VANOS Cream and Skin Barrier Function: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for VANOS Cream and Skin Barrier Function (NCT00819507), a na phase 4 study. The primary outcome is Change in Eczema Severity and Area Index.

2. Clinical Question

3. Trial Design

This was a Phase 4, completed, single-group study registered as NCT00819507. The registry lists enrollment of 25 and identifies Oregon Health and Science University as the sponsor. The recorded study start was 2009-01, and primary completion was 2010-01. Allocation is listed as NA and masking as none. These features describe a treatment group without a randomized concurrent control and without masking.

The intervention is listed as fluocinonide, with the arm described as Vanos Cream, a glucocorticoid cream. The registry summary describes the purpose as examining short-term therapy and skin-barrier function in people with atopic dermatitis. Although skin-barrier function is part of the stated rationale, the primary outcome listed in the record is change in EASI. Change in transepidermal water loss is listed as a secondary outcome.

A single-group design can describe how an outcome changes within the treated group over time. It cannot, by itself, separate a treatment-associated change from changes that might also occur without treatment, such as natural fluctuation or effects of other circumstances. A baseline score is a reference for within-person change, not a substitute for a concurrent control group.

The registry does not report the detailed recruitment process, eligibility criteria, treatment-use instructions, adherence assessment, or co-interventions. It also does not report the protocol’s sample-size justification, interim analyses, or a statistical analysis plan. Those omissions mean the design can be described from its registry classification and recorded outcomes, but not reconstructed in full.

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 Change in Eczema Severity and Area Index, measured over 2 Weeks.

The primary endpoint was change in the Eczema Area and Severity Index (EASI), measured in units, at 2 Weeks. EASI is described in the registry as a validated composite measure of physical signs of atopic dermatitis. It combines assessments of four signs or symptoms—erythema, population, excoriation, and lichenification—with the area of affected skin across the head and neck, trunk, arms, and legs. Severity components are scored on a 0-3 scale for each body region, and the area and severity contributions are weighted by region size.

The registry gives an overall score range of 0-72 and describes scores between 0 and 7 as mild, between 7 and 21 as moderate, and greater than 21 as severe. The stated outcome is not the end score alone: it is the end-of-study EASI score minus the baseline EASI score. A negative change would mean the recorded score was lower at the end than at baseline; a positive change would mean it was higher. These are interpretations of the score’s direction, not findings about this study.

EASI is used to express changes in the signs and extent of eczema through a composite score. The registry record does not report the observed mean change or standard deviation, so the magnitude and variability of the endpoint cannot be evaluated from this record.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

The statistical information available in the registry record is limited. It identifies the primary endpoint as a continuous measure reported as a mean, with standard deviation as the stated measure of dispersion. It also defines the change score as the end-of-study EASI score minus the baseline score. The numerical mean change and standard deviation are not reported in the registry record, and the record does not describe the inferential analysis used for the primary outcome.

What does a mean change describe?

A mean change summarizes the average direction and magnitude of participant-level changes in a group. For this endpoint, each participant’s change is defined by comparing the end-of-study EASI score with that participant’s baseline score, and the group mean summarizes those changes. A mean alone does not show whether participants changed similarly or whether individual responses varied widely. The standard deviation is a measure of dispersion: a larger standard deviation indicates more spread in the observed changes around their mean. Neither statistic is reported numerically for the primary outcome in this registry record.

A group mean also does not describe every participant’s experience. Different individual changes can produce the same mean, and the mean does not show the distribution’s shape or identify outlying observations. Additional information, such as individual-level data or a suitable distributional summary, would be needed to examine those features. Such information is not reported in the registry record.

What would an uncertainty interval add?

A confidence interval is a statistical way to express uncertainty around an estimate. In general, it gives a range of values compatible with the observed data under the specified model and procedure. Its width depends on factors including the amount of information in the data and the variability of the measured outcome. A narrow interval indicates greater precision under that analysis than a wide interval, but neither width nor interval location establishes that a treatment caused the observed change. The registry record does not report a confidence interval for EASI change.

A hypothesis test, if one were specified, would address compatibility between the data and a null hypothesis under its assumptions. A p-value does not measure the size or clinical importance of an effect, and it does not provide the probability that the null hypothesis is true. The registry record does not report a primary-outcome p-value or the test used. Therefore, no inferential result should be inferred from the endpoint description or from the fact that analyses are listed in the record.

Why does the single-group design matter?

In a single-group study, a baseline-to-follow-up comparison is a within-group comparison. It can describe change over time in the observed group, but it does not estimate a contrast between treatment and a concurrent control group. Without that contrast, changes that would have occurred over time for other reasons cannot be distinguished from changes associated with treatment. This is a design limitation, not a defect that a particular statistical test can remove.

Masking is listed as none. In general, masking can reduce some influences on assessment or behavior, depending on who is masked and how outcomes are measured. The registry does not describe further masking procedures or how EASI assessments were conducted, so their possible influence cannot be evaluated from the record. Similarly, details on assessor training and consistency are not reported in the registry record.

