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 Subjects' Satisfaction on Pan Facial Aesthetic Enhancement After Treatment With Azzalure® and the Restylane® Range (NCT01529203), a na phase 3 study. The primary outcome is Subject Satisfaction for the Full Face.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT01529203 |
| Phase | Phase 3 |
| Condition | Aging |
| Allocation | Not applicable (single group) |
| Design model | Single Group |
| Masking | None (open label) |
| Enrollment | 60 |
| Arms in the primary outcome | n/a |
| Lead sponsor | Galderma R&D |
| Results posted | Yes |
2. Clinical Question
Population
The study concerned subjects with aging, as recorded in the registry. It enrolled 60 subjects. The primary satisfaction analysis included only the 56 subjects who provided answers to the satisfaction questionnaire.
Intervention
All subjects were to receive Azzalure, a botulinum toxin type A treatment, and products from the Restylane range. The stated aim was to assess satisfaction linked to pan-facial rejuvenation management using injections of these products.
Comparator
There was no separate comparator group in the registry design. The study is classified as single-group, with allocation listed as not applicable. It therefore does not provide a randomized, like-for-like treatment comparison.
Primary question
At Month 6, what level of subject satisfaction with the full-face treatment was recorded on the satisfaction questionnaire? The registry identifies the outcome and its analysis population, but the numerical satisfaction result is not reported in the registry record.
The central question is descriptive: how did questionnaire respondents rate their satisfaction after receiving the combined treatment? Because all subjects were assigned to the same treatment group and the study was open, the design does not establish how satisfaction would compare with an untreated group or an alternative treatment. It also cannot separate the contribution of Azzalure from that of Restylane. The registry lists global aesthetic improvement from baseline and related adverse events as secondary outcomes, but does not report numerical results for those outcomes in the record described.
3. Trial Design
The registry classifies this as a Phase 3, open, multicentre, single-group study. It records 60 enrolled subjects and a completed status. The recorded study start was 2012-02, and primary completion was 2013-04. The sponsor was Galderma R&D. The stated study aim was to assess subjects’ satisfaction in connection with pan-facial rejuvenation management using injections of Azzalure and Restylane fillers.
All subjects in the treatment group were to receive Azzalure and Restylane. The record lists Azzalure as a drug intervention and Restylane ranges as a device intervention. Allocation is listed as not applicable, and masking as none. Thus, there is no randomized allocation or blinded assessment described in the registry record. The record does not specify further operational details such as the treatment schedule, product-specific dosing, or the timing of individual injections; these details are not reported in the registry record.
The primary outcome is subject satisfaction for the full face at Month 6, assessed using a subject satisfaction questionnaire. The record says that only the 56 subjects who answered that questionnaire were included in the analysis. Secondary outcomes are global aesthetic improvement from baseline and related adverse events. Although the record identifies three outcome measures, it does not report a numerical primary result or numerical results for those secondary measures. It also lists no analysis records.
A single-group design can describe outcomes observed after treatment, but it cannot by itself distinguish treatment effects from other explanations, such as the natural course of perceptions over time or expectations associated with an open study. These are general design considerations, not additional findings about the subjects in this study.
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 | Azzalure and Restylane |
|---|---|
| STARTED | 60 |
| COMPLETED | 57 |
| NOT COMPLETED | 3 |
Analysis population for the primary outcome, as defined in the registry: only the 56 subjects who had provided answers in the subject's satisfaction questionnaire were included in the analysis
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 | Azzalure and Restylane |
|---|---|---|
| Participants analysed | 60 | |
| Age, Continuous | years | 47.6 (SD 7.5) |
| Age, Categorical: <=18 years | Participants | 0 |
| Age, Categorical: Between 18 and 65 years | Participants | 60 |
| Age, Categorical: >=65 years | Participants | 0 |
| Sex: Female, Male: Female | Participants | 50 |
| Sex: Female, Male: Male | Participants | 10 |
| Race (NIH/OMB): American Indian or Alaska Native | Participants | 0 |
| Race (NIH/OMB): Asian | Participants | 0 |
| Race (NIH/OMB): Native Hawaiian or Other Pacific Islander | Participants | 0 |
| Race (NIH/OMB): Black or African American | Participants | 0 |
| Race (NIH/OMB): White | Participants | 60 |
| Race (NIH/OMB): More than one race | Participants | 0 |
| Race (NIH/OMB): Unknown or Not Reported | Participants | 0 |
| Region of Enrollment: France | participants | 20 |
| Region of Enrollment: Spain | participants | 20 |
| Region of Enrollment: United Kingdom | participants | 20 |
6. Primary Endpoint
The registry lists the primary outcome as Subject Satisfaction for the Full Face, measured over Month 6.
