This page provides an independent statistical analysis and educational interpretation of publicly reported results. ClinicalTrials.gov provides the official trial registry record. Numerical trial results on this page are restricted to the results posted in the ClinicalTrials.gov record; calculations added by Clinical Biostats are labelled as such.
1. Trial at a Glance
This page covers the registry results for A Study to Evaluate the Effectiveness of Juvéderm® VOLIFT®™ With Lidocaine for Dynamic Radial Cheek Line Skin Depressions (NCT02980783), a na phase 4 study. The primary outcome is Percentage of Participants by Improvement Rating (Improved and Not Improved) of Their Dynamic Radial Cheek Lines as Assessed by the Participant Using the Global Aesthetic Improvement Scale (GAIS).
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT02980783 |
| Phase | Phase 4 |
| Condition | Cheek Line Depressions |
| Allocation | Not applicable (single group) |
| Design model | Single Group |
| Masking | None (open label) |
| Enrollment | 53 |
| Arms in the primary outcome | n/a |
| Lead sponsor | Allergan |
| Results posted | Yes |
2. Clinical Question
Population
The study concerned participants with dynamic radial cheek line skin depressions. The registry record reports enrollment of 53 participants. The primary endpoint describes the Per Protocol Population, defined in the record as participants with no major protocol deviations; its analyzed size is not reported in the registry record.
Intervention
The intervention was Juvéderm® VOLIFT®™ with Lidocaine, described as hyaluronic acid with Lidocaine. It was injected into the cheek line depressions on Day 1. The investigator determined the injection volume. If applicable, a touch-up injection was given on Day 14.
Comparator
There was no separate comparator group. The registry record identifies a single-group study and lists allocation as not applicable. It therefore does not describe a randomized, controlled comparison or a like-for-like control group.
Primary question
The primary endpoint asks what percentage of participants rated their dynamic radial cheek lines as improved or not improved on the Global Aesthetic Improvement Scale (GAIS), from baseline on Day 1 to Day 45. Ratings of much worse, worse, or no change were grouped as Not Improved; ratings of improved or much improved were grouped as Improved. The percentages are not reported in the registry record.
This is a descriptive question about participants’ ratings after treatment in a single group. Without a comparator, the study cannot directly estimate how participants’ ratings would have differed under another treatment or no treatment. The registry record lists other outcomes, including investigator-rated improvement, measures of line roughness, texture, amplitude and wrinkle volume, self-perceived age, and participants’ ratings of naturalness. Results for those outcomes are not reported in the registry record either.
3. Trial Design
The registry record describes BEAM as a prospective, open-label, Phase 4, single-group study. It is marked completed and reports enrollment of 53. The record lists a start date of 2016-10-13 and a primary completion date of 2016-12-14. Allocation is listed as not applicable, and masking is listed as none. These design features mean the record does not describe random assignment or blinded assessment.
Participants received Juvéderm® VOLIFT®™ with Lidocaine. The intervention description says that the product was injected into dynamic radial cheek line skin depressions on Day 1, with the injection volume determined by the investigator. A touch-up on Day 14 was given if applicable. The primary endpoint covers the period from baseline on Day 1 to Day 45. The registry record does not report how many participants received a touch-up or provide individual treatment details.
The primary endpoint uses participants’ own GAIS ratings and groups the five response categories into Improved and Not Improved. The stated primary analysis population is Per Protocol, defined as participants with no major protocol deviations. The number in that population and the endpoint results are not reported in the registry record.
A single-group design can describe outcomes observed among participants who received the intervention. It cannot, by itself, separate change associated with the intervention from change that might have occurred for other reasons. Open-label status also means the record does not describe masking of participants or other study personnel. The registry record does not report a statistical analysis plan, a sample-size justification, or details of interim analyses.
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
| Stage | Juvéderm® VOLIFT®™ With Lidocaine |
|---|---|
| STARTED | 53 |
| COMPLETED | 52 |
| NOT COMPLETED | 1 |
Reasons for not completing this period:
| Reason | Juvéderm® VOLIFT®™ With Lidocaine |
|---|---|
| Lost to Follow-up | 1 |
Analysis population for the primary outcome, as defined in the registry: Per Protocol Population included all participants with no major protocol deviations.
