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 Evaluation of Aline HA, an Implanted Cross-Linked HA Device (NCT01708213), a na na study. The primary outcome is Assessment of Treatment Site Responses Post Procedure.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT01708213 |
| Phase | NA |
| Condition | Disorder of Soft Tissue |
| Allocation | Not applicable (single group) |
| Design model | Single Group |
| Masking | None (open label) |
| Enrollment | 72 |
| Arms in the primary outcome | n/a |
| Lead sponsor | TauTona Group |
| Results posted | Yes |
2. Clinical Question
Population
The study enrolled 72 participants with a recorded condition of Disorder of Soft Tissue. The official title describes treatment of one anatomic feature per participant, with enrollment planned for up to 100 subjects. The registry record does not report further eligibility details or the characteristics of the participants.
Intervention
Participants received Aline HA, an implanted cross-linked hyaluronic acid device used for soft tissue augmentation. The study was prospective, multicenter, and open-label. The registry record describes a single study arm and a six-month follow-up period.
Comparator
There was no concurrent comparator arm. The registry record identifies the study as single-group and does not report randomized allocation. Outcomes therefore describe participants treated with Aline HA; they do not provide a like-for-like comparison with another device, a placebo, or no treatment.
Primary question
The primary question was whether treatment-site responses and adverse events were observed through six months after the procedure. The primary outcome is described as the percentage of participants with any adverse event. The registry record does not report the numerical result for this primary endpoint, so its observed frequency and precision cannot be assessed from the posted primary outcome information.
The record also lists a decrease in the Wrinkle Severity Scale for Nasolabial Folds and participant satisfaction rated by GAIS as secondary outcomes. Their results are not reported in the registry record. The study can therefore be read as a prospective safety evaluation with additional listed outcome domains, but the available outcome information does not establish how those secondary measures changed.
3. Trial Design
This was a multicenter, prospective, open-label study of the implanted cross-linked HA device Aline HA. Its official title describes soft tissue augmentation in up to 100 subjects, treating only one anatomic feature per subject and following participants for six months. The registry record lists 72 participants enrolled, and the study status is completed. The recorded study dates are 2012-10 for study start and 2013-11 for primary completion.
The study had a single group: Dermal Filler - Aline HA. Allocation is listed as NA, masking as NONE, and the model as SINGLE GROUP. These details mean that the posted design has no randomized allocation or masked comparison. Each participant's observations are therefore reported in the context of receiving the intervention, rather than as a treatment contrast against a separate control group.
The stated protocol hypothesis concerned safety through six months, assessed through clinical evaluation of treatment sites and routine tracking of adverse events. The primary outcome is titled Assessment of Treatment Site Responses Post Procedure. The registry lists two secondary outcomes: the number of participants with a decrease in the Wrinkle Severity Scale for Nasolabial Folds and the percentage of participants satisfied with treatment as rated by GAIS.
The registry record does not report the detailed eligibility criteria, the number of participating centers, the schedule of visits, or the procedures used to assess treatment-site responses. It also does not report the planned statistical analysis, the sample-size justification used when designing the study, or whether interim analyses were planned. The planning illustrations associated with the posted results are not the study's original design justification. They use hypothetical assumptions and should not be read as evidence that the trial was designed around those assumptions.
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 | Dermal Filler - Aline HA |
|---|---|
| STARTED | 72 |
| COMPLETED | 71 |
| NOT COMPLETED | 1 |
5. Baseline Characteristics
The table reproduces the baseline characteristics posted in the registry, which describe the participants analysed at baseline and help show whether the randomized groups were comparable.
| Characteristic | Unit | Dermal Filler - Aline HA |
|---|---|---|
| Participants analysed | 72 | |
| Age, Continuous | years | 50.5 (34 to 70) |
| Sex: Female, Male: Female | Participants | 64 |
| Sex: Female, Male: Male | Participants | 8 |
| Region of Enrollment: Canada | participants | 72 |
6. Primary Endpoint
The registry lists the primary outcome as Assessment of Treatment Site Responses Post Procedure, measured over 6 months.
| Element | Registry entry |
|---|---|
| Result type | Number |
| Measure of spread | not applicable |
| Unit | percentage of participants with any AE |
| Endpoint classification | Binary Endpoint |
The primary endpoint is titled Assessment of Treatment Site Responses Post Procedure. Its description says the study assessed treatment-site responses and adverse events through six months after the procedure. The listed measurement unit is the percentage of participants with any adverse event, making the endpoint a participant-level event measure over the stated follow-up period.
