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 Cetaphil Restoraderm Effect on Young Children With Atopic Dermatitis (NCT02589392), a randomized na study. The primary outcome is Time to Relapse (Quantile 25%).
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT02589392 |
| Phase | NA |
| Condition | Atopic Dermatitis |
| Allocation | Randomized |
| Design model | Parallel |
| Masking | Single |
| Enrollment | 120 |
| Arms in the primary outcome | 2 |
| Lead sponsor | Galderma R&D |
| Results posted | Yes |
2. Clinical Question
Population
Children with atopic dermatitis in the remission phase and very dry atopic skin. The registry describes the efficacy analysis population as all participants who were enrolled and randomized.
Intervention
Cetaphil® Restoraderm® moisturizer used twice daily, together with Cetaphil® Restoraderm® body wash used once daily.
Comparator
Cetaphil® Restoraderm® body wash used once daily, without the moisturizer regimen.
Primary question
How did the estimated time to the first atopic dermatitis relapse compare between the moisturizer-plus-body-wash group and the body-wash group? The registry reports the 25% quantile because the median time to relapse was not reached.
The clinical question concerns the addition of moisturizer to a body-wash regimen, rather than a comparison with no skin-care product. Both groups received the same named body wash, while the moisturizer was included only in the combined regimen. The study description focuses on reducing signs and symptoms of very dry atopic skin in young children whose atopic dermatitis was in remission.
The primary outcome is time from baseline to the first recorded relapse. Its stated timeframe extends up to 89 days. In the posted results, the 25% quantile is 48 days for moisturizer plus body wash, with a 95% confidence interval from 11 to 86 days; for body wash, it is 15 days, with a 95% confidence interval from 8 to 27 days. These are group-level estimates and intervals, not individual predictions. The registry record does not report a formal two-group test or an adjusted estimate of the difference.
3. Trial Design
The study is registered as a randomized, single-masked, parallel-group trial. Randomization means that assignment was intended to occur by chance; the registry record does not describe the sequence-generation method, allocation concealment, or which people were masked. The parallel-group design means participants were assigned to one regimen rather than crossing between regimens during the study, as reflected in the two listed arms.
The registry lists enrollment as 120. For the primary outcome, the posted arm summaries each list 60 participants. The efficacy population is described as the intent-to-treat population, including all participants who were enrolled and randomized. The record does not provide further detail about how missing outcome information, withdrawals, or deviations from the assigned regimen were handled in that population.
The study began on 2015-05-29, reached primary completion on 2016-02-03, and is marked completed. The phase is listed as not applicable. The sponsor is Galderma R&D. The study description identifies children with atopic dermatitis in remission as the intended population and compares body wash alone with body wash plus moisturizer. The listed schedules are moisturizer twice daily and body wash once daily in the combined group, and body wash once daily in the comparator group.
The registry includes one primary outcome measure and does not list posted secondary outcomes. It also does not include a posted analysis entry for a formal two-arm comparison. Details such as the randomization ratio in the protocol, masking procedures, adherence measurement, and the prespecified statistical plan are not reported in the registry record. The design information therefore supports a description of the assigned groups and recorded outcome, but not a reconstruction of every trial procedure.
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 | Moisturizer + Body Wash | Body Wash |
|---|---|---|
| STARTED | 60 | 60 |
| COMPLETED | 54 | 54 |
| NOT COMPLETED | 6 | 6 |
Reasons for not completing this period:
| Reason | Moisturizer + Body Wash | Body Wash |
|---|---|---|
| Adverse Event | 1 | 1 |
| Withdrawal by Subject | 1 | 2 |
| Protocol Violation | 1 | 1 |
| Lost to Follow-up | 2 | 2 |
| Sponsor decision to withdraw subject | 1 | 0 |
Analysis population for the primary outcome, as defined in the registry: Analysis was performed on intent-to-treat efficacy (ITT) population that included all participants who were enrolled and randomized.
