Evaluation of Radiesse® Dermal Filler for Hand Treatment: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Evaluation of Radiesse® Dermal Filler for Hand Treatment (NCT01832090), a randomized na study. The primary outcome is Mean Change on Merz Hand Grading Scale (MHGS), by Hand.

2. Clinical Question

3. Trial Design

This was a randomized, single-masked, crossover study listed as Phase 4. The registry identifies aging hands as the condition and Merz North America, Inc. as the sponsor. Enrollment was 118. The study began in 2013-03, reached primary completion in 2014-08, and is listed as completed.

In the original comparison, one group received Radiesse® Injectable Dermal Filler and the delayed-treatment group served as untreated controls. At 3 months, the delayed-treatment controls crossed over to treatment. This design therefore provides an untreated comparison during the initial period, while subsequent observations may reflect treatment in both original groups. The registry does not report enough detail to describe the exact assessment schedule beyond the primary endpoint’s 3-month timeframe.

Randomization helps create comparable groups at allocation on average, but it does not guarantee that every measured or unmeasured characteristic is balanced in a particular trial. Single masking means one party was masked, but the identity of that party and the masking procedures are not reported in the registry record. Details about the randomization method, allocation concealment, treatment adherence, and handling of protocol deviations are also not reported.

The crossover is relevant when interpreting outcomes after the delayed-treatment group begins treatment. The original untreated-versus-treated contrast is not maintained after that point. The record lists secondary outcomes involving age strata, hand-level and subject-level changes, comparisons between hands, global aesthetic ratings, and outcomes with or without retreatment. It does not report the results for those outcomes in the registry record described for this analysis.

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: All primary effectiveness analyses were performed based on the intent-to-treat (ITT) population. This population includes all subjects randomized. One subject was randomized but did not receive treatment and was imputed as "No change" for the primary endpoint.

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: 113 of 114 subjects (99%) completed the main study through 3 months. One subject randomized to the control group suffered a non-study related broken hand after enrollment but prior to 3 month follow up and treatment. This subject's effectiveness data were imputed as "No change" for the purposes of the primary effectiveness analysis.

6. Primary Endpoint

The registry lists the primary outcome as Mean Change on Merz Hand Grading Scale (MHGS), by Hand, measured over 3 months from baseline.

The primary endpoint is mean change on the Merz Hand Grading Scale (MHGS), assessed separately by hand from baseline to 3 months. It is expressed in units on a scale, and the measure of spread specified in the registry is the standard deviation. The registry describes the MHGS as a 5-point scale and defines a decrease in score as successful or improved treatment effect.

The endpoint is intended to quantify change in the visible consequences of fatty-tissue loss in the hands. The listed scale descriptions refer to increasing loss of fatty tissue and visibility of veins and tendons. A mean change combines each participant’s change into a group-level summary. It can convey the average direction and size of change, while the standard deviation describes how spread out individual changes are around that average. Neither statistic alone describes every participant’s experience.

Using a change from baseline focuses the comparison on how scores shift over the stated follow-up rather than on the follow-up score alone. Assessing results by hand also retains information about each hand, but makes the relationship between two hands belonging to one subject relevant to analysis. The registry does not report the primary mean changes, standard deviations, confidence intervals, or a treatment comparison. The endpoint’s definition is available, but its observed result cannot be characterized from the registry entries.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

The study’s primary outcome is continuous: mean change in MHGS units. For a continuous measure, a mean summarizes the average observed value or change in a group. In this trial, change refers to the difference between the baseline score and the score at the stated follow-up, assessed by hand. The registry defines a decrease in MHGS score as improvement. This direction is important when reading a mean change: the sign must be interpreted using the endpoint’s stated convention, not assumed from the scale’s name.

The standard deviation is the stated dispersion measure. In general, it describes how much individual observations vary around the group mean. It is not a confidence interval and does not by itself show whether a group difference is statistically distinguishable from chance. A confidence interval, when available, describes uncertainty around an estimate under the chosen statistical model. The registry entries do not include a mean, standard deviation, confidence interval, or primary comparison, so none can be interpreted for this endpoint.

Random allocation is a design method intended to reduce systematic differences between groups at the point of assignment. It does not ensure exact balance, and it does not address every issue that can arise after allocation. The registry reports randomized allocation and an intent-to-treat population that includes all randomized subjects. It does not report the randomization sequence method, allocation concealment, or the inferential procedure used for the primary comparison.

The crossover design has an important timing feature: the delayed-treatment group was untreated before crossing over to treatment at 3 months. In general, a crossover can allow observations under different treatment conditions, but interpretation depends on the sequence, timing, and analysis. Once the delayed group receives treatment, it no longer supplies an untreated comparison for later assessments. The registry does not report a detailed statistical plan for crossover-period analyses, nor does it state whether any such analyses account for period or sequence effects. No assumptions about those procedures can be made from the record.

