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 Evaluation Study for the Efficacy and Safety of PinPointe FootLaser in Treatment for Onychomycosis (NCT01920178), a randomized na study. The primary outcome is Measure Improvement in Target Toenails During the Study Period by Deeming a Clinical Success if Patient Experiences at Least a 50% Reduction in the Area of Involved Nail, Judged by the Clinician, and Judged by an Independent Evaluator..
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT01920178 |
| Phase | NA |
| Condition | Onychomycosis of Toenails |
| Allocation | Randomized |
| Design model | Parallel |
| Masking | Single |
| Enrollment | 7 |
| Arms in the primary outcome | n/a |
| Lead sponsor | Cambridge Health Alliance |
| Results posted | Yes |
2. Clinical Question
Population
Patients with onychomycosis of the toenails who had previously received oral terbinafine and failed treatment. The primary outcome description focuses on target toenails, identified as hallux nails. The registry record does not report further eligibility details or participant characteristics.
Intervention
Active treatment with the PinPointe Foot Laser device. The record describes the intervention as a device and calls the active arm PinPointe Foot Laser.
Comparator
A sham laser group received only the localizing, or aiming, beam of the PinPointe Foot Laser. This was intended as the placebo comparison; the record does not report additional details about how the sham procedure was delivered.
Primary question
Whether target toenails met the registry’s definition of clinical success during the 12 months: at least a 50% reduction in the area of involved nail, judged by a clinician and an independent evaluator. The registry record does not report a numerical comparison between the treatment groups.
The study was described as a prospective, randomized, placebo-controlled evaluation of efficacy and safety among patients whose onychomycosis had not responded to oral terbinafine. Its clinical question therefore concerns a specific group and a particular device, rather than all people with toenail onychomycosis or all possible treatments.
The primary endpoint is a threshold-based definition of improvement in the target nail. It asks whether the reduction in involved nail area reaches the stated threshold, with assessment by both a clinician and an independent evaluator. This is different from asking how much nail involvement changed on average, or whether a nail sample tested positive by PCR. The registry lists patient-judged clinical improvement and PCR analysis of nail samples among the secondary outcomes.
Although the design identifies a sham comparison, the posted record does not give outcome values for either group or an estimated treatment effect. The clinical question can be described from the protocol information, but the record does not establish how the groups compared on the primary endpoint.
3. Trial Design
The registry describes a randomized, single-masked, parallel-group study with a placebo control. Participants were assigned to active PinPointe Foot Laser or a sham laser procedure that used only the device’s localizing, or aiming, beam. The record does not identify who was masked, so the masking label should not be interpreted as evidence that participants, clinicians, evaluators, or other study personnel were masked in any particular way.
The study concerned patients with onychomycosis of the toenails who had previously received oral terbinafine and failed treatment. The registry gives an enrollment of 7. It lists Cambridge Health Alliance as sponsor, a start date of 2013-04, primary completion of 2015-05, and a status of terminated. These dates describe the registry record; they do not establish why the study ended or whether all planned follow-up was completed.
The planned primary assessment was at 12 months. The endpoint focused on target toenails, identified as hallux nails, and defined clinical success through a threshold in reduction of involved nail area. The study also listed patient-judged clinical improvement and PCR analysis of nail samples as secondary outcomes.
The record does not report a sample-size justification, the intended allocation ratio, the number randomized to each arm, or the analysis population. The adverse-event summary lists participants at risk in each group, but those figures should not be treated as a complete account of randomization or endpoint follow-up. The registry also lists 0 analyses. Consequently, the design description supplies important context for the clinical question, but the posted record does not provide a treatment-effect analysis.
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 | PinPointe Foot Laser | Sham Laser Group |
|---|---|---|
| STARTED | 5 | 2 |
| COMPLETED | 3 | 1 |
| NOT COMPLETED | 2 | 1 |
Reasons for not completing this period:
| Reason | PinPointe Foot Laser | Sham Laser Group |
|---|---|---|
| Lost to Follow-up | 2 | 1 |
Analysis population for the primary outcome, as defined in the registry: Original grooved markings scored into the Target nails (hallux nails) on initial laser treatment visit to indicate most proximal aspect of fungal infection was intended to track the growth of the nail and to evaluate for improvement. Grooved markings did not survive after initial visit making it impossible to obtain valid primary endpoint data.
