Combination Facial Aesthetic Treatment in Millennials: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Combination Facial Aesthetic Treatment in Millennials (NCT04755595), a na phase 2 study. The primary outcome is FACE-Q Satisfaction With Facial Appearance Overall Scale.

2. Clinical Question

The investigators’ stated hypothesis was that combination treatment would increase patient-reported satisfaction across areas including perceptions of aging concerns and quality of life. This is a hypothesis, not a result. The primary endpoint directly addresses satisfaction with facial appearance overall; the registry also lists secondary FACE-Q measures concerning lines, expectations, social and psychological function, perceived age, cheeks, outcome satisfaction, and aging appraisal.

The study enrolled 20 participants and is marked completed. Its single-group structure means the central statistical question is about change within the treated group over time, not a treatment contrast between randomized groups. Even if a pre-to-post change had been reported, this design alone would not establish how much of that change was caused by treatment rather than other influences. The registry record does not report outcome results, so the magnitude and precision of any change cannot be assessed from the record.

3. Trial Design

This is a Phase 2, completed, single-group study registered as NCT04755595. The registry lists enrollment of 20 and identifies the condition as Dermatological Non-Disease. The study began on 2021-03-09, and primary completion was recorded on 2021-05-19. The sponsor is State University of New York - Downstate Medical Center.

The intervention was a combination facial aesthetic procedure involving Botox Cosmetic (onabotulinumtoxinA), Juvéderm Voluma XC, and Juvéderm Volbella XC. The arm description states that participants receive all three injectables during a single procedure, with an optional touch-up at 2 weeks. The registry does not report how many participants received a touch-up or describe any variation in treatment administration.

There is no randomized allocation: allocation is listed as NA, the model is SINGLE GROUP, and masking is NONE. Accordingly, the study does not contain a control arm for direct comparison. Its design can describe outcomes measured in the treated group, but cannot by itself distinguish treatment-associated change from changes that might also occur over time or for other reasons.

The primary outcome is a continuous FACE-Q score assessed at baseline and 2 months after the procedure. The registry gives the scale’s scoring approach and states that the summary measure is a mean with standard deviation. It also lists secondary FACE-Q outcomes. The registry record does not report the detailed visit schedule beyond the primary endpoint timeframe, the exact analysis population, the handling of missing observations, or the statistical plan.

The stated phase and completion status describe the registered study, not the strength of evidence for a treatment effect. Completion does not imply that every outcome was reported in the registry. In particular, the record lists no analyses and does not report the primary endpoint’s observed values.

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

Reasons for not completing this period:

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 FACE-Q Satisfaction With Facial Appearance Overall Scale, measured over Baseline and 2 months after the procedure.

The primary endpoint is the FACE-Q Satisfaction With Facial Appearance Overall Scale, measured at baseline and 2 months after the procedure. It is intended to capture participants’ satisfaction with their facial appearance, a patient-reported outcome rather than an objective assessment of facial features.

The registry describes a questionnaire with responses from 1 to 4 for each question. Higher responses correspond to greater satisfaction with facial appearance. Raw scores are transformed using the Rasch measurement method to a 0-to-100 point scale. The registry identifies the endpoint summary as a mean with standard deviation, treating the scale as a continuous measure.

A patient-reported scale can help quantify an aspect of treatment experience that may not be captured by clinical examination alone. The baseline assessment gives a reference point for describing subsequent scores, while the later assessment indicates satisfaction at the stated follow-up. However, a score change is interpretable only alongside the actual observed values, variability, and relevant analysis. None of those primary outcome results is reported in the registry record.

The record does not specify a threshold for a clinically important change, nor does it describe how the measure’s validity or reliability was assessed in this study population. The scale’s direction is clear, but a higher score alone would not establish the size, importance, or cause of any change.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

What does a mean and standard deviation describe? The registry characterizes the primary endpoint as a continuous measure summarized by a mean and standard deviation. A mean represents the average score in the assessed group. A standard deviation describes how dispersed individual scores are around that average. The two summaries answer different questions: the mean describes the group’s central score, while the standard deviation describes variation between participants.

For a baseline and follow-up outcome, a statistical analysis might report the mean at each assessment and a mean change. These quantities are not interchangeable. The mean change is based on within-person differences when the same participants contribute measurements at both times; it cannot generally be recovered by simply comparing group means without considering which participants were observed and how the analysis was conducted. The registry record does not report these values or state the method used to analyze change.

What would a confidence interval add? In general, a confidence interval expresses the precision of an estimated quantity under the assumptions of the statistical method. A narrower interval indicates greater precision than a wider interval, while the interval’s location helps show which values are compatible with the data and method. It does not eliminate bias or establish causality. No confidence interval for the primary endpoint is reported in the registry record, so its precision cannot be evaluated.

What does the study design allow? The registered model is single-group, and allocation is listed as NA. The primary outcome has a baseline and a later assessment, so the design can be described as a before-and-after assessment within a treated group. General methods for repeated measurements need to account for the fact that observations from the same participant are related. Treating them as unrelated observations can misrepresent uncertainty. Which method was used in this study is not reported in the registry record.

