Miradry Treatment for Focal Axillary Hyperhidrosis: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Miradry Treatment for Focal Axillary Hyperhidrosis (NCT02295891), a na na study. The primary outcome is Disease Severity as Assessed by the Hyperhidrosis Disease Severity Scale (HDSS).

2. Clinical Question

HDSS asks participants to rate how noticeable sweating is and how much it interferes with daily activities. The scale ranges from 1, describing sweating that is never noticeable and never interferes, to 4, describing intolerable sweating that always interferes. Lower scores are considered better and higher scores worse. Because the study has no separate comparison group in the record, its intended question concerns outcomes observed among participants receiving treatment, rather than a direct estimate of treatment effects against a control condition. The planned assessment times describe the measurement schedule; they do not establish that outcome data were collected at every time point.

3. Trial Design

The registry record describes a single-group device study of MiraDry® for axillary hyperhidrosis. Allocation is listed as NA, masking as NONE, and the model as SINGLE GROUP. These entries indicate that the record does not describe allocation to distinct treatment groups or masking. The enrollment was 31. The study status is TERMINATED. The start is listed as 2014-11 and primary completion as 2019-12; the record does not give a reason for termination.

The intervention description characterizes MiraDry® as a non-invasive thermolytic technology using a microwave energy-based mechanism targeted for eccrine gland reduction at the dermal-fat interface. Each participant was to be scheduled for two treatment appointments approximately three months apart. That is the treatment schedule described in the record; whether every enrolled participant received both appointments is not reported in the registry record.

The primary outcome was mean HDSS score, with standard deviation specified as the measure of dispersion. The planned timeframe was baseline, 6 months, and 1 Year. The registry lists five outcome measures but no analyses. The primary outcome population is described as participants with data collected, but the record does not state how many had measurements at each assessment or how the outcome population was defined in practice.

A single-group design can describe the course of measured outcomes among participants, but it does not provide a concurrent control group for separating treatment-associated change from other influences over time. The record does not identify a control intervention, randomization procedure, or masking procedure. The reasons for these design choices, any protocol changes, and the rationale for terminating the study 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.

Before assignment: Total 31 patients signed consents- * 7 of the 31 consented but never scheduled 1st procedure and were not assigned to the arm * 24 patients were assigned to the arm

Overall Study

Analysis population for the primary outcome, as defined in the registry: Participants with data collected are reported

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.

Population: Data collected for participants who had at least 1 psychological evaluation and 1 MiraDry treatment appointment

6. Primary Endpoint

The registry lists the primary outcome as Disease Severity as Assessed by the Hyperhidrosis Disease Severity Scale (HDSS), measured over Baseline, 6 months, 1 Year.

The primary endpoint is disease severity measured with the Hyperhidrosis Disease Severity Scale. The record describes HDSS as a score on a scale, summarized as a mean with standard deviation. Its four response levels reflect how noticeable sweating is and how much it interferes with daily activities. A score of 1 represents sweating that is never noticeable and never interferes; a score of 4 represents intolerable sweating that always interferes. Lower point values are considered better, while higher point values are considered worse.

This kind of patient-reported measure captures the practical burden of sweating, rather than relying only on a physical measure of sweat production. The registry describes the treatment objective in terms of psychosocial functioning, while naming disease severity assessed by HDSS as the primary outcome. HDSS can therefore reflect an aspect of lived impact relevant to that objective, but the record does not report a separate psychiatric or psychosocial scale as the primary endpoint.

Assessments were specified at baseline, 6 months, and 1 Year. Repeating a measure can describe how scores vary over time, but interpretation requires the observed values, the number of participants measured at each time, and an analysis plan. None of those outcome results or details is reported in the registry record. The endpoint description alone establishes what was intended to be measured, not whether scores improved, worsened, or remained similar.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

The registry describes a continuous primary outcome summarized by a mean and standard deviation. The HDSS itself is a score with ordered response levels: lower values indicate less reported severity and higher values indicate more. A mean can summarize the average score in a group, while a standard deviation describes how spread out individual scores are around that average. Neither quantity is reported for the study's assessment times, so no numerical summary of the endpoint can be interpreted.

What does a mean describe?

In general, a mean is the arithmetic average of the observations included in an analysis. It can be useful for conveying the central level of a measure, but it does not show the full pattern of individual responses. Two groups or time points can have the same mean while differing in how much participants vary. A mean also depends on which observations are included. For repeated HDSS assessments, a mean at each time point would describe the scores available at that point, unless the analysis used a specified method to account for missing observations. The registry record does not report the observed means or the method used to handle incomplete measurements.

What does the standard deviation describe?

In general, the standard deviation describes the dispersion of observations around the mean. A smaller standard deviation indicates scores are more closely clustered around the mean; a larger one indicates greater spread. It is not the same as the uncertainty around the mean. A confidence interval, when reported, addresses uncertainty in an estimate under the assumptions of its method. No standard deviations or confidence intervals for the primary outcome are reported in the registry record.

