Human Testing of an Over-the-Counter (OTC) Cream in Children With Eczema: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Human Testing of an Over-the-Counter (OTC) Cream in Children With Eczema (NCT01326910), a randomized na study. The primary outcome is Eczema Area and Severity Index (EASI).

2. Clinical Question

The trial concerns the management of mild to moderate atopic dermatitis in children. Its stated purpose is to evaluate the safety and efficacy of an over-the-counter cream. The main statistical question is comparative: whether the measured EASI outcome differs between children assigned to the experimental cream and those assigned to a marketed topical cream. Because both arms receive a topical cream, the comparison concerns the experimental product relative to an active control; it does not directly answer how either cream compares with no topical treatment.

The registry record also lists interim EASI, itch assessment, and Investigator's Global Atopic Dermatitis Assessment (IGADA) as secondary outcomes. These are distinct measures or assessments, but their results are not reported in the registry record. The record therefore states what outcomes were intended for assessment without showing whether the groups differed on them. No conclusion about comparative efficacy or safety can be drawn from the stated research question alone.

3. Trial Design

The study is registered as randomized, double-blind, and parallel-group. Randomization is intended to allocate participants to the experimental topical cream or the marketed topical cream. In a parallel design, participants remain in their assigned group for the comparison rather than crossing between treatments. Double masking means the registry describes the study as blinded for two parties, but the specific parties and the procedures used to maintain masking are not reported in the registry record.

The registry lists enrollment as 90 and gives 45 participants at risk in each arm for the adverse-event summaries. It describes the experimental cream as applied twice daily or as needed, and gives the same application instructions for the marketed cream. The brief summary describes a three-week study, while the primary outcome timeframe is stated as 3 weeks. The primary outcome population is identified as Intention to Treat (ITT); details of how that population was defined or handled are not reported in the registry record.

The record lists the study status as completed, with a start of 2011-03 and primary completion of 2011-05. The phase is listed as NA. The sponsor is Johnson & Johnson Consumer Products Company Division of Johnson & Johnson Consumer Companies, Inc. These registration details describe the study's design and administrative record; they do not establish that all planned analyses or outcomes were reported.

The control is active: the comparison is between two topical creams, one experimental and one marketed. This makes the meaning of any possible group difference dependent on the choice of comparator and the treatment instructions. However, no primary outcome estimates are available in the registry record, so the design alone cannot show the direction or size of a difference. The registry record does not report the allocation method, masking procedures, adherence, treatment discontinuations, or a protocol-based sample-size justification.

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

Reasons for not completing this period:

Analysis population for the primary outcome, as defined in the registry: Intention to Treat (ITT)

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 Eczema Area and Severity Index (EASI), measured over 3 weeks.

The primary endpoint is the Eczema Area and Severity Index (EASI), recorded as a mean on a scale, with standard deviation identified as the measure of dispersion. The outcome description combines regional body surface area tabulation with severity ratings for signs of disease. Body surface area is rated from 0 (none) to 3 (severe), and the assessment is combined with the severity of disease signs and body area in a final calculation ranging from 0 to 72. The registry names the Intention to Treat (ITT) population and sets the primary timeframe at 3 weeks.

As a continuous measure, EASI can represent varying levels of disease severity rather than placing every participant into a small set of categories. In general, continuous outcomes can retain gradations in measured status, which may help describe the size and variability of a group result. The meaning of a group mean depends on the measurement scale and the way the measure is collected. EASI is used to quantify affected area and severity together; it is not simply a count of affected body regions.

The registry record does not provide the mean EASI in either group, the standard deviations, a between-group estimate, or a confidence interval. It therefore does not show the observed endpoint values or the precision of a comparative estimate. The outcome definition and its intended timeframe explain what was to be measured, not what the trial found.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

The statistical methods that were actually used to analyse the primary outcome are not reported in the registry record. The record names the outcome as a mean of a continuous measure and identifies standard deviation as its dispersion summary, but it does not specify a statistical test, model, covariate adjustment, confidence-interval method, or handling of repeated or incomplete measurements. Those omissions matter because the analysis method determines how the observed data are converted into an estimate and its uncertainty.

What does a mean describe?

As a general statistical concept, a mean is a measure of the centre of a set of numeric observations. A standard deviation describes how spread out observations are around that mean. For a continuous clinical measure such as EASI, the mean can give a compact group summary, while the standard deviation conveys variability among participants. These summaries do not reveal the full shape of the data. If observations are skewed or contain unusual values, the mean and standard deviation may not describe all relevant features of the distribution. The registry identifies mean and standard deviation for the outcome, but does not report the actual summaries or distributional assessments.

How should a group comparison be read?

In general, a randomized parallel-group comparison estimates how the outcome differs between participants assigned to the two groups. A difference in group means is one way to express that contrast for a continuous outcome. Its uncertainty depends on the observed variation, the amount of outcome information available, and the analysis method. A confidence interval gives a range of plausible values for the contrast under the statistical procedure used. It is not a guarantee that the true value lies within the interval, and it does not by itself determine clinical importance. No group means, contrast, or confidence interval are reported in the registry record, so these interpretations cannot be applied to a numerical primary result.

