A Study to Evaluate the Effectiveness of Juvéderm® VOLIFT™ With Lidocaine for Lip Augmentation: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for A Study to Evaluate the Effectiveness of Juvéderm® VOLIFT™ With Lidocaine for Lip Augmentation (NCT03796728), a na phase 4 study. The primary outcome is Percentage of Participants With a ≥ 1-point Improvement (Increase) in the Lip Fullness Scale (LFS2) Compared to Baseline Assessment at Day 30.

2. Clinical Question

The clinical question is thus about the proportion of participants meeting a prespecified improvement criterion at a particular assessment time, rather than about an average change in scale score or a difference between randomized groups. The study also registered assessments of oral commissures, participant satisfaction, aesthetic improvement, natural look and feel, product smoothness, and dynamic lip lines. Those outcomes can provide additional perspectives, but they do not replace the primary endpoint or create a control group.

3. Trial Design

The LIPS study is recorded as a Phase 4, prospective, open-label, multicenter, single-group study of Juvéderm® VOLIFT™ with Lidocaine for lip augmentation. The registry lists the study as completed and records enrollment of 60. Its start date is 2018-12-19, and its primary completion date is 2020-06-09. These dates describe the registry record and do not establish when each participant was treated or assessed.

All participants in the study group received the injectable gel. The treatment description specifies an initial treatment on Day 1 and an optional touch-up 14 days later, if applicable. The investigator determined treatment volume, which was not to exceed 3.0 milliliters (mL). The registry does not report how many participants received a touch-up or the distribution of treatment volumes.

Open-label means that the study was not masked, as reflected by the registry’s masking field of none. The study has no randomized allocation and no listed control arm. Its single-group structure means the primary endpoint describes change from each participant’s baseline assessment; it does not estimate a between-group treatment contrast. Changes over time in an uncontrolled study can be described, but this design cannot separate a treatment-associated change from other possible influences, such as expectations, assessment conditions, or changes that might occur over time.

The primary endpoint compares Baseline with Day 30. The registry describes the Evaluable Set as participants in the Full Analysis Set who had at least a Baseline and a Day 30 post-treatment efficacy assessment. The number included in that set, and whether it differed from the listed enrollment, are not reported in the registry record. Other details of the protocol, including recruitment procedures and any additional assessment schedule, 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

Reasons for not completing this period:

Analysis population for the primary outcome, as defined in the registry: Evaluable Set included all participants in the Full Analysis Set who had at least a Baseline and a Day 30 post-treatment efficacy assessment during the study.

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 Analysis Set included all participants who were consented and enrolled into this study and were treated with the investigational product Juvéderm® VOLIFT™ with Lidocaine.

6. Primary Endpoint

The registry lists the primary outcome as Percentage of Participants With a ≥ 1-point Improvement (Increase) in the Lip Fullness Scale (LFS2) Compared to Baseline Assessment at Day 30, measured over Baseline (Prior to Treatment) to Day 30.

The primary endpoint is the percentage of participants whose investigator-assessed Lip Fullness Scale (LFS2) score increased by at least 1 point from Baseline to Day 30. The LFS2 is a 5-point scale running from 0, Minimal, through 4, Very Marked. Its descriptions refer to visible lip fullness, including red lip show and the contour or pout of the lower and upper lips. The endpoint reduces each participant’s score change to whether the specified improvement threshold was reached.

A threshold-based percentage can be useful because it expresses the share of the defined population meeting a clinically interpretable scale-change criterion. It is different from reporting the mean score change: participants just below and just above the threshold are placed in different categories, while the size of changes beyond the threshold is not conveyed by the percentage alone. The endpoint also does not capture every dimension of appearance or participant experience; the registry lists other assessments, including participant satisfaction and global aesthetic improvement.

The denominator is the Evaluable Set, defined as Full Analysis Set participants with both Baseline and Day 30 post-treatment efficacy assessments. The registry record does not report the number in that set, the number meeting the improvement criterion, the percentage, or a confidence interval. The endpoint definition therefore clarifies what the primary result is intended to represent, but does not by itself establish the observed result or its precision.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

The primary outcome is a binary classification at the participant level: each eligible participant either did or did not meet the threshold of at least a 1-point increase in LFS2 from Baseline to Day 30. The summary measure is the percentage meeting that criterion. This kind of endpoint is often called a responder proportion. It answers how common the defined response was among participants in the stated analysis population, rather than describing the full distribution of score changes.

