Study to Evaluate Safety, Efficacy and Tolerability of Clobetasol Propionate for Chronic Hand Dermatitis: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Study to Evaluate Safety, Efficacy and Tolerability of Clobetasol Propionate for Chronic Hand Dermatitis (NCT00828464), a na phase 4 study. The primary outcome is Proportion of Subjects With at Least 1-grade Improvement From Baseline to Day 15 in Investigator's Static Global Assessment Score (ISGA) Score.

2. Clinical Question

3. Trial Design

This completed Phase 4 study evaluated clobetasol propionate foam for chronic hand dermatitis. It was an open-label, single-group study: all subjects received the intervention, there was no concurrent control arm, and masking was recorded as none. The registry lists enrollment of 30. Its dates are recorded as a start in 2008-10 and primary completion in 2009-01.

These design features shape what the results can establish. With no control group, a change from baseline can be described among participants receiving the intervention, but the design does not directly estimate how outcomes would have differed under another treatment or without the intervention. Open-label conduct also means participants and investigators were not masked to treatment. This matters when interpreting assessments that require judgment, including the investigator-rated ISGA, and participant-reported measures.

The primary outcome is a change-based binary measure: whether a participant's ISGA score improved by at least 1 grade between baseline and Day 15. The registry also lists secondary outcomes concerning ISGA, a subject's Visual Analogue Assessment Scale, and Hand Eczema Severity Index (HESI) changes. These include assessments at Day 8 and Day 15 and symptom or hand-area descriptions. The record lists 14 outcome measures overall, but does not report numerical findings for the primary outcome.

The registry names Stiefel, a GSK Company, as sponsor and gives the study status as completed. Details such as the treatment schedule, eligibility criteria, study setting, protocol deviations, and the rationale for the enrollment target are not reported in the registry record. The record does not describe a randomized allocation process, consistent with the single-group design.

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.

Before assignment: 1. Washout from use of systemic corticosteroid and/or other prohibited medications if used within 4 weeks of the baseline visit. 2. Washout from use of topical corticosteroid therapy and/or other prohibited topical medications if used within 2 weeks prior to the baseline visit

Overall Study

Reasons for not completing this period:

Analysis population for the primary outcome, as defined in the registry: Intent-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 Proportion of Subjects With at Least 1-grade Improvement From Baseline to Day 15 in Investigator's Static Global Assessment Score (ISGA) Score, measured over Baseline, Day 15.

The primary endpoint is the proportion of participants with at least a 1-grade improvement from baseline to Day 15 in the Investigator's Static Global Assessment score. The registry reports it as a percentage of participants and identifies the primary analysis population as intent-to-treat (ITT). The ISGA grades are 0 (Clear), 1 (Almost Clear), 2 (Mild), 3 (Moderate), and 4 (Severe).

General statistical explanation: an ordinal assessment such as the ISGA places observations in ordered categories, but the gaps between categories are not necessarily equal in a quantitative sense. Defining improvement as at least a 1-grade change converts the assessment into a binary outcome for this endpoint: each participant either meets that improvement threshold or does not. The proportion then expresses how common that threshold-defined change was in the study population, if the result is reported.

A threshold can make an outcome easier to interpret, but it does not retain all the detail in the original grades. It does not distinguish a participant who improves by the threshold from one who improves by more, and it does not show the distribution of final scores on its own. Nor does a before-and-after endpoint establish that the intervention caused the change. The registry record does not report the primary endpoint's percentage, its uncertainty interval, or the underlying participant counts, so the magnitude and precision of the observed result cannot be assessed from this record.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

The registry record describes a single-group study and a binary primary outcome expressed as a percentage of participants. It does not report the statistical methods used to analyze that outcome. The explanations below describe general statistical concepts relevant to this endpoint; they are not claims about methods used in the trial.

What does the primary proportion represent?

For this endpoint, each participant is classified according to whether the ISGA score improved from baseline to Day 15 by at least 1 grade. A proportion is the number of participants meeting the stated criterion relative to the population being analyzed. Expressing it as a percentage makes the result interpretable as the frequency of participants crossing the threshold. The record specifies the percentage scale but does not give the numerator or the reported percentage.

