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Safety and Efficacy of Econazole Nitrate Foam 1% and Foam Vehicle in Subjects With Tinea Pedis
NCT01358240 · View on ClinicalTrials.gov ↗
Study Summary
This is a study of the safety and efficacy of 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. The study will also utilize Econazole Nitrate Cream 1% (for safety comparison) and a Placebo cream for blinding purposes only.
Conditions Studied
Interventions
- DRUG Econazole Nitrate Cream 1%
- DRUG Econazole Nitrate Foam 1%
- DRUG Vehicle Foam
- OTHER Placebo Cream
Study Locations (12)
Florida
- Marta I. Rendon, MD — Boca Raton
- Jonathan Kantor, MD — Jacksonville
Texas
- Michael T. Jarratt, MD — Austin
- William Abramovits, MD — Dallas
California
- Sunil S. Dhawan, MD — Fremont
Delaware
- Guy F. Webster, MD, PhD — Hockessin
Minnesota
- Steven E. Kempers, MD — Fridley
Nebraska
- Joel Schlessinger, MD — Omaha
Oregon
- Phoebe Rich, MD — Portland
Tennessee
- Edward J. Primka III, MD — Knoxville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 336 participants |
| Start Date | 2011-06 |
| Est. Completion | 2012-08 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01358240
The ClinicalTrials.gov registry entry for NCT01358240 describes a study currently listed as completed. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 336 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is AmDerma, which has 3 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 2 conditions, with Tinea Pedis appearing as the primary indexed condition, and to 4 interventions — of which Econazole Nitrate Cream 1% is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT01358240 reports 12 study locations spanning 10 distinct geographic areas — top geographies include Florida, Texas, California. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT01358240 about?
NCT01358240 is a clinical study titled "Safety and Efficacy of Econazole Nitrate Foam 1% and Foam Vehicle in Subjects With Tinea Pedis". This is a study of the safety and efficacy of 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. The study will also utilize Econazol...
What is the current status of trial NCT01358240?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 336 participants. The study started on 2011-06. Estimated completion is 2012-08.
What conditions does trial NCT01358240 study?
This clinical trial studies the following conditions: Tinea Pedis, Athlete's Foot. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT01358240?
The interventions under investigation include: Econazole Nitrate Cream 1% (DRUG), Econazole Nitrate Foam 1% (DRUG), Vehicle Foam (DRUG), Placebo Cream (OTHER). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT01358240?
This trial is sponsored by AmDerma, which has 3 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT01358240 being conducted?
This trial has 12 study locations across California, Delaware, Florida, Minnesota, Nebraska. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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