Tinea PedisPhase 2NCT00893880
A Dose Response Trial to Evaluate Clinical and Mycological Effect of Nitric Oxide in Subjects With Tinea Pedis
A Phase 2 study testing 1% gaseous Nitric Oxide blended in Oxygen in people with Tinea Pedis, run by Nitric BioTherapeutics, Inc at 4 sites in 2 countries.
Trial summary
A multi-arm trial to evaluate the efficacy and safety of using gaseous nitric oxide to treat moderate to severe tinea pedis. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Tinea Pedis
- What is being tested?
- 1% gaseous Nitric Oxide blended in Oxygen
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 92 participants
- Where
- 4 sitesin 2 countries
- Study dates
- Jun 2009to May 2010
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Positive clinical findings (moderate to severe, indicated by a CSSS ≥ 6) for interdigital or bullous tinea pedis as determined by clinical examination (subjects with moccasin symptoms in addition to above may also be included at the discretion of the investigator).
- Written informed consent must be obtained from the subject.
- Must ≥ 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 not be pregnant or nursing, and if of childbearing potential, agree to take measures to avoid pregnancy during the 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 would 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®, Medicis), tolnaftate, haloprogin), Zeasorb-AF , antibacterials and corticosteroids in the preceding 14 days of screening visit (Day 1), on or immediately around the area under evaluation.
- Use of oral or injectable systemic corticosteroids in the preceding 7 or 30 days respectively, of screening visit (Day 1)
- Use of systemic antifungals in the preceding 30 days of screening visit (Day1) including - (terbinafine - (Lamisil®, Novartis), Itraconazole - (Sporanox®, Janssen), fluconazole- (Diflucan®, Pfizer), ketoconazole, miconazole, griseofulvin (Gris-PEG®, Pedinol), butoconazole, terconazole, Potassium iodide)
- Has used any investigational drug(s) within 30 days preceding screening visit (Day 1)
Show all 11Show fewer
- 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 < 18 years of age, unless local laws dictate otherwise.
- Is immunosuppressed (undergoing chemotherapy, neutropenia (PMNs , < 500/mm3), HIV with CD4+ < 200/mm3.
- 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 STATISTICS This clinical evaluation is intended to demonstrate
Trial locations and contacts
4 sites in 2 countries.
4 sites in 2 countries
Saint Kitts and Nevis3 sites
Diversified Healthcare Solutions
Basseterre, Saint Kitts
Medical Associates
Basseterre, Saint Kitts
Eureka Health Services
Ramsbury Site, Nevis
About this study
A multi-arm trial to evaluate the efficacy and safety of using gaseous nitric oxide to treat moderate to severe tinea pedis.
- Conditions
- Tinea Pedis
- Being tested
- 1% gaseous Nitric Oxide blended in Oxygen
- Keywords
- Tinea Pedis, Athletes Foot, Nitric Oxide
- Medical subject headings
- Tinea Pedis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
1% gaseous Nitric Oxide blended in OxygenDrug
1% gaseous nitric oxide blended in oxygen applied for 30-60 minutes over 1-2 consecutive days.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | (1) 30min treatment Receives: Drug: 1% gaseous Nitric Oxide blended in Oxygen |
| 2 | Experimental | (1) 60min treatment Receives: Drug: 1% gaseous Nitric Oxide blended in Oxygen |
| 3 | Experimental | (2) 30min treatments over two consecutive days. Receives: Drug: 1% gaseous Nitric Oxide blended in Oxygen |
| 4 | Experimental | (2) 60min treatments over two consecutive days. Receives: Drug: 1% gaseous Nitric Oxide blended in Oxygen |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complete cure (negative KOH and culture and no signs or symptoms), Effective treatment (negative KOH and culture and at most mild erythema or scaling), Negative mycology (negative KOH and culture).
Measured: 29 days
Secondary outcomes (4)
Determine the clinical and mycological effect of 1% gaseous nitric oxide (gNO) as a treatment for Tinea Pedis in the clinically evaluable population at the Test-of-Cure (TOC) evaluation (4 weeks post-treatment) according to the definitions below:
Measured: 29 days
Determine the clinical and mycological effect of the topical application of 1% gNO as confirmed by pre treatment positive culture and clinical signs and symptoms compared to 2 weeks post treatment outcomes according to definitions below:
Measured: 14 days
Determine the clinical and mycological effect of the topical application of 1% gNO as confirmed by pre treatment positive culture and clinical signs and symptoms compared to 1 week post treatment outcomes according to definitions below:
Measured: 7 days
Determine the safety of daily topical applications of 1% gNO as confirmed by methemoglobin levels and adverse events.
