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 BTX-A Treatment for Palmar Hyperhidrosis (NCT01262339), a na phase 2, phase 3 study. The primary outcome is Evaluate the Efficacy of Botulinum Toxin A (BTX-A) in the Treatment of Primary Palmar Hyperhidrosis Delivered Via Iontophoresis..
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT01262339 |
| Phase | Phase 2, Phase 3 |
| Condition | Primary Focal Hyperhidrosis of the Hands |
| Allocation | Not applicable (single group) |
| Design model | Single Group |
| Masking | Single |
| Enrollment | 2 |
| Arms in the primary outcome | n/a |
| Lead sponsor | University of Wisconsin, Madison |
| Results posted | Yes |
2. Clinical Question
Population
People with primary focal hyperhidrosis of the hands. The registry record lists enrollment as 2 and says the study closed prematurely because the principal investigator left the University of Wisconsin.
Intervention
Botulinum toxin A (BTX-A) delivered via iontophoresis to Hand B. The arm description specifies 100U.
Comparator
BTX-A injected intradermally into Hand A. The arm description specifies 100U and describes this as standard of care.
Primary question
The stated objective was to evaluate the efficacy of BTX-A delivered via iontophoresis for primary palmar hyperhidrosis. The primary outcome timeframe is 26 weeks. The outcome measure itself and an efficacy result are not reported in the registry record.
The clinical question concerns the delivery method, not whether BTX-A is compared with no treatment: both hands were assigned BTX-A by different routes according to the arm description. The record’s official title describes a randomized, single-blind comparison, but the allocation field is NA and the study model is recorded as single-group. The record also explicitly notes that this was not a randomized comparison and that the arms are not a like-for-like control comparison. These details limit how confidently a direct comparative question can be framed.
As a general matter, an efficacy question needs a clearly defined outcome, an assessment time, and a comparison appropriate to the design. The record gives the assessment timeframe but not the outcome’s definition, measurement instrument, scoring rule, or clinically meaningful threshold. Because the study closed prematurely and the registry says data were insufficient for outcome analysis, the question cannot be answered from a reported between-method estimate.
3. Trial Design
The record identifies this as a Phase 2 and Phase 3 study sponsored by the University of Wisconsin, Madison. The listed start is 2010-11, the primary completion date is 2012-04, and the current status is terminated. Enrollment is listed as 2. The masking field says single, while the allocation field is NA and the model is single-group.
The official title calls the study a randomized, single-blind comparison. However, the registry’s design information does not support interpreting it as a randomized comparison: the allocation is recorded as NA, and the record’s own note says it was not a randomized comparison and that the arms are not a like-for-like control comparison. The arm description assigns intradermal injection to Hand A and iontophoresis to Hand B. It does not explain how hands were selected for those routes, or identify who was blinded. Those details are not reported in the registry record.
The treatment description specifies 100U of BTX-A for each route. The primary outcome timeframe is 26 weeks. Beyond that, the protocol details needed to understand treatment delivery and assessment—including the iontophoresis procedure, injection schedule, outcome instrument, and assessment procedures—are not reported in the registry record.
The registry says the study was closed prematurely because the principal investigator left the University of Wisconsin. It also says there was insufficient data for outcome-measure analysis, that data were not entered into tabular format, and that the study was closed and records archived. Accordingly, the planned design should be distinguished from the evidence actually available: the registry records a planned comparison and a short enrollment, but no analyzable efficacy result. The rationale for the enrollment target and any sample-size justification are not reported in the registry record.
The single-blind label alone does not establish which people involved in the study were unaware of treatment route. The identity of the blinded party and procedures for maintaining masking are not reported in the registry record. This matters because assessment of a subjective or observer-rated outcome can be influenced by knowledge of treatment, although the actual primary outcome and its assessment method are also not specified.
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 | Comparator of Hand A Intervention vs Hand B |
|---|---|
| STARTED | 2 |
| COMPLETED | 2 |
| NOT COMPLETED | 0 |
Analysis population for the primary outcome, as defined in the registry: Study was closed prematurely as principal investigator left the University of Wisconsin. Insufficient data for outcome measures analysis. Data was not entered into tabular format. Study closed and records archived.