What do the planning assumptions mean?

The registry record describes a sample-size planning illustration based on an observed effect, rather than the trial's own design justification. Its stated assumptions are a two-sided significance level of 0.05, equal allocation between the two arms, and a normal approximation; the effect to detect is defined as a stated fraction of the observed effect. For time-to-event planning, the stated convention is a total event count; for other outcomes, the convention is participants per arm. These are assumptions for a planning illustration, not evidence that the trial used that method to choose enrollment or that the trial had a particular probability of detecting an effect.

In general, planning calculations estimate how much information may be needed to detect a specified effect under assumptions about variability, allocation, and statistical testing. Changing the effect targeted or the assumptions can change the resulting planning quantity. Such calculations should not be described as observed power after a study is complete. No numerical planning values or observed primary effect are reported in the registry record, and the record does not report the protocol's sample-size justification. The illustration therefore cannot establish what effect the trial was designed to detect.

Why does variability matter?

General statistical reasoning distinguishes the size of an estimated effect from the uncertainty around it. Greater variation in a continuous outcome can make an estimate less precise when other design features are held constant. A standard deviation is one way to describe that variation, but the trial's actual standard deviations are not reported. If the distribution or data structure departs from assumptions used by a model, a different method may be needed; whether such checks or alternatives were considered is not reported in the registry record. There is no basis for asserting that a particular assumption was met or violated in this trial.

Over-dispersion is a general concern for some models when observed variability exceeds what a model expects. It can lead to uncertainty estimates that are too small if it is ignored. The registry identifies a continuous mean outcome and does not state that a count model or an over-dispersion correction was used. This concept is therefore general context, not a claim about the analysis of this trial.

What can randomization and masking contribute?

In general, random allocation is intended to make treatment groups comparable with respect to measured and unmeasured characteristics, on average, before treatment. It does not ensure that every characteristic is balanced in a particular trial, especially when group sizes are limited. Masking can reduce the influence of expectations on assessment or participant reporting, depending on who is masked and how the procedures work. Here the registry describes the study as randomized and double-blind, but the allocation procedure, masked roles, and masking safeguards are not reported in the registry record. These design labels cannot replace outcome estimates or an account of analysis decisions.

10. Multiplicity, Missing Data and Analysis Populations

The registry record lists a primary EASI outcome and secondary outcomes of interim EASI, itch assessment, and IGADA. It does not report a multiplicity strategy for interpreting results across those outcomes or across any repeated assessments. When several outcomes or comparisons are examined, general statistical practice may account for the increased chance of a false-positive finding across a family of tests. The record does not say whether such an adjustment or another prespecified approach was used. Since no outcome analyses are posted, the impact of multiplicity on the reported findings cannot be assessed.

Missing-data handling is not reported in the registry record. The primary outcome population is named as ITT, but this label alone does not explain how participants without a 3-week EASI measurement were treated, whether any values were imputed, or how withdrawals were handled. The record does not describe the completeness of outcome collection, reasons for missing measurements, or sensitivity analyses. These details are important because an analysis can be affected when outcome availability differs across participants or treatment groups.

The registry reports zero analyses and does not post a primary outcome comparison. It also does not report interim analysis procedures or a statistical analysis plan. The record's reference to an interim EASI secondary outcome does not establish that an interim efficacy analysis was conducted; it names an outcome, not an analysis schedule. The ITT designation identifies the intended primary population but does not provide enough information to reconstruct the analysis population or assess departures from assigned treatment.

11. Safety Results

The registry reports serious adverse events as affected participants divided by participants at risk.

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 adverse-event summary lists 45 participants at risk in each group. For serious adverse events, 0 participants are listed as affected in the experimental cream group and 0 in the marketed cream group. The registry lists 6 participants affected by other adverse events in the experimental group and 2 in the marketed-cream group. These are counts as recorded, not a complete account of event type, timing, severity, or duration.

The serious-event entries should not be confused with the broader other-adverse-event counts. A zero in the serious-event field means the registry lists no affected participants in that category for the arm; it does not mean that no adverse events of any kind occurred. The record does not list serious adverse-event terms. It does not identify the other events in the summary, and a participant count does not necessarily convey the number of events when a participant could experience more than one event. No rate or comparative risk calculation is presented.

The deaths field is not reported in the registry record. The event counts alone do not establish whether a difference between groups is statistically reliable or clinically important. The registry record also does not provide a detailed safety analysis or an explanation of event ascertainment.

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

The record establishes that a randomized, double-blind, active-controlled study of topical creams in children with mild to moderate atopic dermatitis was completed. It identifies EASI at 3 weeks as the primary outcome and names the ITT population. It also identifies secondary assessments and posts selected adverse-event counts. These details describe the research question and some of the recorded safety information.

