A Study of the Safety and Effectiveness of JUVÉDERM VOLUMA® XC Injectable Gel for Cheek Augmentation Using Cannula: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for A Study of the Safety and Effectiveness of JUVÉDERM VOLUMA® XC Injectable Gel for Cheek Augmentation Using Cannula (NCT03438266), a randomized na study. The primary outcome is Change From Baseline in Mid-Face Volume Deficit Scale (MFVDS) Score.

2. Clinical Question

The study objective was to evaluate the safety and effectiveness of JUVÉDERM VOLUMA® XC injectable gel using a cannula in participants seeking correction of age-related mid-face volume deficit. The primary endpoint was change from baseline in the evaluating investigator’s Mid-Face Volume Deficit Scale score, assessed from baseline screening to Month 1. The registry describes a scale applied to each cheek, with a negative change indicating improvement.

The treatment descriptions make the cheek-level comparison clear: one cheek was treated with a cannula and the opposite cheek with a needle. However, the registry classifies the model as parallel while also describing both cheek treatments for participants. It does not explain how its parallel-model classification relates to the cheek-level treatment comparison or how treatment assignment was implemented. The record does not report the primary comparison’s estimates, uncertainty, or test result. Consequently, the clinical question can be stated from the design and endpoint, but its answer cannot be determined from the reported information.

3. Trial Design

The registry record describes a randomized, single-blind, controlled study with a parallel model. It lists enrollment of 66, phase as not applicable, and study status as completed. The listed start date is 2018-02-05, and the primary completion date is 2018-05-29. Allergan is identified as the sponsor.

The intervention descriptions specify JUVÉDERM VOLUMA® XC injectable gel with cannula and the same gel with needle. The arm descriptions state that participants had one cheek treated with the cannula and one cheek treated with the needle, on the contralateral side. This is important for interpreting the comparison: treatment is described at the cheek level, while the registry’s model field says parallel. The record does not explain the relationship between those descriptions, identify the unit of randomization, or state whether treatment side was randomized.

The study is single-blind, but the identity of the blinded party and the practical blinding procedures are not reported in the registry record. The record also does not describe concealment of allocation, the protocol’s planned sample-size justification, interim analyses, or detailed statistical procedures. These details should not be inferred from the randomization or masking labels.

The primary analysis population is described as the mITT population: randomized participants who received cannula treatment on one cheek and needle treatment on the other. The registry lists four outcome measures and two analyses, but does not provide enough detail to map every analysis to an outcome or describe the analysis methods. Results for the primary endpoint are not reported in the registry record. The completed status therefore indicates the status recorded for the study, not that outcome estimates are available in the information.

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: mITT population included all randomized participants who received treatment with cannula on 1 cheek and treatment with needle on the contralateral (other) cheek.

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: Modified Intent-to-Treat (mITT) population included all randomized participants who received treatment with cannula on 1 cheek and treatment with needle on the contralateral (other) cheek.

6. Primary Endpoint

The registry lists the primary outcome as Change From Baseline in Mid-Face Volume Deficit Scale (MFVDS) Score, measured over Baseline (Screening) to Month 1.

The primary endpoint is change from baseline in the Mid-Face Volume Deficit Scale score, from baseline screening to Month 1. The evaluating investigator assessed each cheek’s overall mid-face volume deficit using a six-point photonumeric scale, with scores from 0, meaning none or fullness, to 5, meaning severe wasting. A negative change from baseline indicates improvement on this scale. The endpoint is reported as a mean with standard deviation.

In general, a change score expresses how a measurement differs from its starting value over a specified follow-up period. Here, assessing each cheek gives the outcome a direct connection to the two delivery approaches described in the registry. The score is intended to represent the investigator’s assessment of volume deficit, rather than a direct measurement of gel volume or a participant-reported satisfaction score. Its interpretation depends on the stated scale direction: a lower score at follow-up, relative to baseline, corresponds to a negative change and indicates improvement according to the endpoint definition.