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 | Moisturizer + Body Wash | Body Wash | Total |
|---|---|---|---|---|
| Participants analysed | 60 | 60 | 120 | |
| Age, Continuous | years | 5.9 (SD 2.9) | 5.9 (SD 2.9) | 5.9 (SD 2.9) |
| Sex: Female, Male: Female | Participants | 37 | 33 | 70 |
| Sex: Female, Male: Male | Participants | 23 | 27 | 50 |
| Race (NIH/OMB): American Indian or Alaska Native | Participants | 0 | 0 | 0 |
| Race (NIH/OMB): Asian | Participants | 60 | 58 | 118 |
| Race (NIH/OMB): Native Hawaiian or Other Pacific Islander | Participants | 0 | 0 | 0 |
| Race (NIH/OMB): Black or African American | Participants | 0 | 0 | 0 |
| Race (NIH/OMB): White | Participants | 0 | 0 | 0 |
| Race (NIH/OMB): More than one race | Participants | 0 | 0 | 0 |
| Race (NIH/OMB): Unknown or Not Reported | Participants | 0 | 2 | 2 |
| Skin phototype: II | participants | 0 | 1 | 1 |
| Skin phototype: III | participants | 17 | 20 | 37 |
| Skin phototype: IV | participants | 43 | 39 | 82 |
| Atopic Dermatitis (AD) duration | years | 2.9 (SD 3.4) | 2.7 (SD 2.9) | 2.8 (SD 3.1) |
| Number of AD acute phase in the last 12 months | episodes | 4.1 (SD 3.7) | 3.7 (SD 3.3) | 3.9 (SD 3.5) |
| Duration of the last acute phase | days | 27.9 (SD 40.8) | 27.0 (SD 53.5) | 27.4 (SD 47.3) |
| Severity of the last AD acute phase: Mild | Participants | 44 | 41 | 85 |
| Severity of the last AD acute phase: Moderate | Participants | 16 | 19 | 35 |
| Investigator's Global Assessment (IGA): 0-Clear | Participants | 20 | 22 | 42 |
| Investigator's Global Assessment (IGA): 1-Almost clear | Participants | 40 | 38 | 78 |
| Eczema Area and Severity Index (EASI): Erythema | scores on a scale | 0.13 (SD 0.21) | 0.10 (SD 0.17) | 0.12 (SD 0.19) |
| Eczema Area and Severity Index (EASI): infiltration / Papulation | scores on a scale | 0.09 (SD 0.19) | 0.08 (SD 0.17) | 0.09 (SD 0.18) |
| Eczema Area and Severity Index (EASI): Excoriation | scores on a scale | 0.07 (SD 0.15) | 0.10 (SD 0.21) | 0.08 (SD 0.18) |
| Eczema Area and Severity Index (EASI): Lichenification | scores on a scale | 0.04 (SD 0.10) | 0.02 (SD 0.07) | 0.03 (SD 0.09) |
6. Primary Endpoint
The registry lists the primary outcome as Time to Relapse (Quantile 25%), measured over The duration between Baseline and the first AD relapse occurred (up to 89 days).
| Element | Registry entry |
|---|---|
| Result type | Number |
| Measure of spread | 95% Confidence Interval |
| Unit | Days |
| Endpoint classification | not reduced to a single comparison |
The primary endpoint is time to the first atopic dermatitis relapse, measured in days from baseline. It is a time-to-event outcome: each participant contributes information about how long it took for the event to occur, or, when an event is not observed during follow-up, information that the event had not been observed by the participant’s last available follow-up. The registry states that the observation period was up to 89 days.
The posted summary is the 25% quantile rather than the median. The registry explains that the median time to relapse was not reached, so the 25% quantile replaced it. In general, a time quantile describes a point in the event-time distribution; the 25% quantile is associated with the point by which a quarter of the event-time distribution has occurred under the analysis definition. It is not the average time to relapse, and it does not say when every participant relapsed.
Time-to-event endpoints can use information from participants with differing follow-up, including participants whose event was not observed before follow-up ended. In general, this is useful when the timing of an event matters and not every participant has an event recorded during the observation period. The registry record does not specify the event-time estimator, censoring rules, or detailed relapse definition, so those features cannot be assessed from the posted description alone.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The posted 25% quantile estimate is 48 days in the moisturizer-plus-body-wash group, with a 95% confidence interval from 11 to 86 days. In the body-wash group, the estimate is 15 days, with a 95% confidence interval from 8 to 27 days. The point estimate is numerically higher for the combined regimen. These estimates describe the reported time-to-relapse summaries; they are not themselves a formal test of a treatment effect.
