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 Compatibility of a Mild, Moisturizing Hand Cleanser for Patients With Mild to Moderate Hand Dermatitis (NCT00843466), a randomized na study. The primary outcome is Investigator Global Assessment.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT00843466 |
| Phase | NA |
| Condition | Hand Dermatosis |
| Allocation | Randomized |
| Design model | Parallel |
| Masking | Single |
| Enrollment | 46 |
| Arms in the primary outcome | 2 |
| Lead sponsor | Wake Forest University |
| Results posted | Yes |
2. Clinical Question
Population
People with mild to moderate hand dermatitis are the population described in the study title and purpose. The condition is listed in the registry as Hand Dermatosis. Further eligibility details, such as how severity or diagnosis was established, are not reported in the registry record.
Intervention
The intervention was a mild moisturizing hand cleanser. The arm description says the test group would use it for all hand cleansing needs during the study. The registry does not report details such as the amount used, the frequency of use, or adherence.
Comparator
The control description says participants would continue using their current cleanser for hand washing. However, the posted outcome arm is titled “No Treatment,” while the safety record calls the group “Control Group (Current Product).” This difference in labels leaves some ambiguity about how the comparator was represented in the outcome record.
Primary question
The primary outcome asks about investigator-assessed global disease severity at Wk 4, using a scale from 0 to 4, where 0 is clear and 4 is severe. The study purpose frames the question as whether a moisturizing cleanser may help improve rashes associated with frequent hand washing. The registry reports group means and confidence intervals, but no estimable statistical comparison between the groups. The record therefore does not establish the size or precision of a treatment-versus-control effect.
3. Trial Design
The registry describes a randomized, single-masked, parallel-group study. Enrollment is recorded as 46, and the study status is completed. The study is listed as having no applicable phase. Its sponsor is Wake Forest University. The registry records a start date of 2007-05 and a primary completion date of 2008-04.
The test arm is described as using a mild moisturizing hand cleanser for all hand cleansing needs during the study. The control arm description says participants would continue using their current cleanser. Although the allocation field says randomized, the registry does not explain how the random sequence was generated, whether allocation was concealed, or how participants were assigned in practice.
Masking is recorded as single, but the masked party or parties are not identified. The record does not state whether investigators assessing the outcome, participants, or other study personnel were masked. A single-masked designation alone does not reveal how masking was implemented or whether it remained intact.
The record lists one outcome measure and no posted secondary outcomes. It gives an Investigator Global Assessment at Wk 4 as the primary outcome. The posted group labels are not fully consistent with the intervention descriptions: the control arm is called “No Treatment” in the outcome record, while the arm description and safety record characterize it as current cleanser or current product. The registry does not explain this naming difference. Further details about study procedures, follow-up, adherence assessment, or participant flow are not reported in the registry record.
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 | Test Product | Control Group (Current Product) |
|---|---|---|
| STARTED | 24 | 18 |
| COMPLETED | 24 | 18 |
| NOT COMPLETED | 0 | 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 | Test Product | Control Group (Current Product) | Total |
|---|---|---|---|---|
| Participants analysed | 24 | 18 | 42 | |
| Age, Categorical: <=18 years | Participants | 0 | 0 | 0 |
| Age, Categorical: Between 18 and 65 years | Participants | 24 | 18 | 42 |
| Age, Categorical: >=65 years | Participants | 0 | 0 | 0 |
| Age, Continuous | years | 45 (18 to 78) | 40 (20 to 65) | 41 (18 to 78) |
| Sex: Female, Male: Female | Participants | 20 | 14 | 34 |
| Sex: Female, Male: Male | Participants | 4 | 4 | 8 |
| Region of Enrollment: United States | participants | 24 | 18 | 42 |
6. Primary Endpoint
The registry lists the primary outcome as Investigator Global Assessment, measured over Wk 4.
| Element | Registry entry |
|---|---|
| Result type | Mean |
| Measure of spread | 95% Confidence Interval |
| Unit | units on a scale |
| Endpoint classification | Continuous Endpoint |
The primary endpoint is Investigator Global Assessment, described as changes in global disease severity on a scale from 0 to 4. The scale anchors are stated: 0 means clear and 4 means severe. The registry lists the assessment time as Wk 4 and reports the outcome as a mean with a 95% confidence interval.
