Tinea PedisNCT00848666
Safety and Efficacy of a Novel Topical Therapy for Tinea Pedis (Athlete's Foot)
A study testing Topical therapy in people with Tinea Pedis, run by Hillel Yaffe Medical Center at 1 site in Israel.
Trial summary
The purpose of this study is to evaluate the safety and efficacy of a novel topical therapy in patients with laboratory confirmed tinea pedis. During the follow-up period clinical and mycological examinations will be performed. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Tinea Pedis
- What is being tested?
- Topical therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteIsrael
- Study dates
- Apr 2009to Apr 2010
- Phase
- Interventional
- 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Otherwise healthy patients with laboratory proven tinea pedis
Who cannot join
- Age lower than 18 and higher than 80
Trial locations and contacts
1 site in 1 country.
Israel1 site
Hillel Yaffe Medical Center
Hadera, 38100
Kahana, 972-4-6304667, kahanam@hy.health.gov.il
Michael Kahana, MD
About this study
The purpose of this study is to evaluate the safety and efficacy of a novel topical therapy in patients with laboratory confirmed tinea pedis. During the follow-up period clinical and mycological examinations will be performed.
- Conditions
- Tinea Pedis
- Being tested
- Topical therapy
- Medical subject headings
- Tinea Pedis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Topical therapyDrug
One time immersion of the feet in a liquid containing water, alcohol, vinegar, benzoic acid and salicylic acid for a total of 30 minutes.
| Study group | Role | What they receive |
|---|---|---|
| I | Experimental | Patients with tinea pedis Receives: Drug: Topical therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cure of tinea pedis
Measured: One year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2009 (estimated)
- Study startApr 2009
- Primary completionApr 2010 (estimated)
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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hillel Yaffe Medical Center
- Sponsor type
- Other government
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00848666
- Sponsor's protocol ID
- HYMC 48-08
- Status last verified
- Feb 2009
- First submitted
- 28 Aug 2008
- Last updated
- 24 Feb 2009
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of a Novel Topical Therapy for Tinea Pedis (Athlete's Foot)
- ClinicalTrials.gov ID
- NCT00848666
- Acronym / sponsor ID
- HYMC 48-08
- Conditions
- Tinea Pedis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Hillel Yaffe Medical CenterOther government
- Study start
- Apr 2009
- Primary completion
- Apr 2010 (estimated)
- First posted
- 20 Feb 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.
The purpose of this study is to evaluate the safety and efficacy of a novel topical therapy in patients with laboratory confirmed tinea pedis. During the follow-up period clinical and mycological examinations will be performed.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| I | Experimental | Drug: Topical therapyPatients with tinea pedis |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Otherwise healthy patients with laboratory proven tinea pedis
Key exclusion criteria (1 listed)
- Age lower than 18 and higher than 80
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 |
|---|---|---|
| Topical therapyOne time immersion of the feet in a liquid containing water, alcohol, vinegar, benzoic acid and salicylic acid for a total of 30 minutes. | Drug | I |
Primary outcome
Cure of tinea pedis
Time frame: One year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2009.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Topical therapy in people with Tinea Pedis, run by Hillel Yaffe Medical Center at 1 site in Israel.
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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 24 Feb 2009. 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 Israel. 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.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cure of tinea pedis (time frame: One year). 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 24 Feb 2009.