A within-group change is also not equivalent to a randomized treatment contrast. In a randomized comparison, the control group can help account for changes that would occur without the intervention, subject to the design and analysis assumptions. This study has no like-for-like control group. Therefore, even a precisely estimated change would remain a change observed after the procedure, not an isolated causal effect attributable to the combination treatment.

How should the FACE-Q scale be understood? The recorded responses are on a 1-to-4 scale for each question, with higher responses indicating greater satisfaction. The raw scores are transformed using the Rasch measurement method to a 0-to-100 point scale. This transformation yields the scale score described in the registry, but does not itself establish that a particular difference is meaningful to participants. The record does not report a threshold for meaningful change or study-specific measurement properties.

The registry reports a mean and standard deviation for the primary endpoint type. A mean is a familiar summary, but it may not show the full score distribution. If scores cluster near an endpoint or vary in other ways, distributional summaries and model assumptions can matter. General statistical practice may examine those features, but the registry record does not report diagnostic checks or a specific model. No such checks should be inferred from the endpoint’s summary designation.

What is over-dispersion? In general, over-dispersion means that observed variability is greater than a model assumes. It can lead a method to understate uncertainty if the extra variation is ignored. This concept is most often discussed for particular outcome models, and it should not be assumed to apply to this continuous FACE-Q endpoint. The registry does not report a model or a dispersion assessment for the primary analysis.

What do planning assumptions mean? The stated planning illustration assumes a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation; it describes effects as fractions of an observed effect. The record labels this as planning based on an observed effect, not as the trial’s own design. The registered study itself is single-group, not a two-arm comparison. Participants per arm for 80% power, if displayed as a planning quantity, would be a hypothetical design illustration and not observed power. The registry record does not report a sample-size justification for the actual study, nor should the planning assumptions be read as its protocol.

Why distinguish statistical from clinical importance? Statistical precision concerns how uncertain an estimated result is under a specified model. Clinical or practical importance concerns whether the size of a difference matters in context. A small uncertainty interval cannot establish importance, and a potentially important change may be estimated imprecisely. Both require an actual estimate and relevant context. The record reports neither the primary result nor a threshold for meaningful change, so neither judgment can be made.

The registry marks the study completed, but completion does not specify which analyses were performed or which participants contributed to each endpoint. The analysis method, any adjustment for baseline values, the handling of missing scores, and any interim analyses are not reported in the registry record. As a result, the methods explanation can clarify what the design and measures imply in general, but cannot reconstruct the unreported analysis.

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("Baseline", "Post-treatment")
n   <- c(20, 19)
m   <- c(42.35, 59.42)
sp  <- c(8.94, 15.08)
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  Baseline  20  42.350  8.940  38.166  46.534
CARM  Post-treatment  19  59.420  15.080  52.152  66.688

11. Multiplicity, Missing Data and Analysis Populations

The registry lists 10 outcome measures. The primary measure is FACE-Q Satisfaction With Facial Appearance Overall Scale; the listed secondary outcomes include FACE-Q measures of lines, expectations, social function, perceived age, cheek satisfaction, outcome satisfaction, psychological function, and aging appraisal. The record does not report a prespecified hierarchy for interpreting these outcomes or any method for controlling the chance of false-positive findings across multiple tests.

Multiplicity matters when several outcomes are tested: the more opportunities to identify a result as statistically notable, the more important it is to understand whether testing was planned and adjusted. This general concern does not establish that any particular finding is false. Here, the registry lists 0 analyses and reports no outcome results, so there are no recorded tests to evaluate for multiplicity.

The registry record does not report the number of participants with observed primary outcome data at each assessment, the extent or pattern of missing scores, or how missing observations were handled. It also does not specify an analysis population, such as whether the analysis included all enrolled participants or only those with complete measurements. Those omissions limit assessment of potential bias and of how well an estimate, if reported elsewhere, represents the enrolled group.

Methods for missing data depend on the reason observations are absent and on the assumptions of the chosen analysis. In general, excluding participants with missing measurements can affect results if missingness is related to outcomes or participant characteristics. The registry does not provide enough information to assess whether missing data occurred or how it may have affected the findings.

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 0% reporting threshold.

Most frequent non-serious adverse event terms

The registry lists 0 serious adverse events among 20 at risk in the Facial Aesthetic Treatment group. It also lists 17 participants affected by other adverse events among 20 at risk. These are the recorded counts; they should not be treated as a complete description of each event or as a causal assessment.

The record does not report the terms for the other adverse events, and it lists no serious adverse event terms. It also does not describe event severity beyond the serious-versus-other grouping, the time at which events occurred, their duration, or whether investigators considered them related to treatment. The adverse event counts do not establish whether an event was caused by an injectable or by another factor.

A zero count for serious events means none were recorded in this group in the registry data. It does not show that the risk is absent, and it cannot establish how frequently serious events might occur in a larger or different population. The number at risk and study size provide important context, but the record’s limited event detail and lack of a comparator prevent broader safety comparisons.

