A Study to Assess Treatment Satisfaction, Patient-reported Outcomes, Effectiveness, and Safety of a Fixed-dose Combination of Calcipotriene/Betamethasone Dipropionate PAD Cream in the Treatment of Mild-to-moderate Plaque Psoriasis of the Scalp in Adults: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for A Study to Assess Treatment Satisfaction, Patient-reported Outcomes, Effectiveness, and Safety of a Fixed-dose Combination of Calcipotriene/Betamethasone Dipropionate PAD Cream in the Treatment of Mild-to-moderate Plaque Psoriasis of the Scalp in Adults (NCT05811234), a registered phase not stated study. The primary outcome is Absolute Treatment Satisfaction Questionnaire for Medication Version 9 (TSQM-9) Domain Total Score at Week 12.

2. Clinical Question

The study was designed to assess treatment satisfaction and other patient-reported outcomes, as well as effectiveness and safety, in a real-world setting. Its stated interests also included treatment preference, adherence and convenience, psychosocial effects of scalp psoriasis, and sleep quality. The primary endpoint focuses on participants’ satisfaction with their medication rather than a direct measure of scalp disease severity.

Because the record describes no comparator group, the central question is descriptive: what satisfaction scores were observed among participants prescribed the cream? The record does not establish a comparison with another treatment, usual care without the cream, or an untreated group. Nor does it report a primary endpoint estimate that would answer the descriptive question. The registry entry therefore provides the planned endpoint definition and study context, but not the Week 12 satisfaction result.

3. Trial Design

This was an international, prospective, observational cohort study of adults with mild-to-moderate plaque psoriasis of the scalp. The registry lists 291 participants enrolled and gives the study status as completed. The study start date is 2023-06-13, and the primary completion date is 2024-10-01.

Participants who had been prescribed CAL/BDP PAD cream to manage scalp plaque psoriasis in routine clinical practice were observed prospectively. The treatment description states that observation would continue for up to 8-12 weeks. The primary endpoint is specified at the end of the observation period, designated Week 12. The registry record does not report whether every participant completed the same observation duration.

The record describes one treatment group and no comparator. Allocation is not stated, and the study is not described as a randomized comparison. As an observational study, its stated purpose was to assess treatment satisfaction, patient-reported outcomes, effectiveness, and safety in routine practice. This setting can describe outcomes among people receiving treatment in usual clinical circumstances, but without a comparator it does not supply a direct estimate of how outcomes would differ under another treatment strategy.

The primary endpoint was the absolute TSQM-9 domain total score at Week 12, expressed as a mean with a 95% confidence interval. Listed secondary outcomes include Scalpdex scores across symptoms, emotions, and functioning; the percentage achieving Scalp Physician’s Global Assessment treatment success at Week 4 and Week 12; and the Scalp Worst Itch Numerical Rating Scale score. The registry record lists four outcome measures overall, but does not report analysis results for them.

The record does not report the study’s sample-size justification, a prespecified statistical analysis plan, or interim analyses. Although the study is marked completed, the results relevant to the primary endpoint are not reported in the registry record.

4. Participant Flow and Accounting

The registry reports how participants moved through each stage of the study. All counts below are exactly as posted; missing counts are not inferred from other stages.

Before assignment: A total of 291 participants were enrolled in this study.

Overall Study

Reasons for not completing this period:

Analysis population for the primary outcome, as defined in the registry: FAS included all those participants in the safety population that had at least one post-baseline assessment for primary endpoint.

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: Safety population included all participants for whom it is known that they had at least one CAL/BDP PAD cream application during the study observation period.

6. Primary Endpoint

The registry lists the primary outcome as Absolute Treatment Satisfaction Questionnaire for Medication Version 9 (TSQM-9) Domain Total Score at Week 12, measured over At end of study observation period (Week 12).

The primary endpoint is the absolute Treatment Satisfaction Questionnaire for Medication Version 9 (TSQM-9) domain total score at Week 12, at the end of the study observation period. The endpoint is summarized as a mean with a 95% confidence interval. The TSQM-9 is described in the registry as a 9-item, clinically validated psychometric instrument measuring satisfaction with medication across three domains: effectiveness, convenience, and global satisfaction.

Items are combined within their respective domains, and each domain score is transformed to a scale from 0 to 100. Higher scores indicate greater satisfaction within that domain. The registry description gives domain-specific scoring ranges before transformation, reflecting the different response ranges for global satisfaction and the other domains. The primary endpoint title refers to a domain total score, but the registry record does not specify in the endpoint title which of the three domain scores is being reported, nor does it provide a Week 12 estimate.

