This page provides an independent statistical analysis and educational interpretation of publicly reported results. ClinicalTrials.gov provides the official trial registry record. Numerical trial results on this page are restricted to the results posted in the ClinicalTrials.gov record; calculations added by Clinical Biostats are labelled as such.
1. Trial at a Glance
This page covers the registry results for Injectable Filler for Cheek Flattening (NCT01225354), a na phase 4 study. The primary outcome is Blinded Evaluations of First Impression.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT01225354 |
| Phase | Phase 4 |
| Condition | Malar Deficiency |
| Allocation | Not applicable (single group) |
| Design model | Single Group |
| Masking | None (open label) |
| Enrollment | 20 |
| Arms in the primary outcome | n/a |
| Lead sponsor | DeNova Research |
| Results posted | Yes |
2. Clinical Question
Population
The registry record concerns people with malar deficiency, described in the study as cheek flattening. It lists an enrollment of 20. The primary endpoint timeframe refers to 20 subjects, whose photographs were included in the planned evaluations. Further eligibility criteria, participant characteristics, and details about who completed follow-up are not reported in the registry record.
Intervention
The intervention is calcium hydroxylapatite, identified in the study description as Radiesse® injections to the cheeks. The arm description says treatment was given at baseline and, if needed, at 2 weeks. The study was prospective and open-label. The registry record does not report details such as injection volume, the criteria for additional treatment, or how treatment was standardized across participants.
Comparator
There was no separate control group: the study model is single-group, and allocation is listed as not applicable. The registry record therefore does not describe a like-for-like comparison with an untreated group or another intervention. Photographs from baseline and later visits were included in the evaluation, but those time points are not a concurrent control group.
Primary question
The stated purpose was to determine whether cheek injections altered and improved first impressions and self-esteem. The primary endpoint specifically concerns blinded evaluators’ ratings of first impressions from photographs after the 1-month post optimal correction visit. It is a descriptive photographic assessment, not a direct measure of a controlled treatment effect. The registry record does not report the scores or an analysis comparing visits.
3. Trial Design
This was a prospective, open-label, postmarket study listed as Phase 4. The registry record identifies the study model as single-group and the allocation as not applicable. It lists an enrollment of 20 and a completed status. The recorded start was 2010-08, and primary completion was 2011-08. DeNova Research is listed as the sponsor.
The intervention was calcium hydroxylapatite. The arm description says subjects would be treated at baseline and, if needed, at 2 weeks. Because the study had no separate comparator group, its design can describe observations in the treated group but cannot directly distinguish treatment-associated changes from other explanations, such as changes over time or differences in how photographs are perceived.
The primary outcome was titled “Blinded Evaluations of First Impression.” The description says 300 blinded evaluators would evaluate one of three binders containing random visit photographs from baseline, optimal cosmetic result, and 1 month post optimal cosmetic result for 20 subjects. The record does not explain how evaluators were assigned to binders or what information was concealed from them. “Open-label” describes the study’s masking entry as none; it does not, by itself, establish the details of blinding used for the photographic ratings.
Three secondary outcomes are named: Subject First Impression, Assessment of Malar Deficiency, and Aesthetic Improvement. The registry record lists 6 outcome measures in total, but does not report the details of every measure. It records zero analyses. A statistical analysis plan, sample-size justification for the actual single-group study, and details of participant flow are 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
| Stage | Calcium Hydroxylapatite |
|---|---|
| STARTED | 20 |
| COMPLETED | 19 |
| NOT COMPLETED | 1 |
5. Baseline Characteristics
The table reproduces the baseline characteristics posted in the registry, which describe the participants analysed at baseline and help show whether the randomized groups were comparable.
| Characteristic | Unit | Calcium Hydroxylapatite |
|---|---|---|
| Participants analysed | 20 | |
| Age, Categorical: <=18 years | Participants | 0 |
| Age, Categorical: Between 18 and 65 years | Participants | 20 |
| Age, Categorical: >=65 years | Participants | 0 |
| Age, Continuous | years | 48.2 (SD 9.71) |
| Sex: Female, Male: Female | Participants | 20 |
| Sex: Female, Male: Male | Participants | 0 |
| Region of Enrollment: United States | participants | 20 |
6. Primary Endpoint
The registry lists the primary outcome as Blinded Evaluations of First Impression, measured over After the 1-month post optimal correction visit for 20 subjects (averaged).
| Element | Registry entry |
|---|---|
| Result type | Mean |
| Measure of spread | Full Range |
| Unit | score on a scale |
| Endpoint classification | not reduced to a single comparison |
The primary endpoint is a mean score on a scale, with the full range identified as the dispersion measure. The scale is described as a 10-point First Impression Scale, ranging from 1=Not at all to 10=Extremely well; a score of 10 is described as favorable and a score of 1 as unfavorable. The scale consists of 8 criteria. The endpoint timeframe is after the 1-month post optimal correction visit, with ratings averaged for 20 subjects.
