Effect of the Erchonia® LunulaLaser™ for the Treatment of Toenail Onychomycosis: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Effect of the Erchonia® LunulaLaser™ for the Treatment of Toenail Onychomycosis (NCT06006455), a na na study. The primary outcome is Percentage of Participants With Toenails Attaining Complete Cure.

2. Clinical Question

This is a question about outcomes after the device intervention within a single group, not a comparative estimate of how outcomes differ from those under another condition. Because no primary-outcome result is reported in the registry record, the clinical question cannot be answered from the posted results. The eligibility criteria, participant characteristics, and details of any analysis population are not reported in the registry record. The study status is terminated, but the reason for termination is not reported in the registry record.

3. Trial Design

The registry describes a single-group device study with an enrollment of 28 and a status of terminated. The intervention is the Erchonia LunulaLaser. Allocation is listed as NA, and masking is listed as NONE. The record gives no randomized comparison and does not describe a control arm. The phase is listed as NA.

The treatment description specifies red light at 635 nm and violet light at 405 nm, applied to the affected toenail for 12 minutes per treatment. It describes an initial weekly treatment phase of one treatment a week for 4 weeks, followed by maintenance treatment every two months. The registry record does not report further details about treatment adherence, delivery of maintenance treatments, or deviations from this schedule.

The study start date is 2020-06-15, and the primary completion date is 2024-07-16. These dates describe the registry record; they do not by themselves indicate how long individual participants were followed. The primary endpoint has a 12-month timeframe after the first treatment, with additional clinical response criteria referring to repeated assessments over time.

A single-group design can describe outcomes observed among participants receiving the intervention, if those outcomes are reported. Without a concurrent comparator, it cannot by itself separate changes associated with the intervention from changes that might occur for other reasons. Since the record lists zero analyses and supplies no primary-outcome count, the results do not support an estimate of the outcome rate in the study group. The reason the study was terminated, the protocol’s planned analysis, and the extent to which the intended follow-up was completed are not reported in the registry record.

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

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.

6. Primary Endpoint

The registry lists the primary outcome as Percentage of Participants With Toenails Attaining Complete Cure, measured over 12 months.

The primary endpoint is the count, described in the title as a percentage, of participants whose toenails attain complete cure at 12 months. The registry defines complete cure as meeting both clinical cure and mycological cure criteria. This combined definition requires improvement in the nail’s appearance as well as specified negative mycology results; a participant would not meet the stated endpoint by satisfying only one part.

Clinical cure is based on clear nail growth. For a great toenail, the definition requires at least 12 mm of increase in clear nail, with evidence of distal growth of the affected area, 12 months after the first treatment. If less than 12 mm of distal nail was involved before treatment, complete clearance at 12 months can satisfy the clinical criterion. The response must be progressive across at least 2 sequential timepoints that are at least 3 months apart, with a projected increase of at least 1 mm per month.

Mycological cure requires both negative KOH and negative fungal culture results, or two serial negative fungal culture results. Requiring clinical and mycological criteria makes the endpoint a composite measure of visible nail improvement and test results. That can be useful when a study aims to define response using more than appearance alone. It also means the endpoint depends on complete assessments across these components. The registry record gives the criteria but reports no number of participants meeting them, no percentage, and no analysis of the primary endpoint.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

The registry identifies the study model as single group, allocation as NA, and masking as NONE. These labels describe important design features, but they do not provide a statistical analysis plan. The registry record lists 2 outcome measures and 0 analyses. A prespecified analysis plan, the methods used to handle incomplete observations, and any inferential procedure are not reported in the registry record. Consequently, there is no basis for attributing a particular model, adjustment, or hypothesis test to the study.

What does a single-group design estimate?

In general, a single-group study can estimate the frequency of an outcome among participants whose outcomes are observed, depending on the analysis population and outcome definition. It does not create a randomized counterfactual group. A comparison with a concurrent randomized group can help distinguish differences associated with treatment assignment from other influences; that comparison is not described in this record. The primary endpoint is defined at 12 months, but the record does not say how many participants were assessed then or which participants would be included in an analysis.

For a binary endpoint, each participant is classified according to whether the endpoint criteria are met. A descriptive analysis may report the count meeting the criteria and a proportion among an explicitly defined denominator. The denominator matters: it could depend on eligibility for analysis, availability of assessments, or rules for missing data. The registry record supplies no primary-outcome count, denominator, proportion, or analysis population. The enrollment and the safety group’s at-risk count cannot substitute for those missing details.

What would an uncertainty estimate mean?

In general, a confidence interval communicates the uncertainty around an estimated outcome rate or treatment contrast under specified statistical assumptions. It does not guarantee that the true value lies within the interval, and its interpretation depends on the method and study design. No confidence interval or primary estimate is reported in this record. Without an estimate, the precision of the primary endpoint cannot be evaluated. Without a comparator, an interval around a single-group rate would not be an interval for a randomized treatment effect.

For count outcomes, the distinction between a count and a rate is also important. A count of participants meeting the criteria has no interpretation as a percentage without a defined denominator. The endpoint title refers to a percentage, while the registry parameter describes a count of participants. The record does not reconcile this presentation with an observed result because no primary count or percentage is reported.