| Element | Registry entry |
|---|---|
| Result type | Number |
| Measure of spread | not applicable |
| Unit | percentage of total subjects |
| Endpoint classification | not reduced to a single comparison |
The primary endpoint is subject satisfaction for the full face at Month 6, based on a satisfaction questionnaire. The registry describes its unit as a percentage of total subjects and states that the analysis included only the 56 subjects who provided questionnaire answers. The questionnaire’s individual response options, scoring rule, threshold for being classified as satisfied, and the numerical result are not reported in the registry record.
Patient- or subject-reported satisfaction can capture an aspect of treatment experience that may not be represented by an observer’s aesthetic assessment. It can therefore complement clinical assessments, especially when the research question concerns whether subjects felt satisfied with an overall facial treatment. In general, the meaning of a satisfaction percentage depends on how the questionnaire defines satisfaction, how responses are scored, and which respondents are included in the denominator. Those details matter for interpreting both the size and the representativeness of a reported percentage.
Here, the registry identifies the measure and analysis population but does not give the numerator, percentage, or uncertainty around the estimate. The record therefore establishes what the primary question was, but does not allow the satisfaction level at Month 6 to be quantified from the registry information.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry record establishes the study’s stated objective and design, but it does not report the numerical primary satisfaction result. It is therefore not possible to describe the observed satisfaction level, its precision, or whether a particular proportion of respondents met a satisfaction criterion. No such criterion is described either. The record also does not report a confidence interval, standard error, or other uncertainty measure for the primary endpoint.
The available endpoint information says that satisfaction was assessed at Month 6 by questionnaire and that the analysis included 56 questionnaire respondents. Although the outcome unit is described as a percentage of total subjects, the actual percentage and the corresponding count are absent. The precise denominator used to express that percentage is consequently not clear from the recorded information. It would be inappropriate to infer the result from the number of respondents or from the study’s enrollment.
The design also limits the kinds of conclusions that can be drawn. All subjects were in one treatment group, and the study was open. There is no concurrent control group or randomized treatment comparison. A descriptive outcome after treatment can document what was reported by respondents, but it cannot show how those responses would have differed under another treatment or without treatment. In addition, because Azzalure and Restylane were given together, the record cannot isolate the association of either product with satisfaction.
The registry lists global aesthetic improvement from baseline and related adverse events as secondary outcomes, but does not report numerical findings for them. It records 2 serious adverse events among 60 at risk and 18 other adverse events among 60 at risk. These are safety counts, not a substitute for the missing satisfaction result. The record lists colon cancer and cerebral infarction among the serious-event terms, each at 1.7%, but does not describe a causal relationship between those events and treatment. The deaths field has no reported value.
In general, a point estimate describes the observed value in the analyzed group, while an uncertainty interval indicates how imprecisely that estimate is estimated under a statistical model. Without the satisfaction estimate and its uncertainty, neither the magnitude nor precision of the primary finding can be assessed. The record’s completed status should not be interpreted as evidence about the direction or size of the outcome. Completion describes study status; it does not supply missing results.
9. Statistical Methods Explained
Several general statistical ideas help clarify what the registry can and cannot establish. The first is the distinction between a descriptive estimate and a comparison. This study has one treatment group, so its satisfaction outcome is intended to describe questionnaire responses after treatment. A comparative treatment effect ordinarily requires a contrast between groups or conditions. No such randomized comparison is recorded here, and there is no control-group estimate from which to form a treatment contrast.
