Emervel Classic Lidocaine Versus Juvederm® Ultra in Treatment of Moderate to Severe Facial Wrinkles and Folds: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Emervel Classic Lidocaine Versus Juvederm® Ultra in Treatment of Moderate to Severe Facial Wrinkles and Folds (NCT01205048), a randomized na study. The primary outcome is Mean Change From Baseline in Wrinkle Severity Rating Scale (WSRS) at Week 24 After Final Initial Injection.

2. Clinical Question

3. Trial Design

The registry identifies NCT01205048 as a completed, randomized, evaluator-blinded, active-controlled, multi-center, split-face comparison study. Its title and official title identify Emervel Classic Lidocaine and Juvederm Ultra as the treatments under comparison for moderate to severe facial wrinkle folds. The registry lists the study phase as NA and the allocation as randomized. It also records single masking and a parallel model, while the official title describes the study as split-face. The record does not explain that difference in terminology.

The study began in 2010-09, and primary completion is recorded as 2011-06-27. Enrollment was 171. The primary outcome population was defined as participants who were randomized and received an injection on both treatment sides. For the primary endpoint, the posted summaries include 170 participants on each side. Those counts describe the endpoint summaries, not necessarily every analysis or every follow-up time point.

Emervel Classic Lidocaine was injected into nasolabial folds at 20 mg/mL with 0.3% lidocaine; Juvederm Ultra was injected at 24 mg/mL. The registered primary outcome was mean change in Wrinkle Severity Rating Scale score at Week 24 after the final initial injection. Secondary outcomes include wrinkle-severity changes at other follow-up times, participant self-assessment, pain assessments, and adverse events.

The registry record does not report the number of study centers, the randomization sequence or its implementation, the details of evaluator masking, or a full protocol. It also does not report the original sample-size justification or the trial’s own detailed statistical analysis plan. Those omissions limit what can be concluded about design choices beyond the descriptions recorded in the registry.

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.

Before assignment: A total of 171 participants were enrolled, of which 170 participants received treatment in this study.

Overall Study

Reasons for not completing this period:

Analysis population for the primary outcome, as defined in the registry: Intent to Treat (ITT) population included participants who were randomized and received an injection on both treatment sides.

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: The Intent to treat (ITT) population was defined as all participants who were randomized and received an injection on both treatment sides.

6. Primary Endpoint

The registry lists the primary outcome as Mean Change From Baseline in Wrinkle Severity Rating Scale (WSRS) at Week 24 After Final Initial Injection, measured over Baseline, Week 24 after final initial injection.

The primary endpoint is mean change from baseline in the Wrinkle Severity Rating Scale score at Week 24 after the final initial injection. The scale is a validated, five-point reference scale using photographs to classify nasolabial-fold severity. Its grades range from absent to extreme folds and distinguish progressively more prominent wrinkles. A negative change from baseline indicates improvement in the measured severity.

Using a defined scale gives the comparison a common outcome measure for both sides of the face. The mean summarizes the average change across the participants included in each treatment-side summary. The standard deviation describes how much individual changes vary around that average; it is not the uncertainty of the mean itself. Comparing changes from baseline focuses the endpoint on change during follow-up rather than only on the score at the endpoint.

The posted mean change was -1.1 for Emervel Classic Lidocaine and -1.2 for Juvederm Ultra. The registry reports 170 participants in each summary. These averages describe the endpoint population and do not indicate that every participant had the same change. Nor does a group mean by itself describe the distribution of individual responses. The registry record does not report a threshold for interpreting the size of a between-treatment difference as clinically important.

7. Results Posted in the Registry

• Juvederm Ultra: mean -1.20 versus -1.10 on control; difference -0.10 (95% CI -0.26 to 0.06), standardized effect d = -0.13; z-test p = 0.222.

8. Secondary Efficacy Endpoints

The registry also posts results for secondary outcomes. For each outcome below, the endpoint type, the test applied to the posted summary statistics, the result and its interpretation are given in turn. Secondary endpoints are usually not adjusted for multiple testing, so they support rather than confirm the primary finding.

Mean Change From Baseline in Wrinkle Severity Rating Scale (WSRS) at Week 3 After the Final Initial Injection

• Endpoint type: Continuous: a mean value per participant, compared as a difference in means.
• Test: Unadjusted two-sample z-test for the difference in means, using the posted standard deviations.
• Result:
  • Juvederm Ultra: mean -1.80 versus -1.70 on control; difference -0.10 (95% CI -0.25 to 0.05), standardized effect d = -0.14; z-test p = 0.194.
• Interpretation:
  • The 95% confidence interval includes no difference, so these data do not show a statistically significant difference between Juvederm Ultra and the control. The interval gives the range of effects that remain compatible with the data.

