Study the Safety and Efficacy of DBI-001 Gel Versus Aqueous Gel: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Study the Safety and Efficacy of DBI-001 Gel Versus Aqueous Gel (NCT05253755), a randomized phase 2 study. The primary outcome is Change From Baseline in Individual Signs and Symptoms of Atopic Dermatitis.

2. Clinical Question

The intended comparison is topical DBI-001 gel versus aqueous gel in people with atopic dermatitis, with treatment applied to affected skin. The within-person bilateral description indicates that a participant’s two treated sites could serve as a paired comparison. Such a design can account for characteristics shared by the two sites in the same person, but the registry record does not give the allocation procedure for sites, details of how sites were selected, or the planned analysis of paired observations. It also labels the study model as parallel. The difference between that model label and the bilateral within-subject descriptions is not resolved in the registry record.

The record identifies safety and efficacy as study aims, but the primary outcome is the change in signs and symptoms. It specifies assessments through day 42, while the study description states daily application for 4 weeks. The record does not explain the relationship between the treatment period and the later assessment time points. No numerical primary-outcome estimates, uncertainty intervals, or treatment comparison statistics are reported. Accordingly, the registry record identifies the question the study was designed to address, but does not provide the primary results needed to judge the observed comparison.

3. Trial Design

This is a phase 2 study listed as randomized and triple masked. Its official title describes an observer-blinded bilateral comparison, and the treatment descriptions both state that it is a within-subject bilateral controlled study. At the same time, the registry labels the study model as parallel. These design descriptions do not fully align, and the record does not clarify how randomization, masking, and the model label were implemented together. The descriptions establish that the two topical gels were compared, but do not identify which people or roles were masked or how the two treated sites were assigned.

The registry records enrollment of 10. The start date is 2021-10-06, and the primary completion date is 2022-09-09. The status is terminated. The reason for termination, the timing of termination relative to participant follow-up, and whether the study stopped before its intended completion are not reported in the registry record. A reason for termination should not be inferred from status alone.

The study description specifies daily topical application for 4 weeks. The primary outcome timeframe is 42 days of participation, with assessments listed on days 7, 14, 21, 28, 35, and 42. It is therefore important to distinguish the stated application period from the stated outcome assessment period. The record does not describe adherence measurement, treatment discontinuation, or the handling of assessments after treatment ended.

The primary outcome is change from baseline in individual signs and symptoms of atopic dermatitis, described as components of the ADSI score. Component severity is rated from none to severe, with scores from 0 to 3, and the description says the component scores are added to calculate the ADSI score. The outcome parameter is listed as a median, with inter-quartile range as the dispersion measure. The registry record lists one outcome measure and zero analyses. It does not provide an analysis population, a statistical model, or numerical outcome results. The enrollment figure alone does not establish the number of participants with evaluable outcome data or the number of paired sites analyzed.

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

Analysis population for the primary outcome, as defined in the registry: This study is a within-subject bilateral controlled study.

5. Baseline Characteristics

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

6. Primary Endpoint

The registry lists the primary outcome as Change From Baseline in Individual Signs and Symptoms of Atopic Dermatitis, measured over 42 days of participation.

The primary outcome concerns change from baseline in individual signs and symptoms of atopic dermatitis. The listed components are erythema, pruritus, exudation, excoriation, and lichenification. Each component is assigned a severity score: 0 for none, 1 for mild, 2 for moderate, and 3 for severe. The description says these component scores are added to form the Atopic Dermatitis Severity Index, or ADSI. The outcome is assessed at days 7, 14, 21, 28, 35, and 42.

Tracking signs and symptoms over time can describe whether severity scores change from a participant’s baseline during follow-up. A within-person comparison can also be useful for comparing treatments applied to different sites in the same participant, because some characteristics are shared across those sites. These are general reasons such measures and designs may be used; the registry record does not state the specific rationale for choosing this endpoint or how the paired observations were planned to be analyzed.

The endpoint description contains both the phrase individual signs and symptoms and a definition of a summed ADSI score. It does not specify whether the primary analysis was intended to report each component separately, the summed score, or both. The median and inter-quartile range are listed as the summary parameter and dispersion, but no medians, inter-quartile ranges, changes, or between-treatment estimates are reported in the registry record. Thus, the endpoint’s measurement framework is described, while its observed results and the exact primary summary are not available.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

What does the within-person description imply?