Turning an ordered score into a threshold outcome simplifies interpretation, while discarding information. The ISGA categories have an order from clear to severe, but the binary endpoint does not preserve the full pattern of scores. It also does not reveal whether people who fail to meet the threshold had no change or worsened, unless those details are reported separately. The registry record does not provide the distribution of baseline and follow-up grades.

How would uncertainty be described?

General statistical explanation: a confidence interval describes uncertainty around an estimate under the assumptions of the method used. For a proportion, the interval reflects that the observed share in a study sample is an estimate of a wider underlying proportion. Its width depends on factors including the amount of information available and the observed proportion. A narrow interval indicates greater precision than a wide interval, but neither interval width nor an estimate alone resolves limitations of study design.

No confidence interval for the primary endpoint is reported in the registry record. No standard error, statistical test, or method for estimating uncertainty is reported either. Because the outcome estimate itself is absent, its precision cannot be evaluated. It would be inappropriate to infer a p-value or calculate an interval without the underlying result and an identified analysis method.

What does a single-group design imply?

General statistical explanation: a before-and-after analysis within one group can describe temporal change, but it does not supply the counterfactual comparison needed to estimate what would have happened to the same participants under a different treatment or no treatment. Randomized concurrent comparisons can address that question more directly by creating groups that differ in assigned treatment while reducing some sources of systematic difference. This study is not described as randomized and has no comparator group.

For a single-group proportion, an analysis might estimate the percentage meeting the endpoint and quantify its sampling uncertainty. That would still be a within-study description, not a treatment-versus-control effect. The registry record does not say whether the primary analysis used a particular one-sample procedure or how any uncertainty was calculated.

What can be learned from the listed analysis information?

The record lists 14 outcome measures and 0 analyses. It therefore does not provide the analysis specifications, numerical outcome estimates or inferential results needed to evaluate how the endpoints were analyzed. The primary outcome is identified, but the record does not report whether the analysis was prespecified in a protocol, how departures from an analysis plan were handled, or whether statistical adjustment was used.

The record's sample-size assumptions describe a planning illustration based on the observed effect, with a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation; the effect to detect is described as a stated fraction of the observed effect. Such a planning illustration is not evidence of the study's original design rationale, and it is not observed power. The trial itself is single-group, so assumptions for a two-arm illustration do not describe its actual allocation. The original sample-size justification is not reported in the registry record.

General statistical explanation: power is a design quantity tied to a specified effect, variability, analysis and sample size. Calculating power after observing a study result does not add information beyond the estimate and its uncertainty. Planning illustrations are useful for exploring hypothetical future designs, but should not be presented as proof that the completed study had adequate power or that its result is definitive. No planning sample-size values are included in the registry record.

Why can outcome dispersion matter?

General statistical explanation: dispersion describes how much observations vary. For continuous outcomes, greater variability can make a mean difference less precise. For counts, rates or proportions, the relevant uncertainty depends on the outcome structure and analysis assumptions. Over-dispersion refers to variability beyond what a chosen model expects; if not accommodated, it can make uncertainty estimates too small. The primary outcome in this study is a proportion, and the registry does not report a dispersion measure or a model. No conclusion about over-dispersion or its treatment can be drawn from the record.

The most defensible statistical reading is therefore limited: the endpoint is clearly defined, but the registry record does not contain the numerical estimate or analysis details needed to assess effect magnitude, precision, model assumptions or statistical evidence.

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("Clobetasol Propionate Foam")
n      <- c(30)
events <- c(29)
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  Clobetasol Propionate Foam  30  29  96.7  82.8  99.9  83.3  99.4  83.3  99.2

11. Multiplicity, Missing Data and Analysis Populations

The registry record lists 14 outcome measures, including the primary ISGA improvement outcome and secondary measures involving ISGA, a subject's Visual Analogue Assessment Scale, and HESI symptoms or hand areas. The listed assessment times include Day 8 and Day 15. Multiple outcomes can create multiple opportunities to find a result that appears notable by chance, especially when many tests are conducted. General statistical practice may address this through prespecification, outcome hierarchy, adjusted testing procedures, or careful interpretation of exploratory findings.