A global investigator assessment is intended to summarize the overall clinical severity of the condition in a single measure. In general, a global rating can offer a compact way to compare the overall state of a condition across groups, rather than focusing on one symptom alone. Its interpretation depends on clear scale definitions, consistent assessment procedures, and reliable scoring. The registry does not report additional details about assessor training, scoring instructions, or the properties of this scale.
The outcome description uses the word “changes,” but the record does not give baseline values or explain precisely how change was calculated. The posted arm summaries therefore should not be treated as a documented change from baseline without further information. Nor does the registry provide an estimable between-group contrast for the endpoint. The group-level means describe the posted outcome summaries; they do not, by themselves, quantify the causal difference between assigned strategies.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
At Wk 4, the registry reports a mean Investigator Global Assessment of 1.0 for the mild moisturizing hand cleanser test product, with a 95% confidence interval from 0.8 to 1.2. For the arm titled “No Treatment,” it reports a mean of 1.1, with a 95% confidence interval from 0.7 to 1.4. The registry does not report a valid two-arm comparison for this continuous endpoint. In particular, it does not provide an estimated between-group difference or a corresponding inferential result.
These summaries describe the reported mean and its uncertainty within each arm. A confidence interval is a measure of statistical precision: in general, a narrower interval indicates greater precision for the quantity being estimated, while a wider interval indicates more uncertainty. The intervals are arm-specific. They are not a confidence interval for the difference between the arms, and they should not be used as a substitute for a direct comparison.
The registry explicitly indicates that values are missing or not estimable for a two-arm comparison of this continuous endpoint. Consequently, the posted arm means do not support a conclusion about the magnitude or precision of a treatment-versus-control effect. The absence of an estimable comparison is not evidence that the groups are equivalent. Equivalence requires a suitable design and analysis that define and evaluate an acceptable range of differences; such details are not reported in the registry record.
The scale runs from 0, clear, to 4, severe. The means are near the lower end of that scale, but the record does not report baseline severity or the distribution of individual scores. A group mean cannot show how scores varied among participants, whether some participants had different courses, or how many reached a particular scale value. The confidence intervals describe uncertainty around the means, not the spread of individual observations.
The outcome description refers to changes in severity, but no baseline summaries or calculation details are reported. It is therefore not possible to establish from this record whether the posted values are follow-up scores, change scores, or another summary of the assessment. The arm-name inconsistency also warrants care: the control outcome label says “No Treatment,” while the study description and safety record refer to current cleanser or current product. The registry does not resolve that discrepancy.
Overall, the posted results document week-four arm summaries, but not an interpretable comparative effect estimate. The record also does not report a statistical analysis result for the primary comparison. A reader can describe the means and their confidence intervals as posted, while keeping the distinction between those within-arm summaries and a direct treatment-effect estimate clear.
9. Statistical Methods Explained
Statistical interpretation depends on what quantity was estimated and how that estimate was obtained. The registry identifies the primary outcome as a continuous measure summarized by a mean and a 95% confidence interval. It also records that values for a two-arm comparison are missing or not estimable. That means the record contains descriptive arm summaries but does not provide the comparative estimate needed to quantify a difference between assigned groups.
What does a confidence interval describe?
In general, a confidence interval expresses uncertainty around an estimated quantity under the assumptions of the analysis that produced it. For this outcome, the intervals are reported separately for each arm. They give a range of values compatible with the arm-specific mean estimate under the relevant statistical procedure. They do not describe the range of individual participants’ scores, and they do not directly estimate the contrast between the intervention and control groups.