As a general statistical and measurement point, a patient-reported satisfaction measure captures participants’ appraisal of treatment, which is distinct from a clinician-rated assessment of disease severity or a laboratory measure. It can complement clinical outcomes by describing how participants experience treatment. A mean gives a measure of the group’s central score, while the confidence interval conveys uncertainty around that mean under the analysis assumptions. Neither quantity is available in the registry record, so the degree of satisfaction and the precision of its estimate cannot be assessed from the posted results.

The primary endpoint population is defined as those in the safety population who had at least one post-baseline primary-endpoint assessment. The record does not report the number of participants meeting that definition or the number with an observed Week 12 score.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

The registry identifies a continuous primary outcome: a TSQM-9 domain score at Week 12. It specifies the mean as the summary measure and a 95% confidence interval as the accompanying measure of uncertainty. The actual mean and interval are not reported in the registry record. The concepts below explain how these statistics are generally interpreted; they do not supply missing study results.

What does a mean represent?

As a general statistical concept, a mean is the arithmetic average of the observed scores in the analysis population. For a patient-reported score, it gives a group-level summary on the instrument’s scale. The mean does not show how individual participants’ scores are distributed around that average. Two groups of participants could have the same mean but different patterns of individual responses. To describe that variation, additional information such as a standard deviation, distribution, or range may be useful; those summaries are not reported for this endpoint in the registry record.

The TSQM-9 domain scores range from 0 to 100, and higher values indicate greater satisfaction for the relevant domain. Interpretation therefore depends on the reported domain and its score. A group mean can summarize satisfaction, but it should not be mistaken for the score of every participant. The record does not report the endpoint estimate, so no particular mean or distribution can be described.

What does a confidence interval add?

As a general statistical concept, a confidence interval expresses the uncertainty around an estimate under the assumptions of the statistical method used. It is not a range containing a known proportion of individual participant scores. For a mean, the interval helps readers assess the precision of the estimated group average: a narrower interval indicates less sampling uncertainty than a wider interval, given the model and data. The registry specifies a 95% confidence interval but does not report its limits, so its precision cannot be evaluated.

A confidence interval also should not be treated as a test of clinical importance by itself. Interpreting importance requires an appropriate benchmark, such as a meaningful difference defined for the instrument or a comparison with another group. The registry record does not report such a benchmark or a comparator for the primary outcome. The 95% confidence interval is therefore a planned summary type, not evidence that a treatment effect was demonstrated.

How does the study design affect the analysis?

The study is described as prospective and observational. In general, prospective observation means outcomes are followed forward over the observation period, while observational treatment assignment means the study record does not describe random allocation by investigators. Here, participants had been prescribed the cream in routine clinical practice, and no comparator group is described. A mean among participants receiving treatment can be informative about that cohort, but it does not isolate the effect of treatment from other influences. A before-and-after change, if reported, would also require careful interpretation because change over time alone does not establish that treatment caused the change.

For comparative causal questions, random assignment can help balance measured and unmeasured factors between groups on average. This cohort is not described as randomized, and the registry does not report a comparison group or an adjusted treatment-effect analysis. Therefore, the primary endpoint, as recorded, is a descriptive satisfaction measure rather than a randomized estimate of comparative benefit.

What does the analysis population mean?

The primary endpoint population is described as the full analysis set, defined as participants in the safety population who had at least one post-baseline assessment for the primary endpoint. This definition means that enrollment alone does not establish inclusion in the primary endpoint analysis: a participant also needed a qualifying post-baseline assessment. The number meeting that definition is not reported in the registry record. The record also does not report how many had a Week 12 score, how missing assessments were handled, or whether all available observations were included in the final mean.

As a general point, restricting an analysis to participants with observed follow-up can affect how representative the analyzed group is of everyone enrolled. If missing outcomes are related to participant characteristics or outcomes, a complete-case estimate may differ from the estimate that would have been obtained with complete follow-up. This is a general concern, not a claim about why any particular participant may have lacked an assessment in this study. The registry does not report missing-data methods or the extent of missingness.

What can planning calculations tell readers?

The record describes planning illustrations based on a fraction of an observed effect, using a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation. It distinguishes participants per arm for non-time-to-event outcomes from total events for time-to-event calculations. These are planning assumptions, not evidence of an observed study result. The registry does not report the observed effect needed to interpret such an illustration, and this study is described as having one treatment group rather than two randomized arms. The registry’s sample-size justification is not reported. Any planning illustration should be understood as hypothetical rather than as observed power or as evidence that the study was designed to detect a particular effect.

More generally, statistical significance, precision, and practical importance answer different questions. A significance test assesses compatibility with a specified null model under its assumptions; a confidence interval conveys uncertainty around an estimate; and practical importance depends on the meaning of the outcome and the size of a relevant difference. The registry record provides no primary endpoint estimate or test result, so none of those conclusions can be drawn for the Week 12 satisfaction outcome.

