Safety Study That Compares Perlane to Perlane With Lidocaine (Perlane-L) While Correcting Wrinkles in the Area Around Your Nose: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Safety Study That Compares Perlane to Perlane With Lidocaine (Perlane-L) While Correcting Wrinkles in the Area Around Your Nose (NCT00823069), a randomized na study. The primary outcome is Treatment Difference in VAS (Perlane Side - Perlane-L Side) With Difference in VAS >= 10 mm.

2. Clinical Question

The split-face arrangement makes the comparison within each subject: both products were used on the same person, on different sides of the face. This setup can reduce the influence of differences between people when comparing the sides, because each participant contributes information about both treatments. A valid statistical analysis must still account for the paired observations rather than treating the two sides as unrelated groups. Whether and how the recorded analysis handled that pairing is not reported in the registry record.

3. Trial Design

The record describes a randomized, triple-masked study with a planned enrollment of 60 and a completed status. The recorded phase is NA. The study start is listed as 2009-01 and primary completion as 2009-03. Medicis Global Service Corporation is listed as the sponsor.

The treatment description says that each subject received Perlane on one side of the face and Perlane-L on the other, with each product administered once. It also says the study was randomized and that subjects were blinded to which side received which product. The registry lists masking as triple, but does not identify the masked parties or describe how masking was maintained. The randomization procedure, sequence generation, and allocation concealment are not reported in the registry record.

There is a design-description tension in the record: its model is listed as parallel, while the treatment description explicitly describes both products being given to each subject on opposite sides of the face. The split-face description indicates paired observations within subjects, whereas a conventional parallel-group description generally refers to separate participants receiving different treatments. The record does not explain the difference between those entries. Interpretation of the study’s statistical structure therefore needs to take the treatment description into account without assuming details about the analysis.

The record does not describe the injection procedure beyond the products, sides, and once-only administration. It does not report eligibility criteria, participant characteristics, the handling of protocol deviations, or the planned sample-size justification. Details about who performed the injections and how the treatment side was randomized are also 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

Analysis population for the primary outcome, as defined in the registry: This is a split-face design. Perlane and Perlane with Lidocaine was applied to different sides of the subject's face. A total of 60 subjects received both products. The study evaluated which side of the face has less pain, as measured by the Visual Analogue Scale (VAS). Least pain on VAS scale is at 0 mm mark and worst pain is 100 mm mark.

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.

6. Primary Endpoint

The registry lists the primary outcome as Treatment Difference in VAS (Perlane Side - Perlane-L Side) With Difference in VAS >= 10 mm, measured over After Injection on Day of Treatment.

The primary endpoint is described as the treatment difference in VAS, calculated as the Perlane-side score minus the Perlane-L-side score, with the outcome expressed as the number of participants whose difference was >= 10 mm. Its timeframe is after injection on the day of treatment. The registry description says the study evaluated which side had less pain, as measured on the VAS.

A VAS is a way to record a participant’s subjective assessment along a scale. In general, it can translate an experience such as pain into a score that can be compared between treatments. The particular scale anchors, instructions, and timing of the rating are not reported in the registry record, so the exact interpretation of a score or a 10 mm difference cannot be established from the record alone.

Expressing the endpoint as a participant count turns the score comparison into a binary outcome: each participant either meets the stated difference threshold or does not. The threshold may make the result easier to describe as a count, but it also discards information about the size of differences that fall on either side of the cutoff. The record lists a 95% confidence interval as the measure of dispersion, but does not give the interval bounds or the primary-outcome result. The registry record therefore identifies what the endpoint was intended to capture, but does not allow assessment of the observed treatment contrast or its precision.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

The registry describes the primary outcome as a count of participants whose difference in VAS scores met the stated threshold. It lists a 95% confidence interval as the dispersion measure, but does not provide the estimate, interval bounds, or analysis. The statistical methods used for the primary outcome are therefore not reported in the registry record.

What does a confidence interval express?

General explanation: a confidence interval expresses uncertainty around an estimated quantity under the assumptions of the method used to construct it. A narrower interval indicates greater precision than a wider interval, while the interval’s location indicates which values are compatible with the data and method. It does not describe the range of individual participants’ responses. The registry’s reference to a 95% confidence interval does not, by itself, supply a result: the interval endpoints and the estimate are not reported.

Why does the split-face structure matter?

General explanation: when each participant receives both treatments, the two observations from that participant are paired. The participant’s characteristics are shared across the two sides, and the measurements may be correlated. A paired analysis uses the relationship between the two observations, often focusing on each participant’s within-person difference. An analysis that treats the two sides as independent would ignore that structure and could produce an inappropriate estimate of uncertainty.

The registry’s outcome title does state an order for the difference: Perlane-side VAS minus Perlane-L-side VAS. That direction is necessary to interpret the sign of a continuous difference. Here, however, the endpoint is described as a participant count meeting a threshold, and the record does not provide the distribution of the underlying scores or the analysis details. The record also lists the trial model as parallel even though the treatment description is split-face. It does not explain how those design entries relate to the analysis.