The registry record identifies the measure and time frame but does not report the observed mean change for either treatment, the between-treatment estimate, or its uncertainty. It also does not report details such as assessor training, score reliability, or how any missing cheek-level assessment was handled. Without those results and methods, the endpoint can be described, but the magnitude and precision of the observed comparison cannot be evaluated.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

What does a mean change represent?

The primary endpoint is a continuous score summarized as a mean and standard deviation. In general, a mean describes the average observed value in a group, while the standard deviation describes how dispersed individual values are around that average. They answer different questions: a mean locates the group’s average outcome, whereas a standard deviation describes variability among measured outcomes. Neither quantity alone provides the uncertainty of a treatment comparison.

For this endpoint, the score is assessed at baseline and Month 1, and the reported measure is change from baseline. The endpoint definition says that negative change indicates improvement. When comparing delivery approaches, a treatment contrast would ordinarily express how the average change under one approach relates to average change under the other, with the sign interpreted according to the chosen subtraction order. The registry record does not report such a contrast or state its direction convention, so no treatment difference can be described.

What would uncertainty add?

In general, a confidence interval describes the precision of an estimated effect under the assumptions of the analysis. A narrower interval indicates greater precision than a wider interval, but its clinical interpretation depends on the outcome scale and what differences matter. A p-value, in general, measures how compatible the observed data are with a specified null hypothesis under a statistical model. It does not express the probability that the null hypothesis is true, and it does not by itself establish whether an effect is meaningful.

The registry record does not report a confidence interval, p-value, or standard error for the primary comparison. It also does not state the statistical model or the planned hypothesis test. These methods should not be reconstructed from the randomized designation or from the endpoint’s mean-and-standard-deviation description.

How does the cheek-level description affect analysis?

The arm descriptions say that each participant had one cheek treated with cannula and the opposite cheek treated with needle. In general, paired measurements from two sides of the same participant can be statistically related because they share participant characteristics. Accounting for that pairing can affect the estimated uncertainty of a treatment contrast. Treating paired observations as independent can give an inappropriate uncertainty estimate when the within-participant association is relevant.

However, the registry labels the study model as parallel and does not explain how that classification fits the two-cheek treatment descriptions. It does not report the unit of randomization, whether treatment side was randomized, or the analysis method used to account for any paired observations. It would therefore be inappropriate to assert that a paired analysis was performed or to assume a particular model. The record’s mITT description confirms that the primary population included randomized participants who received both cheek treatments, but it does not specify the statistical handling of the two cheek scores.

Why can dispersion matter?

In general, the standard deviation captures variation in individual measurements. If outcomes vary substantially, the average alone may not communicate how consistently participants’ scores changed. For continuous outcomes, a model may also need to consider whether variability is similar across groups and whether the distribution is suitable for the chosen inferential method. These are general considerations, not reported findings about this study. The registry does not provide the primary outcome distributions, standard deviations, model diagnostics, or details of any alternative methods.

Over-dispersion is a general concern most often discussed for count outcomes: observed variability can exceed what a simple model expects. A model that does not allow for that excess variability may understate uncertainty. The primary endpoint in this study is a continuous score, so a count-model over-dispersion issue cannot be inferred from its definition. For the listed adverse events, the record gives participant counts but no event-level count model or analysis plan.

What do planning illustrations mean?

In general, sample-size planning asks how much information a future study might need to detect a prespecified effect with a chosen significance level and power under stated assumptions. A planning illustration based on an observed effect is conditional on that effect and the assumptions used; it is not evidence of the probability that the completed study detected an effect. Such illustrations are not observed power.

The registry record describes planning assumptions involving a two-sided significance level of 0.05, equal allocation between two arms, a normal approximation, and effects expressed as fractions of the observed effect. It says that non-time-to-event planning values are participants per arm. These are described as planning illustrations, not the trial’s own design. The record does not report the trial’s sample-size justification, and the primary outcome results needed to interpret an observed-effect-based illustration are not reported. The illustrations therefore should not be treated as proof that the trial was adequately powered or as estimates of the study’s observed ability to detect a difference.

