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 EpiCeram for Skin Protection in Healthcare Workers (NCT04793711), a na na study. The primary outcome is Change in Patient Reported Outcome of Overall Skin Irritation Symptoms.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT04793711 |
| Phase | NA |
| Condition | Irritant Contact Dermatitis |
| Allocation | Not applicable (single group) |
| Design model | Single Group |
| Masking | None (open label) |
| Enrollment | 1 |
| Arms in the primary outcome | n/a |
| Lead sponsor | Primus Pharmaceuticals |
| Results posted | Yes |
2. Clinical Question
Population
The study concerned healthcare workers experiencing skin irritation associated with extensive use of personal protective equipment (PPE). The registry describes symptoms such as pain, redness, roughness, dryness, cracking, and itching, and identifies irritant contact dermatitis as the condition. Although that was the intended population, the study enrolled only one participant before termination, so the record cannot establish how well that participant represents healthcare workers more broadly.
Intervention
The intervention was EpiCeram, described in the registry as a topical emollient-type skin barrier repair product. The listed regimen was open-label application to the hands and face, 3 times per day, for 28 days. The record describes ingredients intended to improve skin barrier function; it does not report a measured treatment effect for the enrolled participant.
Comparator
There was no comparator group. The study is registered as a single-group, open-label study, and only one product was used. Consequently, the design cannot distinguish changes occurring during the study from changes that might have occurred over the same period without EpiCeram or with another intervention.
Primary question
The primary outcome was change from baseline to Day 28 in the participant-reported overall irritation symptoms of the face and hands. The combined symptom assessment used an ordinal scale from 0 to 10, where 0 meant none and 10 meant worst. The registry record does not report an outcome value or analysis, so it does not answer whether the score changed during the study.
3. Trial Design
The registry describes a single-group, open-label study of EpiCeram for skin protection in healthcare workers using PPE. The study had no control arm and no masking. The registry explains open-label status as meaning that people involved in the study would know the product being used. The intervention was topical application to the hands and face, 3 times per day, for 28 days. The planned primary assessment compared a participant-reported symptom score at baseline with the score at Day 28.
The record lists enrollment of 1 and status as terminated. Its summary states that the study ended after one participant was enrolled because willing participants could not be found. Thus, the study did not accrue a group large enough to describe a pattern across participants or support a comparative treatment estimate. The registry record does not report whether the enrolled participant completed the planned regimen or the Day 28 assessment.
The listed secondary outcomes concern changes in surface skin pH, transepidermal water loss, and stratum corneum hydration. The registry also records ten outcome measures, but it reports zero analyses. The presence of outcome measures in a registry does not itself mean that results were collected or analyzed. Numerical results for the primary and secondary outcomes are not reported in the registry record.
The record identifies the study as not applicable for phase and allocation. No randomized allocation is described, and there is no like-for-like control comparison. The registry record does not report a statistical analysis plan, a sample-size justification for this single-group design, or an interim analysis plan. A separate planning description refers to equal allocation between two arms, a two-sided significance level of 0.05, and a normal approximation. Those are planning assumptions, not a description of the registered single-group study or its observed results.
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 | EpiCeram |
|---|---|
| STARTED | 1 |
| COMPLETED | 1 |
| NOT COMPLETED | 0 |
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 | Active Arm EpiCeram |
|---|---|---|
| Participants analysed | 1 | |
| Age, Categorical: <=18 years | Participants | 0 |
| Age, Categorical: Between 18 and 65 years | Participants | 1 |
| Age, Categorical: >=65 years | Participants | 0 |
| Sex: Female, Male: Female | Participants | 1 |
| Sex: Female, Male: Male | Participants | 0 |
| Ethnicity (NIH/OMB): Hispanic or Latino | Participants | 0 |
| Ethnicity (NIH/OMB): Not Hispanic or Latino | Participants | 1 |
| Ethnicity (NIH/OMB): Unknown or Not Reported | Participants | 0 |
| Race (NIH/OMB): American Indian or Alaska Native | Participants | 0 |
| Race (NIH/OMB): Asian | Participants | 0 |
| Race (NIH/OMB): Native Hawaiian or Other Pacific Islander | Participants | 0 |
| Race (NIH/OMB): Black or African American | Participants | 0 |
| Race (NIH/OMB): White | Participants | 1 |
| Race (NIH/OMB): More than one race | Participants | 0 |
| Race (NIH/OMB): Unknown or Not Reported | Participants | 0 |
| Overall Irritation Score | units on a scale | 7 |
6. Primary Endpoint
The registry lists the primary outcome as Change in Patient Reported Outcome of Overall Skin Irritation Symptoms, measured over Baseline to Day 28.