What does a threshold-based endpoint retain and leave out?

Turning scale changes into a responder category can make the outcome straightforward to interpret. It retains whether a participant crossed the specified threshold. However, the percentage does not show the amount of improvement for participants who crossed it, nor does it distinguish among participants who did not cross it. A participant with no score change and a participant with a decrease both fall outside the improvement category, unless the registry defines separate categories. The primary endpoint description does not report separate breakdowns of those outcomes.

The LFS2 itself is an investigator assessment on a 5-point scale, from 0, Minimal, to 4, Very Marked. Its ordered categories describe increasing lip fullness, but the registry does not report an assumption that the distance between adjacent categories is equal. The chosen endpoint avoids treating the scale as if a particular average score difference were the only meaningful summary; instead it focuses on meeting the stated increase threshold. The trade-off is that dichotomization discards information about the size and pattern of score changes.

Why does the analysis population matter?

The endpoint population is defined as the Evaluable Set, which includes participants in the Full Analysis Set with at least a Baseline and a Day 30 post-treatment efficacy assessment. This rule makes clear that a participant needs both observations to contribute to the stated change-from-baseline endpoint. It also means the resulting percentage describes that defined evaluable group, not automatically everyone listed as enrolled. The number in the Evaluable Set is not reported in the registry record.

In general, excluding participants without a required follow-up assessment can affect how representative an estimate is if follow-up availability is related to the outcome. Understanding that possibility requires information about missing assessments, reasons for missingness, and the analysis approach. Those details are not reported in the registry record. The population definition alone does not show whether missing data were common or whether additional methods were used.

How should uncertainty be understood?

A confidence interval is a statistical summary of uncertainty around an estimate. In general, it indicates how much the estimated proportion may vary because it is based on a sample rather than every possible participant in the target population. Its interpretation depends on the statistical method and assumptions. The primary numerical percentage, confidence interval, and inferential method are not reported in the registry record, so the uncertainty cannot be evaluated for this endpoint.

For count outcomes, over-dispersion is a general concern when observed variability exceeds what a simple model assumes. It can make uncertainty estimates from that simple model too small. That issue is not a reported feature of this binary percentage endpoint, and the registry record does not report a model or an over-dispersion assessment for the primary analysis.

What does a planning sample size mean?

Sample-size calculations are planning illustrations, not observed outcomes and not observed power. The stated planning assumptions describe a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation, with the target effect expressed as a fraction of the observed effect. Such an illustration is distinct from this trial’s actual single-group design; it does not mean the trial randomized participants to two arms. No numerical planning estimates or primary observed effect are reported in the registry record, so the calculations cannot be interpreted as evidence of the study’s precision or result.

More generally, the assumptions used for a planning calculation determine what question its output addresses. A calculation based on an observed effect is retrospective in its choice of effect size and should not be presented as a prospective justification for the trial’s enrollment. The protocol’s sample-size justification is not reported in the registry record. The registry record also does not report the primary analysis method, any adjustment approach, or interim analyses.

10. Exact Estimates for Each Arm

No two-arm comparison is shown for this trial, but each arm's result can still be summarized with exact interval estimates computed from the posted counts. The Clopper-Pearson interval is exact and conservative; the Wilson interval is a common closer-to-nominal alternative; the Bayesian credible interval uses a uniform Beta(1, 1) prior. For small groups the three can differ noticeably.