The registry record does not report whether multiplicity adjustments were planned or used, whether each outcome was analyzed, or how the outcomes were prioritized beyond identifying the primary endpoint. It lists 0 analyses, so numerical findings and tests for the listed outcomes are not available in the record. The presence of multiple registered measures does not by itself show that multiple statistical tests were performed.

The primary analysis population is identified as intent-to-treat (ITT). General statistical explanation: an ITT approach typically aims to retain participants in the groups to which they were assigned, regardless of subsequent treatment adherence. In this single-group study, the registry does not describe how the ITT population was operationalized, how many participants contributed to the primary endpoint, or how participants with missing follow-up assessments were handled. The number enrolled does not establish the number analyzed for each outcome.

Missing-data methods, reasons for missing assessments, and sensitivity analyses are not reported in the registry record. This matters because a percentage based only on participants with observed Day 15 assessments can differ from an analysis that makes assumptions about participants whose outcomes are unavailable. Without the analysis population count and missing-data approach, the potential effect of missing observations on the endpoint cannot be evaluated.

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 5% reporting threshold.

Most frequent serious adverse event terms

Most frequent non-serious adverse event terms

Serious events with the highest arm-level rate: skin infection (3.3%).

The registry record reports 30 participants at risk for serious adverse events, with 1 participant affected. For other adverse events, it reports 30 at risk and 4 affected. Skin infection is listed among the serious adverse event terms at 3.3%. The record gives deaths as null.

These figures should be read as descriptive safety information for the single treated group. A serious adverse event is a category distinct from other adverse events; the counts should not be combined or treated as interchangeable. The record does not define the event-collection period, provide a comparator rate, or explain whether events were judged related to treatment. It also does not describe event-level details beyond the listed serious term.

General statistical explanation: an event count in a small study can be informative as a safety signal to describe, but it is not a precise estimate of the frequency expected in a broader population. Without a control group, the counts cannot establish whether events occurred more or less often because of the intervention. The reported skin infection percentage is retained as stated in the registry. Null for deaths should not be expanded into an assumption about ascertainment beyond the record's entry.

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

The record establishes that a completed, open-label, single-group study enrolled 30 participants and evaluated clobetasol propionate foam for chronic hand dermatitis. Its primary endpoint is the percentage of participants with at least a 1-grade improvement in ISGA from baseline to Day 15. These registry entries describe the intended question and study structure, but the registry record does not report the numerical primary outcome result.

Because the numerical result and its uncertainty are absent, the record does not show how many participants met the endpoint, how large the percentage was, or how precise an estimate would be. It therefore cannot support a conclusion about the observed frequency of improvement in this study. This missing result is not evidence that no participants improved, nor is it evidence that the endpoint was met.

Even if a before-and-after estimate were available, the single-group design would limit causal interpretation. A change over time would not, by itself, distinguish intervention effects from natural variation, other influences during follow-up, or measurement effects. The open-label design and investigator-rated outcome are also relevant when considering possible assessment bias. The registry record does not report safeguards or analysis details that would resolve these concerns.

The secondary outcome list adds context about what the study intended to assess, including subject-reported assessment and HESI changes at specified times and hand areas. But listed outcomes are not findings. Since the record lists 0 analyses and does not give numerical results for those outcomes, they cannot provide corroboration or a fuller account of response in this statistical reading.

The safety counts describe reported events among participants in the treated group, not a comparative safety effect. The serious event count, other event count, and listed skin infection term should be interpreted within the limits of the registry's reporting. No control group is available to distinguish background events from events attributable to treatment.

In short, the registry record is informative about the planned endpoint, design, enrollment and selected safety counts. It does not provide the primary outcome estimate, confidence interval, or analysis methods. Those omissions prevent an assessment of the magnitude and precision of the primary result and restrict interpretation to design and reporting features.