How should repeated measurements be understood?

The planned HDSS time points are baseline, 6 months, and 1 Year. Measurements from the same participant are related, because each person's responses may be more similar to their own responses at another time than to those of a different participant. In general, analyses of repeated measurements need to account for this within-participant relationship when estimating change or uncertainty. A model that treats each observation as independent can misstate uncertainty when observations are correlated. The registry record does not state what model, if any, was used to analyze repeated scores.

Comparing a later group mean with a baseline mean is not necessarily the same as analyzing each participant's change. A change analysis requires paired observations or a model that appropriately uses the available repeated data. The number of participants contributing at each assessment, the treatment of participants with incomplete follow-up, and the exact estimand are not reported in the registry record. The endpoint population is described only as participants with data collected.

What can a confidence interval tell a reader?

In general, a confidence interval gives a range of values compatible with an estimate under the method's assumptions and conveys precision. A narrow interval indicates greater precision than a wide interval, for the same type of estimate and method. It is not a guarantee that the true value lies in the interval, nor does it resolve bias or limitations in study design. No confidence interval for HDSS or a treatment-associated change is reported in the registry record. Without an estimate and its uncertainty, readers cannot assess the magnitude or precision of an outcome effect.

What does the single-group structure mean for inference?

The record classifies the study as a single-group model and reports no comparator. General statistical inference can estimate patterns or changes within a group, but a within-group contrast does not isolate the treatment effect from other time-related influences. Random variation, changes in participants' circumstances, and other factors can contribute to differences between measurements. A concurrent comparison group can help address such explanations, though the registry record does not describe one. No causal treatment estimate can be recovered from the design description alone.

The record identifies no analyses, so it does not specify whether the primary comparison was between time points, whether a repeated-measures model was planned, or which covariates or assumptions were considered. It also does not report a statistical analysis plan. These details should not be inferred from the endpoint's mean-and-standard-deviation description, which states how the measure was to be summarized rather than how change was to be tested.

In general, over-dispersion matters when observed variability exceeds what a chosen model assumes. If a model underestimates variability, its uncertainty estimates can be too small and its inferential conclusions too confident. This is a general consideration, not a reported feature of this study; no model fit or dispersion assessment is reported in the registry record. Likewise, the record does not report distributional checks or whether the scale was analyzed as a continuous score or with an alternative method.

Sample-size calculations are planning tools based on assumptions about the effect, variability, significance level, allocation, and analysis. A planning illustration is not an observed result and cannot substitute for endpoint data. The record does not report the study's own sample-size justification or a statistical plan, and the enrolled number alone does not establish the precision achieved. No observed-power conclusion can be drawn from the enrollment entry or from the absence of analyses.

10. Multiplicity, Missing Data and Analysis Populations

The registry lists five outcome measures, but does not report analyses. It does not specify which outcomes were primary beyond the named HDSS endpoint, how many hypotheses were tested, whether additional time-point comparisons were planned, or whether any adjustment for multiple comparisons was used. When several outcomes or comparisons are examined, the chance of at least one apparently notable result can increase. In general, multiplicity methods can control that risk, but the appropriate approach depends on the prespecified analysis plan. The plan and any adjustment are not reported in the registry record.

The primary endpoint population is described as participants with data collected. The record does not give the number contributing HDSS data at baseline, 6 months, or 1 Year, nor does it explain why measurements might be missing. It also does not report whether analyses included all enrolled participants, only participants with available observations, or another defined population. These details matter because missing outcome data can affect both the estimate and its precision, especially if missingness is related to participants' scores or experiences.

In general, complete-case analysis uses only participants with the required observations, while other approaches may use partial data under explicit assumptions. Neither approach can be identified. The registry record does not report imputation, sensitivity analyses, or a missing-data assumption. The study's terminated status does not reveal how much follow-up was completed or why measurements may be absent. Readers therefore cannot assess attrition patterns or determine whether the endpoint analysis represents all enrolled participants.

11. 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 adverse-event summary lists 24 participants at risk in the MiraDry® Treatment Group. It reports zero participants affected by serious adverse events and zero affected by other adverse events, with zero deaths. No top serious-event terms are listed. These are the entries in the safety summary; they should be read as reported counts for the listed group, not as proof that no adverse events could occur.

The safety population entry of 24 is distinct from the enrollment of 31. The record does not explain why the number at risk differs from enrollment or give further details about safety follow-up. It also does not describe event definitions, collection procedures, observation duration, or whether all participants had the same opportunity for events to be detected. The absence of listed serious-event terms is not a substitute for a detailed event report.

In general, zero recorded events in a study's observed participants does not demonstrate that the underlying event risk is zero. The amount of safety information depends on how many participants were observed, for how long, and how events were ascertained. Those details are not reported in the registry record beyond the listed at-risk count and event totals. The entries describe what was recorded in this summary and should not be interpreted as a comprehensive estimate of safety.

