Global Management of Facial Rejuvenation With a New Range of Hyaluronic Acid Dermal Fillers: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Global Management of Facial Rejuvenation With a New Range of Hyaluronic Acid Dermal Fillers (NCT01151436), a na na study. The primary outcome is Full Face Global Aesthetic Improvement.

2. Clinical Question

3. Trial Design

The registry record describes a completed, single-group study sponsored by Galderma R&D. Enrollment was 77. The study start is recorded as 2010-03 and primary completion as 2010-11. The phase is listed as NA, and allocation is also listed as NA. Masking is listed as none. These entries do not describe a randomized, masked comparison with a separate control group.

The intervention is identified as hyaluronic acid dermal fillers, with the intervention type recorded as device. The aim was to assess performance and tolerance, together with investigator and subject satisfaction, for global management of facial rejuvenation. The record lists facial wrinkles as the condition. Detailed eligibility requirements, baseline characteristics, treatment procedures, the particular filler products, and the number or timing of injections are not reported in the registry record.

The primary outcome is Full Face Global Aesthetic Improvement, expressed as the mean score on a scale, with standard deviation as the stated measure of dispersion. The timeframe is 3 weeks after the last injection. The listed analysis population is intent to treat on the observed population, with no replacement of missing values. The record does not state the actual number contributing to the primary endpoint.

There are 27 outcome measures recorded, including repeated listings for nasolabial fold and periorbital line severity assessments. The registry record does not provide enough detail in these listings to determine the specific assessment schedule or how the outcomes were analyzed. It reports no analysis entries. The registry record does not report a detailed statistical analysis plan, a sample-size justification for this single-group study, or interim analyses.

Although planning assumptions are described for a two-arm sample-size illustration, this study is listed as single-group. Such an illustration is not a description of the study’s observed design or evidence of observed power. It should not be interpreted as a calculation based on a controlled comparison conducted in this trial.

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: INTENT TO TREAT ON OBSERVED POPULATION (NO REPLACEMENT OF MISSING VALUE)

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 Full Face Global Aesthetic Improvement, measured over 3 weeks after last injection.

The primary endpoint is a mean score for full-face global aesthetic improvement from baseline, assessed 3 weeks after the last injection. Its scale is described as -1 for worse, 0 for no change, 1 for improved, 2 for much improved, and 3 for very much improved. The measure is intended to capture an overall judgment of aesthetic change across the face rather than the severity of a single wrinkle area.

A global assessment can be useful when a study’s aim concerns facial rejuvenation as a whole. It condenses an overall judgment into a scale that can be summarized across participants. The registry record identifies the mean as the endpoint summary and the standard deviation as its dispersion. In general, a mean describes the average score, while a standard deviation describes how much individual scores vary around that average. Neither statistic is reported for this endpoint in the registry record.

The scale has ordered response categories, from worsening through increasing degrees of improvement. Reporting a mean treats the scale values numerically, but the record does not describe how that choice was justified or whether additional summaries were planned. The single-group design also means that a change from baseline is not, by itself, a controlled estimate of what would have happened without the intervention.

The assessment time is anchored to the last injection, not to a fixed time from study enrollment. The interval between enrollment, injections, and the endpoint assessment is not reported in the registry record. The stated timeframe therefore identifies when the outcome was intended to be measured relative to treatment, but does not establish the duration of any change beyond that assessment.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

What does a mean summarize?

For a continuous summary, the mean is the arithmetic average of the observed scores. In general, it offers a compact description of the group’s central result, but it does not show every participant’s score or the shape of the score distribution. In this study, the primary outcome is defined as the mean on the full-face global aesthetic improvement scale. The registry record also names the standard deviation as the dispersion measure, but does not report either statistic as an observed result.

The endpoint scale uses ordered categories with numeric labels from -1 to 3. The labels convey a progression from worse, through no change, to increasing levels of improvement. A mean score can summarize these labels numerically, but its interpretation should remain tied to the categories and the study context. For example, an average is not itself a count of participants who selected a particular category. The record does not report category frequencies or explain whether another summary was used alongside the mean.