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 | PinPointe Foot Laser | Sham Laser Group | Total |
|---|---|---|---|---|
| Participants analysed | 5 | 2 | 7 | |
| Age, Categorical: <=18 years | Participants | 0 | 0 | 0 |
| Age, Categorical: Between 18 and 65 years | Participants | 5 | 2 | 7 |
| Age, Categorical: >=65 years | Participants | 0 | 0 | 0 |
| Age, Continuous | years | 43.2 (SD 13.2) | 47.0 (SD 2.8) | 44.3 (SD 11.0) |
| Sex: Female, Male: Female | Participants | 3 | 1 | 4 |
| Sex: Female, Male: Male | Participants | 2 | 1 | 3 |
| Region of Enrollment: United States | participants | 5 | 2 | 7 |
6. Primary Endpoint
The registry lists the primary outcome as Measure Improvement in Target Toenails During the Study Period by Deeming a Clinical Success if Patient Experiences at Least a 50% Reduction in the Area of Involved Nail, Judged by the Clinician, and Judged by an Independent Evaluator., measured over 12 months.
| Element | Registry entry |
|---|---|
| Result type | N/A |
| Measure of spread | not applicable |
| Unit | not stated |
| Endpoint classification | not reduced to a single comparison |
The primary endpoint was intended to assess improvement in target toenails over 12 months. Clinical success was defined as at least a 50% reduction in the area of involved nail, judged by the clinician and an independent evaluator. The target nails were described as hallux nails. The record says that grooved markings were placed in the nails at the initial laser treatment visit to indicate the most proximal aspect of fungal infection and to help track nail growth and evaluate improvement. It also notes that the markings did not survive after the initial visit.
A threshold endpoint turns a measured change into a success-or-not classification. This can make a clinical definition easier to interpret, but it does not show the full range of changes within either category. A nail just meeting the threshold and a nail with a much larger reduction would both satisfy the stated success criterion. Conversely, a change that falls short of the threshold would not count as success under that definition.
Assessment by a clinician and an independent evaluator can bring more than one perspective to an outcome that involves judgment. The registry does not report how disagreements between evaluators would be handled, or whether both assessments had to meet the threshold. It also does not post primary endpoint results, so the frequency of clinical success and any comparison between arms are not reported in the registry record.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry record describes a randomized comparison, but it does not provide a reported estimate of the primary outcome or an analysis comparing the active laser and sham groups. It lists 0 analyses. The endpoint definition and study design therefore establish what the trial set out to assess, not what the posted results show about the relative outcomes.
The enrollment is listed as 7. This is a small enrolled group in practical terms, and any comparison based on a group of this size would generally be imprecise. General statistical explanation: estimates from small groups tend to be sensitive to the outcome of each participant, and confidence intervals, when reported, communicate the range of effects compatible with the data under the analysis assumptions. No primary-outcome estimate or confidence interval is reported in the registry record, so precision cannot be quantified from the posted information.
The adverse-event summary lists 5 participants at risk in the PinPointe Foot Laser group and 2 in the sham laser group. It reports 0 serious adverse events and 0 other adverse events in those groups. These are descriptive figures in the registry. They do not establish that no events occurred outside the recorded categories, that all participants completed follow-up, or that the groups had equivalent safety. Death counts are not reported in the registry record.
The endpoint description identifies a potential measurement issue: the grooves intended to mark the proximal extent of fungal involvement did not survive after the initial visit. The record does not state what measurement approach was used after this problem, whether the endpoint was modified, or how the issue affected outcome assessment. Without those details and endpoint results, the reliability and completeness of the planned measurement cannot be evaluated from the registry information.
