Tinea PedisPhase 3NCT01353976
Safety and Efficacy of Econazole Nitrate Foam 1% in Subjects With Tinea Pedis
A Phase 3 study testing Econazole Nitrate Foam 1% in people with Tinea Pedis and Athlete's Foot, run by AmDerma at 7 sites in United States.
Trial summary
This is a study of the safety and efficacy of topical Econazole Nitrate Foam 1% and the foam vehicle in subjects with interdigital tinea pedis (athlete's foot between the toes). This is a 6 week study which has a 4 week treatment period and a 2 week follow-up evaluation. Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Tinea Pedis, Athlete's Foot
- What is being tested?
- Econazole Nitrate Foam 1%
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 264 participants
- Where
- 7 sitesUnited States
- Study dates
- May 2011to Aug 2012
- Phase
- Phase 3
- 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 12 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Be at least 12 years of age and of either sex.
- Have a clinical diagnosis of interdigital tinea pedis involving at least2 web spaces in total which extends no more than approximately 1 inch proximal to the web spaces or metatarsophalangeal joints with at least i) moderate scaling and ii) mild erythema defined as a Grade 2 and Grade 1, respectively on the Grading of Signs and Symptoms at baseline.
- Be willing and able to give informed consent/assent or have their parent/guardian do so, if applicable.
- Be willing and able to use the assigned study medication as directed and to commit to all follow-up visits for the duration of the study.
- Have microscopic evidence (positive KOH) of the presence of fungi. Evaluable subjects must have a positive KOH and a fungal culture positive for a dermatophyte in the skin scrapings taken at the Baseline Visit. 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.
- Females must be non-pregnant (confirmed by a negative urine pregnancy test at baseline), non-lactating and not intending to become pregnant during the course of the study.
Who cannot join
- Is pregnant, nursing or planning a pregnancy during the study.
- Has used topical antifungals or topical corticosteroids on the feet 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 used systemic antibacterials or systemic corticosteroids within 30 days prior to the start of the study. Systemic corticosteroids do not include intranasal, inhaled, and ophthalmic corticosteroids used for the management of allergies, pulmonary disorders or other conditions.
- Has a history of uncontrolled diabetes mellitus or is immunocompromised (due to disease, e.g., HIV, or medications).
- Has concurrent tinea infection e.g. tinea versicolor, tinea cruris, moccasin-type tinea pedis, etc. (in the opinion of the Investigator).
Show all 12Show fewer
- Onychomycosis, involving ≥ 20% of the area of either great toenail or involvement of more than five toenails in total.
- Has any other skin disease which might interfere with the evaluation of tinea pedis.
- 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
7 sites in 1 country.
7 sites in 1 country
United States7 sites
Daniel M. Stewart, DO
Clinton Township, Michigan, 48038
Cyaandi Dove, DPM
Las Vegas, Nevada, 89119
Francisco Flores, MD
Miramar, Florida, 33027
Cynthia Strout, MD
Mt. Pleasant, South Carolina, 29464
Michael H. Gold, MD
Nashville, Tennessee, 37215
Jeffrey Adelglass, MD
Plano, Texas, 75234
Robert S. Haber, MD
South Euclid, Ohio, 44118
About this study
Official title: A Multi-Center, Randomized, Double-Blind, Vehicle Controlled, Parallel Group Comparison Study of the Safety and Efficacy of Econazole Nitrate Foam 1% and Foam Vehicle in Subjects With Interdigital Tinea Pedis
This is a study of the safety and efficacy of topical Econazole Nitrate Foam 1% and the foam vehicle in subjects with interdigital tinea pedis (athlete's foot between the toes). This is a 6 week study which has a 4 week treatment period and a 2 week follow-up evaluation.
- Conditions
- Tinea Pedis, Athlete's Foot
- Being tested
- Econazole Nitrate Foam 1%, Vehicle Foam
- Keywords
- Econazole Nitrate, Foam, Quinnova, Tinea Pedis
- 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 Foam 1%Drug
Econazole Nitrate Foam 1% applied once a day for 4 weeks
Vehicle FoamOther
Vehicle foam applied once a day for 4 weeks
| Study group | Role | What they receive |
|---|---|---|
| Econazole Nitrate Foam 1% | Experimental | Study medication Receives: Drug: Econazole Nitrate Foam 1% |
| Vehicle Foam | Placebo comparator | Placebo medication Receives: Other: Vehicle Foam |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complete Cure
Complete Cure is defined as a negative KOH and negative fungal culture and no evidence of clinical disease as indicated by scores of 0 (none) for each sign and symptom at Day 43.
