A Study of Glycopyrronium Cloth, 2.4% in Patients With Palmar Hyperhidrosis: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for A Study of Glycopyrronium Cloth, 2.4% in Patients With Palmar Hyperhidrosis (NCT03880266), a randomized phase 2 study. The primary outcome is Mean Change From Baseline to Week 2 in Hand Sweating Severity Score.

2. Clinical Question

3. Trial Design

The registry describes a randomized, triple-masked, parallel-group, vehicle-controlled Phase 2 study. Its stated objective was to assess the efficacy and safety of glycopyrronium cloth, 2.4%, when used to treat palmar hyperhidrosis. The study is recorded as completed, with an enrollment of 72.

Eight groups are listed: four active-treatment groups and four corresponding vehicle groups. All regimens involved once-daily application to the hands for 14 days. Two used 15 minutes of application and two used 30 minutes; within each duration, one regimen used occlusion with a non-latex glove and the other did not. This arrangement allows comparisons of active treatment with vehicle under each application condition. It does not, by itself, establish that the study was designed or powered to compare the different durations or occlusion conditions against one another.

The primary outcome was mean change from baseline to Week 2 in the Hand Sweat Severity Score. The registry identifies the Intent to Treat Population for this outcome. The arm-level outcome counts differ across groups, and the reported comparison counts are not identical to all safety denominators. Reasons for these differences, including any exclusions or missing observations, are not reported in the registry record.

The registry lists four secondary outcomes: improvement of at least two grades on the Hyperhidrosis Disease Severity Scale, absolute change in gravimetrically measured sweat production, percent change in that measure, and the percentage of participants with at least a 50% reduction in sweat production. The record lists five outcome measures and 20 analyses overall. Details of the allocation procedure, the sample-size justification, interim analyses, and the prespecified statistical plan 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.

Only the first 6 of 8 groups are shown.

Overall Study

Reasons for not completing this period:

Analysis population for the primary outcome, as defined in the registry: Intent to Treat Population

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.

Only the first 6 of 9 groups are shown.

6. Primary Endpoint

The registry lists the primary outcome as Mean Change From Baseline to Week 2 in Hand Sweating Severity Score, measured over Baseline, Week 2.

The primary endpoint is mean change from baseline to Week 2 in the Hand Sweat Severity Score. The registry describes this as a patient-reported measure designed to assess the severity of palmar hyperhidrosis. Its scale runs from 0, better, to 10, worse. The endpoint therefore captures participants’ reported symptom severity rather than a direct measurement of sweat volume.

Change from baseline expresses how the score shifted over the study period. A negative change means the Week 2 score was lower than the baseline score; given the scale direction, that is a change toward a better score. The endpoint is reported as a mean, with standard deviations describing the spread of individual values around each group mean. The group means alone do not show whether the active and vehicle groups differed reliably: between-group estimates, confidence intervals, and the reported tests are also relevant.

Using a patient-reported severity measure can address an aspect of the condition that matters directly to participants, while the listed secondary outcomes include gravimetric measures of sweat production. These outcomes capture different dimensions and should not be treated as interchangeable. The registry does not report a minimal clinically important difference or other threshold for interpreting the size of a score change. As a result, the practical importance of a particular numerical change cannot be determined from the endpoint definition alone.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

The primary outcome is continuous: it is a score that can take values along a numerical scale, and the registry reports group means and standard deviations. General statistical explanation: a mean summarizes the central level of scores in a group, while a standard deviation describes how dispersed the individual observations are around that mean. These summaries help describe the data, but a difference between two means does not by itself indicate how much uncertainty surrounds the comparison.

What does a confidence interval convey?

General statistical explanation: a confidence interval gives a range of values compatible with the observed data under the method used to calculate it. A narrower interval indicates greater precision than a wider interval, while an interval spanning zero for a difference includes the possibility of no difference under that analysis. It does not mean that every value in the interval is equally plausible, and it is not a guarantee that the true value lies within that particular interval. In the registry comparisons, each reported 95% confidence interval spans zero. The endpoints of those intervals also extend in both directions, so the estimates do not narrowly settle the direction or size of a group difference.

Why does the analysis method matter?

The registry lists Wilcoxon (Mann-Whitney) as the method for each active-versus-vehicle test. In general, this rank-based method compares observations by their ordering rather than relying directly on a comparison of arithmetic means. It is often useful when distributional assumptions for a mean-based test are questionable, but the precise interpretation depends on the study design and the distributions being compared. The registry labels the reported parameter as a mean difference in final values. It does not report further details that reconcile this parameter label with the rank-based test, nor does it give the calculation details for the confidence intervals. The numerical comparisons and p-values should therefore be described as registry-reported rather than as independently verified reconstructions.

