Clinical Investigation on the Efficacy and Safety of Relizema Ecofoam: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Clinical Investigation on the Efficacy and Safety of Relizema Ecofoam (NCT05001139), a na na study. The primary outcome is Number of Participants Who Responded to Treatment With IGA Scale.

2. Clinical Question

The central statistical question is therefore descriptive: what participant response count was recorded at the stated assessment time? A single-group study can describe outcomes among the participants receiving the intervention, but it cannot estimate a contrast against a concurrent untreated or alternative-treatment group. Without a comparator, changes over time cannot be separated from other influences, such as the natural course of dermatitis, concurrent care, or expectations in an open-label study.

The IGA is described as a five-point severity scale, ranging from 0 = clear to 4 = severe. The registry record says severity would be measured after 28 days, but it does not state which score or change counted as a response. Nor does it report the observed distribution of IGA scores at that assessment. The participant-level result needed to answer the primary question is therefore not reported in the registry record.

3. Trial Design

The registry describes a completed, multicenter, open-label, uncontrolled, single-group study of Relizema ecofoam. Its official title identifies adults with atopic and contact dermatitis, while the recorded condition is dermatitis. Enrollment was 13. The registry lists no phase beyond NA, and allocation is also recorded as NA. Masking is listed as NONE. No randomized comparison or control arm is described.

The intervention is classified as a device. The arm description states that Relizema ecofoam was used for 42 days, 2 times per day. The primary endpoint is specified after 28 days of treatment, which is an assessment during the stated treatment period. Secondary outcomes include participant response, Eczema Area and Severity Index (EASI) scores, visual analogue scale scores for itching, burning, pain and pruritus, quality-of-life scores, global evaluations of performance by the subject and investigator, and the subject's overall acceptability of treatment. The listed time points for several secondary measures are 14, 28 and 42 days.

The registry record gives a start date of 2021-11-15, a primary completion date of 2022-12-29 and a status of COMPLETED. Those entries describe the study's recorded status and timing; they do not supply the clinical results. The record does not report the recruitment pathway, detailed eligibility criteria, participant characteristics, adherence, concomitant treatments, protocol deviations, or the number of participants assessed at each time point.

Because the design has no control group and is open label, the study can document observations among participants treated in this group, but it cannot provide a controlled estimate of the intervention's effect relative to another group. The registry record does not report a detailed statistical analysis plan, a rationale for the enrollment target, or a sample-size justification. The listed study design and enrollment should not be interpreted as evidence that a particular effect could be detected with a specified precision.

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

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 Number of Participants Who Responded to Treatment With IGA Scale, measured over after 28 days of treatment.

The primary endpoint is the number of participants who responded to treatment with the Investigator Global Assessment (IGA) after 28 days of treatment. The registry describes the IGA as a five-point scale for dermatitis severity: 0 = clear, 1 = almost clear, 2 = mild, 3 = moderate and 4 = severe. The endpoint is a count of participants, rather than a continuous measure of severity, according to the registry description.

A response count can provide a direct summary of how many participants met a defined outcome criterion at a stated assessment. It is often easier to interpret clinically than a scale average, because it focuses on the number meeting the response definition. That usefulness depends on a clear, prespecified definition of response. In this record, the title refers to participants who responded, but the response threshold or rule is not reported in the registry record. It is not possible to determine whether response meant reaching a particular IGA category, improving by a specified amount, or meeting another criterion.

The registry record also does not report the observed count or the number with an available IGA assessment at the primary time point. Therefore, neither the response frequency nor its precision can be evaluated from the posted primary result. The endpoint's stated timing is after 28 days, while the arm description specifies use for 42 days; no further details of assessment scheduling are reported in the registry record.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

What does a single-group result describe?

General statistical context: a single-group study summarizes outcomes among participants who received the intervention. A count endpoint can state how many participants met a defined criterion, while a scale endpoint can describe scores or changes in scores. These summaries answer a descriptive question about the observed group. They do not, by themselves, identify what would have happened to those same participants under a different treatment or without the intervention. A comparator group can help estimate such a contrast when the groups and their follow-up are suitable for that purpose.