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 | Comparator of Hand A Intervention vs Hand B |
|---|---|---|
| Participants analysed | 2 | |
| Age, Categorical: <=18 years | Participants | 2 |
| Age, Categorical: Between 18 and 65 years | Participants | 0 |
| Age, Categorical: >=65 years | Participants | 0 |
| Sex: Female, Male: Female | Participants | 2 |
| Sex: Female, Male: Male | Participants | 0 |
| Region of Enrollment: United States | participants | 2 |
6. Primary Endpoint
The registry lists the primary outcome as Evaluate the Efficacy of Botulinum Toxin A (BTX-A) in the Treatment of Primary Palmar Hyperhidrosis Delivered Via Iontophoresis., measured over 26 weeks.
| 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 objective is stated as evaluating the efficacy of BTX-A delivered via iontophoresis in primary palmar hyperhidrosis. The listed timeframe is 26 weeks. The primary outcome measure’s name, unit, definition, and method of assessment are not reported in the registry record. The record’s outcome description instead explains that the study closed prematurely, data were insufficient for outcome analysis, and the data were not entered into tabular format.
That distinction is important: a clinical objective is not itself a measurable endpoint. To interpret an endpoint, readers need to know what was measured, how it was scored, whether a larger or smaller value represents improvement, and how measurements were compared across treatment conditions. Those details are not reported in the registry record, so neither the direction nor magnitude of a possible effect can be interpreted.
In general, an endpoint provides a prespecified way to translate a clinical question into data that can be analyzed. The chosen measurement should reflect the condition and be collected consistently at the stated time. A defined endpoint also allows readers to distinguish observed change from a judgment about whether that change is important. Here, the 26-week timeframe is available, but the actual measure and any result are not. No efficacy conclusion can therefore be drawn from the stated objective alone.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The central statistical limitation is that the registry does not report an analyzed primary outcome. It lists one outcome measure, but the measure is not described in a usable form, and the record states that there was insufficient data for outcome-measure analysis. It further says the data were not entered into tabular format and the records were archived. There is consequently no reported treatment-effect estimate, uncertainty interval, or statistical test for efficacy to interpret.
The design labels also require caution. Although the official title uses the word randomized, allocation is recorded as NA, the model is single-group, and the record states that the study was not a randomized comparison. It also cautions that the arms are not a like-for-like control comparison. The two routes are described at the hand level, but the registry does not describe how the route-to-hand assignment was made. The title should therefore not be taken as evidence that random allocation occurred.
The enrollment entry is 2, but the record does not provide participant-level outcome data or analysis populations. It is not possible to determine how many observations were available at the outcome assessment, whether any measurements were missing, or how the recorded enrollment relates to the analyzed data. The rationale for the target enrollment and any sample-size justification are not reported in the registry record.
The study status is terminated. The registry attributes premature closure to the principal investigator’s departure from the University of Wisconsin, rather than reporting an efficacy-based stopping decision. Whether any interim analyses were conducted is not reported in the registry record. No conclusion about a treatment difference follows from the reason for termination, and the absence of a reported result does not show that the routes had equivalent outcomes.
In general, estimates are more informative when accompanied by a measure of uncertainty, such as a confidence interval. A confidence interval describes a range of values compatible with the data and analysis under the stated method; it is not a guarantee that the true effect lies in that range. There is no such interval reported for this primary outcome. Without an estimate and its uncertainty, readers cannot assess either the direction or precision of an efficacy comparison.
Planning calculations based on an effect size are not observed evidence. The sample-size assumptions describe an illustration based on an observed effect and specified planning assumptions, but no efficacy estimate is reported in the registry record. Any planning value should therefore be read only as a design illustration, not as observed power or as evidence of treatment benefit. The effect and uncertainty needed to evaluate clinical importance are unavailable in the registry entry.