What does the thresholded endpoint retain?

General explanation: converting a score difference into a yes-or-no classification can make an outcome straightforward to report as a count. It also means that differences on the same side of a cutoff are treated alike, even when their magnitudes are not alike. Participants near the threshold may be classified differently from participants with very similar scores on the other side of it. The record states the >= 10 mm criterion but does not explain why that cutoff was selected or report the individual or group-level scores.

How should planning estimates be read?

The registry describes a planning illustration based on the observed effect, with a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation. It says the effect to detect is a stated fraction of the observed effect. The record does not contain the observed effect or specific planning counts in the registry record for this analysis, so those quantities cannot be interpreted. These are planning illustrations, not observed power and not evidence about the result. The stated equal-allocation, two-arm assumption should also be distinguished from the split-face treatment description, in which each subject received both products.

General explanation: a sample-size calculation depends on the effect being targeted, the assumed variability, the chosen significance level, the desired power, and the analysis structure. A planning count describes a hypothetical design under its assumptions; it does not show that a completed study had a particular probability of detecting an effect after data collection. An illustration based on an observed effect is especially dependent on that estimate and should not be mistaken for a result or for the trial’s original design justification.

What role do over-dispersion and model choice play?

General explanation: over-dispersion occurs when the variability in count data exceeds what a chosen model expects. If it is ignored, uncertainty can be understated. Whether over-dispersion is relevant depends on the actual outcome and analysis model. The registry record does not describe a count model, a dispersion assessment, or any model diagnostics, so over-dispersion cannot be assessed for this trial. More broadly, a statistical method should reflect the outcome type and the dependence between observations; the methods used for this endpoint are not reported.

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("Perlane-L and Perlane")
n      <- c(60)
events <- c(60)
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  Perlane-L and Perlane  60  60  100.0  94.0  100.0  94.0  100.0  94.1  100.0

11. Multiplicity, Missing Data and Analysis Populations

The record lists two outcome measures: the primary VAS-based treatment difference after injection on the treatment day and a secondary outcome counting subjects showing wrinkle improvement at Day 14. It does not report analysis results for either outcome in the information. The registry lists zero analyses, and a primary-outcome analysis is not reported in the registry record.

Multiplicity concerns arise when several outcomes, time points, or comparisons are tested. General explanation: the more opportunities there are to identify a nominally unusual result, the more important it is to know whether analyses were prespecified and whether any adjustment or hierarchy was used. The record does not report a multiplicity strategy, a statistical analysis plan, or how the primary and secondary outcomes were intended to be interpreted together. It is therefore not possible to determine whether or how multiplicity was addressed.

Missing-data handling is also not described. The record does not report the number of participants with evaluable primary-outcome data, reasons for missing measurements, imputation methods, or sensitivity analyses. It does not identify analysis populations, such as which participants were included in each analysis, or describe exclusions after randomization. These details matter because incomplete or excluded observations can affect both the estimate and its uncertainty.

The registry reports 60 subjects receiving both products, but that enrollment figure does not establish that every participant contributed complete data to every outcome. The number analyzed for the primary endpoint is not reported in the registry record. No assumptions about missing observations, analysis populations, interim analyses, or the planned statistical approach can be made from the record.

12. Safety Results

The registry reports serious adverse events as affected participants divided by participants at risk.

Other (non-serious) adverse events

Participants with at least one non-serious event at or above the registry's 0% reporting threshold.

Most frequent non-serious adverse event terms

The registry lists serious adverse events for Perlane-L and Perlane separately. For each product, 60 participants were at risk and zero were recorded as affected by a serious adverse event. No serious adverse-event terms are listed. Deaths are not reported as a numeric value in the registry record.

For the separate other-adverse-event category, the record lists 60 participants at risk and 60 affected for Perlane-L, and 60 at risk and 60 affected for Perlane. These are participant counts. The entries do not identify the specific events, their severity, timing, duration, or relationship to treatment. The registry does not explain the event collection or coding procedures in the information.

In general, a zero count for a recorded category means that no events were recorded in that category for the listed group; it does not establish that the risk is absent. Similarly, the same affected count in two groups does not establish that the types, timing, or severity of events were alike. Because the study used both products in each participant, safety observations may also be related within individuals. The registry record does not report a comparative safety analysis or its methods, so the counts should be read descriptively rather than as a formal estimate of relative risk.

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

The record establishes that a randomized, masked comparison of Perlane and Perlane-L was conducted for nasolabial-fold correction, with both products used on different sides of each subject’s face. Its primary outcome concerned pain measured by VAS after injection on the treatment day. The outcome title defines a directional difference and a >= 10 mm criterion for counting participants. The record does not provide the count, treatment estimate, confidence-interval bounds, or analysis result.