The ratings were intended to come from blinded evaluators viewing photographs rather than from a direct clinical measurement of facial structure. This makes the endpoint relevant to the study’s stated question about first impressions: it captures evaluators’ perceptions of appearance in the photographs. The endpoint description does not specify how the 8 criteria were combined into a subject-level or overall score, or how evaluations were aggregated across evaluators.
A mean can communicate the average rating across the observations included in an analysis. The full range can help convey how widely ratings varied, but it does not show how frequently particular ratings occurred. Neither the endpoint score nor its range is reported in the registry record, so the magnitude and precision of the recorded evaluation cannot be assessed from the registry information.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry record describes a study question and an intended assessment, but it does not report the primary endpoint result. It gives no mean first-impression score, full range of scores, confidence interval, or statistical test result. It also records zero analyses. Consequently, the registry information does not establish the direction or size of any difference in first impressions, nor how precisely an estimate may have been measured.
The design matters when interpreting the question. This is a single-group study without a control group. Photographs from baseline and later visits allow evaluators to view images from different time points, but the registry record does not describe a formal within-person comparison or report its results. Even if ratings differed across photographs, a single-group design would not by itself separate the intervention’s contribution from other influences, including changes in photography, presentation, expectations, or time.
The record describes the evaluators as blinded, but does not report what was concealed or how the blinding process worked. It also does not say whether evaluators were asked to compare photographs directly, rate each image independently, or use a specified aggregation procedure. These details affect how the ratings should be understood and how much confidence to place in a measured difference.
The 10-point scale gives the direction of favorable and unfavorable ratings, but a scale description is not an outcome result. Without the observed scores and a measure of their variability, it is not possible to judge whether ratings were tightly grouped or widely dispersed. Without an interval estimate, it is also not possible to assess the precision of an estimated mean. Those are general considerations for interpreting rating data; the relevant numerical estimates are not reported in the registry record.
The registry record also does not report participant-level results for self-esteem, despite the study’s stated purpose mentioning self-esteem. Nor does it provide numerical results for the named secondary outcomes. The appropriate reading is therefore limited: the registry describes a planned photographic first-impression assessment and other outcomes, but the posted record does not provide results that answer whether or how ratings changed.
Planning illustrations are not trial findings. The stated assumptions for those illustrations include a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation, with effects expressed as a fraction of an observed effect. Those are planning assumptions, not evidence that this single-group trial used a two-arm design or that an observed effect was established. Sample-size illustrations do not represent observed power.
9. Statistical Methods Explained
The methods described in the registry record are limited. The study is identified as prospective, open-label, postmarket, and single-group. Its primary endpoint is described as a mean score with full range as the dispersion measure. The record does not provide a detailed statistical analysis plan, endpoint estimates, or analysis entries. The explanations below describe general statistical concepts relevant to the stated measures; they do not imply that a particular analysis was performed.
What does a mean score represent?
A mean is an average of the included ratings. For this endpoint, it would summarize the evaluators’ first-impression scores as described by the analysis procedure. A mean can be useful when the aim is to express an overall rating, but it does not reveal the pattern of individual scores. Different sets of ratings can have the same mean while differing in how concentrated or spread out those ratings are.
The registry identifies the measure as a 10-point scale, from 1=Not at all to 10=Extremely well, with higher values described as favorable. It says the scale consists of 8 criteria, but does not describe how the criteria contribute to the mean score. It also does not specify whether the mean is calculated first within evaluator, within subject, across photographs, or through another aggregation rule. That missing detail limits the ability to reconstruct the endpoint from the description alone.
What does the full range tell a reader?
The range describes the lowest and highest observed values included in a summary. It can indicate whether ratings covered a narrow or broad span of the scale. However, it does not show the number of ratings at each value, the typical distance of ratings from the mean, or whether a few extreme values account for much of the spread. Other summaries may describe variation differently, but the registry record names the full range and does not report its value.
In general, dispersion matters because an average alone can hide disagreement among evaluators or differences among subjects. For a photographic rating, variation could reflect differing impressions, differences among images, or other sources of rating variation. These are general possibilities, not explanations established by this record.
How should a confidence interval be read?
In general, a confidence interval expresses uncertainty around an estimate under a specified statistical procedure and its assumptions. A narrower interval indicates greater precision under that procedure; a wider interval indicates more uncertainty. An interval does not resolve design limitations, measurement problems, or bias. The registry record does not report a confidence interval for the primary endpoint, so its precision cannot be evaluated from the recorded information.
A test of statistical significance and an estimate of effect answer different questions. A test evaluates compatibility with a specified null hypothesis under a model, while an estimate describes the size and direction of the observed quantity. Neither is reported for the primary outcome in this record. The absence of a reported test is not evidence that a result was or was not statistically significant.
