Trial · NCT01353976

Safety and Efficacy of Econazole Nitrate Foam 1% in Subjects With Tinea Pedis

NCT01353976, Phase 3, Completed, AmDerma; results first posted 2013-01-09

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Safety and Efficacy of Econazole Nitrate Foam 1% in Subjects With Tinea Pedis. Trials, record NCT01353976. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01353976

On this page

Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Safety and Efficacy of Econazole Nitrate Foam 1% in Subjects With Tinea Pedis
NCT number: NCT01353976
Status: Completed
Phases: Phase 3
Enrollment: 264 participants, actual
Lead sponsor: AmDerma
Conditions: Tinea Pedis, Athlete's Foot
Interventions: Econazole Nitrate Foam 1%, Vehicle Foam
First posted: 2011-05-16
Last updated: 2013-01-09
Results first posted: 2013-01-09

Source ClinicalTrials.gov

Registered outcomes3

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Complete Cure	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.
Secondary	Effective Treatment	Day 43	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.
Secondary	Mycological Cure	Day 43	Mycological Cure defined as negative KOH and negative culture at Day 43.

Source ClinicalTrials.gov

Outcomes3

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Complete Cure	Day 43	MITT	Participants	NUMBER
SECONDARY	Effective Treatment	Day 43	MITT	Participants	NUMBER
SECONDARY	Mycological Cure	Day 43	MITT	Participants	NUMBER

Source ClinicalTrials.gov

Results by group12

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Units
Complete Cure	Econazole Nitrate Foam 1%	No	63	Participants
Complete Cure	Vehicle Foam	No	81	Participants
Complete Cure	Econazole Nitrate Foam 1%	Yes	19	Participants
Complete Cure	Vehicle Foam	Yes	2	Participants
Effective Treatment	Econazole Nitrate Foam 1%	No	42	Participants
Effective Treatment	Vehicle Foam	No	74	Participants
Effective Treatment	Econazole Nitrate Foam 1%	Yes	40	Participants
Effective Treatment	Vehicle Foam	Yes	9	Participants
Mycological Cure	Econazole Nitrate Foam 1%	No	26	Participants
Mycological Cure	Vehicle Foam	No	70	Participants

1 to 10 of 12Source ClinicalTrials.gov

See all 12 results by group

Participant flow6

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Econazole Nitrate Foam 1%	130
Overall Study	STARTED	Vehicle Foam	134
Overall Study	COMPLETED	Econazole Nitrate Foam 1%	82
Overall Study	COMPLETED	Vehicle Foam	83
Overall Study	NOT COMPLETED	Econazole Nitrate Foam 1%	48
Overall Study	NOT COMPLETED	Vehicle Foam	51

Source ClinicalTrials.gov

Adverse events36

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk	Events
other	Oral Pain	Gastrointestinal disorders	Econazole Nitrate Foam 1%	1	130	1
other	Oral Pain	Gastrointestinal disorders	Vehicle Foam	0	134	0
other	Application Site Dermatitis	General disorders	Econazole Nitrate Foam 1%	0	130	0
other	Application Site Dermatitis	General disorders	Vehicle Foam	1	134	1
other	Cystitis	Infections and infestations	Econazole Nitrate Foam 1%	1	130	1
other	Cystitis	Infections and infestations	Vehicle Foam	0	134	0
other	Helicobacter gastritis	Infections and infestations	Econazole Nitrate Foam 1%	1	130	1
other	Helicobacter gastritis	Infections and infestations	Vehicle Foam	0	134	0
other	Influenza	Infections and infestations	Econazole Nitrate Foam 1%	1	130	1
other	Influenza	Infections and infestations	Vehicle Foam	0	134	0

1 to 10 of 36Source ClinicalTrials.gov

See all 36 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Econazole Nitrate Foam 1%
Total, all-cause mortality	Vehicle Foam
Total, other adverse events	Econazole Nitrate Foam 1%	17	130
Total, other adverse events	Vehicle Foam	16	134
Total, serious adverse events	Econazole Nitrate Foam 1%	0	130
Total, serious adverse events	Vehicle Foam	1	134

Source ClinicalTrials.gov

Papers0

The papers the trial lists on ClinicalTrials.gov.

None in this release.

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons1

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison
Econazole Nitrate Foam 1% vs Vehicle Foam: serious adverse events

Source Trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT01353976

GET https://conductscience.org/api/trials/v1/NCT01353976/events?page=2

API reference For AI assistants