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NCT01358240 · ClinicalTrials.gov registry record · Phase 3
Safety and Efficacy of Econazole Nitrate Foam 1% and Foam Vehicle in Subjects With Tinea Pedis
A Phase 3 study of Tinea Pedis and Athlete's Foot, sponsored by AmDerma.
- Completed
- Registry status
- Phase 3
- Development phase
- 336
- Enrollment target
- 12
- Study locations
NCT01358240: Completed Phase 3 study of Tinea Pedis and Athlete's Foot, sponsored by AmDerma.
NCT01358240 is a Phase 3 study of Tinea Pedis and Athlete's Foot that has completed, run by AmDerma. The registered enrollment target is 336 participants, above the 290-participant average among 9 other Tinea Pedis trials with a reported enrollment target (16% higher). The trial reports 12 study locations across 10 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01358240, a Phase 3 study of Tinea Pedis and Athlete's Foot, has completed, sponsored by AmDerma.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 336 participants
- Enrollment target
- 12
- Study locations
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.
Primary Outcome
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 system at Day 43, analysis of the Econazole Nitrate Foam 1% and Foam Vehicle treatment groups 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 |
What the finished NCT01358240 record still lists
NCT01358240 is an interventional study that assigns participants to a tested intervention. The registered 336 participants enrollment target is mid-sized for trials with a published cap, above the 290-participant average among 9 other Tinea Pedis trials with a reported enrollment target (16% higher).
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.
NCT01358240 lists 12 locations in 10 states (Florida, Texas, California).
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.
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).
Who is sponsoring clinical trial NCT01358240?
This trial is sponsored by AmDerma, which has 6 total clinical trials registered on ClinicalTrials.gov.
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.
Learn More About Clinical Trials
Similar trials for Tinea Pedis
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT01358240's enrollment target sits among peer trials
336 4th of 9 higher than 6 of 9 other Tinea Pedis trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Tinea Pedis trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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