Trial · NCT00443820
Efficacy Safety, and Tolerability of Topical Terbinafine in Patients With Mild to Moderate Toenail Fungus of the Big Toenail
NCT00443820, Phase 3, Completed, Novartis Pharmaceuticals; results first posted 2011-04-19
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Efficacy Safety, and Tolerability of Topical Terbinafine in Patients With Mild to Moderate Toenail Fungus of the Big Toenail. Trials, record NCT00443820. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00443820
On this page
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
- NCT00443820
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 526 participants, actual
- Lead sponsor
- Novartis Pharmaceuticals
- Conditions
- Onychomycosis
- Interventions
- terbinafine, Placebo, terbinafine, Placebo
- First posted
- 2007-03-06
- Last updated
- 2011-04-19
- Results first posted
- 2011-04-19
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 the Percentage of Participants With Complete Cure 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. |
| Secondary | Efficacy Assessed by the Percentage of Participants With Mycological Cure at the End of Study After Treating Participants for 24 or 48 Weeks | 52 weeks | Mycological cure is defined as negative KOH microscopy and negative culture for dermatophytes. |
| Secondary | Efficacy Assessed by the Percentage of Participants With Clinical Effectiveness at the End of Study After Treating Participants 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: * If mycological cure (negative KOH and negative culture for dermatophytes) and * = 10% residual involvement of the target toenail "No" if otherwise |
| Secondary | Safety and Tolerability Assessed by the Number of Participants With Adverse Events | 52 weeks | Safety and tolerability data as assessed by the number of participants with Adverse Events (AE), Serious Adverse Events, Drug discontinuation due to an AE and death. Additional details can be found in the Adverse Event Section. |
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 the Percentage of Participants With Complete Cure at the End of Study (Week 52) After Treating for 24 or 48 Weeks | 52 weeks | Intent to treat (ITT) population, Last observation carried forward (LOCF) | Percentage of participants | NUMBER |
| SECONDARY | Efficacy Assessed by the Percentage of Participants With Mycological Cure at the End of Study After Treating Participants for 24 or 48 Weeks | 52 weeks | Intent to treat (ITT) population, Last observation carried forward (LOCF) | Percentage of participants | NUMBER |
| SECONDARY | Efficacy Assessed by the Percentage of Participants With Clinical Effectiveness at the End of Study After Treating Participants for 24 or 48 Weeks | 52 weeks | Intent to treat (ITT) population, Last observation carried forward (LOCF) | Percentage of participants | NUMBER |
| SECONDARY | Safety and Tolerability Assessed by the Number of Participants With Adverse Events | 52 weeks | Safety Population | Number of participants | NUMBER |
Source ClinicalTrials.gov
Results by group28
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Efficacy Assessed by the Percentage of Participants With Complete Cure at the End of Study (Week 52) After Treating for 24 or 48 Weeks | Terbinafine 24 Weeks | 1.50 | -1.82 to 3.29 | Percentage of participants | |
| Efficacy Assessed by the Percentage of Participants With Complete Cure at the End of Study (Week 52) After Treating for 24 or 48 Weeks | Vehicle 24 Weeks | 0.77 | -1.82 to 3.29 | Percentage of participants | |
| Efficacy Assessed by the Percentage of Participants With Complete Cure at the End of Study (Week 52) After Treating for 24 or 48 Weeks | Terbinafine 48 Weeks | 2.96 | 0.10 to 5.82 | Percentage of participants | |
| Efficacy Assessed by the Percentage of Participants With Complete Cure at the End of Study (Week 52) After Treating for 24 or 48 Weeks | Vehicle 48 Weeks | 0 | 0.10 to 5.82 | Percentage of participants | |
