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 Non-interventional Study, Long Term Treatment on Glabellar Lines With Dysport® in Subjects of Chinese Origin (NCT05089357), a registered phase not stated study. The primary outcome is Percentage of Participants in Each Response Category for Overall Participant Satisfaction at Visit 6, Assessed by the Subject Satisfaction Questionnaire.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT05089357 |
| Phase | Phase not stated |
| Condition | Glabellar Lines |
| Allocation | Not Stated |
| Design model | Not Stated |
| Masking | Not Stated |
| Enrollment | 250 |
| Arms in the primary outcome | n/a |
| Lead sponsor | Galderma R&D |
| Results posted | Yes |
2. Clinical Question
Population
Subjects of Chinese origin with moderate to severe glabellar lines were included in the study description. The registry lists enrollment of 250. The primary endpoint population was the per-protocol set, defined as a subset of the full analysis set with evaluable primary efficacy endpoints, overall good compliance, and no major protocol deviations.
Intervention
The intervention was AbobotulinumtoxinA, identified as Dysport®. The arm description specifies a total dose of 50 U (0.25 mL total), with 10 U (0.05 mL per injection site) at five intramuscular injection sites: two injections into each corrugator muscle and one into the procerus muscle.
Comparator
No control comparator is described. This was a non-interventional study, not a randomized comparison, and allocation is not stated. The registry record therefore does not support a like-for-like comparison between treatment groups.
Primary question
At Visit 6, described as three weeks after the third injection, how did participants rate their overall satisfaction after three treatment cycles with Dysport? The registry labels the timeframe Month 14 and lists response categories of Very Satisfied, Satisfied, Dissatisfied, and Very Dissatisfied. Category percentages and confidence intervals are not reported in the registry record.
The study’s stated purpose was to collect subject and physician satisfaction and treatment experience in real clinical practice. Its primary endpoint concerns participants’ own overall satisfaction, rather than a comparison of treatment with an untreated or alternative-treatment group. Physician satisfaction was listed as a secondary outcome, along with participant satisfaction assessed using a subject satisfaction questionnaire.
This question is descriptive: it concerns the distribution of satisfaction responses among participants assessed at the specified visit. The registry record does not establish that the study was designed to estimate a causal treatment effect, and it does not report a comparator or random allocation. Consequently, satisfaction responses would describe participants’ experiences in the study context, not the difference that would have occurred under another treatment or no treatment.
3. Trial Design
NCT05089357 is described as a prospective, longitudinal, non-interventional, multicenter study of long-term treatment of glabellar lines with Dysport in subjects of Chinese origin. The sponsor is Galderma R&D. The registry lists a start date of 2021-11-11, primary completion on 2023-09-12, a completed status, and enrollment of 250.
Prospective follow-up means the study set out to collect information as participants moved through the observation period, rather than relying only on records assembled after the fact. The stated real-clinical-practice setting distinguishes this study from a randomized efficacy trial with assigned comparison groups. The registry lists AbobotulinumtoxinA as the biological intervention and provides an arm description for participants with moderate to severe glabellar lines.
The arm description specifies a total dose of 50 U (0.25 mL total), with 10 U (0.05 mL per injection site) administered intramuscularly at five injection sites: two injections into each corrugator muscle and one into the procerus muscle. It ends with a reference to “Visits” without giving the remaining visit schedule in the record. The primary endpoint is tied to Visit 6, described as three weeks after the third injection, while its timeframe is labeled Month 14. These labels are both recorded; the registry does not explain their relationship.
No randomized comparator is described, and allocation is not stated. The record does not report the protocol’s sample-size justification, eligibility details beyond the information in the endpoint population definition, or a complete schedule of assessments. Those omissions limit how fully the study’s planned conduct can be reconstructed from the registry entry.
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.
Before assignment: A total of 250 participants were enrolled and received study treatment.