Mean Change From Baseline in Wrinkle Severity Rating Scale (WSRS) at Week 12 After Final Initial Injection

• Endpoint type: Continuous: a mean value per participant, compared as a difference in means.
• Test: Unadjusted two-sample z-test for the difference in means, using the posted standard deviations.
• Result:
  • Juvederm Ultra: mean -1.50 versus -1.50 on control; difference 0.00 (95% CI -0.16 to 0.16), standardized effect d = 0.00; z-test p = 1.000.
• Interpretation:
  • The 95% confidence interval includes no difference, so these data do not show a statistically significant difference between Juvederm Ultra and the control. The interval gives the range of effects that remain compatible with the data.

Mean Change From Baseline in Wrinkle Severity Scale (WSRS) at Week 36 After Final Initial Injection

• Endpoint type: Continuous: a mean value per participant, compared as a difference in means.
• Test: Unadjusted two-sample z-test for the difference in means, using the posted standard deviations.
• Result:
  • Juvederm Ultra: mean -1.10 versus -1.00 on control; difference -0.10 (95% CI -0.26 to 0.06), standardized effect d = -0.13; z-test p = 0.216.
• Interpretation:
  • The 95% confidence interval includes no difference, so these data do not show a statistically significant difference between Juvederm Ultra and the control. The interval gives the range of effects that remain compatible with the data.

The secondary wrinkle-severity outcomes follow a broadly similar descriptive pattern to the primary result: the posted mean changes are negative, and the recalculated treatment contrasts are small where comparisons are available. At Week 12 the posted means are the same for both treatments. At the other posted wrinkle-severity follow-up times, the mean changes are close, and the recalculated contrasts are small. These descriptive findings are consistent with the primary summaries in the limited sense that they do not show a large separation between the posted group means.

The secondary outcomes add context across follow-up times, but they do not replace the primary endpoint or resolve its uncertainty. The primary question is the comparison at Week 24. Results at other visits concern different time points, and a pattern across visits should not be treated as a separate confirmation unless the analysis plan accounts for the multiple opportunities to examine results. The registry record does not report a sponsor analysis for these secondary comparisons.

Several registered secondary outcomes address participant self-assessment, pain after injections, and adverse events, as well as wrinkle-severity changes. The registry lists nine outcome measures overall and reports eight secondary outcomes as posted. However, the outcome details in the record are not equally complete: the posted numerical results include wrinkle-severity changes at Week 3, Week 12, and Week 36, while the remaining registered outcomes do not have numerical results in the information recorded. Their results are therefore not reported in the registry record.

Unadjusted secondary results carry less weight because multiple outcomes and follow-up times create multiple opportunities for apparently notable findings. Without a reported multiplicity strategy, it is difficult to distinguish a confirmatory result from a chance pattern across many comparisons. The registry also reports no analyses for the secondary outcomes. Taken together, the secondary summaries are best treated as descriptive context for the primary result, not as independent proof of a treatment difference or of equivalence.

Secondary outcomes registered for this trial, for reference (only those above were recalculated):

• Mean Change From Baseline in Wrinkle Severity Rating Scale (WSRS) at Week 3 After the Final Initial Injection
• Mean Change From Baseline in Wrinkle Severity Rating Scale (WSRS) at Week 12 After Final Initial Injection
• Mean Change From Baseline in Wrinkle Severity Scale (WSRS) at Week 36 After Final Initial Injection
• Mean Change From Baseline in Wrinkle Severity Rating Scale (WSRS) at Week 48 After Final Initial Injection
• Mean Change From Baseline in Participant Self-Assessment of Wrinkle Severity at Week 24 After Final Initial Injection
• Participant Pain Assessment After the Initial Injection
• Participant Pain Assessment After the Initial Touch-up Injection
• Number of Participants With Adverse Events (AEs)

9. Statistical Interpretation

10. Statistical Methods Explained

The primary endpoint is continuous: each participant’s outcome is a change in a numerical wrinkle-severity score. The registry reports group means and standard deviations for that change. A mean is the average across observations in a group. A standard deviation describes the spread of those observations around the mean. The standard deviation is about variability among participant outcomes; it is not a confidence interval and is not a direct measure of how precisely the mean difference is estimated.