A comparison of two groups requires an estimate of their difference, together with uncertainty for that difference. The uncertainty of a contrast depends on the uncertainty in both groups and on the method used to construct the contrast. It cannot be recovered reliably merely by inspecting whether separate confidence intervals overlap. The registry does not post a contrast estimate, its confidence interval, or a p-value for this endpoint. Those comparative results should not be inferred from the arm means.
Why is the comparison not available?
The record states that values are missing or not estimable for the two-arm continuous-endpoint comparison. The reason is not reported in the registry record. It could not be appropriate to invent an explanation, such as a particular model, distribution, data problem, or analysis decision. The record lists no posted analyses. That does not establish whether analyses were conducted outside the registry; it means that a comparative analysis is not reported in the registry record.
The outcome is on a bounded scale from 0 to 4, and the registry reports means. In general, the suitability of a mean-based comparison depends on the data and the analysis plan. Relevant considerations may include the scale’s behavior, the distribution of scores, baseline values, and the design of the comparison. None of those details should be presumed from the summary alone. No statistical model or method for the primary comparison is reported in the registry record.
What does randomization contribute?
In general, random allocation is intended to make assigned groups comparable on average with respect to characteristics known and unknown at assignment. It does not guarantee that every characteristic will be balanced in a particular study, nor does it replace a clearly specified outcome analysis. The record identifies the allocation as randomized, but does not report the sequence-generation method, concealment procedures, or an analysis population. These omissions limit the detail available for evaluating how randomization was implemented and incorporated into analysis.
Masking can, in general, reduce the influence of expectations on treatment behavior, outcome assessment, or both. The registry says the study was single-masked but does not identify who was masked or how masking was maintained. For an investigator-assessed outcome, knowing the assessor’s masking status would be useful context. That information is not reported in the registry record, so the potential role of masking in the assessment cannot be evaluated from this entry.
What do the planning assumptions mean?
The registry describes sample-size calculations as planning illustrations based on the observed effect, rather than as the trial’s own design. It states assumptions of a two-sided significance level of 0.05, equal allocation, and a normal approximation, with the target effect set as a stated fraction of the observed effect. These are assumptions for planning illustrations, not observed properties of the trial and not evidence of observed power.
The record does not report numerical planning results for this endpoint, and it does not provide an estimable two-arm effect from which to interpret such a calculation. A planning illustration is not a finding about the study’s actual precision, nor does it establish that a study was adequately powered. Sample-size calculations address what a future design might require under specified assumptions; they do not repair a missing comparative result or turn arm summaries into an effect estimate.
More generally, power is a design-stage probability tied to a particular effect, analysis, and set of assumptions. After a study, the observed estimate and its confidence interval are more informative for describing the result than a retrospective claim about power. Since this record lacks the comparative estimate, its uncertainty, and the underlying analysis details, the precision of a treatment effect cannot be assessed from the registry entry.
Why can over-dispersion matter?
In general, over-dispersion means that the observed variability is greater than a model assumes. It matters because a model that understates variability may produce confidence intervals that are too narrow and inferential results that are too optimistic. This issue commonly arises in particular outcome models, but the registry does not report a model for this endpoint or evidence of over-dispersion. It is therefore a general statistical consideration, not a finding about this study.
The main methodological conclusion is limited but clear: the registry supplies arm-level mean summaries with confidence intervals and explicitly notes that the two-arm continuous comparison is not estimable or is missing. The appropriate interpretation is descriptive, not comparative. A more complete evaluation would require a reported analysis plan, a definition of the analyzed outcome, the comparative estimate and its uncertainty, and information about the analysis population and missing observations. Those details are not reported in the registry record.
