Evaluation of the Vasoconstriction Properties of MC2-01 Cream: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Evaluation of the Vasoconstriction Properties of MC2-01 Cream (NCT03758365), a randomized phase 1 study. The primary outcome is Comparison of the Vasoconstriction Potential (Skin Blanching Effect) of the MC2-01 Cream With Active Comparators and Vehicle.

2. Clinical Question

The endpoint concerns vasoconstriction, assessed through visible skin blanching. The record describes trained observers scoring blanching individually while blinded to treatment. It does not report the resulting scores, group means, standard deviations, or comparisons, so the direction and size of any difference cannot be determined from the registry record.

The trial is described as an evaluation in healthy subjects, not as a study of treatment in people with a clinical skin condition. Its primary question is therefore about a measured pharmacodynamic response under the study conditions, rather than a clinical outcome such as symptom relief or disease control. The registry record does not report further details about application sites, treatment order, or how individual observer scores were combined for analysis.

3. Trial Design

The registry identifies this as a randomized, evaluator-blinded, single-centre phase 1 study, with enrollment of 36 and status listed as completed. The listed study dates are 2018-11-05 for study start and 2018-11-23 for primary completion. The study objective was to compare vasoconstriction potential, described in the primary outcome as skin blanching, after MC2-01 Cream and comparator products.

The design descriptions are not fully consistent within the registry record. The study title and primary outcome population description characterize the evaluation as within-subject, and that population description states that all 36 subjects received a single treatment with all 7 products. A separate design field labels the model as parallel. These descriptions point to different ways of interpreting the comparison structure, and the record does not explain the discrepancy. The within-subject description suggests that each subject’s responses to different products were intended to be compared; the parallel label ordinarily describes different groups receiving different treatments. The record does not provide enough detail to resolve which design description governs the analysis.

The interventions comprise MC2-01 Cream, five corticosteroid comparators, and vehicle. Each is described as a single application. Evaluators were blinded to treatment, but the registry record does not report whether subjects or other study personnel were masked, how randomization was implemented, or how treatment sequence or allocation was handled.

The outcome was assessed on Day 2. The record reports no primary outcome estimates or statistical analyses. The detailed protocol, analysis plan, and explanations for the design-field discrepancy are not reported in the registry record, so conclusions about the planned comparison method must remain limited.

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: The study consist of a screening period up to 15 day prior to randomization, a test period and a follow-up period. The study design is a within subject evaluation of the vasoconstriction properties of MC2-01 cream compared with vehicle cream and 5 other corticosteroids. All subjects received therefore a single treatment with all 7 products.

Overall Study

Analysis population for the primary outcome, as defined in the registry: As the study design is a within subject evaluation of the vasoconstriction properties of MC2-01 cream compared with vehicle cream and 5 other corticosteroids, all 36 enrolled subjects received a single treatment with all 7 products.

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: All patients received all 7 types of treatments.

6. Primary Endpoint

The registry lists the primary outcome as Comparison of the Vasoconstriction Potential (Skin Blanching Effect) of the MC2-01 Cream With Active Comparators and Vehicle, measured over Day 2.

The primary endpoint is the comparison of vasoconstriction potential, described as the skin-blanching effect, for MC2-01 Cream versus active comparators and vehicle on Day 2. Blanching was scored by two trained observers who were blinded to treatment. The registry describes a scale from 0-4: 0 means no change in skin color; 1 means slight, barely visible blanching; 3 means obvious blanching; and 4 means blanching judged to be maximal. The registry does not give a description for score 2.

The endpoint is reported in the registry as a mean with standard deviation. In general, a mean provides a summary of the recorded scores, while the standard deviation describes how spread out those scores are around their mean. Such a summary can make responses easier to compare across products, though it does not show the full distribution of individual scores. Because the scale represents ordered categories of visible blanching, the meaning of a difference between means also depends on how scores were recorded and summarized.

Blanching is used in this study as a measure of vasoconstriction potential, the outcome named in the study objective. It is a measured skin response, not a direct measure of a patient-centered clinical benefit. The registry record does not report the observed means or standard deviations, the method used to combine the two observers’ assessments, or the statistical comparison results. The endpoint’s measured values and comparative precision therefore cannot be assessed from the registry record.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

What does a mean and standard deviation describe?

The primary outcome is defined as a mean score with standard deviation. In general, the mean is a summary of the observed values, while the standard deviation describes variation among those values. A small or large standard deviation has meaning only in the context of the scale and the observed score distribution. Neither statistic alone establishes whether two treatments differ in a reliable or clinically important way.

The blanching ratings are ordered categories, ranging from 0-4 as described in the registry record. A mean can be a compact summary of such ratings, but it may conceal how many assessments fell into each category. For instance, different score distributions can yield the same mean. The registry record does not include the scores or their distributions, so those features cannot be evaluated. It also does not report why the registry does not describe the meaning of score 2.

Why does the design description matter?