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

The record documents a study of MiraDry® treatment in participants with axillary hyperhidrosis, with HDSS identified as the primary measure and assessments planned at baseline, 6 months, and 1 Year. It also documents enrollment of 31 and a terminated status. These details describe the intended study and its registry entries; they do not give the observed HDSS scores or change estimates.

Because no primary outcome results or analyses are reported, the record does not show whether average HDSS scores changed, how variable the scores were, or how precise any estimate might be. It therefore cannot establish the direction or size of an observed outcome pattern. The absence of posted results is not evidence that scores were unchanged, nor is it evidence that they improved or worsened.

The single-group design also limits what a change over time could establish. In general, without a concurrent comparator, a measured change cannot be separated confidently from other influences occurring over time. Even if outcome values were available, a within-group pattern would not by itself identify a causal treatment effect. No direct treatment-versus-control estimate is reported.

The record's safety entries report zero serious adverse events, zero other adverse events, and zero deaths among 24 listed as at risk. These counts describe the safety summary, not every possible event or a guarantee of safety. The record does not report the reason for the difference between enrollment and the safety population or provide the follow-up details needed to interpret event ascertainment.

Accordingly, the defensible interpretation is narrow: the registry records the study design, planned outcome, treatment schedule, status, and selected safety counts, while leaving the clinical outcome results and statistical analyses unreported. It does not support a conclusion about whether the treatment did or did not improve HDSS scores.

13. Why This Trial Matters Statistically

This study is statistically informative as an example of the difference between a study's stated question and the evidence available to answer it. The registry identifies a patient-reported severity measure, its direction of interpretation, and planned follow-up times. Those details clarify what investigators intended to observe, but they are not outcome evidence. A reader needs the actual measurements, the analysis, and an account of missing observations to assess results.

The single-group structure is central to interpretation. Repeated assessment can describe how participants' scores vary over time, but the lack of a reported comparator means that change cannot be attributed uniquely to treatment. This illustrates why design determines the strength of causal claims even before statistical modeling begins. A sophisticated analysis cannot create a concurrent comparison that the design does not contain.

The record also underscores that enrollment, outcome population, and safety population are not interchangeable. Enrollment is 31, while 24 are listed as at risk in the adverse-event summary. The HDSS population is described as participants with data collected, without counts at each time point. Clear reporting of these populations is necessary to understand who contributed to each estimate and how much information supports it.

Finally, statistical interpretation depends on both estimates and uncertainty. The registry specifies a mean and standard deviation for the primary outcome but posts neither the outcome values nor analyses. Without those results, readers cannot assess magnitude, variability, or precision. The study's terminated status adds context, but the record does not state the reason or its consequences for data collection. This case shows why design details and planned endpoints are valuable, while remaining distinct from complete, interpretable 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.

Several limitations are specific to the record for this study. It is classified as a single-group study, with no separate comparator, allocation listed as NA, and masking listed as NONE. Those features mean the record does not describe a controlled comparison and do not support attributing any hypothetical change to treatment alone.

The study status is TERMINATED, but the reason for termination is not reported in the registry record. The record also does not say whether termination affected recruitment, treatment delivery, follow-up, or analysis. Enrollment is 31, but the number with HDSS observations at each planned assessment is not reported. The primary outcome population is described only as participants with data collected, leaving the amount and pattern of missing follow-up unclear.

The intervention schedule calls for two appointments approximately three months apart, but the record does not report how many participants received each appointment or whether the schedule was completed. The endpoint timeframe lists baseline, 6 months, and 1 Year, but no observed values are posted. Thus, the planned measurement schedule cannot be treated as evidence of complete follow-up.

The registry lists five outcome measures but no analyses, and it does not report a statistical analysis plan, a sample-size justification, or a reason for the discrepancy between enrollment and the safety population of 24. These omissions prevent assessment of endpoint multiplicity, analysis populations, precision, and safety ascertainment. The safety counts are therefore limited to the summary entries and lack reported follow-up context.

15. Related Tutorials

16. Related Statistical Calculators

17. Sources

• ClinicalTrials.gov: Miradry Treatment for Focal Axillary Hyperhidrosis — NCT02295891.
• Registry record last updated 2025-05-30; status last verified 2025-05.
• Results first posted 2025-05-30.
• 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.

18. Record Summary

The registry record describes a terminated, single-group study of MiraDry® for axillary hyperhidrosis, sponsored by Johns Hopkins University. Enrollment was 31; the record lists the study start as 2014-11 and primary completion as 2019-12. The intervention description specifies two treatment appointments approximately three months apart.

The primary outcome was mean HDSS score, with standard deviation, assessed at baseline, 6 months, and 1 Year. Lower scores are considered better and higher scores worse. Five outcome measures are listed, but no analyses are reported and the primary outcome results are not reported in the registry record.

The safety summary lists 24 participants at risk, zero serious adverse events, zero other adverse events, and zero deaths. The reason for termination and the reason the safety population differs from enrollment are not reported in the registry record.