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 Poly-l-lactic Acid (PLLA) for the Improvement in Appearance of Cellulite (NCT05064761), a na na study. The primary outcome is Number of Aesthetic Improved Thighs of Responders According to Global Aesthetic Improvement Scale (GAIS) as Assessed Live by Treating Investigator at Month 9.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT05064761 |
| Phase | NA |
| Condition | Cellulite |
| Allocation | Not applicable (single group) |
| Design model | Single Group |
| Masking | None (open label) |
| Enrollment | 29 |
| Arms in the primary outcome | n/a |
| Lead sponsor | Galderma R&D |
| Results posted | Yes |
2. Clinical Question
Population
The study concerned participants with cellulite. The primary endpoint description defines the Full Analysis Set as participants who were injected in both thighs. Further eligibility details, such as age range and other inclusion or exclusion criteria, are not reported in the registry record.
Intervention
Participants received PLLA described as Sculptra new dilution. The treatment group description says the regimen was intended to improve the appearance of cellulite. The record frames the study as evaluating safety and effectiveness after a change in reconstitution procedure. Detailed administration procedures are not reported in the registry record.
Comparator
The record describes a single-group study, with allocation and masking listed as not applicable and none, respectively. A separate untreated, placebo, or active comparator is not reported in the registry record. The study therefore does not provide a randomized, like-for-like comparison against another group.
Primary question
The primary endpoint was the number of thighs judged aesthetically improved at Month 9 by the treating investigator using the Global Aesthetic Improvement Scale. A responder was defined by a rating of improved or better relative to pretreatment. The endpoint asks how many thighs met that rating threshold; the count and its uncertainty are not reported in the registry record.
This is a question about investigator-assessed appearance at a specified follow-up, not a comparison of treatment effects between groups. The study also registered assessments at other visits and by participant photography, but those do not replace the stated primary endpoint. The registry record does not report the primary outcome result, so no estimate of the frequency of improved thighs can be drawn from this record.
3. Trial Design
This was a completed pilot study of PLLA for cellulite, registered as a single-group study. Enrollment was 29. The intervention was Sculptra new dilution, described as PLLA new dilution for treatment intended to improve cellulite appearance. The registry lists allocation as not applicable and masking as none. It does not describe a concurrent control group, so the study is not a randomized comparison and its treatment group cannot be contrasted with a like-for-like control arm.
The registry gives a study start date of 2021-11-19 and a primary completion date of 2022-12-21. It lists the status as completed and the phase as not applicable. The sponsor is Galderma R&D. The registry describes the work as a pilot study evaluating safety and effectiveness after changes in the reconstitution procedure. Further details about the protocol, treatment schedule, follow-up procedures, or the rationale for the enrolled sample size are not reported in the registry record.
The primary endpoint concerns investigator-assessed GAIS response at Month 9. Registered secondary outcomes include investigator live assessments at Month 1, 2, 6 and 12, and participant photography assessments at Month 1, 2, 6, 9 and 12. Those are assessment occasions and approaches, not results. Outcome values and statistical analyses are not reported in the registry record. The single-group design can describe outcomes observed among treated participants, but without a concurrent comparison it cannot separate changes during follow-up from other explanations for those changes.
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 29 participants were enrolled in the study. All enrolled participants were treated and completed the study.
Overall Study
| Stage | Treatment Group (Sculptra) |
|---|---|
| STARTED | 29 |
| COMPLETED | 29 |
| NOT COMPLETED | 0 |
Analysis population for the primary outcome, as defined in the registry: Full Analysis Set (FAS) Included all participants who were injected in both thighs.
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 | Treatment Group (Sculptra) |
|---|---|---|
| Participants analysed | 29 | |
| Age, Continuous | years | 41.2 (SD 9.01) |
| Sex: Female, Male: Female | Participants | 29 |
| Sex: Female, Male: Male | Participants | 0 |
| Ethnicity (NIH/OMB): Hispanic or Latino | Participants | 1 |
| Ethnicity (NIH/OMB): Not Hispanic or Latino | Participants | 27 |
| Ethnicity (NIH/OMB): Unknown or Not Reported | Participants | 1 |
| Race (NIH/OMB): American Indian or Alaska Native | Participants | 0 |
| Race (NIH/OMB): Asian | Participants | 5 |
| 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 | 23 |
| Race (NIH/OMB): More than one race | Participants | 1 |
| Race (NIH/OMB): Unknown or Not Reported | Participants | 0 |
6. Primary Endpoint
The registry lists the primary outcome as Number of Aesthetic Improved Thighs of Responders According to Global Aesthetic Improvement Scale (GAIS) as Assessed Live by Treating Investigator at Month 9, measured over At Month 9.
| Element | Registry entry |
|---|---|
| Result type | Count Of Units |
| Measure of spread | not applicable |
| Unit | Thighs |
| Endpoint classification | not reduced to a single comparison |
The primary endpoint is a count of thighs rated as aesthetically improved at Month 9 by the treating investigator using GAIS. The assessor compares a photograph taken before the first treatment at baseline with the current visit. GAIS is described as a 7-graded scale ranging from very much worse to very much improved. A responder is a participant rated improved, much improved, or very much improved relative to pretreatment. The endpoint counts thighs meeting that response definition.