They do not show whether the experimental cream produced a higher or lower mean EASI than the marketed cream, or how large or precise any difference was. No primary outcome group summaries, comparative estimate, confidence interval, or test result are reported in the registry record. Therefore, the posted record cannot support a conclusion about comparative efficacy based on the primary outcome. The lack of a posted estimate is not evidence that the groups were identical, nor does it establish that one group had a better result.

The adverse-event entries also have limited scope. They show zero participants affected by serious adverse events in each arm and list other adverse events for 6 participants in the experimental arm and 2 in the marketed-cream arm. Without event descriptions, timing, a prespecified safety analysis, or uncertainty estimates, these counts do not establish the nature or comparative importance of safety differences. The deaths field is not reported in the registry record.

More broadly, a completed trial record is not equivalent to a complete account of the study's findings. Information about the analysis plan, missing measurements, adherence, and protocol-based sample-size justification is not reported. These gaps limit reproducibility and make it difficult to assess how the intended outcomes were translated into final analyses. The justified interpretation is narrow: the trial's design and outcomes are specified, but the primary result needed to quantify the EASI comparison is unavailable in the registry record.

13. Why This Trial Matters Statistically

This trial illustrates a central issue in clinical-trial interpretation: a clearly named endpoint and a completed study do not by themselves provide evidence about the size or precision of a treatment contrast. The record identifies a continuous primary measure, the intended population, and a timeframe. Yet without the group means, between-group estimate, and uncertainty interval, a reader cannot evaluate the primary comparison. Registration details are useful for understanding what was intended, but outcome reporting is needed to interpret what the data show.

The active-control design also makes the comparator important. The question is about an experimental topical cream relative to a marketed topical cream, not relative to no treatment. That distinction defines the scope of any future result. The registry's description of both creams as applied twice daily or as needed gives some context for the comparison, while leaving adherence and other treatment-use details unreported.

The record highlights why analysis transparency matters. Naming ITT as the primary population does not explain how missing outcomes were handled, and listing several outcomes does not show whether multiplicity was considered. A statistical plan and transparent results would help readers understand which comparisons were prespecified, how uncertainty was quantified, and how incomplete data affected the estimates.

Finally, the safety entries demonstrate the difference between descriptive counts and a full comparative safety assessment. Counts can signal what was recorded in each arm, but they do not describe event details or quantify uncertainty. In this case, the registry record contains some safety counts but no primary efficacy estimates. Reading these elements separately avoids treating a limited safety summary as a substitute for the missing primary outcome analysis.

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 most important limitation of the registry record for interpreting this trial is that the primary EASI results are not reported. There are no group means, standard deviations, between-group estimate, confidence interval, or test result. Consequently, the direction, magnitude, and precision of the primary comparison cannot be assessed. The record's completed status does not resolve that information gap.

The record identifies the ITT population but does not define its operational handling. It does not report how missing EASI measurements, withdrawals, or deviations from assigned treatment were addressed. Outcome completeness, adherence, and discontinuations are not reported in the registry record. These omissions prevent assessment of whether the posted analysis population matches the intended population or whether missingness could have affected the estimate.

Several secondary outcomes are named, but their results and analysis details are not reported. The record does not describe multiplicity handling, an interim-analysis plan, or the statistical analysis plan. It also does not provide a protocol-based sample-size justification. The planning assumptions described for an illustration should not be mistaken for documentation of the trial's original design rationale.

For safety, the record gives counts of affected participants but does not provide event descriptions for the other-adverse-event category or details such as timing and severity. The deaths field is not reported in the registry record. The description of the intervention list includes colloidal oatmeal and topical cream, while the arm descriptions identify experimental and marketed topical creams; the relationship between these entries is not explained. Further eligibility details and the procedures for allocation and double masking are also not reported. These limitations are specific to the information available in the registry record and constrain interpretation beyond the posted design and counts.

15. Related Tutorials

16. Related Statistical Calculators

17. Sources

• ClinicalTrials.gov: Human Testing of an Over-the-Counter (OTC) Cream in Children With Eczema — NCT01326910.
• Registry record last updated 2012-08-03; status last verified 2012-06.
• Results first posted 2012-08-03.
• 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

NCT01326910 is a completed, randomized, double-blind, parallel-group trial of an experimental topical cream versus a marketed topical cream for children with mild to moderate atopic dermatitis. The record lists enrollment as 90 and gives 45 participants at risk in each arm for the adverse-event summaries. The primary outcome is mean EASI in the ITT population at 3 weeks.

The registry lists interim EASI, itch assessment, and IGADA as secondary outcomes. It reports zero participants affected by serious adverse events in each arm, and other adverse events affecting 6 participants in the experimental arm and 2 in the marketed-cream arm. The deaths field is not reported in the registry record.

Primary outcome results and analyses are not reported in the registry record. The statistical analysis plan, missing-data handling, multiplicity approach, and protocol-based sample-size justification are also not reported. The design and selected safety counts can be described, but the primary EASI comparison cannot be evaluated from the posted results.