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 Safety and Effectiveness of Restylane® Kysse for Lip Augmentation in Chinese Subjects (NCT05342753), a na na study. The primary outcome is Percentage of Participants Assessed as At Least 1-point Improvement From Baseline on Medicis Lip Fullness Scale (MLFS).
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT05342753 |
| Phase | NA |
| Condition | Lip Augmentation |
| Allocation | Not applicable (single group) |
| Design model | Single Group |
| Masking | None (open label) |
| Enrollment | 22 |
| Arms in the primary outcome | n/a |
| Lead sponsor | Galderma R&D |
| Results posted | Yes |
2. Clinical Question
Population
Chinese subjects with lip augmentation were enrolled. The registry record lists an enrollment of 22. The primary outcome’s analysis population is described as participants treated in both lips who were evaluable for that outcome.
Intervention
Participants received Restylane Kysse, described as hyaluronic acid. The study was open-label and evaluated aesthetic improvement following treatment.
Comparator
There was no separate comparator group. The registry identifies a single-group design, with allocation listed as NA; the baseline assessment is the reference for measuring change.
Primary question
At Week 8, what percentage of participants were assessed as having at least 1-point improvement from baseline on the Medicis Lip Fullness Scale (MLFS)? The registry record does not report the outcome result.
The primary question concerns whether participants’ lip fullness ratings changed from their own baseline assessment after treatment. It is not a comparison of Restylane Kysse with an untreated group or another product. Consequently, the design can describe outcomes among treated participants, but it does not provide a direct estimate of how those outcomes differ from what would have occurred under a separate control condition.
The registry also lists secondary outcomes involving the Wrinkle Assessment Scale and the Global Aesthetic Improvement Scale, including investigator assessment at specified follow-up visits. It lists 14 outcome measures in total. However, the registry record does not report the primary outcome percentage, the secondary outcome results, or statistical analyses for these measures. The clinical question is therefore identifiable, while its answer cannot be established from the posted results.
3. Trial Design
This is a prospective, open-label, single-group clinical study of Restylane Kysse for lip augmentation in Chinese subjects. The registry describes it as a phase IV, post-marketing study in the brief summary, while the phase field is listed as NA. Galderma R&D is identified as the sponsor. The study status is completed, and the registry lists enrollment of 22.
All enrolled participants received the same intervention, Restylane Kysse, which is described as hyaluronic acid. The record lists no masking and no allocation to different study groups. There is therefore no randomized treatment contrast or like-for-like control group. The planned primary assessment is a change from baseline in the MLFS, assessed at Week 8. The listed secondary outcomes include responder measures on the Wrinkle Assessment Scale and the Global Aesthetic Improvement Scale at follow-up visits.
The registry lists the study start as 2022-06-13 and primary completion as 2024-10-25. These dates describe the record’s timeline; they do not supply results or establish when any analysis was performed.
For the primary endpoint, the record defines the modified intent-to-treat population as participants treated in both lips. It further clarifies that the overall number analyzed refers to participants evaluable for that outcome. The number of participants actually included in the primary analysis, the number with missing endpoint assessments, and the handling of missing values are not reported in the registry record.
Because the study is single-group and open-label, results would be descriptive of the observed participants and assessments. Without a concurrent comparator, changes from baseline cannot by themselves separate a treatment-associated change from other influences, such as assessment expectations or changes that might occur over time. The registry record does not report a protocol-based statistical plan, a sample-size justification, or details of any interim analyses.
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 25 participants with a score of 1 (Very Thin) or 2 (Thin) on the Medicis Lip Fullness Scale (MLFS) were screened for the study, of which 3 were screen failures. 22 participants were treated with Restylane Kysse in at least 1 lip.
Overall Study
| Stage | Restylane Kysse |
|---|---|
| STARTED | 22 |
| COMPLETED | 15 |
| NOT COMPLETED | 7 |
Reasons for not completing this period:
| Reason | Restylane Kysse |
|---|---|
| Withdrawal by Subject | 6 |
| Lost to Follow-up | 1 |
Analysis population for the primary outcome, as defined in the registry: The modified intent-to-treat (mITT) population included all participants who were treated in both lips. Here, 'overall number of participants analyzed' signifies participants evaluable for this outcome measure.