Counting participants with an event is useful for communicating how many people experienced at least one recorded event, rather than how many separate event episodes occurred. It can give a reader a broad view of reported safety experience during follow-up. However, a broad any-event measure does not by itself describe the event's type, severity, timing, duration, or relationship to treatment. Those details require additional outcome information.
The registry record does not report the numerical result for the primary endpoint. Although the adverse-event information separately lists 56 participants with other adverse events among 72 at risk, that figure should not be substituted for the missing primary-endpoint result: the record does not explicitly identify it as the primary endpoint estimate. It also lists 0 participants with serious adverse events among 72 at risk. These safety counts provide context, but they do not supply a complete account of treatment-site responses or the primary measure as registered.
The stated six-month period defines the time window for interpreting the endpoint. The registry record does not report whether all participants completed that period or how missing follow-up information was handled. Consequently, the posted information does not establish the completeness of endpoint ascertainment.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry record describes a completed, prospective, open-label, single-group study with 72 participants receiving Aline HA. Its primary safety question concerned treatment-site responses and adverse events through six months. However, the numerical result for the registered primary endpoint is not reported in the registry record. This prevents a direct assessment of the frequency of participants meeting that endpoint and prevents an estimate of its statistical precision.
The adverse-event information reports 0 participants with serious adverse events among 72 at risk, and 56 participants with other adverse events among 72 at risk. These are descriptive counts for the single Aline HA group. They are not a comparison of risk between treatments, because no control group is reported. The record also does not identify the listed other adverse events by term or provide their severity, duration, timing, or relationship to the device. The list of top serious adverse-event terms is empty; the participant count for serious events is reported as 0.
These counts answer different questions from an estimate of the primary endpoint. In particular, the broad primary measure is described as the percentage of participants with any adverse event, while the adverse-event record separates serious events from other events. Without an explicit primary result, the other-event count cannot be assumed to equal the primary endpoint. The registry record does not report a confidence interval, hypothesis test, or other measure of uncertainty for the primary outcome.
The secondary outcomes concern wrinkle severity and participant satisfaction. Their titles indicate that the study intended to assess a decrease in the Wrinkle Severity Scale for Nasolabial Folds and satisfaction rated by GAIS, but numerical results are not reported in the registry record. No conclusion about those outcome measures can be drawn from the titles alone.
Because this was an open-label single-group study, the posted outcomes describe observations after treatment without a concurrent comparator. General statistical interpretation: without a comparison group, changes or events cannot be separated from changes that might occur over time, measurement variation, or other influences. The study can describe the recorded experience in its enrolled group, but the registry information does not quantify a comparative treatment effect.
The primary-completion date and completed status indicate that the study is recorded as finished; they do not establish that every planned measure was reported or that all participants contributed complete follow-up. The registry record does not report the analysis population or the handling of missing outcomes. In the absence of these details and the primary endpoint estimate, the main statistical reading is constrained: safety counts are available, but the registered primary result and its precision are not.
9. Statistical Methods Explained
What kind of outcome is registered?
The primary measure is described as the percentage of participants with any adverse event through six months. This is a binary participant-level outcome: each participant is classified according to whether an event was recorded during the specified period. General statistical explanation: a binary outcome can be summarized as a count of participants with the event and a proportion of those assessed. The proportion is more informative when accompanied by an uncertainty interval, because the observed value alone does not show how much it might vary across comparable samples. The registry record does not report a primary endpoint estimate or confidence interval.
What does a confidence interval communicate?
General statistical explanation: a confidence interval expresses uncertainty around an estimate under the assumptions of the statistical method used. A narrow interval indicates greater precision than a wide interval, while neither interval by itself establishes that an outcome is important or that a treatment caused it. For a single-group event proportion, an interval would describe uncertainty about the event frequency in a population resembling the participants studied. It would not create a treatment comparison where no control group exists. No confidence interval for the primary endpoint is reported in the registry record.
How should the single-group design affect interpretation?