What does a percentage summarize?
In general, a percentage expresses a count relative to a denominator. To interpret it, a reader needs to know what qualifies as an event or response in the numerator and which people are represented in the denominator. For a questionnaire endpoint, the scoring definition is also important: different rules for combining response categories can yield different percentages. The registry calls the primary measure a percentage of total subjects and says that the analysis included 56 subjects who answered the questionnaire. It does not give the numerator, the percentage, or the scoring and classification rules. The percentage therefore cannot be reconstructed from the record.
Why does the analysis population matter?
In general, an analysis population is the set of people whose data contribute to a particular result. An outcome limited to questionnaire respondents describes those respondents, unless additional information supports extending the interpretation to those without responses. If questionnaire nonresponse is related to satisfaction or other characteristics, the respondents may not represent everyone enrolled. This is a general concern, not evidence that nonresponse was related to satisfaction in this study. The registry does not report reasons for missing questionnaire answers or comparisons between respondents and nonrespondents.
What would an uncertainty interval add?
In general, a confidence interval gives a range of values compatible with an estimate under the assumptions of the chosen statistical method. A narrower interval indicates greater statistical precision, while a wider interval indicates greater uncertainty. It does not remove biases from study design, missing data, or measurement. No confidence interval or other uncertainty estimate for satisfaction is reported in the registry record, so the precision of the primary result cannot be evaluated.
How should an unadjusted result be distinguished from a causal effect?
In general, an unadjusted estimate is calculated without controlling for other variables. Even a precisely estimated difference does not necessarily represent a causal effect if the groups differ in ways that influence the outcome. In this study, the central limitation is more basic: the record describes a single treatment group rather than a comparison between groups. It does not report an adjusted or unadjusted comparative treatment estimate. No statistical model, covariate adjustment, or hypothesis test for the primary endpoint is described in the registry record.
What do the safety counts represent?
In general, adverse-event counts and the number of people at risk describe recorded safety experience over a specified observation period. They do not, on their own, establish whether treatment caused an event. Interpretation may depend on event definitions, follow-up, seriousness criteria, and whether the reported value counts events or people with events. The registry records 2 serious adverse events among 60 at risk and 18 other adverse events among 60 at risk. It does not provide further event-level detail or the follow-up rules needed for a broader safety interpretation.
The record also includes planning assumptions for illustrative sample-size calculations: two-sided significance level 0.05, equal allocation between two arms, and a normal approximation, with the effect to detect defined as a stated fraction of an observed effect. These are planning assumptions, not a description of the study’s actual single-group design. The registry does not report the study’s own sample-size justification or statistical analysis plan. In general, sample-size calculations describe design requirements under assumptions; they are not observed power and do not replace estimates and uncertainty intervals for the results actually observed.
Finally, no analysis records are listed. That absence does not demonstrate that no analyses were conducted; it means the registry record does not provide analysis details. Without a reported analysis method and numerical endpoint results, the primary outcome cannot be independently checked or assessed for sensitivity to alternative methods.
10. Multiplicity, Missing Data and Analysis Populations
The registry lists a primary satisfaction outcome and two secondary outcomes: global aesthetic improvement from baseline and related adverse events. It does not report a multiplicity strategy, such as a prespecified hierarchy or an adjustment for testing several outcomes. The statistical analysis plan is not reported in the registry record, so it is not possible to determine whether multiplicity was addressed outside the information recorded there.
In general, examining multiple outcomes or multiple statistical tests can increase the chance of a seemingly notable result arising by chance. Methods for controlling that risk depend on the questions and testing plan. This general issue does not imply that any particular result in this study is significant; numerical outcome results and hypothesis tests are not reported in the record.
The primary analysis included the 56 subjects who answered the satisfaction questionnaire. The record does not explain why the other enrolled subjects did not contribute questionnaire answers, how missing responses were handled, or whether any imputation or sensitivity analysis was used. In general, complete-response analyses may be vulnerable to bias if response availability is related to the outcome. Whether that concern applies in this study cannot be assessed from the registry information.