5. Baseline Characteristics
The table reproduces the baseline characteristics posted in the registry, which describe the participants analysed at baseline and help show whether the randomized groups were comparable.
Population: Safety Population included all participants who were treated with test product at least once.
| Characteristic | Unit | Juvéderm® VOLIFT®™ With Lidocaine |
|---|---|---|
| Participants analysed | 53 | |
| Age, Continuous | years | 56 (SD 7) |
| Sex: Female, Male: Female | Participants | 53 |
| Sex: Female, Male: Male | Participants | 0 |
6. Primary Endpoint
The registry lists the primary outcome as Percentage of Participants by Improvement Rating (Improved and Not Improved) of Their Dynamic Radial Cheek Lines as Assessed by the Participant Using the Global Aesthetic Improvement Scale (GAIS), measured over Baseline (Day 1) to Day 45.
| Element | Registry entry |
|---|---|
| Result type | Number |
| Measure of spread | not applicable |
| Unit | percentage of participants |
| Endpoint classification | Binary Endpoint |
The primary endpoint is the percentage of participants classified as Improved or Not Improved on the participant-rated Global Aesthetic Improvement Scale (GAIS), from baseline on Day 1 to Day 45. The GAIS has five ratings, ranging from much worse at -2 to much improved at +2. Ratings of -2, -1, or 0 are combined as Not Improved; ratings of +1 or +2 are combined as Improved. The endpoint therefore reduces an ordered set of ratings to two categories.
A participant-rated endpoint captures participants’ own assessment of change in their cheek lines. Grouping ratings makes the result easier to express as a proportion in each category, but it also conceals distinctions within a category: for example, the Not Improved group includes both worsening and no change. The endpoint does not provide the full distribution of the five original ratings in the registry record.
Percentages can describe how responses were distributed in the defined analysis population. Their interpretation depends on the denominator and on how missing ratings are handled. The record identifies the Per Protocol Population but does not report its size, the endpoint counts, the percentages, or uncertainty estimates. As a result, the endpoint’s observed value and precision are not reported in the registry record.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry record specifies a participant-rated primary endpoint but does not report the endpoint results. It gives no count or percentage of participants classified as Improved or Not Improved, and no confidence interval or p-value for that outcome. The data therefore do not support a numerical description of the primary result or its precision. The record lists eight outcome measures and zero analyses; the outcome definitions alone do not establish what was observed.
The primary outcome is a binary grouping of the GAIS ratings, not a direct measure of the size of any change. Participants who reported much worse, worse, or no change are grouped together, while participants reporting improved or much improved form the other group. Without the category counts or full rating distribution, it is not possible to tell how responses were spread across the original rating scale. The registry record also does not give the analyzed Per Protocol Population size, so the denominator for the primary percentages cannot be checked from the record.
General statistical context: an estimate from a sample is subject to sampling uncertainty. A confidence interval, when reported, describes a range of values compatible with the data and the interval method under its assumptions. It does not remedy design limitations such as the absence of a comparator, and it does not show that a causal effect has been established. No confidence interval is reported for the primary outcome in the registry record.
The single-group, open-label design is important when interpreting participant ratings. Without a control group, observed ratings cannot be contrasted with outcomes under an alternative condition. Open-label assessment also means participants knew the intervention they received, according to the masking status in the record. These features do not determine what participants reported, but they constrain how the observations can be interpreted.
The record reports 53 enrolled participants, but enrollment is not the same as the endpoint denominator. The primary population is described as Per Protocol, and its size is not reported in the registry record. It is also not reported how many participants completed the Day 45 assessment, whether any endpoint ratings were missing, or how missing observations were treated. The primary finding, its uncertainty, and the extent to which it represents all enrolled participants therefore cannot be assessed from this record.
The registry record lists secondary outcomes involving instrument-assessed line characteristics, wrinkle volume, investigator assessment, self-perceived age, and naturalness ratings. Their results are not reported in the registry record. No conclusion about the direction, magnitude, or statistical uncertainty of those outcomes can be drawn from their names alone. Overall, the posted information describes the question and design, but does not include the numerical effectiveness results needed to characterize the observed response.
9. Statistical Methods Explained
What does the primary outcome count?