What does the treatment contrast represent?

The contrast is the mean change for Juvederm Ultra minus the mean change for Emervel Classic Lidocaine. The posted means are -1.2 and -1.1, respectively, and the unadjusted recalculated contrast is -0.1. A negative contrast means that the average change is numerically more negative for Juvederm Ultra. Since the endpoint description says a negative change indicates improvement, the direction can be described in that way without implying that the difference is important or that one treatment is superior.

The registry presents a split-face design. In such a design, both treatments are used in the same participant, so the two sides’ outcomes may be correlated. When paired participant-level data are available, an analysis can account for that within-person relationship. The posted summaries do not include the side-to-side covariance needed to reconstruct a paired standard error. The recalculated contrast is a simple unadjusted calculation from summary statistics; it does not use individual paired observations. The registry record does not report a sponsor analysis for the primary endpoint, so the handling of paired data in a trial analysis is not reported in the registry record.

How should the p-value be read?

The unadjusted p-value for the primary recalculated contrast is 0.222. In general, a p-value describes how compatible the observed data are with a specified null model, under the assumptions of the analysis. It is not the probability that the null hypothesis is true, and it does not measure the size or clinical importance of a difference. The value is unadjusted, and the registry record does not report a trial-level multiplicity plan or the sponsor’s primary analysis. The planning illustration names a two-sided significance level of 0.05, but that planning assumption does not establish the complete hypothesis-testing procedure used by the trial.

A p-value should be read alongside the estimate and its uncertainty interval. An estimate close to zero can still be imprecise, and a p-value alone cannot show the range of effects compatible with the data. Here the interval spans values on both sides of zero. That is why the estimate, interval, design, and analysis details all matter to interpretation.

What does the confidence interval add?

A confidence interval is a general statistical way to express uncertainty around an estimated quantity. It gives a range of values that are compatible with the data under the interval’s method and assumptions. It is not a range containing a fixed proportion of individual participant outcomes. The primary recalculated interval runs from -0.261 to 0.060. The confidence level and the precise interval method are not reported in the registry record, so they should not be inferred from the posted endpoints alone.

For a difference in means, an interval that includes zero indicates that the data do not clearly distinguish a negative contrast from a positive one under that interval method. It does not prove that the true difference is exactly zero. Nor does an interval spanning zero establish equivalence: that requires a margin defining which differences would count as sufficiently similar, together with an appropriate design and analysis.

Why do planning illustrations depend on the effect?

The sample-size planning illustration starts from the observed effect and considers planning for 100% of that effect, 75% of the observed effect, and 50% of the observed effect. It assumes a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation. The displayed values are participants per arm for 80% power and for 90% power. For continuous outcomes, power is the probability of detecting an effect of the specified size under the assumptions of a planning model, if that effect is the true one.

Smaller effects are harder to distinguish from random variation, so the illustration requires more participants per arm when the effect used for planning is smaller. These calculations are planning illustrations based on the observed effect, not a reconstruction of the trial’s original design. The original sample-size justification is not reported in the registry record. The illustration is not observed power: it does not measure the probability that the completed trial correctly detected an effect after observing its results.

Several important analytical details are not available. The registry record does not report the primary analysis model, any adjustment for baseline score or other covariates, the approach to missing endpoint data, or whether a paired analysis was used. It also does not report a multiplicity method for the outcomes. Those omissions mean the recalculations should be distinguished from a full protocol-based analysis.

11. Confidence Intervals and Precision

The primary recalculated mean difference is -0.1 for Juvederm Ultra relative to Emervel Classic Lidocaine. Its interval extends from -0.261 to 0.060. The interval includes zero and covers both a negative and a positive contrast, so the estimate does not pin down the direction of a small between-treatment difference with high precision. The unadjusted p-value is 0.222, which is consistent with the interval’s inclusion of zero under the recalculation.

Precision refers to how narrowly an estimate is determined by the data and the analysis. It is different from the amount of variability among participants. The reported standard deviations are 0.75 for Emervel Classic Lidocaine and 0.76 for Juvederm Ultra; these describe spread in individual changes. The interval around the difference instead concerns uncertainty in the estimated contrast. Neither statistic tells whether a difference matters to participants, and the registry record does not report a threshold for clinical importance.

The interval should be interpreted with the design and analysis limitations in mind. The study is described as split-face, but participant-level paired information is not available in the posted summaries. The recalculated comparison uses arm-level summary statistics rather than a paired estimate based on the within-participant relationship. The confidence level and interval method are also not reported in the registry record. These details affect how precisely the interval can be interpreted as an account of the trial analysis.