Here, the registry describes the study as uncontrolled and single group, with no comparator listed. The posted primary result is not reported, so there is no observed response count to summarize. The response rule is also not stated, which matters because different rules can yield different counts even when based on the same scale.

What does the IGA scale measure?

The registry describes the Investigator Global Assessment as a five-point severity scale, with 0 = clear, 1 = almost clear, 2 = mild, 3 = moderate and 4 = severe. The levels are ordered categories: a higher category denotes greater severity in the stated description, but the distances between adjacent categories are not established as equal. General statistical context: an ordered scale may be summarized using category counts or an explicitly justified numerical summary. Treating the scale as if every step represents the same amount of change requires assumptions that are not specified in the registry record.

A responder endpoint converts a scale or other measurement into a count by applying a rule. That rule should be clear enough to identify who qualifies and at what time. The registry lists a primary outcome named as the number of participants who responded to treatment with IGA after 28 days, but the criterion for response is not reported in the registry record. The outcome count and the number assessed at that time are also not reported.

Why do uncertainty estimates matter?

General statistical context: a confidence interval expresses the uncertainty around an estimate under a stated statistical model and method. For a participant count or proportion, uncertainty depends on the observed outcome information and the analysis approach. A point estimate without an uncertainty interval can appear more definitive than the data warrant; an interval can show the range of values compatible with the data under the method's assumptions. Neither an interval nor a p-value resolves limitations in study design, such as the absence of a comparator.

No confidence interval or other inferential estimate for the primary endpoint is reported in the registry record. Since the observed response count and response definition are absent, the primary endpoint's precision cannot be assessed from the posted results. The number enrolled should not be mistaken for an outcome count or an estimate of precision.

What can be inferred from the study structure?

General statistical context: an open-label design means treatment assignment is not masked from those involved in the study, as reflected by the masking entry NONE. An investigator-rated endpoint may be affected by expectations or knowledge of treatment, although the magnitude and direction of any influence cannot be determined from the design label alone. A comparator can address some questions about change over time, but this record lists none. The registry does not report masking safeguards, assessor training, or other procedures for measurement consistency.

The study is described as multicenter, but the registry record does not report the number of centers or center-specific results. When outcomes are collected across centers, differences in recruitment, assessment or practice may affect how results are interpreted. Whether or how such variation was handled statistically is not reported in the registry record.

How should planning calculations be distinguished from results?

General statistical context: sample-size planning uses assumptions about the effect to detect, variability, error rates and design. It is a prospective illustration of what a study might require under those assumptions, not an observed result and not proof that the completed study had adequate power. A post hoc calculation based on an observed effect is also not “observed power”; it cannot substitute for the estimate and its uncertainty.

The record's planning assumptions describe a two-sided significance level of 0.05, equal allocation between two arms, a normal approximation, and an effect to detect stated as a fraction of the observed effect. These assumptions describe a planning illustration, not the design of this single-group study. No sample-size justification for the trial itself is reported in the registry record, and no planning result should be read as an outcome or an efficacy finding.

What is over-dispersion?

General statistical context: over-dispersion occurs when observed variability is greater than a statistical model assumes. It can make standard errors too small and confidence intervals too narrow if the model does not account for that extra variability. It is relevant to some count or clustered data analyses, but the registry record does not report an analysis of this kind, an over-dispersion assessment, or an efficacy model. It would be inappropriate to infer that such a method was used.

In short, the registry gives enough information to identify the planned primary measure and broad design, but not enough to reconstruct an efficacy analysis. The response criterion, observed primary result, analysis population, missing-data handling, and inferential methods are not reported in the registry record.

10. Exact Estimates for Each Arm

No two-arm comparison is shown for this trial, but each arm's result can still be summarized with exact interval estimates computed from the posted counts. The Clopper-Pearson interval is exact and conservative; the Wilson interval is a common closer-to-nominal alternative; the Bayesian credible interval uses a uniform Beta(1, 1) prior. For small groups the three can differ noticeably.

