Duration of the study, 31 days for each participant.
Secondary outcomes (1)
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.
Measured: Day 1 and 31
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2016 (estimated)
- Study start13 Aug 2016
- Primary completion14 Nov 2016
- Study completion21 Feb 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Tinea PedisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nitric Solutions Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Lisa Miller, M.D., Principal investigator, Nitric Solutions Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02871011
- Sponsor's protocol ID
- SAN-CPT-01
- Status last verified
- Aug 2019
- First submitted
- 4 Aug 2016
- Last updated
- 20 Sep 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 20 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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)
- ClinicalTrials.gov ID
- NCT02871011
- Acronym / sponsor ID
- SAN-CPT-01
- Conditions
- Tinea Pedis
- Keywords
- Tinea Bronchodilator Agents, Tinea Pedis, Nitric Oxide, Dermatomycoses, Endothelium-Dependent Relaxing Factors, Infectious, Infection, Mycoses
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Nitric Solutions Inc.Industry (pharma, biotech, devices)
- Study start
- 13 Aug 2016 (actual)
- Primary completion
- 14 Nov 2016 (actual)
- Study completion
- 21 Feb 2017 (actual)
- First posted
- 18 Aug 2016 (estimated)
- Results
- Posted 20 Sep 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | Placebo comparator | Drug: WaterWater, delivered as a footbath for 30 minutes, daily for 3 consecutive days. |
| Nitric oxide | Experimental | Drug: Nitric OxideNitric oxide delivered as a footbath for 30 minutes, daily for 3 consecutive days. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (10 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nitric OxideAlso: NORSDelivered as a footbath | Drug | Nitric oxide |
| WaterAlso: PlaceboDelivered as a footbath | Drug | Control |
Primary outcome
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.
Number of Participants With Complete Cure: Post Treatment (Day 31)
Time frame: 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.
Number of Participants With Therapeutic Failure: Post Treatment (Day 17)
Time frame: 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.
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
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.
Incidence of Adverse Events
Time frame: Duration of the study, 31 days for each participant.
Number of moderate A/E possibly related to treatment
1 secondary outcome
Change in Participants Clinical Symptom Severity Score Between Day 1 and Day 31
Time frame: Day 1 and 31
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Sep 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lisa Miller, M.D. principal investigator
Nitric Solutions Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Nitric Oxide and Water in people with Tinea Pedis, run by Nitric Solutions Inc. at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 20 Sep 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Complete Cure: Post Treatment (Day 17) (time frame: Day 17). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Sep 2019.