Durability of Two Skin Barrier Protectants (SBP): Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Durability of Two Skin Barrier Protectants (SBP) (NCT05756348), a na na study. The primary outcome is Duration.

2. Clinical Question

The study uses the Corneometer® CM 825 capacitance method to measure skin at product-treated sites and at a skin control site without protectant. Measurements are described in arbitrary units and are taken at baseline and subsequent visits. The registry record explains that low arbitrary-unit readings correlate with less moisture, which it associates with better skin protection; increasing readings over time are intended to indicate that a protectant is wearing off.

This is a question about measurement patterns over time, not a reported estimate of comparative benefit. The record does not report the primary endpoint values, the size or precision of any product-specific changes, or an inferential comparison between the products. It also does not report a numerical conclusion about which product had longer duration of wear. The central question can therefore be described from the study design, but the posted registry information does not establish an answer to it.

3. Trial Design

The registry record describes a completed study of two commercially available skin barrier protectants: Marathon® XL No Sting Cyanoacrylate Skin Protectant and 3M™ Cavilon™ Advanced Skin Protectant. The study condition is skin hydration in healthy volunteers. Enrollment is listed as 42, and the record identifies the study model as single group. All participants receive both products under evaluation.

That structure matters for interpretation. The record does not describe separate, randomized product groups or a like-for-like control comparison. The product names appear in separate safety summaries, but those entries should not be read as independent randomized arms: the record says that participants receive both products. It does not report the order of product application, how application sites were selected, whether the same sites were assessed repeatedly, or whether the order or location was counterbalanced. Those details are not reported in the registry record.

The primary outcome is duration, measured using skin capacitance in arbitrary units. Its timeframe is described as seven days, with baseline plus six visits. Skin readings at protectant-treated sites are compared with readings at a control site without protectant at the same time points. The intended interpretation is that increasing readings over time may reflect a loss of the product’s protective effect as it wears off.

The study is listed as completed. Its start date is 2022-10-06, and its primary completion date is 2022-11-22. Phase and allocation are listed as NA, while masking is listed as none. The record does not report a protocol-based sample-size justification, a detailed schedule of assessments, or a statistical analysis plan. Although participant feedback is listed among the secondary outcomes, the registry record does not provide numerical outcome results or analyses.

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: All participants received both the Medline and Cavilon products. Analysis was performed per product not per arm randomization. The dominant arm of participants was randomized to receive one intervention (i.e., " Marathon® or Cavilon™ ), and the non-dominant arm received the other intervention.

Overall Study

Analysis population for the primary outcome, as defined in the registry: Low arbitrary units correlate with less moisture (better skin protectant). As skin protectant wears off, arbitrary units will increase over time indicating duration of wear of skin protectant.

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.

6. Primary Endpoint

The registry lists the primary outcome as Duration, measured over 7 Days - Baseline + 6 visits = 7.

The primary endpoint is duration of wear assessed through skin hydration measurements. The Corneometer® CM 825 uses a capacitance method to measure skin at sites with Marathon® or Cavilon™ applied and at a control site without protectant. Results are expressed in arbitrary units. The record describes measurements at baseline and six visits over a seven-day timeframe.

The registry’s stated rationale gives the measurements a directional interpretation: low arbitrary-unit readings correlate with less moisture and are described as indicating better skin protection. As a protectant wears off, readings are expected to increase over time. Comparing product-treated skin with a control site at the same time points is intended to help characterize this pattern during wear.

This endpoint is used as an indirect measurement of product duration; it is not a direct measurement of a clinical outcome. Its interpretation depends on the relationship between capacitance readings, skin moisture, and the protective characteristics being evaluated. The record does not report the observed means or standard deviations, the product-specific changes over time, or a summary estimate of duration. It therefore describes what the endpoint was intended to measure, but not the numerical findings.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

The primary outcome is a continuous measurement summarized in the registry as a mean with standard deviation. A mean describes the central level of a set of measurements. The standard deviation describes how dispersed individual measurements are around that mean. These summaries answer different questions: the mean concerns the average measurement, while the standard deviation concerns variability among measurements. Neither is reported numerically for the primary endpoint in the registry record.

What does the capacitance measurement represent?

The study uses the Corneometer® CM 825 capacitance method to take skin measurements in arbitrary units. The registry describes these readings as a way to assess hydration at product-treated sites and at a control site without protectant. Its stated interpretation is that low arbitrary-unit values correlate with less moisture and indicate better protection, while increasing values over time may indicate that a protectant is wearing off. This is the study’s measurement rationale; it does not by itself establish that a particular reading corresponds to a clinically meaningful difference.

Because readings are planned at baseline and six visits, the endpoint concerns a time pattern rather than a single isolated reading. In general, comparing measurements across time can help characterize whether the response changes after application. The timing and nature of the reported summary are important: an average across visits, a visit-specific mean, and a model of change over time answer different questions. The registry record does not report which summary or model was used, nor does it provide numerical values for any visit.