The primary outcome is expressed as a percentage of participants in each of two response groups. The groups are formed from the five-point participant-rated GAIS. Ratings of -2, -1, or 0 are classified as Not Improved, and ratings of +1 or +2 are classified as Improved. This is a binary summary of an underlying ordered scale. It is important to keep the grouping rule in mind: the Not Improved category combines worsening with no change, while the Improved category combines improved with much improved.
The registry record identifies the Per Protocol Population as the population for the primary outcome. It defines that population as participants with no major protocol deviations. It does not report the population size or the number in either response group. Without the counts and denominator, a reader cannot verify or interpret the resulting percentages. Enrollment of 53 does not establish that all enrolled participants were included in this endpoint analysis.
What can a percentage tell us?
General statistical context: a sample percentage describes the fraction of observations in a specified category among the observations used in its denominator. It is a descriptive estimate for that sample, not a guarantee that the same percentage would occur in another group of participants. Its precision depends in part on the amount of information available and on the distribution of observations. A confidence interval can communicate uncertainty around an estimate, provided its method and assumptions are appropriate.
No primary endpoint percentage, count, confidence interval, or p-value is reported in the registry record. The absence of those quantities means that the endpoint’s observed level and statistical precision cannot be evaluated. It would not be appropriate to infer the result from the study description, enrollment, or the listed outcome measures.
Why does the study design matter?
The record describes one treatment group, no allocation, and no masking. General statistical context: a randomized comparison can help distinguish outcomes between assigned groups, while a single-group description records outcomes only among participants who received the intervention. In a single-group study, a before-and-after observation does not provide the same contrast as a concurrent control group. Other influences on reported change cannot be separated from the intervention using a treatment group alone.
Open-label status is relevant because the primary outcome is based on participants’ own ratings. General statistical context: knowledge of treatment can affect expectations or reporting, so masking can be relevant for subjective assessments. This is a design consideration, not evidence that any particular participant’s rating was biased. The record does not report a blinded assessment procedure.
What is known about the analysis plan?
The registry record lists zero analyses. It does not report the statistical method used to estimate the primary percentages, a method for calculating uncertainty, or a hypothesis test. It also does not report adjustments for baseline characteristics or other covariates. No particular model, test, or adjustment should therefore be attributed to this trial based on the registry record.
The record includes planning assumptions for sample-size illustrations: a two-sided significance level of 0.05, equal allocation between two arms, a normal approximation, and an effect defined as a stated fraction of the observed effect. It describes such sample-size calculations as planning illustrations rather than the trial’s own design. Because this study is single-group and no numerical illustration values are reported in the record, these assumptions should not be treated as the study’s enrollment rationale, an analysis of observed power, or evidence that the study was designed around a particular effect. The trial’s sample-size justification is not reported in the registry record.
General statistical context: power is a property of a planned design under specified assumptions about an effect, variability, sample size, and analysis. It is not a measure of whether a result is true, and calculating power from an observed estimate does not establish how likely that estimate is to be replicated. A planning illustration based on an observed effect is different from a prospectively justified sample-size calculation. The record does not report a trial-specific power calculation.
How should multiple outcomes be considered?
The registry record lists a primary outcome and several secondary outcomes. General statistical context: evaluating many outcomes can increase the chance that at least one result appears notable by chance when multiple statistical tests are conducted. Methods to address multiplicity depend on the planned hypotheses, outcome hierarchy, and analysis strategy. The record does not report a multiplicity adjustment or an analysis plan specifying how the outcome set was handled. Since outcome results and analyses are not reported, it is not possible to assess whether multiplicity affected any reported inference.
Other general considerations include the handling of missing observations, the timing of assessments, and whether the analyzed population matches the population named for the endpoint. The primary timeframe is baseline on Day 1 to Day 45, and the analysis population is described as Per Protocol. The registry record does not state how missing Day 45 ratings were handled, how many ratings were unavailable, or whether any sensitivity analyses were conducted. Those omissions matter for understanding the denominator and the robustness of a percentage estimate, but they do not justify assuming that missing data occurred or that a particular method was used.
