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 PinPointe FootLaser for the Treatment of Onychomycosis (NCT00935649), a randomized phase 2, phase 3 study. The primary outcome is Nail Bed Clearing.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT00935649 |
| Phase | Phase 2, Phase 3 |
| Condition | Infected Toenails, Onychomycosis |
| Allocation | Randomized |
| Design model | Single Group |
| Masking | Single |
| Enrollment | 134 |
| Arms in the primary outcome | n/a |
| Lead sponsor | PathoLase, Inc. |
| Results posted | Yes |
2. Clinical Question
Population
The trial concerned people with infected toenails, described as onychomycosis. The randomized comparison was limited to participants whose both great toes were infected. The registry record reports enrollment of 134, but does not explain how that enrollment relates to the 139 treated great toes listed in the adverse-event record.
Intervention
The intervention was PinPointe FootLaser, identified as a device. The registry summary describes the purpose as evaluating the safety and efficacy of FootLaser treatment of infected toenails.
Comparator
For participants with both great toes infected, the right or left great toe was randomized to treatment and the other toe was left untreated. This creates a within-participant comparison of treated and untreated toes, although the registry model is also labeled single group.
Primary question
The primary outcome was nail bed clearing, described as change in the amount of clear nail over time, with a timeframe of 48 weeks. The registry record does not report a numerical treatment comparison or an inferential analysis for this outcome. It describes a design problem: investigators collected nail samples for mycologic analysis at each visit, which removed the clear nail used as the primary outcome. Consequently, the posted record does not establish the size or precision of a treatment-associated difference in nail bed clearing.
3. Trial Design
This was a completed multicenter trial of PinPointe FootLaser for infected toenails. The registry classifies it as phase 2 and phase 3, randomized, single-masked, and single-group. Enrollment is reported as 134. The record gives a start of 2009-06 and primary completion of 2010-11.
The arm description specifies a randomized great-toe comparison among participants with both great toes infected: one side, right or left, was assigned to treatment and the other to no treatment. This is a paired structure because both comparison toes belong to the same participant. Such a design can account for some shared participant characteristics when the analysis properly compares outcomes within each participant. The registry's single-group model label does not describe that paired allocation in the same way, and the record does not clarify the reason for the label.
Although the design is described as randomized, the record does not state the randomization method, allocation concealment procedures, or who was masked. “Single” masking is reported, but the identity of the masked party is not reported in the registry record. The record names one device intervention and an untreated-toe comparator; it does not describe a separate parallel group of participants receiving a different treatment.
The primary outcome was nail bed clearing at 48 weeks. Mycology is listed as a secondary outcome. The record reports two outcome measures but no analyses. It also contains a warning that the repeated nail sampling for mycologic analysis interfered with measurement of clear nail growth. No protocol details beyond the record's descriptions, including further visit schedules or the allocation procedure, are 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
| Stage | Randomized Great Toe |
|---|---|
| STARTED | 139 |
| COMPLETED | 134 |
| NOT COMPLETED | 5 |
Analysis population for the primary outcome, as defined in the registry: There was a fatal design flaw to the trial. We were advised to collect nail samples for mycologic analysis at every visit. As a result investigators were removing our primary outcome variable, increase in clear nail, at each visit. Consequently our estimates of nail growth following treatment are inaccurate and invalid.
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 | Randomized Great Toe |
|---|---|---|
| Participants analysed | 139 | |
| Age Continuous | years | 52.1 (SD 13.7) |
| Sex: Female, Male: Female | Participants | 38 |
| Sex: Female, Male: Male | Participants | 101 |
6. Primary Endpoint
The registry lists the primary outcome as Nail Bed Clearing, measured over 48 weeks.
| Element | Registry entry |
|---|---|
| Result type | N/A |
| Measure of spread | not applicable |
| Unit | not stated |
| Endpoint classification | not reduced to a single comparison |
Nail bed clearing was the primary endpoint. It was described as change in the amount of clear nail over time, with assessment at 48 weeks. The intended measure focuses on visible nail clearing as the nail grows, rather than solely on whether a nail sample shows mycologic findings. In general, a clearly specified endpoint helps connect the clinical question to an observable outcome and provides a basis for comparing assigned treatments.
The registry record also explains why this measurement was compromised. Investigators were advised to collect nail samples for mycologic analysis at every visit. The record says that sampling removed the primary outcome variable, the increase in clear nail, and that estimates of nail growth following treatment were affected. The account ends before completing its explanation, so the full description of the consequences is not reported in the registry record.