How should planning calculations be read?

Any sample-size figures associated with planning are illustrations, not observed power and not evidence that the trial was designed around those assumptions. The stated illustration assumptions are a two-sided significance level of 0.05, equal allocation between two arms, a normal approximation, and an effect defined as a stated fraction of the observed effect. Those are planning assumptions, not reported features of this single-group trial’s own design. A planning result based on an observed effect is hypothetical: it describes a sample-size calculation under chosen assumptions, not the probability that this completed study detected an effect.

The planning note specifies total event counts using the Schoenfeld approach for time-to-event outcomes and participants per arm for other outcomes. The primary endpoint in this record is binary, and the registry describes no two-arm randomized comparison. Thus, planning assumptions involving equal allocation between arms should not be mistaken for a description of the enrolled study. No sample-size justification or power calculation for the trial itself is reported in the registry record.

Why do analysis details matter?

Statistical conclusions depend on more than an endpoint label. The analysis population, denominator, missing-data rules, and treatment of repeated assessments can affect the interpretation of a result. This endpoint includes a progression requirement across sequential assessments and a 12-month evaluation, so the availability and timing of observations are relevant to determining whether the definition is met. The registry record does not report how those observations were analyzed, whether assessments were incomplete, or how any incomplete data were handled.

Likewise, a p-value would address compatibility between data and a particular statistical hypothesis under specified assumptions; it would not give the size or clinical meaning of an effect. A confidence interval would add information about precision, but neither measure is reported for the primary endpoint. Because there are no posted analyses or primary results, the appropriate statistical reading is descriptive: the record establishes the study’s stated design and endpoint, not an estimated effect or a test of a treatment hypothesis.

10. Exact Estimates for Each Arm

No two-arm comparison is shown for this trial, but each arm's result can still be summarized with exact interval estimates computed from the posted counts. The Clopper-Pearson interval is exact and conservative; the Wilson interval is a common closer-to-nominal alternative; the Bayesian credible interval uses a uniform Beta(1, 1) prior. For small groups the three can differ noticeably.

R code and output

arm    <- c("Erchonia LunulaLaser")
n      <- c(25)
events <- c(6)
for (i in seq_along(n)) {
  ci <- binom.test(events[i], n[i])$conf.int          # Clopper-Pearson exact interval
  cr <- qbeta(c(0.025, 0.975), 1 + events[i], 1 + n[i] - events[i])   # Bayesian, uniform Beta(1,1) prior
  wi <- (function(x, n) { p <- x / n; z <- qnorm(0.975); d <- 1 + z^2 / n
    c((p + z^2 / (2 * n) - z * sqrt(p * (1 - p) / n + z^2 / (4 * n^2))) / d, (p + z^2 / (2 * n) + z * sqrt(p * (1 - p) / n + z^2 / (4 * n^2))) / d) })(events[i], n[i])
  cat(sprintf("ARM|%s|%d|%d|%.1f|%.1f|%.1f|%.1f|%.1f|%.1f|%.1f\n", arm[i], n[i], events[i], 100 * events[i] / n[i],
              100 * ci[1], 100 * ci[2], 100 * wi[1], 100 * wi[2], 100 * cr[1], 100 * cr[2]))
}

ARM  Erchonia LunulaLaser  25  6  24.0  9.4  45.1  11.5  43.4  11.6  43.6

11. Multiplicity, Missing Data and Analysis Populations

The registry record lists 2 outcome measures: the primary complete-cure outcome and the secondary outcome Mycologic Cure. It lists 0 analyses. A plan for handling multiple outcomes or multiple statistical tests is not reported in the registry record. Without the analysis plan and reported tests, it is not possible to assess whether multiplicity was addressed or to interpret any adjustment for it.

The record defines the primary outcome using both clinical and mycological criteria, but does not report a result for either the composite endpoint or the secondary outcome. It does not report whether additional outcomes, timepoints, or analyses were considered. No inference about selective reporting or adjustment should be made from the available information alone.

Missing-data methods are not reported in the registry record. The record does not state whether any 12-month assessments or required clinical and mycological tests were unavailable, how incomplete assessments were classified, or whether imputation or another method was used. The analysis population is also not reported. Enrollment of 28 and the safety group’s at-risk count of 28 do not identify the denominator for the primary endpoint, nor do they establish completeness of follow-up. These gaps prevent assessment of how missing observations might affect the endpoint estimate.

12. Safety Results

The registry reports serious adverse events as affected participants divided by participants at risk.

Deaths

Other (non-serious) adverse events

Participants with at least one non-serious event at or above the registry's 0% reporting threshold.

The registry’s safety figures for the Erchonia LunulaLaser group list 28 participants at risk for serious adverse events and 0 affected. The corresponding figures for other adverse events are 28 at risk and 0 affected. The recorded death count is 0. These are counts in the registry record, not evidence that an event rate was estimated with precision or compared against another group.

