Study to Evaluate Subject Satisfaction With Facial Appearance and Impact of Combined Facial Treatment: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Study to Evaluate Subject Satisfaction With Facial Appearance and Impact of Combined Facial Treatment (NCT04609020), a na phase 4 study. The primary outcome is Change From Baseline in the Rasch-transformed Score of the FACE-Q Satisfaction With Facial Appearance Scale..

2. Clinical Question

This study asks whether satisfaction with facial appearance changes from before treatment to the final study visit among participants receiving a combined facial treatment plan. The primary measure is change in the Rasch-transformed score of the FACE-Q Satisfaction With Facial Appearance Scale, assessed from Visit 0 (Day 1) to Visit 7 (Up to approximately 5 months). The registry describes the primary analysis population as the evaluable population.

The broader objective is to assess psychological, social, and emotional impact alongside satisfaction with facial appearance. Secondary outcomes include FACE-Q measures of aging appraisal, psychological and social function, and satisfaction with skin; self-perception of age; global aesthetic improvement assessments by investigators and participants; and a periorbital appearance questionnaire. The registry lists nine outcome measures in total, but their numerical findings are not reported in the registry record.

This is a before-and-after question, not a comparative efficacy question. A change over time can describe what happened among participants in the study, but without a concurrent control group it cannot isolate the contribution of treatment from other explanations for change.

3. Trial Design

The registry identifies this as a Phase 4, prospective, multi-site study. Its stated title concerns participant satisfaction with facial appearance and the aesthetic and psychosocial impact of combined facial treatment. The study is marked completed, with enrollment of 64. The listed start date is 2023-02-15 and the primary completion date is 2024-05-10.

The design is single-group, with allocation recorded as NA and masking recorded as NONE. The registry describes a treatment plan involving JUVÉDERM, BOTOX, and HArmonyCA Lidocaine. Its arm description says treatments are administered according to the respective label and an agreed plan between the participant and health care provider. It also indicates that treatment may be administered if required. The complete details of which products each participant received, the timing of every component, and how treatment decisions were made are not reported in the registry record.

With a single group, each participant’s baseline measure serves as the reference for the later measure. This can be useful for describing within-participant change, but it does not create a like-for-like comparison with an untreated or alternative-treatment group. Differences between baseline and follow-up may reflect treatment, the passage of time, expectations, other care, changes in circumstances, or measurement variability. The design cannot separate these explanations by comparing treatment groups.

The registry lists an evaluable population for the primary endpoint. The criteria defining evaluability, the number of participants with endpoint data, and the analysis set used for each secondary outcome are not reported in the registry record. The record also does not report a statistical analysis plan, the approach to missing observations, or whether any interim analyses were planned or conducted. These details matter when judging how closely the reported analysis, if available, follows the intended design.

The posted information identifies five analyses and nine outcome measures. These counts do not, by themselves, describe which analysis corresponds to each outcome or establish how analyses were selected. The numerical outcome results 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.

Overall Study

Analysis population for the primary outcome, as defined in the registry: Evaluable population

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 the Rasch-transformed Score of the FACE-Q Satisfaction With Facial Appearance Scale., measured over Visit 0 (Day 1) to Visit 7 (Up to approximately 5 months).

The primary endpoint is change from baseline in the Rasch-transformed score of the FACE-Q Satisfaction With Facial Appearance Scale. The registry describes the questionnaire as a 10-item measure focused on satisfaction with facial appearance. It gives an overall score range of 0 to 100, with higher scores representing higher satisfaction. The assessment runs from Visit 0 (Day 1) to Visit 7 (Up to approximately 5 months), and the primary population is the evaluable population.

A change score summarizes how the measure differs at follow-up from its baseline value. It is useful because the study’s objective is framed around change in participants’ satisfaction after treatment, rather than a comparison between treatment groups. The Rasch-transformed score is the stated form of the FACE-Q measure; details of the transformation and the precise scoring procedure are not reported in the registry record.

As a patient-reported measure, the scale captures participants’ own assessments of their facial appearance. This is distinct from an investigator’s rating of appearance or from a clinical measure of a physical feature. The registry also names other patient-reported and global aesthetic outcomes, but those do not replace the designated primary endpoint.

The endpoint definition alone does not show the observed change. The registry record does not report the primary mean change, its standard deviation, a confidence interval, or a test result. Without these, readers cannot determine the size of the recorded change or how precisely it was estimated. Nor does a score change on its own establish what caused it, particularly in a single-group study without a separate control.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

The primary outcome is continuous: it is a score, and the registry identifies the mean as the parameter of interest and the standard deviation as the measure of dispersion. In general, a mean summarizes the center of a set of measurements. For a change endpoint, the mean summarizes the average change among the participants whose data enter the analysis. It is a summary, not a description of every participant’s experience.