| Efficacy Assessed by the Percentage of Participants With Mycological Cure at the End of Study After Treating Participants for 24 or 48 Weeks | Terbinafine 24 Weeks | 15.04 | 1.54 to 16.23 | Percentage of participants | |
| Efficacy Assessed by the Percentage of Participants With Mycological Cure at the End of Study After Treating Participants for 24 or 48 Weeks | Vehicle 24 Weeks | 6.15 | 1.54 to 16.23 | Percentage of participants | |
| Efficacy Assessed by the Percentage of Participants With Mycological Cure at the End of Study After Treating Participants for 24 or 48 Weeks | Terbinafine 48 Weeks | 22.22 | 6.00 to 22.82 | Percentage of participants | |
| Efficacy Assessed by the Percentage of Participants With Mycological Cure at the End of Study After Treating Participants for 24 or 48 Weeks | Vehicle 48 Weeks | 7.81 | 6.00 to 22.82 | Percentage of participants | |
| Efficacy Assessed by the Percentage of Participants With Clinical Effectiveness at the End of Study After Treating Participants for 24 or 48 Weeks | Terbinafine 24 Weeks | 3.01 | Percentage of participants | ||
| Efficacy Assessed by the Percentage of Participants With Clinical Effectiveness at the End of Study After Treating Participants for 24 or 48 Weeks | Vehicle 24 Weeks | 0.77 | Percentage of participants |
1 to 10 of 28Source ClinicalTrials.gov
See all 28 results by groupParticipant flow16
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Terbinafine 24 Weeks | 133 | |
| Overall Study | STARTED | Vehicle 24 Weeks | 130 | |
| Overall Study | STARTED | Terbinafine 48 Weeks | 135 | |
| Overall Study | STARTED | Vehicle 48 Weeks | 128 | |
| Overall Study | Safety Population | Terbinafine 24 Weeks | 131 | |
| Overall Study | Safety Population | Vehicle 24 Weeks | 129 | |
| Overall Study | Safety Population | Terbinafine 48 Weeks | 134 | |
| Overall Study | Safety Population | Vehicle 48 Weeks | 126 | |
| Overall Study | COMPLETED | Terbinafine 24 Weeks | 112 | |
| Overall Study | COMPLETED | Vehicle 24 Weeks | 111 |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 participant flowAdverse events148
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 | Infections and infestations | Terbinafine 24 Weeks | 2 | 131 | |
| other | Influenza | Infections and infestations | Vehicle 24 Weeks | 1 | 129 | |
| other | Influenza | Infections and infestations | Terbinafine 48 Weeks | 13 | 134 | |
| other | Influenza | Infections and infestations | Vehicle 48 Weeks | 10 | 126 | |
| other | Nasopharyngitis | Infections and infestations | Terbinafine 24 Weeks | 13 | 131 | |
| other | Nasopharyngitis | Infections and infestations | Vehicle 24 Weeks | 11 | 129 | |
| other | Nasopharyngitis | Infections and infestations | Terbinafine 48 Weeks | 15 | 134 | |
| other | Nasopharyngitis | Infections and infestations | Vehicle 48 Weeks | 15 | 126 | |
| other | Sinusitis | Infections and infestations | Terbinafine 24 Weeks | 3 | 131 | |
| other | Sinusitis | Infections and infestations | Vehicle 24 Weeks | 0 | 129 |
1 to 10 of 148Source ClinicalTrials.gov
See all 148 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Terbinafine 24 Weeks | ||
| Total, all-cause mortality | Vehicle 24 Weeks | ||
| Total, all-cause mortality | Terbinafine 48 Weeks | ||
| Total, all-cause mortality | Vehicle 48 Weeks | ||
| Total, other adverse events | Terbinafine 24 Weeks | 37 | 131 |
| Total, other adverse events | Vehicle 24 Weeks | 38 | 129 |
| Total, other adverse events | Terbinafine 48 Weeks | 54 | 134 |
| Total, other adverse events | Vehicle 48 Weeks | 52 | 126 |
| Total, serious adverse events | Terbinafine 24 Weeks | 8 | 131 |
| Total, serious adverse events | Vehicle 24 Weeks | 3 | 129 |
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/NCT00443820
GET https://conductscience.org/api/trials/v1/NCT00443820/results?page=2