A confidence interval conveys uncertainty around an estimated quantity. In general, a 95% confidence interval is generated by a procedure that, over repeated comparable studies and under its assumptions, would cover the target quantity at the stated rate. It is not a range containing 95% of individual participants’ relapse times, nor is it a guarantee that the true value lies inside the particular interval. The intervals are fairly broad, especially for the combined regimen, so the point estimate should not be treated as precise.
The intervals overlap. That observation alone does not establish whether a formal comparison would or would not be statistically significant. A comparison requires an analysis of the contrast between groups and its uncertainty, which is not posted in the registry record. The record gives no p-value, hazard ratio, difference estimate, or other inferential result for this outcome. It also gives no adjusted analysis. The figures therefore support describing the reported group estimates and their uncertainty, but not a claim about statistical significance.
The registry says that the median was not reached and reports the 25% quantile instead. This matters because the result is not a median time-to-relapse estimate. It should not be paraphrased as the typical participant’s relapse time or as the time at which half of the group had relapsed. A quantile estimate is a feature of the event-time distribution; its interpretation depends on how events and follow-up were analyzed. The registry record does not report the estimator or censoring details.
The study enrolled children with atopic dermatitis in remission, and the primary endpoint was observed over a period described as up to 89 days. The reported estimates should be understood within that population, regimen comparison, endpoint definition, and follow-up window. The registry also lists zero serious adverse events in each group, while other adverse events are listed as 14 for moisturizer plus body wash and 17 for body wash. These safety counts do not change the interpretation of the primary endpoint and do not establish that either regimen is free of risk.
Overall, the posted results show different point estimates for the two groups, with substantial uncertainty and without a posted formal comparison. They do not, on their own, establish the size or statistical reliability of a between-group effect. Interpretation should retain the distinction between a descriptive quantile, its confidence interval, and a comparative treatment-effect analysis.
9. Statistical Methods Explained
Several statistical ideas are relevant to interpreting the primary result. The registry reports an event-time quantile and a confidence interval for each group, but it does not report the statistical procedure used to estimate them. Consequently, the general explanations below describe what these quantities ordinarily mean, not a claim about the exact analysis implemented in this trial.
What does a time-to-event endpoint represent?
In general, a time-to-event outcome records the duration from a defined starting point until a specified event. Here, the registry defines the duration as the date of relapse minus the date of baseline, with the first atopic dermatitis relapse as the event. This differs from an outcome measured only as a yes-or-no status at a single visit: timing carries information, and participants may have different amounts of observed follow-up.
When follow-up ends before an event is recorded, or a participant leaves observation, the exact event time may be unknown. In general, time-to-event methods can retain the information that the event had not been observed up to the last known follow-up rather than treating that observation as if an event occurred at that time. This is often called censoring. The registry record does not explain how censoring was defined or handled in this study, so the appropriateness of a particular approach cannot be evaluated from the record.
Why is a quantile reported instead of the median?
The registry states that the median time to relapse was not reached, and that the 25% quantile replaced the median. The median is the point at which half of the event-time distribution has occurred, under the analysis definition. If the observed follow-up does not support estimating that point, a lower quantile may be estimable and can provide a summary earlier in the event-time distribution. The posted 25% quantile is therefore a different summary from the median; it should not be presented as an estimate of the median or as an average.
In general, a quantile describes a location in a distribution, not the experience of each person. A group quantile does not mean that every participant experienced an event at that time. Its exact interpretation also depends on the estimator and event handling. The registry identifies the quantile but does not report the estimator, its assumptions, or detailed handling of participants without a recorded relapse.
How should the confidence intervals be read?
