Trial · NCT01110330

An Efficacy Study of a New Formulation of Ketoconazole 2% Cream in Patients With Tinea Pedis, Commonly Known as Athlete's Foot

NCT01110330, Phase 3, Terminated, Johnson & Johnson Pharmaceutical Research & Development, L.L.C.; results first posted 2013-06-06

3 sourcestrials-2026-11-12-0.5.0

Download JSON

Cite this record

ConductScience Library. An Efficacy Study of a New Formulation of Ketoconazole 2% Cream in Patients With Tinea Pedis, Commonly Known as Athlete's Foot. Trials, record NCT01110330. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01110330

On this page

Trial

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

Title: An Efficacy Study of a New Formulation of Ketoconazole 2% Cream in Patients With Tinea Pedis, Commonly Known as Athlete's Foot
NCT number: NCT01110330
Status: Terminated
Phases: Phase 3
Enrollment: 583 participants, actual
Lead sponsor: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Conditions: Tinea Pedis
Interventions: Placebo cream, Ketoconazole 2% cream (formulation F012) (Nizoral), Ketoconazole 2% cream (formulation F126)
First posted: 2010-04-26
Last updated: 2014-04-29
Results first posted: 2013-06-06
Limitations and caveats: The study was terminated prematurely by the sponsor due to significant discrepancies between potassium hydroxide and mycological culture results.

Source ClinicalTrials.gov

Registered outcomes2

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

List	Outcome	Time frame	Description
Primary	The Number of Patients in the Positive Baseline Culture Set (PBCS) With Mycological Cure (MC) at Week 6	Week 6	Mycological Cure (MC) was defined as having a negative potassium hydroxide (KOH) microscopy and negative fungal culture at Week 6.
Secondary	The Number of Patients in the Positive Baseline Culture Set (PBCS) With Overall Cure (OC) at Week 6	Week 6	Overall Cure (OC) was defined as Mycological Cure (MC) in addition to a global clinical evaluation of either 'Completely Cleared' (clearance of all signs and symptoms of Tinea pedis) or 'Marked Improvement' (significant improvement of signs and symptoms of Tinea pedis; residual signs and symptoms only), assessed at Week 6.

Source ClinicalTrials.gov

Outcomes2

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

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	The Number of Patients in the Positive Baseline Culture Set (PBCS) With Mycological Cure (MC) at Week 6	Week 6	Only patients who had a positive Tinea pedis culture at baseline, ie 281 patients, were included in the Positive Baseline Culture Set (PBCS), which was the set used for analysis of the Primary Outcome Measure.	participants	NUMBER
SECONDARY	The Number of Patients in the Positive Baseline Culture Set (PBCS) With Overall Cure (OC) at Week 6	Week 6	Only patients who had a positive Tinea pedis culture at baseline, ie 281 patients, were included in the Positive Baseline Culture Set (PBCS), which was the set used for analysis of the Secondary Outcome Measure.	participants	NUMBER

Source ClinicalTrials.gov

Results by group6

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

Outcome	Group	Value	Units
The Number of Patients in the Positive Baseline Culture Set (PBCS) With Mycological Cure (MC) at Week 6	Placebo	11	participants
The Number of Patients in the Positive Baseline Culture Set (PBCS) With Mycological Cure (MC) at Week 6	Nizoral	64	participants
The Number of Patients in the Positive Baseline Culture Set (PBCS) With Mycological Cure (MC) at Week 6	Ketoconazole	64	participants
The Number of Patients in the Positive Baseline Culture Set (PBCS) With Overall Cure (OC) at Week 6	Placebo	5	participants
The Number of Patients in the Positive Baseline Culture Set (PBCS) With Overall Cure (OC) at Week 6	Nizoral	55	participants
The Number of Patients in the Positive Baseline Culture Set (PBCS) With Overall Cure (OC) at Week 6	Ketoconazole	50	participants

Source ClinicalTrials.gov

Participant flow12

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

Period	Milestone	Group	Participants
Overall Study	STARTED	Placebo	119
Overall Study	STARTED	Nizoral	230
Overall Study	STARTED	Ketoconazole	234
Overall Study	Positive Baseline Culture Set	Placebo	56
Overall Study	Positive Baseline Culture Set	Nizoral	111
Overall Study	Positive Baseline Culture Set	Ketoconazole	114
Overall Study	COMPLETED	Placebo	104
Overall Study	COMPLETED	Nizoral	207
Overall Study	COMPLETED	Ketoconazole	208
Overall Study	NOT COMPLETED	Placebo	15

1 to 10 of 12Source ClinicalTrials.gov

See all 12 participant flow

Adverse events291

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
other	Palpitations	Cardiac disorders	Ketoconazole	1	234
other	Palpitations	Cardiac disorders	Nizoral	0	230
other	Palpitations	Cardiac disorders	Placebo	0	119
other	Tinnitus	Ear and labyrinth disorders	Ketoconazole	0	234
other	Tinnitus	Ear and labyrinth disorders	Nizoral	1	230
other	Tinnitus	Ear and labyrinth disorders	Placebo	0	119
other	Conjunctivitis	Eye disorders	Ketoconazole	1	234
other	Conjunctivitis	Eye disorders	Nizoral	1	230
other	Conjunctivitis	Eye disorders	Placebo	0	119
other	Conjunctivitis Allergic	Eye disorders	Ketoconazole	0	234

1 to 10 of 291Source ClinicalTrials.gov

See all 291 adverse events

Adverse event totals9

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Ketoconazole
Total, all-cause mortality	Nizoral
Total, all-cause mortality	Placebo
Total, other adverse events	Ketoconazole	55	234
Total, other adverse events	Nizoral	50	230
Total, other adverse events	Placebo	28	119
Total, serious adverse events	Ketoconazole	2	234
Total, serious adverse events	Nizoral	5	230
Total, serious adverse events	Placebo	2	119

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 comparisons0

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

None in this release.

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/NCT01110330

GET https://conductscience.org/api/trials/v1/NCT01110330/events?page=2

API reference For AI assistants