Tinea PedisPhase 2NCT00768599
A Study of Econazole Foam 1% in Athlete's Foot
A Phase 2 study testing Econazole Nitrate Cream 1% and Econazole Nitrate Foam 1% in people with Tinea Pedis and Athlete's Foot, run by AmDerma at 6 sites in United States.
Trial summary
This is a 6-week clinical study (4 weeks of treatment, once per day, plus a 2-week follow-up period) of a topical foam to treat athlete's foot. The active ingredient in the foam -- econazole nitrate 1% -- is the same active pharmaceutical ingredient in a cream that your doctor can currently prescribe to treat… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Tinea Pedis, Athlete's Foot
- What is being tested?
- Econazole Nitrate Cream 1% and Econazole Nitrate Foam 1%
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 135 participants
- Where
- 6 sitesUnited States
- Study dates
- Mar 2008to Oct 2008
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Be at least 18 years or age and of either sex.
- Has a clinical diagnosis of tinea pedis with at least i) moderate scaling(interdigital and/or moccasin) and ii) mild erythema (interdigital only).
- Be willing to give informed consent.
- Be willing and able to give informed consent.
- Has microscopic evidence (positive KOH) of the presence of fungi. Evaluable subjects must have a positive KOH and a fungal culture positive for a dermatophyte at Baseline. Subjects with a positive KOH may be entered into the study pending the results of the fungal culture.
- Be in good health and free of any disease or physical condition which might, in the investigator's opinion, expose the subject to an unacceptable risk by study participation.
- Women of childbearing potential must have a negative urine pregnancy test and agree to use an effective, non-prohibited form of birth control for the duration of the study (abstinence, stabilized on oral contraceptives for at least two months, implant, injection, IUD, patch, NuvaRing, condom and spermicidal or diaphragm and spermicidal).
Who cannot join
- Is nursing or planning a pregnancy during the study.
- Has used topical antifungal or corticosteroid therapy or systemic antibacterial therapy within 30 days prior to the start of the study.
- Has received systemic antifungal therapy within 12 weeks prior to the start of the study medication.
- Has a history of diabetes mellitus or is immunocompromised (due to disease, e.g., HIV, or medications).
- Has concurrent tinea infection (in the opinion of the investigator). However, concurrent onychomycosis is allowed.
- Has any other skin disease which might interfere with the evaluation of tinea pedis.
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- Is currently enrolled in an investigational drug or device study.
- Has received an investigational drug or treatment with an investigational device within 30 days prior to entering this study
- Is unreliable, including subjects with a history of drug or alcohol abuse.
- Has known hypersensitivity to any of the components of the study medications.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
Michael Jarratt, MD
Austin, Texas, 78759
Daniel Stewart, DO
Clinton Township, Michigan, 48038
Steven Kempers, MD
Fridley, Minnesota, 55432
Michael Gold, MD
Nashville, Tennessee, 37215
Leonard Swinyer, MD
Salt Lake City, Utah, 84124
Stacy Smith, MD
San Diego, California, 92123
About this study
Official title: A Multi-Center Randomized, Evaluator-Blinded, Vehicle Controlled, Parallel Group Comparison Study of the Safety and Efficacy of Econazole Nitrate Foam 1%, Econazole Nitrate 1% Cream, and Foam Vehicle in Subjects With Tinea Pedis
This is a 6-week clinical study (4 weeks of treatment, once per day, plus a 2-week follow-up period) of a topical foam to treat athlete's foot. The active ingredient in the foam -- econazole nitrate 1% -- is the same active pharmaceutical ingredient in a cream that your doctor can currently prescribe to treat athlete's foot. This study will help to understand if the foam works the same as the cream to treat athlete's foot.
Read the detailed description
Treating athlete's foot with a cream can leave a greasy, wet feeling on the foot that is uncomfortable to the user and messy on clothing and foot wear. A foam formulation that spreads easily and rubs-in easily that is as effective as the (reference) cream formulation in treating athlete's foot would be a benefit to the user. This study is designed to substantiate a clinical bridge between econazole nitrate foam 1% and econazole nitrate cream 1% based on clinical outcome, safety, and pharmacokinetic data. The study is (foam) vehicle-controlled and is randomized 1 to 1 to 1 (foam:cream:vehicle).
- Conditions
- Tinea Pedis, Athlete's Foot
- Being tested
- Econazole Nitrate Cream 1%, Econazole Nitrate Foam 1%, Vehicle Foam
- Keywords
- Econazole, Foam, Quinnova
- Medical subject headings
- Tinea Pedis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Econazole Nitrate Cream 1%Drug
Also called Econazole Nitrate Cream 1%, Fougera - Altana Inc.
Topical cream, applied once daily for 4 weeks.
Econazole Nitrate Foam 1%Drug
Also called Quinnova Econazole Nitrate Foam 1%
Topical foam, applied once daily for 4 weeks.
Vehicle FoamDrug
Also called Quinnova Foam Vehicle
Topical foam, applied once daily for 4 weeks.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Econazole Nitrate Cream 1% Receives: Drug: Econazole Nitrate Cream 1% |
| 2 | Experimental | Econazole Nitrate Foam 1% Receives: Drug: Econazole Nitrate Foam 1% |
| 3 | Placebo comparator | Vehicle Foam Receives: Drug: Vehicle Foam |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complete Cure Rate: Interdigital Disease
A negative KOH and negative culture and no evidence of clinical disease as indicated by scores of 0 for each sign and symptom at Day 43.
Measured: Day 43
Complete Cure Rate: Moccasin Disease
A negative KOH and negative culture and no evidence of clinical disease as indicated by scores of 0 for each sign and symptom at Day 43.