Measured: Day 43
Secondary outcomes (2)
Effective Treatment
Effective Treatment defined as 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.
Measured: Day 43
Mycological Cure
Mycological Cure defined as negative KOH and negative culture at Day 43.
Measured: Day 43
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2011 (estimated)
- Study startMay 2011
- Primary completionApr 2012
- Study completionAug 2012
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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 264 participants (actual)
Sponsor and investigators
- Lead sponsor
- AmDerma
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- AmDerma Pharmaceuticals, LLC
- Responsible party
- Sponsor
- Investigators
- Daniel Piacquadio, MD, Study director, Therapeutics, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01353976
- Sponsor's protocol ID
- 079-2951-302
- Status last verified
- Dec 2012
- First submitted
- 12 May 2011
- 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, Double-Blind, Vehicle Controlled, Parallel Group Comparison Study of the Safety and Efficacy of Econazole Nitrate Foam 1% and Foam Vehicle in Subjects With Interdigital Tinea Pedis
- ClinicalTrials.gov ID
- NCT01353976
- Acronym / sponsor ID
- 079-2951-302
- Conditions
- Tinea Pedis, Athlete's Foot
- Keywords
- Econazole Nitrate, Foam, Quinnova, Tinea Pedis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 264 participants (actual)
- Lead sponsor
- AmDermaIndustry (pharma, biotech, devices)
- Collaborators
- AmDerma Pharmaceuticals, LLC
- Study start
- May 2011
- Primary completion
- Apr 2012 (actual)
- Study completion
- Aug 2012 (actual)
- First posted
- 16 May 2011 (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 study of the safety and efficacy of topical Econazole Nitrate Foam 1% and the foam vehicle in subjects with interdigital tinea pedis (athlete's foot between the toes). This is a 6 week study which has a 4 week treatment period and a 2 week follow-up evaluation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Econazole Nitrate Foam 1% | Experimental | Drug: Econazole Nitrate Foam 1%Study medication |
| Vehicle Foam | Placebo comparator | Other: Vehicle FoamPlacebo medication |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- Be at least 12 years of age and of either sex.
- Have a clinical diagnosis of interdigital tinea pedis involving at least2 web spaces in total which extends no more than approximately 1 inch proximal to the web spaces or metatarsophalangeal joints with at least i) moderate scaling and ii) mild erythema defined as a Grade 2 and Grade 1, respectively on the Grading of Signs and Symptoms at baseline.
- Be willing and able to give informed consent/assent or have their parent/guardian do so, if applicable.
- Be willing and able to use the assigned study medication as directed and to commit to all follow-up visits for the duration of the study.
- Have microscopic evidence (positive KOH) of the presence of fungi. Evaluable subjects must have a positive KOH and a fungal culture positive for a dermatophyte in the skin scrapings taken at the Baseline Visit. Subjects with a positive KOH may be entered into the study pending the results of the fungal culture.
Key exclusion criteria (12 listed)
- Is pregnant, nursing or planning a pregnancy during the study.
- Has used topical antifungals or topical corticosteroids on the feet 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 used systemic antibacterials or systemic corticosteroids within 30 days prior to the start of the study. Systemic corticosteroids do not include intranasal, inhaled, and ophthalmic corticosteroids used for the management of allergies, pulmonary disorders or other conditions.
- Has a history of uncontrolled diabetes mellitus or is immunocompromised (due to disease, e.g., HIV, or medications).
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 Foam 1%Econazole Nitrate Foam 1% applied once a day for 4 weeks | Drug | Econazole Nitrate Foam 1% |
| Vehicle FoamVehicle foam applied once a day for 4 weeks | Other | Vehicle Foam |
Primary outcome
Complete Cure
Time frame: Day 43
Complete Cure is defined as a negative KOH and negative fungal culture and no evidence of clinical disease as indicated by scores of 0 (none) for each sign and symptom at Day 43.
2 secondary outcomes
Effective Treatment
Time frame: Day 43
Mycological Cure
Time frame: Day 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.
Daniel Piacquadio, MD study director
Therapeutics, Inc.
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Econazole Nitrate Foam 1% in people with Tinea Pedis and Athlete's Foot, run by AmDerma at 7 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 12 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 7 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 (time frame: Day 43). 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.