In general, a within-subject study compares multiple conditions assessed in the same person. Because measurements from one person tend to be related, analyses commonly account for this pairing or repeated-measures structure. A parallel-group study instead compares outcomes across separate groups. The registry’s primary outcome description says all subjects received all products, while the model field says parallel. The record does not clarify this inconsistency or identify a statistical method that would resolve it.

In a within-subject comparison, the pattern of scores within each person can affect the precision of a treatment contrast. Information about the correlation between a person’s repeated measurements is therefore relevant. A parallel-group analysis does not use the same within-person information. Without the actual analysis plan and results, it is not possible to assess whether the reported design labels reflect a data-collection detail, an administrative classification, or a difference in the intended analysis.

What would a treatment comparison estimate?

In general, a comparative analysis would estimate how the blanching score differs between MC2-01 Cream and a comparator. The estimate would be more informative when accompanied by a confidence interval. A confidence interval expresses the uncertainty around an estimated effect under the assumptions of the analysis; it is not a guarantee that the true effect lies within the interval. The registry record does not report an estimated difference or confidence interval for any comparison.

A p-value, if reported, would describe how compatible the observed data are with a specified statistical model and null hypothesis. It would not quantify the size or importance of a difference. The registry record reports no p-values and no analysis results. It is therefore not possible to interpret statistical evidence for or against any comparison.

How should the observer assessments be considered?

The outcome description says two trained observers scored blanching individually and were blinded to treatment. Blinding can reduce the chance that knowledge of treatment influences subjective assessment. It does not remove all measurement variability, and it does not explain how separate ratings were used in the outcome summary. The record does not state whether observer scores were averaged, reconciled, analyzed separately, or handled by another method. Agreement between observers is also not reported.

In general, observer variability can affect the precision of a score-based endpoint. Clear assessment procedures and an analysis plan specifying how ratings are combined help readers understand how the endpoint was constructed. Those details are not reported in the registry record. The record also does not describe randomization procedures, treatment order, or application-site procedures, so their relationship to the observed assessments cannot be evaluated.

What can be inferred from the statistical record?

The registry lists 2 outcome measures and 0 analyses. This record therefore gives the endpoint definition but not the numerical results or the statistical methods used to compare products. The sample-size assumptions field describes a planning illustration based on an observed effect, but no corresponding planning estimates are included in the registry record for interpretation. The registry also indicates that the sample-size section is skipped because there are fewer than two arms in the primary outcome. No planning illustration can therefore be interpreted as a result from this trial.

In general, sample-size calculations are prospective planning tools, whereas statistical power calculated from an observed effect after a study is complete is not a substitute for an effect estimate and its uncertainty. Any planning illustration would depend on assumptions about the target effect, variability, significance level, and allocation. The registry record does not report trial-specific assumptions or a sample-size justification. No claim about observed power, adequacy of enrollment, or the precision achieved is supported by the posted results.

10. Multiplicity, Missing Data and Analysis Populations

The registry lists 2 outcome measures, but it describes the primary outcome as the comparison of blanching scores on Day 2. The other outcome measure and its role are not reported in the registry record. The record also does not report which treatment contrasts were designated as primary, whether all comparators were to be tested against MC2-01 Cream, or whether any other contrasts were planned.

Multiplicity arises when several statistical tests or outcomes are considered: the chance of at least one apparently unusual result can increase as more comparisons are made. In general, a prespecified strategy may address this through a hierarchy of tests, an adjustment, or another approach. The statistical plan and any multiplicity handling are not reported in the registry record. Since no analyses or outcome estimates are reported, it is not possible to assess how multiple comparisons were handled or how they affect interpretation.

The registry record does not describe missing outcome data, exclusions, or the number of assessments included in each analysis. It does not report whether every subject had complete assessments from both observers or how incomplete scores would be handled. Missing-data methods and sensitivity analyses are not reported in the registry record.

Analysis populations are also not specified. The record states that all enrolled subjects received all 7 products, but it does not give a defined analysis set or explain whether all enrolled subjects were included in every endpoint analysis. The randomized allocation method and any deviations from the intended treatment or assessment procedures are not detailed. These omissions prevent evaluation of whether the analyzed population matched the intended study population, whether missingness could have affected comparisons, or whether any adjustment was made for multiple endpoints and contrasts.

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.

The safety figures list 36 subjects at risk in each treatment entry. For every listed product, the registry reports 0 serious adverse events, 0 other adverse events, and 0 deaths. These are the counts recorded in the registry for the listed groups; they do not provide information about the nature of events that were absent from the counts or the completeness of safety follow-up.

The record describes all subjects as receiving all 7 products in a within-subject evaluation, while a separate model field labels the trial parallel. Because of that design-description discrepancy, the group-specific safety entries should be read as registry entries for each product, not assumed to represent separate sets of subjects. The registry does not explain how adverse events occurring after exposure to multiple products were attributed, how long safety was monitored, or what event-collection procedures were used.

A recorded zero is not proof that an event is impossible or that a product has no safety risks. In general, the interpretation of zero reported events depends on the amount and duration of observation, event definitions, and completeness of reporting. Those details are not reported in the registry record. The figures describe what was entered in the registry for this study; they do not establish broader safety conclusions.