The interval does not establish equivalence. To support an equivalence conclusion, an analysis would need a prespecified range of differences considered acceptably similar, and the uncertainty interval would need to be interpreted against that range. No such margin is reported in the registry record. Thus, the most direct reading is that the recalculated estimate is small and its uncertainty includes zero, while the summaries alone do not settle whether the treatments differ by a clinically meaningful amount.

12. Planning a Similar Trial: Sample Size

This is a planning illustration, not a re-evaluation of the original trial. It asks: if a new study wanted to detect a difference like the one observed, or a smaller one, how large would it need to be? It is deliberately not “observed power” of the finished trial, which is not a meaningful quantity.

The planning illustration gives participants per arm, not a total number of events. It uses a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation. Its target effect is expressed as a stated fraction of the observed effect: 100%, 75%, or 50%. These are planning assumptions for an illustration; the trial’s original design assumptions and sample-size justification are not reported in the registry record.

The 80% power column gives the number of participants per arm the planning model estimates would be needed for an 80% chance of detecting the chosen effect, if that effect were the true effect and the assumptions held. The 90% power column gives the corresponding planning number for a 90% chance. Higher planned power generally requires more participants under the same assumptions. When the effect used for planning is smaller, it is harder to distinguish from random variation, so the illustration requires more participants per arm.

For example, the primary-endpoint illustration lists 895 participants per arm for planning for 100% of the observed effect at 80% power, and 3,580 participants per arm for planning for 50% of the observed effect at 80% power. The corresponding 90% power figures are 1,198 and 4,792 participants per arm. These are model-based illustrations, not enrollment targets documented as the trial’s original plan. They should not be read as evidence that the completed study had, or lacked, adequate power.

This is not observed power. It is a planning exercise based on the observed effect and the stated assumptions, rather than a measure of the trial’s success after the results were known. The registry record does not report the original assumptions that informed enrollment.

13. How the Sample Size Is Derived

Power is the probability that a study of a given size rejects the null hypothesis when a specific true effect exists. It depends on four things: the effect to detect, the variability of the outcome, the significance level (here a two-sided α of 0.05, so z_1−α/2 = 1.960) and the desired power (z_1−β = 0.842 for 80% and 1.282 for 90%).

Formula

n is the number of participants in each arm, Δ is the difference in means to detect and σ is the common standard deviation.

Worked calculation for this trial

1. Observed difference Δ = -0.100; pooled standard deviation σ = 0.755.
2. n = 2 × (1.96 + 0.842)² × 0.755² / -0.100² = 894.9, rounded up to 895 participants per arm for 80% power.

The smaller-effect rows in the table above repeat the same calculation with the effect multiplied by 0.75 and 0.5 (for ratios, applied to the logarithm of the ratio).

R code

alpha <- 0.05
z_a   <- qnorm(1 - alpha / 2)          # two-sided
delta <- -0.0999999999999999                      # observed difference in means
sigma <- 0.755016556109864                     # pooled standard deviation
n_per_arm <- function(power, frac = 1) {
  ceiling(round(2 * (z_a + qnorm(power))^2 * sigma^2 / (delta * frac)^2, 6))
}
for (f in c(1, 0.75, 0.5))
  cat(sprintf("%3.0f%% of observed effect: n per arm = %s (80%% power), %s (90%% power)\n", 100 * f,
              format(n_per_arm(0.80, f), big.mark = ","), format(n_per_arm(0.90, f), big.mark = ",")))

# Check against R's built-in function (t-based, so very slightly larger)
cat("power.t.test:", round(power.t.test(delta = delta, sd = sigma, power = 0.80)$n, 1), "\n")

# Simulation: exact two-sample t-test using simulated means and variances
set.seed(1205048)
n    <- n_per_arm(0.80)
reps <- 20000
m_diff <- rnorm(reps, delta, sigma * sqrt(2 / n))             # difference in sample means
s2     <- sigma^2 * rchisq(reps, 2 * (n - 1)) / (2 * (n - 1))   # pooled sample variance
tstat  <- m_diff / sqrt(s2 * 2 / n)
cat(sprintf("Simulated power at n = %s per arm: %.3f (%d replicates)\n", format(n, big.mark = ","), mean(abs(tstat) > qt(0.975, 2 * (n - 1))), reps))

Output from running the code

100% of observed effect: n per arm = 895 (80% power), 1,198 (90% power)
 75% of observed effect: n per arm = 1,591 (80% power), 2,130 (90% power)
 50% of observed effect: n per arm = 3,580 (80% power), 4,792 (90% power)
power.t.test: 895.8 
Simulated power at n = 895 per arm: 0.797 (20000 replicates)

The simulation draws many sets of group means and variances at the planned sample size and counts how often the two-sample t-test rejects the null. It should land close to the target power; at very small required sample sizes it can fall below it, because the normal approximation is rough there.