The study status is terminated, but the record does not report the reason for termination. It would be inappropriate to infer that the study stopped because of efficacy, safety, recruitment, or operational concerns. Nor does the record state whether participants completed the planned 12-month assessment.
Overall, the posted information supports a description of the intended clinical question, trial structure, and recorded adverse-event counts. It does not support a quantitative conclusion about the primary endpoint, the size or direction of any treatment effect, or the uncertainty around an effect. The absence of a reported analysis is not itself evidence that the intervention did or did not change clinical outcomes.
9. Statistical Methods Explained
Interpreting a randomized trial requires separating its design, endpoint definition, observed data, and statistical analysis. The registry describes random allocation and a parallel comparison between active laser treatment and sham laser treatment. Randomization is generally used to make groups comparable on average with respect to measured and unmeasured characteristics. It does not guarantee that small groups will be balanced, and it cannot replace reporting how many participants were assigned, followed, and included in the analysis. Those details are not reported in the registry record.
What does the endpoint measure?
The primary endpoint was a binary clinical-success definition based on a threshold: at least a 50% reduction in the area of involved nail, judged by a clinician and an independent evaluator. General statistical explanation: a binary endpoint can be summarized as the proportion meeting the definition in each group, followed by a comparison of those proportions or an effect measure derived from them. The registry does not report the group-level success counts, proportions, effect estimate, or uncertainty interval. No such comparison can be reconstructed from the information available in the registry record.
A threshold is useful when a study needs a defined criterion for meaningful improvement, but it discards information about the amount of change on either side of the cut-off. The endpoint description also depends on how involved nail area was measured over time. The record says that grooved markings intended to track the nail and fungal involvement did not survive after the initial visit. It does not report a replacement measurement procedure or a statistical response to this issue.
Why do masking and allocation matter?
In general, masking can reduce the risk that knowledge of treatment assignment influences care, assessment, or reporting. The record labels the study single-masked but does not identify who was masked. This limits interpretation of how masking might have protected the clinician-judged endpoint from assessment bias. The presence of an independent evaluator is part of the endpoint description, but the record does not explain the evaluator’s masking or the process for resolving different judgments.
Random allocation is a design feature, not a statistical result. To interpret its implementation, readers would need information on assignment, group sizes, departures from assigned treatment, and participant flow. These details are not reported in the registry record. The adverse-event group listings identify participants at risk for safety summaries, but those figures do not establish the analysis population for the primary endpoint.
What can be inferred from the posted analysis information?
The registry lists 0 analyses and does not report a primary-outcome comparison. There is consequently no reported test statistic, p-value, effect estimate, or confidence interval to interpret. General statistical explanation: a p-value, when available, describes how compatible the observed data are with a specified statistical model and null hypothesis; it does not measure the size or clinical importance of an effect. A confidence interval communicates uncertainty around an estimate, conditional on the chosen method and assumptions. Neither can be assessed without a reported analysis.
General statistical explanation: estimates from sparse data may be especially uncertain, and standard methods can behave poorly when outcome counts are very low. The record does not supply primary outcome counts, so it is not possible to evaluate which comparison method would be suitable or whether an adjustment for sparse data would be needed. No statistical method should be attributed to the study unless it is reported.
The sample-size assumptions describe planning illustrations based on an observed effect, with a two-sided significance level of 0.05, equal allocation, and a normal approximation. Those are assumptions for planning illustrations, not evidence about the study’s original design. The registry does not report its own sample-size justification, and it does not provide a primary endpoint effect from which to interpret such planning scenarios. A planning illustration is not observed power and does not show the probability that this completed study detected an effect.
How should the safety counts be read?
General statistical explanation: adverse-event counts are most interpretable when the population at risk, observation period, event definitions, and ascertainment procedures are clear. The registry lists serious and other adverse-event figures by arm, but does not report detailed event definitions or the duration and completeness of safety follow-up. The counts are descriptive; they do not estimate comparative risk precisely or establish equivalence between groups.