No numerical endpoint values, treatment contrast, variability estimate, confidence interval, or analysis result for nail bed clearing is reported. Therefore, the endpoint's intended clinical meaning can be described, but the magnitude and precision of any observed difference cannot be assessed from the registry record. Mycology is named as a secondary outcome, but its numerical results and analysis are not reported in the registry record.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry record identifies a randomized treatment-versus-untreated-toe comparison, but does not post a numerical result for the primary outcome. It gives no estimate of nail bed clearing by group or toe, no treatment contrast, and no confidence interval or p-value. The record therefore does not permit a statistical assessment of the size, direction, or precision of a primary-outcome difference.
A notable feature is the pairing: both great toes were infected, and right or left was randomized to treatment while the other toe remained untreated. In general, paired designs compare the two observations within each participant and can reduce the influence of characteristics shared by that participant. The gain depends on collecting and analyzing valid paired outcomes. The registry record does not report how many complete pairs were available, how missing observations were handled, or whether the posted analysis used the paired allocation.
The registry's account of the endpoint measurement raises a specific interpretive concern. It states that nail samples were collected for mycologic analysis at each visit and that this removed the clear nail used to measure the primary outcome. This is more than an ordinary uncertainty about sampling variability: the measurement process itself could alter the outcome being measured. The record does not provide enough completed information to determine the extent of that effect or how it was addressed.
The registry reports two outcome measures and lists mycology as secondary, but reports zero analyses. The primary outcome is not reduced to a single comparison in the posted record. No numerical mycology findings are included either. Thus, the available registry information describes the trial question and a measurement problem, rather than an interpretable estimate of efficacy.
The adverse-event record lists zero serious events among 139 treated great toes at risk and 15 other events among those treated great toes. For untreated great toes it lists zero at risk and zero events. The untreated category's zero at-risk count means it does not provide a usable observed comparator for safety. These entries should not be interpreted as evidence that no adverse events could occur, and they do not resolve the absent primary-outcome analysis.
In general, a confidence interval communicates the range of effect values compatible with an estimate under the analysis assumptions; a narrow interval indicates greater statistical precision than a wide interval. No such interval is reported for the primary outcome. No claim about a treatment effect, its statistical significance, or its precision can be made from the numerical efficacy results because those results are not reported in the registry record.
9. Statistical Methods Explained
The available statistical information is limited. The registry identifies randomization and a paired-toe structure in the arm description, but it does not report a statistical analysis plan or outcome analyses. The following concepts explain how such a design is generally interpreted; they do not describe analyses established by the registry record.
How does the paired comparison work?
In a paired design, each participant contributes observations under both conditions: in this case, a treated great toe and an untreated great toe. An analysis can calculate the within-participant contrast and then assess the distribution of those contrasts across participants. In general, this approach controls for participant characteristics shared by both toes, such as characteristics that affect both observations similarly. It does not automatically control for differences between the participant's toes, measurement problems, or effects that carry from one toe to the other.
The record says the right or left toe was randomized to treatment, but does not describe the randomization procedure or the analysis used. It does not report the number of complete paired outcomes or whether any participant contributed only one measurable toe. Without these details, the extent to which the results could be analyzed as paired data is not reported in the registry record.
What does the endpoint's measurement problem imply?
In general, an outcome should be measured in a way that does not materially alter the quantity being observed. Here, the registry specifically states that collecting nail samples at each visit removed the clear nail used for the primary measure. This raises a measurement-integrity concern: the act of collecting data for the secondary mycology outcome could interfere with the primary nail-clearing measure. The record does not fully describe the resulting estimates, how the problem was addressed, or whether an alternative outcome analysis was performed.
Randomization helps balance factors affecting assignment, but it cannot by itself correct an outcome measure that is altered during observation. Nor does the record establish whether measurement procedures were the same for both toes. Those details, as well as the identity of the party masked under the single-masked designation, are not reported in the registry record.
What can be concluded from the reported analysis information?
The record reports zero analyses and does not give a numerical primary-outcome estimate. It therefore provides no test statistic, p-value, standard error, or confidence interval for nail bed clearing. In general, a p-value addresses how compatible data are with a specified statistical model under a null hypothesis; it is not a measure of effect size or clinical importance. A confidence interval gives information about estimate precision. Neither can be interpreted when the estimate and analysis are absent.