Overall, the record documents a study objective, treatment-route descriptions, a timeframe, and early termination, but not an analyzable efficacy result. The evidence in the registry supports describing what was planned and why the study stopped; it does not support a statistical comparison of the two routes.
9. Statistical Methods Explained
The statistical information in this record is limited. It includes design labels, an enrollment entry, a primary objective and timeframe, and a statement that outcome data were insufficient for analysis. A statistical method should not be inferred from the title or from general conventions. The analysis method, estimand, adjustment strategy, and statistical plan are not reported in the registry record.
What does a treatment-effect estimate represent?
General explanation: A treatment-effect estimate summarizes the contrast in an outcome between treatment conditions, according to a defined analysis. Its meaning depends on the outcome scale, the comparison being made, and the population included. For example, a difference in a measured score answers a different question from a difference in the probability of meeting a response definition. A meaningful estimate requires an endpoint definition and a valid comparison structure.
For this study, the primary outcome measure and scoring method are not reported in the registry record. The allocation is listed as NA, and the study model is single-group; the record explicitly cautions that this is not a randomized comparison and that the arms are not a like-for-like control comparison. There is no reported estimate for which to identify a scale, direction, or interpretation.
Why does uncertainty matter?
General explanation: An estimate alone does not communicate how precisely the data support it. A confidence interval represents uncertainty around an estimate under the assumptions of the analysis. A narrow interval generally indicates greater precision than a wide interval, but precision does not establish that an effect is clinically important or that the analysis is unbiased. A p-value, when reported, measures compatibility between observed data and a specified null model; it does not measure the probability that a treatment is effective.
No confidence interval, p-value, or other inferential result for the primary outcome is reported in the registry record. The record states that the available data were insufficient for outcome analysis, so statistical significance and precision cannot be evaluated.
How should planning calculations be read?
General explanation: A sample-size calculation is a planning exercise. It asks what amount of information might be needed to detect an effect under stated assumptions, such as a significance level, allocation scheme, statistical model, and effect size. It is not a measure of what the completed study actually achieved. “Observed power” calculated after a study is complete is not a substitute for reporting an effect estimate and its uncertainty.
The planning assumptions associated with this record specify a two-sided significance level of 0.05, equal allocation between arms, and a normal approximation. They describe target effects as fractions of an observed effect. For time-to-event calculations, the convention is a total number of events using the Schoenfeld method; other calculations are expressed as participants per arm. These are planning conventions, not findings from the trial. The registry record does not report an efficacy estimate or sample-size justification, and the posted outcome data do not support treating any planning illustration as observed power.
Why can over-dispersion matter?
General explanation: Over-dispersion occurs when observed variability is greater than a model assumes. If a model underestimates variability, its uncertainty estimates can be too small and its statistical tests can appear more decisive than warranted. A suitable model may need to account for extra variability, clustering, repeated observations, or other structure, depending on the data and design.
The outcome scale and analysis model are not reported in the registry record, so it is not possible to determine whether over-dispersion is relevant to this study or how it was handled. No particular model should be attributed to the investigators.
What can the design tell us about analysis?
General explanation: The analysis must reflect how treatment was assigned and how observations are related. Measurements from the same person, or from paired body sites, may be correlated rather than independent. A paired analysis can use that relationship, whereas treating correlated observations as independent can misstate uncertainty. Randomization, when used and documented, can support causal interpretation by balancing factors on average; it does not eliminate the need to report the allocation method and analysis.
The arm description assigns one route to Hand A and another to Hand B, but does not explain the assignment procedure or provide paired outcome measurements. The registry’s warning that the trial was not a randomized comparison and its single-group model label should be retained when interpreting the design. The analysis populations, treatment of within-person dependence, and statistical model are not reported in the registry record.
10. Multiplicity, Missing Data and Analysis Populations
The registry record identifies one primary outcome measure, but does not define it or report an analysis. The number and details of secondary outcomes, if any, are not reported in the registry record. The record lists 0 analyses. A multiplicity adjustment or a plan for prioritizing outcomes is not reported in the registry record.