The study is recorded as SINGLE GROUP, with allocation listed as NA and masking as NONE. General statistical explanation: a single-group study can describe outcomes observed after an intervention, but it cannot directly estimate the difference between that intervention and a concurrent comparator. An open-label design also means the record does not describe masked outcome assessment. These design features do not invalidate the descriptive safety counts, but they limit the kinds of causal or comparative conclusions those counts can support.
What is the role of the posted adverse-event counts?
The adverse-event record gives counts of participants at risk and affected, separately for serious and other adverse events. It lists 0 serious events among 72 at risk and 56 other events among 72 at risk. These should be interpreted as participant counts, not as the total number of individual event episodes. The record does not list serious-event terms, and it does not provide the terms for the other events in the information available. General statistical explanation: distinguishing participant counts from event counts matters because one participant can experience more than one event, while a participant-level summary counts that person only once within the relevant category.
What do the planning illustrations mean?
The associated sample-size calculations are planning illustrations based on an observed effect, not the trial's own design justification and not observed power. Their stated assumptions include a two-sided significance level of 0.05, equal allocation between two arms, a normal approximation, and an effect specified as a fraction of the observed effect. For outcomes other than time-to-event measures, the illustrations are expressed as participants per arm. The Aline HA study itself is single-group, so those hypothetical two-arm assumptions do not describe its actual allocation or design. No new sample-size value should be inferred from the assumptions alone, and the registry record does not report the original sample-size justification.
General statistical explanation: a planning calculation asks how many participants might be needed to detect a chosen effect under specified assumptions. It does not show the probability that the completed study has established an effect, and it does not replace the observed estimate or its uncertainty. The sample-size assumptions should therefore be read as illustrations rather than as evidence about the trial's original planning or its results.
Why can over-dispersion matter?
General statistical explanation: over-dispersion occurs when observed variation is greater than a statistical model assumes. If a model underestimates variation, its uncertainty intervals may be too narrow and its tests may appear more decisive than warranted. This issue is especially relevant when outcomes are counts or clustered observations, but whether it affects a particular analysis depends on the data and model. The registry record does not report a model, an over-dispersion assessment, or an analysis of clustered data, so no such adjustment can be attributed to this study.
What analysis details are available?
The registry record lists one analysis, but does not report its method, estimand, statistical model, confidence-interval method, or hypothesis test for the primary endpoint. It does not report whether analyses were adjusted for participant or site characteristics. The reported outcome information is insufficient to reconstruct an analysis or to assess whether the method's assumptions were met. The primary result and its precision are not reported in the registry record, so statistical interpretation must remain focused on the descriptive design and the separately posted adverse-event counts.
10. Exact Estimates for Each Arm
No two-arm comparison is shown for this trial, but each arm's result can still be summarized with exact interval estimates computed from the posted counts. The Clopper-Pearson interval is exact and conservative; the Wilson interval is a common closer-to-nominal alternative; the Bayesian credible interval uses a uniform Beta(1, 1) prior. For small groups the three can differ noticeably.
| Arm | Participants | Events | Observed % | Clopper-Pearson 95% CI | Wilson 95% CI | Bayesian 95% credible interval |
|---|---|---|---|---|---|---|
| Dermal Filler - Aline HA | 72 | 56 | 77.8% | 66.4% to 86.7% | 66.9% to 85.8% | 66.9% to 85.8% |
R code and output
arm <- c("Dermal Filler - Aline HA")
n <- c(72)
events <- c(56)
for (i in seq_along(n)) {
ci <- binom.test(events[i], n[i])$conf.int # Clopper-Pearson exact interval
cr <- qbeta(c(0.025, 0.975), 1 + events[i], 1 + n[i] - events[i]) # Bayesian, uniform Beta(1,1) prior
wi <- (function(x, n) { p <- x / n; z <- qnorm(0.975); d <- 1 + z^2 / n
c((p + z^2 / (2 * n) - z * sqrt(p * (1 - p) / n + z^2 / (4 * n^2))) / d, (p + z^2 / (2 * n) + z * sqrt(p * (1 - p) / n + z^2 / (4 * n^2))) / d) })(events[i], n[i])
cat(sprintf("ARM|%s|%d|%d|%.1f|%.1f|%.1f|%.1f|%.1f|%.1f|%.1f\n", arm[i], n[i], events[i], 100 * events[i] / n[i],
100 * ci[1], 100 * ci[2], 100 * wi[1], 100 * wi[2], 100 * cr[1], 100 * cr[2]))
}
ARM Dermal Filler - Aline HA 72 56 77.8 66.4 86.7 66.9 85.8 66.9 85.811. Multiplicity, Missing Data and Analysis Populations
The registry record lists three outcome measures: one primary safety endpoint and two secondary outcomes concerning wrinkle severity and treatment satisfaction. When several outcomes are assessed, general statistical explanation: the chance of at least one apparently unusual result can increase if each is tested separately without accounting for the number of tests. Procedures to address multiplicity can include prioritizing outcomes or adjusting inference, but the appropriate approach depends on the prespecified analysis plan.
