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 Post-Market Study of JUVÉDERM VOLIFT™ With Lidocaine for the Correction of Nasolabial Folds (NCT01680497), a na na study. The primary outcome is Investigator Assessment of Nasolabial Fold Severity Using the 5-point Nasolabial Fold Severity Scale (NLFSS).
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT01680497 |
| Phase | NA |
| Condition | Moderate to Severe Nasolabial Folds |
| Allocation | Not applicable (single group) |
| Design model | Single Group |
| Masking | None (open label) |
| Enrollment | 70 |
| Arms in the primary outcome | n/a |
| Lead sponsor | Allergan |
| Results posted | Yes |
2. Clinical Question
Population
People with moderate to severe nasolabial folds were enrolled. The primary outcome was defined for an efficacy population: subjects who completed their first treatment session as planned, had no major protocol violations that could affect outcome measures, and had data at the relevant time point. The size of this efficacy population is not reported in the registry record.
Intervention
The study evaluated JUVÉDERM VOLIFT™, described as a crosslinked hyaluronic acid dermal filler. The record characterizes the study as prospective, open-label, multi-center, observational, and post-market.
Comparator
The study used a single-group model. A concurrent control group or randomized comparison is not reported in the registry record. Consequently, the study does not set up a like-for-like comparison between treatment and an untreated or alternative-treatment group.
Primary question
The registered primary outcome is the investigator assessment of nasolabial fold severity on the 5-point Nasolabial Fold Severity Scale (NLFSS) at Month 12, with scores recorded for the right and left sides. The record does not report the Month 12 mean, standard deviation, or an analysis of change. It therefore specifies what was to be assessed, but does not establish the observed severity scores or their precision.
The question is descriptive: what investigator-assessed fold-severity scores were recorded among the defined efficacy population after treatment? Because the design has one group and no reported comparator, it cannot by itself separate changes associated with treatment from changes that might occur over time for other reasons. It also does not directly answer how scores compare with another intervention or with no treatment. The record lists subject and investigator satisfaction, ease of injection, and subject-reported severity and local symptoms among secondary outcomes, but it does not give their results.
3. Trial Design
The registry describes a prospective, open-label, multi-center, observational, post-market study of JUVÉDERM VOLIFT™ for moderate to severe nasolabial folds. The study status is completed, and enrollment is listed as 70. The recorded intervention is a crosslinked hyaluronic acid dermal filler. The registered arm description identifies subjects receiving JUVÉDERM VOLIFT™; the design is classified as single-group, with allocation listed as NA and masking listed as none.
These features matter for interpretation. A prospective study records assessments according to a forward-looking study process, but the word prospective does not itself establish randomization or a controlled comparison. Open-label means that masking is not part of the registered design. A single-group study can describe outcomes among treated participants, but, without a concurrent comparator, cannot estimate a treatment-versus-control difference from its design. The registry does not report a randomized allocation procedure, and the record identifies the study as not being a randomized comparison.
The listed primary outcome is assessed at Month 12. It is the investigator’s mean severity score on the 5-point NLFSS for the right and left sides, with standard deviation as the stated dispersion measure. The record defines an efficacy population using completion of the first treatment session as planned, absence of major protocol violations that could affect outcome measures, and availability of data at the time point. The number of participants meeting that definition is not reported in the registry record.
The record lists 7 outcome measures and 0 analyses. It does not report the analysis methods used for the primary outcome, a protocol-specific sample-size justification, or the details of follow-up and assessment procedures beyond the registered time point and scale description. Start is listed as 2012-06-01, and primary completion as 2014-03-06. These dates and the completed status describe the registry record; they do not substitute for outcome estimates.
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™ |
|---|---|
| STARTED | 70 |
| COMPLETED | 68 |
| NOT COMPLETED | 2 |
Reasons for not completing this period:
| Reason | JUVÉDERM VOLIFT™ |
|---|---|
| Lost to Follow-up | 2 |
Analysis population for the primary outcome, as defined in the registry: Efficacy Population: all subjects who completed their first treatment session as planned, had no major protocol violations that would potentially affect outcome measures, and had data at the time point
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.
| Characteristic | Unit | JUVÉDERM VOLIFT™ |
|---|---|---|
| Participants analysed | 70 | |
| Age, Continuous | Years | 49.3 (SD 9.5) |
| Sex: Female, Male: Female | Participants | 66 |
| Sex: Female, Male: Male | Participants | 4 |
6. Primary Endpoint
The registry lists the primary outcome as Investigator Assessment of Nasolabial Fold Severity Using the 5-point Nasolabial Fold Severity Scale (NLFSS), measured over Month 12.
| Element | Registry entry |
|---|---|
| Result type | Mean |
| Measure of spread | Standard Deviation |
| Unit | Scores on a Scale |
| Endpoint classification | Continuous Endpoint |
The primary endpoint is investigator-assessed nasolabial fold severity at Month 12, measured using the 5-point Nasolabial Fold Severity Scale. The scale runs from 1 (none) to 5 (extreme), with mild, moderate, and severe as the intervening categories. The registry specifies assessment of both the right and left sides and identifies the mean as the summary measure, with standard deviation describing variability.
