This page provides an independent statistical analysis and educational interpretation of publicly reported results. ClinicalTrials.gov provides the official trial registry record. Numerical trial results on this page are restricted to the results posted in the ClinicalTrials.gov record; calculations added by Clinical Biostats are labelled as such.
1. Trial at a Glance
This page covers the registry results for Efficacy, Safety, and Tolerability of HTS-519 Insert in Patients With Toenail Fungus of the Big Toenail (NCT02798380), a na phase 2 study. The primary outcome is Treatment Related Adverse Events.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT02798380 |
| Phase | Phase 2 |
| Condition | Onychomycosis |
| Allocation | Not applicable (single group) |
| Design model | Single Group |
| Masking | None (open label) |
| Enrollment | 30 |
| Arms in the primary outcome | n/a |
| Lead sponsor | Hallux, Inc. |
| Results posted | Yes |
2. Clinical Question
Population
The study enrolled people with mild to moderate toenail fungus affecting the big toenail. The official title describes distal lateral subungual onychomycosis of the great toenail. The condition listed in the registry is onychomycosis. The safety population is defined as all enrolled participants, and the registry reports an enrollment of 30.
Intervention
The intervention was the HTS-519 Insert, described as active treatment. The study purpose was to assess its efficacy, safety, and tolerability in the treatment of the condition. The registry does not report a dose or additional treatment details.
Comparator
There was no comparator arm. The registry identifies a single-group model and no masking; allocation is listed as NA. This design can describe outcomes among participants receiving the insert, but it does not provide a like-for-like control comparison.
Primary question
The primary outcome was treatment-related adverse events, measured as the number of participants and assessed up to 48 weeks. The outcome description refers to frequency and severity. The registry record does not report an analyzed result for this primary endpoint, so the posted safety counts should not be treated as a complete estimate of the primary outcome.
3. Trial Design
This was an open-label Phase 2 study of the HTS-519 Insert in people with onychomycosis of the great toenail. The registry lists a single-group model, no masking, and allocation as NA. The intervention arm is described as active treatment. The study enrolled 30 participants and is marked completed.
The registry gives a start date of 2016-07 and a primary completion date of 2018-10. These dates describe the study record; they do not, by themselves, establish how long each participant was followed. The primary outcome timeframe is stated as up to 48 weeks.
Because there is only one treatment group, outcomes can be described for participants who received the insert, but the design cannot directly compare their outcomes with an untreated or alternative-treatment group. Changes over time, if measured, would not by themselves separate a treatment effect from other explanations. No randomized comparison is reported, and the registry specifically cautions that the arms are not a like-for-like control comparison.
The record identifies one primary outcome measure and no analyses. It includes safety counts for serious and other adverse events, but it does not report an analyzed result for the named primary endpoint of treatment-related adverse events. The protocol details, including the rationale for enrollment, are not reported in the registry record. The record also does not report a comparator, a masking procedure, or a statistical plan that would support an efficacy comparison.
4. Participant Flow and Accounting
The registry reports how participants moved through each stage of the study. All counts below are exactly as posted; missing counts are not inferred from other stages.
Overall Study
| Stage | HTS-519 Insert |
|---|---|
| STARTED | 30 |
| COMPLETED | 30 |
| NOT COMPLETED | 0 |
Analysis population for the primary outcome, as defined in the registry: Safety Population: All Enrolled
5. Baseline Characteristics
The table reproduces the baseline characteristics posted in the registry, which describe the participants analysed at baseline and help show whether the randomized groups were comparable.