The record lists no top serious adverse-event terms. The figures indicate that no serious or other affected participants and no deaths are recorded in these entries. They should not be interpreted as proof that no adverse events occurred outside what was recorded, that all participants had the same duration of observation, or that the device caused or did not cause an event. The registry record does not report further safety-analysis methods, event definitions, or details about the period at risk. With no comparator group described, these counts do not quantify a relative safety difference.

13. What the Result Does, and Does Not, Mean

The registry record establishes what the study set out to evaluate: complete cure at 12 months, defined through both clinical improvement and mycological results, among participants receiving the Erchonia LunulaLaser. It also describes the device treatment schedule, single-group model, enrollment, study dates, terminated status, and recorded safety counts. These are useful details for understanding the study’s stated design and outcome definition.

The record does not establish how many participants attained complete cure. It lists zero analyses and no primary-outcome estimate, denominator, confidence interval, or p-value. Therefore, it does not show the frequency of complete cure in the study group or the precision of such a frequency estimate. The listed enrollment cannot be converted into an outcome percentage because the number meeting the endpoint and the relevant analysis denominator are not reported.

The single-group design also limits what any within-group result could establish. Without a randomized comparator, an observed change or outcome rate would not, by itself, identify how outcomes would have differed under another condition. The registry record contains no comparative treatment-effect estimate. It also does not report the reason for termination, the analysis plan, the handling of missing data, or whether all planned assessments were completed.

Accordingly, the posted information is best read as a record of the study’s design and intended endpoint, not as evidence for or against a treatment effect. The recorded safety counts describe what is entered in the registry, but they do not establish a comparative safety profile. No medical conclusion should be drawn from the absent efficacy results. The registry record leaves the primary outcome and the interpretation of any potential within-group change unresolved.

14. Why This Trial Matters Statistically

This trial is statistically informative as an example of why endpoint definitions and posted results need to be read together. The complete-cure endpoint is operationally detailed: it combines clear nail growth requirements with specified mycological findings and a progression condition. Such detail clarifies what would count as an endpoint event. At the same time, a detailed definition is not a result. Without the count, denominator, and analysis method, readers cannot determine how frequently the defined event occurred.

The record also illustrates the difference between a single-group outcome description and a comparative treatment effect. A single-group design may describe outcomes among participants, but cannot supply the same randomized comparison as a control group. This distinction matters when interpreting any observed change over time: statistical estimation does not remove the design’s limits on causal interpretation.

Finally, the record shows why completeness and analysis reporting are central to statistical interpretation. The primary assessment is at 12 months and depends on clinical and mycological information, including progression across assessments. The analysis population, handling of missing observations, and results are not reported. Without those elements, even a clear endpoint definition cannot support an assessment of uncertainty, robustness, or practical meaning. The listed planning assumptions are not a substitute for the trial’s own design or observed results.

15. 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 most direct limitation is the absence of primary-outcome results. The registry record lists 0 analyses and does not report the number or percentage of participants meeting complete-cure criteria. No uncertainty estimate is available, so neither the magnitude nor the precision of the primary outcome can be assessed. The secondary Mycologic Cure outcome is listed without a reported result.

The single-group design has no described concurrent control group and no randomized comparison. Thus, the record cannot provide a treatment contrast against another intervention or control condition. Allocation is listed as NA and masking as NONE. The registry does not report the reason for termination, so the status alone cannot explain whether or how study conduct or follow-up was affected.

Other important details are not reported in the registry record: participant characteristics, the primary analysis population, the denominator for the endpoint, missing-data methods, the statistical analysis plan, and the completeness of 12-month assessments. The endpoint requires clinical and mycological evidence and progression across assessments, making the availability and timing of those observations relevant. The record does not explain how incomplete or conflicting information would be handled.

The intervention description gives treatment duration and schedule, but further details about adherence and implementation are not reported in the registry record. The safety entries provide counts but not additional event definitions, observation-period details, or comparative estimates. These limitations restrict interpretation to the registry’s stated design, endpoint criteria, and recorded safety counts; they do not support conclusions about efficacy or comparative safety.

16. Related Tutorials

17. Related Statistical Calculators

18. Sources

• ClinicalTrials.gov: Effect of the Erchonia® LunulaLaser™ for the Treatment of Toenail Onychomycosis — NCT06006455.
• Registry record last updated 2025-08-01; status last verified 2025-07.
• Results first posted 2025-08-01.
• 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.

19. Record Summary

NCT06006455 is a terminated, single-group device study of the Erchonia LunulaLaser for toenail onychomycosis. The registry lists enrollment of 28, allocation as NA, masking as NONE, and phase as NA. The start date is 2020-06-15, and the primary completion date is 2024-07-16.

The primary endpoint is complete cure at 12 months, defined by both clinical and mycological criteria. Mycologic Cure is listed as a secondary outcome. The record lists 2 outcome measures and 0 analyses, and reports no primary-outcome count or percentage. The reason for termination, analysis population, missing-data handling, and analysis plan are not reported in the registry record. Safety entries list 0 serious adverse events, 0 other adverse events, and 0 deaths among the reported group figures.