14. Why This Trial Matters Statistically

This study illustrates why a well-defined endpoint and a reported estimate are both needed for statistical interpretation. The primary outcome is specified in concrete terms: a participant must have at least a 1-grade improvement in investigator-rated ISGA from baseline to Day 15. The registry also identifies the outcome scale and the ITT population. These details help a reader understand what the study set out to measure.

However, a definition is not a result. Without the reported percentage and its uncertainty, readers cannot assess how commonly the threshold was met or how stable the estimate may be. Statistical interpretation depends on the estimate, its precision, the analysis population and the design that generated the data. The registry record's listing of 0 analyses leaves those elements unavailable for the primary endpoint.

The single-group, open-label structure also makes the distinction between observing change and estimating a comparative treatment effect especially important. Before-and-after outcomes may be useful for describing participants' course during a study, but they do not provide a concurrent counterfactual. This affects the strength and type of conclusions that can follow, regardless of whether a measured change is large or small.

The registry lists 14 outcome measures, making clear why outcome hierarchy and multiplicity procedures matter. When multiple measures are assessed, transparent reporting of prespecified analyses helps readers distinguish confirmatory questions from exploratory ones. Those procedures are not reported in the registry record.

Finally, the safety entries demonstrate the need to separate descriptive event counts from comparative risk claims. The record reports counts for the treated group but no control group. The statistical value of this record is therefore mainly in understanding what was studied and what remains unavailable: the primary estimate, its precision, and the methods used to analyze outcomes.

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 most immediate limitation for statistical interpretation is that the registry record does not report the numerical result for the primary endpoint. It also does not provide an uncertainty interval, participant counts contributing to the endpoint, or statistical test. As a result, neither magnitude nor precision can be assessed.

The study was single-group and open label, with no concurrent comparator. This prevents a direct estimate of the contrast between clobetasol propionate foam and another treatment or no treatment. Knowledge of treatment can also be relevant to investigator ratings and participant reports. The registry record does not describe masking or other safeguards beyond recording masking as none.

Further design information is limited. The treatment dose and schedule, eligibility criteria, baseline participant characteristics, follow-up completeness and protocol deviations are not reported in the registry record. The record gives the primary analysis population as ITT but does not explain how that population was defined for this single-group study or how missing Day 15 assessments were handled.

Although 14 outcome measures are listed, 0 analyses are listed. The registry does not report whether multiplicity was addressed, which secondary analyses were completed, or whether the analysis plan changed. The original sample-size justification and any interim analyses are not reported in the registry record. The planning assumptions described for a sample-size illustration do not establish the study's original design rationale or observed power.

Safety reporting is also limited to the stated counts and serious term. The record does not describe event definitions, collection details, attribution, or a comparator rate. These gaps constrain interpretation of both the efficacy endpoint and the safety information.

16. Related Tutorials

17. Related Statistical Calculators

18. Sources

• ClinicalTrials.gov: Study to Evaluate Safety, Efficacy and Tolerability of Clobetasol Propionate for Chronic Hand Dermatitis — NCT00828464.
• Registry record last updated 2012-10-03; status last verified 2012-09.
• Results first posted 2010-09-28.
• 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

NCT00828464 is a completed Phase 4, open-label, single-group study of clobetasol propionate foam for chronic hand dermatitis. The registry lists enrollment of 30, a start in 2008-10 and primary completion in 2009-01. All subjects received clobetasol propionate; allocation is listed as not applicable and masking as none.

The primary outcome is the percentage of participants with at least a 1-grade improvement in ISGA from baseline to Day 15, with an ITT population specified. The record lists 14 outcome measures and 0 analyses. It does not report a numerical primary outcome result, uncertainty interval, or analysis methods.

Safety entries report 30 at risk and 1 affected for serious adverse events, 30 at risk and 4 affected for other adverse events, and Skin infection at 3.3% among the listed serious terms. Deaths are recorded as null. No concurrent comparator is reported.