The registry lists mycology as a secondary outcome, but does not provide its results or an analysis. No adjustment for multiple outcomes or comparisons is described. An analysis plan, including how the paired structure would be incorporated, is not reported in the registry record.
How should planning illustrations be understood?
In general, a sample-size calculation is a prospective planning exercise based on assumptions about the effect to detect, variability, significance level, allocation, and analysis. A sample-size illustration based on an observed effect is not evidence of the trial's actual power and is not the same as an observed treatment result. The planning assumptions described for the illustrations use a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation; the effect to detect is expressed as a fraction of the observed effect. They are described as planning illustrations, not as the trial's own design justification. The registry record does not report the trial's sample-size justification or observed primary-outcome effect needed to evaluate such planning assumptions.
In general, over-dispersion occurs when outcome variability exceeds what a chosen statistical model expects. If present, ignoring it can make uncertainty appear smaller than it is. The registry record does not identify an over-dispersion analysis or provide the outcome data needed to assess whether it is relevant. No particular statistical model or adjustment should be attributed to this trial beyond what the registry record states.
10. Multiplicity, Missing Data and Analysis Populations
The record lists two outcome measures, identifies nail bed clearing as primary, and lists mycology as secondary. It reports zero analyses and does not provide a statistical analysis plan. The number of outcome measures alone does not show how many hypotheses were tested, because the registry does not report the actual comparisons or tests.
In general, testing multiple outcomes or multiple comparisons can increase the chance of finding a nominally unusual result by chance. Analysts may address this through a prespecified testing hierarchy or adjustment, but no such approach is reported in the registry record. Interim analyses, stopping rules, and multiplicity procedures are not reported in the registry record.
Missing-data methods and analysis populations are also not described. The record does not report the number of participants with complete nail-clearing measurements, the number with missing visits, exclusions from analysis, or whether all randomized toes were analyzed as assigned. The endpoint narrative says repeated sampling removed clear nail, but does not give a completed account of its impact on the dataset or the analysis.
In general, missing observations can affect precision and may also bias a comparison if the reasons for missingness are related to outcomes or treatment. A paired comparison can be especially difficult to interpret if one toe's measurement is absent, because the within-participant contrast may no longer be available. The registry record does not describe any imputation, complete-case approach, sensitivity analysis, or other handling of missing outcomes. Consequently, neither the impact of missing data nor the multiplicity of any analyses can be evaluated from the posted information.
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 |
|---|---|---|---|
| Treated Great Toe | 0 | 139 | 0.0% |
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 |
|---|---|
| Treated Great Toe | 15 of 139 |
| Untreated Great Toe | 0 of 0 |
Most frequent non-serious adverse event terms
| Event term | Organ system | Treated Great Toe | Untreated Great Toe |
|---|---|---|---|
| intraoperative foot pain | Surgical and medical procedures | 15 of 139 | 0 of 0 |
The registry lists the treated great-toe group as having 139 at risk, zero serious adverse events, and 15 other adverse events. For the untreated great-toe group it lists zero at risk, zero serious adverse events, and zero other adverse events. These are the counts recorded in the safety entries; the record does not clarify the relationship between the 139 treated great toes at risk and the overall enrollment of 134.
The untreated group has no reported great toes at risk. Its zero event counts therefore do not represent an observed safety experience among an at-risk comparison group. They cannot be used to compare the frequency of events between treated and untreated toes.
In general, a zero count in an observed group means that no event was recorded in that group during the reported observation, not that the event is impossible. The registry does not provide event descriptions for the 15 other events, their timing, seriousness criteria, or participant-level detail. It also does not report deaths in these entries. The serious-event figures should be read as registry counts, not as a complete account of all safety outcomes or proof of safety.
12. What the Result Does, and Does Not, Mean
The trial record documents a randomized toe-level comparison of PinPointe FootLaser with an untreated great toe in participants whose both great toes were infected. It identifies nail bed clearing at 48 weeks as the primary outcome and mycology as a secondary outcome. It also records a measurement problem arising from repeated nail sampling.
What the record does not provide is a numerical primary-outcome result. There is no reported estimate of change in clear nail, no between-toe contrast, and no uncertainty interval or inferential result. The secondary mycology outcome is named but its results are also not reported. The record's zero analyses entry reinforces that there is no posted statistical analysis to interpret.