| Characteristic | Unit | HTS-519 Insert |
|---|---|---|
| Participants analysed | 30 | |
| Age, Categorical: <=18 years | Participants | 0 |
| Age, Categorical: Between 18 and 65 years | Participants | 18 |
| Age, Categorical: >=65 years | Participants | 12 |
| Age, Continuous | years | 59.9 (26 to 74) |
| Sex: Female, Male: Female | Participants | 9 |
| Sex: Female, Male: Male | Participants | 21 |
| Race (NIH/OMB): American Indian or Alaska Native | Participants | 0 |
| Race (NIH/OMB): Asian | Participants | 1 |
| Race (NIH/OMB): Native Hawaiian or Other Pacific Islander | Participants | 0 |
| Race (NIH/OMB): Black or African American | Participants | 1 |
| Race (NIH/OMB): White | Participants | 28 |
| Race (NIH/OMB): More than one race | Participants | 0 |
| Race (NIH/OMB): Unknown or Not Reported | Participants | 0 |
| Region of Enrollment: United States | Participants | 30 |
6. Primary Endpoint
The registry lists the primary outcome as Treatment Related Adverse Events, measured over Up to 48 weeks.
| Element | Registry entry |
|---|---|
| Result type | Count Of Participants |
| Measure of spread | not applicable |
| Unit | Participants |
| Endpoint classification | Binary Endpoint |
The primary endpoint is titled Treatment Related Adverse Events. It is measured as a count of participants, and its description specifies the frequency and severity of treatment-related events. The stated timeframe is up to 48 weeks, and the named population is the safety population, defined as all enrolled participants.
Counting participants who experience an event is a binary-outcome approach: each participant either meets the event definition or does not. This gives a direct descriptive measure of how many people in the stated population experienced the outcome. Severity adds clinically relevant context, since event counts alone do not distinguish events by seriousness.
The registry record does not report an analyzed result for this primary endpoint. It does report safety figures divided into serious and other adverse events, but the record does not establish that these counts are the endpoint’s treatment-related event result. The safety categories should therefore be read as posted safety data, not substituted for an unreported endpoint analysis.
In a single-group study, an adverse-event count can describe what was observed among participants receiving the intervention. Without a control group and a reported comparison, it cannot establish how the frequency would differ under another treatment or no treatment. The registry does not report further endpoint definitions, such as the rules used to determine treatment relatedness.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry describes a completed, open-label study with a single treatment group and enrollment of 30. Its primary outcome is treatment-related adverse events, measured by participant count over a timeframe of up to 48 weeks. However, the record reports no analyses and does not provide an analyzed result for that primary endpoint. This limits the conclusions that can be drawn about the endpoint as defined.
The posted safety figures list 2 participants affected by serious adverse events and 28 affected by other adverse events in the HTS-519 Insert group. The record also lists 0 deaths. These are descriptive counts from the safety information. They do not, on their own, provide a controlled estimate of risk, establish causality, or indicate whether events were judged related to treatment. The primary endpoint is specifically treatment-related events, while the posted safety categories are labeled serious and other adverse events.
The listed serious-event terms are Leg edema and Spinal Fusion Surgery, each accompanied by 3.3%. Those entries provide additional event information, but the record does not explain how the term-level entries relate to affected participants or whether a participant could contribute more than one event. They should not be used to reconstruct participant-level outcomes.
Statistically, a single-group count describes the study experience under the conditions recorded. It does not estimate a treatment-versus-control contrast. Open-label conduct also means there was no masking, but the registry does not provide enough detail to assess how that feature affected event reporting or classification.
Any sample-size illustrations associated with the displayed material are planning calculations based on stated assumptions, not observed study results or evidence about the study’s power. The assumptions describe a two-sided significance level of 0.05, equal allocation between two arms, a normal approximation, and an effect defined as a fraction of the observed effect. Those assumptions do not match this registry’s single-group design and should not be read as the trial’s original design rationale. That rationale is not reported in the registry record.
Overall, the posted information supports a limited description of safety counts and the study structure. It does not provide a reported primary endpoint analysis, a comparative efficacy estimate, or a basis for attributing the listed events to the insert. Unreported results should not be inferred from the study’s completed status.
9. Statistical Methods Explained
For a binary outcome, the basic observation is whether each participant meets a defined event criterion. A participant count records how many participants experienced the event; it is not the same as counting every event occurrence, because one participant could experience more than one event. The primary endpoint is defined as a participant count, but the registry does not report its analyzed result or give further operational details for deciding whether an adverse event was treatment related.