Measured: 29 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2009 (estimated)
- Study startJun 2009
- Primary completionJan 2010
- Study completionMay 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 92 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nitric BioTherapeutics, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00893880
- Sponsor's protocol ID
- CTP8
- Status last verified
- Oct 2012
- First submitted
- 4 May 2009
- Last updated
- 22 Oct 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Dose Response Trial to Evaluate Clinical and Mycological Effect of Nitric Oxide in Subjects With Tinea Pedis
- ClinicalTrials.gov ID
- NCT00893880
- Acronym / sponsor ID
- CTP8
- Conditions
- Tinea Pedis
- Keywords
- Tinea Pedis, Athletes Foot, Nitric Oxide
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 92 participants (actual)
- Lead sponsor
- Nitric BioTherapeutics, IncIndustry (pharma, biotech, devices)
- Study start
- Jun 2009
- Primary completion
- Jan 2010 (actual)
- Study completion
- May 2010 (actual)
- First posted
- 6 May 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A multi-arm trial to evaluate the efficacy and safety of using gaseous nitric oxide to treat moderate to severe tinea pedis.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: 1% gaseous Nitric Oxide blended in Oxygen(1) 30min treatment |
| 2 | Experimental | Drug: 1% gaseous Nitric Oxide blended in Oxygen(1) 60min treatment |
| 3 | Experimental | Drug: 1% gaseous Nitric Oxide blended in Oxygen(2) 30min treatments over two consecutive days. |
| 4 | Experimental | Drug: 1% gaseous Nitric Oxide blended in Oxygen(2) 60min treatments over two consecutive days. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Positive clinical findings (moderate to severe, indicated by a CSSS ≥ 6) for interdigital or bullous tinea pedis as determined by clinical examination (subjects with moccasin symptoms in addition to above may also be included at the discretion of the investigator).
- Written informed consent must be obtained from the subject.
- Must ≥ 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 not be pregnant or nursing, and if of childbearing potential, agree to take measures to avoid pregnancy during the study period
Key exclusion criteria (11 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 would 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®, Medicis), tolnaftate, haloprogin), Zeasorb-AF , antibacterials and corticosteroids in the preceding 14 days of screening visit (Day 1), on or immediately around the area under evaluation.
- Use of oral or injectable systemic corticosteroids in the preceding 7 or 30 days respectively, of screening visit (Day 1)
- Use of systemic antifungals in the preceding 30 days of screening visit (Day1) including - (terbinafine - (Lamisil®, Novartis), Itraconazole - (Sporanox®, Janssen), fluconazole- (Diflucan®, Pfizer), ketoconazole, miconazole, griseofulvin (Gris-PEG®, Pedinol), 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 |
|---|---|---|
| 1% gaseous Nitric Oxide blended in Oxygen1% gaseous nitric oxide blended in oxygen applied for 30-60 minutes over 1-2 consecutive days. | Drug | 1, 2, 3, 4 |
Primary outcome
Complete cure (negative KOH and culture and no signs or symptoms), Effective treatment (negative KOH and culture and at most mild erythema or scaling), Negative mycology (negative KOH and culture).
Time frame: 29 days
4 secondary outcomes
Determine the clinical and mycological effect of 1% gaseous nitric oxide (gNO) as a treatment for Tinea Pedis in the clinically evaluable population at the Test-of-Cure (TOC) evaluation (4 weeks post-treatment) according to the definitions below:
Time frame: 29 days
Determine the clinical and mycological effect of the topical application of 1% gNO as confirmed by pre treatment positive culture and clinical signs and symptoms compared to 2 weeks post treatment outcomes according to definitions below:
Time frame: 14 days
Determine the clinical and mycological effect of the topical application of 1% gNO as confirmed by pre treatment positive culture and clinical signs and symptoms compared to 1 week post treatment outcomes according to definitions below:
Time frame: 7 days
Determine the safety of daily topical applications of 1% gNO as confirmed by methemoglobin levels and adverse events.
Time frame: 29 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2012.
Related trials for Tinea Pedis
RecruitingObservational study
In Vitro Susceptibility of Dermatophytes to Terbinafine and Itraconazole: MIC Distributions and Elevated-MIC Isolates in Faisalabad, Pakistan
Dermatophytosis, Tinea Corporis
RecruitingPhase 1
A Phase 1b Study of ZYG24004 in Participants With Tinea Pedis Caused by Dermatophytes
Tinea Pedis
Recruiting
Atmospheric Pressure Cold Plasma for Moderate-to-severe Tinea Pedis
Tinea Pedis
RecruitingPhase 2
Topical Tolnaftate Stick for Tinea Pedis: An Open-Label Interventional Study
Tinea Pedis
Not yet recruitingObservational study
Sports Nutrition Assessment Program
Diet Habit, Body Weight
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.
The record lists no contact. Use the official record to reach the sponsor.
4 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing 1% gaseous Nitric Oxide blended in Oxygen in people with Tinea Pedis, run by Nitric BioTherapeutics, Inc at 4 sites in 2 countries.
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 5 inclusion and 11 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 22 Oct 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Saint Kitts and Nevis, 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Complete cure (negative KOH and culture and no signs or symptoms), Effective treatment (negative KOH and culture and at most mild erythema or scaling), Negative mycology (negative KOH and culture). (time frame: 29 days). 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 22 Oct 2012.