Why does repeated measurement matter?

In general, measurements from the same person may be more alike than measurements from different people. This dependence is called within-person correlation. An analysis that accounts for it can produce uncertainty estimates suited to the repeated-measures structure; an analysis that ignores it may produce inappropriate precision. The record identifies a single-group study in which all participants receive both products, but it does not state how repeated readings, product-treated sites, or control-site readings were modeled. The statistical method for handling these features is not reported in the registry record.

The control site offers a reference for measurements taken at the same time points, according to the outcome description. In general, a concurrent reference can help distinguish a product-site pattern from changes also observed at an untreated site. However, the registry record does not say how the control readings were incorporated into the analysis. It does not report whether the primary analysis compared levels, changes from baseline, or differences between product and control sites.

How should uncertainty be understood?

In general, a confidence interval gives a range of values compatible with the data under the statistical model and indicates the precision of an estimate. A narrow interval indicates greater precision than a wide interval, while an interval alone does not establish that an effect is clinically important. No confidence interval for the primary endpoint is reported in the registry record. No p-value or other inferential result is reported either, so statistical significance cannot be assessed from the posted information.

Standard deviation is not a substitute for a confidence interval. It describes variability among measurements, rather than directly expressing uncertainty in an estimated mean. To judge precision, readers would need the relevant estimate and its uncertainty, along with an understanding of the analysis population and model. Those details are not reported in the registry record.

What does over-dispersion mean in general?

For outcomes that are counts, over-dispersion means that the observed variability is greater than a simple model assumes. A model that fails to accommodate extra variability can understate uncertainty. This concept is not a description of the primary endpoint in this study, which is a continuous skin measurement, and the registry record does not report a count-outcome analysis for that endpoint.

The record lists five outcome measures, including participant-feedback outcomes. In general, assessing multiple endpoints or time points creates multiplicity: the more results examined, the more care is needed in distinguishing prespecified questions from exploratory findings. A correction, outcome hierarchy, or other multiplicity strategy is not reported in the registry record. The existence of multiple listed measures does not reveal which analyses were planned or performed.

A planning illustration is described using a two-sided significance level of 0.05, equal allocation between two arms, a normal approximation, and a chosen fraction of an observed effect. It is explicitly a planning illustration based on an observed effect, not the trial’s own design. In general, such calculations estimate a sample size for a future study under their assumptions. They are not observed power and do not establish that the completed study had adequate precision. The numerical planning estimates are not reported in the registry record. The illustration’s equal-allocation assumption also should not be confused with this study’s described design, in which all participants receive both products and allocation is listed as NA.

Finally, a statistical method cannot be inferred solely from the outcome type or study title. The record does not report a detailed analysis plan, model specification, handling of missing observations, analysis population, or results of statistical tests. Any interpretation beyond the measurement rationale and the descriptive information in the registry would require details that are not reported there.

10. Multiplicity, Missing Data and Analysis Populations

The registry record lists five outcome measures, including three participant-feedback outcomes. The primary endpoint also involves measurements over baseline and six visits. When several outcomes, time points, or comparisons are examined, multiplicity can affect how exploratory findings should be interpreted. In general, a prespecified hierarchy or adjustment can help control the chance of over-interpreting results across multiple tests. The record does not report whether a hierarchy, adjustment, or other multiplicity strategy was planned or used.

Missing-data handling is not reported in the registry record. The record does not state whether any scheduled measurements were missing, how missing observations were handled, or whether a sensitivity analysis was conducted. It also does not report the analysis population used for the primary endpoint or participant-feedback outcomes. Enrollment is listed as 42, but the record does not provide an endpoint-specific analysis denominator or explain whether every enrolled participant contributed measurements at every visit.

The registry identifies zero analyses. This means no statistical analyses are listed in the record; it does not establish what analyses may have been performed outside the registry. Numerical primary results, inferential tests, and uncertainty estimates are not reported in the registry record. In their absence, readers cannot assess multiplicity adjustments, missing-data assumptions, or the relationship between a planned analysis and reported findings.

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 safety summaries list 42 participants at risk for each product entry. For Marathon® XL No Sting Cyanoacrylate Skin Protectant, the summary records zero serious events, zero other events, and zero deaths. For 3M™ Cavilon™ Advanced Skin Protectant, it also records zero serious events, zero other events, and zero deaths. No top serious-event terms are listed.

These are counts in the registry record. They should not be interpreted as a comparison between independent treatment groups: all participants receive both products, and the study is described as single group. The record does not report additional details about event definitions, ascertainment, timing, or the duration of safety observation. A zero recorded count means that no events are recorded in that category in the summary; it does not by itself establish that a product has no risk or that the products have equivalent safety.

