To Show the Safety and Effectiveness of the Demetech Barbed Polydioxanone (PDO) Suture: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for To Show the Safety and Effectiveness of the Demetech Barbed Polydioxanone (PDO) Suture (NCT06404372), a na na study. The primary outcome is Improvement From Baseline on the Lemperle Classification Wrinkle Scale.

2. Clinical Question

3. Trial Design

The record identifies NCT06404372 as a completed, pivotal, multi-center study of the Demetech Barbed PDO Suture. It lists the study start as 2022-07-18 and primary completion as 2023-12-04. Enrollment is listed as 57, and the summary describes follow-up over a 12-month period across up to four sites. The arm description states that 57 subjects would be treated, with up to 2 additional run-in subjects potentially treated for investigator familiarization. The run-in details are truncated, and the registry record does not clarify whether those participants were included in enrollment or analyses.

The design is recorded as single group, with allocation listed as NA. Consequently, the study has no listed concurrent control arm and does not support a randomized, like-for-like treatment comparison. The primary effectiveness benchmark is a target response rate rather than outcomes observed in a control group. The record lists phase as NA.

The official title calls the study blinded, and the primary endpoint description specifies a panel of three blinded evaluators who assess subject photographs. However, the masking field is NONE. The registry record does not explain how these descriptions relate, which participants or study personnel were masked, or whether masking applied only to outcome assessment. The endpoint description supports evaluator blinding for the wrinkle rating, but details beyond that are not reported.

The study evaluates a device for temporary treatment of midface wrinkles. Its listed primary completion date and completed status describe the trial’s registry status, not whether its endpoint met the stated criterion. Outcome results and a detailed statistical analysis plan are not reported in the registry record.

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 59 subjects were consented and screened; 2 subjects did not pass inclusion/exclusion criteria, for a total of 57 subjects enrolled. Although the protocol allowed for up to 2 run-in subjects per investigator, no run-in subjects were enrolled.

Overall Study

Analysis population for the primary outcome, as defined in the registry: Per Protocol Set, consisting of all treated subjects for whom the 6-month assessment was completed with no major protocol deviations

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: Intent to Treat/Safety Evaluation Set

6. Primary Endpoint

The registry lists the primary outcome as Improvement From Baseline on the Lemperle Classification Wrinkle Scale, measured over 6 Month.

The primary effectiveness endpoint is the percentage of participants with at least a 1-point improvement from baseline on the Lemperle Classification Facial Wrinkle Scale at 6 months. A panel of three blinded evaluators rates subject photographs, and the median panel score is used to determine whether each participant is a responder. The analysis population is the Per Protocol Set: treated participants who completed the six-month assessment without major protocol deviations.

This endpoint turns a change in a wrinkle rating into a responder outcome. Each participant is classified according to whether the specified improvement threshold is met, and the primary summary is the proportion who respond. The threshold gives the responder definition a clear rule, while the blinded panel is intended to reduce the influence of knowledge of treatment when ratings are made. These are general statistical considerations; the registry record does not provide evidence about the reliability of the ratings or the extent to which masking was maintained.

The record states that clinical effectiveness would be demonstrated by superiority of the six-month response rate over a target rate of 60%. This is a one-group benchmark question, not a comparison with an untreated or alternative-treatment group. The actual responder count, response percentage, uncertainty interval, and test result are not reported in the registry record. The endpoint definition therefore explains what would be measured, but does not reveal the observed result.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

What does a responder endpoint measure?

In general, a responder endpoint converts a continuous or graded measurement into a yes-or-no classification using a prespecified threshold. In this study, the classification is based on whether the Lemperle Classification Facial Wrinkle Scale improves by at least 1 point from baseline at 6 months. The primary summary is the percentage of participants classified as responders. That percentage is meaningful only alongside the responder definition, the analysis population, and the number of participants whose outcomes were assessed.

A responder endpoint can be easy to interpret because it expresses how many participants met a stated criterion. It also discards some information: participants just below and far below the threshold are both classified as nonresponders, even though their scale changes may differ. The registry record describes the threshold and rating process, but does not report the distribution of individual score changes or the observed responder proportion.