What does a standard deviation tell readers?

In general, a standard deviation describes the spread of individual observations around the mean. A smaller standard deviation corresponds to scores that cluster more closely around the average, while a larger one corresponds to greater variation. It does not measure uncertainty in the mean in the same way as a confidence interval. A confidence interval, in general, gives a range of values compatible with the data and the method used to calculate it, while reflecting sampling uncertainty. No standard deviation or confidence interval for the primary endpoint is reported in the registry record.

Variability matters because two groups could have the same mean but very different distributions of individual scores. In a clinical assessment, that difference can affect how representative the mean is of participants’ experiences. Without the observed distribution or dispersion, the registry record does not allow readers to judge how consistent the endpoint scores were.

Why does the single-group design matter?

The study is listed as single-group, with no masking and no allocation information beyond NA. In general, a comparator group helps distinguish change associated with an intervention from change that might occur for other reasons over the same period. A single-group result is descriptive of the observed group. It cannot provide the same controlled contrast as a randomized comparison. Lack of masking can also matter for outcomes involving judgments, because expectations may influence assessments; the registry record does not specify how investigator and subject assessments were conducted or whether any safeguards were used.

The primary outcome is measured from baseline, but the record does not report a baseline score, an endpoint score, or an estimated change. It also does not describe the statistical model or any adjustment for baseline characteristics. Those details are not reported in the registry record and should not be inferred from the fact that the outcome is expressed as a mean.

What do the planning assumptions mean?

In general, a sample-size calculation uses assumptions about the target effect, variability, significance level, power, allocation, and statistical method to illustrate how many participants might be needed for a planned comparison. The registry record’s planning illustration assumes two-sided significance level 0.05, equal allocation between two arms, and a normal approximation; its target effect is a stated fraction of the observed effect. These are planning assumptions, not observed trial results, and not evidence that the study achieved any particular power.

The illustration refers to two arms, whereas the study itself is listed as single-group. It therefore does not describe the observed allocation in this trial. The record does not report a study-specific sample-size justification or indicate that the planning illustration was the basis for enrollment. Any sample-size outputs should be read as hypothetical planning examples rather than as an assessment of the study’s success or as a substitute for the missing endpoint estimate.

In general, an observed effect used as the basis for planning can be uncertain, especially when estimated from a small or uncontrolled study. Planning for a fraction of an effect asks what sample size would correspond to detecting a smaller assumed effect under the stated method. It does not establish that the assumed effect is real, clinically important, or causally attributable to an intervention. The record does not report an observed primary effect from which to evaluate such assumptions.

How should multiplicity and missing observations be considered?

The registry record lists 27 outcome measures and no analysis entries. It includes multiple listings of severity assessments for nasolabial folds and periorbital lines. When many outcomes or timepoints are tested, general statistical practice considers multiplicity because the chance of at least one apparently notable result can increase with the number of analyses. The record does not report a multiplicity adjustment, a prespecified hierarchy of outcomes, or a detailed analysis plan, so the handling of multiple outcomes is not reported in the registry record.

The primary population is described as intent to treat on the observed population, with no replacement of missing values. In general, this means missing observations are not filled in with substituted values for the stated analysis, but the registry wording does not give the number or pattern of missing observations. It also does not clarify the exact denominator for each outcome. An enrollment count should therefore not be assumed to be the endpoint analysis count. No method for assessing the consequences of missing data is reported in the registry record.

10. Confidence Intervals for Each Arm

No two-arm comparison is shown for this trial, but each arm's mean can be given with a t-based 95% confidence interval computed from the posted mean, spread and number of participants.