In general, the standard deviation describes how spread out participant-level measurements are around their mean. It is not the same as the standard error, which describes the sampling uncertainty of an estimated mean. A confidence interval is a range constructed by a statistical procedure to show uncertainty around an estimate. Its interpretation depends on the procedure and assumptions used. The registry record does not report the primary mean change, standard deviation, standard error, confidence interval, or p-value, so none of these can be assessed for this endpoint.

What does a change score represent?

In general, a change score compares a participant’s later measurement with that participant’s baseline measurement. Summarizing these individual changes can account for the fact that participants start at different values. The result depends on which participants have usable measurements at both time points and how missing measurements are handled. The record names the baseline and final visits and an evaluable population, but the evaluability criteria, endpoint analysis sample size, and missing-data approach are not reported in the registry record.

The listed measure is a Rasch-transformed FACE-Q score. The registry describes the questionnaire as a 10-item measure with scores from 0 to 100, where higher scores indicate higher satisfaction. The record does not explain the transformation, the handling of individual questionnaire items that are unanswered, or whether the analysis used any further adjustment. These omissions prevent a full reconstruction of the score calculation from the registry description alone.

Why does the design affect the analysis?

In a single-group study, a baseline-to-follow-up analysis describes change over time within the enrolled group. In general, this is different from comparing the change in a treatment group with the change in a control group. A control group can help account for influences that affect both groups over time, while this study has no separate control group. The registry explicitly identifies the design as single-group and lists no randomized comparison. Statistical adjustment cannot be assumed to remove all alternative explanations, and the analysis methods are not reported in the registry record.

The study is prospective and multi-site, according to the registry. These design descriptions do not reveal how sites were handled in the statistical analysis. For example, whether the analysis accounted for site or other participant characteristics is not reported in the registry record. No particular model or variance estimator should be inferred from the endpoint description alone.

What is the role of a p-value and an interval?

In general, a p-value summarizes how compatible the observed data are with a specified null hypothesis under the assumptions of a statistical test. It is not the probability that the null hypothesis is true, and it does not measure the size or importance of an effect. A confidence interval focuses on the range of values compatible with the data and the chosen procedure, offering a way to assess precision. Neither can be interpreted for this primary endpoint because the registry record does not report them.

Even if a result were statistically distinguishable from a null value, that alone would not establish a causal effect in a single-group design. Design and measurement limitations remain relevant regardless of the p-value. Likewise, a wide or narrow interval would describe statistical uncertainty in the estimate, not automatically resolve bias or uncertainty about what caused the observed change.

What does over-dispersion mean in general?

For outcomes analyzed as counts, over-dispersion means that the observed variability exceeds what a particular statistical model assumes. In general, accounting for over-dispersion can be important because an incorrectly narrow model for variability may make uncertainty appear smaller than it is. This is a general concept, not a description of this trial’s primary endpoint: the primary measure is continuous, and the registry record does not report a count-outcome model or an over-dispersion assessment.

The registry lists nine outcome measures and five analyses, but does not give enough detail to identify the statistical test or model used for each. The analysis plan, assumptions checks, handling of repeated measurements, and any transformations beyond the stated Rasch transformation are not reported in the registry record. Consequently, readers should not infer a particular parametric test, adjustment strategy, or model from the endpoint’s summary parameter alone.

How should the planning illustration be read?

The sample-size section is described as a planning illustration based on an observed effect, not as the trial’s own design. Its stated assumptions are a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation; the effect to detect is a stated fraction of the observed effect. The section’s convention is participants per arm for 80% power for non-time-to-event outcomes. These are planning assumptions, not observed trial results and not observed power.

This hypothetical two-arm planning setup should not be confused with the actual single-group design, which has no like-for-like control comparison. The numerical planning outputs and the observed effect on which they are said to depend are not reported in the registry information, so they should not be reconstructed or treated as evidence about the trial’s design adequacy. In general, planning estimates depend on their assumptions and are not a substitute for reporting the actual endpoint estimate and its uncertainty.

10. Confidence Intervals for Each Arm

No two-arm comparison is shown for this trial, but each arm's mean can be given with a t-based 95% confidence interval computed from the posted mean, spread and number of participants.