What does a single-group count tell us?
A count in a single treatment group is descriptive. It tells readers how many participants were recorded in a category under the study’s conditions. To interpret it fully, readers also need the outcome definition, the analysis population, and the relevant follow-up information. The registry identifies the safety population as all enrolled participants and reports 30 enrolled. It states that the primary endpoint timeframe was up to 48 weeks, but does not report participant-level follow-up or an analysis that connects the listed safety categories to the primary endpoint.
A controlled comparison asks a different question: whether outcomes differ between groups assigned to different conditions. This study has a single-group model and no comparator. Thus, even a clearly reported event count would not estimate a between-group treatment effect. A comparison with an external rate would require information and assumptions not reported in the registry record.
Why do event definitions matter?
Safety data can be organized by seriousness, type, severity, or judged relationship to treatment. These classifications answer different questions. Seriousness is not interchangeable with severity, and neither is equivalent to treatment relatedness. The registry’s primary outcome refers to treatment-related adverse events and their frequency and severity. The posted safety figures are organized as serious and other adverse events. Without a reported analysis linking these categories to the primary endpoint definition, they should remain distinct in interpretation.
Term-level event listings also need careful interpretation. A term may describe an event rather than a unique participant, and the record does not state whether multiple terms could apply to a participant. The listed terms and percentages should therefore be read as reported entries, not as a participant-level breakdown beyond what the registry explicitly gives.
What would an uncertainty interval add?
In general, a confidence interval expresses the uncertainty around an estimated quantity under a statistical model. A narrow interval indicates greater precision under that model, while a wide interval indicates less precision. An interval does not resolve limitations such as the lack of a comparator, uncertainty in event classification, or incomplete reporting. The registry record does not report a confidence interval or an analyzed primary endpoint estimate, so no precision claim for that endpoint can be made from the posted information.
For a binary endpoint, interval estimation depends on the number of participants at risk and the number meeting the outcome definition, as well as the method used. Different methods can behave differently when event counts are small. No interval method or interval result for the primary endpoint is reported in the registry record. It would therefore be inappropriate to present a recalculated estimate as though it were the sponsor’s analysis.
How should planning illustrations be read?
Sample-size calculations are prospective planning tools: they describe the number of participants a hypothetical design might require under specified assumptions. The stated assumptions for the planning illustrations are a two-sided significance level of 0.05, equal allocation between two arms, a normal approximation, and an effect expressed as a fraction of the observed effect. For time-to-event calculations, the stated quantity is a total number of events; other illustrations are expressed as participants per arm for a specified power.
These illustrations are not observed outcomes, and they are not observed power. They also do not show that this trial was designed around those assumptions. The actual study is a single-group study, whereas the planning assumptions describe two-arm allocation. The trial’s own sample-size justification and statistical plan are not reported in the registry record. Any recalculated values based on posted summary statistics would be simple unadjusted calculations, not a replacement for a sponsor analysis; no primary endpoint analysis is reported in the registry record.
Finally, the study’s completed status means the registry marks it completed, not that every planned outcome analysis is available in the record. The distinction between study status, outcome reporting, and statistical analysis is important: the record can identify the design and list safety counts while still not reporting an analyzed result for the named primary endpoint.
10. Multiplicity, Missing Data and Analysis Populations
Multiplicity arises when several hypotheses or outcomes are tested and the chance of a chance-positive finding increases across the set of tests. The registry identifies one primary outcome measure and reports no analyses. It does not report a testing hierarchy, multiplicity adjustment, or interim analysis plan. Those details are not reported in the registry record, so there is no basis for describing how multiple testing was handled.
The endpoint timeframe is up to 48 weeks, but the record does not describe how missing observations or incomplete follow-up were handled. It does not report imputation, censoring rules, sensitivity analyses, or the number of participants with endpoint data at particular assessment times. No assumptions about missingness should be inferred.