14. Multiplicity, Missing Data and Analysis Populations

The registry lists one primary endpoint and several secondary outcomes, including wrinkle-severity changes at different follow-up times, participant self-assessment, pain assessments, and adverse events. Examining multiple outcomes or time points raises a multiplicity issue: even when no true differences exist, looking across many comparisons increases the chance that one will appear notable by chance. Statistical plans may address this by defining a hierarchy, adjusting significance thresholds, or treating secondary analyses as exploratory. The registry record does not report a multiplicity strategy or a hierarchy among secondary outcomes.

The record lists no reported analyses for the primary endpoint and no reported analyses for the secondary endpoints. The posted arm summaries allow simple unadjusted recalculations, but these are not a substitute for the trial’s full analysis plan. The registry record does not report whether the sponsor used covariate adjustment, how the split-face structure was handled, or what inferential procedures were prespecified. The planning illustration’s two-sided significance level of 0.05 is a stated planning assumption, not enough information to reconstruct all trial testing decisions.

Missing-data handling is also not reported in the registry record. The primary population is defined as randomized participants who received an injection on both treatment sides, but the record does not explain how participants with missing Week 24 measurements were handled, whether any imputation was used, or how follow-up losses were summarized. The endpoint summaries report 170 participants per treatment side; the registry does not provide enough information to determine whether those counts reflect all randomized participants with follow-up or a particular analysis subset.

The registry defines the primary outcome population but does not give a detailed analysis-population plan for every outcome. It does not report whether the analysis followed an intention-to-treat principle beyond the stated inclusion definition, whether protocol deviations affected inclusion, or whether sensitivity analyses were conducted. Those details matter because analysis populations and missing-data assumptions can influence estimates and uncertainty. In their absence, the posted summary statistics can be described, but the robustness of the treatment comparison to alternative analysis choices cannot be assessed.

15. 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 serious adverse event terms

Most frequent non-serious adverse event terms

Serious events with the highest arm-level rate: cholecystitis (0.6%), worsening right knee osteoarthritis (0.6%).

The registry reports serious adverse-event figures for 170 participants at risk in each treatment group. Serious events were reported for 2 participants in the Emervel Classic Lidocaine group and 2 in the Juvederm Ultra group. The record also reports other adverse events for 10 and 11 participants, respectively. No deaths were reported in either group.

The listed serious-event terms are Cholecystitis and Worsening right knee osteoarthritis, each reported as 0.6%. These are the top serious terms in the registry record; the record does not provide enough information to assign either term to a particular treatment group or to establish causation. Counts of participants with events are not counts of every event occurrence, and the listed figures do not describe event severity beyond the serious classification recorded.

These numbers are descriptive safety summaries. They do not establish that an event was caused by a treatment, and the registry record does not report a formal comparative safety analysis or an interpretation of between-treatment differences. The figures also should not be treated as a complete account of all possible risks beyond the events captured and reported in the study.

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

The primary endpoint summaries show mean score changes of -1.1 for Emervel Classic Lidocaine and -1.2 for Juvederm Ultra at Week 24. The scale description says that a negative change from baseline indicates improvement. The unadjusted recalculated difference is -0.1, with an interval from -0.261 to 0.060 and an unadjusted p-value of 0.222. These figures describe the observed group summaries and the uncertainty around a simple recalculation from them.

They do not establish that the treatments are equivalent. A conclusion of equivalence needs a prespecified acceptable difference and an analysis designed to test that question. Neither an equivalence margin nor an equivalence analysis is reported in the registry record. The interval’s inclusion of zero means the recalculated data do not clearly distinguish the treatments in either direction under the interval method; it does not demonstrate that the true difference is exactly zero.

The figures also do not establish that a small numerical difference is clinically important or unimportant. The registry record does not report a minimal clinically important difference for this scale or explain how participants might value changes of this size. A statistical estimate and its uncertainty answer a different question from whether a difference matters in practice.