A severity scale gives a structured way to record an observer’s assessment rather than relying only on an unstructured impression. The ordered categories convey increasing severity, and consistent category definitions can support comparison of assessments made under a common study procedure. Reporting a mean describes the average coded score in the analyzed group; the standard deviation describes how dispersed those scores are around the average. These summaries do not show the full distribution of ratings, and a mean on an ordered-category scale does not reveal how many people received each category.
The endpoint is relevant to the study’s stated purpose because it directly records the severity of the nasolabial folds under evaluation. However, the registry record does not report the Month 12 mean or standard deviation, nor does it report side-specific results, baseline scores, or a change-from-baseline estimate. The registered endpoint therefore identifies the assessment and its timing, but the posted record does not establish the observed level of severity or the amount of change. The number of participants with an evaluable Month 12 assessment is also not reported in the registry record.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry record identifies a completed single-group study with enrollment of 70 and a primary assessment scheduled at Month 12. It defines that assessment as the investigator’s mean NLFSS severity score, with a standard deviation, for the right and left sides. However, it does not report the primary outcome values. No mean, standard deviation, change estimate, confidence interval, or primary-outcome test is reported in the registry record. The observed severity and the precision of any estimate therefore cannot be interpreted from the posted results.
The distinction between a registered endpoint and a reported result is important. An endpoint definition tells readers what was intended to be measured, on what scale, at what time, and in which analysis population. It does not show the values actually observed. Without a reported estimate and an account of how many participants contributed data, readers cannot judge the distribution of scores, the variability, or the uncertainty around an average.
The single-group design also limits what any within-group outcome could establish. In general, a score recorded after treatment can describe participants’ outcomes, but a one-group observation does not provide a concurrent estimate of what would have happened without the intervention or under another treatment. It is therefore not possible to attribute a difference over time to the intervention using a treatment-versus-control contrast from this design. The registry’s classification of allocation as NA and its single-group model align with that limitation.
The record lists several secondary measures, including investigator and subject assessments of severity, satisfaction, and ease of injection, as well as subject assessments of pain, swelling, and bruising intensity. It does not report their numerical results or analyses. These listed outcomes indicate additional areas of assessment, but their presence in the registry is not evidence about the direction, size, or precision of any observed outcome.
For safety, the registry lists 70 participants at risk for serious adverse events and 0 affected; it also lists 70 at risk for other adverse events and 0 affected. Deaths are recorded as null rather than as a numerical count. These entries describe what the registry lists for the stated groups, not a complete account of every possible safety event or an estimate of risk relative to a comparator. The absence of reported outcome analyses means that the primary efficacy findings and their statistical uncertainty remain unavailable in this record.
9. Statistical Methods Explained
The registered primary measure is continuous in the registry’s statistical classification and is summarized by a mean with standard deviation. A mean is the arithmetic average of the recorded scores in the analysis set. A standard deviation describes how much individual scores vary around that mean. Neither statistic is reported for the primary endpoint in the registry record, so there is no posted numerical estimate to interpret.
What does the mean represent?
Each NLFSS assessment uses ordered categories from 1 (none) to 5 (extreme). Calculating a mean treats the numerical codes as values that can be averaged. This provides a compact group summary, but it does not show the number of participants in each category. In general, readers should remember that the underlying response options are ordered descriptions; the mean can conceal differences in the shape of the score distribution. The registry also specifies right- and left-side assessments, but does not report how those side-specific measurements were combined or analyzed.
What does the standard deviation add?
In general, a standard deviation is a measure of dispersion among individual observations, not a measure of uncertainty in the group mean. A larger standard deviation indicates more spread in participant scores; a smaller one indicates scores closer to the mean. To understand uncertainty in an estimated mean, researchers commonly use a confidence interval or another inferential summary. A confidence interval expresses a range of values compatible with the data under the analysis assumptions. No confidence interval for the primary endpoint is reported in the registry record.
What can a single-group design estimate?
