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 The Effects of Dupilumab on Allergic Contact Dermatitis (NCT03935971), a na phase 4 study. The primary outcome is Change From Baseline in Investigator's Global Assessment (IGA) Score.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT03935971 |
| Phase | Phase 4 |
| Condition | Allergic Contact Dermatitis |
| Allocation | Not applicable (single group) |
| Design model | Single Group |
| Masking | None (open label) |
| Enrollment | 17 |
| Arms in the primary outcome | n/a |
| Lead sponsor | Brigham and Women's Hospital |
| Results posted | Yes |
2. Clinical Question
Population
People with allergic contact dermatitis, described in the record as subjects with allergic contact dermatitis. The registered enrollment is 17. Further eligibility details and a more specific description of the population are not reported in the registry record.
Intervention
Dupilumab, with a registered regimen of 600 mg/4 mL subcutaneously once, followed by 300 mg/2 mL every 2 weeks for 10 weeks.
Comparator
There is no separate comparator group in the registered design. The study is listed as single-group, with allocation recorded as not applicable and masking as none.
Primary question
How does the mean Investigator’s Global Assessment score change from baseline at week 6 and week 12 among participants receiving the registered dupilumab regimen?
The primary measure is a physician-reported global assessment of disease activity, rated from 0, clear, to 4, severe. The registry frames the outcome as change from baseline and identifies measurements at week 0, week 6, and week 12. However, it does not report the observed mean scores, changes, confidence intervals, or an analysis comparing time points.
The record also lists secondary outcomes involving Body Surface Area, Eczema Area and Severity Index, itch, dermatology-related quality of life, sleep, and skin and blood samples. These measures describe additional clinical, patient-reported, and biological questions, but their results are not reported in the registry record. The design can describe changes observed in the enrolled group; without a comparator, it cannot distinguish changes associated with treatment from changes that might have occurred for other reasons.
3. Trial Design
This is a phase 4, single-group study sponsored by Brigham and Women’s Hospital. The condition listed is allergic contact dermatitis, and the registered enrollment is 17. The study is marked active, not recruiting. Its start date is 2019-12-18, and its primary completion date is 2024-12-31. Those registry fields describe the study’s administrative status and planned timing; they do not establish that follow-up or analysis is complete.
Participants are described as receiving dupilumab according to a regimen of 600 mg/4 mL subcutaneously once, followed by 300 mg/2 mL every 2 weeks for 10 weeks. The record lists no separate control arm. Allocation is recorded as not applicable, the study model as single-group, and masking as none. Therefore, the registered design is not a randomized comparison, and the study does not provide a like-for-like control group against which to compare changes.
The primary outcome is change from baseline in mean Investigator’s Global Assessment score, with assessment times at week 0, week 6, and week 12. The stated scale runs from 0, clear, to 4, severe. Secondary outcomes include changes in Body Surface Area, Eczema Area and Severity Index, itch ratings, dermatology-related quality of life, and sleep questionnaire scores, as well as skin and blood samples.
The registry record does not report a sample-size justification, a detailed statistical analysis plan, or the analysis population. It lists no analyses, and the primary outcome results are not reported in the registry record. The planned enrollment and study design should not be mistaken for evidence of a treatment effect. The plotted and tabulated statistics, if read alongside the registry information, need to be interpreted in light of the absence of a registered comparator and the lack of reported primary outcome estimates.
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: 6 of the 17 subjects enrolled were found ineligible due to not having a strong enough patch test reaction at visit 3
Overall Study
| Stage | Subjects With Allergic Contact Dermatitis |
|---|---|
| STARTED | 17 |
| COMPLETED | 6 |
| NOT COMPLETED | 11 |
Reasons for not completing this period:
| Reason | Subjects With Allergic Contact Dermatitis |
|---|---|
| Did not meet inclusion criteria | 6 |
| Lost to Follow-up | 2 |
| Withdrawal by Subject | 3 |
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.