The registry record does not report whether any multiplicity procedure was planned or used, how the primary and secondary outcomes were ordered for formal testing, or whether secondary analyses were considered exploratory. It also does not report a detailed statistical analysis plan. The posted secondary-outcome titles therefore indicate areas of assessment, not evidence that a particular testing strategy was followed.
The analysis population is not reported in the registry record. The record does not state whether the primary endpoint used all enrolled participants, only participants with evaluable follow-up, or another population. It also does not report the number with completed six-month assessment, the amount or pattern of missing data, or how missing outcome information was handled. Without those details, the extent to which the reported event counts represent complete follow-up cannot be determined.
The record lists 72 participants at risk for both serious and other adverse events, but this does not by itself describe completeness of the primary endpoint assessment or the analysis population for the secondary outcomes. No imputation method, sensitivity analysis, or missing-data assumption is reported in the registry record. These omissions limit assessment of both the reliability of the endpoint summaries and the possibility that missing observations affected the results.
12. 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 |
|---|---|---|---|
| Dermal Filler - Aline HA | 0 | 72 | 0.0% |
Other (non-serious) adverse events
Participants with at least one non-serious event at or above the registry's 0% reporting threshold.
| Arm | Participants affected of at risk |
|---|---|
| Dermal Filler - Aline HA | 56 of 72 |
Most frequent non-serious adverse event terms
| Event term | Organ system | Dermal Filler - Aline HA |
|---|---|---|
| Administration Site Conditions | General disorders | 53 of 72 |
| Headache | Nervous system disorders | 3 of 72 |
The registry record lists 72 participants at risk for serious adverse events and 0 participants affected. It lists 72 at risk for other adverse events and 56 participants affected. These counts are specific to the single Aline HA group and should be read as participants with at least one event in each category, not as counts of every event episode. The registry record does not report the terms for the other adverse events, their severity, timing, duration, or relationship to the device. It lists no top serious-event terms.
A count of 0 serious adverse events in this study is a descriptive observation in the enrolled group. General statistical explanation: observing no events in a study does not establish that the underlying event risk is zero; the precision of that conclusion depends on the amount and completeness of follow-up and on an uncertainty estimate. No confidence interval for the serious-event count is reported in the registry record. Follow-up was stated as six months, but the record does not report whether all participants completed that period.
The other-event count is separate from the registered primary endpoint result, which is not reported in the registry record. It should not be treated as a substitute for that missing endpoint estimate. Nor can these single-group counts establish whether event frequency would differ under another treatment or without treatment.
13. What the Result Does, and Does Not, Mean
The posted information establishes that this was a completed, open-label, prospective, multicenter, single-group evaluation of Aline HA, with 72 participants enrolled and a stated six-month follow-up period. The record includes descriptive adverse-event counts: 0 participants with serious events among 72 at risk and 56 participants with other events among 72 at risk. These observations describe the recorded experience in this study group.
The information does not establish the numerical result of the primary endpoint. Although the endpoint is described as the percentage of participants with any adverse event, that result is not reported in the registry record. The adverse-event counts add safety context but do not replace the primary estimate or provide its precision. The listed secondary outcomes also lack reported results, so no statistical conclusion about wrinkle-severity change or participant satisfaction can be made from the outcome titles.
The study does not provide a concurrent control group. General statistical explanation: a comparison is needed to estimate how outcomes differ between treatment strategies under the study conditions. Without that comparison, the observed counts cannot show whether Aline HA changes event risk relative to another option, nor can they isolate the intervention's effect from other explanations for observed outcomes.
