Trial · NCT03129321
Therapeutic Equivalence and Safety of Two Econazole Nitrate Cream, 1% Products in Tinea Pedis
NCT03129321, Phase 3, Completed, Mylan Inc.; results first posted 2018-08-02
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Therapeutic Equivalence and Safety of Two Econazole Nitrate Cream, 1% Products in Tinea Pedis. Trials, record NCT03129321. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03129321
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Therapeutic Equivalence and Safety of Two Econazole Nitrate Cream, 1% Products in Tinea Pedis
- NCT number
- NCT03129321
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 876 participants, actual
- Lead sponsor
- Mylan Inc.
- Conditions
- Tinea Pedis
- Interventions
- Econazole Nitrate Cream, 1%, Placebo
- First posted
- 2017-04-26
- Last updated
- 2022-03-07
- Results first posted
- 2018-08-02
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Proportion of Patients in Each Active Treatment Group Who Are Considered a Therapeutic Cure | Day 42 | To be considered a Therapeutic Cure, the patient must have both Clinical Cure (patient's total severity score must be ≤ 2 with no individual severity score \> 1) and Mycological Cure (patient must have a negative KOH test and a negative fungal culture) of tinea pedis |
| Primary | Proportion of Patients in Each Treatment Group Who Are Considered a Therapeutic Cure | Day 42 | To be considered a Therapeutic Cure, the patient must have both Clinical Cure (patient's total severity score must be ≤ 2 with no individual severity score \> 1) and Mycological Cure (patient must have a negative KOH test and a negative fungal culture) of tinea pedis |
| Secondary | Proportion of Patients in Each Active Treatment Group Who Are Considered a Clinical Cure (Patient's Total Severity Score Must be ≤ 2 With no Individual Severity Score > 1) | Day 42 | The following Clinical Signs and Symptoms of a target lesion with tinea pedis are individually rated for severity (none, mild, moderate, or severe): fissuring/cracking, erythema, maceration, scaling, pruritus, and burning/stinging |
| Secondary | Proportion of Patients in Each Active Treatment Group Who Are Considered a Mycological Cure | Day 42 | To be considered a mycological cure the patient must have a negative KOH test and a negative fungal culture for T. rubrum, T. mentagrophytes or E. floccosum |
| Secondary | Proportion of Patients in Each Treatment Group Who Are Considered a Clinical Cure (Patient's Total Severity Score Must be ≤ 2 With no Individual Severity Score > 1) | Day 42 | The following Clinical Signs and Symptoms of a target lesion with tinea pedis are individually rated for severity (none, mild, moderate, or severe): fissuring/cracking, erythema, maceration, scaling, pruritus, and burning/stinging |
| Secondary | Proportion of Patients in Each Treatment Group Who Are Considered a Mycological Cure | Day 42 | To be considered a mycological cure the patient must have a negative KOH test and a negative fungal culture for T. rubrum, T. mentagrophytes or E. floccosum |
Source ClinicalTrials.gov
Outcomes6
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Proportion of Patients in Each Active Treatment Group Who Are Considered a Therapeutic Cure | Day 42 | Active Treatments of the Per Protocol Population | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Proportion of Patients in Each Treatment Group Who Are Considered a Therapeutic Cure | Day 42 | Modified Intent to Treat. Patients who are missing mycological culture data at baseline are not included in the analysis. Patients who are missing mycological culture data at the test of cure visit are not included in the analysis unless they were a treatment failure. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Proportion of Patients in Each Active Treatment Group Who Are Considered a Clinical Cure (Patient's Total Severity Score Must be ≤ 2 With no Individual Severity Score > 1) | Day 42 | Active treatment groups of the Per Protocol population | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Proportion of Patients in Each Active Treatment Group Who Are Considered a Mycological Cure | Day 42 | Active treatment groups of the Per Protocol population | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Proportion of Patients in Each Treatment Group Who Are Considered a Clinical Cure (Patient's Total Severity Score Must be ≤ 2 With no Individual Severity Score > 1) | Day 42 | Modified Intent to Treat | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Proportion of Patients in Each Treatment Group Who Are Considered a Mycological Cure | Day 42 | Modified Intent to Treat. Patients who are missing mycological culture data at baseline are not included in the analysis. Patients who are missing mycological culture data at the test of cure visit are not included in the analysis unless they were a treatment failure. | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group15
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Proportion of Patients in Each Active Treatment Group Who Are Considered a Therapeutic Cure | Test | 96 | Participants | ||
| Proportion of Patients in Each Active Treatment Group Who Are Considered a Therapeutic Cure | Reference Standard | 81 | Participants | ||
| Proportion of Patients in Each Treatment Group Who Are Considered a Therapeutic Cure | Test | 102 | Participants | ||
| Proportion of Patients in Each Treatment Group Who Are Considered a Therapeutic Cure | Reference Standard | 88 | Participants | ||
| Proportion of Patients in Each Treatment Group Who Are Considered a Therapeutic Cure | Placebo | 22 | Participants | ||
| Proportion of Patients in Each Active Treatment Group Who Are Considered a Clinical Cure (Patient's Total Severity Score Must be ≤ 2 With no Individual Severity Score > 1) | Test | 113 | Participants | ||
| Proportion of Patients in Each Active Treatment Group Who Are Considered a Clinical Cure (Patient's Total Severity Score Must be ≤ 2 With no Individual Severity Score > 1) | Reference Standard | 99 | Participants | ||
| Proportion of Patients in Each Active Treatment Group Who Are Considered a Mycological Cure | Test | 136 | Participants | ||
| Proportion of Patients in Each Active Treatment Group Who Are Considered a Mycological Cure | Reference Standard | 125 | Participants | ||
| Proportion of Patients in Each Treatment Group Who Are Considered a Clinical Cure (Patient's Total Severity Score Must be ≤ 2 With no Individual Severity Score > 1) | Test | 131 | Participants |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 results by groupParticipant flow9
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Test | 351 | |
| Overall Study | STARTED | Reference Standard | 350 | |
| Overall Study | STARTED | Placebo | 175 | |
| Overall Study | COMPLETED | Test | 253 | |
| Overall Study | COMPLETED | Reference Standard | 241 | |
| Overall Study | COMPLETED | Placebo | 120 | |
| Overall Study | NOT COMPLETED | Test | 98 | |
| Overall Study | NOT COMPLETED | Reference Standard | 109 | |
| Overall Study | NOT COMPLETED | Placebo | 55 |
Source ClinicalTrials.gov
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Test | ||
| Total, all-cause mortality | Reference Standard | ||
| Total, all-cause mortality | Placebo | ||
| Total, other adverse events | Test | 0 | 351 |
| Total, other adverse events | Reference Standard | 0 | 350 |
| Total, other adverse events | Placebo | 0 | 175 |
| Total, serious adverse events | Test | 0 | 351 |
| Total, serious adverse events | Reference Standard | 0 | 350 |
| Total, serious adverse events | Placebo | 0 | 175 |
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 comparisons3
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Test vs Reference Standard: Proportion of Patients in Each Active Treatment Group Who Are Considered a Therapeutic Cure | Trial comparisons |
| Test vs Reference Standard: Proportion of Patients in Each Active Treatment Group Who Are Considered a Mycological Cure | Trial comparisons |
| Test vs Reference Standard: Proportion of Patients in Each Active Treatment Group Who Are Considered a Clinical Cure (Patient's Total Severity Score Must be ≤ 2 With no Individual Severity Score > 1) | 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.
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/NCT03129321
GET https://conductscience.org/api/trials/v1/NCT03129321/registered