R code and output

arm <- c("Hyaluronic Acid")
n   <- c(77)
m   <- c(2.5)
sp  <- c(0.6)
sd  <- sp      # posted standard deviations
for (i in seq_along(n)) {
  se <- sd[i] / sqrt(n[i]); h <- qt(0.975, n[i] - 1) * se
  cat(sprintf("CARM|%s|%d|%.3f|%.3f|%.3f|%.3f\n", arm[i], n[i], m[i], sd[i], m[i] - h, m[i] + h))
}

CARM  Hyaluronic Acid  77  2.500  0.600  2.364  2.636

11. Multiplicity, Missing Data and Analysis Populations

The registry record lists 27 outcome measures and no analysis entries. Multiple listings refer to nasolabial fold severity and periorbital line severity. The record does not make clear whether these repeated listings correspond to different assessment times, raters, or other distinctions. Those details are not reported in the registry record, so the listings alone do not establish the number of distinct hypotheses tested.

In general, testing many outcomes or repeated assessments creates a multiplicity issue: as the number of tests grows, a finding may appear notable by chance even when no true difference exists. Methods such as defining a primary outcome in advance, setting an analysis hierarchy, or adjusting for multiple testing can address this issue, depending on the design and question. The registry record identifies a primary endpoint but does not report a detailed analysis plan or a multiplicity procedure. It is therefore not possible to assess how multiplicity was handled.

The stated analysis population is intent to treat on the observed population, with no replacement of missing values. This identifies an approach that uses observed data rather than substituting values for missing outcomes. The number of participants with observed primary endpoint scores, the amount and reasons for missingness, and any sensitivity analyses are not reported in the registry record. Enrollment of 77 should not be treated as the number analyzed for every endpoint.

These omissions limit assessment of both the risk of selective emphasis among many outcomes and the possible effect of missing observations. The registry record does not report enough detail to determine whether missingness was related to participant characteristics or outcomes, or whether the analysis addressed that possibility.

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 5% reporting threshold.

Most frequent non-serious adverse event terms

For the hyaluronic acid group, the registry record lists 77 participants at risk for serious adverse events and 0 affected. It lists 77 at risk for other adverse events and 5 affected. These are counts in the registry record; no percentages need to be inferred to interpret them.

The record lists no serious adverse event terms among its top serious terms. The deaths field is null, so deaths are not reported in the registry record; a null entry should not be read as a reported count of zero. The record also does not describe the duration of safety follow-up, event definitions, severity grading, relatedness assessments, or how events were collected. Those details are not reported in the registry record.

These figures describe what the record reports for this group and should not be taken as proof that no unrecorded or unobserved harms occurred. The small, single-group study design and the absence of a comparator also limit interpretation of event counts. The counts do not establish whether an event was caused by the intervention or how the observed safety experience compares with another treatment or no treatment.

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

The registry record establishes that a completed, single-group study enrolled 77 participants and defined a primary outcome focused on full-face global aesthetic improvement. The intended assessment was 3 weeks after the last injection, with results to be summarized as a mean and standard deviation. It also records the study’s broad aim of assessing performance, tolerance, and investigator and subject satisfaction.

The registry record does not report the primary endpoint result. Without an observed mean, standard deviation, confidence interval, or analysis, the magnitude and precision of the measured outcome cannot be determined. No conclusion about how participants scored on the scale can be drawn from the endpoint definition alone. The count of enrolled participants is not an outcome result.

The design also constrains causal interpretation. With one group and no comparator, observed change from baseline would not by itself show what would have happened over the same period without the intervention. The registry record does not report a controlled estimate that could separate treatment-associated change from other influences. The lack of masking may be relevant to subjective assessments, but the record does not explain assessment procedures in enough detail to evaluate that concern.

The safety entries report 0 participants affected by serious adverse events and 5 affected by other adverse events among 77 at risk in each category. The deaths field is not reported. These entries are limited to the information recorded and do not establish comparative safety or the absence of unreported events.

Accordingly, the record supports a description of the question, design, intended outcome, and certain adverse event counts. It does not support a numerical conclusion about the primary outcome, its uncertainty, or a causal treatment effect. Further outcome and analysis details are not reported in the registry record.

14. Why This Trial Matters Statistically

This trial illustrates why a clearly named endpoint and an enrollment count are not enough to interpret a clinical study. The registry record defines a full-face improvement scale, its timeframe, and the planned mean and standard deviation, yet it does not report the endpoint result. Without the observed estimate and its variability, readers cannot assess the magnitude, spread, or precision of the measured scores.