Population: IGA of at least 3 at baseline and at least one 2+ (strong) or 3+ (extreme) reaction on patch testing to participate in this open-label pilot study.
| Characteristic | Unit | Subjects With Allergic Contact Dermatitis |
|---|---|---|
| Participants analysed | 17 | |
| Age, Categorical: <=18 years | Participants | 0 |
| Age, Categorical: Between 18 and 65 years | Participants | 9 |
| Age, Categorical: >=65 years | Participants | 8 |
| Sex: Female, Male: Female | Participants | 11 |
| Sex: Female, Male: Male | Participants | 6 |
| Ethnicity (NIH/OMB): Hispanic or Latino | Participants | 1 |
| Ethnicity (NIH/OMB): Not Hispanic or Latino | Participants | 16 |
| Ethnicity (NIH/OMB): Unknown or Not Reported | Participants | 0 |
| Race (NIH/OMB): American Indian or Alaska Native | Participants | 0 |
| Race (NIH/OMB): Asian | Participants | 0 |
| Race (NIH/OMB): Native Hawaiian or Other Pacific Islander | Participants | 0 |
| Race (NIH/OMB): Black or African American | Participants | 3 |
| Race (NIH/OMB): White | Participants | 13 |
| Race (NIH/OMB): More than one race | Participants | 1 |
| Race (NIH/OMB): Unknown or Not Reported | Participants | 0 |
6. Primary Endpoint
The registry lists the primary outcome as Change From Baseline in Investigator's Global Assessment (IGA) Score, measured over week 0, week 6, week 12.
| Element | Registry entry |
|---|---|
| Result type | Mean |
| Measure of spread | 95% Confidence Interval |
| Unit | mean IGA scores |
| Endpoint classification | Continuous Endpoint |
The primary endpoint is change from baseline in the mean Investigator’s Global Assessment score. The assessment is physician-reported and provides a global rating of disease activity on a scale whose endpoints are 0, clear, and 4, severe. The registry identifies week 0, week 6, and week 12 as assessment times. It does not report the actual scores or changes at those times.
A global assessment can provide a compact clinical summary: rather than describing a single symptom or body area, it asks an investigator to rate overall disease activity. Such an endpoint can be useful when the study question concerns the overall clinical state. It is also a judgment-based measure, so the rating may depend on how the assessment is conducted and how the scale is applied. The registry describes the scale and its range, but further details about assessor training, rating procedures, or efforts to ensure consistency are not reported in the registry record.
Because the endpoint is described as a mean of a continuous measure, a mean change would summarize the average direction and magnitude of change across the analyzed participants. That summary does not show how much individual responses varied, and the mean alone cannot establish whether every participant experienced a similar change. The registered dispersion measure is a 95% confidence interval, but interval estimates and endpoint results are not reported in the registry record. Without those values, the direction, size, and precision of any observed change cannot be assessed.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry describes a study intended to examine dupilumab in allergic contact dermatitis, but the primary outcome values are not reported in the registry record. Although the endpoint, assessment times, and intended confidence-interval format are specified, no mean scores, changes from baseline, confidence intervals, or analysis results are listed. Consequently, the record does not establish the size or direction of change in Investigator’s Global Assessment score, or how precisely any change was estimated.
The design is single-group, with no separate comparator arm. A change between baseline and later assessments in such a study would be a within-group observation. It would not, by itself, show what would have happened over the same period without the intervention. Changes can reflect treatment, but can also arise from natural variation in disease activity, other care, participant behavior, assessment variability, or other influences. The record does not provide information that would separate these possibilities.
The registered enrollment is 17. This is a description of planned or registered enrollment, not a count of participants with observed endpoint data. The registry record does not report the number assessed at each time point, the number included in an outcome analysis, or whether all enrolled participants completed follow-up. It therefore does not support an assessment of attrition or the amount of missing outcome information.
The 95% confidence interval named for the primary outcome would ordinarily express uncertainty around an estimated mean or mean change under the analysis assumptions. A narrower interval generally indicates greater precision, while a wider interval indicates less precision. But there is no interval estimate in the registry record to interpret. A confidence interval is not a guarantee about the range of individual participant outcomes, and it does not remedy the absence of a comparator.