R code and output

arm    <- c("Juvéderm® VOLIFT™ With Lidocaine")
n      <- c(59)
events <- c(55)
for (i in seq_along(n)) {
  ci <- binom.test(events[i], n[i])$conf.int          # Clopper-Pearson exact interval
  cr <- qbeta(c(0.025, 0.975), 1 + events[i], 1 + n[i] - events[i])   # Bayesian, uniform Beta(1,1) prior
  wi <- (function(x, n) { p <- x / n; z <- qnorm(0.975); d <- 1 + z^2 / n
    c((p + z^2 / (2 * n) - z * sqrt(p * (1 - p) / n + z^2 / (4 * n^2))) / d, (p + z^2 / (2 * n) + z * sqrt(p * (1 - p) / n + z^2 / (4 * n^2))) / d) })(events[i], n[i])
  cat(sprintf("ARM|%s|%d|%d|%.1f|%.1f|%.1f|%.1f|%.1f|%.1f|%.1f\n", arm[i], n[i], events[i], 100 * events[i] / n[i],
              100 * ci[1], 100 * ci[2], 100 * wi[1], 100 * wi[2], 100 * cr[1], 100 * cr[2]))
}

ARM  Juvéderm® VOLIFT™ With Lidocaine  59  55  93.2  83.5  98.1  83.8  97.3  83.8  97.2

11. Multiplicity, Missing Data and Analysis Populations

The registry lists several secondary outcomes in addition to the primary LFS2 responder endpoint. These cover oral commissures, participant satisfaction with lips, investigator and participant global aesthetic improvement, perceived natural look and feel, investigator-assessed smoothness, and dynamic lip lines. Looking at multiple outcomes creates a general multiplicity issue: when many statistical questions are examined, the chance of at least one apparently notable result can increase if each is assessed independently. Whether and how that concern was addressed is not reported in the registry record.

The registry record lists no analyses. It does not report a hierarchy among the primary and secondary outcomes, an adjustment for multiple testing, or a plan for interpreting secondary findings. The outcome descriptions should therefore be treated as definitions of what was assessed, not as evidence that a particular result was statistically significant or clinically important.

For the primary endpoint, the Evaluable Set requires participants to have both Baseline and Day 30 post-treatment efficacy assessments. This defines which participants can contribute to the stated comparison. The number with missing assessments, the reasons for missingness, and any imputation or sensitivity analyses are not reported in the registry record. It is not possible to determine from the population definition alone whether missingness could affect the estimated percentage.

The Full Analysis Set is referenced in the endpoint population definition, but its own membership rules and size are not reported in the registry record. Other details of analysis populations, including whether different populations were used for safety or secondary outcomes, are also not reported. These omissions limit assessment of how participants were handled across the planned analyses.

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 5% reporting threshold.

The registry reports adverse-event counts for the Juvéderm® VOLIFT™ With Lidocaine group. For serious adverse events, 0 of 60 participants at risk were reported as affected. For other adverse events, 0 of 60 participants at risk were reported as affected. The reported number of deaths is 0. These are the registry’s recorded counts for this group.

Counts of zero mean that no affected participants were recorded in the corresponding registry fields. They do not establish that the risk of an event is impossible, and they do not describe events that may not have been captured or reported. The registry record does not report further detail about adverse-event definitions, collection methods, duration of safety follow-up, or event-level assessments. The figures should therefore be read as reported counts, not as a complete characterization of safety.

Serious and other adverse events are separate categories in the record. The zero count for serious adverse events should not be confused with the primary efficacy endpoint, which is a Day 30 percentage based on the Evaluable Set. Nor do the safety counts establish whether the treatment caused or did not cause an event. No treatment advice or causal conclusion follows from these registry counts alone.

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

This study addresses a focused measurement question: what percentage of participants in the defined evaluable population had at least a 1-point increase in investigator-assessed LFS2 from Baseline to Day 30 after treatment with Juvéderm® VOLIFT™ with Lidocaine? The registry record describes the scale, endpoint threshold, assessment time, and population rule. It records a completed, open-label, single-group study with enrollment of 60.

The registry record does not report the numerical primary endpoint result or its uncertainty. It is therefore not possible to state the percentage meeting the criterion, how precise that estimate is, or how the observed score changes were distributed. The presence of an endpoint definition is not a result. The listed secondary outcome definitions likewise do not establish their findings.

Even if a numerical within-group change were available, this design would not provide a randomized comparison with an untreated group or another intervention. A change from baseline can be described for participants in the study, but without a concurrent comparator it cannot by itself isolate the contribution of treatment from other influences. The open-label design also means that the registry does not describe masking of participants or assessors.