General: In a bilateral within-person design, two sites on the same participant receive different treatments, and the contrast can be based on the difference between those sites. Because the sites belong to one person, their observations are related rather than independent. A paired analysis accounts for that relationship; treating the two sites as if they came from unrelated people can misstate the uncertainty. The registry record describes a bilateral within-subject comparison, but does not state the analysis method or whether the primary analysis used paired data.

The record also labels the model as parallel. In a conventional parallel design, participants are allocated to different treatment groups. That differs from the within-person bilateral description. The registry record does not reconcile these labels or state whether the parallel label reflects a broader registry classification rather than the actual treatment comparison. A reader cannot determine the exact analysis structure from the design fields alone.

Why report a median and inter-quartile range?

The primary outcome lists a median and inter-quartile range. General: The median gives a central value that is less affected by extreme observations than the mean. The inter-quartile range describes the span between the middle portions of the observations and communicates variability. These summaries can be useful for bounded or ordinal severity scores, although the registry record does not explain why they were selected for this study. The record does not report the actual summary values, so their interpretation in this trial is not possible.

The component scores have ordered severity levels, from none through severe, and the description states that the component scores are summed to form the ADSI. General: Ordinal categories preserve rank but do not necessarily imply equal distances between categories. A summed score can provide a compact measure across multiple signs, but it can conceal which components account for a change. Here, the description refers both to individual signs and symptoms and to the summed ADSI; the planned primary summary and the way component-level results were to be handled are not reported in the registry record.

What would an effect estimate and confidence interval add?

General: An effect estimate expresses the contrast between treatments on a defined outcome scale. A confidence interval communicates uncertainty around that estimate, with a wider interval indicating less precision under the method used. Neither an estimate nor a confidence interval is reported for the primary outcome in the registry record. There are also no reported hypothesis tests or p-values for that outcome. Without those results, the direction, magnitude, and precision of the primary comparison cannot be described.

A statistical test and an effect estimate answer different questions. A test assesses compatibility with a specified null hypothesis under its assumptions, while an estimate describes the contrast itself. A p-value alone would not show the size or clinical meaning of a difference; conversely, an estimate without uncertainty would not show how precisely it was determined. These are general principles, not statements about analyses conducted in this study. The registry record lists zero analyses, so no primary-outcome inferential result is available.

Why do repeated outcomes and over-dispersion matter?

General: Multiple observations from one participant are usually correlated. Repeated symptom assessments over time may also be correlated, and multiple treated sites within a participant are not automatically independent. Statistical methods should reflect the structure of the observations. The registry record identifies multiple assessment days and a bilateral design, but does not report a model, covariance structure, or other method for accounting for repeated observations.

Over-dispersion is a general issue that arises when observed variation exceeds what a statistical model assumes. If a model underestimates variability, its uncertainty estimates may be too small. The registry record does not identify a count model or report an over-dispersion assessment, so there is no basis for saying that over-dispersion was relevant to or addressed in this trial. This concept should not be confused with the inter-quartile range listed as a descriptive measure.

Can the available enrollment establish power?

The registry records enrollment of 10, but does not report a sample-size justification, target enrollment, assumed treatment effect, or planned power. The reason for the enrollment size is not reported in the registry record. A sample-size calculation depends on design assumptions, the outcome scale, variability, the analysis, and a target effect. Those details are not available for the primary outcome.

General: Power is a design-stage probability defined in relation to a specified effect and statistical procedure. It cannot be inferred simply from the number enrolled, and it should not be described as observed power after the results. No sample-size justification or inferential outcome results are reported. Any numerical planning illustration based on an observed effect would not establish the study’s original design rationale and would not substitute for reported trial results.

What can be said about the analysis plan?

The registry record does not report a statistical analysis plan, a primary analysis model, interim analyses, or methods for handling missing values. It also does not state whether the analysis was intended to follow treatment assignment, include all enrolled participants, or use another analysis population. These details matter because the treatment contrast depends on which observations are included and how incomplete or repeated measurements are handled. Their absence in the record prevents a fuller appraisal of the intended statistical analysis.