The primary endpoint itself is described as change from baseline to Week 2, while the comparison parameter is labeled a mean difference in final values. The record does not explain whether the comparison used Week 2 values, change scores, or another specific construction. Those choices can matter: an analysis of final scores and an analysis of change scores answer related but not always identical questions, particularly when baseline values vary. No unreported adjustment or baseline procedure should be inferred.

How should the p-values be read?

General statistical explanation: a p-value measures how unusual the observed data, or more extreme data, would be under a specified null hypothesis and analysis model. It is not the probability that the null hypothesis is true, nor does it measure the clinical importance of an effect. The posted p-values are 0.244, 0.168, 0.699, and 0.833. Considered with the confidence intervals, they do not provide strong evidence against the no-difference hypothesis for their respective comparisons. The record does not state a multiplicity adjustment or a prespecified threshold for interpreting these tests, so no such procedure should be assumed.

The four tests are matched active-versus-vehicle comparisons, one for each regimen. General statistical explanation: when several hypotheses are tested, the chance of obtaining at least one small p-value by chance can increase, depending on how the tests are related and how the testing plan is defined. Adjustment procedures can address this issue, but may change the interpretation of individual tests. The registry lists 20 analyses overall and does not report how the family of tests was defined or whether any adjustment was made. The four primary comparisons should not be treated as an isolated testing family without further information.

What can the group counts tell us?

The primary outcome counts range from 4 to 13 across the listed groups. General statistical explanation: small groups often yield less precise estimates because fewer observations contribute information, although the actual precision also depends on the variability and analysis method. The reported standard deviations range from 0.73 to 2.223. These values describe observed spread, not uncertainty in the estimated comparison. The confidence intervals are more directly informative about the uncertainty in each reported contrast.

The total registry enrollment is 72, but the primary outcome counts vary by group and do not all match the safety denominators. Enrollment is not the same as the number contributing to a particular outcome analysis. The registry does not report why counts differ, how missing outcome data were handled, or whether any participants were excluded from a particular analysis. Those details are important for assessing the analysis population and potential bias.

The record also gives no sample-size justification or detailed statistical analysis plan. General statistical explanation: a trial’s planned sample size is usually linked to assumptions about the effect to detect, variability, significance level, power, and allocation. Without the study’s actual design assumptions, the adequacy of the sample for its intended question cannot be judged from enrollment alone. Planning calculations based on observed effects, if considered, are illustrations rather than observed power and do not replace the trial’s original justification.

10. Confidence Intervals for Each Arm

No two-arm comparison is shown for this trial, but each arm's mean can be given with a t-based 95% confidence interval computed from the posted mean, spread and number of participants.

R code and output

arm <- c("Group 1 Active", "Group 1 Vehicle", "Group 2 Active", "Group 2 Vehicle", "Group 3 Active", "Group 3 Vehicle")
n   <- c(12, 5, 11, 4, 12, 6)
m   <- c(-2.14, -0.56, -1.64, -3.03, -2.53, -2.2)
sp  <- c(2.199, 0.73, 1.41, 2.161, 2.223, 1.084)
sd  <- sp      # posted standard deviations
for (i in seq_along(n)) {
  se <- sd[i] / sqrt(n[i]); h <- qt(0.975, n[i] - 1) * se
  cat(sprintf("CARM|%s|%d|%.3f|%.3f|%.3f|%.3f\n", arm[i], n[i], m[i], sd[i], m[i] - h, m[i] + h))
}

CARM  Group 1 Active  12  -2.140  2.199  -3.537  -0.743
CARM  Group 1 Vehicle  5  -0.560  0.730  -1.466  0.346
CARM  Group 2 Active  11  -1.640  1.410  -2.587  -0.693
CARM  Group 2 Vehicle  4  -3.030  2.161  -6.469  0.409
CARM  Group 3 Active  12  -2.530  2.223  -3.942  -1.118
CARM  Group 3 Vehicle  6  -2.200  1.084  -3.338  -1.062

11. Analyses Reported by the Sponsor

The registry reports four active-versus-vehicle superiority analyses using the Wilcoxon (Mann-Whitney) method. Each is reported with a comparison estimate, a 95% confidence interval, and a p-value. The estimates and uncertainty are the results to use when describing the posted inferential findings; the arm-level means and standard deviations are descriptive summaries and are not a substitute for those tests.