This endpoint translates an ordinal appearance rating into a responder count: ratings at or above the defined threshold qualify, while ratings below it do not. The threshold makes the outcome easier to describe as a count, but it does not preserve all distinctions among the scale’s categories. For example, the endpoint does not separately quantify the difference between improved and very much improved ratings.
The unit is thighs, while the response definition is stated for participants. The primary population is the Full Analysis Set, defined as participants injected in both thighs. The registry record does not report the Month 9 count, the distribution of individual GAIS ratings, or the denominator used for the endpoint result. It also does not report an uncertainty interval or a statistical test. The endpoint is useful for describing the recorded appearance assessment at a specified follow-up, but the available record does not provide a numerical outcome to interpret.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry record identifies a primary outcome and defines how a responder was classified, but it does not report the primary endpoint count. It also lists zero analyses. As a result, the posted record does not establish how many thighs met the response threshold at Month 9, how precise an estimate would be, or whether any statistical comparison was made. The endpoint definition alone is not a result.
The study’s single-group design is central to interpretation. A before-and-current photograph comparison can describe the treating investigator’s assessment of appearance over follow-up. Without a concurrent control group, however, an observed change cannot be attributed uniquely to the intervention. The record does not include a randomized control, and the stated allocation is not applicable. This limitation remains even if a response count is reported elsewhere; a within-group observation is not the same as an estimated difference between treatment and control.
The primary outcome is a thresholded count based on an ordinal rating. It communicates how many assessed thighs crossed the specified response threshold, but not the full spread of GAIS ratings or the magnitude of change for each thigh. Because the endpoint is expressed in thighs and both thighs are included in the defined analysis population, observations from the same participant may be related. Any analysis of such data would need to account for the structure of the observations, but the statistical model is not reported in the registry record.
The secondary assessments cover additional follow-up visits and include both treating-investigator live assessments and participant photography assessments. They offer different views of appearance ratings, but their result values are not reported. Nor is it reported whether the assessment approaches were intended to be combined, compared, or analyzed separately. The existence of multiple visits and outcome assessments also raises questions about how results were selected and how chance findings were controlled; the registry record does not report a multiplicity plan.
Safety information is limited to the adverse-event figures recorded for the treatment group: zero serious adverse events among 29 at risk, 10 affected by other reported adverse events among 29 at risk, and zero deaths. These counts describe the registry categories and do not establish that no safety events could occur. The record does not provide event descriptions, severity details for the other events, or an exposure-adjusted analysis.
Overall, the record supports describing the study design, endpoint definition, and posted safety counts. It does not support a numerical conclusion about the primary appearance outcome, its precision, or comparative effectiveness. Those results are not reported in the registry record.
9. Statistical Methods Explained
The registry record names the primary outcome and defines the responder threshold, but does not report the statistical analysis plan or an analysis of the endpoint. The following concepts are general explanations of how outcomes of this kind may be interpreted; they are not claims about methods used in this study.
What does a responder count represent?
A responder count records the number of units meeting a specified rule. Here, the rule is a treating-investigator GAIS rating of improved, much improved, or very much improved compared with pretreatment, and the unit reported is thighs. A count is descriptive unless it is paired with a clear denominator and an analysis that answers a specified question. The registry record does not report the Month 9 count or its denominator, so neither a response proportion nor an uncertainty estimate can be stated from this record.
Turning an ordinal rating into a responder category can make a result straightforward to communicate. It also discards information: ratings just on either side of the threshold are treated differently, while ratings within the responder category are grouped together. The count therefore does not show how many thighs received each GAIS category or how far assessments shifted across the scale. Those details are not reported in the registry record.
Why does the unit of analysis matter?
The endpoint is expressed in thighs, and the defined Full Analysis Set includes participants injected in both thighs. Two observations from the same participant may share characteristics and may not be statistically independent. In general, treating related observations as if they were independent can make uncertainty appear smaller than it is. Suitable approaches may account for clustering or summarize outcomes at the participant level, depending on the research question and data structure. The registry record does not report which approach, if any, was used.
That distinction also affects the interpretation of denominators. A thigh count is not automatically a participant count. The registry record defines responders by participant rating but describes the primary outcome as a number of thighs; it does not report enough outcome detail to reconstruct the relationship between participant responses and the thigh count. No denominator or conversion should be inferred.
What would uncertainty add?