| Element | Registry entry |
|---|---|
| Result type | Mean |
| Measure of spread | Full Range |
| Unit | score on a scale |
| Endpoint classification | not reduced to a single comparison |
The primary endpoint was change in the participant-reported overall irritation symptoms of the face and hands from baseline to Day 28. The participant was asked to combine the overall irritation experience into one score on an ordinal scale from 0 to 10, with 0 defined as no irritation and 10 as the worst irritation. An ordinal score represents ordered categories: a larger score indicates a worse position on the scale, but the distance between adjacent score values is not necessarily equal in lived symptom intensity.
A combined symptom score can provide a direct account of how a participant perceives the overall burden of irritation, rather than relying only on a physical measurement. It is relevant to the symptoms described in the registry, including dryness, redness, pain, roughness, cracking, and itching. General statistical context: subjective measures can capture experiences that laboratory or instrument readings do not, while also depending on how a participant interprets and uses the scale. Repeated assessment at baseline and a later time point can describe within-person change if both measurements are available.
The record names a mean and full range as the endpoint summary, but it does not report the actual baseline score, Day 28 score, change, or range. With only one participant enrolled, the registry record also provides no distribution of participant scores. The intended endpoint is therefore clear, but its observed value and precision are not reported in the registry record.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The main statistical feature of this study is that it ended after one participant was enrolled. The registry states that termination followed an inability to find willing participants. This severely limits what can be learned from the study: one participant cannot provide a reliable estimate of the range of outcomes among healthcare workers, and the design includes no concurrent comparison group.
The primary outcome was defined as change in overall irritation symptoms from baseline to Day 28, using a participant-reported 0-10 ordinal scale. However, the registry record does not report the participant's score at either time point or the change between them. It also reports zero analyses. There is therefore no posted primary outcome estimate to interpret, and no reported confidence interval or hypothesis test for that outcome. The endpoint definition describes what the study intended to measure, not what the participant experienced.
The same distinction applies to the listed secondary outcomes: surface skin pH, transepidermal water loss, and stratum corneum hydration. Their inclusion identifies intended measurements, but numerical results and analyses are not reported in the registry record. The count of ten outcome measures does not fill that gap. Without reported observations and an analysis, neither the direction nor the size of change can be described from the registry.
The single-group design also limits causal interpretation even if a before-and-after score were available. General statistical context: a change measured in one group over time can reflect the intervention, but can also reflect natural fluctuation, changes in exposure, expectations, measurement variability, or other events occurring during the same period. A concurrent control group can help distinguish these explanations; this study had none. Open-label assessment can also be influenced by awareness of the product, particularly for a subjective symptom score. These are design considerations, not claims about what happened to the participant.
The registry does not report whether the participant completed treatment or attended the final assessment. It therefore cannot be assumed that baseline and Day 28 data were both collected. No missing-data method or analysis population is reported. The participant's enrollment does not establish that the participant contributed an endpoint result.
The study's termination should be read as a recruitment limitation documented by the registry, not as evidence about the product's effect. Likewise, the absence of reported outcome analyses is not evidence that symptoms stayed the same or changed. The record supports a description of the intended question, intervention, and reason for stopping, but not an estimate of benefit or lack of benefit.