Overall Study
| Stage | AbobotulinumtoxinA |
|---|---|
| STARTED | 250 |
| Per Protocol Set (PPS) | 204 |
| COMPLETED | 216 |
| NOT COMPLETED | 34 |
Reasons for not completing this period:
| Reason | AbobotulinumtoxinA |
|---|---|
| Withdrawal by Subject | 23 |
| Lost to Follow-up | 6 |
| Medical reason | 1 |
| Due to completion of project, participants did not enter the follow-up window period and withdrew | 2 |
| Pregnancy | 2 |
Analysis population for the primary outcome, as defined in the registry: PPS was a subset of the FAS that included all participants who had evaluable primary efficacy endpoints, had overall good compliance, and had no major protocol deviations during the study.
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: FAS included all participants who were screened, enrolled in the study, and treated at least once with study drug.
| Characteristic | Unit | AbobotulinumtoxinA |
|---|---|---|
| Participants analysed | 250 | |
| Age, Continuous | years | 37.1 (SD 9.32) |
| Sex: Female, Male: Female | Participants | 214 |
| Sex: Female, Male: Male | Participants | 36 |
| Race (NIH/OMB): American Indian or Alaska Native | Participants | 0 |
| Race (NIH/OMB): Asian | Participants | 250 |
| 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 | 0 |
| Race (NIH/OMB): More than one race | Participants | 0 |
| Race (NIH/OMB): Unknown or Not Reported | Participants | 0 |
| Race/Ethnicity, Customized: Han (East Asian) | Participants | 229 |
| Race/Ethnicity, Customized: Other | Participants | 21 |
| Region of Enrollment: China | Participants | 250 |
6. Primary Endpoint
The registry lists the primary outcome as Percentage of Participants in Each Response Category for Overall Participant Satisfaction at Visit 6, Assessed by the Subject Satisfaction Questionnaire, measured over Month 14.
| Element | Registry entry |
|---|---|
| Result type | Number |
| Measure of spread | 95% Confidence Interval |
| Unit | percentage of participants |
| Endpoint classification | Binary Endpoint |
The primary endpoint is the percentage of participants in each response category for overall participant satisfaction at Visit 6, assessed with a subject satisfaction questionnaire. Participants were asked, “What is your overall satisfaction after three treatment cycles with Dysport?” The listed response options are Very Satisfied, Satisfied, Dissatisfied, and Very Dissatisfied. The registry gives the timeframe as Month 14 and describes Visit 6 as three weeks after the third injection.
This endpoint captures a participant-reported assessment of the treatment experience. Reporting each category separately preserves the distinction between degrees and directions of satisfaction; combining categories would lose information about the response distribution. The percentage scale is intended to express how common each response was in the analysis population, while the 95% confidence interval, if reported, would convey uncertainty around an estimated percentage.
The endpoint is not a direct measure of glabellar-line severity, nor does it by itself establish a treatment effect compared with another option. It records satisfaction at the specified assessment. The registry defines the primary population as the per-protocol set, a subset of the full analysis set meeting evaluability, compliance, and protocol-deviation criteria. The category percentages, confidence intervals, and number analyzed are not reported in the registry record, so the observed response distribution and its precision cannot be described from this record.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry identifies a participant-satisfaction endpoint but does not report the endpoint’s category percentages or confidence intervals. It is therefore not possible to state how responses were distributed, which category was most common, or how precisely any category percentage was estimated. The endpoint description and the fact that an outcome is registered should not be mistaken for a result.
The endpoint asks participants to rate their overall satisfaction after three treatment cycles. That makes it a patient-reported experience measure at a specified follow-up, rather than a direct measure of clinical change or a controlled estimate of treatment effect. The registry also lists overall physician satisfaction as a secondary outcome, but does not report those results either. With no comparator described and no random allocation stated, the study record cannot establish whether satisfaction would differ under another treatment or under no treatment.