The record labels the comparison parameter as a mean difference in final values, although the listed test is rank-based. It does not give further calculation details. No discrepancy is flagged between the registry-reported analysis and any recalculated result, but the record does not provide a separate recalculated numerical contrast to compare with the reported estimates. If a discrepancy between a sponsor analysis and a simple unadjusted recalculation were present, the sponsor’s own analysis would take precedence. Here, the interpretation should stay with the reported estimates, confidence intervals, and p-values, while noting that the precise construction of the comparison is not explained.

The reported confidence intervals all include zero, and the p-values are 0.244, 0.168, 0.699, and 0.833. These results do not establish a difference in the four active-versus-vehicle comparisons. They also do not establish equivalence or rule out effects in either direction. No additional conclusion about a pooled effect, subgroup, or alternate analysis should be drawn from the registry record.

12. Multiplicity, Missing Data and Analysis Populations

The registry lists a primary outcome and four secondary outcomes, and reports 20 analyses overall. It also provides four primary active-versus-vehicle comparisons, one for each application regimen. Testing several outcomes or comparisons can raise a multiplicity concern: in general, the more hypotheses examined, the greater the possibility of at least one apparently unusual result arising by chance. The degree of concern depends on which analyses were planned, how they relate to one another, and what conclusions are drawn from them.

Whether the study used a multiplicity adjustment, a hierarchical testing strategy, or another approach is not reported in the registry record. The record also does not describe which outcomes or comparisons were designated as confirmatory, whether the four regimen-specific tests were considered a single family, or how the 20 analyses were organized. Consequently, the posted p-values should be read as the reported results for their individual comparisons, not as evidence that a particular family-wise error procedure was applied.

Missing-data handling is also not reported in the registry record. The primary outcome group counts range from 4 to 13, while the registry enrollment is 72. Safety denominators differ from some of the primary outcome counts. These differences do not identify whether observations were missing, excluded, or handled in another way. The reasons, timing, and treatment of any missing measurements are not reported. The record does not state whether an imputation method, complete-case analysis, or another approach was used.

The primary outcome population is identified as the Intent to Treat Population, but the record does not define how that population was operationalized for each comparison. Details of protocol deviations and analysis-set exclusions are not reported in the registry record. Without those details, it is not possible to assess how closely the analyzed participants matched the intended analysis population or how missing data may have affected the findings.

Interim analyses and a detailed statistical plan are not reported in the registry record. The absence of these details in the record should not be interpreted as evidence that a particular procedure was or was not used; it limits what can be concluded about the testing strategy and analysis decisions.

13. 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.

Most frequent non-serious adverse event terms

The posted serious adverse event counts are zero in every group. The corresponding numbers at risk are 12 for Group 1 Active, 6 for Group 1 Vehicle, 12 for Group 2 Active, 4 for Group 2 Vehicle, 12 for Group 3 Active, 6 for Group 3 Vehicle, 13 for Group 4 Active, and 7 for Group 4 Vehicle. The registry also reports zero deaths in every group.

These are counts over the safety populations identified in the record. They do not mean that no adverse events of any kind occurred: the registry separately reports other adverse events in five participants in Group 1 Active, two in Group 1 Vehicle, five in Group 2 Active, one in Group 2 Vehicle, one in Group 3 Active, two in Group 3 Vehicle, two in Group 4 Active, and none in Group 4 Vehicle. Serious events and other adverse events are different categories.

General statistical explanation: when event counts are zero, particularly in groups with limited numbers of participants, the observed data provide limited information about how often uncommon events might occur in a broader population. A zero count is not proof that an event is impossible. The registry record does not provide serious adverse event terms, follow-up details, or additional context for interpreting safety beyond the posted counts. These figures should therefore be read as a description of what was reported in this study, not as a complete characterization of safety.

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

The posted results describe short-term changes in a patient-reported hand sweating severity score across four active-versus-vehicle comparisons. Mean scores decreased from baseline in all eight groups, but the active and vehicle groups did not show a consistent relative pattern across the four regimens. The registry-reported comparisons have 95% confidence intervals that include zero, with p-values of 0.244, 0.168, 0.699, and 0.833. The results therefore do not establish a difference between glycopyrronium cloth and vehicle in any of these reported comparisons.

That conclusion is narrower than saying there is no effect. A confidence interval spanning zero is compatible with no difference, but also with differences in either direction within the interval. The group sizes are small, and the intervals are broad enough that the exact size and direction of a possible difference are not resolved. A failure to establish a difference is not the same as evidence of equivalence; an equivalence conclusion would require an appropriate design and prespecified equivalence margins, neither of which is reported in the registry record.

The findings do not establish which application duration or occlusion condition is preferable. The posted inferential tests compare active treatment with vehicle within each regimen; they do not directly test active regimens against one another. Nor do the primary endpoint results establish what happened on the secondary measures of HDSS improvement or gravimetric sweat production, for which outcome values are not included in the record.

