Comparison · NCT03110029-sae
Efinaconazole 10% and Nail Polish vs Efinaconazole 10% Without Nail Polish: serious adverse events
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
2 sourcestrial-comparisons-2026-03-23-0.1.0
Cite this record
ConductScience Library. Efinaconazole 10% and Nail Polish vs Efinaconazole 10% Without Nail Polish: serious adverse events. Trial comparisons, record NCT03110029-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT03110029-sae
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Measures6
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
| Measure | Value | 95% interval, lower | 95% interval, upper | Method | Note |
|---|---|---|---|---|---|
| Risk in group 1 | 0 | 0.0000000000000000555 | 0.354 | wilson | |
| Risk in group 2 | 0 | 0.0000000000000000278 | 0.39 | wilson | |
| Risk difference, group 1 minus group 2 | 0 | -0.39 | 0.354 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | log | a group has no participants with the outcome | |||
| Odds ratio, group 1 over group 2 | log | a cell of the two-by-two table is zero | |||
| Number needed to harm | from the risk difference interval | the two groups' risks are equal |
Source ClinicalTrials.gov
Groups2
Neither group, or both, names a comparator, so the groups keep ClinicalTrials.gov's order.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code |
|---|---|---|---|---|---|
| Group 1 | Efinaconazole 10% and Nail Polish | Patients who self-identified as frequently wearing toenail polish were placed in the study group. Inclusion criteria consisted of being female and aged 19-70 with DLSO effecting at least one great toenail. The target great toenail thickness was less than or equal to 3mm. DLSO was diagnosed by having a positive potassium hydroxide microscopy and culture of a dermatophyte. Exclusion criteria included a history of either immunosuppression, uncontrolled diabetes mellitus, or psoriasis. Patients were also excluded if they had severe target toenail DLSO or three or more dermatophytomas on the target toenail. Patients were required to refrain from wearing gel or plastic based polishes that are used in salons and require curing.~Patients with symptomatic tinea pedis at screening were treated with luliconazole cream for 2 weeks. | 0 | 7 | EG000 |
| Group 2 | Efinaconazole 10% Without Nail Polish | The control group was comprised of women who agreed to abstain from wearing toenail polish throughout the length of the study.~Inclusion criteria consisted of being female and aged 19-70 with DLSO effecting at least one great toenail. The target great toenail thickness was less than or equal to 3mm. DLSO was diagnosed by having a positive potassium hydroxide microscopy and culture of a dermatophyte. Exclusion criteria included a history of either immunosuppression, uncontrolled diabetes mellitus, or psoriasis. Patients were also excluded if they had severe target toenail DLSO or three or more dermatophytomas on the target toenail. Patients were required to refrain from wearing gel or plastic based polishes that are used in salons and require curing.~Patients with symptomatic tinea pedis at screening were treated with luliconazole cream for 2 weeks. | 0 | 6 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
Source ClinicalTrials.gov
Trial
- Title
- Evaluating the Efficacy and Compatibility of Efinaconazole 10% Solution (Jublia) for the Treatment of Toenail Onychomycosis in Patients Wearing Toenail Polish Compared to Those Without Polish
- NCT number
- NCT03110029
- Phases
- PHASE4
- Conditions
- Onychomycosis of Toenail
- Interventions
- Efinaconazole 10% Topical Application Solution [JUBLIA], Application of Nail Polish
- Lead sponsor
- University of Alabama at Birmingham
- Results first posted
- 2019-03-20
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT03110029?tab=results
Source ClinicalTrials.gov
Source
- Release
- trial-comparisons-2026-03-23-0.1.0
- Release manifest SHA-256
- f66225897fbf258b57ea10bdacfd0347d3cdfda93f7f5685234b7e06ea36fa57
- AACT copy
- 2026-03-23
- Tables read
- outcome_counts.parquet, outcome_measurements.parquet, outcomes.parquet, reported_event_totals.parquet, reported_events.parquet, result_groups.parquet, studies.parquet, ctgov_trial.parquet
Source ClinicalTrials.gov
Sources 2
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
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
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions. The measures are ConductScience's calculation from them.
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