In short, statistical interpretation is constrained by the absence of reported outcome data and analysis. The design and endpoint can be explained, but a treatment effect, its direction, and its precision cannot be inferred from the record.
10. Multiplicity, Missing Data and Analysis Populations
The registry lists 3 outcome measures and identifies a primary outcome focused on clinical success in target toenails. It also describes secondary outcomes concerning clinical improvement as judged by the patient and the presence of onychomycosis by PCR analysis of nail samples. Multiple outcomes can raise a multiplicity issue because testing several questions may increase the chance of a nominally notable result by chance. General statistical explanation: prespecifying a primary outcome and an approach to multiple testing can help readers distinguish the main confirmatory question from supporting analyses. The registry record does not report a multiplicity adjustment or a plan for prioritizing secondary outcomes.
The posted record lists 0 analyses and does not provide outcome values for the primary or secondary measures. It therefore does not reveal whether all planned outcomes were measured, whether any analyses were conducted outside the registry record, or how missing outcome data were handled. A missing-data method, such as an approach to incomplete follow-up or a sensitivity analysis, is not reported in the registry record.
The registry gives a 12-month timeframe for the primary endpoint, but it does not report completion of that assessment by group or the analysis population. The enrollment figure and safety listings do not establish how many participants had evaluable primary outcome data. The record also does not report whether the primary analysis was intended to include all randomized participants or a different population.
These gaps matter because missing outcomes and selective reporting can affect the interpretation of group comparisons. Without participant flow, outcome completeness, analysis-population definitions, and a statistical plan, readers cannot assess whether the posted outcomes represent the intended full analysis or how incomplete follow-up may have influenced results.
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 |
|---|---|---|---|
| PinPointe Foot Laser | 0 | 5 | 0.0% |
| Sham Laser Group | 0 | 2 | 0.0% |
Other (non-serious) adverse events
Participants with at least one non-serious event at or above the registry's 0% reporting threshold.
| Arm | Participants affected of at risk |
|---|---|
| PinPointe Foot Laser | 0 of 5 |
| Sham Laser Group | 0 of 2 |
The registry’s safety summary lists the PinPointe Foot Laser group with 5 participants at risk and 0 serious adverse events and 0 other adverse events. The sham laser group is listed with 2 participants at risk and 0 serious adverse events and 0 other adverse events. The death counts are not reported in the registry record.
These are event counts as recorded in the registry, not a demonstration that treatment groups have the same safety profile. With few participants listed at risk, zero recorded events should be read as a limited observation rather than evidence that an event cannot occur. General statistical explanation: when no events are observed, the data may still be compatible with a range of underlying event risks, particularly when the amount of observation is limited.
The record does not give detailed event terms, definitions, observation duration, or information on completeness of safety follow-up. It also does not explain whether the at-risk figures correspond to all randomized participants or a safety population defined after assignment. The reported counts therefore support only a narrow statement about what the registry lists; they do not establish absence of all harms or permit a precise comparison between groups.
12. What the Result Does, and Does Not, Mean
The registry record documents a randomized, parallel, single-masked study of active PinPointe Foot Laser compared with a sham laser procedure among patients with onychomycosis who had failed oral terbinafine treatment. It defines clinical success using a reduction in involved nail area assessed over 12 months. It also records an enrollment of 7 and a terminated status.
What the posted information does not provide is a numerical primary outcome result. There is no reported success count by group, comparative effect estimate, confidence interval, or p-value. The registry lists 0 analyses. As a result, the direction and magnitude of any difference between active laser and sham treatment are not reported in the registry record. No conclusion about efficacy can be drawn from the design description or the absence of an analysis.
The safety summary reports 0 serious and 0 other adverse events in both listed groups, with 5 participants at risk in the active group and 2 in the sham group. Those figures describe the registry’s recorded counts. They do not show that the treatments are equally safe, rule out unrecorded events, or provide a precise estimate of comparative safety. Death counts are not reported in the registry record.