How is the wrinkle response assigned?

The primary description says three blinded evaluators rate subject photographs and that the median panel score determines responder status. A median is the middle value after ratings are ordered. In general, it can reduce the influence of an unusually high or low rating from one evaluator compared with relying on a single rating or an arithmetic average. The record does not report evaluator agreement, rating procedures in detail, or whether evaluators remained blinded throughout assessment. The masking field is NONE even though the endpoint description calls the evaluators blinded; this discrepancy is not explained.

What does the target-rate test ask?

The record says the six-month response rate is intended to be assessed for superiority over a target rate of 60%. In general, a one-sample test of a proportion asks whether the observed response rate is sufficiently inconsistent with a specified benchmark under a statistical model. A confidence interval would describe a range of values compatible with the observed data and assumptions, helping readers assess precision as well as direction. Neither the observed response rate, a confidence interval, nor a test result is reported in the registry record. The statistical test, sidedness, and exact inferential procedure are also not reported.

A target-rate comparison is not the same as a randomized treatment comparison. The target is not a group of participants observed in the same study under an alternative condition. Therefore, a finding relative to the target would not remove the limitations of a single-group design or identify what would have happened to the same population under another approach.

How should the analysis population be understood?

The primary population is identified as the Per Protocol Set: all treated participants for whom the six-month assessment was completed with no major protocol deviations. This definition excludes at least the types of participants described as lacking the assessment or having a major deviation, but the record does not state how many participants fell into either category. It also does not provide a participant flow or an analysis-population count. In general, a per-protocol analysis can describe outcomes among participants who met specified study requirements, but the exclusions can affect how representative the result is of everyone who began treatment.

What do the planning assumptions mean?

General sample-size calculations estimate how many observations might be needed to detect a specified effect under selected assumptions. They are planning illustrations, not evidence that an observed result is reliable and not “observed power.” The stated illustration assumptions use a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation, with effects expressed as fractions of the observed effect. Those assumptions describe a two-arm planning framework, whereas this registry study is recorded as single group. They should not be interpreted as the trial’s prospective design justification or as a direct description of its primary analysis. A sample-size justification for the trial is not reported in the registry record.

General statistical interpretation also depends on variability and the amount of information available. For count or binary outcomes, precision is influenced by the number of participants and the number meeting the event definition. A confidence interval communicates that uncertainty; it does not guarantee that the underlying value lies within the interval. Since the endpoint count and interval are not reported, the precision of the primary response estimate cannot be assessed from the registry record.

The record lists nine outcome measures, including wrinkle-scale outcomes, investigator- and subject-rated improvement, and patient-reported measures. It lists no analyses. The statistical procedures for secondary outcomes, the approach to multiplicity, and the handling of missing observations are not reported in the registry record. Those omissions limit assessment of how the many planned measurements were intended to inform inference.

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.

R code and output

arm    <- c("Demetech Barbed PDO Suture")
n      <- c(37)
events <- c(7)
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  Demetech Barbed PDO Suture  37  7  18.9  8.0  35.2  9.5  34.2  9.6  34.3

11. Multiplicity, Missing Data and Analysis Populations

The registry record lists nine outcome measures, including the primary wrinkle-response endpoint and secondary measures involving wrinkle-scale ratings, global aesthetic improvement, and FACE-Q assessments. Examining several outcomes can create a multiplicity issue: in general, when many statistical tests are conducted, the chance of at least one apparently notable result can increase unless the analysis plan accounts for the number and relationship of the tests. The record does not report a multiplicity procedure, a hierarchy among secondary endpoints, or which outcomes were intended to support confirmatory claims.

The number of analyses is listed as 0, and no analysis results are reported. This does not establish whether analyses were conducted outside the registry record; it means the record does not document them. The statistical plan, test procedures, and reporting conventions are not reported in the registry record.

Missing-data handling is also not reported. The primary population requires completion of the six-month assessment and no major protocol deviations, but the record does not say how participants without that assessment were treated, whether any values were imputed, or how protocol deviations were classified. The number included in the Per Protocol Set is not reported. These details matter because the analyzed participants may differ from all enrolled or treated participants.