What do the planning assumptions mean?

The recorded sample-size assumptions describe a planning illustration based on the observed effect, not the trial’s own design. They specify a two-sided significance level of 0.05, equal allocation between two arms, a normal approximation, and an effect defined as a stated fraction of the observed effect. For non-time-to-event outcomes, the illustration is expressed as participants per arm for 80% power or another stated power level. Such planning values are hypothetical design calculations; they are not observed participant counts from a two-arm trial and are not observed power for this single-group study.

The registry does not report a prospective sample-size justification for the actual study. The listed planning framework should therefore not be treated as evidence that the study was designed with a particular power, nor as an analysis of the study’s achieved ability to detect a treatment effect. Since the numerical EASI result is not reported in the record, the observed-effect basis for any such illustration cannot be independently evaluated from the registry information.

Why can variability affect an analysis?

For continuous outcomes, variation among observations affects the precision of a mean estimate and the ability of a study to distinguish a signal from random variation. If outcome variation is greater than assumed by a model, standard errors and intervals based on that model can understate uncertainty. In general, over-dispersion means that the observed variability exceeds what a chosen model expects. Whether over-dispersion was assessed or relevant to any analysis in this study is not reported in the registry record. The endpoint’s continuous, mean-based description alone does not establish which model or distributional assumptions were used.

These general concepts clarify what would be needed to interpret a numerical estimate: its scale and direction, variability, uncertainty, analytic method, and design context. For this study, the record identifies the scale and intended comparison over time but does not provide the primary estimate, its dispersion, an uncertainty interval, or the analysis procedure. The statistical interpretation must remain correspondingly limited.

10. Confidence Intervals for Each Arm

No two-arm comparison is shown for this trial, but each arm's mean can be given with a t-based 95% confidence interval computed from the posted mean, spread and number of participants.

R code and output

arm <- c("Vanos Cream")
n   <- c(25)
m   <- c(6.01)
sp  <- c(7.9)
sd  <- sp      # posted standard deviations
for (i in seq_along(n)) {
  se <- sd[i] / sqrt(n[i]); h <- qt(0.975, n[i] - 1) * se
  cat(sprintf("CARM|%s|%d|%.3f|%.3f|%.3f|%.3f\n", arm[i], n[i], m[i], sd[i], m[i] - h, m[i] + h))
}

CARM  Vanos Cream  25  6.010  7.900  2.749  9.271

11. Multiplicity, Missing Data and Analysis Populations

The registry lists a primary outcome of EASI change and a secondary outcome of change in transepidermal water loss. It records two outcome measures and two analyses, but does not describe the analyses in enough detail to determine which outcome or contrast each analysis addressed. The numerical results for the primary endpoint and the secondary outcome are not reported in the registry record.

When a study evaluates multiple outcomes or performs multiple statistical tests, the chance of at least one apparently notable result can increase if the tests are interpreted independently without accounting for multiplicity. Statistical approaches can control or describe that issue, but the appropriate approach depends on the planned hypotheses and analysis structure. A multiplicity adjustment, testing hierarchy, or prespecified distinction between confirmatory and exploratory analyses is not reported in the registry record. It is therefore not possible to determine how multiplicity was handled.

The registry record also does not report how missing outcome measurements were handled, whether all enrolled participants contributed to the endpoint analysis, or how the analysis population was defined. It does not state whether any imputation, complete-case analysis, or sensitivity analysis was used. These are important details because missing measurements can affect both the estimate and its uncertainty, particularly when missingness is related to participants’ outcomes or circumstances.

Enrollment of 25 is recorded, but enrollment alone does not establish the number included in a particular outcome analysis. The record does not provide participant flow or outcome-specific analysis counts. The actual sample-size justification and interim-analysis plan are also not reported in the registry record. These omissions prevent a full assessment of the analysis population, missing-data assumptions, multiplicity control, and the prespecification of the statistical approach.

12. 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 25 participants at risk for serious adverse events and 0 affected by a serious adverse event. For other adverse events, it lists 25 at risk and 1 affected. These figures describe the counts recorded in the registry categories; they do not establish that every possible event was captured or that an event was or was not caused by treatment.

The deaths field is not populated with a numerical value, so a death count is not reported in the registry record. The record also lists no top serious adverse-event terms. That does not add detail about the nature, timing, or severity of the other adverse event, and those details are not reported in the registry record.

Safety counts should be interpreted in light of the single-group design and the registry’s reporting scope. With no concurrent comparator, these figures cannot show whether event occurrence differed from what would have happened without treatment or under another treatment. They are descriptive counts, not estimates of comparative risk. The registry record does not provide further information on event definitions, ascertainment procedures, follow-up for safety, or the relationship of the reported other event to treatment.