General explanation: Multiplicity arises when multiple outcomes, timepoints, treatment contrasts, or statistical tests are considered. Looking across many tests can increase the chance of finding an apparently unusual result even when there is no underlying effect. A statistical plan may address this by defining a primary endpoint, specifying a hierarchy, or adjusting inference. None of those procedures can be attributed to this study from the registry information.
The endpoint timeframe is 26 weeks, but other assessment times are not reported in the registry record. It is also not reported whether there were interim analyses, how any such analyses were handled, or whether the analysis plan changed. No assumptions should be made about these procedures.
Missing-data handling and analysis populations are not reported in the registry record. The record says the study closed prematurely, data were insufficient for outcome analysis, and data were not entered into tabular format. It does not explain whether measurements were missing, whether any participants withdrew, what data were collected, or whether an intention-to-treat, per-protocol, or other population was used.
General explanation: Missing-data methods depend on why values are absent and on the structure of the outcome data. Different assumptions can yield different estimates, so reporting the amount and pattern of missingness, the population analyzed, and the method used is important. In this record, the available description is not enough to characterize missingness or assess the consequences of an analysis choice.
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 |
|---|---|---|---|
| Comparator of Hand A Intervention vs Hand B | 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 |
|---|---|
| Comparator of Hand A Intervention vs Hand B | 0 of 2 |
The adverse-event record lists one group titled “Comparator of Hand A Intervention vs Hand B.” For serious adverse events, it reports 2 at risk and 0 affected. For other adverse events, it also reports 2 at risk and 0 affected. Deaths are recorded as null, rather than as a count of zero.
These entries describe what is recorded in the registry, not a complete safety analysis. The record does not give event types, observation duration for safety, severity definitions, attribution to treatment, or separate safety results by delivery route. The group is presented jointly for Hand A and Hand B, so its figures cannot identify which route, if either, was associated with an event.
General explanation: “At risk” denotes the population used as the denominator for the adverse-event entry, while “affected” denotes the number recorded as experiencing the event category. A zero affected count in a small, prematurely closed study is not evidence that the risk is absent. It also does not establish that the treatments have equivalent safety profiles. Null is different from zero: it indicates that the death value is not recorded as a count in this entry.
The registry’s limited outcome information and early termination also constrain broader interpretation of safety. The posted figures should be read as registry entries, not as proof of no adverse events or as a basis for comparing safety between routes.
12. What the Result Does, and Does Not, Mean
The record establishes that investigators planned to evaluate BTX-A delivered to the palms by iontophoresis, with intradermal injection described for the other hand. It identifies primary focal hyperhidrosis of the hands as the condition, gives a 26-week primary timeframe, and lists 100U for each delivery route. It also records a study status of terminated and gives a reason for premature closure.
It does not establish whether iontophoresis reduced sweating, whether the injection route produced a different outcome, or whether either route was better tolerated. The primary outcome measure is not described, and the registry says there was insufficient data for outcome analysis. No treatment-effect estimate, confidence interval, or test result is reported. The absence of these results is not evidence of no effect and is not evidence that the routes are equivalent.
The study’s design information also limits claims about the comparison. Although the official title describes randomization, the allocation field is NA, the model is single-group, and the record says the study was not a randomized comparison and that the arms are not a like-for-like control comparison. The details of assignment to Hand A and Hand B are not reported in the registry record. A causal treatment-route interpretation should not be inferred from the title alone.
General explanation: A result can be inconclusive because an estimate is imprecise, because data are missing, because a comparison is not valid for the question, or because no analysis was completed. These are different limitations. Here, the registry directly reports insufficient outcome data and the absence of tabular data for analysis; it does not provide a statistical result that can distinguish among possible effect sizes.
The safety entries list 0 serious adverse events and 0 other adverse events among 2 at risk in the single combined group, while deaths are null. Those entries should not be expanded into a claim of no risk or a route-specific safety comparison. In sum, the registry documents a clinical question and a terminated study, but does not provide evidence that answers the efficacy comparison.
