Trial · NCT01433107
Efficacy and Safety of Terbinafine Film Forming Solution in Patients With Tinea Pedis
NCT01433107, Phase 3, Completed, Novartis; results first posted 2013-12-27
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Efficacy and Safety of Terbinafine Film Forming Solution in Patients With Tinea Pedis. Trials, record NCT01433107. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01433107
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Efficacy and Safety of Terbinafine Film Forming Solution in Patients With Tinea Pedis
- NCT number
- NCT01433107
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 290 participants, actual
- Lead sponsor
- Novartis
- Conditions
- Tinea Pedis
- Interventions
- Terbinafine, Terbinafine Placebo
- First posted
- 2011-09-13
- Last updated
- 2013-12-27
- Results first posted
- 2013-12-27
Source ClinicalTrials.gov
Registered outcomes3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Effective Treatment Outcome (Direct Microscopy and Culture Negative and Total Signs and Symptom Score Less or Equal to 2) | week 6 | Each clinical sign or symptom will be assessed separately. The investigator will evaluate the severity of each sign or symptom over the entire target foot. Clinical signs and symptoms including desquamation (scaling), erythema, incrustation (crusting), pustules, vesiculation and pruritus will be evaluated by the investigator or designee and recorded at every visit using the following scale: 0 = absent 1. = mild 2. = moderate 3. = severe In order to calculate the total symptoms score the rating for all symptoms are added up. Possible range 0 to 18 |
| Secondary | Total Clinical Signs and Symptoms (S/S) Scores | week 6 | Each clinical sign or symptom will be assessed separately. The investigator will evaluate the severity of each sign or symptom over the entire target foot. Clinical signs and symptoms including desquamation (scaling), erythema, incrustation (crusting), pustules, vesiculation and pruritus will be evaluated by the investigator or designee and recorded at every visit using the following scale: 0 = absent 1. = mild 2. = moderate 3. = severe In order to calculate the total symptom score, the scores for each individual symptom are added up. Possible range : 0 to 18 |
| Secondary | Number of Subjects With Adverse Event | 6 weeks | Number of Subjects with adverse event |
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 | Effective Treatment Outcome (Direct Microscopy and Culture Negative and Total Signs and Symptom Score Less or Equal to 2) | week 6 | Number of success. The discrepancy between number of participants analyzed and participants completed is explained by delayed exclusions (people having negative mycology results received after completion of the study). | participants | NUMBER |
| SECONDARY | Total Clinical Signs and Symptoms (S/S) Scores | week 6 | units on a scale | MEAN | |
| SECONDARY | Number of Subjects With Adverse Event | 6 weeks | Number of subject with any adverse events mild or moderate having signed the informed consent. One subject had an adverse event but did not receive any study drug and was not included in the number of subjects started. | 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 | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Effective Treatment Outcome (Direct Microscopy and Culture Negative and Total Signs and Symptom Score Less or Equal to 2) | Terbinafine | 73 | participants | ||
| Effective Treatment Outcome (Direct Microscopy and Culture Negative and Total Signs and Symptom Score Less or Equal to 2) | Placebo | 10 | participants | ||
| Total Clinical Signs and Symptoms (S/S) Scores | Terbinafine | 1.6 | 95% Confidence Interval 1.3 to 2.0 | units on a scale | |
| Total Clinical Signs and Symptoms (S/S) Scores | Placebo | 4.7 | 95% Confidence Interval 4.1 to 5.2 | units on a scale | |
| Number of Subjects With Adverse Event | Terbinafine | 9 | participants | ||
| Number of Subjects With Adverse Event | Placebo | 11 | participants |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Terbinafine | 145 | |
| Overall Study | STARTED | Placebo | 145 | |
| Overall Study | COMPLETED | Terbinafine | 118 | |
| Overall Study | COMPLETED | Placebo | 128 | |
| Overall Study | NOT COMPLETED | Terbinafine | 27 | |
| Overall Study | NOT COMPLETED | Placebo | 17 |
Source ClinicalTrials.gov
Adverse events2
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 | General Disorders | General disorders | Terbinafine | 0 | 146 | 0 |
| other | General Disorders | General disorders | Placebo | 7 | 144 | 7 |
Source ClinicalTrials.gov
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Terbinafine | ||
| Total, all-cause mortality | Placebo | ||
| Total, other adverse events | Terbinafine | 0 | 146 |
| Total, other adverse events | Placebo | 7 | 144 |
| Total, serious adverse events | Terbinafine | 0 | 146 |
| Total, serious adverse events | Placebo | 0 | 144 |
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 |
|---|---|
| Terbinafine vs Placebo: Number of Subjects With Adverse Event | Trial comparisons |
| Terbinafine vs Placebo: Effective Treatment Outcome (Direct Microscopy and Culture Negative and Total Signs and Symptom Score Less or Equal to 2) | Trial comparisons |
| Terbinafine vs Placebo: serious adverse events | 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/NCT01433107
GET https://conductscience.org/api/trials/v1/NCT01433107/registered