A one-group design can describe outcomes among participants who received the intervention. It does not create a concurrent control estimate. In general, a comparison of a group’s later score with its earlier score can be affected by factors other than treatment, including time-related changes and the way participants enter or remain in the analysis. A controlled comparison can help address some of these questions, but a randomized comparison is not reported for this study. No treatment-versus-control effect estimate can be derived from the registered single-group design.
Why does the analysis population matter?
The primary outcome population is defined by completion of the first treatment session as planned, absence of major protocol violations that could affect outcome measures, and data availability at the time point. This definition makes the analysis dependent on who both meets the stated criteria and has an evaluable assessment. In general, excluding people without outcome data can affect the composition of the analyzed group if the reasons for missingness relate to their outcomes. The number included in this efficacy population, the reasons for missing assessments, and the methods used to address missing data are not reported in the registry record.
What does multiplicity mean for several outcomes?
Multiplicity arises when several outcomes or statistical tests are considered. In general, conducting multiple tests can increase the chance of at least one apparently notable result if each is interpreted without regard to the set of analyses. Researchers may prespecify a primary outcome, a hierarchy, or an adjustment strategy to address this issue. The registry lists 7 outcome measures and 0 analyses, but a multiplicity strategy and a detailed statistical analysis plan are not reported in the registry record. It is not possible to determine how the listed outcomes were prioritized or how any testing was handled.
How should planning illustrations be read?
The study’s sample-size assumptions describe a planning illustration based on an observed effect, not the trial’s own design. They specify a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation; the effect to detect is described as a stated fraction of the observed effect. These are assumptions for an illustration, not evidence that this single-group study enrolled two randomized arms or used those assumptions in its own design. Any resulting sample sizes are planning illustrations, not observed power. The illustration cannot replace the registry’s missing outcome estimates, and no protocol-specific sample-size justification is reported in the registry record.
10. Multiplicity, Missing Data and Analysis Populations
The registry lists 7 outcome measures, including the primary investigator assessment and secondary assessments by investigators and subjects. It lists 0 analyses. That combination means the record identifies several outcomes but does not provide posted analysis results for them. A statistical analysis plan, multiplicity adjustment, outcome hierarchy, and rules for interpreting multiple comparisons are not reported in the registry record. Without those details, readers cannot tell whether or how the several outcomes were intended to be considered together.
The primary outcome population is defined as subjects who completed their first treatment session as planned, had no major protocol violations that would potentially affect outcome measures, and had data at the time point. This definition describes eligibility for the efficacy analysis, but the record does not state how many participants satisfied it. It also does not report the number assessed at Month 12, the number missing, reasons for missing data, or whether missing values were imputed or otherwise handled.
In general, missing outcome data can reduce precision and can also affect interpretation if participants with missing assessments differ from those with observed assessments. A reported analysis would ideally make clear who contributed to each outcome and how missingness was addressed. That information is not reported in the registry record. The record’s enrollment figure does not establish the number included in the primary analysis, because the efficacy population has additional criteria and requires data at the relevant time point.
Because no primary or secondary analysis is posted, there are no reported estimates to compare across outcomes or to evaluate for consistency. The absence of analyses in the record should not be taken as evidence that no analysis was conducted; what was conducted is 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™ | 0 | 70 | 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™ | 0 of 70 |
The registry lists one group, JUVÉDERM VOLIFT™, with 70 participants at risk for serious adverse events and 0 affected. For other adverse events, it likewise lists 70 at risk and 0 affected. These are registry counts for the listed group. They are not a comparison with another group, and the record does not provide event-level descriptions in the serious-event terms list.
Deaths are recorded as null. A null entry is not a numerical count and should not be read as a reported zero. The record therefore does not report a numerical death count. It also does not provide additional detail about event definitions, duration of safety follow-up, completeness of event reporting, or how the at-risk counts relate to the efficacy population.
In general, a zero count in a registry field means that no affected participants are listed for that category in the posted entry. It does not establish that the event is impossible, provide a comparative safety estimate, or characterize events outside the recorded scope. Since the study is single-group and the record supplies no comparator, the listed counts cannot quantify relative safety. They should be interpreted as descriptive registry entries rather than as a complete assessment of safety.
12. What the Result Does, and Does Not, Mean
The record establishes that a prospective, open-label, multi-center, observational, post-market study of JUVÉDERM VOLIFT™ was completed, with enrollment listed as 70. It specifies a Month 12 investigator assessment of nasolabial fold severity using the 5-point NLFSS and defines an efficacy population. It also lists subject and investigator secondary assessments. These details describe the study’s measurement framework and the questions it registered.
The record does not report the primary endpoint values, secondary outcome results, or analyses. Consequently, it does not show the observed average severity score, the variability of participants’ scores, the change over time, or the precision of an estimate. It also does not establish how many enrolled participants contributed data to the primary analysis. A registered scale and time point are not a substitute for the outcome data themselves.