In general, a confidence interval communicates the precision of an estimate by giving a range of values compatible with the data under the analysis assumptions. A count by itself does not show whether the estimate is precise. For this single-group endpoint, an interval could describe uncertainty around a response frequency if the necessary result and denominator were reported. It would not, by itself, create a control comparison or show that a change was caused by treatment. No interval for the primary endpoint is reported in the registry record.
For count outcomes, a statistical model may be selected according to whether the count is a total, a rate, or a count bounded by a known set of assessed units. General count models can rely on assumptions about the mean and variability of the outcome. Over-dispersion means the observed variability is greater than a model expects; ignoring it can lead to uncertainty estimates that are too narrow. These are general considerations only. The registry record does not report a model, its assumptions, or checks of model fit.
How should the planning illustrations be read?
The planning illustrations are described as calculations based on the observed effect, not as the trial’s original design justification. Their stated assumptions are a two-sided significance level of 0.05, equal allocation between two arms, a normal approximation, and an effect set to a stated fraction of the observed effect. For time-to-event calculations, the stated quantity is a total event count using the Schoenfeld approach; other calculations are expressed as participants per arm.
These are planning assumptions for hypothetical future studies, not observed power for the completed single-group study. In particular, an equal-allocation, two-arm planning setup does not describe the registered single-group design. The registry record does not report the observed primary effect needed to evaluate those illustrations, and it does not report the underlying outcome result. The planning figures should therefore be treated as conditional design illustrations rather than evidence that the study had a particular power or that its primary endpoint reached a particular result.
A planning calculation also depends on the effect chosen for detection and on the assumptions used to translate that effect into a sample-size requirement. In general, smaller target effects require more information to distinguish them from random variation, all else being equal. That general principle does not fill in missing study results or reveal the sample-size rationale used by the sponsor. Such a rationale is not reported in the registry record.
10. Multiplicity, Missing Data and Analysis Populations
The record registers a primary endpoint at Month 9 and secondary GAIS assessments at several follow-up visits, using treating-investigator live assessment or participant photography. When a study examines multiple outcomes, visits, assessors, or contrasts, the chance of at least one apparently notable result can rise if many tests are conducted. A multiplicity plan can specify which outcome is primary, whether secondary tests are confirmatory or exploratory, and whether adjustments or an ordered testing strategy will be used. These are general statistical considerations.
The registry record does not report a multiplicity strategy, a statistical analysis plan, or any analyses. It therefore does not say whether results across visits or assessment methods were adjusted, prioritized, or interpreted as exploratory. The primary endpoint designation identifies the stated principal outcome, but it does not establish how other outcomes were handled analytically.
The primary outcome population is described as the Full Analysis Set, including participants injected in both thighs. The record does not report missing-data counts, reasons for missing assessments, imputation methods, rules for incomplete follow-up, or whether the analysis population changed for any visit. These omissions matter because an outcome count can depend on which assessments are available and how missing observations are treated.
The registry record also does not report whether any analyses excluded participants or observations, or whether sensitivity analyses were conducted. Without those details, readers cannot assess the effects of incomplete data or compare alternative analysis assumptions. No conclusions about multiplicity control or missing-data handling can be drawn from the available registry information.
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 |
|---|---|---|---|
| Treatment Group (Sculptra) | 0 | 29 | 0.0% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| Treatment Group (Sculptra) | 0 of 29 |
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 |
|---|---|
| Treatment Group (Sculptra) | 10 of 29 |
Most frequent non-serious adverse event terms
| Event term | Organ system | Treatment Group (Sculptra) |
|---|---|---|
| Nasopharyngitis | Infections and infestations | 3 of 29 |
| COVID-19 | Infections and infestations | 2 of 29 |
| Bronchitis | Infections and infestations | 1 of 29 |
| Sinusitis | Infections and infestations | 1 of 29 |
| Urinary tract infection | Infections and infestations | 1 of 29 |
| Intervertebral disc protrusion | Musculoskeletal and connective tissue disorders | 1 of 29 |
| Urethral prolapse | Renal and urinary disorders | 1 of 29 |
The registry lists the Treatment Group (Sculptra) with 29 at risk for serious adverse events and zero affected; it also lists 29 at risk for other adverse events and 10 affected. Deaths are listed as zero. These are counts in the registry’s safety categories. The record does not provide descriptions of the other reported events, their severity, timing, relationship to treatment, or the method used to collect them.
A zero count for serious adverse events means that none are recorded in that category for the listed group. It does not establish that serious events are impossible, nor does it describe risks outside the observed study experience. The record does not provide a control group for comparison or an exposure-adjusted event rate. The other-adverse-event count should likewise be read as a recorded count, not as a complete characterization of safety.
These figures describe the safety information posted in the registry record; they do not determine whether treatment is appropriate for any person. More detailed event-level reporting and a suitable comparison would be needed to make broader statistical comparisons of safety.