10. Multiplicity, Missing Data and Analysis Populations

The primary outcome is assessed at days 7, 14, 21, 28, 35, and 42 and concerns several signs and symptoms: erythema, pruritus, exudation, excoriation, and lichenification. The description also defines a summed ADSI score. These features create multiple possible results to report, including results across times and components. The registry record does not state which time point or summary was the primary inferential comparison, whether component-level outcomes were secondary, or whether any adjustment for multiple comparisons was planned.

General: When many outcomes or time points are tested, the chance of a seemingly notable result arising by chance can increase. A prespecified testing strategy or multiplicity adjustment can help define how evidence should be interpreted across several comparisons. The absence of a reported strategy does not establish that no strategy was used; it means the strategy is not reported in the registry record. No analyses or primary-outcome test results are listed.

The registry record also does not report missing-data amounts, reasons for missing assessments, or methods for handling missing values. In a longitudinal study, incomplete observations can affect the interpretation of change over time, particularly if missingness is related to symptoms or treatment experience. General: Methods such as complete-case analysis or model-based approaches rely on assumptions about missingness, and those assumptions should be described when such methods are used. No particular method can be attributed to this study.

An analysis population is not reported in the registry record. It is therefore not possible to determine which participants or treated sites were included in the primary analysis, or whether the planned analysis population differed from those enrolled. The record’s within-person bilateral description also makes clarity about paired-site inclusion relevant. The enrollment figure should not be treated as confirmation that all participants had complete outcome data or were analyzed.

11. Safety Results

The registry reports serious adverse events as affected participants divided by participants at risk.

Deaths

Other (non-serious) adverse events

Participants with at least one non-serious event at or above the registry's 0% reporting threshold.

Most frequent non-serious adverse event terms

The registry reports serious adverse-event counts separately for DBI-001 Gel and Aqueous Gel. Each group lists 10 at risk, 0 affected by serious adverse events, and 0 deaths. For other adverse events, each group lists 10 at risk and 2 affected. These are the reported counts; the registry record does not provide event terms for the other adverse events or further details about severity, timing, or outcome.

The figures describe what is recorded in each treatment group, not a complete comparative safety analysis. The record does not provide estimates of uncertainty, statistical comparisons, or a participant-level account of whether the same person contributed events associated with both treated sites. Because the study is described as a within-subject bilateral comparison, group counts should not automatically be interpreted as counts from two independent sets of participants.

Zero reported serious events is a description of the posted count, not evidence that serious events are impossible or that all potential harms have been characterized. The enrollment recorded as 10 also limits how much can be learned from sparse event counts, but no numerical precision estimate is reported. The status is terminated; the reason for termination and whether it affected the completeness of safety follow-up are not reported in the registry record. The figures should therefore be read narrowly as the available recorded counts, rather than as a definitive comparison of safety between gels.

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

The record establishes that a randomized phase 2 study was registered to compare DBI-001 gel with aqueous gel in atopic dermatitis. The intervention descriptions specify topical application to affected skin, and the study description specifies daily application for 4 weeks. The primary outcome focuses on changes in symptom and sign severity, with assessments listed through day 42. The record also provides adverse-event counts for the two gel groups.

What the posted information does not establish is the size or direction of the primary-outcome difference. No outcome medians, inter-quartile ranges, treatment contrasts, confidence intervals, or p-values are reported. The record lists zero analyses, and its primary outcome is not reduced to one comparison. Consequently, there is no numerical primary result to interpret for the relative changes under the two treatments. Absence of a reported estimate is not evidence that the treatments had the same outcome, nor is it evidence of a difference.

The safety counts show no reported serious adverse events or deaths in either group and list other adverse events for 2 participants in each group. These counts do not provide detailed event descriptions or comparative uncertainty, and the bilateral design complicates any assumption that the group counts represent independent participant samples. They should not be treated as a complete characterization of harms.

The design record includes both a parallel model label and within-subject bilateral descriptions, without an explanation of the discrepancy. It does not report the statistical analysis plan, analysis population, handling of missing data, or rationale for the recorded enrollment. Its terminated status is documented, but the reason is not reported. These limitations leave important questions about study conduct and analysis unanswered.