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: The safety population included all participants who were treated with Restylane Kysse in at least 1 lip and were analyzed according to the treatment actually received.
| Characteristic | Unit | Restylane Kysse |
|---|---|---|
| Participants analysed | 22 | |
| Age, Continuous | years | 43.1 (SD 13.5) |
| Sex: Female, Male: Female | Participants | 21 |
| Sex: Female, Male: Male | Participants | 1 |
| Race (NIH/OMB): American Indian or Alaska Native | Participants | 0 |
| Race (NIH/OMB): Asian | Participants | 22 |
| 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 Chinese | Participants | 22 |
| MLFS-upper lip: 1 (very thin) | Participants | 0 |
| MLFS-upper lip: 2 (thin) | Participants | 22 |
| MLFS-lower lip: 1 (very thin) | Participants | 0 |
| MLFS-lower lip: 2 (thin) | Participants | 22 |
6. Primary Endpoint
The registry lists the primary outcome as Percentage of Participants Assessed as At Least 1-point Improvement From Baseline on Medicis Lip Fullness Scale (MLFS), measured over At Week 8.
| Element | Registry entry |
|---|---|
| Result type | Number |
| Measure of spread | not applicable |
| Unit | percentage of participants |
| Endpoint classification | Binary Endpoint |
The primary endpoint is the percentage of participants assessed as having at least 1-point improvement from baseline on the Medicis Lip Fullness Scale at Week 8. The MLFS is described as a validated, photograph-based instrument designed specifically to quantify lip fullness. In this study, the investigator assessed fullness by live visual assessment. The scale ranges from Grade 1, “Very Thin,” to Grade 5, “Very Full,” with higher scores reflecting greater lip fullness.
The endpoint converts each participant’s change into a responder classification: a participant is counted as a responder if the assessment is at least 1 point higher than baseline. The reported measure is intended to express the proportion of evaluable participants meeting that threshold, rather than the average scale score or the size of change for every participant. The registry record does not report the number of responders, the number analyzed, or the resulting percentage.
A responder threshold can make an outcome easier to interpret as a count of participants meeting a defined change criterion. At the same time, it does not show how far above the threshold a participant’s score changed, nor does it describe participants who did not meet the threshold in detail. The registry record does not state whether the threshold was chosen as a clinically important difference or provide a justification for the Week 8 assessment timing. These details are not reported in the registry record.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry establishes the study question and design, but it does not provide the primary endpoint result. Although the primary outcome is defined as the percentage of participants with at least 1-point improvement from baseline on the MLFS at Week 8, no responder count, analyzed denominator, percentage, confidence interval, or hypothesis-test result is reported in the registry record. Therefore, the size and precision of the observed primary outcome cannot be described from the posted results.
The same limitation applies to the listed secondary outcomes. The record names responder outcomes on the Wrinkle Assessment Scale and the Global Aesthetic Improvement Scale, including investigator assessments at Weeks 8, 16, 24, 32, 40, and 48, but does not report their results. It lists 14 outcome measures and zero analyses. That listing does not show which outcomes were measured successfully or how any observed values were distributed.
The available safety figures report zero participants with serious adverse events among 22 at risk, and two participants with other adverse events among 22 at risk. The record also reports zero deaths. These are descriptive counts from this study; they are not estimates of comparative risk because no control group is listed. The record does not identify the other adverse events by term, and it lists no serious adverse-event terms.
A confidence interval, if reported, would indicate the range of values compatible with the observed data under the specified statistical method. Its width would help convey precision. Since no primary estimate or interval is reported, the uncertainty around the primary outcome cannot be assessed from the registry record. Likewise, there is no basis to describe statistical significance or to distinguish a small, uncertain estimate from a larger, more precise one.
The single-group design also limits interpretation of any before-and-after result that might have been observed. A baseline comparison describes change over time among treated participants; it does not establish what the corresponding change would have been without treatment or with another intervention. Open-label assessment may also be susceptible to expectations because participants and investigators were not masked, though the registry does not report whether or how such influences were assessed.