In general, a randomized allocation supports a comparison by reducing systematic differences in assignment, while a paired structure can use within-participant contrasts. Those design features do not substitute for valid outcome measurement or a reported analysis. The registry's description of sampling that removed the primary outcome makes the absence of a completed endpoint result particularly important. The available record does not show how the problem affected the observed data or whether it was addressed.
The adverse-event counts are limited: the treated category reports 139 at risk, zero serious events, and 15 other events, while the untreated category reports zero at risk. These counts do not provide a meaningful observed safety contrast, and the record does not describe the other events in detail.
Accordingly, the registry information establishes the trial's question, broad design, endpoint, and a stated outcome-measurement concern. It does not establish the magnitude or precision of a treatment effect, and it cannot support a conclusion about whether the treatment changed nail bed clearing. The absence of a posted efficacy analysis is not itself evidence of no effect; it means the effect is not reported in the registry record.
13. Why This Trial Matters Statistically
This trial is statistically notable because its randomized design and its measurement process are closely connected. Participants with both great toes infected had one toe randomized to treatment and the other left untreated. In general, this paired allocation can make a within-participant comparison informative, provided the outcomes remain measurable and the analysis respects the pairing.
The registry's endpoint narrative identifies a direct conflict between collecting samples for mycology and measuring clear nail. It says sampling at every visit removed the primary outcome variable. This illustrates a general trial-design principle: repeated measurement procedures should be assessed for whether they change the outcome they are intended to measure. Randomization cannot repair interference caused by the measurement procedure itself.
The record also illustrates the distinction between a declared endpoint and an interpretable result. Nail bed clearing is named as primary, but no numerical result or analysis is posted. Without an estimate and measure of uncertainty, readers cannot determine the size or precision of a treatment comparison. A design label such as randomized does not supply that missing evidence.
Finally, the record's labels do not fully align: the trial is marked randomized, while its model is labeled single group, and its arm description specifies treated and untreated toes within a participant. Such labels need to be read alongside the actual arm description rather than treated as a complete account of the design. The reported safety counts likewise require attention to denominators: the untreated-toe group has zero at risk, so its zero event count cannot serve as a direct safety comparison.
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 most important trial-specific limitation recorded is the interference between mycologic sampling and the nail-clearing endpoint. The registry says investigators were advised to collect samples at every visit and that doing so removed the increase in clear nail used as the primary outcome. Its explanation ends before completing the account of how estimates were affected. The extent of this problem and any corrective approach are not reported in the registry record.
The primary endpoint is described as change in the amount of clear nail over time, with a 48-week timeframe, but no numerical results are posted. The record also does not report a completed analysis or mycology results. Thus, the direction, magnitude, and precision of the primary comparison cannot be assessed.
The paired-toe allocation is not matched by a reported statistical analysis description. The registry's single-group model label sits alongside an arm description that assigns treatment to one great toe and no treatment to the other. The record does not explain this classification or report how the within-participant design was incorporated in analysis.
Safety denominators also warrant caution. The treated great-toe group is listed with 139 at risk, while enrollment is 134; the record does not reconcile those counts. The untreated great-toe group is listed with zero at risk, preventing a meaningful event-rate comparison. Descriptions of the 15 other adverse events are not reported in the registry record.
Further details such as who was masked, missing-outcome handling, analysis populations, and a statistical analysis plan are not reported in the registry record. These gaps limit assessment of both the outcome-measurement problem and the statistical handling of the trial.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: PinPointe FootLaser for the Treatment of Onychomycosis — NCT00935649.
- Registry record last updated 2013-04-09; status last verified 2010-11.
- Results first posted 2013-04-09.
- 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 describes a completed multicenter, randomized, single-masked trial listed as phase 2 and phase 3, with enrollment of 134. The intervention was PinPointe FootLaser. Participants with both great toes infected had right or left randomized to treatment, with the other toe untreated, while the registry model is labeled single group.
The primary outcome was nail bed clearing, described as change in clear nail over time at 48 weeks. Mycology was listed as a secondary outcome. The record reports two outcome measures and zero analyses. It also describes a problem in which repeated nail sampling removed the clear nail used for the primary outcome measurement.
No numerical primary-outcome analysis or mycology result is reported. Safety entries list zero serious events and 15 other events among 139 treated great toes at risk; the untreated category lists zero at risk and zero events. The record does not reconcile the at-risk count with enrollment or provide an interpretable safety comparison.