The record lists 8 outcome measures and 0 analyses. It names secondary outcomes, but does not report their estimates or explain how multiple outcomes were handled. The absence of listed analyses is not evidence that no analyses were performed; it means analyses are not reported in the registry record. Likewise, the absence of endpoint results cannot be interpreted as a finding of no change or no effect.
The serious adverse event listing reports 0 serious adverse events among 17 participants at risk, and 0 deaths. These are the recorded figures for the listed group, not proof that no adverse experiences of any kind occurred. The record’s serious-event fields do not describe non-serious events, event ascertainment procedures, or the completeness of safety follow-up.
Overall, the registry supports description of the study design and specified outcomes, not a conclusion about efficacy or safety. Any numerical plots or planning illustrations should be read with the same distinction in mind: a descriptive change in a single group is not a controlled treatment contrast, and a planning calculation is not an observed clinical result.
9. Statistical Methods Explained
The registered primary outcome is a mean of a continuous measure: change from baseline in Investigator’s Global Assessment score. The registry gives the scale endpoints as 0, clear, and 4, severe, and names week 0, week 6, and week 12 as assessment times. The statistical meaning of a mean is an average across the observations included in the analysis. It can summarize a group, but does not show the full distribution of scores or how consistently participants changed. The registry record does not report the observed values or define the participants included in an analysis.
What does a confidence interval communicate?
The registered dispersion measure is a 95% confidence interval. In general, a confidence interval communicates the uncertainty associated with an estimate under the method’s assumptions. It is not a range that contains a specified proportion of individual participant scores, and it does not account automatically for bias, missing observations, or design limitations. Its width helps readers judge precision: more uncertainty is reflected by a wider interval. Here, the registry record names the interval type but does not report interval limits, so precision cannot be judged from the registry information.
What can a within-group change establish?
In a single-group design, the primary outcome compares measurements over time within the enrolled group. General statistical interpretation distinguishes that observed change from a treatment effect established through a controlled contrast. Without a separate comparator, the change cannot distinguish the intervention’s contribution from other explanations, such as natural fluctuation, concurrent care, changes in behavior, or measurement variability. This limitation remains even if a within-group change estimate is precise. Precision and causal interpretation are different issues.
Why does the absence of a control matter?
A comparator can help estimate how outcomes might have changed over the same period under a different treatment condition or under usual care, depending on the design. This record lists no such group and specifies no random allocation. Therefore, a between-group treatment contrast is not part of the registered design. The registry’s note that the arms are not a like-for-like control comparison is consistent with its single-group model. The observed scores, if reported elsewhere, would need to be described as changes in the study group rather than as a randomized comparison.
How should repeated measurements be understood?
Measurements at baseline, week 6, and week 12 are repeated observations over time. In general, measurements from the same participant may be related; they should not automatically be treated as independent observations. Statistical methods for repeated measurements can account for that dependence, but the registry record does not report the analysis method used. It also does not state whether the primary comparison is based on each follow-up time separately, a model of the time course, or another approach. No particular method should be inferred from the endpoint description alone.
What about sample-size illustrations?
Planning calculations answer a hypothetical design question: how many participants per arm might be needed under stated assumptions to detect an effect of a specified size with a chosen power and significance level. They are not observed power, and they do not show that a study has obtained a particular result. The planning assumptions associated with this record describe equal allocation between two arms, a two-sided significance level of 0.05, and a normal approximation, with the effect defined as a fraction of an observed effect. These are planning assumptions, not the registered single-group design. The registry record does not report its own sample-size justification, and the observed effect needed to ground a planning illustration is not reported in the registry record. Such illustrations cannot substitute for outcome estimates or establish that the study was adequately powered.
How should outcome multiplicity be considered?