The single-group design is relevant to the scope of any conclusion. In general, outcomes observed in one treated group can describe that group, but cannot provide a direct estimate of the difference between treatment and a concurrent control. The record does not report a randomized comparison. Even if outcome values were available, the design would not by itself show what would have happened to a comparable group without treatment or under another intervention.
The safety entries list zero affected participants for serious adverse events and other adverse events among the stated at-risk group. The deaths entry is null, not a numerical count. These registry fields do not provide a comparative safety analysis or a full account of event definitions and follow-up.
Accordingly, the registry supports conclusions about the study’s design, registered endpoint, enrollment, and selected safety counts. It does not support conclusions about the magnitude or precision of the primary outcome, comparisons with another treatment, or causal effects. The missing analyses and results leave those questions unresolved in the registry record.
13. Why This Trial Matters Statistically
This study illustrates why statistical interpretation starts with the design and the availability of results, not just the name of an endpoint. The registry defines a clinically focused severity measure, identifies its scale and Month 12 timing, and specifies a population for the efficacy assessment. Those details help readers understand what the study intended to describe. But without the mean, standard deviation, or another result, there is no empirical estimate to evaluate.
The single-group structure is also a useful reminder that descriptive assessment and comparative evidence answer different questions. A group’s outcomes can be characterized without a control group, but a treatment effect usually requires a contrast that distinguishes the intervention from other explanations. The registry’s single-group classification and absence of a reported randomized comparison limit the causal claims that could follow from this study design.
Reporting the analysis population and missing-data approach matters because the number enrolled is not necessarily the number included in an endpoint analysis. Here, the efficacy definition requires both specified study completion and data at the relevant time point, while the size of that population and the handling of missing data are not reported. Those omissions constrain judgments about representativeness and precision.
The record also lists several secondary outcomes but no analyses. This highlights the value of clearly reported statistical plans and results when multiple measures are registered. Readers need to know which outcomes were analyzed, how they were summarized, and how inference across outcomes was approached. A planning illustration cannot fill that gap: it is distinct from the trial’s design and does not supply observed evidence. The statistical importance of this record lies as much in clarifying what cannot be concluded as in describing what was registered.
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 central limitation for interpretation is that the registry record does not report numerical results for the primary endpoint. It gives the endpoint definition and time point, but not the mean or standard deviation. There is consequently no reported estimate, confidence interval, or analysis result on which to assess the observed severity scores or their precision.
The design is single-group, open-label, and has no randomized comparison reported. This precludes a direct treatment-versus-control estimate from the registered design and limits causal interpretation of any group outcome. The record also does not report baseline primary scores or a change-from-baseline estimate, so the amount of change cannot be assessed from the posted entry.
The stated efficacy population requires completion of the first treatment session as planned, no major protocol violations that could affect outcomes, and available data at the time point. Its size is not reported. The number with Month 12 data, reasons for missing assessments, and missing-data methods are also not reported in the registry record. The enrollment count should not be treated as the primary analysis count.
Although the record lists secondary measures and 7 outcome measures overall, it lists 0 analyses. The analysis plan, multiplicity approach, and detailed methods for combining or interpreting the right- and left-side scores are not reported in the registry record. These gaps prevent assessment of whether outcome reporting followed prespecified analysis choices.
For safety, the record gives at-risk and affected counts but does not report a numerical death count; that entry is null. It also does not provide additional detail about safety follow-up or event ascertainment. The listed counts therefore have a limited descriptive scope and cannot support comparisons with other treatments.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Post-Market Study of JUVÉDERM VOLIFT™ With Lidocaine for the Correction of Nasolabial Folds — NCT01680497.
- Registry record last updated 2019-04-16; status last verified 2019-04.
- Results first posted 2015-06-23.
- 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.
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18. Record Summary
The registry record describes a completed, prospective, open-label, multi-center, observational, post-market, single-group study of JUVÉDERM VOLIFT™ for moderate to severe nasolabial folds. Enrollment is listed as 70. The primary outcome is investigator-assessed NLFSS severity at Month 12, summarized as a mean and standard deviation for right and left sides. The defined efficacy population requires planned completion of the first treatment session, no major protocol violations potentially affecting outcomes, and available data at the time point.
The record lists 7 outcome measures and 0 analyses. It does not report primary or secondary numerical results, the size of the primary efficacy population, a detailed analysis plan, or missing-data methods. For the listed group, serious adverse events and other adverse events each show 70 at risk and 0 affected; deaths are null. The study has no reported randomized comparator, so the record does not provide a treatment-versus-control estimate.