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

The registry record establishes that a completed Phase 2, single-group study evaluated a combination facial aesthetic procedure in a millennial cohort. It identifies the three injectables, describes an optional touch-up at 2 weeks, and specifies a patient-reported primary endpoint assessed at baseline and 2 months after the procedure. It also describes how the FACE-Q score is constructed and lists safety counts.

The record does not report the primary endpoint means, changes, uncertainty estimates, or statistical test results. It therefore does not show whether satisfaction scores increased, decreased, or remained similar, nor does it show how precisely any change was estimated. The investigators’ hypothesis about increased satisfaction and psychosocial impact should not be mistaken for evidence that those changes occurred.

Even if the primary outcome results were available, a single-group before-and-after design would not by itself distinguish an effect of treatment from other influences on responses over time. Without a comparator, the design cannot supply a direct estimate of what would have happened to a comparable group without the procedure. This is a limitation of causal interpretation, not a claim that the observed participants did or did not change.

The registry also does not report a threshold for interpreting the clinical importance of a score change, nor does it provide detailed outcome results for the secondary measures. The listed safety counts offer a limited description, but the absence of event terms and details means they cannot characterize the types or causes of adverse events.

In short, the posted information describes what the study set out to measure and the design in which it did so. It does not provide enough outcome information to support a conclusion about the magnitude, precision, clinical importance, or cause of any change in satisfaction.

14. Why This Trial Matters Statistically

This study is statistically instructive because it pairs a patient-reported continuous endpoint with a before-and-after, single-group design. The FACE-Q measure gives a structured way to record satisfaction with facial appearance, and the stated assessment times make change over follow-up a natural descriptive question. Yet measurement detail alone is not a result: without observed scores and an analysis, readers cannot quantify change or its uncertainty.

The design also illustrates why outcome change and treatment effect are not synonymous. A within-group difference can describe what happened among participants who received the procedure, but causal attribution requires a basis for judging what would have happened without it. A comparator can help answer that question; this registry record lists none. Precision in estimating a before-and-after difference would not remove that design limitation.

The set of patient-reported outcomes brings another statistical issue into focus. Several dimensions of satisfaction and psychosocial function are listed, but the record does not describe how the primary and secondary outcomes were prioritized or how multiplicity was addressed. Clear outcome priorities help readers distinguish the central question from additional exploratory questions and interpret multiple findings coherently.

Finally, the safety record demonstrates why counts need context. The serious and other adverse-event counts are informative as registry entries, but event descriptions, timing, severity, and relatedness are absent. Statistical interpretation depends not only on numerical summaries but also on outcome definitions, analysis choices, and completeness of reporting. The missing primary results and methods limit what can be concluded, even though the study’s measurement plan is clearly described.

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 most consequential limitation for interpreting the posted results is that the registry record does not report the primary outcome values or any analyses. The FACE-Q scale, assessment times, and summary type are described, but there is no reported baseline mean, follow-up mean, change estimate, standard deviation, confidence interval, or test result. The direction and precision of change therefore cannot be assessed.

The single-group design has no control arm, and the registry lists no random allocation or masking. Any observed pre-to-post change would be vulnerable to alternative explanations, including general time effects, expectations, or changes in how participants respond. These are design considerations; the record does not say whether such influences occurred.

Population detail is limited. The cohort is identified as millennial, but the registry record does not report an age range, detailed eligibility criteria, participant characteristics, or the representativeness of those enrolled. The study’s enrollment is 20, which also limits the scope for broad generalization, particularly when the outcome results and their uncertainty are not reported.

The record does not report missing-data amounts or methods, analysis populations, the statistical model, multiplicity procedures, a threshold for meaningful change, or study-specific measurement properties. These omissions make it difficult to assess analytic robustness and clinical interpretation. The safety data are similarly limited by the absence of event terms and information on severity, timing, and treatment relatedness.

The registry’s planning assumptions describe a hypothetical two-arm exercise, whereas the registered study is single-group. Those assumptions should not be treated as the original design rationale or as evidence of observed power. The sample-size justification and any interim analyses are not reported in the registry record.

16. Related Tutorials

17. Related Statistical Calculators

18. Sources

• ClinicalTrials.gov: Combination Facial Aesthetic Treatment in Millennials — NCT04755595.
• Registry record last updated 2025-01-14; status last verified 2024-12.
• Results first posted 2021-09-24.
• 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.

19. Record Summary

NCT04755595 is a completed Phase 2, single-group study sponsored by State University of New York - Downstate Medical Center. The registry lists enrollment of 20, a start date of 2021-03-09, and primary completion on 2021-05-19. Participants were to receive Botox Cosmetic, Juvéderm Voluma XC, and Juvéderm Volbella XC during a single procedure, with an optional touch-up at 2 weeks.

The primary endpoint is FACE-Q Satisfaction With Facial Appearance Overall Scale at baseline and 2 months after the procedure, summarized as a mean and standard deviation. The registry record describes the scale but does not report primary outcome results or analyses. It lists 10 outcome measures and adverse-event counts of 0 serious events and 17 participants affected by other events among 20 at risk. Detailed event terms and the analysis plan are not reported in the registry record.