Why does the study structure matter?
A single-group study has no concurrent control group. General statistical adjustment cannot create the missing comparison unless additional data and assumptions are available. Comparing photographs from different visits may be useful for describing ratings over time, but it does not provide the same protection against alternative explanations as a controlled comparison. The record does not report a defined statistical contrast between baseline and later photographs.
The random selection of visit photographs for the binders, as described in the registry, should not be confused with random assignment of participants to treatment groups. The study is listed as single-group, with allocation not applicable. The record also does not explain how binder contents were selected in detail or whether all evaluators saw comparable sets of images.
Blinding can reduce the influence of knowledge about treatment or study hypotheses on ratings, but its effectiveness depends on what information is concealed and how the assessment is conducted. The primary outcome description calls the evaluators blinded. The registry’s masking entry is none, and it does not describe the evaluator blinding procedure. These statements can refer to different aspects of study conduct, but the record does not clarify the distinction.
How do planning assumptions relate to this study?
Planning illustrations use assumptions that include a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation. They are described as based on a fraction of an observed effect and as planning illustrations rather than the trial’s own design. Those assumptions do not describe the recorded single-group study, which has no two-arm allocation. The record does not provide a sample-size justification for the actual design, and the illustrations should not be read as observed power or as evidence of an effect.
More generally, planning calculations depend on a target effect, variability assumptions, the analysis method, and the design. If those assumptions do not match the study that is conducted, the calculations may not characterize that study’s ability to estimate an outcome. The registry record does not report enough information to assess how any planning assumptions were chosen or whether they were used in study conduct.
10. Multiplicity, Missing Data and Analysis Populations
The registry record lists 6 outcome measures. It names the primary outcome, “Blinded Evaluations of First Impression,” and three secondary outcomes: Subject First Impression, Assessment of Malar Deficiency, and Aesthetic Improvement. Details for the remaining outcome measures are not reported in the registry record. It also records zero analyses, so it does not provide a set of outcome-specific estimates or tests to interpret.
Multiplicity is a general concern when several outcomes or comparisons are examined. If many separate statistical tests are conducted, the chance of at least one apparently notable result can increase, depending on the testing strategy. Researchers may address this through a prespecified hierarchy, adjustment, or another analysis plan. The registry record does not report a multiplicity procedure, a hierarchy among outcomes beyond identifying a primary endpoint, or the results of any tests. No claim about false-positive control or statistical significance can therefore be made from this record.
Missing-data methods are also not reported. The record does not describe missing photographs or ratings, incomplete visits, exclusions, or how incomplete outcome information would be handled. It does not define an analysis population or say whether analyses would include all enrolled participants, those completing particular visits, or another group. The enrollment entry alone does not establish the number contributing data to each endpoint.
These omissions matter because the interpretation of an average depends on which observations contributed to it and how missing information was handled. Without those details, the registry record does not allow assessment of whether outcome summaries might be affected by incomplete data or selective inclusion.
11. Safety Results
The registry reports serious adverse events as affected participants divided by participants at risk.
| Arm | Participants with serious adverse events | Participants at risk | Percentage |
|---|---|---|---|
| Calcium Hydroxylapatite | 0 | 20 | 0.0% |
Other (non-serious) adverse events
Participants with at least one non-serious event at or above the registry's 0% reporting threshold.
| Arm | Participants affected of at risk |
|---|---|
| Calcium Hydroxylapatite | 0 of 20 |
The safety entries list 20 at risk for serious adverse events and 0 affected. They also list 20 at risk for other adverse events and 0 affected. The record lists no top serious adverse event terms. These are the posted affected counts for the group; they do not provide event descriptions, severity grading beyond the serious-versus-other distinction, or a safety observation period.
A count of zero affected in the recorded group means no affected participants are listed in that category in this registry entry. It does not establish that the intervention has no safety risks, or that an event could not have occurred outside the recorded period or been unreported. The registry record does not describe how adverse events were collected, how long participants were monitored for safety, or whether reporting was complete.
Deaths are listed as null, which is not the same as a reported count of zero. Death information is therefore not reported in the registry record. The safety figures should be read as limited registry counts, not as a complete characterization of safety.
12. What the Result Does, and Does Not, Mean
The registry record establishes that a prospective, open-label, single-group postmarket study was conducted to assess first impressions and self-esteem following calcium hydroxylapatite injections to the cheeks. It describes the primary endpoint as blinded evaluators’ mean first-impression ratings of photographs after the 1-month post optimal correction visit. It also names secondary outcomes related to first impression, malar deficiency, and aesthetic improvement.
