TineaPhase 2NCT00771342
Efficacy Study to Evaluate the Effect of Nitric Oxide on the Treatment of Tinea Pedis (Athlete's Foot)
A Phase 2 study testing Nitric Oxide and Nitrogen in people with Tinea, run by Nitric BioTherapeutics, Inc at 1 site in Canada.
Trial summary
The purpose of this study is to determine the fungicidal efficacy of nitric oxide 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 older
- Conditions the study is for
- Tinea
- What is being tested?
- Nitric Oxide and Nitrogen
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteCanada
- Study dates
- Dec 2008to Aug 2009
- 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 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
- 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 12 day (or 26 day if in cross over group) study period
Who cannot join
- Has a diagnosis of either psoriasis or eczema
- Has a visual diagnosis, by the investigator, of onychomycosis.
- 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 5 days of screening visit (Day 1)
- Use of systemic corticosteroids in the preceding 7 days 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 (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
- Has cardiovascular disease, diabetes mellitus, Cushing's Disease, hematological malignancy, chronic mucocutaneous candidiasis or atopy
- 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
- Suffers from a condition, which, in the opinion of the medical investigator, would compromise his/her safety
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Blinded Placebo Controlled Single Cross-over Clinical Trial to Evaluate Fungicidal Activity With Topical Application of 1% Gaseous Nitric Oxide 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 and it's effect on the clinical signs and symptoms associated with Tinea Pedis
- Conditions
- Tinea
- Being tested
- Nitric Oxide, Nitrogen
- Medical subject headings
- Tinea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nitric OxideDrug
1% gaseous nitric oxide, delivered for 40 minutes daily for 3 consecutive days
NitrogenDrug
Nitrogen gas, delivered topically for 40 minutes daily for 3 consecutive days
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | 1% gasoue nitric oxide, delivered topically for 40 minutes daily for three consecutive days Receives: Drug: Nitric Oxide |
| 2 | Placebo comparator | Nitrogen gas delivered topically for 40 minutes, daily, for 3 consecutive days Receives: Drug: Nitrogen |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evidence of fungicidal activity as confirmed by mycological culture or microscopic evaluation and improvement in Clinical Symptom Severity Score
Measured: Day 12 or Day 26
Secondary outcomes (1)
Incidence of adverse events
Measured: Duration of the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2008 (estimated)
- Study startDec 2008
- Primary completionJun 2009
- Study completionAug 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TineaStudies 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
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nitric BioTherapeutics, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00771342
- Sponsor's protocol ID
- CTP 6
- Status last verified
- Feb 2010
- First submitted
- 10 Oct 2008
- Last updated
- 3 Feb 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Blinded Placebo Controlled Single Cross-over Clinical Trial to Evaluate Fungicidal Activity With Topical Application of 1% Gaseous Nitric Oxide in Subjects With Moderate to Severe Tinea Pedis (Athlete's Foot)
- ClinicalTrials.gov ID
- NCT00771342
- Acronym / sponsor ID
- CTP 6
- Conditions
- Tinea
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Nitric BioTherapeutics, IncIndustry (pharma, biotech, devices)
- Study start
- Dec 2008
- Primary completion
- Jun 2009 (actual)
- Study completion
- Aug 2009 (actual)
- First posted
- 13 Oct 2008 (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.
The purpose of this study is to determine the fungicidal efficacy of nitric oxide and it's effect on the clinical signs and symptoms associated with Tinea Pedis
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: Nitric Oxide1% gasoue nitric oxide, delivered topically for 40 minutes daily for three consecutive days |
| 2 | Placebo comparator | Drug: NitrogenNitrogen gas delivered topically for 40 minutes, daily, for 3 consecutive days |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not 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
- 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 (11 listed)
- Has a diagnosis of either psoriasis or eczema
- Has a visual diagnosis, by the investigator, of onychomycosis.
- 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 5 days of screening visit (Day 1)
- Use of systemic corticosteroids in the preceding 7 days 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 (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 |
|---|---|---|
| Nitric Oxide1% gaseous nitric oxide, delivered for 40 minutes daily for 3 consecutive days | Drug | 1 |
| NitrogenNitrogen gas, delivered topically for 40 minutes daily for 3 consecutive days | Drug | 2 |
Primary outcome
Evidence of fungicidal activity as confirmed by mycological culture or microscopic evaluation and improvement in Clinical Symptom Severity Score
Time frame: Day 12 or Day 26
1 secondary outcome
Incidence of adverse events
Time frame: Duration of the study
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 3 Feb 2010.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Nitrogen in people with Tinea, run by Nitric BioTherapeutics, 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 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 3 Feb 2010. 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?
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?
Evidence of fungicidal activity as confirmed by mycological culture or microscopic evaluation and improvement in Clinical Symptom Severity Score (time frame: Day 12 or Day 26). 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 3 Feb 2010.