10. Multiplicity, Missing Data and Analysis Populations
The registry record lists a primary outcome and several secondary outcomes. The secondary outcomes include instrument-assessed roughness, texture and amplitude of radial cheek lines, wrinkle volume, investigator-assessed improvement, self-perceived age category, and participant-rated naturalness. The record does not report results for these outcomes or describe a statistical analysis plan. It does not state whether a hierarchy among outcomes was used, whether multiplicity was addressed, or whether any confirmatory testing was planned.
General statistical context: when several outcomes are tested, the chance of at least one apparently notable finding can increase, depending on the number and relationship of the tests and the decision rules used. A prespecified testing strategy can help clarify which findings are intended to support primary inference and how other outcomes should be treated. Without reported analyses or a plan, no assessment of multiplicity handling is possible.
The primary endpoint is specified for the Per Protocol Population, defined as participants with no major protocol deviations. The record reports enrollment of 53 but does not state the size of the Per Protocol Population or the number assessed at Day 45. It does not report whether observations were missing, how missing values were handled, or whether sensitivity analyses were conducted. These details are needed to understand the endpoint denominator and how closely the analysis represents enrolled participants. Their absence is not evidence that data were missing; the handling is simply not reported in the registry record.
The record lists zero analyses. Consequently, no conclusion can be drawn about a particular missing-data method, adjustment for multiple outcomes, or sensitivity analysis. These aspects of the statistical plan are not reported in the registry record.
11. Safety Results
The registry reports serious adverse events as affected participants divided by participants at risk.
| Arm | Participants with serious adverse events | Participants at risk | Percentage |
|---|---|---|---|
| Juvéderm® VOLIFT®™ With Lidocaine | 0 | 53 | 0.0% |
Other (non-serious) adverse events
Participants with at least one non-serious event at or above the registry's 5% reporting threshold.
| Arm | Participants affected of at risk |
|---|---|
| Juvéderm® VOLIFT®™ With Lidocaine | 31 of 53 |
Most frequent non-serious adverse event terms
| Event term | Organ system | Juvéderm® VOLIFT®™ With Lidocaine |
|---|---|---|
| Injection site haematoma | General disorders | 16 of 53 |
| Injection site bruising | General disorders | 13 of 53 |
| Injection site mass | General disorders | 12 of 53 |
The registry record reports 53 participants at risk for serious adverse events and zero participants affected by serious adverse events in the Juvéderm® VOLIFT®™ with Lidocaine group. It also reports 53 participants at risk for other adverse events and 31 affected by other adverse events. Deaths are not reported in the registry record. No serious adverse event terms are listed.
These figures describe the recorded safety counts for this group. They do not provide event-level detail for the other adverse events, their severity, timing, duration, or relationship to the intervention. The record does not give a comparison group, so these counts cannot be interpreted as comparative safety estimates. The at-risk count is the registry’s reported group count; it should not be assumed to equal the primary endpoint analysis population, which is defined as Per Protocol and whose size is not reported.
General statistical context: observing zero recorded serious adverse events in a study does not establish that the underlying risk is zero. The amount of information available and the way adverse events were collected affect what can be inferred. These registry figures are a description of the reported observations, not a guarantee about safety for other participants or settings.
12. What the Result Does, and Does Not, Mean
The registry record describes a study designed to assess participant-rated improvement in dynamic radial cheek line skin depressions after treatment with Juvéderm® VOLIFT®™ with Lidocaine. It specifies a Day 1 baseline, a Day 45 primary assessment, and a rule for grouping GAIS ratings into Improved and Not Improved. It also reports enrollment of 53 and a single-group, open-label design.
The record does not report the primary endpoint percentages, response counts, confidence intervals, or p-values. It also does not report results for the listed secondary outcomes. Consequently, the posted information cannot establish what participants reported, how large or precise any observed change was, or whether any outcome differed from a comparison condition. The absence of a reported result should not be mistaken for a result showing no change.
The design further limits what could be concluded even if descriptive outcome values were available. With no comparator group, observed ratings in this group would not directly indicate how outcomes compare with another treatment or no intervention. Open-label status is also relevant to a participant-reported endpoint. These points concern interpretation of the design; they do not determine the actual responses.
The safety record lists zero participants affected by serious adverse events among 53 at risk, and 31 affected by other adverse events among 53 at risk. Deaths are not reported in the registry record. Those counts describe this group in the registry and do not provide comparative estimates or detailed event information. Taken together, the record makes the study question and safety counts visible, but it does not provide the effectiveness results needed to characterize the primary endpoint.