The planning description refers to sample-size illustrations based on a stated fraction of an observed effect, with a two-sided significance level of 0.05 and equal allocation between two arms. Such figures, when available, are planning illustrations rather than observed power. They do not alter the fact that the registered study was single-group and enrolled one participant. A sample-size illustration cannot substitute for observed outcome data or a treatment comparison.
9. Statistical Methods Explained
The registry names a primary outcome and a summary approach, but reports zero analyses. This distinction matters: a planned outcome is a measurement the study intended to collect, while an analysis requires observed data and a specified procedure for describing or comparing them. The outcome's title and timeframe do not establish that the measurement was obtained. Numerical outcome results are not reported in the registry record.
What does a change score represent?
General statistical context: a change score is a participant's later measurement considered relative to that participant's earlier measurement. For this study, the intended timepoints were baseline and Day 28. If both values are observed, the change can describe the direction and size of within-participant movement on the symptom scale. It does not, by itself, identify why the movement occurred. In an uncontrolled study, time, changing PPE exposure, symptom fluctuation, expectations, and measurement variability remain possible explanations alongside the intervention.
The registry describes the primary outcome as a mean with a full range. A mean is a measure of central tendency, while a range describes the lowest and highest observed values. General statistical context: these summaries convey different aspects of a distribution. A mean does not show whether participants had similar or widely varying responses; a range can show the observed span but is sensitive to the number of observations. With one participant enrolled, the record cannot provide a meaningful between-participant distribution. It also does not report the individual score or a calculated change.
How should the ordinal scale be understood?
The symptom scale is ordinal: its values are ordered from none to worst. General statistical context: ordinal measurements rank responses, but do not necessarily guarantee that every one-step increase represents the same amount of symptom change. Calculating a mean from ordinal scores can be useful as a compact summary in some settings, but interpretation depends on whether treating the score spacing as approximately equal is reasonable. The registry names the mean and full range but does not report further details about the analytic approach or its assumptions.
A confidence interval, in general, describes the uncertainty around an estimated quantity under a statistical model. It is not a guarantee that the true value lies within the interval. A hypothesis test evaluates data against a specified null hypothesis under its assumptions. Neither an interval nor a test is reported for the primary outcome in this record. With no outcome estimate posted, there is no basis for interpreting the precision of a treatment-related change. A p-value cannot be inferred from the endpoint definition, enrollment count, or safety counts.
What does a control group contribute?
General statistical context: a control group gives a reference for changes over the same period, helping separate changes associated with the intervention from background changes and other influences. This study is registered as single-group and open-label, so it has no such reference. A baseline assessment can act as a within-person reference but is not equivalent to a concurrent control group. In particular, before-and-after observations cannot alone rule out changes in PPE use, work conditions, symptom course, or expectations.
Masking is listed as none. For a subjective symptom outcome, awareness of treatment may affect reporting or assessment. This possibility is a general design concern, not evidence that the participant's responses were biased. The registry record does not describe any steps used to limit such influence.
How do the planning assumptions fit?
The registry's planning description refers to a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation. It also says that the effect to detect is a stated fraction of an observed effect. These are planning assumptions, not observed results, and they do not describe the registered single-group design. The record does not report a sample-size justification for the study as conducted. Any planning sample sizes are illustrations, not observed power and not evidence that the trial had a particular probability of detecting an effect.
General statistical context: normal approximations rely on conditions under which a sampling distribution is sufficiently well represented by a normal distribution. Small or sparse datasets can make approximations unstable or unsuitable. Over-dispersion, in general, means that variation in the observed data exceeds what a chosen model expects; accounting for it can affect uncertainty estimates. The registry does not report a model, dispersion assessment, or inferential analysis for the primary endpoint. These concepts therefore explain possible methods considerations, not procedures confirmed for this study.
The record does not provide an analysis plan, adjustment strategy, confidence interval method, hypothesis test, or model specification. It is not appropriate to infer one from the description of the outcome or from generic planning assumptions. The reported design and outcome definition are enough to explain the intended question, but not enough to reconstruct an unreported analysis.