The termination status is also not an explanation of what happened. The reason for termination, the extent of follow-up, and whether planned outcome assessments were completed are not reported. The note that the grooved markings did not survive raises a measurement question, but the record does not explain how the endpoint was assessed after that problem.
The appropriate interpretation is therefore limited: the registry describes the intended comparison and records sparse safety counts, but it does not report the primary result needed to judge how the groups compared. A missing reported result should not be treated as a negative result, a positive result, or evidence of no effect.
13. Why This Trial Matters Statistically
This trial is statistically notable because its registry record illustrates the difference between a clearly stated clinical question and an interpretable treatment-effect result. The design identifies active laser treatment, a sham comparison, a target population, and a threshold-based primary endpoint. Yet without outcome counts or a reported analysis, readers cannot estimate the contrast that the randomized design was intended to address.
The enrollment of 7 also puts the emphasis on uncertainty and transparent reporting. In general, small studies can produce unstable estimates, and a single participant’s outcome can have substantial influence on a group summary. This makes group counts, effect estimates, and confidence intervals particularly important. Those primary-outcome details are not reported in the registry record.
The endpoint’s measurement history matters as well. Grooved markings were intended to identify the extent of fungal involvement and track nail growth, but the record says they did not survive after the initial visit. This raises a question about how change was measured consistently over time. The registry does not explain what measurement procedure replaced the markings, if any.
Finally, a terminated status and a lack of posted analyses should prompt caution without encouraging speculation. The record does not explain why the study terminated or whether planned assessments were completed. The trial’s statistical value to readers is therefore partly methodological: it shows why outcome reporting, participant flow, missing-data methods, and analysis details are essential for interpreting randomized studies. Its registry information is insufficient to quantify the intended treatment 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 registry record does not report primary endpoint results, group-level success counts, an effect estimate, a confidence interval, or a statistical test. Although the primary endpoint is described, its comparative result cannot be evaluated. The record lists 0 analyses.
The study is listed as terminated, but the reason is not reported. The record does not state whether participants completed the 12-month assessment, how many had evaluable primary outcomes, or whether the planned follow-up was completed. It also does not define the primary analysis population or explain how missing outcome data were handled.
The primary endpoint relied on assessment of involved nail area. The record describes grooved markings intended to support tracking but notes that the markings did not survive after the initial visit. It does not explain how the measurement problem was addressed, how clinician and independent evaluator judgments were combined, or how disagreements were resolved.
Although the design is labeled single-masked, the record does not identify who was masked or describe procedures for maintaining masking. It also does not provide further information about the randomization process, participant flow, adherence, or departures from assigned treatment. These omissions limit assessment of how the planned comparison was implemented.
The safety summary contains few participants at risk and does not report detailed event terms, event definitions, or the duration and completeness of safety observation. Death counts are not reported in the registry record. The record also does not report the study’s own sample-size justification or a plan for handling multiple outcomes. Together, these limitations mean that the available information supports a description of the study but not an estimate of its clinical effect or a comprehensive appraisal of its safety findings.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Evaluation Study for the Efficacy and Safety of PinPointe FootLaser in Treatment for Onychomycosis — NCT01920178.
- Registry record last updated 2017-05-30; status last verified 2016-07.
- Results first posted 2017-05-30.
- 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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18. Record Summary
The registry describes a randomized, single-masked, parallel, placebo-controlled study of PinPointe Foot Laser for onychomycosis of the toenails in patients who had failed oral terbinafine treatment. The comparator was a sham procedure using only the localizing beam. The primary endpoint was clinical success in target toenails, defined as at least a 50% reduction in involved nail area at 12 months, judged by a clinician and an independent evaluator.
The record lists an enrollment of 7, a start date of 2013-04, primary completion of 2015-05, and terminated status. It lists 3 outcome measures and 0 analyses. Primary endpoint results and the reason for termination are not reported in the registry record.
The safety summary lists 5 participants at risk in the active group and 2 in the sham group, with 0 serious and 0 other adverse events in each. Death counts are not reported in the registry record. These data do not provide a reported efficacy comparison or a precise comparative safety estimate.