10. Multiplicity, Missing Data and Analysis Populations
The registry lists one outcome measure and reports no posted secondary outcomes. It also lists no analyses. The record does not describe a multiplicity adjustment or explain whether multiple outcome assessments, time points, or analyses were considered. With only the registry entry, it is not possible to determine what testing strategy was prespecified or whether any adjustment was used. That information is not reported in the registry record.
The record does not state how missing outcome data were handled, whether any participants lacked the Wk 4 assessment, or what analysis population was used. The reported enrollment and arm summaries do not answer those questions. The registry also does not describe exclusions, withdrawals, imputation, or sensitivity analyses. These details are not reported in the registry record.
In general, missing data can affect interpretation when the availability of an outcome is related to participants’ condition, treatment, or other factors. Different assumptions and handling methods can lead to different estimates. Without a missing-data description and a defined analysis population, readers cannot assess whether the posted arm summaries represent all randomized participants or a subset, or how incomplete observations may have influenced them.
The absence of a reported two-arm comparison is especially important: there is no inferential result to interpret alongside any multiplicity approach or missing-data method. The registry does not provide enough detail to reconstruct those analyses, and no method should be inferred from the arm summaries alone.
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 |
|---|---|---|---|
| Test Product | 0 | 24 | 0.0% |
| Control Group (Current Product) | 0 | 18 | 0.0% |
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 |
|---|---|
| Test Product | 0 of 24 |
| Control Group (Current Product) | 0 of 18 |
The safety record lists serious adverse events in 0 of 24 participants at risk in the test-product group and 0 of 18 participants at risk in the control group. It also lists other adverse events in 0 of 24 and 0 of 18, respectively. These entries mean that the registry reports no affected participants for the listed categories in those groups. Death counts are not reported in the registry record.
These figures should be read as registry counts, not as proof that no harm occurred. The entry does not describe how adverse events were collected, what observation period applied to safety reporting, or how events were defined and attributed. It also does not provide event-level descriptions; no top serious-event terms are listed. The absence of a reported event in this record does not establish that the risk is zero.
In general, safety counts are most interpretable when accompanied by clear definitions, follow-up duration, completeness of reporting, and information about the population monitored. Those details are not reported. The figures are therefore a narrow description of what the registry records, rather than a comprehensive assessment of safety or a basis for individual medical decisions.
12. What the Result Does, and Does Not, Mean
The registry supports a descriptive account of the primary outcome: at Wk 4, it reports an Investigator Global Assessment mean of 1.0 with a 95% confidence interval from 0.8 to 1.2 for the test-product arm, and a mean of 1.1 with a 95% confidence interval from 0.7 to 1.4 for the arm titled “No Treatment.” The assessment scale is described as ranging from 0, clear, to 4, severe.
Those values do not establish the treatment effect. A treatment effect requires a direct comparison between groups, while the registry explicitly says values for the continuous two-arm comparison are missing or not estimable. No difference estimate, confidence interval for a difference, or primary-comparison p-value is reported. The arm means cannot be substituted for these missing comparative results.
The record also does not establish whether the means represent follow-up scores or changes from baseline, despite the outcome description’s reference to changes. No baseline results, individual score distributions, or outcome calculation details are reported. The group-level summaries cannot show how much participants varied or how many experienced a particular course.
Randomization is recorded, but the registry does not describe the sequence method, masking roles, analysis population, or handling of missing data. The control arm’s outcome label also differs from the current-cleanser description. These points leave important context unresolved. The posted results should therefore be interpreted as incomplete descriptive summaries, not as evidence that one strategy is superior, equivalent, or ineffective.
In general, a non-significant or unavailable comparison cannot be treated as proof of no difference. Equivalence or non-inferiority would require an appropriate design, prespecified margins, and corresponding analyses; these are not reported in the registry record. The entry does not support medical advice or a treatment recommendation.