The posted 95% confidence intervals accompany the group-specific quantile estimates. In general, an interval communicates sampling uncertainty under the method’s assumptions. A narrower interval represents greater precision than a wider interval, all else being equal. A confidence interval is not an interval containing most participants’ event times, and it does not show the spread of individual outcomes. The interval for the combined regimen runs from 11 to 86 days, and the interval for body wash runs from 8 to 27 days. These bounds show that the point estimates should be interpreted with uncertainty.
Separate confidence intervals for two groups do not substitute for a confidence interval or test for their contrast. The uncertainty in a between-group comparison depends on the joint analysis, including how the observations and any censoring are treated. The registry record does not post a comparative estimate or test. It is therefore not possible to infer a formal comparison merely by inspecting the individual intervals.
What does randomization contribute?
In general, random assignment is intended to make comparison groups similar, on average, with respect to both measured and unmeasured baseline characteristics. It supports causal interpretation when the trial is conducted and analyzed appropriately, but randomization does not by itself guarantee balance or eliminate uncertainty. The record describes the allocation as randomized but does not report the sequence-generation procedure, concealment method, or baseline characteristics. Nor does the posted primary result provide an adjusted or unadjusted comparative estimate. Those omissions limit assessment of how the randomized design was implemented and analyzed.
What can be learned from the posted analyses?
The registry lists one outcome measure and no posted secondary outcomes. It lists no analysis entry for a two-arm comparison, and the comparison is not available from the posted summary statistics. Accordingly, there is no sponsor-reported comparative test to interpret alongside the arm-level quantiles. There is no recalculated comparison to discuss. The record also does not provide a model specification, covariate adjustment, or a prespecified analysis plan. It is not appropriate to invent those methods or to substitute a calculation that the record does not support.
For context, the record describes planning illustrations based on the observed effect, using a two-sided significance level of 0.05, equal allocation, and a normal approximation; for time-to-event outcomes, the planning quantity is total events using the Schoenfeld method. Such illustrations are planning exercises, not observed power and not evidence about the trial’s original design. The registry record does not report a sample-size justification or the protocol’s planning assumptions. No numerical planning result is stated in the available record.
Why might event-time methods need careful assumptions?
In general, event-time analyses rely on assumptions about the relationship between follow-up and the chance of an event being observed. If participants with incomplete follow-up differ systematically in their event experience, a simple interpretation of the observed times may be misleading. The record does not report the number or pattern of withdrawals, whether follow-up was complete, or how missing event information was handled. These are important details for evaluating the reliability of a time-to-relapse estimate.
The registry also does not describe the operational criteria for a relapse, whether outcome assessment was masked, or whether relapse was adjudicated. The single-masked designation does not identify who was masked. These are not statistical quantities, but they affect how confidently the event definition and observation process can be understood. The posted summaries remain interpretable as registry-reported quantiles with confidence intervals, while the details needed for a fuller methodological assessment are not reported in the registry record.
10. Multiplicity, Missing Data and Analysis Populations
Multiplicity concerns arise when several outcomes, time points, groups, or analyses are tested and results are selected or interpreted together. In general, conducting multiple statistical tests can increase the chance of finding an apparently notable result by chance unless the analysis plan accounts for that multiplicity. The registry lists one primary outcome measure and no posted secondary outcomes. It does not report whether additional outcomes or analyses were prespecified in the protocol, whether there were interim analyses, or whether any multiplicity adjustment was planned. Those details are not reported in the registry record.
The primary outcome is described for an intent-to-treat efficacy population that includes all participants who were enrolled and randomized. This is the population definition stated in the registry; the record does not describe the exact analysis procedure used to implement it. It does not say how participants with missing relapse dates, incomplete follow-up, withdrawal, or protocol deviations were handled. The extent and pattern of missing data are also not reported in the registry record.
For a time-to-event endpoint, incomplete observation is not necessarily equivalent to an ordinary missing value, because information up to the last known follow-up may remain usable under appropriate methods. In general, interpretation depends on the reason follow-up ended and on the method used to handle censoring. The registry does not report these details, so it is not possible to assess whether missingness could have affected the quantile estimates.