R code and output

arm    <- c("Relizema Ecofoam")
n      <- c(7)
events <- c(3)
for (i in seq_along(n)) {
  ci <- binom.test(events[i], n[i])$conf.int          # Clopper-Pearson exact interval
  cr <- qbeta(c(0.025, 0.975), 1 + events[i], 1 + n[i] - events[i])   # Bayesian, uniform Beta(1,1) prior
  wi <- (function(x, n) { p <- x / n; z <- qnorm(0.975); d <- 1 + z^2 / n
    c((p + z^2 / (2 * n) - z * sqrt(p * (1 - p) / n + z^2 / (4 * n^2))) / d, (p + z^2 / (2 * n) + z * sqrt(p * (1 - p) / n + z^2 / (4 * n^2))) / d) })(events[i], n[i])
  cat(sprintf("ARM|%s|%d|%d|%.1f|%.1f|%.1f|%.1f|%.1f|%.1f|%.1f\n", arm[i], n[i], events[i], 100 * events[i] / n[i],
              100 * ci[1], 100 * ci[2], 100 * wi[1], 100 * wi[2], 100 * cr[1], 100 * cr[2]))
}

ARM  Relizema Ecofoam  7  3  42.9  9.9  81.6  15.8  75.0  15.7  75.5

11. Multiplicity, Missing Data and Analysis Populations

The record lists several secondary outcome families: participant response, Eczema Area and Severity Index scores, visual analogue scale scores for itching, burning, pain and pruritus, quality-of-life scores, global evaluations of performance by the subject and investigator, and overall acceptability. Several are scheduled at 14, 28 and 42 days. Examining multiple outcomes or time points can increase the chance of a seemingly notable finding arising by chance if results are tested repeatedly. General statistical context: prespecified priorities and a multiplicity strategy can clarify how a set of tests should be interpreted.

A multiplicity adjustment, hierarchy of outcomes, or other strategy for handling multiple comparisons is not reported in the registry record. The record lists 8 outcome measures, but it does not provide the analysis results for those outcomes. There are no efficacy analyses listed in the posted results.

Missing-data handling is also not reported in the registry record. The enrollment is 13, but the number with an available primary assessment after 28 days is not stated. The record does not describe withdrawals, incomplete assessments, imputation, or sensitivity analyses. Without this information, the extent and possible influence of missing outcome data cannot be evaluated.

The analysis population is not reported in the registry record. It is not clear whether the planned analyses were to include all enrolled participants, only participants with a particular level of treatment exposure, or those with observed outcome assessments. The registry also does not report exclusions or protocol deviations. These omissions prevent a detailed assessment of how participants were included in outcome summaries.

12. 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 reports 13 participants at risk for serious adverse events, with 0 affected. It also reports 13 at risk for other adverse events, with 0 affected, and 0 deaths. These figures describe the posted safety counts for the Relizema Ecofoam group. They are counts, not comparative risk estimates, because no control group is listed.

A zero count in a study with 13 participants does not establish that an event cannot occur or that risk is absent. General statistical context: safety observations from a small group can identify events that were recorded in that group, but may provide limited information about uncommon events or differences in risk. The record does not provide event narratives, event definitions beyond the serious and other categories, or a detailed reporting window. It also does not describe how events were solicited or adjudicated.

The registry's figures should therefore be read narrowly: no serious adverse events, other adverse events or deaths are listed among the participants recorded as at risk. The counts do not answer how the intervention compares with another treatment, and they do not establish a broader safety profile.

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

The registry record identifies a completed, open-label, uncontrolled study of Relizema ecofoam in adults with atopic and contact dermatitis, with enrollment of 13. Its primary endpoint is a count of participants who responded by IGA after 28 days. This identifies the study's intended primary clinical measure, but the record does not report the response definition or participant count. As a result, the posted record does not provide a numerical efficacy result for the primary endpoint.

The record lists other outcomes intended to assess severity, symptoms, quality of life, global evaluation and treatment acceptability. Their presence does not establish what participants experienced: the corresponding numerical results are not reported in the registry record. Likewise, the absence of listed efficacy analyses means no inferential estimate can be interpreted from the posted results.

