Clinical Evaluation of T.R.U.E. Test Allergens in Children an Adolescents: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Clinical Evaluation of T.R.U.E. Test Allergens in Children an Adolescents (NCT01797562), a na na study. The primary outcome is Number of Participants With Negative, Positive, Irritant or Doubtful Reaction Scores.

2. Clinical Question

The clinical question is therefore descriptive: what reaction categories were observed after testing with the study allergens, and what safety events were recorded? The trial record sets out the intended evaluation but does not post the primary outcome results needed to describe the distribution of reactions. It also does not report a diagnostic reference standard or a comparison against another test. Without those details, the record cannot establish how the patch-test results correspond to an independently defined diagnosis. The study's stated objective and listed outcomes should be distinguished from findings: an objective identifies what investigators set out to assess, while results are the observed data and their analyses.

3. Trial Design

The registry describes a completed diagnostic-test study sponsored by Allerderm. Enrollment is listed as 116. The study start date is 2012-12-10, and the primary completion date is 2015-09-08. Phase is listed as NA. The design is recorded as single group; allocation is NA, and masking is NONE. These entries describe a study without a reported randomized allocation or masked comparison.

Participants were to be patched with T.R.U.E. Test Panels 1.3, 2.2 and 3.2. The brief summary states that 11 allergens were evaluated, comprising 7 new allergens on panels 2.2 and 3.2 and 4 previously approved allergens with changes to dose and excipient. The record identifies allergic contact dermatitis as the condition. It does not provide a full protocol description, detailed participant eligibility criteria, or enough information to reconstruct the testing schedule beyond the primary outcome timeframe.

The primary outcome is described as the number of participants with negative, positive, irritant or doubtful reaction scores. Investigator determination of positive reaction is timed at 21 days post application. A secondary outcome concerns participants with late or persistent positive patch-test reactions. Two outcome measures are listed, but the registry record does not report their observed results. It also lists zero analyses. This means the posted record does not give inferential or descriptive analysis results for the outcomes.

There is no like-for-like control comparison described. That matters because the data from a single-group evaluation can characterize observed responses in the enrolled participants, but cannot by itself separate the effects of the test from differences that might arise under another testing strategy or comparator. The available registry entries do not report further design features, such as a prespecified statistical analysis plan, interim analyses, or a sample-size justification.

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: Entry criteria required avoidance of systemic or topical (near the test area) corticosteroid treatment during the 7 days prior to patch application, and any treatment with UV light for 3 weeks prior to patch application.

Overall Study

Reasons for not completing this period:

5. Baseline Characteristics

The table reproduces the baseline characteristics posted in the registry, which describe the participants analysed at baseline and help show whether the randomized groups were comparable.

6. Primary Endpoint

The registry lists the primary outcome as Number of Participants With Negative, Positive, Irritant or Doubtful Reaction Scores, measured over Investigator Determination of Positive Reaction: 21 days post application.

The primary endpoint counts participants by patch-test reaction category: negative, positive, irritant or doubtful. The registry's reaction descriptions distinguish no reaction from signs that may be erythematous, infiltrated or vesicular. It describes a negative reaction as no reaction; an irritant reaction as discrete, patchy, follicular or homogenous erythema with no infiltration; and a doubtful reaction as faint macular or homogenous erythema with no infiltration. Positive grades include 1+, described as faint macular or homogenous erythema with no infiltration; 2+, described as erythema, papules, infiltration or discrete vesicles; and 3+, described as coalescing vesicles or a bullous reaction.

The endpoint is used to summarize how investigators classified reactions at patch-test sites. Such categories can describe the observed response to tested allergens, while keeping reaction types distinct rather than combining them into a single outcome. The stated timeframe for investigator determination of positive reaction is 21 days post application. The registry record does not report how category counts were analyzed, whether a participant could contribute to more than one allergen-specific result, or how the categories were summarized across allergens.