Accordingly, the posted information supports a description of the study’s intended endpoint, follow-up outcomes, and selected safety counts. It does not support a numerical conclusion about aesthetic response, comparative effects, or the statistical certainty of any treatment-associated change. Missing outcome results should not be interpreted as evidence of either benefit or lack of benefit.
9. Statistical Methods Explained
Statistical interpretation depends on matching the method to the outcome, the design, and the way participants entered the analysis. The registry record identifies a binary responder endpoint, a single-group design, and a modified intent-to-treat population, but it does not report the statistical analysis plan or outcome estimates. The concepts below explain how such information is generally read; they do not assert that a particular method was used in this study.
What does a responder percentage represent?
For a binary responder outcome, each evaluable participant is classified according to whether the stated criterion was met. The responder percentage is a summary of the number meeting that criterion relative to the number analyzed. Its interpretation depends on both quantities: the count of responders and the denominator. A percentage without a clear denominator can be difficult to interpret, especially if some participants lack an assessment or are excluded from the analysis.
Here, the stated criterion is at least 1-point improvement from baseline on the MLFS at Week 8. The registry defines the primary population as participants treated in both lips and says that the overall number analyzed means participants evaluable for this outcome. It does not give the actual denominator or the responder count. As a result, the endpoint definition is available, but its estimate cannot be reconstructed from the registry record.
How should uncertainty be understood?
An estimate from a study is subject to sampling uncertainty: another set of participants could produce a different observed result, even if the study procedures were unchanged. A confidence interval is a statistical range intended to express uncertainty around an estimate under its method and assumptions. A narrow interval generally indicates greater precision than a wide interval, but an interval does not resolve design limitations or bias. No confidence interval for the primary outcome is reported in the registry record.
A hypothesis test and its p-value address a different question: how compatible the observed data are with a specified null hypothesis under the model. A p-value does not express the probability that a treatment works, the size of an effect, or its clinical importance. No primary outcome p-value or hypothesis test is reported. In a single-group study with change from baseline, interpretation would also depend on the precise null hypothesis and analysis model, neither of which is reported in the registry record.
What can a single-group design estimate?
In general, a single-group before-and-after analysis describes change within the participants who were assessed. It does not directly estimate a difference between treatment groups. Without a concurrent comparator, changes may reflect the intervention, natural changes over time, expectations, measurement conditions, or other influences. These possibilities are not separated by a baseline comparison alone. The registry describes no randomized comparison, and the listed skip note indicates that the arms are not a like-for-like control comparison.
Open-label status means masking is absent. For an investigator-assessed visual outcome, knowledge of treatment could potentially affect assessment; participants’ expectations could also influence subjective assessments. These are general considerations, not evidence that an assessment bias occurred in this trial. The registry record does not report procedures to reduce or evaluate such influences.
How do analysis populations matter?
The primary outcome population is described as modified intent-to-treat and includes participants treated in both lips, with analysis limited to those evaluable for the measure. An analysis restricted to evaluable participants may differ from an analysis that includes everyone enrolled or treated. If participants without endpoint data differ in important ways from those with data, the observed responder proportion may not represent the full enrolled group. The registry record does not report how many participants were evaluable, whether any assessments were missing, or how missing data were handled.
General statistical practice may include sensitivity analyses to explore how assumptions about missing outcomes affect conclusions. Such analyses are not reported in the registry record. It is also not possible to determine whether the stated population was the only population analyzed, because detailed analysis results are not listed.
What do planning sample sizes mean?
Sample-size calculations are planning illustrations, not observed evidence of an outcome. A calculation based on an observed effect is especially dependent on that effect estimate and on the assumptions used for significance level, allocation, and statistical approximation. The registry record describes a planning illustration based on the observed effect, with two-sided significance level 0.05, equal allocation between two arms, and a normal approximation. It does not report the calculated sample-size values in the registry record for this analysis, and it does not identify these assumptions as the trial’s own design justification. They should not be interpreted as observed power. The record does not report the trial’s sample-size justification.