The design also matters to the meaning of an outcome. A single-group study can describe what was observed among participants, but it does not supply a concurrent comparison for evaluating change against an alternative course. This distinction is especially important for assessments that involve judgments, such as global aesthetic improvement and satisfaction. The record lists no masking and does not describe detailed assessment procedures.

The record’s 27 outcome measures make transparency about outcome selection and analysis important. In general, multiple outcomes can create opportunities to emphasize selected findings unless the analysis plan clarifies priorities and methods. Here, analysis entries and detailed multiplicity procedures are not reported. The registry record also describes an observed-data population without replacement of missing values, but does not state how many participants contributed to each result.

Finally, the safety entries show why event counts should be read with their denominators and reporting context. They describe serious and other adverse events recorded for the single group, but do not provide a comparison or enough follow-up and event-collection detail to establish a broader safety profile. Together, these features make this record useful for understanding what was intended to be measured, while underscoring the limits of drawing statistical conclusions when outcome estimates and analysis details are absent.

15. Limitations

• The posted summary statistics are the only data these results rest on; patient-level data, full protocols and statistical analysis plans are not available.
• Recalculated results are simple, unadjusted calculations from posted summaries. They do not replace the sponsor's prespecified analysis.

The registry record does not report the observed primary endpoint mean or standard deviation, a confidence interval, or a test result. This is the central limitation for interpreting the stated primary question. The endpoint’s definition and timeframe do not show what scores participants actually had.

The study is listed as single-group, with no masking and no allocation information beyond NA. A separate comparator is not described, limiting any causal interpretation of change from baseline. The record does not provide detailed participant eligibility criteria or baseline characteristics, so the enrolled population cannot be characterized beyond the condition and enrollment information listed.

Intervention details are limited to the identification of hyaluronic acid dermal fillers as a device. Product specifics, treatment procedures, dose or volume, injection sites, and treatment schedule are not reported in the registry record. The primary assessment is timed 3 weeks after the last injection, but longer-term outcome results are not included in the primary outcome description.

The record lists 27 outcome measures and no analysis entries. It does not report a detailed statistical plan, how multiple outcomes were handled, or whether any interim analyses occurred. It also does not state the number of participants contributing observed data to the primary endpoint, the amount or pattern of missing data, or sensitivity analyses. The stated observed-population approach does not fill in those details.

Safety reporting is also limited: event counts are listed, but event definitions, follow-up duration, severity, relatedness, and collection procedures are not reported in the registry record. These omissions prevent a fuller assessment of both the outcome evidence and the context of the safety counts.

16. Related Tutorials

17. Related Statistical Calculators

18. Sources

• ClinicalTrials.gov: Global Management of Facial Rejuvenation With a New Range of Hyaluronic Acid Dermal Fillers — NCT01151436.
• Registry record last updated 2021-03-10; status last verified 2012-05.
• Results first posted 2012-05-07.
• Data retrieved from ClinicalTrials.gov on 2026-11-09.
• Group sizes, means, event counts and sponsor-reported p-values are reproduced as posted. Effect estimates, confidence intervals and p-values not attributed to the sponsor are independently calculated from the posted summary statistics.

19. Record Summary

The registry record describes a completed, single-group study sponsored by Galderma R&D, with 77 participants enrolled. It lists facial wrinkles as the condition and hyaluronic acid dermal fillers as the intervention. The phase and allocation are listed as NA, and masking is listed as none. The recorded study dates are 2010-03 for start and 2010-11 for primary completion.

The primary endpoint is the mean full-face global aesthetic improvement score from baseline, assessed 3 weeks after the last injection, with standard deviation specified as the measure of dispersion. The analysis population is described as intent to treat on the observed population, with no replacement of missing values. The registry record does not report the primary endpoint result or analysis entries.

For safety, 0 of 77 participants at risk are listed as affected by serious adverse events, and 5 of 77 are listed as affected by other adverse events. Deaths are not reported in the registry record. Detailed outcome results, analysis methods, missing-data counts, and additional safety context are not reported in the registry record.