12. What the Result Does, and Does Not, Mean
The record establishes that a completed pilot study evaluated a new PLLA dilution in a single group, and it specifies a Month 9 investigator-assessed GAIS responder count as the primary endpoint. It also gives the responder definition and identifies secondary assessments at other visits and by participant photography. This information clarifies what the study set out to measure.
It does not establish the primary outcome result. The registry record does not report the number of improved thighs at Month 9, the corresponding denominator, an uncertainty interval, or a statistical test. It is therefore not possible to quantify the observed appearance outcome or its precision from the record. The presence of an endpoint definition should not be mistaken for evidence that the threshold was met by any particular number of thighs.
Even if an outcome count were available, the single-group design would remain important. Without a randomized control group, a change from pretreatment cannot be distinguished from other influences on appearance ratings over time. The registry record also does not provide analysis details that would establish how dependence between thighs, missing assessments, or multiple visits were handled.
The safety record lists zero serious adverse events among 29 at risk, 10 affected by other adverse events among 29 at risk, and zero deaths. Those figures are limited to the posted categories and do not supply event descriptions or a comparative safety estimate. They should not be interpreted as proof that no risk exists.
The appropriate statistical reading is consequently bounded: the registry describes the study question, design, responder rule, and limited safety counts, but does not report the primary result or its analysis. It cannot support a quantified statement about the endpoint’s magnitude, precision, or comparative effect.
13. Why This Trial Matters Statistically
This trial is statistically informative as an example of why a clearly defined outcome and a reported outcome result are both needed. The registry specifies a Month 9 GAIS threshold and the unit as thighs. That makes the intended endpoint understandable, but without the count, denominator, and analysis, the central outcome cannot be evaluated quantitatively.
The single-group design also illustrates the difference between describing a within-group observation and estimating a comparative effect. An assessment relative to pretreatment can document a change in rating, but it does not supply the counterfactual information that a concurrent comparison would provide. The record explicitly lacks a like-for-like control comparison, so any causal interpretation would exceed the design information posted.
The endpoint’s thigh-level unit raises a further general issue: observations within a participant can be related. Good statistical reporting explains how the analysis handles that structure, alongside the response definition and the denominator. The registry record does not report such methods, which limits assessment of precision even if a count were available.
Finally, the multiple registered assessment visits and methods make transparency about analysis choices important. A stated primary endpoint helps readers distinguish the main question from supporting assessments, while multiplicity and missing-data reporting help explain how the evidence was assembled. Those methods are not reported. The posted safety counts offer limited descriptive information, but do not replace event-level detail or a comparative safety analysis.
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 follow from the registry information. The study is single-group, with no randomized control or like-for-like comparator reported. It is therefore not designed in the record as a direct comparative evaluation. The registry describes the study as a pilot, but does not report a sample-size justification or explain the intended precision of the primary estimate.
The principal limitation for interpreting the primary outcome is that the Month 9 count is not reported. Neither its denominator nor an uncertainty estimate is available in the registry record. The record also lists no analyses, and does not report the statistical model or analysis plan. It is not possible to determine how the endpoint was summarized or how the relation between thighs from the same participant was handled.
The secondary outcomes cover multiple visits and assessment approaches, but their results are not reported. The registry record does not state how multiplicity was addressed, whether any assessments were exploratory, or whether missing data occurred. Eligibility details and further treatment and follow-up procedures are also not reported in the registry record, limiting assessment of how broadly the findings might apply.
Safety reporting is restricted to summary counts. The record does not give event descriptions, timing, severity details for other events, or comparative rates. These limitations concern what can be assessed from the registry record; they do not establish that additional information was not collected.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Safety and Effectiveness of Poly-l-lactic Acid (PLLA) for the Improvement in Appearance of Cellulite — NCT05064761.
- Registry record last updated 2024-09-26; status last verified 2024-05.
- Results first posted 2024-09-26.
- 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.
Continue through the Clinical Biostats statistical pathway
Use this trial's endpoint as a starting point for deeper study of effect measures, confidence intervals, and sample-size planning.
18. Record Summary
NCT05064761 is a completed pilot study of Sculptra new dilution, a PLLA intervention intended to improve cellulite appearance. It is described as a single-group study with enrollment of 29, no masking, and allocation listed as not applicable. The primary endpoint is the number of thighs rated improved or better on investigator-assessed GAIS at Month 9 among the Full Analysis Set, defined as participants injected in both thighs.
The registry record does not report the primary endpoint result, an analysis, or a statistical analysis plan. It lists zero serious adverse events among 29 at risk, 10 affected by other adverse events among 29 at risk, and zero deaths. These safety counts do not provide event-level or comparative information. The record supports description of the design and outcome definitions, but not a quantified conclusion about the primary appearance result.