10. Multiplicity, Missing Data and Analysis Populations
The registry identifies a primary outcome concerning overall irritation symptoms and lists secondary outcomes for surface skin pH, transepidermal water loss, and stratum corneum hydration. It also records ten outcome measures and zero analyses. Numerical results and analysis details are not reported in the registry record. The record does not explain whether the outcomes were intended to be tested jointly, in a hierarchy, or as separate exploratory measures.
General statistical context: multiplicity arises when several outcomes or hypotheses are examined. If each is tested separately, the chance of at least one apparently notable result can increase, depending on the testing plan and the relationships among outcomes. Prespecified strategies, such as prioritizing one primary test or adjusting for multiple tests, can address that issue. The registry record does not report a multiplicity strategy, so no particular adjustment or outcome hierarchy should be assumed.
The study enrolled one participant and was terminated because willing participants could not be found. The registry does not state whether all intended measurements were obtained for that participant, whether the Day 28 visit occurred, or whether any measurement was missing. A missing-data method, imputation procedure, or sensitivity analysis is not reported. No analysis population is specified; the record does not say whether analyses would have included all enrolled participants, only participants with completed assessments, or another group.
General statistical context: missing observations can affect interpretation when the likelihood of missingness is related to a participant's symptoms, experience, or participation. Imputation does not recover a known value; it relies on assumptions that need to be described. With no posted endpoint analysis and no reported assessment-completion information, the impact of missing data cannot be evaluated. The one-person enrollment count should not be treated as proof that an endpoint measurement was available.
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 |
|---|---|---|---|
| Active Arm EpiCeram | 0 | 1 | 0.0% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| Active Arm EpiCeram | 0 of 1 |
Other (non-serious) adverse events
Participants with at least one non-serious event at or above the registry's 0% reporting threshold.
| Arm | Participants affected of at risk |
|---|---|
| Active Arm EpiCeram | 0 of 1 |
The registry lists one participant at risk in the active EpiCeram arm. It records zero serious adverse events, zero other adverse events, and zero deaths. These are counts in the registry record; they are not a comparison of event rates between treatment groups, because there was no control group.
General statistical context: a zero count in a very small group does not establish that an event cannot occur or that a treatment is free of risk. With only one participant listed at risk, the observations provide very limited information about the range or frequency of possible adverse events. The record does not report a statistical uncertainty estimate for these counts.
The registry lists no top serious adverse-event terms. That entry should be read alongside the recorded count of zero serious events and the small number at risk, rather than as evidence from a broad safety assessment. The record does not provide detail on the duration or completeness of safety follow-up, or confirm whether the participant completed the planned 28-day regimen. These safety figures describe what was entered in the registry, not a definitive characterization of safety.
12. What the Result Does, and Does Not, Mean
The registry record establishes that EpiCeram was studied in an open-label, single-group study intended for healthcare workers experiencing skin irritation associated with PPE use. The planned regimen was topical application to the hands and face, 3 times per day, for 28 days. The primary outcome was a participant-reported overall irritation score from baseline to Day 28. The study enrolled one participant and was terminated because willing participants could not be found.
Those details do not establish the direction or size of any change in symptoms. The registry record does not report the primary outcome values, a calculated change, or an analysis. It also does not report numerical results for the listed secondary measurements. The outcome definitions describe what was to be assessed; they are not evidence that a particular result occurred.
The design cannot determine what would have happened to the participant over the same period without EpiCeram, because it had no comparator group. Open-label status and the subjective nature of the primary symptom measure are additional interpretation considerations. General statistical context: these features can limit confidence in attributing a before-and-after difference to an intervention, even when a difference is measured. In this record, no such difference is reported.
The safety entries report zero serious adverse events, zero other adverse events, and zero deaths among one participant listed at risk. Those counts are highly limited observations, not a guarantee about safety in a larger population. The record also does not establish whether all planned follow-up was completed.