13. Why This Trial Matters Statistically
This trial is statistically informative as an example of the distinction between a well-defined outcome and a reported result. The registry record specifies how participant ratings on the GAIS were combined into Improved and Not Improved, identifies the assessment period, and names the Per Protocol Population. Yet it does not report the response counts or percentages. A clear endpoint definition is necessary for interpreting a result, but it cannot substitute for the result itself.
The study also illustrates why design features belong alongside outcome estimates. It is a single-group, open-label study with no separate comparator. That design can describe outcomes among participants who received the intervention, but it does not provide a randomized comparison. For a subjective rating, the absence of masking is also relevant context. These features define limits on interpretation rather than proving that any particular outcome is biased.
The record lists multiple secondary outcomes, but their results and the analysis plan are not reported. This highlights the value of transparent reporting about outcome hierarchies, multiplicity, analysis populations, and missing observations. Without those details, readers cannot determine how analyses were conducted or assess the uncertainty of the primary estimate.
Finally, the posted safety counts show why counts should be read in context: the record distinguishes participants at risk from those affected, reports zero serious adverse events, and lists 31 participants affected by other adverse events. Those observations do not replace detailed event descriptions or a comparator. The statistical lesson is to separate the question a trial asks, the design used to address it, and the numerical evidence actually reported.
14. Limitations
- The posted summary statistics are the only data these results rest on; patient-level data, full protocols and statistical analysis plans are not available.
- Recalculated results are simple, unadjusted calculations from posted summaries. They do not replace the sponsor's prespecified analysis.
The most immediate limitation for interpretation is that the registry record does not report numerical results for the primary endpoint. It gives no Improved or Not Improved counts or percentages and no confidence interval or p-value. Results for the listed secondary outcomes are also not reported. Therefore, the magnitude and precision of the observed response cannot be described from the registry record.
The study is single-group, open-label, and has no separate comparator. The record therefore does not support a direct comparison with another treatment or control condition. The participant-rated endpoint is subjective in nature, and masking is listed as none. These features are important context, but do not establish that responses were inaccurate or biased.
The record reports enrollment of 53, while the primary outcome is defined for the Per Protocol Population. It does not report the size of that population, the number with Day 45 ratings, or how missing observations were handled. The relationship between enrollment and the endpoint denominator cannot be determined. The registry record also does not report a statistical analysis plan, sample-size justification, interim analyses, or methods for handling multiple outcomes.
Safety reporting is limited to group counts: 53 at risk and zero affected by serious adverse events, and 53 at risk and 31 affected by other adverse events. The record does not list serious event terms, detailed descriptions of other events, or deaths. These omissions restrict interpretation of the safety profile and do not allow a comparison across groups. All of these limitations describe what is not reported in the registry record; they should not be treated as evidence that an analysis, event, or participant observation did or did not occur.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: A Study to Evaluate the Effectiveness of Juvéderm® VOLIFT®™ With Lidocaine for Dynamic Radial Cheek Line Skin Depressions — NCT02980783.
- Registry record last updated 2019-02-15; status last verified 2018-09.
- Results first posted 2019-02-15.
- 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.
Continue through the Clinical Biostats statistical pathway
Use this trial's endpoint as a starting point for deeper study of effect measures, confidence intervals, and sample-size planning.
18. Record Summary
The registry record describes NCT02980783, titled BEAM, as a completed, prospective, open-label, Phase 4, single-group study sponsored by Allergan. It reports enrollment of 53 and lists the condition as cheek line depressions. Juvéderm® VOLIFT®™ with Lidocaine was injected on Day 1, with volume determined by the investigator and an optional touch-up on Day 14.
The primary outcome is the percentage of participants rated Improved or Not Improved by the participant on the GAIS from baseline on Day 1 to Day 45. The outcome is specified for the Per Protocol Population. Its counts and percentages are not reported in the registry record. The record lists secondary outcome measures but does not report their results or the statistical analyses.
For safety, the record reports zero participants affected by serious adverse events among 53 at risk and 31 affected by other adverse events among 53 at risk. Deaths are not reported in the registry record. The single-group, unmasked design does not provide a like-for-like control comparison.