13. Why This Trial Matters Statistically
This record matters statistically because it illustrates the difference between a planned clinical question and an answerable analysis. The title and treatment descriptions may suggest a direct comparison of delivery routes, but the allocation entry is NA, the model is single-group, and the registry itself cautions that the trial was not randomized and the arms are not a like-for-like control comparison. Design labels must be checked against the registry’s other details before drawing conclusions.
It also illustrates why an endpoint must be fully defined. The objective refers to efficacy and the timeframe is 26 weeks, but the measurement, scale, and analysis are not reported. Without knowing what outcome was measured, a numerical result would be difficult to interpret even if one were available.
General explanation: Small or incomplete datasets can yield estimates with substantial uncertainty, but sample size alone does not determine whether a study is informative. The design, quality and completeness of measurements, analysis plan, and validity of the comparison all matter. Here, the registry reports premature closure and insufficient outcome data, so no efficacy estimate can be evaluated for precision or clinical relevance.
The record’s planning assumptions further distinguish planning from evidence. A significance level, allocation assumption, approximation, and target effect describe how a sample-size illustration is constructed; they are not results from the trial. Without a reported outcome estimate and its uncertainty, such calculations cannot be used to claim observed power or to support a treatment conclusion.
Finally, this record makes transparent reporting important. Reporting the endpoint definition, allocation method, analysis population, missing-data approach, and estimates with uncertainty would help readers understand what was tested and what the data can support. Those details are not reported in the registry record, and the stated reason for termination explains why the planned question remains unanswered in the posted results.
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 primary limitation is the absence of an analyzable efficacy result. The registry states that data were insufficient for outcome-measure analysis, were not entered into tabular format, and were archived after study closure. The endpoint’s name, definition, measurement instrument, and scoring are not reported in the registry record.
The planned comparison is also difficult to characterize. The official title says randomized, but allocation is NA, the study model is single-group, and the registry says the comparison was not randomized and was not a like-for-like control comparison. How the treatments were assigned to Hand A and Hand B is not reported in the registry record. The single-blind label is present, but the blinded party and masking procedures are not described.
The record lists enrollment as 2 and indicates premature termination after the principal investigator left the University of Wisconsin. It does not report a sample-size justification, the number of outcome observations, analysis populations, participant flow, or missing-data methods. Whether interim analyses occurred is not reported in the registry record. These omissions prevent evaluation of precision, attrition, and analysis choices.
Safety reporting is limited to aggregate adverse-event entries. Event descriptions, timing, attribution, and route-specific results are not reported in the registry record, and deaths are null. The entries therefore cannot support a detailed safety comparison.
Finally, the registry does not report the statistical analysis plan or inferential methods. The primary result, uncertainty interval, and significance test are absent. As a result, it is not possible to assess model fit, multiplicity handling, or the sensitivity of conclusions to assumptions. The limitations are not merely about the amount of data: the available record does not define enough of the outcome and comparison to interpret an efficacy estimate, even if one were presented.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: BTX-A Treatment for Palmar Hyperhidrosis — NCT01262339.
- Registry record last updated 2015-01-26; status last verified 2015-01.
- Results first posted 2015-01-26.
- 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 record describes BTX-A treatment for primary focal hyperhidrosis of the hands, with intradermal injection specified for Hand A and iontophoresis for Hand B. Each route is described as using 100U, and the primary outcome timeframe is 26 weeks. The sponsor is the University of Wisconsin, Madison; the listed phase is Phase 2 and Phase 3.
The record lists enrollment as 2 and status as terminated. It says the study closed prematurely because the principal investigator left the University of Wisconsin, that data were insufficient for outcome analysis, and that data were not entered into tabular format. The primary outcome measure and efficacy results are not reported in the registry record.
Although the official title describes a randomized, single-blind comparison, allocation is NA, the model is single-group, and the registry states that this was not a randomized comparison and not a like-for-like control comparison. The available record supports describing the planned question and the reason for early closure, but not a statistical conclusion about comparative efficacy.