Trial · NCT00443898
Efficacy, Safety, and Tolerability of Topical Terbinafine in Patients With Mild to Moderate Toenail Fungus of the Big Toenail
NCT00443898, Phase 3, Completed, Novartis Pharmaceuticals; results first posted 2011-04-20
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Efficacy, Safety, and Tolerability of Topical Terbinafine in Patients With Mild to Moderate Toenail Fungus of the Big Toenail. Trials, record NCT00443898. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00443898
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Efficacy, Safety, and Tolerability of Topical Terbinafine in Patients With Mild to Moderate Toenail Fungus of the Big Toenail
- NCT number
- NCT00443898
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 518 participants, actual
- Lead sponsor
- Novartis Pharmaceuticals
- Conditions
- Onychomycosis
- Interventions
- terbinafine, Placebo, terbinafine, Placebo
- First posted
- 2007-03-07
- Last updated
- 2012-05-03
- Results first posted
- 2011-04-20
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Efficacy Assessed by Complete Cure Rate at the End of Study (Week 52) After Treating for 24 or 48 Weeks. | 52 weeks | Complete cure is defined as negative KOH microscopy and negative culture for dermatophytes. and no residual involvement of the target toenail. The complete cure was a composite binary variable defined as "Yes" if: * Mycological cure (negative KOH and negative culture for dermatophytes) and * No residual involvement of the target toenail "No" if otherwise |
| Secondary | Efficacy Assessed by Mycological Cure (Negative Culture and Negative KOH Microscopy) at the End of Study After Treating Patients for 24 or 48 Weeks. | 52 weeks | Mycological cure is defined as negative KOH microscopy and negative culture for dermatophytes. Mycological cure was a composite binary variable defined as "Yes"if : * Negative microscopy and * Negative culture for dermatophytes "No" if otherwise. |
| Secondary | Efficacy Assessed by Clinical Efficacy at the End of Study After Treating Patients for 24 or 48 Weeks. | 52 weeks | Clinical effectiveness is defined as negative KOH microscopy and negative culture for dermatophytes and \<= 10% residual involvement of the target toenail. Clinical effectiveness was a composite binary variable defined as "Yes" if * Mycological cure (negative KOH and negative culture for dermatophytes) and * = 10% residual involvement of the target toenail "No" if otherwise |
| Secondary | Number of Participants Assessed With Adverse Events and Serious Adverse Events | 52 weeks | An adverse event (AE) is any adverse change in health or side effect that occurs while the participant is receiving the treatment or within a previously specified period of time after the treatment has been completed. A Serious Adverse Event (SAE) is any untoward medical occurrence that results in death, is life-threatening requires, inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or requires intervention to prevent permanent impairment or damage. |
Source ClinicalTrials.gov
Outcomes4
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Efficacy Assessed by Complete Cure Rate at the End of Study (Week 52) After Treating for 24 or 48 Weeks. | 52 weeks | All participants were included in the intention to treat (ITT) population, defined as all participants who were randomized and received study drug. The Last Observation was Carried Forward (LOCF). | Percentage of Participants | NUMBER |
| SECONDARY | Efficacy Assessed by Mycological Cure (Negative Culture and Negative KOH Microscopy) at the End of Study After Treating Patients for 24 or 48 Weeks. | 52 weeks | All participants were included in the intention to treat (ITT) population, defined as all participants who were randomized and received study drug. The Last Observation was Carried Forward (LOCF). | Percentage of Participants | NUMBER |
| SECONDARY | Efficacy Assessed by Clinical Efficacy at the End of Study After Treating Patients for 24 or 48 Weeks. | 52 weeks | All participants were included in the intention to treat (ITT) population, defined as all participants who were randomized and received study drug. The Last Observation was Carried Forward (LOCF). | Percentage of Participants | NUMBER |
| SECONDARY | Number of Participants Assessed With Adverse Events and Serious Adverse Events | 52 weeks | Safety Population was defined as all participants who received at least one dose of study drug and had at least one post-baseline safety assessment. All except 4 participants who were randomized to the vehicle 24 w group and one participant randomized to the terbinafine 48 w group, were included in the safety population. | Participants | NUMBER |