The record lists 8 outcome measures, including the primary IGA outcome and secondary clinical, patient-reported, and biological measures. When many outcomes or time points are examined, the chance of finding an apparently notable result by chance can increase if no adjustment or prespecified hierarchy is used. General approaches include defining a primary outcome, specifying which comparisons are confirmatory, and describing any adjustment for multiple testing. The registry record does not report such a strategy or list analyses. It is therefore not possible to determine how multiplicity was handled or whether a particular estimate was designated confirmatory.
Statistical interpretation also depends on who was analyzed, how missing observations were treated, and whether the analysis followed a prespecified plan. Those details are not reported in the registry record. With no reported endpoint estimates, confidence intervals, analysis methods, or analysis population, the statistical evidence for the primary question cannot be evaluated from the registry record.
10. Multiplicity, Missing Data and Analysis Populations
The registry lists 8 outcome measures, including a primary outcome and several secondary outcomes. It does not report a multiplicity strategy: no testing hierarchy, adjustment method, or distinction between confirmatory and exploratory secondary analyses is described. In general, when several outcomes or comparisons are examined, readers need to know how the analysis accounts for the possibility of chance findings across those tests. Without that information, the strength of any individual secondary result would be harder to assess. The record lists 0 analyses, and outcome estimates are not reported in the registry record.
The analysis population is not reported in the registry record. The entry does not specify whether the primary analysis would include all enrolled participants, only participants with measurements at particular visits, or another defined group. It also does not report attendance at the week 6 or week 12 assessment, the number of missing outcome values, reasons for missingness, or any method used to handle missing data.
These omissions matter because missing measurements can affect both the estimated change and its uncertainty, especially if participants with missing data differ from those with observed data. General methods can make assumptions about missingness, but no assumptions or procedures should be attributed to this study without documentation. The registered enrollment of 17 is not, by itself, evidence that 17 participants contributed to each outcome analysis. The registry record therefore does not permit an assessment of attrition, analysis-set selection, or the robustness of results to missing-data assumptions.
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 |
|---|---|---|---|
| Subjects With Allergic Contact Dermatitis | 0 | 17 | 0.0% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| Subjects With Allergic Contact Dermatitis | 0 of 17 |
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 |
|---|---|
| Subjects With Allergic Contact Dermatitis | 0 of 17 |
For the group titled Subjects With Allergic Contact Dermatitis, the registry lists 17 participants at risk for serious adverse events and 0 with a serious adverse event. It also lists 17 at risk for other adverse events and 0 with an event in that category, along with 0 deaths. These are registry counts for the recorded categories; they are not estimates of risk relative to a comparator, because the study has no separate control group.
A zero count in a registry field should be read narrowly. It does not prove that no adverse experiences occurred, and it does not establish the absence of risk. The record does not give details about event definitions, how events were collected, the duration or completeness of safety observation, or non-serious events beyond the listed fields. The serious adverse event section does not provide event terms for the group, and the listed zero count cannot indicate whether participants experienced events that did not meet the serious-event definition. Safety interpretation is therefore limited to the counts recorded and the reporting details available in the registry record.
12. What the Result Does, and Does Not, Mean
The registry record describes a phase 4, single-group study of dupilumab in allergic contact dermatitis. It specifies a regimen and a primary outcome based on change from baseline in mean Investigator’s Global Assessment score at week 6 and week 12. It also lists several secondary clinical, patient-reported, and biological outcomes. These details establish what the study was registered to examine; they do not establish what the study found.
The registry record does not report the primary outcome estimates, confidence intervals, or results for the secondary outcomes. This absence should not be interpreted as evidence that scores did not change, that participants did not respond, or that the intervention had no effect. It means that the registered record does not provide the information needed to assess the magnitude, direction, or precision of the outcomes.
Even if changes in scores were available, a single-group before-and-after comparison would not by itself establish that the intervention caused those changes. Without a comparator, other explanations for changes over time cannot be separated from the contribution of treatment. Nor can the registered enrollment alone establish how many participants had complete follow-up or were included in an analysis; those details are not reported in the registry record.