The posted findings also do not establish that all participants completed follow-up, how missing measurements were handled, or which participants were included in each analysis. The registry record does not report a detailed statistical plan, primary-endpoint confidence interval, or formal comparison. Those gaps limit assessment of precision, completeness, and the strength of any broader inference.
Accordingly, the defensible reading is descriptive: the record documents the study design and the adverse-event counts that were posted. It does not provide the primary or secondary outcome estimates needed for a fuller statistical appraisal, and it does not support a comparative treatment-effect conclusion.
14. Why This Trial Matters Statistically
This study illustrates a common distinction in clinical-trial interpretation: a registry can describe a clearly stated safety question and study design while leaving the key endpoint result unavailable. The primary question concerned treatment-site responses and adverse events through six months, yet the numerical primary result and its precision are not reported in the registry record. Recognizing that gap prevents a descriptive safety count from being mistaken for the missing endpoint estimate.
The single-group design also highlights the difference between describing outcomes and estimating comparative effects. Counts of participants with recorded events can characterize what was observed among people receiving Aline HA. Without a concurrent comparator, however, the study does not estimate how those outcomes differ from another treatment or from no treatment. This distinction is important whenever evidence is interpreted beyond the setting in which it was collected.
The record also makes clear why safety summaries need detail beyond a broad count. Serious and other adverse events are listed separately, but the types and timing of the other events are not reported in the information available. A participant count does not convey the number of event episodes or their clinical characteristics. The absence of serious events in the recorded group is a useful descriptive fact, but it is not a precise estimate of risk without uncertainty and follow-up information.
Finally, the trial underscores the value of reporting outcome estimates, analysis populations, missing-data handling, and statistical methods alongside registry design details. Those elements allow readers to assess not just what was intended, but how complete and precise the results are. Here, the record permits a limited design and safety reading while leaving substantial uncertainty about the registered primary and secondary outcomes.
15. 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 primary limitation for interpreting this study is that the numerical result for its registered primary endpoint is not reported in the registry record. The endpoint is described as a percentage of participants with any adverse event through six months, but no estimate or confidence interval is available. The secondary outcome titles are present, but their results are also not reported.
The single-group, open-label design has no concurrent control arm and no randomized allocation. Consequently, the available observations cannot provide a direct treatment comparison. The registry record does not report whether outcome assessment was standardized across centers or whether assessors were masked; masking is listed as NONE.
The adverse-event summary is limited in detail. The record lists 0 participants with serious adverse events and 56 with other adverse events, each among 72 at risk, but it does not report the terms, severity, duration, timing, or treatment relationship for the other events. The record does not report whether all participants completed six-month follow-up or how missing data were managed.
Further details needed to assess representativeness and analysis are not reported in the registry record, including eligibility criteria, participant characteristics, the analysis population, the statistical methods for the primary outcome, and the original sample-size justification. The planning illustrations are not evidence of the trial's actual design rationale. These limitations mean the posted information supports only a restricted descriptive interpretation, rather than a full evaluation of outcome precision, completeness, or comparative effects.
16. Related Tutorials
17. Related Statistical Calculators
18. Sources
- ClinicalTrials.gov: Safety Evaluation of Aline HA, an Implanted Cross-Linked HA Device — NCT01708213.
- Registry record last updated 2014-12-17; status last verified 2014-12.
- Results first posted 2014-12-17.
- 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.
19. Record Summary
NCT01708213 is recorded as a completed, prospective, multicenter, open-label, single-group study of the implanted cross-linked HA device Aline HA. The study enrolled 72 participants and focused on soft tissue augmentation for one anatomic feature, with a stated six-month follow-up. The registry lists the study start as 2012-10 and primary completion as 2013-11.
The primary outcome concerned treatment-site responses and adverse events, measured as the percentage of participants with any adverse event. Its numerical result is not reported in the registry record. The adverse-event information lists 0 participants with serious events and 56 with other events, each among 72 at risk. Results for the two listed secondary outcomes are not reported.
Because the study had no concurrent comparator, the posted counts are descriptive and do not estimate a comparative treatment effect. The registry record also does not report the primary analysis method, analysis population, or missing-data handling.