10. Multiplicity, Missing Data and Analysis Populations

The registry lists four outcome measures and two analyses. It identifies the primary outcome as change from baseline in MFVDS score and names secondary outcomes concerning at least a 1-point MFVDS improvement, FACE-Q satisfaction with cheeks, and treatment-emergent adverse events. The record does not report a multiplicity adjustment, a hierarchy of secondary hypotheses, or a strategy for controlling the chance of false-positive findings across outcomes or analyses. Whether such procedures were planned or used is not reported in the registry record.

In general, testing multiple outcomes or comparisons can increase the chance of finding at least one apparently unusual result when all null hypotheses are true. A prespecified hierarchy or adjustment can address that issue, but the registry information does not establish whether either was used. Since outcome results are not reported, there is no basis to assess how multiplicity would affect a particular finding.

The primary analysis population is described as randomized participants who received both specified cheek treatments. The registry does not provide a count for this population, explain exclusions from it, or report how missing baseline or follow-up measurements were handled. It also does not state whether all randomized participants were included in any other analysis population, or describe imputation, sensitivity analyses, or reasons for missingness. Those details are not reported in the registry record. Missing-data methods matter because analyses may rely on assumptions about why outcomes are unavailable; without the analysis plan and data-completeness information, the robustness of any treatment comparison cannot be assessed.

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 5% reporting threshold.

Most frequent non-serious adverse event terms

The registry lists a safety group titled JUVÉDERM VOLUMA® XC (All Participants). For serious adverse events, 60 participants were at risk and 0 were recorded as affected; deaths are recorded as 0. For other adverse events, 60 were at risk and 3 were recorded as affected. These are participant counts in the registry’s safety fields, not a comparison of event rates between the cannula and needle approaches. The record does not report the number of events per affected participant.

The serious adverse-event terms are not listed. The record also does not report event timing, duration, severity beyond the serious-versus-other classification, treatment relatedness, or the observation period used for these counts. The group covers all participants rather than separating outcomes by delivery approach, so the counts cannot establish whether one approach had more adverse events than the other. A count of 0 affected participants in the reported serious-event field describes what that field records; it does not establish that no unrecorded event occurred or resolve safety beyond the recorded scope.

In general, safety counts are interpreted in relation to who was monitored, for how long, and how events were defined and collected. Those details are not reported in the registry record. The figures therefore provide a limited description of recorded participants affected, not a complete comparative safety analysis.

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

The registry record establishes the study’s purpose, its cheek-level treatment descriptions, and the primary outcome definition. It describes randomized, single-blind treatment with JUVÉDERM VOLUMA® XC injectable gel delivered using a cannula or needle. The primary measure is investigator-assessed change in MFVDS score from baseline screening to Month 1, with negative change defined as improvement. The record also includes selected adverse-event counts.

These registry entries do not reveal the observed primary outcome or the comparison between delivery approaches. The record does not report mean changes, a treatment contrast, uncertainty intervals, or a statistical test result. Thus, it cannot establish from the reported information whether scores changed, how large any change was, whether the two approaches differed, or how precise a comparison may have been. Completion status and an endpoint’s direction do not provide those missing results.

The recorded safety counts are likewise limited. They are reported for an all-participant group, not by approach, and the event terms, follow-up duration, and relatedness assessments are not reported. Those data cannot support a comparative safety estimate. The listed secondary outcomes show what was measured or planned for assessment, but their results are not reported in the registry record.

In general, an outcome estimate must be considered alongside its uncertainty, the analysis population, missing-data handling, and the study’s design. Here, the record’s description of a parallel model sits alongside arm descriptions in which each participant received both cheek treatments. The relationship between those descriptions and the analysis is not explained. The registry also does not report multiplicity procedures or detailed statistical methods. These limitations prevent a full statistical appraisal of the comparison.