Overall, the registry record supports a description of the planned comparison and the posted safety counts, but not a conclusion about the primary efficacy comparison. A treatment effect cannot be inferred from the study title, aims, or outcome definitions. Any interpretation of efficacy would require reported outcome results and sufficient information about how the paired observations and multiple assessments were analyzed.

13. Why This Trial Matters Statistically

This study is statistically notable because its treatment descriptions specify a bilateral within-person comparison. In that design, observations from different treated sites in the same participant may be paired. The statistical analysis should reflect that dependency rather than treating every site as an independent observation. The registry record does not state how the paired structure was handled, so the distinction between design description and analysis method is important when reading the available information.

The primary outcome also spans several signs and symptoms and multiple assessment days. The description defines a summed severity index, while the title refers to individual signs and symptoms. This raises a reporting question: a single prespecified comparison is easier to interpret than a collection of unprioritized results across components and time points. The registry record does not explain the intended hierarchy or multiplicity approach, and it lists no analyses.

Reporting uncertainty is essential when the number enrolled is 10. A point estimate, if available, would need to be read alongside its variability and uncertainty, particularly for a small study and a potentially paired outcome. No primary-outcome estimates or confidence intervals are reported. The median and inter-quartile range are identified as summary measures, but the actual values are absent.

The record’s inconsistent model descriptions and terminated status further underscore the value of transparent reporting. The record does not explain the design-label discrepancy or the reason for termination. These omissions do not establish a flaw in study conduct, but they limit readers’ ability to assess how the trial was run and analyzed. Statistically, the case illustrates why design structure, outcome definitions, analysis plans, and complete results need to be reported together for a treatment comparison to be interpretable.

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 most direct limitation is that numerical results for the primary outcome are not reported in the registry record. Although the outcome definition, summary measure, and assessment days are specified, the record gives no actual medians, inter-quartile ranges, changes, between-treatment estimates, or uncertainty intervals. It therefore does not permit a statistical assessment of the primary comparison.

The design descriptions are not fully consistent. The record is labeled parallel, while the official title and treatment descriptions describe an observer-blinded within-patient bilateral comparison. Randomized and triple-masked labels are also present, but the masking roles and allocation procedures are not detailed. The record does not explain these differences, making it difficult to establish the exact structure of the planned comparison from the registry fields alone.

The recorded enrollment is 10, and the status is terminated. The reason for termination, any effect on completion of follow-up, and the relationship between the recorded enrollment and the analysis population are not reported in the registry record. The record also does not explain the sample-size rationale or give a statistical analysis plan.

Outcome interpretation is further limited by the distinction between the stated individual signs and symptoms and the description of a summed ADSI score. The planned primary summary, treatment contrast, handling of repeated observations, multiplicity strategy, and missing-data methods are not reported. The registry also gives limited detail about safety events beyond the counts. These are limitations of the available registry information; they do not establish what may have been specified in other study documents or conducted outside the reported record.

15. Related Tutorials

16. Related Statistical Calculators

17. Sources

• ClinicalTrials.gov: Study the Safety and Efficacy of DBI-001 Gel Versus Aqueous Gel — NCT05253755.
• Registry record last updated 2023-11-08; status last verified 2023-10.
• Results first posted 2023-11-08.
• 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

NCT05253755 is a phase 2 randomized study of DBI-001 gel versus aqueous gel for atopic dermatitis. The record describes daily topical application for 4 weeks and a within-subject bilateral comparison, while also labeling the study model as parallel. It is listed as triple masked and observer-blinded in its official title. The registry records enrollment of 10, a start date of 2021-10-06, primary completion on 2022-09-09, and terminated status.

The primary outcome is change from baseline in atopic dermatitis signs and symptoms, assessed on days 7, 14, 21, 28, 35, and 42. Component scores range from 0 for none to 3 for severe and are described as contributing to the summed ADSI. The outcome summary is specified as median with inter-quartile range, but numerical primary results are not reported and the record lists zero analyses.

Safety counts list no serious adverse events or deaths in either gel group and other adverse events affecting 2 of 10 in each group. The reason for termination, analysis methods, missing-data handling, and sample-size justification are not reported in the registry record.