The endpoint title gives a count of participants, but the posted results do not state the counts in any category. Nor do they report a measure of precision, such as a confidence interval. As a result, the endpoint definition can be explained, but the observed frequency and uncertainty of each type of reaction cannot be assessed from the registry record.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

General: An endpoint defines what is measured, in whom, and at what time. A statistical analysis then specifies how the observed measurements will be summarized or compared. For this study, the primary endpoint is described in terms of participant counts in reaction-score categories, with investigator determination of positive reaction at 21 days post application. The registry record provides the endpoint definition but does not report an analysis plan or results.

What does a count endpoint convey?

General: A count of participants in a category is a descriptive quantity. It tells readers how many participants were classified in that category, provided that the denominator and the rules for assigning participants are clear. A count alone does not convey the proportion of participants affected, and it does not show the uncertainty around an estimate. For a proportion or rate to be interpreted, the relevant denominator and the handling of missing or repeated observations must also be specified.

In this record, the primary outcome title refers to the number of participants with negative, positive, irritant or doubtful scores. However, the posted record does not provide the category counts, category-specific denominators, or an explanation of how participant observations were handled across the 11 allergens. It is therefore not possible to derive an event rate, compare categories, or determine whether an individual participant could contribute to multiple categories across different tests.

Why do reaction categories matter?

General: Categorization preserves distinctions that may be clinically or diagnostically meaningful. Combining categories can simplify a summary, but can also conceal differences between types or grades of response. The registry describes negative, irritant, doubtful and graded positive reactions, including distinct site findings for the grades. Whether categories were analyzed separately, combined, or treated as an ordered scale is not reported in the registry record. Those choices affect the question answered and should not be assumed from the outcome title.

General: If categories are ordered by increasing reaction intensity, an analysis might account for that ordering; if they are treated as separate nominal categories, an analysis might instead estimate or compare category frequencies. These are general possibilities, not analyses documented for this trial. The registry record lists zero analyses, so it does not identify which approach, if any, was used.

What would precision measures add?

General: A confidence interval expresses the range of values reasonably compatible with an estimate under the assumptions of the analysis. A narrow interval indicates greater precision than a wide interval, while neither width alone nor an interval's position establishes clinical importance. Confidence intervals are especially useful alongside estimated proportions or differences because they show uncertainty that a point estimate cannot convey.

No confidence interval or other precision measure is reported for the primary endpoint. Because the category counts and the analysis denominators are also absent, the precision of any primary outcome estimate cannot be reconstructed. The registry record does not provide p-values or an inferential test either. A p-value, in general, summarizes compatibility of data with a specified null model; it is not a measure of effect size or the probability that a hypothesis is true. No such interpretation can be applied to this record without a reported analysis.

How should multiple allergens be considered?

General: Evaluating multiple allergens can create multiple opportunities for descriptive findings or statistical tests. If many hypothesis tests are performed, the chance of at least one apparently notable result may increase unless the analysis plan addresses multiplicity. Methods to address this issue depend on the scientific aims, the number and structure of comparisons, and whether analyses are confirmatory or exploratory. This is a general statistical consideration, not evidence that any particular testing strategy was used in this study.

The record states that 11 allergens were evaluated, but it does not report a multiplicity plan, the number of hypothesis tests, or whether results were treated as confirmatory or exploratory. It is therefore not possible to determine whether any adjustment was planned or applied, or how to interpret results across allergens. The number of listed outcome measures does not reveal the number of statistical comparisons.

What is the role of the sample-size illustrations?

General: A planning calculation estimates how many participants might be needed for a future study under stated assumptions about the effect to detect, significance level, allocation and statistical model. Such an illustration is not an observed result and is not the same as power calculated after the study. The registry record states that any sample-size illustrations are planning illustrations based on the observed effect, using a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation. It further specifies that the effect to detect is a stated fraction of the observed effect, and that time-to-event calculations would report total events while other calculations would report participants per arm.

Those assumptions describe hypothetical planning, not the design of this single-group evaluation. No trial-specific sample-size justification is reported in the registry record. Nor does the record provide an observed primary effect from which to evaluate such an illustration. Sample-size illustrations should therefore not be read as evidence of observed power, as the planned enrollment target for this trial, or as proof that an endpoint was adequately powered.