The uncontrolled design places a limit on what any within-group observation could establish. A change after treatment would be an observation over time in treated participants, not a controlled estimate of the difference attributable to the intervention. Open-label assessment adds another interpretive consideration for investigator-rated outcomes. Neither point proves that an observed change would be biased; rather, they describe why the design cannot rule out alternative explanations as a controlled comparison might.

The posted safety counts are 0 serious adverse events, 0 other adverse events and 0 deaths, with 13 participants at risk for each adverse-event category. Those data describe the recorded group and do not establish that events are impossible or characterize comparative safety.

Accordingly, the registry record supports a description of the intended study question, treatment schedule, design and recorded safety counts. It does not support a quantitative estimate of response, a claim about change in dermatitis severity, or a treatment comparison. The primary outcome count, response rule, secondary outcome results and uncertainty estimates are not reported in the registry record.

14. Why This Trial Matters Statistically

This study is statistically informative as an example of the distinction between a registered question and a reportable result. The record specifies a primary outcome—participants responding by IGA after 28 days—and describes the scale used to assess dermatitis severity. Yet the response criterion and the observed count are not reported. Without those details, the primary endpoint cannot be translated into an interpretable estimate.

The design also illustrates the role of a comparator. A single-group study can document what was observed among participants receiving an intervention, but it does not estimate a controlled contrast. For an outcome that may change over time, the absence of a comparator leaves other explanations unresolved. That limitation is important independently of whether the observed outcomes, if available, were favorable or unfavorable.

Enrollment of 13 makes it especially important not to overread a zero adverse-event count or a hypothetical planning calculation. The registry records 0 serious adverse events, 0 other adverse events and 0 deaths, but those figures describe only the recorded group. Planning assumptions are distinct from observed outcomes and cannot establish that the trial had adequate precision.

The record names multiple secondary outcomes and assessment times, raising a further general issue: results across several measures need a clear statistical interpretation, including disclosure of how multiplicity and missing observations were handled. Those methods are not reported in the registry record. Together, these features show why transparent endpoint definitions, participant flow, outcome data and analysis methods are necessary for readers to assess both the magnitude and reliability of clinical findings.

15. 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 limitations restrict interpretation of the registry record. The study is open label, uncontrolled and single group, with no comparator listed. Thus, the record does not provide a controlled treatment contrast. Enrollment was 13, and the registry does not report participant characteristics or the number with outcome assessments at each time point.

The primary endpoint is named as the number of participants who responded to treatment with IGA after 28 days, but the response threshold is not reported. The observed count and IGA score distribution are also not reported. The registry does not clarify how the 28-day assessment relates to treatment discontinuation or other assessment procedures. Although the intervention is described as use for 42 days, 2 times per day, adherence information is not reported.

Secondary outcomes are listed at stated time points, but numerical findings are not reported in the registry record. The record also does not report analysis populations, missing-data methods, protocol deviations, multiplicity handling, or a detailed statistical analysis plan. The number of centers and any center-level variation are not reported, despite the multicenter description.

Safety reporting is limited to the event counts and numbers at risk. Event details, the adverse-event observation window and collection procedures are not reported in the registry record. These omissions mean the posted record can be used to describe the study's design and recorded counts, but not to reconstruct a full efficacy or safety analysis.

16. Related Tutorials

17. Related Statistical Calculators

18. Sources

• ClinicalTrials.gov: Clinical Investigation on the Efficacy and Safety of Relizema Ecofoam — NCT05001139.
• Registry record last updated 2025-03-18; status last verified 2025-02.
• Results first posted 2025-03-18.
• 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.

19. Record Summary

NCT05001139 is recorded as a completed, multicenter, open-label, uncontrolled, single-group study of Relizema ecofoam in adults with atopic and contact dermatitis. Enrollment was 13. The arm description specifies use for 42 days, 2 times per day. The primary endpoint is the number of participants responding by Investigator Global Assessment after 28 days; the response definition and observed count are not reported in the registry record.

The record lists secondary outcomes concerning participant response, severity, symptoms, quality of life, global evaluation and acceptability, but does not report their numerical results. It records 0 serious adverse events, 0 other adverse events and 0 deaths, with 13 participants at risk for each category. Analysis methods, missing-data handling, analysis populations and a trial-specific sample-size justification are not reported in the registry record.