The endpoint is analyzed by hand, while the subject is the unit used in some listed secondary outcomes. In general, two hands from the same subject may have correlated outcomes because they share characteristics. Treating such observations as independent when they are not can make uncertainty estimates inaccurate. Suitable methods can account for within-subject dependence, but the registry entries do not specify how the primary by-hand analysis handled it. The secondary outcome list includes both hand-level and subject-level measures, but this alone does not reveal the analysis method.

Masking can reduce the influence of expectations on assessment or other study processes. The record identifies the study as single-masked but does not identify who was masked or how masking was maintained. Because the primary outcome involves a grading scale, information about assessor masking and assessment procedures would help readers evaluate potential measurement bias; those details are not reported in the registry record.

The registry states that primary analyses used the intent-to-treat population, defined as all randomized subjects. One subject was randomized but did not receive treatment and was imputed as “No change” for the primary endpoint. In general, retaining randomized participants in their assigned groups helps preserve the comparison created by randomization. Imputation is a method for addressing a missing outcome, but its implications depend on the missingness and the assumed value. The record does not report whether other primary endpoint data were missing, how any additional missing values were handled, or whether sensitivity analyses were conducted.

The record lists 13 outcome measures and 8 analyses. Multiple outcomes or analyses can raise multiplicity concerns: when many hypotheses are examined, the chance of at least one apparently unusual result may increase. General approaches include prespecifying a primary outcome, adjusting inference for multiple comparisons, or interpreting secondary findings as exploratory. The registry identifies the primary endpoint but does not report a multiplicity-adjustment method, a testing hierarchy, or an analysis plan. The count of listed outcomes alone does not show how many statistical tests were performed or whether adjustment was necessary.

The sample-size assumptions describe a planning illustration based on the observed effect, using a two-sided significance level of 0.05, equal allocation, and a normal approximation; the target effect is a stated fraction of the observed effect. Such sample-size figures are planning illustrations, not observed power. They do not establish the trial’s original design rationale or prove that a study was adequately powered. The trial’s own sample-size justification and statistical plan are not reported in the registry record. No planning output values are available in the registry record to interpret.

In general, a recalculation from posted summary statistics would be an unadjusted re-analysis, not a replacement for the sponsor’s own analysis. No primary summary statistics are reported, and no recalculated primary result is available. If recalculated results were discrepant with a sponsor analysis, the sponsor’s own analysis would take precedence; the record details do not establish such a discrepancy.

10. Multiplicity, Missing Data and Analysis Populations

The registry identifies a primary endpoint and lists secondary outcomes, including measures assessed by hand or by subject, age-stratified outcomes, left-right hand evenness, global aesthetic ratings, and outcomes involving retreatment. It lists 13 outcome measures and 8 analyses. Multiple outcomes can create multiplicity concerns because testing many hypotheses can make chance findings more likely. This is a general statistical concern, not evidence that any particular result is false.

The registry record does not report whether the analyses were organized into a prespecified hierarchy, whether any multiplicity adjustment was applied, or which secondary analyses were considered confirmatory versus exploratory. It also does not report outcome estimates for the listed secondary measures in the registry record. Readers therefore cannot assess the size or precision of those findings, or how any multiplicity strategy might affect interpretation.

The primary analysis population is described as intent-to-treat and includes all randomized subjects. One randomized subject did not receive treatment and was imputed as “No change” for the primary endpoint. The record does not report whether other values were missing, what additional missing-data methods were used, or whether sensitivity analyses evaluated alternative assumptions. In general, an imputed value is an analytical assumption rather than an observed measurement; its influence depends on the amount and pattern of missing data and the method used.

Details of the statistical analysis plan, including the handling of missing observations and any adjustments for multiple testing, are not reported in the registry record. These gaps limit evaluation of whether the analysis choices were prespecified and how sensitive results might be to alternative methods. They do not establish that the methods were inappropriate; they mean that the relevant details are unavailable in this record.

11. 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 2.5% reporting threshold.

Most frequent non-serious adverse event terms

For the Radiesse® Injectable Dermal Filler group, the registry lists 113 subjects at risk for serious adverse events and 0 affected. It lists 113 at risk for other adverse events and 50 affected. The death count is not reported in the registry record. These are safety counts, distinct from the primary MHGS efficacy endpoint.

The serious-event figure means that the registry records no subjects affected by serious adverse events in this group. It should not be read as proof that serious events are impossible or that no safety concern exists. The “other adverse events” figure records subjects affected, not necessarily the total number of event episodes. The registry does not provide event terms for serious adverse events, and no comparative safety group is included in the registry record.

These counts alone do not describe event timing, duration, severity for non-serious events, relatedness to treatment, or how many events each affected subject experienced. The record also does not provide a complete safety analysis or enough information to compare risks between treatment strategies. Interpretation should therefore remain limited to the counts and group specified in the registry record.