10. Multiplicity, Missing Data and Analysis Populations

The registry lists a primary endpoint and several secondary outcomes, but does not report a statistical analysis plan or multiplicity adjustment. Multiplicity is the general issue that arises when many outcomes or comparisons are examined: with more tests, the chance of at least one apparently unusual result can increase if each is interpreted in isolation. Whether and how that issue was addressed in this study is not reported in the registry record. No adjustment method, testing hierarchy, or distinction between confirmatory and exploratory analyses is described.

The primary endpoint is defined as a TSQM-9 domain total score at Week 12. The secondary outcomes include absolute Scalpdex scores for symptoms, emotions, and functioning; the percentage achieving Scalp-PGA treatment success at Week 4 and Week 12; and the absolute Scalp Worst Itch Numerical Rating Scale score. The record lists four outcome measures overall and does not report their numerical results or analyses. It is not possible to infer whether all listed outcomes were analyzed, whether additional outcomes were assessed, or how any analyses were prioritized.

The primary endpoint population includes participants in the safety population with at least one post-baseline primary-endpoint assessment. The registry does not report the size of that population, the number assessed at Week 12, or the amount and pattern of missing outcome data. It also does not state whether missing values were imputed, whether only observed values were analyzed, or whether sensitivity analyses were conducted. These details matter because missingness can affect both the number of participants contributing to an estimate and the interpretation of that estimate.

As a general statistical point, a clearly defined analysis population and transparent missing-data methods help readers assess how results relate to the enrolled cohort. In this record, the population definition is available, but the participant counts and missing-data procedures are not reported. The registry record also does not report interim analyses or the sample-size justification, so those aspects cannot be evaluated.

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 serious adverse event terms

Most frequent non-serious adverse event terms

Serious events with the highest arm-level rate: lung adenocarcinoma (0.3%), pneumonia (0.3%).

For CAL/BDP PAD cream, the registry reports 291 participants at risk for serious adverse events and 2 affected participants. It reports 291 participants at risk for other adverse events and 13 affected participants. The record also lists 1 death. These are counts recorded in the registry; they do not by themselves establish whether an event was caused by treatment.

The serious adverse event terms listed are lung adenocarcinoma and pneumonia, each reported as 0.3%. The record does not provide event narratives, timing, duration, outcome details, or an investigator’s causality assessment. It also does not say whether events overlapped within participants or provide further detail on how the reported categories were defined. No additional interpretation of those events can be made from the listed information alone.

As a general statistical point, safety counts in a single-group observational study describe events recorded among the participants under observation. They do not provide a rate comparison against another treatment or an untreated group. The number at risk is the recorded denominator for the relevant safety category; it is not necessarily the number with complete follow-up for every other study outcome. The record does not report exposure-adjusted rates or participant-level follow-up time for safety outcomes.

The difference between a serious adverse event and an adverse event is a classification distinction, not a statement about causality. The listed counts should be read as registry safety summaries, not as proof that the cream did or did not cause any particular event. The record does not report a formal comparative safety analysis.

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

The registry record identifies the primary outcome as treatment satisfaction measured by a TSQM-9 domain score at Week 12. It explains the score’s range and direction: domain scores range from 0 to 100, with higher scores indicating greater satisfaction. It also defines the primary endpoint population and specifies a mean with a 95% confidence interval as the planned summary. But it does not report the mean, the confidence interval, or the number of participants included in that analysis. Consequently, the posted results do not establish the observed satisfaction level or the precision of its estimate.

The same boundary applies to effectiveness and other patient-reported outcomes. Scalp-PGA treatment success, Scalpdex scores, and worst-itch scores are listed as outcomes, but their results are not reported in the registry record. The study’s aims include treatment preference, adherence and convenience, psychosocial effects, sleep quality, effectiveness, and safety; the record does not provide results for those aims beyond the safety counts described separately.

The design also limits what an estimate could establish. The study is a prospective observational cohort with no comparator group described. As a general principle, observed outcomes in a treated cohort can describe participants’ experiences, but do not alone show what would have happened under another treatment. Changes over time, if reported, would not by themselves separate treatment effects from other changes or influences. No such primary outcome change is reported.

The safety record lists adverse event and death counts, but those counts do not establish that the treatment caused an event. There is no comparison group described, and the registry does not report causal assessments or additional event details. Likewise, the completed status indicates the study is recorded as completed; it does not supply missing endpoint estimates or analysis methods.

In short, the record gives a useful account of the study question, endpoint definition, cohort, and selected safety summaries. It does not report the primary or secondary outcome estimates needed to characterize the observed satisfaction or effectiveness findings. No conclusion about treatment effectiveness, comparative performance, or causal safety can be drawn from the registry record alone.