The safety entries are distinct from the primary skin-hydration endpoint. They do not provide the means, standard deviations, or time patterns needed to interpret duration of wear. The record does not report a statistical safety comparison or event-specific narrative that would support a more detailed assessment.

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

The record establishes the study’s purpose and measurement approach: assess the duration and durability of Marathon® and Cavilon™ using skin capacitance readings over a seven-day timeframe, with baseline and six visits. It describes the rationale for interpreting changes in arbitrary units and includes safety counts for each product entry. These details help readers understand what the study was designed to observe.

The record does not report numerical primary-endpoint results. It therefore does not establish the average measurements, variability, product-specific time patterns, or precision of any estimated difference. It also does not report a statistical test or confidence interval that would support an inferential claim about comparative duration. No conclusion that one product lasted longer, or that the products were similar, can be drawn from the registry information alone.

The safety summaries record zero serious events, zero other events, and zero deaths for both product entries. Those counts are limited to the reported summaries and are not evidence that risks are absent. They also do not constitute a direct comparison between independent groups, because the registry says all participants received both products.

More generally, a measurement pattern is not automatically a clinical benefit. The endpoint is an indirect indicator based on capacitance and the record’s stated relationship between arbitrary-unit values, moisture, and protection. The record does not report how large a change would be clinically meaningful or whether the measurements were linked to a patient-centered outcome. Thus, the design description clarifies the question, but the absence of numerical results and analysis details prevents a conclusion about the observed duration or its clinical significance.

13. Why This Trial Matters Statistically

This study raises useful statistical questions about how to assess a product whose intended durability is expressed as a changing measurement over time. A baseline value and repeated visits can describe a trajectory, while a control site measured at the same time points can provide context for that trajectory. Interpretation depends on how those readings are compared and how their repeated nature is handled.

The single-group structure is particularly important. All participants receive both products, so the registry’s separate product entries should not be mistaken for randomized, independent arms. A sound interpretation of any comparison would need clear information about product placement, application order, repeated observations, and the analysis strategy. Those details are not reported in the registry record.

The endpoint also illustrates the distinction between a measurement and the concept it is intended to represent. Capacitance is recorded in arbitrary units; the registry uses its direction over time as an indicator of wear. Statistical precision, measurement variability, and a clinically meaningful threshold would all inform how such a pattern should be interpreted, but numerical results and those interpretive details are not reported.

Finally, the record lists multiple outcomes and visits but no analyses. That makes multiplicity and selective emphasis important considerations in general, while leaving it impossible to determine how they were addressed in this study. The registry entry is therefore useful for understanding the intended design and endpoint, but not for estimating or comparing observed effects.

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 principal limitation for interpretation is that numerical results for the primary endpoint are not reported in the registry record. Means, standard deviations, product-specific changes over time, comparisons with the control site, and confidence intervals are absent. The record therefore does not permit an assessment of either the size or precision of the measured patterns.

The design is described as single group, with all participants receiving both products and allocation listed as NA. The record does not explain how product sites were chosen, whether application order was controlled, or how possible site and sequence effects were handled. It also does not describe the statistical model used for repeated measurements. These omissions make it difficult to evaluate how a product comparison would separate product-related patterns from other influences.

Further limitations include the absence of a reported analysis population, endpoint-specific denominators, missing-data methods, and multiplicity strategy. Although participant feedback is listed as a secondary outcome, numerical feedback results are not reported. The record also does not report a sample-size justification for the study’s own design. A planning illustration based on an observed effect is not that justification and is not observed power.

The safety summaries provide counts but no event-specific detail, timing, or account of ascertainment. They should be read as limited registry summaries rather than comprehensive comparative evidence. Finally, the primary measure is an indirect indicator of duration, and the record does not report a threshold for clinical importance. These limitations are specific to the information and design described in the registry; they do not establish what may have been reported elsewhere.

15. Related Tutorials

16. Related Statistical Calculators

17. Sources

• ClinicalTrials.gov: Durability of Two Skin Barrier Protectants (SBP) — NCT05756348.
• Registry record last updated 2024-02-20; status last verified 2023-08.
• Results first posted 2024-02-20.
• 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 describes a completed, single-group evaluation of Marathon® XL No Sting Cyanoacrylate Skin Protectant and 3M™ Cavilon™ Advanced Skin Protectant in healthy volunteers. Enrollment is listed as 42, and all participants receive both products. The primary endpoint is duration of wear assessed by Corneometer® CM 825 capacitance measurements in arbitrary units at baseline and six visits over a seven-day timeframe, with a skin control site measured at the same time points.

The study is listed as completed, with a start date of 2022-10-06 and primary completion date of 2022-11-22. The record lists participant feedback among the secondary outcomes. Its safety summaries record zero serious events, zero other events, and zero deaths for each product entry. Numerical primary results, statistical analyses, analysis populations, and missing-data methods are not reported in the registry record. The entry therefore describes the research question and measurement plan but does not establish the observed duration or a comparative result.