General: Over-dispersion occurs when observed variability exceeds what a chosen probability model expects. If present, it can make standard errors and confidence intervals from a simpler model too small, leading to overconfident inference. The registry record does not report a model, variance assessment, or over-dispersion evaluation. This is a general consideration for count-based or grouped outcomes rather than a finding about this trial.

10. Multiplicity, Missing Data and Analysis Populations

The study evaluated 11 allergens, and the registry lists two outcome measures. Evaluating several allergens and outcomes can raise multiplicity concerns if investigators perform multiple statistical tests. In general, repeated testing can increase the chance of finding an apparently notable result by chance. A prespecified plan may distinguish primary from secondary analyses, define which comparisons are confirmatory, or use a method to control multiplicity. The registry record does not report such a plan or any multiplicity adjustment.

The registry lists zero analyses. It does not report whether outcomes were analyzed by allergen, pooled across allergens, or both. It also does not state whether the secondary outcome was tested inferentially or treated descriptively. As a result, the number and interpretation of statistical comparisons cannot be established from the posted record.

Missing-data methods are not reported in the registry record. The entry does not say whether all 116 enrolled participants completed testing, whether all participants contributed data at the 21-day assessment, or how incomplete or uninterpretable patch tests were handled. It does not report an analysis population definition, such as an intention-to-treat or evaluable-participant group. These omissions prevent assessment of whether the endpoint denominators included all enrolled participants and whether any exclusions could affect the results.

General: Missing outcomes can bias a result when the likelihood of missingness is related to participant characteristics or the outcome itself. Reporting the amount of missing data, reasons for missingness, and the analysis population helps readers judge this risk. No specific missingness mechanism can be inferred from the registry entries.

11. 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 serious adverse event terms

Most frequent non-serious adverse event terms

Serious events with the highest arm-level rate: appendicitis (0.9%).

The safety group lists 116 participants at risk for serious adverse events, with 1 affected, and 116 at risk for other adverse events, with 47 affected. These are the registry's reported counts. They should be read as safety summaries rather than as evidence about whether the test caused an event. The record does not report a comparison group, an event-rate analysis, or an assessment of causality.

Appendicitis is listed among the top serious adverse event terms at 0.9%. That entry identifies a reported term and percentage in the registry, but does not provide a narrative account, timing, or attribution. The record does not clarify whether the serious event is represented by that term or provide participant-level details. The death count is not reported in the registry record.

General: Serious adverse events are distinct from all other adverse events by the seriousness classification used for reporting; the term does not by itself imply that an event was caused by an intervention. Counts also do not describe duration, recurrence, severity among non-serious events, or the relationship of events to exposure unless those details are reported. The available safety entries therefore provide limited descriptive information and do not support a causal safety conclusion.

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

The registry record establishes that a completed single-group study evaluated T.R.U.E. Test allergens in children and adolescents aged 6-17 years. It describes the intended diagnostic-performance and safety objectives, the panels used, the reaction categories, and the timeframe for investigator determination of positive reaction. It also records safety counts and a serious adverse event term.

Those descriptions do not amount to reported efficacy or diagnostic-performance findings. The primary outcome counts are not reported in the registry record, and no statistical analyses are listed. The record does not report how often negative, positive, irritant or doubtful reactions occurred, or the precision of any such estimate. It also does not provide a reference-standard comparison from which diagnostic accuracy could be assessed. Thus, the posted information cannot establish the extent to which test results identify allergic contact dermatitis or distinguish it from other findings.

The design information matters to interpretation. With a single group and no reported comparator, the registry does not present a concurrent comparison that could quantify a relative difference. Masking is recorded as NONE. The record does not describe additional safeguards or adjustment methods that would address the potential influence of unmasked assessment. These features do not negate the descriptive purpose, but they constrain what conclusions a reader can draw from the record.

The safety entries show reported event counts for the listed risk groups, including 1 participant with a serious adverse event and 47 with other adverse events. They do not show whether events were caused by the testing, how the counts compare with another group, or whether all events were captured. The serious term Appendicitis is listed at 0.9%; the registry does not provide enough detail to interpret that term as a causal finding.