The named safety population is all enrolled participants. The registry reports enrollment of 30 and safety counts for the HTS-519 Insert group, but it does not give a separate analysis population for the primary endpoint or explain how participants with incomplete safety follow-up were treated. The record’s definition of the safety population should not be expanded into a claim that every participant contributed complete data through the full timeframe.
Because no analysis is reported for the primary endpoint, its handling of multiplicity and missing data cannot be evaluated. The absence of those details is a reporting limitation; it does not establish that a particular procedure was or was not used outside the registry record.
11. Safety Results
The registry reports serious adverse events as affected participants divided by participants at risk.
| Arm | Participants with serious adverse events | Participants at risk | Percentage |
|---|---|---|---|
| HTS-519 Insert | 2 | 30 | 6.7% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| HTS-519 Insert | 0 of 30 |
Other (non-serious) adverse events
Participants with at least one non-serious event at or above the registry's 5% reporting threshold.
| Arm | Participants affected of at risk |
|---|---|
| HTS-519 Insert | 28 of 30 |
Most frequent serious adverse event terms
| Event term | Organ system | HTS-519 Insert |
|---|---|---|
| Leg edema | Investigations | 1 of 30 |
| Spinal Fusion Surgery | Surgical and medical procedures | 1 of 30 |
Most frequent non-serious adverse event terms
| Event term | Organ system | HTS-519 Insert |
|---|---|---|
| Mild Subungual Hematoma | General disorders | 17 of 30 |
| Mild Onycholysis | Skin and subcutaneous tissue disorders | 5 of 30 |
| Mild Punctate Bleeding | General disorders | 4 of 30 |
| Mild Pain in Toe | Investigations | 2 of 30 |
Serious events with the highest arm-level rate: leg edema (3.3%), spinal fusion surgery (3.3%).
The registry lists 2 participants affected by serious adverse events and 28 affected by other adverse events in the HTS-519 Insert group. It lists 0 deaths. These are the posted safety counts and should be read as descriptive observations, not as a comparison against another treatment or a population benchmark.
The serious-event terms listed are Leg edema and Spinal Fusion Surgery, each with 3.3%. The record does not explain whether these entries count events or participants, whether a participant could have more than one listed term, or how the term percentages were derived. The percentages should therefore be quoted as recorded and not converted into additional counts or used to infer a participant-level distribution.
Seriousness, severity, and treatment relatedness are separate classifications. The primary endpoint concerns treatment-related adverse events, while the safety figures are organized by serious and other adverse events. The record does not report an analysis demonstrating that the listed categories are the primary endpoint result, nor does it provide a causal assessment for the terms. In a single-group, open-label study, these counts describe reported safety experience but cannot establish comparative risk or causation.
12. What the Result Does, and Does Not, Mean
The record establishes that a completed, open-label Phase 2, single-group study evaluated the HTS-519 Insert in people with onychomycosis of the great toenail. It identifies treatment-related adverse events as the primary outcome and gives a timeframe of up to 48 weeks. It also reports safety counts, including serious and other adverse events and deaths.
Those details do not amount to a reported analysis of the primary endpoint. The registry lists no analyses, and it does not provide an analyzed result for treatment-related adverse events. The safety counts can describe the categories as recorded, but they cannot be assumed to represent the primary endpoint’s treatment-related classification. Nor do they show whether the intervention changes event frequency compared with another option.
The single-group design is central to interpretation. Without a control group, observed events cannot be contrasted with outcomes that might have occurred under another condition. A completed status does not resolve this limitation and does not imply that all outcomes or analyses have been reported.
Likewise, a count or a listed event term does not by itself establish that the insert caused an event. The record does not provide an attribution analysis or the detailed event-classification rules needed to assess that question. It also does not report endpoint uncertainty intervals or the missing-data procedures, limiting assessment of precision and completeness.
The appropriate reading is therefore bounded: the record describes the study design and posts selected safety information, while leaving the primary endpoint analysis and comparative interpretation unreported. Planning calculations, where displayed, are hypothetical design illustrations based on stated assumptions rather than observed treatment effects or observed power.