The serious adverse event fields list 0 events and 0 deaths, but these counts do not establish that no adverse experiences occurred or that the treatment is safe. The registry record does not supply the broader event details needed for a comprehensive safety assessment.
The appropriate conclusion is limited: the record documents a study design, outcomes, and safety counts, while outcome analyses and results are not reported in the registry record. It does not support a claim that dupilumab works or does not work for allergic contact dermatitis, nor does it provide a controlled estimate of benefit or harm.
13. Why This Trial Matters Statistically
This study is statistically notable because its primary question concerns change over time in a group without a separate comparator. That design can document the course of measured scores among participants receiving the registered regimen, but it cannot isolate the treatment contribution from other causes of change. Understanding this distinction is central to reading before-and-after clinical data without treating association as a controlled causal estimate.
The primary endpoint also illustrates why an outcome definition and an outcome result are different things. The record names a physician-reported global score, its range, and its scheduled assessment times. Those details make the intended measure understandable, but they do not show the observed score changes or their precision. A 95% confidence interval is specified as the dispersion measure, yet no interval is reported in the registry record. Readers therefore cannot judge the statistical uncertainty of the primary estimate from this record.
The entry also highlights the importance of transparent analysis details. It lists 8 outcome measures and 0 analyses, while leaving the analysis population, missing-data approach, and multiplicity strategy unreported. These details affect how outcome estimates should be interpreted, particularly when multiple measures and time points are involved. The registered enrollment of 17 describes the study’s enrollment field, not the number with complete outcome data.
Finally, the safety fields demonstrate the limits of interpreting zero event counts without context. Counts can be reported clearly, but their meaning depends on event definitions and observation and reporting procedures, which are not described in detail in the registry record. The statistical value of this record lies in clarifying the design and identifying what remains unavailable, rather than in supporting a treatment-effect conclusion.
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 main design limitation is the absence of a comparator. The study is registered as single-group, with allocation not applicable and masking none. Any observed change over time would therefore be difficult to attribute specifically to the intervention, because the design cannot distinguish treatment-related change from natural variation, other care, or measurement effects.
The registry record gives a planned regimen and outcome schedule but does not report the primary outcome estimates or confidence intervals. It also does not report the secondary outcome results. As a result, the magnitude, direction, and precision of measured changes cannot be evaluated from the registry record. The listed enrollment of 17 does not establish how many participants contributed data at each assessment.
Further details needed to evaluate the conduct and analysis are not reported in the registry record. These include the analysis population, missing-data procedures, assessor procedures beyond the scale description, and a detailed statistical analysis plan. The record lists multiple outcomes but does not describe how multiplicity was handled. It also does not provide a sample-size justification for the registered design.
The status is active, not recruiting, and the primary completion date is 2024-12-31. These administrative entries do not demonstrate that analyses were completed or results posted. The registry’s serious adverse event counts are limited to the fields shown and do not describe all possible adverse experiences, event ascertainment, or follow-up completeness. Taken together, these gaps constrain interpretation of both clinical outcomes and safety.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: The Effects of Dupilumab on Allergic Contact Dermatitis — NCT03935971.
- Registry record last updated 2026-07-16; status last verified 2026-02.
- Results first posted 2026-02-27.
- 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
NCT03935971 is a phase 4, single-group study sponsored by Brigham and Women’s Hospital, registered for allergic contact dermatitis. The regimen is dupilumab 600 mg/4 mL subcutaneously once, followed by 300 mg/2 mL every 2 weeks for 10 weeks. The registered enrollment is 17, and the study status is active, not recruiting.
The primary outcome is change from baseline in mean Investigator’s Global Assessment score, assessed at week 0, week 6, and week 12. The registry describes the scale as ranging from 0, clear, to 4, severe, and specifies a 95% confidence interval. Primary and secondary outcome results, analysis methods, analysis population, and missing-data procedures are not reported in the registry record. The serious adverse event fields list 0 events and 0 deaths. Without reported outcome estimates or a comparator group, the record does not establish a treatment effect.