The endpoint represents one aspect of lip fullness assessed by an investigator. Other registered outcomes address participant satisfaction and different aesthetic assessments, indicating that the study considered additional dimensions. The primary percentage alone would not describe all those domains, and the registry record does not report their numerical results.

The reported adverse-event fields list zero affected participants for both serious and other adverse events among 60 at risk, and zero deaths. Those counts describe the entries in the registry and do not prove absence of all possible harms. Overall, the record supports a description of the study’s design and measurement plan, but the missing numerical efficacy result and limited comparative design prevent a quantified treatment-effect conclusion.

14. Why This Trial Matters Statistically

This trial illustrates why the outcome definition and analysis population matter when reading a clinical study. The primary endpoint is not simply a change in lip fullness: it is the percentage of a defined evaluable group that crossed a specified LFS2 improvement threshold by Day 30. That distinction determines both the interpretation of the statistic and which participants contribute to it.

It also demonstrates the difference between a within-group endpoint and a comparative treatment effect. The single-group design can describe change from baseline among treated participants, but it does not create a control-based estimate of what would have happened under another condition. Readers should not interpret a change-from-baseline measure as though it were a randomized treatment contrast.

Registry completeness is another statistical consideration. The record identifies the endpoint and its population but does not report the primary numerical result, its uncertainty, or analysis details. Without those elements, readers cannot assess the magnitude or precision of the primary finding. The record’s completed status and enrollment figure do not fill that gap.

Finally, the trial highlights the need to distinguish outcome definitions, safety counts, and planning calculations. A list of outcomes is not a list of findings; zero recorded adverse-event counts are not proof of zero risk; and planning sample-size illustrations are not observed power. Keeping these concepts separate helps prevent stronger conclusions than the design and reported information support.

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 main limitation for statistical interpretation is that the registry record does not report the numerical primary endpoint result or a measure of its uncertainty. It also does not report the size of the Evaluable Set, so the denominator for the stated primary percentage cannot be confirmed from the record. The listed enrollment of 60 should not be assumed to equal that analysis population.

The single-group, open-label design has no concurrent control and no masking. A baseline-to-Day 30 change can describe observed change in the study group, but cannot distinguish treatment-associated change from other influences. The registry record does not report information that would allow those influences to be evaluated.

The primary endpoint converts an ordered 5-point assessment into a threshold-based response. This is interpretable as the share meeting the criterion, but it does not convey the full distribution of scale changes or the extent of improvement beyond the threshold. The registry record does not report the numerical result or additional distributional summaries.

Further details are absent about missing assessments, reasons for missingness, handling of missing data, analysis methods, multiplicity control, interim analyses, and the protocol’s sample-size justification. Numerical results for the registered secondary outcomes are also not reported in the registry record. The safety fields give counts but do not provide additional information on event definitions, ascertainment, or follow-up. These gaps restrict assessment of both statistical robustness and the scope of conclusions that can be drawn.

16. Related Tutorials

17. Related Statistical Calculators

18. Sources

• ClinicalTrials.gov: A Study to Evaluate the Effectiveness of Juvéderm® VOLIFT™ With Lidocaine for Lip Augmentation — NCT03796728.
• Registry record last updated 2021-07-28; status last verified 2021-07.
• Results first posted 2021-07-28.
• 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

The registry describes NCT03796728, the LIPS study, as a completed Phase 4, prospective, open-label, multicenter, single-group study sponsored by Allergan. It lists enrollment of 60 and evaluates Juvéderm® VOLIFT™ with Lidocaine for lip augmentation. Treatment was initially given on Day 1, with an optional touch-up 14 days later if applicable, at investigator-determined volume not exceeding 3.0 milliliters (mL).

The primary endpoint is the percentage of participants with at least a 1-point increase in LFS2 from Baseline to Day 30, among participants in the defined Evaluable Set. The numerical primary result, its uncertainty, and the Evaluable Set size are not reported in the registry record. The record lists 0 of 60 participants affected by serious adverse events, 0 of 60 affected by other adverse events, and 0 deaths.