The record does not report an intention-to-treat analysis population, a per-protocol population, or other analysis-population definitions beyond the stated questionnaire respondent group. It also does not explain exclusions, protocol deviations, or how participants with incomplete follow-up were treated. These omissions limit the ability to assess whether the analyzed group and endpoint measurement matched a prespecified plan.
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 |
|---|---|---|---|
| Azzalure and Restylane | 2 | 60 | 3.3% |
Other (non-serious) adverse events
Participants with at least one non-serious event at or above the registry's 2% reporting threshold.
| Arm | Participants affected of at risk |
|---|---|
| Azzalure and Restylane | 18 of 60 |
Most frequent serious adverse event terms
| Event term | Organ system | Azzalure and Restylane |
|---|---|---|
| Colon cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 1 of 60 |
| Cerebral infarction | Nervous system disorders | 1 of 60 |
Most frequent non-serious adverse event terms
| Event term | Organ system | Azzalure and Restylane |
|---|---|---|
| Skin swelling | Skin and subcutaneous tissue disorders | 9 of 60 |
| Nasopharyngitis | Infections and infestations | 3 of 60 |
| Injection site haematoma | General disorders | 2 of 60 |
| contusion | Injury, poisoning and procedural complications | 2 of 60 |
| headache | Nervous system disorders | 2 of 60 |
Serious events with the highest arm-level rate: colon cancer (1.7%), cerebral infarction (1.7%).
The registry records 2 serious adverse events among 60 at risk in the Azzalure and Restylane group. It records 18 other adverse events among 60 at risk. The record lists colon cancer and cerebral infarction as serious-event terms, each reported at 1.7%. These entries describe safety events recorded in the study; they do not by themselves establish that treatment caused the events.
In general, serious adverse events are distinguished by seriousness criteria, not simply by how often an event occurs. The registry information does not provide enough detail to assess event timing, individual clinical circumstances, duration of follow-up, or causal attribution. It also does not clarify whether the counts represent events or people with at least one event. The deaths field has no reported value, so deaths are not reported in the registry record.
These counts should be read as descriptive safety information for the recorded treatment group. With no comparator group in the design, the counts do not provide a comparative estimate of safety. They also should not be treated as a complete account of all possible harms beyond the events captured and recorded in this study.
12. What the Result Does, and Does Not, Mean
The registry record identifies an open, single-group study of combined Azzalure and Restylane treatment, with subject satisfaction for the full face at Month 6 as the primary outcome. It reports that the satisfaction analysis included 56 questionnaire respondents. It does not report the numerical satisfaction result, the questionnaire scoring rule, or an uncertainty estimate. The central outcome therefore cannot be quantified from the registry information.
Even if a numerical satisfaction estimate were available, the single-group design would support a descriptive interpretation rather than a randomized comparison. It would describe the responses observed among the analyzed subjects, not establish what their responses would have been under an alternative treatment or without treatment. The open design also means that subjects were not masked, and the registry does not report any blinded outcome assessment. These features are relevant when interpreting a subjective questionnaire outcome.
Because both interventions were given to the same treatment group, the record cannot distinguish the separate contributions of Azzalure and Restylane. It also does not report results for its listed secondary outcomes, global aesthetic improvement from baseline and related adverse events, beyond the adverse-event counts and terms recorded.
The safety entries document 2 serious adverse events and 18 other adverse events among 60 at risk, with colon cancer and cerebral infarction each listed at 1.7% among serious-event terms. These descriptive entries do not establish causation or provide a comparison with another treatment. Overall, the record defines a research question and provides limited design and safety information, but does not provide the primary numerical result needed to judge the observed level of satisfaction.