R code and output

arm <- c("HArmonyCA")
n   <- c(62)
m   <- c(46.6)
sp  <- c(23.61)
sd  <- sp      # posted standard deviations
for (i in seq_along(n)) {
  se <- sd[i] / sqrt(n[i]); h <- qt(0.975, n[i] - 1) * se
  cat(sprintf("CARM|%s|%d|%.3f|%.3f|%.3f|%.3f\n", arm[i], n[i], m[i], sd[i], m[i] - h, m[i] + h))
}

CARM  HArmonyCA  62  46.600  23.610  40.604  52.596

11. Multiplicity, Missing Data and Analysis Populations

The registry lists nine outcome measures and five analyses. The primary measure is change in the Rasch-transformed FACE-Q Satisfaction With Facial Appearance score. Secondary outcomes include change in FACE-Q Aging Appraisal, psychological and social function, satisfaction with skin, self-perception of age, investigator and participant global aesthetic improvement assessments, and change in the periorbital aesthetic appearance questionnaire. The record does not explain how these outcomes map to the five analyses.

When a study evaluates multiple outcomes or performs multiple statistical tests, the chance of at least one apparently notable result can increase. In general, a prespecified testing hierarchy or a multiplicity adjustment can help define how such results should be interpreted. The registry record does not report whether the investigators used either approach, which outcomes were formally tested, or whether analyses were exploratory. It also does not report the statistical analysis plan. No claim about the presence or absence of an adjustment can be made from the outcome list alone.

The primary population is described as evaluable, but the registry does not report its definition or its size. It also does not report how many participants had baseline and final-visit scores, whether all enrolled participants were included in any analysis, or how missing data were handled. In general, excluding participants without complete data can affect both the size and representativeness of an analysis group; the extent of any such issue cannot be assessed without participant-flow and missing-data details.

Methods such as imputation, complete-case analysis, or sensitivity analyses should not be assumed. Their use, along with any protocol deviations and analysis-population rules, is not reported in the registry record. These gaps matter because the reported estimate, if available, depends on who was analyzed and what assumptions were made about missing observations.

12. 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 1% reporting threshold.

Most frequent serious adverse event terms

Most frequent non-serious adverse event terms

Serious events with the highest arm-level rate: pyelonephritis (1.6%), rhabdomyolysis (1.6%).

The registry’s adverse-event section lists one group, HArmonyCA, with 64 participants at risk. It records 2 as affected by serious adverse events, 8 as affected by other adverse events, and 0 deaths. These figures are descriptive summaries in the registry record; they do not, by themselves, establish that an event was caused by a study treatment.

The top serious adverse event terms are PYELONEPHRITIS at 1.6% and RHABDOMYOLYSIS at 1.6%. The record does not give event narratives, onset dates, duration, severity details beyond the serious classification, or individual-level treatment histories in the information. It also does not indicate whether the listed terms refer to separate participants or whether a participant could contribute more than one event. The percentages should be read as posted, not recalculated.

“At risk” describes the denominator reported for the group; it does not tell readers how long each participant was observed or whether exposure duration was the same for everyone. The registry information does not give exposure-adjusted event rates. A zero recorded deaths count means the registry lists zero deaths for this group, but it does not describe the frequency of nonfatal events beyond the counts above.

Because there is no control group, these counts cannot be interpreted as comparative safety estimates. The data support reporting the recorded counts and terms, not attributing them to treatment or making comparisons with another regimen.

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

The result that this registry record can establish most clearly is the study’s measurement plan: a prospective, multi-site, single-group assessment of change in facial appearance satisfaction from baseline to the final visit. It identifies the FACE-Q Satisfaction With Facial Appearance Scale as the primary measure, specifies the evaluable population, and describes the direction of the scale so that higher scores indicate higher satisfaction.

The registry information does not report the primary mean change or its uncertainty. Therefore, readers cannot determine from this record whether the average score increased or decreased, how large any change was, how variable participant changes were, or how precisely the mean was estimated. The completed study status and the existence of a defined endpoint do not answer those questions. The accompanying tables and plots should be consulted for any displayed result estimates; where a value is absent from the registry record, it remains unreported.

Even a documented change from baseline would be a description of the study group over time, not a controlled estimate of the effect attributable to treatment. There is no separate comparator arm. In general, a before-and-after result can be influenced by factors other than the treatment plan, including natural change over time, expectations, other care, or changes in participants’ circumstances. This design cannot distinguish those explanations through a between-group comparison.

The registry also names several secondary measures that cover psychological and social function, satisfaction with skin, aging appraisal, self-perception of age, and aesthetic improvement. Their presence broadens the domains under study but does not establish what those outcomes showed. Their numerical findings, the handling of multiple outcomes, and the missing-data methods are not reported in the registry record.