For a single-group study, a hypothetical two-arm planning calculation does not create a control group or change the interpretation of the actual design. Planning assumptions cannot replace reported endpoint estimates, uncertainty intervals, or a transparent account of the analysis population. In this registry record, those outcome analysis details are not reported.
Why do event distributions matter?
For binary outcomes, statistical precision depends in part on the number of participants and how many meet the criterion. Sparse events can make estimates less stable and confidence intervals wider. This is a general property of binary data, not a claim about the unreported MLFS response distribution. The registry’s safety counts are also descriptive and do not establish comparative safety in the absence of a control group.
10. Multiplicity, Missing Data and Analysis Populations
The record lists 14 outcome measures, including a primary MLFS responder endpoint and secondary responder outcomes assessed at multiple follow-up visits. When several outcomes or time points are tested, the chance of obtaining at least one apparently notable result by chance can increase. General approaches to address multiplicity include specifying a testing hierarchy, adjusting significance thresholds, or treating analyses as descriptive. The registry record does not report whether any multiplicity strategy was planned or used, so the status of any statistical claims across outcomes cannot be assessed.
The registry reports zero analyses. It does not provide the primary endpoint result, secondary outcome estimates, confidence intervals, p-values, or a statistical analysis plan. It is therefore not possible to determine which outcomes were analyzed, whether any results were selected for reporting, or whether analyses were prespecified.
The primary population is described as participants treated in both lips and evaluable for the endpoint. The record does not report the number evaluable or the number with missing Week 8 assessments. It also does not explain how missing data were handled, whether participants with incomplete follow-up were included in any other analysis, or whether sensitivity analyses were conducted. These omissions matter because a responder percentage depends on both the response count and the analysis denominator, and exclusions or missing assessments can affect interpretation.
The registry record does not report an interim-analysis plan or whether any interim analyses took place. It also does not report a sample-size justification. These details should not be inferred from the completion status, enrollment figure, or planning assumptions.
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 |
|---|---|---|---|
| Restylane Kysse | 0 | 22 | 0.0% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| Restylane Kysse | 0 of 22 |
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 |
|---|---|
| Restylane Kysse | 2 of 22 |
Most frequent non-serious adverse event terms
| Event term | Organ system | Restylane Kysse |
|---|---|---|
| Dermatitis allergic | Skin and subcutaneous tissue disorders | 1 of 22 |
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | 1 of 22 |
The registry reports zero participants with serious adverse events among 22 at risk in the Restylane Kysse group. It reports two participants with other adverse events among 22 at risk, and zero deaths. These are counts of affected participants as recorded, not a comparison between treatment groups.
The record lists no serious adverse-event terms. It also does not identify the other adverse events by name, describe their severity or timing, or indicate whether they were judged related to the intervention. The categories therefore provide only a limited summary of reported safety events.
A count of zero serious adverse events in a study of this size does not establish that serious events cannot occur. More generally, observed event counts describe what was recorded among the participants followed; they do not by themselves quantify comparative risk or rule out uncommon events. Because there is no control group, these figures cannot show whether event counts differ from those under another intervention or no intervention.
The record’s safety information should be read as a descriptive account rather than a complete characterization of risks. Further detail on event definitions, collection procedures, follow-up, and individual event terms is not reported in the registry record.
12. What the Result Does, and Does Not, Mean
The study’s primary question is clearly defined: it concerns the percentage of evaluable participants assessed as having at least 1-point improvement from baseline on the MLFS at Week 8. The registry identifies the scale, the assessment method, and the analysis population. However, the primary result itself is not reported in the registry record. There is no reported responder count, denominator, percentage, interval, or test result from which to assess the outcome’s magnitude or precision.
The absence of a posted estimate is not evidence that no change occurred. It also does not show that a change did occur. The endpoint description tells readers what investigators intended to measure, while the results are needed to establish what was observed. The same distinction applies to the listed secondary outcomes: their names and assessment times do not substitute for their results.