13. Why This Trial Matters Statistically

This study is statistically relevant because it centers treatment satisfaction in a prospective observational cohort rather than relying only on clinician-rated disease assessments. The TSQM-9 is described as a 9-item measure covering effectiveness, convenience, and global satisfaction. A patient-reported measure addresses an aspect of treatment experience that is different from the listed scalp severity and symptom outcomes. Considering more than one perspective can be useful in clinical research, provided each measure and its results are clearly reported.

The registry also illustrates why endpoint definitions and endpoint results need to be distinguished. It defines a Week 12 mean score and a 95% confidence interval, describes the score’s 0 to 100 range, and explains that higher values indicate greater satisfaction. Those details enable readers to understand the planned measurement. Yet without the estimate, interval, and analysis population count, readers cannot assess the result’s magnitude or precision. The distinction matters: a well-defined endpoint does not substitute for its observed data.

The real-world observational design is another important statistical feature. It offers a way to study outcomes among participants prescribed treatment in routine clinical practice. At the same time, without a comparator or random allocation described, observed outcomes cannot be interpreted as a controlled treatment contrast. Clear communication of this limitation is essential when patient-reported outcomes and effectiveness measures are discussed.

Finally, the entry highlights the value of reporting outcome completion, missing-data methods, multiplicity decisions, and analysis populations. The record supplies a definition for the primary endpoint population, but not its size or missing-data handling. It lists outcomes but does not report results or an analysis plan. These reporting details help readers distinguish a descriptive cohort summary from stronger comparative or causal evidence.

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 for interpreting this study record is that it does not report the primary endpoint estimate. The Week 12 TSQM-9 mean and its 95% confidence interval are not reported in the registry record. The number of participants contributing to that analysis is also not reported, preventing assessment of both the observed satisfaction level and its precision.

The registry does not report numerical results for the listed secondary outcomes, including Scalpdex scores, Scalp-PGA treatment success, and the Scalp Worst Itch Numerical Rating Scale score. Although the study status is completed and the record lists four outcome measures, the posted entry does not provide outcome analyses. The listed study aims also include preference, adherence and convenience, psychosocial effects, sleep quality, effectiveness, and safety, but results for those aims are not reported apart from the safety counts.

The design is observational, with one treatment group described and no comparator. Allocation is not stated. As a result, the record does not support a direct comparative estimate, and observed outcomes cannot be attributed to treatment on the basis of this design description alone. The study’s routine-practice setting is relevant to describing the cohort but does not remove the limitations of having no comparator.

Important analysis details are also absent. The registry record does not report the sample-size justification, a full statistical analysis plan, interim analyses, multiplicity procedures, or missing-data methods. It defines the primary endpoint population as the safety population with at least one post-baseline primary-endpoint assessment, but does not report its size or the number with a Week 12 observation. The record therefore does not permit evaluation of the extent or potential impact of missing outcome data.

Safety summaries are limited to counts and two serious-event terms with their reported percentages. The record does not provide further event narratives, timing, exposure-adjusted rates, causal assessments, or a comparator. These omissions limit interpretation of both outcome estimates and safety findings from the registry entry.

15. Related Tutorials

16. Related Statistical Calculators

17. Sources

• ClinicalTrials.gov: A Study to Assess Treatment Satisfaction, Patient-reported Outcomes, Effectiveness, and Safety of a Fixed-dose Combination of Calcipotriene/Betamethasone Dipropionate PAD Cream in the Treatment of Mild-to-moderate Plaque Psoriasis of the Scalp in Adults — NCT05811234.
• Registry record last updated 2025-09-24; status last verified 2025-09.
• Results first posted 2025-09-24.
• 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 an international, prospective, observational cohort study of adults with mild-to-moderate plaque psoriasis of the scalp who were prescribed CAL/BDP PAD cream in routine clinical practice. Enrollment was 291, and the study is marked completed. Participants were to be observed for up to 8-12 weeks.

The primary endpoint is the mean TSQM-9 domain total score at Week 12, accompanied by a 95% confidence interval. The scale ranges from 0 to 100, with higher domain scores indicating greater satisfaction. The registry record does not report the primary endpoint result, its confidence interval, or the number of participants in the primary endpoint analysis.

Listed secondary outcomes include Scalpdex scores, Scalp-PGA treatment success at Week 4 and Week 12, and worst-itch scores. Their results are not reported. Safety summaries list 2 participants with serious adverse events, 13 with other adverse events, and 1 death among 291 participants at risk; lung adenocarcinoma and pneumonia are each listed as serious-event terms at 0.3%. The record does not describe a comparator group, and it does not report the analysis plan, sample-size justification, or missing-data methods.