Accordingly, the registry entry does not establish whether the VAS outcome favored one side, how large any observed difference was, or how precisely it was estimated. It also does not establish that the chosen threshold represents a clinically meaningful difference; the rationale for that threshold is not reported. The secondary outcome concerns subjects showing wrinkle improvement at Day 14, but its result is not reported in the registry record.

The safety entries report zero serious adverse events among 60 at risk for each product, while listing 60 affected among 60 at risk for other adverse events in each group. Those categories have different meanings and should remain distinct. The absence of serious events in these entries is not proof that no serious event could occur, and the other-event counts alone do not explain what happened to participants.

General explanation: statistical significance, effect size, and clinical importance are different questions. A significance test addresses compatibility of data with a statistical model and a null hypothesis; an effect estimate describes the size and direction of a contrast; clinical importance depends on context and is not determined by a test alone. The available registry record does not report the primary estimate or test, and it does not provide enough detail to judge clinical importance.

The record therefore supports a description of the design, endpoint, and selected safety counts, but not a conclusion about comparative pain, wrinkle improvement, or overall safety. It also does not allow assessment of missing observations, the analysis population, multiplicity, or the precision of the primary comparison.

14. Why This Trial Matters Statistically

This trial is statistically notable because the treatment description is split-face: each subject received both products on opposite sides of the face. Such a design can provide a within-person comparison, which in general helps control variation between participants. It also requires analysis methods that respect the pairing. The registry does not report whether the primary analysis did so, and its model entry is listed as parallel despite the split-face description.

The outcome is also defined by a threshold applied to a VAS difference. General explanation: a thresholded endpoint changes a continuous score comparison into a participant count. This can be easy to communicate, but it loses detail about the magnitude of score differences and makes the chosen cutoff important. The record gives the >= 10 mm criterion but does not report its rationale or the underlying score data.

Another statistical issue is the difference between design information and analysis evidence. The record reports randomization and triple masking, but does not describe the randomization procedure, identify masked parties, or provide a statistical analysis. Design labels alone do not reveal how the data were analyzed. The record also names a secondary outcome, so a complete interpretation would ordinarily depend on knowing how outcomes were prioritized and how multiplicity was handled; that plan is not reported.

Finally, the registry includes limited safety counts but no primary-outcome result. The missing estimate and confidence interval prevent an assessment of the magnitude and precision of the principal comparison. This makes the distinction between what the study set out to measure and what the registry reports especially important. The record supports careful description of the design and selected counts, but not a statistical conclusion about the primary treatment contrast.

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.

Several trial-specific reporting limitations constrain interpretation. The primary endpoint result is not reported: the record provides no count of participants meeting the VAS criterion, estimate, confidence-interval bounds, or analysis output. It lists zero analyses. The secondary Day 14 wrinkle-improvement outcome is named, but its result is also not reported in the registry record.

The design description is not fully consistent. The record labels the model parallel, while the arm description says both products were administered to each subject on opposite sides of the face. The record does not clarify this difference or explain the analysis structure. It also does not report how the treated side was randomized, the randomization procedure, or who was masked, despite listing triple masking.

Important endpoint details are unavailable. The record does not give the VAS scale anchors, the instructions for rating pain, the rationale for the >= 10 mm cutoff, or the underlying score distribution. It does not report the primary analysis method or explain how within-subject pairing was handled.

Participant characteristics and eligibility criteria are not reported in the registry record. Missing-data methods, analysis populations, protocol deviations, multiplicity handling, interim analyses, and the statistical analysis plan are also not reported. The safety entries do not describe the other adverse events or their collection period, and deaths are not given as a numeric value. These limitations mean that the registry supports only a partial account of the study and does not allow reconstruction of its primary statistical result.

16. Related Tutorials

17. Related Statistical Calculators

18. Sources

• ClinicalTrials.gov: Safety Study That Compares Perlane to Perlane With Lidocaine (Perlane-L) While Correcting Wrinkles in the Area Around Your Nose — NCT00823069.
• Registry record last updated 2010-11-30; status last verified 2010-11.
• Results first posted 2010-11-30.
• 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

NCT00823069 is a completed randomized study of Perlane and Perlane-L during correction of nasolabial folds. The record lists triple masking, a planned enrollment of 60, and a study start of 2009-01 with primary completion in 2009-03. It describes each subject receiving both products once, on opposite sides of the face, while also listing the model as parallel.

The primary outcome concerns the Perlane-side minus Perlane-L-side VAS difference after injection on the treatment day, with participants counted when the difference was >= 10 mm. A secondary outcome concerns subjects showing wrinkle improvement at Day 14. The primary and secondary outcome results and the statistical analyses are not reported in the registry record.

The safety entries list zero serious adverse events among 60 at risk for each product, and 60 affected among 60 at risk for other adverse events in each group. The record does not provide further event details or a comparative safety analysis.