The result applies to the registered setting and endpoint: participants who were randomized and received injections on both treatment sides, assessed using the Wrinkle Severity Rating Scale at Week 24 after the final initial injection. It does not determine outcomes outside the recorded follow-up, or establish safety beyond the reported adverse-event summaries. The study is described as split-face, but the posted arm-level summaries do not reveal the within-participant covariance needed to reproduce a paired comparison.

Finally, the registry does not report the sponsor’s primary statistical analysis, missing-data procedures, or multiplicity plan. The recalculated comparison should therefore be viewed as a useful reading of the posted summaries, not as a definitive reconstruction of all trial analyses. Broader conclusions require those design and analysis details, as well as the clinical context for interpreting score changes.

17. Why This Trial Matters Statistically

This trial illustrates why the design and the comparison method both matter. A split-face study places both treatments within the same participant, which can make the comparison less affected by differences between people. But using that advantage analytically requires information about how the two sides’ outcomes relate within each participant. The registry’s arm-level means and standard deviations do not contain that covariance, so a simple recalculation cannot reproduce a paired analysis.

It also demonstrates why an estimate should be read with its uncertainty rather than in isolation. The primary recalculated difference is -0.1, and its interval extends from -0.261 to 0.060. The estimate is close to zero, but the interval shows uncertainty on both sides of zero. That combination is not proof of equivalence, and it does not define whether a difference would matter clinically.

The record also shows a distinction between trial planning and retrospective planning illustrations. The sample-size figures are based on the observed effect and stated assumptions, while the original sample-size justification is not reported. They can illustrate how smaller target effects require more participants per arm, but cannot establish what assumptions informed the trial’s enrollment.

Finally, the registry lists multiple outcomes and follow-up times without reporting a multiplicity plan or sponsor analyses. This makes it important to distinguish the primary endpoint from descriptive secondary patterns and to avoid treating each unadjusted comparison as a separate confirmatory test. Taken together, the study is a useful example of interpreting a small contrast, its uncertainty, and the limits of registry-level summaries.

18. 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 primary comparison available from the registry is an unadjusted recalculation from arm-level summary statistics. The trial is described as split-face, but the posted summaries do not include participant-level paired outcomes or the covariance between treatment sides. A paired analysis could use information that this recalculation cannot. The registry reports no sponsor analysis for the primary endpoint, so the intended analysis and its treatment of the within-participant design are not reported in the registry record.

The record does not report the confidence level or exact method used for the recalculated interval. It also does not report a minimal clinically important difference for the Wrinkle Severity Rating Scale. As a result, the interval can describe statistical uncertainty in the recalculation, but the registry record does not supply a basis for deciding whether a particular difference is clinically meaningful.

Missing-data handling and analysis populations beyond the stated primary population are not reported. The record does not describe follow-up completion, imputation, sensitivity analyses, or the handling of protocol deviations. This limits assessment of possible bias due to missing outcome measurements or choices about which participants were analyzed.

The registry includes multiple secondary outcomes and time points but does not report a multiplicity plan or sponsor analyses. Numerical summaries are not available in the record for every registered secondary outcome. In addition, the record does not provide detailed information on the randomization procedure, evaluator masking implementation, number of centers, or the original sample-size rationale. These omissions limit reconstruction of the full design and statistical analysis, beyond the study features expressly recorded.

19. Related Tutorials

20. Related Statistical Calculators

21. Sources

• ClinicalTrials.gov: Emervel Classic Lidocaine Versus Juvederm® Ultra in Treatment of Moderate to Severe Facial Wrinkles and Folds — NCT01205048.
• Registry record last updated 2023-07-25; status last verified 2023-06.
• Results first posted 2023-07-25.
• 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.

22. Record Summary

NCT01205048 is recorded as a completed randomized, evaluator-blinded, active-controlled, multi-center, split-face study sponsored by Galderma R&D. It compared Emervel Classic Lidocaine with Juvederm Ultra for moderate to severe facial wrinkles and folds, with injections into nasolabial folds. Enrollment was 171; the primary endpoint summaries include 170 participants per treatment side.

The primary outcome was mean change from baseline in Wrinkle Severity Rating Scale score at Week 24 after the final initial injection. The posted means were -1.1 and -1.2, and the unadjusted recalculated mean difference was -0.1, with an interval from -0.261 to 0.060 and an unadjusted p-value of 0.222. The registry lists secondary wrinkle-severity, participant-assessment, pain, and adverse-event outcomes. Sponsor analyses, missing-data procedures, multiplicity handling, and the original sample-size justification are not reported in the registry record.