The record does not report the primary endpoint score, its full range, a confidence interval, or any statistical analysis. It therefore does not show whether the ratings were more favorable, less favorable, or unchanged, and it does not establish the precision of any estimate. It also does not report numerical results for self-esteem or the named secondary outcomes. The stated study purpose should not be mistaken for a finding.
Even if results were available, a single-group design without a comparator would limit conclusions about cause and effect. Photographic ratings can describe evaluators’ impressions, but they do not by themselves establish that an intervention caused a change. The registry record does not provide the procedures needed to assess the construction of the rating score, the evaluator blinding process, or how missing ratings were handled.
The safety entries list zero affected for serious and other adverse events among the recorded group, but do not provide the monitoring period or collection procedures. Deaths are not reported. These entries are not a complete safety assessment.
In general, statistical results should be interpreted alongside the design, measurement, uncertainty, missing-data handling, and analysis methods. Here, the registry record offers limited design and endpoint descriptions but no outcome estimates or analysis details. The statistical meaning that can be drawn is therefore about what was planned and recorded, not about whether the intervention changed first impressions or self-esteem.
13. Why This Trial Matters Statistically
This study raises a statistical question that is distinct from whether a cosmetic procedure changes appearance: how should a subjective first-impression outcome be measured and interpreted? The registry describes ratings by blinded evaluators using photographs and a scale with favorable and unfavorable anchors. Such outcomes depend not only on the participants and images, but also on the rating instrument and the process used to combine evaluations.
The record also illustrates why design and endpoint must be considered together. The primary question concerns impressions after treatment, but the study is single-group and has no concurrent control group. Photographs from baseline and later visits may support descriptive assessments, yet they do not alone distinguish an intervention-related change from other factors. Statistical summaries cannot remove that design limitation.
Blinding is relevant when outcomes depend on human judgment. The endpoint description says evaluators were blinded, while the registry’s masking entry is none. Because the record does not explain what was concealed from evaluators or how the assessment was conducted, readers cannot fully assess the potential for expectation-related influence. Clear reporting of blinding procedures and rating aggregation would help make the endpoint more reproducible.
Finally, the distinction between a stated purpose and a reported result is essential. The registry identifies first impressions and self-esteem as aims, but provides no outcome estimates and records zero analyses. This makes the record useful for understanding the study’s question and structure, while leaving the empirical answer unavailable. Statistical interpretation requires results, uncertainty, and analysis details as well as a design description.
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.
Several trial-specific limitations follow from the registry record. The study has a single-group design and no separate comparator, so it cannot offer a direct controlled estimate of treatment effect. The record does not describe a formal comparison between baseline and later ratings, despite describing photographs from multiple visits.
The primary endpoint relies on evaluators’ impressions of photographs. The registry does not provide the detailed scoring procedure, explain how the 8 criteria contribute to the endpoint, or specify how ratings were aggregated across evaluators and subjects. It also does not clarify how the three binders were assembled or assigned to evaluators. Although evaluators are described as blinded, the information concealed and the process used are not reported.
The registry record provides no primary or secondary outcome estimates, variability summaries, confidence intervals, or analysis results. It records zero analyses. The number of outcome measures is listed as 6, but full descriptions are not available for every measure. The statistical analysis plan, multiplicity approach, missing-data procedures, and analysis populations are not reported.
Participant characteristics, eligibility criteria, participant flow, and details of follow-up are not reported in the registry record. The listed enrollment does not establish how many participants contributed data to each endpoint. For safety, the record lacks an observation period and adverse-event collection details; deaths are not reported.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Injectable Filler for Cheek Flattening — NCT01225354.
- Registry record last updated 2020-12-16; status last verified 2020-11.
- Results first posted 2012-09-28.
- Data retrieved from ClinicalTrials.gov on 2026-11-09.
- Group sizes, means, event counts and sponsor-reported p-values are reproduced as posted. Effect estimates, confidence intervals and p-values not attributed to the sponsor are independently calculated from the posted summary statistics.
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18. Record Summary
The registry record identifies NCT01225354 as “Injectable Filler for Cheek Flattening,” with the official title “An Open-label, Prospective, Postmarket Study to Assess Altering First Impressions and Self-esteem Following Radiesse® Injections.” It lists malar deficiency as the condition, calcium hydroxylapatite as the intervention, DeNova Research as the sponsor, and Phase 4 as the phase.
The study is recorded as completed, prospective, open-label, and single-group, with an enrollment of 20. The recorded start is 2010-08, and primary completion is 2011-08. The primary outcome is a blinded photographic evaluation of first impressions after the 1-month post optimal correction visit. Three secondary outcomes are named: Subject First Impression, Assessment of Malar Deficiency, and Aesthetic Improvement.
The registry record describes the study question and endpoint but does not report outcome estimates or analysis results. It lists zero analyses. Safety entries report 0 affected for serious and other adverse events; deaths are not reported in the registry record.