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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 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.

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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.

Conditions Studied

Tinea Pedis Athlete's Foot

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

FieldValue
Enrollment Target 336 participants
Start Date 2011-06
Est. Completion 2012-08
Phase Phase 3

Sponsor

AmDerma

6 total trials

Interested in This Trial?

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, categorized as Phase 3. The registered enrollment target is 336 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 290-participant average among 9 other Tinea Pedis trials with a reported enrollment target (16% higher). The listed sponsor is AmDerma, which has 6 total studies on file at ClinicalTrials.gov.

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 reports 12 study locations spanning 10 distinct geographic areas - top geographies include 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.

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Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.