The primary endpoint is specified for the per-protocol set. This set is defined as a subset of the full analysis set with evaluable primary efficacy endpoints, overall good compliance, and no major protocol deviations. The registry does not give the number in either analysis population or describe how missing questionnaire responses were handled. If participants with missing or unevaluable responses were excluded, the resulting response distribution could describe a selected subset rather than everyone enrolled; the extent of any such selection cannot be assessed from the record.
The registry lists enrollment of 250, but enrollment is not the same as the number contributing evaluable endpoint data. The endpoint-specific denominator is not reported in the registry record. The registry lists three outcome measures and no analysis entries. It does not report the statistical model or calculation used for the primary endpoint, nor does it give a rationale for the planned enrollment.
The record also presents the endpoint timing using both Visit 6 and Month 14, while describing Visit 6 as three weeks after the third injection. Without further detail, those timing labels should be read as recorded rather than reconciled by assumption. Overall, the registry supports a description of the study question and design, but not a numerical interpretation of participant satisfaction or a conclusion about treatment benefit.
9. Statistical Methods Explained
Statistical interpretation depends on matching each estimate to its outcome, population, and assessment time. In this study, the primary outcome is a set of response-category percentages for overall participant satisfaction, and the specified population is the per-protocol set. The registry gives the assessment as Visit 6 and the timeframe as Month 14. It does not report numerical estimates for the response categories, their confidence intervals, or the analyzed denominator.
What does a percentage describe?
In general, a percentage for a response category describes the share of participants in the analysis population who selected that category, subject to the endpoint’s response and missing-data rules. The denominator matters: a percentage among participants with evaluable questionnaires may differ from a percentage based on everyone enrolled. Enrollment of 250 is recorded, but the number contributing to the primary endpoint is not reported in the registry record. No category percentage can be reconstructed without both the relevant response count and denominator.
The response categories are ordered in a meaningful way, from Very Satisfied through Satisfied and Dissatisfied to Very Dissatisfied. Reporting them separately retains the full pattern of responses. A single combined satisfaction value could obscure whether responses were concentrated in one category or spread across several; however, the registry does not report any combined measure. The listed primary outcome is the percentage in each category.
How should a confidence interval be read?
In general, a confidence interval describes the uncertainty associated with an estimate under the method used to calculate it. A narrower interval indicates greater precision under that method, while a wider interval indicates less precision. It does not remove possible bias from missing responses, selection into the analysis population, or the observational design. The primary endpoint lists a 95% confidence interval as its dispersion measure, but the interval limits are not reported in the registry record. Therefore, no claim about the precision of the observed satisfaction percentages is possible.
What does the analysis population imply?
The primary population is the per-protocol set, defined in the registry as a subset of the full analysis set. It includes participants with evaluable primary efficacy endpoints, overall good compliance, and no major protocol deviations. These criteria specify who is intended to contribute to the primary endpoint, but the registry does not state how many participants met them. A per-protocol analysis can be sensitive to exclusions because adherence and evaluability may be related to participant experience or outcomes. Whether that occurred cannot be assessed without counts and missing-data details.
What can be inferred from the study design?
In general, prospective data collection helps define when outcomes are assessed, and longitudinal follow-up can capture experiences over time. Neither feature alone creates a randomized comparison. This study is explicitly non-interventional, with no control comparator described and allocation not stated. Satisfaction results, if available, would be descriptive of the study participants and setting. They would not by themselves separate treatment effects from expectations, clinical practice, changes over time, or other influences.
The registry lists a sample-size planning illustration based on an observed effect, with a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation. It says that the effect to detect is a stated fraction of the observed effect; it also distinguishes calculations for time-to-event outcomes from those for other outcomes. Such illustrations are planning exercises, not observed power and not evidence that the study had a comparator or used those assumptions in its conduct. The registry does not report the trial’s own sample-size justification. Because no calculated planning values are reported in the record, none should be inferred.