The most defensible interpretation is therefore narrow: the study was initiated with a defined symptom endpoint and a topical EpiCeram regimen, but recruitment stopped after one participant and the registry reports no outcome analyses. It is not possible to conclude from this record that the intervention improved symptoms, failed to improve symptoms, or had a particular safety profile. The documented recruitment difficulty explains why the intended study question remains unanswered in the posted results.
13. Why This Trial Matters Statistically
This study illustrates how a clearly defined clinical question can remain statistically unanswered when recruitment is insufficient and outcome analyses are not reported. The registry specifies the target population, topical regimen, primary symptom measure, and assessment timeframe. Those details matter because they show what the study was designed to investigate. Yet a defined endpoint is not an estimate: the registry reports one participant enrolled, termination because willing participants could not be found, and zero analyses.
The record also makes visible the difference between a within-person study and a controlled comparison. A baseline-to-Day 28 assessment can describe change for a participant if both measurements are available, but without a comparator it cannot separate intervention-associated change from other changes over time. This distinction is especially relevant when the primary outcome is a subjective report and the study is open-label.
There is also an important gap between planning language and a trial's actual design. The registry's sample-size planning description refers to equal allocation between two arms and a two-sided significance level of 0.05, whereas the study is registered as a single group. Such planning assumptions cannot be treated as the study's achieved sample size, observed power, or evidence of efficacy. The record does not report a sample-size justification for the study as conducted.
Finally, the safety counts demonstrate why denominators and context matter. Zero recorded events among one participant is a small descriptive observation, not a precise estimate of event frequency. Together, these features make the record useful as an example of the limits imposed by early termination and missing analyses, rather than as evidence resolving the clinical question.
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 central limitation is the enrollment of one participant before termination. The registry attributes termination to an inability to find willing participants. With only one enrollee, the record cannot characterize variation in response across healthcare workers or support a stable estimate of a group-level outcome.
There was no comparator group, and the study was open-label. Any measured before-and-after change, if it had been reported, would therefore lack a concurrent reference and would be open to alternative explanations, including symptom fluctuation and changes in circumstances. The primary endpoint was subjective and combined irritation of the face and hands into one ordinal score, which may conceal differences between sites or symptoms.
The registry record does not report the participant's primary outcome scores, secondary outcome results, or any analyses. It also does not report whether the participant completed treatment or the Day 28 assessment. As a result, endpoint availability and follow-up completeness cannot be established from the record.
The record does not report an analysis plan, sample-size justification for the single-group study, handling of missing data, analysis populations, or a strategy for multiple outcomes. It lists ten outcome measures but reports zero analyses. The separate planning description assumes equal allocation between two arms, which does not match the registered single-group design and should not be taken as a description of the study conducted.
Finally, the safety information consists of counts for one participant at risk, with zero serious adverse events, zero other adverse events, and zero deaths. The record does not provide enough observations to characterize uncommon or variable safety outcomes. These limitations restrict interpretation of both effectiveness and safety, independently of the intended biological rationale for the product.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: EpiCeram for Skin Protection in Healthcare Workers — NCT04793711.
- Registry record last updated 2024-08-28; status last verified 2024-06.
- Results first posted 2022-11-02.
- 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.
Continue through the Clinical Biostats statistical pathway
Use this trial's endpoint as a starting point for deeper study of effect measures, confidence intervals, and sample-size planning.
18. Record Summary
The registry describes an open-label, single-group study of EpiCeram for healthcare workers using PPE and experiencing skin irritation. The planned topical regimen was application to the hands and face, 3 times per day, for 28 days. The primary outcome was change in participant-reported overall irritation symptoms from baseline to Day 28 on a 0-10 ordinal scale.
The study was terminated after one participant was enrolled because willing participants could not be found. The registry lists secondary measures of surface skin pH, transepidermal water loss, and stratum corneum hydration. It reports ten outcome measures and zero analyses, but numerical primary and secondary outcome results are not reported in the registry record.
The safety record lists zero serious adverse events, zero other adverse events, and zero deaths among one participant at risk. With no control group, no reported outcome analyses, and enrollment limited to one participant, the record does not establish an effect estimate or a comparative safety assessment.