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

The record describes a Phase 4, single-group study of VANOS Cream in participants with atopic dermatitis. Its primary endpoint was change in EASI at 2 Weeks, calculated as the end-of-study score minus the baseline score. This establishes what the study set out to measure and how the direction of change is defined.

The primary outcome result itself is not reported in the registry record. The mean change, standard deviation, and an uncertainty estimate are absent, so the magnitude, direction, and precision of the observed change cannot be stated. The secondary outcome, change in transepidermal water loss, is also listed without a numerical result in the record. A statement of study purpose or endpoint does not provide an observed treatment effect.

The design further limits what a change could establish. With one group and no concurrent control, a before-and-after comparison cannot distinguish a treatment-associated change from changes related to time, natural variation, or other influences. The registry lists no masking. These design features should be kept in view even if numerical within-group results are available elsewhere; they do not convert a single-group change into a controlled treatment comparison.

The safety summary records 0 participants affected by serious adverse events and 1 affected by an other adverse event, among 25 at risk in each category. The deaths figure is not reported in the registry record. These are descriptive registry counts and do not establish causation, comparative safety, or the absence of unrecorded events.

Accordingly, the record supports a clear account of the planned clinical question, outcome definition, study structure, and limited adverse-event counts. It does not support a quantitative conclusion about EASI change, skin-barrier change, or the causal effect of treatment. The absence of reported outcome estimates is a limitation of the registry information, not evidence that no change occurred.

14. Why This Trial Matters Statistically

This study is statistically notable because its clinical rationale concerns skin-barrier function while its recorded primary endpoint is change in EASI, a composite measure of eczema signs and affected area. The registry also lists change in transepidermal water loss as a secondary outcome. Keeping these measures distinct matters: they represent different recorded outcomes, and a result on one would not automatically answer the question addressed by the other.

The single-group design makes the distinction between observed change and treatment effect especially important. A baseline comparison can describe movement in scores during the study period, but it does not supply a concurrent counterfactual. Statistical analysis can summarize the within-group data, yet it cannot by itself remove the design’s inability to compare outcomes against an untreated or alternative-treatment group.

The record also illustrates why an endpoint definition is not enough for statistical interpretation. The EASI change direction is clear, but without the mean change, dispersion, or uncertainty estimate, readers cannot judge the size or precision of the result. Transparent reporting of both outcome estimates and analysis details is needed to move from a stated measurement plan to an interpretable result.

Finally, the registry’s planning assumptions describe a hypothetical two-arm sample-size illustration, whereas the actual study is listed as single group. Keeping planning calculations separate from observed study design and observed results avoids treating a design illustration as trial evidence. These distinctions are broadly useful when assessing registry records: design, endpoint, estimate, uncertainty, and causal interpretation answer different statistical questions.

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.

The primary limitation for interpreting this trial from the registry record is that the primary outcome result is not reported. The mean EASI change and standard deviation are absent, as are an uncertainty interval and a reported inferential result. Numerical results for the secondary outcome are also not reported in the registry record. Consequently, the magnitude and precision of any measured change cannot be assessed.

The single-group design does not include a concurrent comparator, and allocation is listed as NA. This limits causal interpretation because observed change over time cannot be separated from other influences using a between-group contrast. Masking is listed as none. The record does not describe the assessment procedures, so the potential effects of unmasked outcome assessment cannot be examined in detail.

Important design and analysis details are not reported in the registry record, including eligibility criteria, participant characteristics, participant flow, outcome-specific analysis counts, missing-data handling, analysis population, and the statistical model or test used. The record also does not describe multiplicity handling, interim analyses, or the protocol’s sample-size justification. These omissions restrict assessment of the analysis and its assumptions.

The adverse-event information is limited to category counts. Further event descriptions, ascertainment details, safety follow-up, and the deaths figure are not reported in the registry record. The recorded counts should therefore be read as registry summaries, not comprehensive comparative safety estimates.

16. Related Tutorials

17. Related Statistical Calculators

18. Sources

• ClinicalTrials.gov: VANOS Cream and Skin Barrier Function — NCT00819507.
• Registry record last updated 2017-07-11; status last verified 2017-06.
• Results first posted 2017-07-11.
• 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

NCT00819507 is a completed Phase 4, single-group study sponsored by Oregon Health and Science University. The registry records enrollment of 25, a start date of 2009-01, and primary completion in 2010-01. Masking is listed as none, and allocation is NA.

The study evaluated VANOS Cream, listed as fluocinonide and described as a glucocorticoid cream, in participants with atopic dermatitis. The primary endpoint was change in EASI at 2 Weeks, defined as the end-of-study score minus baseline. Change in transepidermal water loss was listed as a secondary outcome.

The registry record does not report numerical results for either outcome, the primary endpoint’s dispersion, or its uncertainty. The adverse-event summary lists 0 participants with serious adverse events and 1 with an other adverse event, with 25 at risk in each category. The deaths figure is not reported in the registry record.