The record does not include a posted analysis entry for a formal comparison between groups, and no comparative test result is reported. It also does not report a statistical analysis plan, rules for handling multiple analyses, or a strategy for missing data. These absences mean that the posted summaries can be described, but the analysis decisions behind them cannot be fully evaluated from the registry record.
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 |
|---|---|---|---|
| Moisturizer + Body Wash | 0 | 60 | 0.0% |
| Body Wash | 0 | 60 | 0.0% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| Moisturizer + Body Wash | 0 of 60 |
| Body Wash | 0 of 60 |
Other (non-serious) adverse events
Participants with at least one non-serious event at or above the registry's 2% reporting threshold.
| Arm | Participants affected of at risk |
|---|---|
| Moisturizer + Body Wash | 14 of 60 |
| Body Wash | 17 of 60 |
Most frequent non-serious adverse event terms
| Event term | Organ system | Moisturizer + Body Wash | Body Wash |
|---|---|---|---|
| UPPER RESPIRATORY TRACT INFECTION | Infections and infestations | 3 of 60 | 6 of 60 |
| PYREXIA | General disorders | 4 of 60 | 3 of 60 |
| NASOPHARYNGITIS | Infections and infestations | 3 of 60 | 3 of 60 |
| URTICARIA | Skin and subcutaneous tissue disorders | 2 of 60 | 3 of 60 |
| COUGH | Respiratory, thoracic and mediastinal disorders | 2 of 60 | 2 of 60 |
| VIRAL INFECTION | Infections and infestations | 1 of 60 | 2 of 60 |
The registry lists serious adverse events for participants at risk in each group. For moisturizer plus body wash, zero serious adverse events are listed among 60 at risk; for body wash, zero are listed among 60 at risk. The record also lists zero deaths in each group. These are the posted counts for the safety entries, not proof that serious harm was impossible or that no event could occur outside the recorded observation and definitions.
Other adverse events are listed as 14 in the moisturizer-plus-body-wash group and 17 in the body-wash group, with 60 at risk in each. The registry does not provide the event terms in this summary, their severity, timing, relatedness assessments, or the method used to collect them. A count of other adverse events may reflect people or events depending on the record’s definition; that distinction is not explained here, so the figures should be read as registry-listed counts rather than converted into participant-level rates.
In general, safety counts are most informative when the event definitions, ascertainment methods, observation time, and denominators are clear and comparable across groups. The posted values describe the recorded results, but they do not establish that one regimen is safer or less safe. The registry record does not report a comparative safety analysis.
12. What the Result Does, and Does Not, Mean
The primary result is a group-level estimate of the 25% quantile of time to first relapse. The estimate is 48 days for moisturizer plus body wash and 15 days for body wash, with the respective 95% confidence intervals of 11 to 86 days and 8 to 27 days. The first point estimate is numerically higher, but the registry does not report a formal comparative analysis. The estimates should therefore be described as observed summaries rather than as a demonstrated treatment effect.
The result does not show the median time to relapse. The registry explicitly states that the median was not reached and that the 25% quantile was used instead. It also does not show that a particular child would remain relapse-free for the duration of a group estimate. Group summaries do not predict an individual’s outcome.
The confidence intervals indicate uncertainty in each estimated quantile. They do not give a range of individual relapse times, and the overlap between intervals is not itself a statistical test of the difference between groups. Without a reported comparative estimate, uncertainty interval for the contrast, or p-value, the registry record does not establish whether the apparent difference is statistically distinguishable from chance under a specified analysis.
The study description concerns children with atopic dermatitis in remission and a specific comparison: adding moisturizer to the same named body wash. The results should not be generalized beyond that population, regimen, endpoint, and observation period on the basis of this record alone. The timeframe is described as up to 89 days, and longer-term outcomes are not reported in the posted primary result.
These data also do not establish the mechanism of any observed difference, the role of adherence, or how the results would apply to other products or populations. The registry does not report detailed relapse criteria, missing-data handling, or the statistical analysis plan. The defensible interpretation is limited to the posted group-level quantiles and their confidence intervals, alongside the stated design and the important methodological details that remain unreported.