More broadly, an analysis plan would ordinarily clarify the estimator, the confidence-interval method, handling of missing questionnaires, and any planned subgroup or sensitivity analyses. Those details are not reported in the registry record. The record lists three outcome measures and no analysis entries, so it cannot establish which inferential procedures were ultimately carried out. The primary endpoint’s stated 95% confidence interval identifies an intended uncertainty summary, but not the method used to obtain it.
10. Multiplicity, Missing Data and Analysis Populations
The registry lists three outcome measures, including the primary participant-satisfaction endpoint and secondary outcomes for physician satisfaction and participant satisfaction. It does not report a multiplicity-adjustment strategy or explain how interpretation across outcomes was planned. When several outcomes or response categories are examined, the chance of at least one apparently notable result can increase if each is assessed independently. That general concern does not show that any particular analysis was conducted or that any result is misleading; the registry record does not provide the analysis details needed to evaluate this.
Missing-data handling is not reported in the registry record. The primary endpoint depends on questionnaire responses, so the number of participants with evaluable responses and the treatment of incomplete questionnaires are important for understanding the denominator. The record does not say whether missing responses were excluded, imputed, or handled by another method. It also does not provide the number of participants included in the primary analysis.
The endpoint population is the per-protocol set, described as a subset of the full analysis set. Eligibility for that set required evaluable primary efficacy endpoints, overall good compliance, and no major protocol deviations. The record does not give the size of the full analysis set or per-protocol set, or counts excluded for any reason. Consequently, it is not possible to assess how much the primary analysis population differs from enrollment or whether exclusions could affect representativeness.
The registry lists no analysis entries. It does not report a prespecified statistical analysis plan, interim analyses, or any sensitivity analyses. Their existence or absence beyond what is stated cannot be inferred; those details are not reported in the registry record.
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 |
|---|---|---|---|
| AbobotulinumtoxinA | 1 | 250 | 0.4% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| AbobotulinumtoxinA | 0 of 250 |
Other (non-serious) adverse events
Participants with at least one non-serious event at or above the registry's 5% reporting threshold.
| Arm | Participants affected of at risk |
|---|---|
| AbobotulinumtoxinA | 107 of 250 |
Most frequent serious adverse event terms
| Event term | Organ system | AbobotulinumtoxinA |
|---|---|---|
| Severe leiomyoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 1 of 250 |
Most frequent non-serious adverse event terms
| Event term | Organ system | AbobotulinumtoxinA |
|---|---|---|
| COVID-19 | Infections and infestations | 58 of 250 |
| Upper respiratory tract infection | Infections and infestations | 49 of 250 |
Serious events with the highest arm-level rate: severe leiomyoma (0.4%).
The registry lists 250 participants at risk in the AbobotulinumtoxinA group for the serious-event and other-event summaries. The serious-event entry records 1 affected participant, and the other-event entry records 107 affected participants. Deaths are listed as 0. These are registry-record counts; the entry does not provide additional detail about event timing, duration, severity beyond the serious classification, or causal attribution.
The leading serious-event term is listed as Severe leiomyoma, with a reported percentage of 0.4%. This should be read as the registry’s recorded term and percentage, not as a conclusion that the study established a causal relationship to treatment. The record does not provide a comparator group for assessing relative safety, and non-interventional observation cannot by itself determine whether an event was caused by treatment.
The event summaries do not describe the complete clinical context or provide participant-level information. The registry record does not state how event seriousness or relatedness was assessed, or whether the event categories overlap. Counts from separate categories should not be added together or treated as a total of unique participants. These figures describe the recorded safety entries, not a comparative safety estimate.
12. What the Result Does, and Does Not, Mean
The registry record describes a prospective, non-interventional study designed to collect participant and physician satisfaction and treatment experience during long-term Dysport use for glabellar lines in subjects of Chinese origin. It identifies participant satisfaction at Visit 6 as the primary endpoint and gives the questionnaire response categories. This allows readers to understand what the study intended to measure and in whom.