13. Why This Trial Matters Statistically
This study illustrates an important distinction in clinical-trial reporting: a mean for each group is not the same as an estimate of the difference between groups. Readers may be tempted to compare the reported means directly or to infer a result from their separate confidence intervals. The registry, however, says that the continuous two-arm comparison is missing or not estimable. The appropriate statistical conclusion is that the comparative effect is unavailable in this record.
The distinction matters because the research question concerns the relative outcome under two assigned strategies. Within-arm summaries describe each group separately; a direct contrast addresses how the groups differ, with uncertainty that reflects both arms and the analysis method. Without that contrast, the record cannot quantify the size or precision of the comparison.
The endpoint also highlights why outcome definitions need to be explicit. The registry describes changes in severity, but does not give baseline results or explain how change was derived. The measure is on a bounded 0-to-4 scale, yet the entry does not describe scoring procedures or score distributions. These omissions make it harder to connect the reported means to the intended clinical construct.
Finally, the differing control labels show how consistent registry terminology supports interpretation. The study description refers to current cleanser, while the outcome label says “No Treatment.” The safety record refers to current product. The registry does not explain whether these labels refer to the same comparator as implemented. This uncertainty does not change the reported numbers, but it limits clarity about what the comparison represents.
Statistically, the key lesson is to separate what is reported from what a reader might wish to infer. The means and confidence intervals can be described; a treatment-versus-control result cannot be reconstructed from them. Clear reporting of the estimand, analysis, missing data, and comparator would make the findings easier to assess.
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 principal limitation of the registry results is the lack of an estimable or reported two-arm comparison for the primary continuous outcome. The record provides group means and confidence intervals, but no comparative estimate or uncertainty for that estimate. As a result, the primary treatment contrast cannot be quantified from the registry entry.
The outcome’s description refers to changes in global disease severity, yet no baseline values or calculation method are reported. This leaves uncertainty about what the posted means represent. The record does not provide distributions, individual-level results, or information about assessor procedures, so the summaries offer limited detail about variation and measurement.
The comparator naming is inconsistent across the registry entry. The control arm description specifies current cleanser, the outcome arm is titled “No Treatment,” and the safety group is called “Control Group (Current Product).” The record does not reconcile these terms. Masking is identified as single, but the masked party is not specified. Randomization is recorded, but the sequence generation and allocation concealment are not described.
The registry does not report the analysis population, missing-data handling, participant flow, adherence, or a statistical analysis method. It also does not explain why the comparison is unavailable. These omissions prevent a fuller assessment of the analysis and its assumptions. Safety reporting is limited to the listed counts; event definitions and the observation period are not reported in the registry record.
Finally, the registry entry alone does not provide context beyond its posted fields. It does not report additional study results or explain how the findings were interpreted by the investigators. These limitations call for a cautious, descriptive reading, without extending the reported summaries into a conclusion about comparative effectiveness or safety.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Compatibility of a Mild, Moisturizing Hand Cleanser for Patients With Mild to Moderate Hand Dermatitis — NCT00843466.
- Registry record last updated 2018-09-10; status last verified 2018-08.
- Results first posted 2017-03-16.
- 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.
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18. Record Summary
NCT00843466 is a completed randomized, single-masked, parallel-group study sponsored by Wake Forest University. The registry records enrollment of 46, a start date of 2007-05, and primary completion in 2008-04. The study examined a mild moisturizing hand cleanser in people described as having mild to moderate hand dermatitis.
The primary outcome was Investigator Global Assessment at Wk 4, on a scale from 0, clear, to 4, severe. The registry reports arm-level means and 95% confidence intervals, but states that values for the continuous two-arm comparison are missing or not estimable. No analyses or secondary outcomes are posted. The control group’s labels differ across the outcome, intervention description, and safety record.
The safety entry records no affected participants for serious or other adverse events in either listed group; death counts are not reported. Important details about the analysis, missing data, masking roles, and outcome calculation are not reported in the registry record. The results are therefore best read as limited descriptive summaries rather than a comparative treatment-effect estimate.