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

This registry record establishes that the study was designed to assess skin blanching after a single application of MC2-01 Cream and comparator products, with assessment on Day 2. It identifies the outcome scale, the use of two blinded trained observers, and the intended comparative question. These details describe the measurement and purpose of the study, but they do not supply the observed endpoint results.

Because no means, standard deviations, treatment contrasts, confidence intervals, or p-values are reported, the posted results cannot show whether blanching scores differed among products, by how much they differed, or how precisely any difference was estimated. The record also cannot establish whether the measured response was similar across products. The lack of reported comparative results is not evidence that there was no effect; it means that the outcome comparison is not available in the registry record.

The study concerns a skin response used as an indicator of vasoconstriction potential in healthy subjects. It does not report patient-centered outcomes or outcomes in people being treated for a skin condition. A measured blanching score should not be treated as proof of clinical benefit or as a substitute for evidence about other outcomes. No treatment recommendation follows from the record.

The safety entries report zero serious events, zero other events, and zero deaths for each product. Those counts are descriptive registry entries and, without details about monitoring and event attribution, do not establish that there is no risk. The discrepancy between the within-subject description and parallel model label further limits certainty about how to interpret comparisons and group-specific entries.

Overall, the registry supports a description of the study question and measurement framework, but not a conclusion about which product produced more or less blanching, the size or precision of any difference, or the clinical meaning of a response. Those questions require outcome data and analysis details that are not reported in the registry record.

13. Why This Trial Matters Statistically

This trial is statistically notable because it measures a subjective, ordered score and compares several products. The endpoint depends on observers’ assessments, so blinding and the handling of scores from the two observers are relevant to measurement quality. The registry reports that the observers were trained and blinded to treatment, but it does not report how their ratings were combined or whether their agreement was evaluated.

The stated within-subject design could make comparisons more informative by allowing each subject’s response across products to contribute to the contrast. In general, however, repeated observations from the same subject are correlated and should be analyzed with that dependence in mind. The separate parallel-model label conflicts with the within-subject description, and the registry record does not identify which structure was used in the statistical analysis. This makes the comparison method difficult to evaluate.

The study also raises the usual interpretive issue of multiple outcomes and treatment contrasts. The registry lists 2 outcome measures and multiple products, but it does not report the multiplicity plan or statistical analyses. Without outcome estimates and uncertainty intervals, the reader cannot distinguish a precise similarity from an imprecise estimate or assess whether any observed contrast would be robust to the analysis choices.

These features matter because a clear endpoint definition and a completed study status do not on their own make the results interpretable. Results, analysis methods, and handling of the repeated assessments are necessary to understand what the data show. In this record, the measurement and design questions can be identified, but the comparative results cannot be evaluated.

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 limitation for interpreting this trial is that the registry record does not report numerical results for the primary endpoint. Means and standard deviations, comparative estimates, confidence intervals, and statistical tests are not reported in the registry record. Without them, the magnitude, direction, and precision of differences among products cannot be assessed.

There is also an unresolved inconsistency in design description: the primary outcome text describes a within-subject evaluation in which all subjects received all products, while the model field labels the study parallel. The record does not explain this discrepancy or report the statistical analysis used. This limits assessment of whether the analysis appropriately accounted for the stated repeated measurements.

The endpoint relies on observer ratings, yet details about combining the two blinded observers’ scores, observer agreement, application sites, and treatment order are not reported in the registry record. The description of the score scale gives meanings for 0, 1, 3, and 4 but does not describe score 2. The record does not report missing assessments, exclusions, analysis populations, multiplicity handling, or sensitivity analyses. These omissions leave uncertainty about how the recorded endpoint was constructed and analyzed.

The study is described as a phase 1 evaluation in healthy subjects, and its primary outcome is a skin-blanching score on Day 2. The registry record does not report broader clinical outcomes or longer-term safety observation details. Its findings, even if available, would need to be interpreted within that measurement and population context. The safety counts alone cannot address risks outside the recorded event categories or observation procedures.

15. Related Tutorials

16. Related Statistical Calculators

17. Sources

• ClinicalTrials.gov: Evaluation of the Vasoconstriction Properties of MC2-01 Cream — NCT03758365.
• Registry record last updated 2020-01-09; status last verified 2020-01.
• Results first posted 2020-01-09.
• 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 describes a completed, randomized, evaluator-blinded, single-centre phase 1 study of MC2-01 Cream and comparator products. It lists enrollment of 36 and describes a single application of each product, with skin blanching scored by two trained observers blinded to treatment on Day 2.

The primary endpoint is reported as mean ± SD on a 0-4 scale. The record describes the evaluation as within-subject, with all subjects receiving all 7 products, but separately labels the model parallel. This inconsistency is not explained. Although the study objective and endpoint are listed, the primary outcome values and comparative analyses are not reported in the registry record.

For each product entry, the registry reports 0 serious adverse events, 0 other adverse events, and 0 deaths. Analysis methods, missing-data handling, multiplicity procedures, and analysis populations are not reported in the registry record. The available record permits description of the study question and measurement approach, but not evaluation of comparative blanching results.