Measured: 43 Days
Secondary outcomes (4)
Effective Treatment: Interdigital Disease
Negative KOH, negative fungal culture, no or mild (a score of 0 or 1) erythema and/or scaling with all other signs or symptoms being absent (score = 0) at Day 43 (Week6).
Measured: 43
Effective Treatment: Mocassin Disease
Negative KOH, negative fungal culture, no or mild (a score of 0 or 1) erythema and/or scaling with all other signs or symptoms being absent (score = 0) at Day 43 (Week6).
Measured: 43
Mycological Cure: Interdigital Disease
Negative KOH and negative fungal culture at Day 43
Measured: 43
Mycological Cure: Mocassin Disease
Negative KOH and negative fungal culture at Day 43
Measured: 43
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2008 (estimated)
- Study startMar 2008
- Primary completionSep 2008
- Study completionOct 2008
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
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 135 participants (actual)
Sponsor and investigators
- Lead sponsor
- AmDerma
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00768599
- Sponsor's protocol ID
- D79-2902-07
- Status last verified
- Dec 2012
- First submitted
- 7 Oct 2008
- Last updated
- 9 Jan 2013
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-Center Randomized, Evaluator-Blinded, Vehicle Controlled, Parallel Group Comparison Study of the Safety and Efficacy of Econazole Nitrate Foam 1%, Econazole Nitrate 1% Cream, and Foam Vehicle in Subjects With Tinea Pedis
- ClinicalTrials.gov ID
- NCT00768599
- Acronym / sponsor ID
- D79-2902-07
- Conditions
- Tinea Pedis, Athlete's Foot
- Keywords
- Econazole, Foam, Quinnova
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 135 participants (actual)
- Lead sponsor
- AmDermaIndustry (pharma, biotech, devices)
- Study start
- Mar 2008
- Primary completion
- Sep 2008 (actual)
- Study completion
- Oct 2008 (actual)
- First posted
- 8 Oct 2008 (estimated)
- Results
- Posted 9 Jan 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a 6-week clinical study (4 weeks of treatment, once per day, plus a 2-week follow-up period) of a topical foam to treat athlete's foot. The active ingredient in the foam -- econazole nitrate 1% -- is the same active pharmaceutical ingredient in a cream that your doctor can currently prescribe to treat athlete's foot. This study will help to understand if the foam works the same as the cream to treat athlete's foot.
Detailed description
Treating athlete's foot with a cream can leave a greasy, wet feeling on the foot that is uncomfortable to the user and messy on clothing and foot wear. A foam formulation that spreads easily and rubs-in easily that is as effective as the (reference) cream formulation in treating athlete's foot would be a benefit to the user. This study is designed to substantiate a clinical bridge between econazole nitrate foam 1% and econazole nitrate cream 1% based on clinical outcome, safety, and pharmacokinetic data. The study is (foam) vehicle-controlled and is randomized 1 to 1 to 1 (foam:cream:vehicle).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Drug: Econazole Nitrate Cream 1%Econazole Nitrate Cream 1% |
| 2 | Experimental | Drug: Econazole Nitrate Foam 1%Econazole Nitrate Foam 1% |
| 3 | Placebo comparator | Drug: Vehicle FoamVehicle Foam |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Be at least 18 years or age and of either sex.
- Has a clinical diagnosis of tinea pedis with at least i) moderate scaling(interdigital and/or moccasin) and ii) mild erythema (interdigital only).
- Be willing to give informed consent.
- Be willing and able to give informed consent.
- Has microscopic evidence (positive KOH) of the presence of fungi. Evaluable subjects must have a positive KOH and a fungal culture positive for a dermatophyte at Baseline. Subjects with a positive KOH may be entered into the study pending the results of the fungal culture.
Key exclusion criteria (10 listed)
- Is nursing or planning a pregnancy during the study.
- Has used topical antifungal or corticosteroid therapy or systemic antibacterial therapy within 30 days prior to the start of the study.
- Has received systemic antifungal therapy within 12 weeks prior to the start of the study medication.
- Has a history of diabetes mellitus or is immunocompromised (due to disease, e.g., HIV, or medications).
- Has concurrent tinea infection (in the opinion of the investigator). However, concurrent onychomycosis is allowed.
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 |
|---|---|---|
| Econazole Nitrate Cream 1%Also: Econazole Nitrate Cream 1%, Fougera - Altana Inc.Topical cream, applied once daily for 4 weeks. | Drug | 1 |
| Econazole Nitrate Foam 1%Also: Quinnova Econazole Nitrate Foam 1%Topical foam, applied once daily for 4 weeks. | Drug | 2 |
| Vehicle FoamAlso: Quinnova Foam VehicleTopical foam, applied once daily for 4 weeks. | Drug | 3 |
Primary outcome
Complete Cure Rate: Interdigital Disease
Time frame: Day 43
A negative KOH and negative culture and no evidence of clinical disease as indicated by scores of 0 for each sign and symptom at Day 43.
Complete Cure Rate: Moccasin Disease
Time frame: 43 Days
A negative KOH and negative culture and no evidence of clinical disease as indicated by scores of 0 for each sign and symptom at Day 43.
4 secondary outcomes
Effective Treatment: Interdigital Disease
Time frame: 43
Effective Treatment: Mocassin Disease
Time frame: 43
Mycological Cure: Interdigital Disease
Time frame: 43
Mycological Cure: Mocassin Disease
Time frame: 43
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2013.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Econazole Nitrate Cream 1% and Econazole Nitrate Foam 1% in people with Tinea Pedis and Athlete's Foot, run by AmDerma at 6 sites in United States.
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 7 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 9 Jan 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United States. 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 9 Jan 2013). 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?
Complete Cure Rate: Interdigital Disease (time frame: Day 43). The study lists 2 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 9 Jan 2013.