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

The record establishes that the trial addressed hand treatment with Radiesse® Injectable Dermal Filler and defined a 3-month primary outcome based on mean MHGS change by hand. It also establishes the direction used to interpret that endpoint: a decrease in score indicates improvement. These details clarify what the investigators intended to evaluate, but they do not disclose the observed primary result.

The primary mean changes, between-group estimate, and uncertainty measures are not reported in the registry record. Without those results, readers cannot determine the observed size or precision of the treated-versus-untreated comparison. The absence of a reported estimate should not be interpreted as a finding of no change, no difference, or lack of statistical significance.

The study’s randomized, single-masked crossover structure and delayed-treatment comparison provide context for interpreting any results that might be reported elsewhere. The untreated comparison applies to the period before delayed treatment; after crossover, both original groups receive treatment. The registry does not report the detailed analysis needed to assess later-period comparisons or the handling of correlation between a subject’s hands.

The safety counts provide a limited description of events in the Radiesse group: 0 subjects affected by serious adverse events and 50 affected by other adverse events, among 113 at risk in each category. They do not provide a treatment-versus-control safety comparison in the registry record, and they do not determine the efficacy result.

Accordingly, the registry record supports a careful account of the trial question, design, endpoint, analysis population, and selected adverse-event counts. It does not support a conclusion about the magnitude, precision, or statistical significance of the primary efficacy effect. No medical recommendation follows from these record details alone.

13. Why This Trial Matters Statistically

This trial illustrates why an endpoint definition and an outcome result are different kinds of information. The registry explains that the primary outcome was mean change on the MHGS by hand at 3 months and defines a decrease as improvement. Yet the primary group estimates and comparison are not reported in the registry record. Statistical interpretation requires the observed estimate and its uncertainty, not only a clear description of what was planned to be measured.

The design also raises questions that are central to biostatistical reading. Randomization supports a comparative design, while the crossover means the delayed-treatment group ceases to be untreated after 3 months. The endpoint is assessed by hand, but some secondary outcomes are by subject; accounting for the relationship between a subject’s hands may matter for valid uncertainty estimates. The registry does not report the relevant analysis details.

The record also illustrates the distinction between an intent-to-treat population and missing-data handling. It states that all randomized subjects were included and specifies a “No change” imputation for one randomized subject who did not receive treatment. That information is useful, but does not disclose whether there were other missing measurements or how alternative assumptions were assessed.

Finally, the listed range of secondary outcomes makes multiplicity a relevant general consideration, while the registry does not report a testing hierarchy or adjustment method. These design and reporting details help readers identify what can be evaluated and what remains uncertain. The main statistical lesson is not a conclusion about treatment effect; it is that the strength of an interpretation depends on accessible estimates, precision measures, and analysis methods.

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 primary limitation for interpreting efficacy is that the registry entries do not include the primary mean changes, standard deviations, confidence intervals, or between-group comparison. The endpoint and its timeframe are defined, but the observed result and its precision cannot be assessed. Secondary outcome results are also not reported in the registry record.

Some design and analysis details are absent. The registry identifies randomized allocation, single masking, and a crossover model, but does not report the randomization procedure, allocation concealment, identity of the masked party, or detailed assessment procedures. It does not specify how the by-hand endpoint accounts for dependence between hands from the same subject, or provide a detailed analysis plan for the crossover period.

The stated intent-to-treat population includes all randomized subjects, with one subject who did not receive treatment imputed as having no change. The record does not report whether other primary data were missing, the methods used for any further missingness, or sensitivity analyses. The record also does not report whether multiplicity adjustments were used across the listed outcomes and analyses.

For safety, the reported counts are limited to the Radiesse group. The death count is not reported in the registry record, and no serious adverse-event terms are listed. The available counts do not provide detailed event timing, severity, relatedness, or a comparative safety analysis. These limitations describe what the record does not establish; they should not be mistaken for evidence that an unreported event or analysis did not occur.

15. Related Tutorials

16. Related Statistical Calculators

17. Sources

• ClinicalTrials.gov: Evaluation of Radiesse® Dermal Filler for Hand Treatment — NCT01832090.
• Registry record last updated 2017-10-19; status last verified 2017-09.
• Results first posted 2017-10-19.
• 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.

18. Record Summary

NCT01832090 is a completed, randomized, single-masked crossover study listed as Phase 4 and sponsored by Merz North America, Inc. It concerns aging hands and evaluates Radiesse® Injectable Dermal Filler mixed with lidocaine-HCl against delayed treatment. Enrollment was 118; the study began in 2013-03 and reached primary completion in 2014-08.

The primary endpoint was mean MHGS change by hand from baseline to 3 months, with lower scores defined as improvement. The primary analysis population was intent-to-treat; one randomized subject who did not receive treatment was imputed as having no change. The primary efficacy estimates are not reported in the registry record.

For the Radiesse group, the registry lists 0 subjects affected by serious adverse events and 50 affected by other adverse events, with 113 at risk in each category. The death count is not reported in the registry record.