The single-group, open-label design is important to the interpretation. If a change from baseline were reported, it would describe the participants’ course after treatment, not a randomized difference from a separate comparison group. The design cannot, by itself, distinguish treatment-associated change from time effects, expectations, or other influences. This is a limitation of the comparison structure, not a finding about whether any particular influence occurred.
The safety counts offer a narrow descriptive view: zero participants with serious adverse events, two with other adverse events, and zero deaths are reported among 22 at risk in the intervention group. The record does not supply event terms for the other adverse events or further clinical details. These counts should not be read as proof that risks are absent or as a comparison with another option.
Overall, the registry record supports statements about the design, intended endpoints, and recorded safety counts. It does not support a conclusion about the size, statistical certainty, or comparative meaning of the primary aesthetic outcome. Any interpretation should keep that gap between a defined outcome and a reported result explicit.
13. Why This Trial Matters Statistically
This study is statistically informative as an example of the distinction between a clearly specified endpoint and an available result. The registry defines a responder threshold on the MLFS, specifies Week 8, and describes who could enter the primary analysis. Those details allow the clinical question to be understood. Yet without the responder count and denominator, the primary estimate cannot be assessed.
The design also illustrates why the comparison structure matters. A single-group study can describe observed outcomes among treated participants, but a baseline reference is not equivalent to a concurrent control. Statistical analysis cannot remove the central interpretive limitation that no separate group is available to represent what might have happened under another condition. An estimate’s precision, even if reported, would not by itself address that limitation.
The record lists multiple outcome measures and repeated assessment times. This raises general questions about prespecification and multiplicity: readers need to know which analyses were planned and how results across endpoints and visits were interpreted. Those details are not reported in the registry record. The absence of analysis results makes it impossible to evaluate the outcome pattern or any multiplicity handling.
The safety summary further demonstrates the difference between descriptive counts and comparative evidence. Counts among participants at risk can communicate what was recorded in the study, but without event detail or a comparator they cannot establish relative safety. The posted information is therefore useful for identifying the study’s intended measurement framework and the limits of its available reporting, rather than for making a comparative statistical judgment.
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 main trial-specific limitation in interpreting the posted record is that the primary endpoint result is not reported. The registry provides no responder count, analysis denominator, percentage, confidence interval, or hypothesis-test result. Secondary outcome results are also not reported, despite the listed outcome measures and follow-up assessments.
The study has no separate comparator group and is open-label. Consequently, a change from baseline, if reported, would not quantify a randomized difference against another intervention or a control condition. Investigator assessment of lip fullness is described as live visual assessment, and no masking is listed. The registry does not report procedures for assessing or limiting potential influence from expectations or unmasked assessment.
The primary analysis population is restricted to participants treated in both lips who are evaluable for the endpoint. The number meeting that definition is not reported. Nor does the record state whether participants missed the Week 8 assessment, how missing values were handled, or whether sensitivity analyses were performed. This prevents assessment of how exclusions or incomplete data could affect the endpoint estimate.
The registry does not report the statistical analysis plan, multiplicity handling, sample-size justification, or interim-analysis details. The safety information is also limited: serious-event terms are not listed, other adverse events are not named, and further event detail is not reported. These reporting gaps limit assessment of both efficacy outcomes and safety patterns; they should not be filled by assumptions about the protocol or the unreported analyses.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Safety and Effectiveness of Restylane® Kysse for Lip Augmentation in Chinese Subjects — NCT05342753.
- Registry record last updated 2025-12-22; status last verified 2025-12.
- Results first posted 2025-12-22.
- 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
NCT05342753 is a completed, prospective, open-label, single-group study of Restylane Kysse for lip augmentation in Chinese subjects. The registry lists enrollment of 22 and describes the study as phase IV and post-marketing in its brief summary, while the phase field is NA. The primary outcome is the percentage of participants with at least 1-point improvement from baseline on the MLFS at Week 8.
The registry identifies the outcome population as participants treated in both lips who were evaluable for the measure, but it does not report the analyzed denominator or primary result. It lists 14 outcome measures and zero analyses. Serious adverse events were reported for zero participants among 22 at risk; other adverse events were reported for two participants among 22 at risk, with zero deaths. The event terms and primary statistical results are not reported in the registry record.