The record does not report the primary endpoint’s response percentages, confidence intervals, or analysis denominator. It therefore does not show whether participants were mostly satisfied, how varied their responses were, or how precise any estimated category percentage might be. No numerical conclusion about the primary endpoint can be drawn from the endpoint description alone.
Even if satisfaction results were available, an observational study without a described comparator would answer a descriptive question about reported experience in the study setting. It would not, on its own, establish what would have happened to the same participants under a different treatment or without treatment. Satisfaction is also distinct from a direct measure of clinical severity, and the registry does not provide a clinical efficacy result in the information recorded for this endpoint.
The safety counts are also descriptive. The registry records serious and other adverse-event entries and deaths, but does not provide comparative estimates or enough detail to attribute events to treatment. The completed status means the registry marks the study as completed; it does not substitute for reported endpoint results or a detailed analysis. The clearest conclusion is about scope: the record identifies a real-clinical-practice satisfaction study, while leaving its primary numerical findings and several analysis details unreported.
13. Why This Trial Matters Statistically
This study is statistically useful to consider because it illustrates the difference between a clearly stated outcome and a reported result. The registry describes the satisfaction question, response categories, assessment visit, and target analysis population. Those details define what an eventual estimate would mean. Without category percentages, confidence intervals, and denominators, however, the result itself cannot be quantitatively interpreted.
The record also highlights why analysis populations matter. The primary endpoint is assigned to a per-protocol set defined by evaluability, compliance, and absence of major protocol deviations. Those criteria may make the analysis population different from the enrolled group, but the registry does not report the relevant counts. Readers therefore cannot judge how much the analysis population represents all enrolled participants.
Finally, the design distinguishes real-practice experience from a randomized comparison. Participant satisfaction is meaningful as a report of experience, but a non-interventional study without a stated comparator does not isolate a causal effect. Keeping that distinction clear helps prevent descriptive outcomes from being overstated. The record offers a useful outline of the question, while demonstrating why full numerical results and analysis methods are needed for statistical interpretation.
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 what the registry record does and does not report. The primary endpoint’s numerical results are absent: there are no response-category percentages, confidence intervals, or endpoint-specific denominator. As a result, the magnitude and precision of participant satisfaction cannot be assessed.
The design is non-interventional, no control comparator is described, and allocation is not stated. Consequently, the record does not support a randomized or controlled treatment-effect interpretation. The study concerns subjects of Chinese origin, and the information recorded does not establish how broadly the findings would apply beyond the study population.
The primary endpoint is described for a per-protocol population, but the sizes of the full analysis set and per-protocol set are not reported. The record also omits missing-questionnaire handling, the statistical method for the confidence interval, and a detailed analysis plan. The primary timing is labeled Month 14 and also described as Visit 6, three weeks after the third injection; the registry does not clarify this timing description.
The intervention description includes dose and injection-site details but does not provide the full visit schedule in the recorded text. Although enrollment and study dates are listed, the record does not give a sample-size justification. These reporting gaps limit assessment of precision, selection, timing, and the analysis actually performed.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Non-interventional Study, Long Term Treatment on Glabellar Lines With Dysport® in Subjects of Chinese Origin — NCT05089357.
- Registry record last updated 2025-07-09; status last verified 2023-02.
- Results first posted 2025-02-12.
- 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
NCT05089357 is a completed, prospective, longitudinal, multicenter, non-interventional study sponsored by Galderma R&D. It examined participant and physician satisfaction and treatment experience during Dysport treatment for glabellar lines in subjects of Chinese origin. The registry lists enrollment of 250, a start date of 2021-11-11, and primary completion on 2023-09-12.
The primary outcome was the percentage of participants in each overall satisfaction category at Visit 6, described as three weeks after the third injection and labeled Month 14. The primary analysis population was the per-protocol set. The registry lists three outcome measures and no analysis entries. Primary endpoint percentages, confidence intervals, and the analyzed denominator are not reported in the registry record. The safety summary records 1 serious-event entry, 107 other-event entries, and 0 deaths among 250 at risk.