The safety section reports the counts and serious-event terms. These entries are relevant descriptive information, but they do not establish causality or provide a controlled comparison. Overall, the record describes what the study set out to measure and some safety observations; it does not, in the information, permit a conclusion about the size, precision, or cause of the primary change.

14. Why This Trial Matters Statistically

This trial is statistically notable for the distinction between measuring change and estimating a treatment effect. A baseline and follow-up score can show how participants’ reported satisfaction changed while enrolled. But a single-group design does not provide a concurrent reference for changes that might have occurred in the absence of the treatment plan. That difference is essential when interpreting the purpose and limits of an analysis.

The primary endpoint is a patient-reported measure, which makes the participant’s view of facial appearance central to the outcome. This is conceptually distinct from an investigator rating or a physical assessment. The registry’s secondary outcomes also span psychological, social, and aesthetic domains. Such breadth may be useful for describing multiple aspects of experience, while also making it important to know which outcomes were prespecified and how multiple analyses were handled. Those methods are not reported in the registry record.

The primary endpoint is defined as a mean change, with standard deviation as the dispersion measure. That definition is not enough to judge the evidence: readers also need the estimate, an uncertainty measure, the analysis population size, and information about missing observations. Those numerical results and details are not reported in the registry information. Without them, neither the magnitude nor precision of the change can be assessed.

The planning illustration also highlights why design assumptions should be kept separate from the actual trial. Its description uses a hypothetical two-arm, equal-allocation setup, whereas the registered study is single-group. Planning figures are not observed power and cannot transform a within-group study into a controlled comparison. Readers should interpret any planning values as illustrations under their stated assumptions, not as observed trial findings or proof that the analysis could detect a particular effect.

These points make the record useful for understanding what was intended to be measured, but they also define what remains uncertain. Clear reporting of the primary result, analysis population, missing-data approach, and multiplicity strategy would be needed for a fuller statistical appraisal.

15. 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 central limitation for interpreting the posted record is that the primary outcome estimate is not reported in the registry information. The record gives no mean change, standard deviation, confidence interval, or p-value. It is therefore not possible to assess the observed direction, magnitude, variability, or statistical precision of the primary endpoint from these details.

The design is single-group, with allocation listed as NA and masking as NONE. There is no separate control group, so the study cannot make a like-for-like comparison against no treatment or an alternative treatment plan. A within-group change over time cannot isolate the treatment contribution from other influences. The registry’s description of a multi-product plan also does not identify the contribution of any one component.

The treatment description is incomplete in the registry information. It lists JUVÉDERM, BOTOX, and HArmonyCA Lidocaine and says treatment follows product labeling and an agreed plan. The full regimen, participant-level exposure, and any variation in product use are not reported in the registry record. The precise definition and size of the evaluable population are also not reported.

The record does not describe the statistical model, the missing-data method, the analysis plan, or the handling of multiple outcomes. It lists nine outcome measures and five analyses, but does not explain their mapping or the testing strategy. The duration of observation for each participant and the detail needed to interpret event exposure are not given in the information. These reporting gaps limit assessment of both effectiveness-related outcomes and safety summaries.

Finally, the registry’s adverse-event counts are descriptive and do not establish causality. The record does not provide event narratives or a control group for comparison. These limitations concern interpretation of the available registry information; they should not be filled by assumptions about methods or results that are not reported.

16. Related Tutorials

17. Related Statistical Calculators

18. Sources

• ClinicalTrials.gov: Study to Evaluate Subject Satisfaction With Facial Appearance and Impact of Combined Facial Treatment — NCT04609020.
• Registry record last updated 2025-06-17; status last verified 2025-06.
• Results first posted 2025-06-17.
• 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.

19. Record Summary

This completed Phase 4 study is listed as prospective, multi-site, and single-group, with enrollment of 64. The registry gives a start date of 2023-02-15 and a primary completion date of 2024-05-10. The treatment portfolio includes JUVÉDERM, BOTOX, and HArmonyCA Lidocaine; the full participant-level regimen is not reported in the registry record.

The primary endpoint is change from baseline to the final study visit in the Rasch-transformed FACE-Q Satisfaction With Facial Appearance Scale, for the evaluable population. The questionnaire is described as having 10 items and scores from 0 to 100, with higher scores representing higher satisfaction. The primary numerical result and its uncertainty are not reported in the registry information.

The registry lists nine outcome measures and five analyses. Its HArmonyCA safety group lists 2 serious adverse event entries and 8 other adverse event entries among 64 at risk, with 0 deaths. The record does not establish event causality or provide a concurrent comparison group.