The observation period for the primary endpoint is baseline to Week 2 after once-daily application for 14 days. These results do not characterize persistence after treatment, longer-term outcomes, or effects in populations not represented by the study. The serious adverse event counts were zero in all groups, but the small safety denominators and limited information in the record do not show that serious events cannot occur.

Overall, the registry record supports a careful description of the observed group summaries and reported tests. It does not support a definitive claim of superiority, equivalence, or a comparison among application regimens.

15. Why This Trial Matters Statistically

This trial is statistically informative because it separates four application conditions rather than treating application duration and occlusion as a single undifferentiated regimen. Each active group has a corresponding vehicle group with the same stated duration and occlusion instructions. That structure makes the active-versus-vehicle comparisons understandable within each condition, while also making clear why comparisons across conditions require separate evidence.

The results illustrate the difference between a within-group change and a between-group treatment comparison. Each group’s mean score fell from baseline, but that pattern alone does not show whether the active treatment changed scores more than vehicle. The reported contrasts and their confidence intervals address the comparative question more directly. Here, all four intervals include zero, and the observed direction varies across regimens. Looking only at the active-group means, or only at change from baseline, would therefore omit important comparative uncertainty.

The record also highlights the value of reporting analysis details. The endpoint is described as a change from baseline, while the comparison parameter is labeled a mean difference in final values and the method is rank-based. Without further explanation, readers cannot determine exactly how the estimate and interval were constructed. Clear specification of the estimand, analysis method, confidence interval procedure, and missing-data handling would make the results easier to reproduce and interpret.

Finally, the registry reports multiple outcomes and analyses, but does not describe the multiplicity strategy or sample-size justification. Those omissions limit conclusions about the intended strength of the tests and the precision sought by the design. The trial is therefore a useful example of how registry results can offer substantive group-level information while leaving important questions about analysis and interpretation unresolved.

16. 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 outcome counts are small and uneven across the eight groups, ranging from 4 to 13. The resulting confidence intervals are wide enough to include both positive and negative values for every comparison. This limits the precision with which the relative effects can be described. The registry enrollment of 72 does not indicate how many participants contributed to each outcome comparison, and the record does not explain the differences among the group counts.

The comparison-method description is incomplete. The registry lists a Wilcoxon (Mann-Whitney) test but labels the parameter as a mean difference in final values, while the primary outcome is described as mean change from baseline to Week 2. Further details about the tested quantity, confidence interval calculation, and handling of baseline values are not reported in the registry record. This prevents a full assessment of how the inferential estimates relate to the descriptive change scores.

Multiplicity handling, missing-data methods, the sample-size justification, interim analyses, and a detailed statistical plan are not reported in the registry record. The primary outcome is assigned to the Intent to Treat Population, but the operational definition and analysis-set details are not reported. These omissions constrain assessment of bias, precision, and the interpretation of the four comparisons among the wider set of analyses.

The primary results concern a patient-reported score at Week 2. Although four secondary outcomes are listed, their outcome values are not included in the registry record described for these results. The record therefore does not permit a joined interpretation of symptom severity and gravimetrically measured sweat production. It also does not give a threshold for a clinically important score change. Finally, the safety data are limited to counts, with zero serious adverse events and zero deaths in the listed groups; the posted information does not provide detailed event descriptions or longer-term safety follow-up.

17. Related Tutorials

18. Related Statistical Calculators

19. Sources

• ClinicalTrials.gov: A Study of Glycopyrronium Cloth, 2.4% in Patients With Palmar Hyperhidrosis — NCT03880266.
• Registry record last updated 2021-08-25; status last verified 2021-08.
• Results first posted 2021-03-15.
• 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.

20. Record Summary

NCT03880266 is a completed, randomized, triple-masked, parallel-group, vehicle-controlled Phase 2 study sponsored by Journey Medical Corporation. It enrolled 72 participants with palmar hyperhidrosis and evaluated glycopyrronium cloth, 2.4%, applied once daily for 14 days under four conditions: 15 minutes or 30 minutes, with or without occlusion. Each active regimen had a corresponding vehicle group.

The primary outcome was mean change from baseline to Week 2 in the Hand Sweat Severity Score, a patient-reported scale from 0, better, to 10, worse. The four reported active-versus-vehicle comparisons had 95% confidence intervals that included zero and p-values of 0.244, 0.168, 0.699, and 0.833. The posted results do not establish a difference in these comparisons. Serious adverse events and deaths were reported as zero in all groups. Details about multiplicity, missing-data handling, the sample-size justification, and the statistical plan are not reported in the registry record.