13. Why This Trial Matters Statistically
This study illustrates why an outcome’s label is not enough to interpret it. “Subject satisfaction” sounds straightforward, but a percentage depends on the questionnaire, its scoring rule, the threshold used to define satisfaction, and the denominator. The registry identifies a satisfaction questionnaire and a respondent analysis group, yet does not report the score definition or numerical result. Those omissions prevent assessment of both the magnitude and precision of the primary outcome.
The design also makes the estimand—the quantity the study can describe—important. A single-group study can characterize responses in its treatment group, but it does not provide a randomized contrast. Since Azzalure and Restylane were administered together, the study record also cannot distinguish their individual contributions. These are not merely technical details: they set the boundary between describing an observed experience and claiming a comparative treatment effect.
The difference between the enrollment and questionnaire analysis populations further highlights the importance of missing-data reporting. The registry records 60 enrolled subjects and states that 56 questionnaire respondents were analyzed. Without reasons for nonresponse or information about missing-data handling, readers cannot determine how representative the respondent-based outcome may be of everyone enrolled. This is a general interpretive limitation, not proof that the observed responses were biased.
Finally, the registry’s safety counts are informative as descriptive entries but not as causal comparisons. Counts, denominators, event definitions, follow-up, and attribution all matter when evaluating safety. The record gives some counts and serious-event terms, while leaving other details unreported. Taken together, this trial is a useful example of how design, outcome definition, analysis population, and result reporting jointly determine what can be concluded from a clinical study record.
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 limitations specific to this study follow from the information in the registry record. First, the primary numerical satisfaction result is not reported. The numerator, percentage, and uncertainty measure are absent, so the outcome’s magnitude and precision cannot be evaluated. The record also does not state the questionnaire’s response options, scoring method, or the rule used to classify satisfaction.
Second, the analysis was limited to 56 subjects who answered the satisfaction questionnaire, while the recorded enrollment was 60. Reasons for missing answers, missing-data methods, and comparisons of respondents with nonrespondents are not reported in the registry record. The possibility of nonresponse-related selection is a general concern; the record does not establish whether it occurred.
Third, there was no randomized comparator group, and masking was listed as none. The study can describe the treatment group’s recorded experience, but it cannot make a like-for-like comparison or separate the effects of the two interventions given together. The registry does not report a control condition or blinded outcome assessment.
Fourth, numerical results for the listed secondary outcomes are not reported. The record does not describe the statistical analysis plan, multiplicity handling, or analysis-population definitions beyond the questionnaire respondent group. It also does not report the study’s sample-size justification. These gaps limit assessment of prespecification and analytic robustness.
Finally, safety information is limited to the recorded event counts and terms. Details about timing, event-level circumstances, follow-up, and causal attribution are not reported in the registry record. The deaths field is also without a reported value. These limitations do not establish that an outcome or event was absent; they describe what cannot be determined from the registry information.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Subjects' Satisfaction on Pan Facial Aesthetic Enhancement After Treatment With Azzalure® and the Restylane® Range — NCT01529203.
- Registry record last updated 2021-02-18; status last verified 2014-09.
- Results first posted 2014-04-25.
- Data retrieved from ClinicalTrials.gov on 2026-11-09.
- Group sizes, means, event counts and sponsor-reported p-values are reproduced as posted. Effect estimates, confidence intervals and p-values not attributed to the sponsor are independently calculated from the posted summary statistics.
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18. Record Summary
This is a completed, open, multicentre, single-group Phase 3 study sponsored by Galderma R&D. The registry records 60 enrolled subjects and treatment with Azzalure and Restylane. The stated aim was to assess satisfaction with pan-facial rejuvenation management using injections of the two products.
The primary endpoint was full-face subject satisfaction at Month 6, assessed by questionnaire. The analysis included 56 subjects who provided answers. The numerical satisfaction result, questionnaire scoring details, and uncertainty estimate are not reported in the registry record. Listed secondary outcomes were global aesthetic improvement from baseline and related adverse events.
The record reports 2 serious adverse events and 18 other adverse events among 60 at risk. Colon cancer and cerebral infarction are each listed at 1.7% among serious-event terms. The study has no recorded comparator group, and no analysis records are listed.