The appropriate reading is therefore descriptive: the registry records a randomized study with a defined cheek-volume endpoint and limited safety counts, but does not report the primary outcome findings needed to judge the comparative result. No conclusion about effectiveness or relative safety follows from the available outcome information alone.

13. Why This Trial Matters Statistically

This study is statistically notable because its treatment descriptions place two delivery approaches on opposite cheeks of a participant. In general, comparing sides within the same participant can control for characteristics shared by that participant, while also requiring analysis that recognizes the relationship between the two measurements. The registry’s parallel-model label makes clarification of the design and analysis especially relevant; the record does not explain how that label corresponds to the bilateral treatment descriptions.

The endpoint also makes direction important. The evaluating investigator used a scale in which higher scores indicate more severe volume deficit, and the registry states that a negative change from baseline indicates improvement. Clearly stating the direction helps readers interpret a change score, but an endpoint definition cannot replace the observed estimate or its uncertainty. Neither is reported for the primary comparison.

The record offers a useful distinction between outcome selection and outcome reporting. It names a primary score and secondary measures, including participant-level improvement, satisfaction, and adverse events. Yet the primary effect estimate and secondary efficacy results are not reported in the registry record. Without those findings, the study’s statistical contribution cannot be judged from the endpoint list alone.

Finally, the listed safety counts are aggregated across participants, rather than separated by delivery approach. That limits their use for a comparative safety interpretation. The record’s design labels, analysis-population description, and event counts are useful context, but the missing outcome estimates and method details constrain what can be learned about the comparison.

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 trial-specific limitation is that the registry record does not report the primary endpoint results. It gives the score definition, direction, time frame, and analysis-population description, but not the mean changes, treatment contrast, standard deviations, confidence interval, or p-value. The comparative effectiveness question therefore remains unanswered by the recorded results.

The registry describes participants as receiving cannula treatment on one cheek and needle treatment on the other, yet classifies the model as parallel. It does not explain the relationship between those descriptions, identify the randomization unit, or report whether side assignment was randomized. It also does not state how the analysis accounted for the possibility that cheek measurements from the same participant are related.

Additional analytic details are not reported in the registry record, including missing-data handling, the statistical model, multiplicity procedures, and the detailed analysis populations beyond the mITT description. The single-blind label is not accompanied by information about who was blinded or how blinding was maintained. The registry also does not describe the primary sample-size justification or interim analyses.

Safety information is limited to aggregated counts. The record does not report serious-event terms, event timing, follow-up duration, treatment relatedness, or counts separated by delivery approach. These limitations restrict both the interpretation of the safety fields and the ability to compare the two techniques. They are limitations of the information reported in the registry record and do not establish what may have been documented elsewhere.

15. Related Tutorials

16. Related Statistical Calculators

17. Sources

• ClinicalTrials.gov: A Study of the Safety and Effectiveness of JUVÉDERM VOLUMA® XC Injectable Gel for Cheek Augmentation Using Cannula — NCT03438266.
• Registry record last updated 2019-08-05; status last verified 2019-08.
• Results first posted 2019-08-05.
• 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 a completed, randomized, single-blind study sponsored by Allergan, with enrollment of 66. It lists a start date of 2018-02-05 and primary completion date of 2018-05-29. The study evaluated JUVÉDERM VOLUMA® XC injectable gel delivered with a cannula for age-related mid-face volume deficit, with needle delivery described as the comparator.

The primary endpoint was change from baseline in evaluating investigator-assessed MFVDS score from baseline screening to Month 1; negative change indicates improvement. The mITT population is described as randomized participants who received cannula treatment on one cheek and needle treatment on the other. The record lists secondary outcomes on MFVDS improvement, FACE-Q satisfaction with cheeks, and treatment-emergent adverse events.

Primary outcome estimates and detailed statistical methods are not reported in the registry record. Safety fields list 0 participants affected by serious adverse events, 3 affected by other adverse events, and 0 deaths, with the reported at-risk counts described in the safety section.