13. Why This Trial Matters Statistically
This trial illustrates why the choice of summary matters for time-to-event outcomes. A median is often familiar, but it may not be estimable when follow-up does not capture enough events. The registry therefore reports the 25% quantile and explicitly notes that the median was not reached. Reading the result as a median would change its meaning; recognizing the quantile preserves what was actually reported.
It also illustrates the distinction between a group-specific estimate and a comparison. The registry gives a quantile and confidence interval for each group, but no formal two-arm analysis. A visual or numerical contrast between arm estimates is not equivalent to an estimated treatment effect with its own uncertainty. This is a central statistical distinction in randomized trials: a comparative conclusion depends on analysis of the contrast, not simply on separate summaries.
The confidence intervals are important because the estimates are uncertain. Reporting a point estimate without its interval could invite an overly precise reading. Conversely, the intervals alone do not answer whether a treatment contrast meets a statistical criterion. A reader needs to know what quantity was estimated, how uncertainty was represented, and whether the comparison itself was analyzed.
The study also highlights the importance of registry completeness for interpretation. The record identifies randomization, masking as single, the parallel design, the efficacy population, and the endpoint timeframe. It does not report several details needed for a full statistical audit, including the analysis method, censoring rules, missing-data handling, and comparative test. Stating these limits is part of interpreting the evidence rather than filling the gaps with assumptions.
Finally, the safety entries show why zero recorded serious events should be reported precisely and cautiously. Counts depend on definitions and observation; they do not establish absence of risk. Together, these features make the trial useful for understanding how endpoint choice, uncertainty, analysis reporting, and safety summaries shape the conclusions that can be drawn from a registry record.
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 trial-specific reporting gaps restrict interpretation. The registry identifies the primary outcome as time to first relapse and defines its duration from baseline, but it does not provide detailed criteria for what counted as a relapse or explain how relapse was assessed. It also does not state the estimator used for the 25% quantile, the censoring rules, or the handling of participants without a recorded event.
The record identifies the trial as single-masked but does not say who was masked or how masking was maintained. It describes randomized allocation but does not report sequence generation or allocation concealment. Baseline characteristics and adherence information are not reported in the registry record, limiting assessment of group comparability and exposure to the assigned regimens.
The registry gives arm-level outcome summaries but no posted formal comparison, p-value, adjusted estimate, or statistical analysis plan. Consequently, the statistical significance and precision of a between-group contrast cannot be evaluated from the posted results. The record also does not describe whether analyses were prespecified, whether there were interim analyses, or how multiplicity was addressed.
Although the efficacy population is described as intent-to-treat, operational details about withdrawals, protocol deviations, missing outcome information, and incomplete follow-up are not reported. The extent of missingness and its possible influence on the time-to-relapse summaries therefore cannot be assessed. The study timeframe is up to 89 days, so the registry result does not characterize outcomes beyond that stated period.
The safety summary lists serious adverse events, deaths, and other adverse events, but does not provide definitions, event terms, relatedness, severity for other events, or details of ascertainment. These limitations do not negate the posted results, but they narrow the conclusions that can be drawn from them.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Cetaphil Restoraderm Effect on Young Children With Atopic Dermatitis — NCT02589392.
- Registry record last updated 2024-02-26; status last verified 2024-02.
- Results first posted 2024-02-26.
- 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
NCT02589392 is a completed, randomized, single-masked, parallel-group study sponsored by Galderma R&D. It enrolled 120 participants and compared Cetaphil® Restoraderm® moisturizer plus body wash with body wash alone in children with atopic dermatitis in remission. The study began on 2015-05-29 and reached primary completion on 2016-02-03.
The primary outcome was time from baseline to first atopic dermatitis relapse, observed for up to 89 days. Because the median was not reached, the registry reports the 25% quantile: 48 days, with a 95% confidence interval from 11 to 86 days, for moisturizer plus body wash; and 15 days, with a 95% confidence interval from 8 to 27 days, for body wash.
The registry lists zero serious adverse events and zero deaths in each group. Other adverse events are listed as 14 and 17, respectively. No secondary outcomes or formal two-arm analysis are posted. Further details about the statistical plan, missing-data handling, and event-time methods are not reported in the registry record.