13. Why This Trial Matters Statistically
This study is statistically informative as an example of how design determines the questions a result can answer. A single-group study can describe observations among participants receiving an intervention. It cannot, by design alone, show how those observations compare with a control condition. That distinction remains important even when a study is marked completed and its safety counts are available.
The endpoint also illustrates why outcome labels and safety categories should not be treated as interchangeable. The primary measure concerns treatment-related adverse events, while the posted safety figures separate serious and other adverse events. Without a reported endpoint analysis connecting these classifications, a reader should not substitute one for the other.
Reporting completeness matters alongside design. The record gives the study population, intervention, timeframe, and selected safety counts, but reports no analyses and no analyzed primary outcome result. It does not report methods for missing data, multiplicity, or the primary endpoint’s statistical estimation. These omissions constrain both interpretation and reproducibility.
Finally, planning calculations answer prospective questions under assumptions; they are not a retrospective score of what the study achieved. The stated planning assumptions describe a two-arm setting, while the trial itself is single-group. Keeping those purposes distinct prevents hypothetical design quantities from being mistaken for trial findings.
14. Limitations
- The posted summary statistics are the only data these results rest on; patient-level data, full protocols and statistical analysis plans are not available.
- Recalculated results are simple, unadjusted calculations from posted summaries. They do not replace the sponsor's prespecified analysis.
The registry record supports only a limited assessment of the study’s results. It reports one primary outcome measure but no analyses, and it does not provide an analyzed result for treatment-related adverse events. The safety counts are not identified as a complete primary endpoint analysis.
The single-group, open-label design has no comparator and no masking. Consequently, the posted observations cannot establish a comparative treatment effect, and event counts cannot establish causality. The registry itself cautions that there is no like-for-like control comparison.
Further details needed to interpret the endpoint are not reported in the registry record. These include the operational definition of treatment relatedness, the analysis method, uncertainty estimates, and the handling of incomplete follow-up. Although the primary timeframe is up to 48 weeks, participant-level follow-up information is not reported.
The record’s safety population is defined as all enrolled participants, but it does not explain whether every participant contributed complete safety information throughout the stated timeframe. The serious-event term entries are not accompanied by enough detail to reconstruct participant-level outcomes or determine how terms relate to the affected-participant counts.
The registry does not report the sample-size justification, statistical analysis plan, multiplicity procedures, interim analyses, or missing-data methods. No conclusions about these unreported procedures can be drawn. The completed status and listed safety counts do not fill those reporting gaps.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Efficacy, Safety, and Tolerability of HTS-519 Insert in Patients With Toenail Fungus of the Big Toenail — NCT02798380.
- Registry record last updated 2021-11-02; status last verified 2021-10.
- Results first posted 2019-09-24.
- Data retrieved from ClinicalTrials.gov on 2026-11-09.
- Group sizes, means, event counts and sponsor-reported p-values are reproduced as posted. Effect estimates, confidence intervals and p-values not attributed to the sponsor are independently calculated from the posted summary statistics.
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Use this trial's endpoint as a starting point for deeper study of effect measures, confidence intervals, and sample-size planning.
18. Record Summary
The registry record concerns NCT02798380, a completed, open-label Phase 2 study of the HTS-519 Insert for onychomycosis of the great toenail. It lists a single-group model, no masking, allocation as NA, and enrollment of 30. The recorded dates are a start date of 2016-07 and a primary completion date of 2018-10.
The primary endpoint is treatment-related adverse events among the safety population, defined as all enrolled participants, with a timeframe of up to 48 weeks. The registry reports no analyses and no analyzed result for that endpoint. Posted safety counts list 2 affected by serious adverse events, 28 affected by other adverse events, and 0 deaths. The listed serious-event terms are Leg edema and Spinal Fusion Surgery, each with 3.3%.
The single-group design does not provide a controlled comparison. The registry record does not report the primary endpoint analysis, statistical plan, missing-data procedures, or sample-size justification.