In short, the record documents a study objective and some design and safety information, but does not post the outcome analyses needed to judge the observed diagnostic performance, uncertainty, or comparative safety. The absence of results in the registry is not evidence that an outcome was absent; it means the outcome findings are not reported in the registry record.

13. Why This Trial Matters Statistically

This trial raises several statistical issues relevant to diagnostic evaluations. The endpoint is based on investigator-classified reaction categories rather than a single continuous measurement. Clear definitions help readers understand what each category represents, but interpreting category counts also requires knowing the denominators, how participants and allergens were handled, and whether categories were analyzed separately or combined. Those details are not reported in the registry record.

The study evaluates multiple allergens, including new allergens and previously approved allergens with changes to dose and excipient. General: Multiple evaluations can produce a complex set of findings, so a statistical plan should clarify which questions are primary, how comparisons are organized, and how multiplicity is handled when inferential testing is planned. The record does not report those analysis details. Without them, it is not possible to distinguish prespecified confirmatory conclusions from exploratory summaries.

The single-group design is another central feature. It can describe reaction patterns in tested participants, but cannot make a direct comparison with an alternative test or control group when none is reported. For diagnostic-performance claims, a reference standard and a clear account of how test results are compared with it are important. The registry record does not report such an analysis.

Finally, transparent outcome reporting is essential for statistical interpretation. Enrollment and safety counts do not replace primary results, denominators, uncertainty estimates, or analysis methods. The record's completed status indicates that the study is marked completed, but completion alone does not provide evidence about its outcomes. The absence of posted analyses limits independent assessment of both the magnitude and precision of findings.

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 registry record leaves important details of the study population and conduct unreported. It identifies children and adolescents aged 6-17 years and allergic contact dermatitis, but does not provide fuller eligibility criteria, baseline characteristics, or the number of participants who completed each assessment. Enrollment is listed as 116, but the primary endpoint denominator is not reported.

The design is recorded as single group, with allocation listed as NA and masking as NONE. No comparator group is described. The record does not explain whether reaction assessments were independently reviewed or whether any procedures were used to reduce observer variability. Because the primary endpoint relies on investigator reaction classifications, reproducibility and assessment procedures would be useful context, but are not reported.

The study evaluates 11 allergens, yet the posted record does not give allergen-specific outcome counts, explain how results were summarized across allergens, or describe how multiple testing was addressed. It does not report a diagnostic reference standard or an analysis of agreement with one. No primary outcome results, secondary outcome results, estimates of precision, or statistical analyses are posted.

Missing-data handling and analysis populations are not reported in the registry record. The sample-size justification, interim analyses and statistical analysis plan are also not reported. The safety entries give counts and a serious-event term but do not describe event timing, attribution, or participant-level overlap. These gaps mean that the registry record supports only a limited account of the study design and reported safety summaries, not a full evaluation of outcome validity or the strength of evidence.

15. Related Tutorials

16. Related Statistical Calculators

17. Sources

• ClinicalTrials.gov: Clinical Evaluation of T.R.U.E. Test Allergens in Children an Adolescents — NCT01797562.
• Registry record last updated 2020-08-21; status last verified 2020-04.
• Results first posted 2020-08-12.
• 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.

18. Record Summary

The registry record describes a completed, single-group diagnostic-test evaluation sponsored by Allerderm, with enrollment of 116 participants. The study objective was to evaluate diagnostic performance and safety of T.R.U.E. Test allergens in pediatric participants aged 6-17 years. It reports evaluation of 11 allergens: 7 new and 4 previously approved allergens with dose and excipient changes. Panels 1.3, 2.2 and 3.2 are identified.

The primary outcome concerns participant counts in negative, positive, irritant and doubtful reaction categories, with investigator determination of positive reaction at 21 days post application. A secondary outcome concerns late or persistent positive patch-test reactions. The registry lists zero analyses and does not report outcome results or a statistical analysis plan.

Safety reporting lists 1 serious adverse event among 116 at risk and 47 other adverse events among 116 at risk. Appendicitis is listed among serious terms at 0.9%. The record does not report a comparator group, diagnostic reference-standard analysis, or causal safety assessment.