Source ClinicalTrials.gov
Results by group16
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Efficacy Assessed by Complete Cure Rate at the End of Study (Week 52) After Treating for 24 or 48 Weeks. | Terbinafine 24 w | 0.79 | -2.16 to 2.19 | Percentage of Participants | |
| Efficacy Assessed by Complete Cure Rate at the End of Study (Week 52) After Treating for 24 or 48 Weeks. | Vehicle 24 w | 0.78 | -2.16 to -2.16 | Percentage of Participants | |
| Efficacy Assessed by Complete Cure Rate at the End of Study (Week 52) After Treating for 24 or 48 Weeks. | Terbinafine 48 w | 1.47 | -0.55 to 3.49 | Percentage of Participants | |
| Efficacy Assessed by Complete Cure Rate at the End of Study (Week 52) After Treating for 24 or 48 Weeks. | Vehicle 48 w | 0.00 | -0.55 to 3.49 | Percentage of Participants | |
| Efficacy Assessed by Mycological Cure (Negative Culture and Negative KOH Microscopy) at the End of Study After Treating Patients for 24 or 48 Weeks. | Terbinafine 24 w | 10.32 | -2.70 to 10.83 | Percentage of Participants | |
| Efficacy Assessed by Mycological Cure (Negative Culture and Negative KOH Microscopy) at the End of Study After Treating Patients for 24 or 48 Weeks. | Vehicle 24 w | 6.25 | -2.70 to 10.83 | Percentage of Participants | |
| Efficacy Assessed by Mycological Cure (Negative Culture and Negative KOH Microscopy) at the End of Study After Treating Patients for 24 or 48 Weeks. | Terbinafine 48 w | 15.44 | 5.54 to 19.10 | Percentage of Participants | |
| Efficacy Assessed by Mycological Cure (Negative Culture and Negative KOH Microscopy) at the End of Study After Treating Patients for 24 or 48 Weeks. | Vehicle 48 w | 3.13 | 5.54 to 19.10 | Percentage of Participants | |
| Efficacy Assessed by Clinical Efficacy at the End of Study After Treating Patients for 24 or 48 Weeks. | Terbinafine 24 w | 1.59 | Percentage of Participants | ||
| Efficacy Assessed by Clinical Efficacy at the End of Study After Treating Patients for 24 or 48 Weeks. | Vehicle 24 w | 2.34 | Percentage of Participants |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 results by groupParticipant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Terbinafine 24 w | 126 | |
| Overall Study | STARTED | Vehicle 24 w | 128 | |
| Overall Study | STARTED | Terbinafine 48 w | 136 | |
| Overall Study | STARTED | Vehicle 48 w | 128 | |
| Overall Study | COMPLETED | Terbinafine 24 w | 102 | |
| Overall Study | COMPLETED | Vehicle 24 w | 103 | |
| Overall Study | COMPLETED | Terbinafine 48 w | 107 | |
| Overall Study | COMPLETED | Vehicle 48 w | 110 | |
| Overall Study | NOT COMPLETED | Terbinafine 24 w | 24 | |
| Overall Study | NOT COMPLETED | Vehicle 24 w | 25 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events96
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 | Influenza like illness | General disorders | Terbinafine 24 w | 2 | 126 | |
| other | Influenza like illness | General disorders | Vehicle 24 w | 1 | 124 | |
| other | Influenza like illness | General disorders | Terbinafine 48 w | 0 | 135 | |
| other | Influenza like illness | General disorders | Vehicle 48 w | 8 | 128 | |
| other | Nasopharyngitis | Infections and infestations | Terbinafine 24 w | 7 | 126 | |
| other | Nasopharyngitis | Infections and infestations | Vehicle 24 w | 9 | 124 | |
| other | Nasopharyngitis | Infections and infestations | Terbinafine 48 w | 18 | 135 | |
| other | Nasopharyngitis | Infections and infestations | Vehicle 48 w | 18 | 128 | |
| other | Upper respiratory tract infection | Infections and infestations | Terbinafine 24 w | 4 | 126 | |
| other | Upper respiratory tract infection | Infections and infestations | Vehicle 24 w | 6 | 124 |
1 to 10 of 96Source ClinicalTrials.gov
See all 96 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Terbinafine 24 w | ||
| Total, all-cause mortality | Vehicle 24 w | ||
| Total, all-cause mortality | Terbinafine 48 w | ||
| Total, all-cause mortality | Vehicle 48 w | ||
| Total, other adverse events | Terbinafine 24 w | 35 | 126 |
| Total, other adverse events | Vehicle 24 w | 38 | 124 |
| Total, other adverse events | Terbinafine 48 w | 47 | 135 |
| Total, other adverse events | Vehicle 48 w | 56 | 128 |
| Total, serious adverse events | Terbinafine 24 w | 2 | 126 |
| Total, serious adverse events | Vehicle 24 w | 7 | 124 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers0
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.
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/NCT00443898
GET https://conductscience.org/api/trials/v1/NCT00443898/events?page=2