The record does not report an intention-to-treat analysis or another analysis population alongside the Per Protocol Set. Without participant flow and a clear account of missing outcomes, readers cannot determine how much the primary estimate reflects exclusions or incomplete follow-up.

12. Safety Results

The registry reports serious adverse events as affected participants divided by participants at risk.

Deaths

Other (non-serious) adverse events

Participants with at least one non-serious event at or above the registry's 3% reporting threshold.

Most frequent non-serious adverse event terms

The registry record lists 57 participants at risk in the Demetech Barbed PDO Suture group. It records 0 participants with serious adverse events and 0 deaths. It also records 26 participants with other adverse events. These are participant counts; the figures do not state how many separate events occurred in total or how often each event type occurred. No top serious adverse-event terms are listed.

The serious-event count is a description of what was recorded for this group, not proof that serious risks are absent. A study of this size and follow-up cannot, from a zero count alone, establish that an uncommon event cannot occur. General interpretation of safety counts also depends on how events were defined, collected, followed, and assessed. Those details, including event timing, severity for the other adverse events, and attribution to the device, are not reported in the registry record.

Because there is no control group, these counts cannot show whether event frequency was higher or lower than it would have been under another treatment or no treatment. The 26 participants with other adverse events should not be combined with the serious-event count: the registry presents these as separate categories, and no participant-level overlap information is reported.

13. What the Result Does, and Does Not, Mean

The record describes a study designed to measure six-month improvement in midface wrinkles and to record adverse events after treatment with the Demetech Barbed PDO Suture. It specifies how a responder was to be classified, identifies a Per Protocol Set for the primary effectiveness analysis, and states that the response rate would be assessed against a target rate of 60%. It also lists safety counts for the single study group.

What the registry record does not establish is whether the primary response criterion was met. The observed responder count and rate, the uncertainty around that rate, and the result of a statistical test are not reported. The trial’s completed status does not supply those missing results. Without them, readers cannot judge the size or precision of the observed response against the target.

Even if the response estimate were available, a single-group benchmark comparison would not be equivalent to a randomized comparison against another treatment. It could describe how the observed rate relates to a chosen threshold, but it would not directly show how the treated participants’ outcomes compare with outcomes under an alternative. The record does not describe a concurrent control group.

The safety counts likewise describe recorded participants in the study group and cannot provide a comparative safety estimate. Zero participants recorded with serious adverse events or deaths does not establish that such events are impossible, and the record does not provide detailed event descriptions or attribution. The 26 participants with other adverse events provide a count, but not a full account of event types or clinical context.

These distinctions separate endpoint design from endpoint evidence. The registry record explains what the study intended to measure and gives limited safety counts; it does not report the primary effectiveness finding or enough statistical detail to assess its precision, missing-data sensitivity, or comparative meaning.

14. Why This Trial Matters Statistically

This trial is statistically notable because its primary effectiveness question uses a single-group target-rate benchmark rather than a concurrent control group. That design makes the wording of the conclusion especially important. A response rate can be compared with a specified threshold, but the threshold is not a sample of participants receiving another treatment. This distinction helps prevent a benchmark result from being mistaken for a randomized treatment effect.

The endpoint also illustrates how measurement choices shape a result. The study defines response as at least a 1-point improvement on a named wrinkle scale at a specified follow-up, with classification based on the median rating from three evaluators. A reader needs all of those elements to understand what the responder percentage would represent. The registry does not report the observed percentage or the rating reliability, so the endpoint definition is clearer than the evidence available for its outcome.

The record highlights the importance of analysis populations and follow-up. The Per Protocol Set requires a completed six-month assessment and no major protocol deviations, but its size and participant flow are not reported. Without these details, it is difficult to understand the reach of the primary estimate or how incomplete follow-up might matter.

Finally, the record pairs a title describing a blinded study with a masking field of NONE, while the endpoint description specifies blinded evaluators. This makes reporting clarity relevant to interpretation: readers need to know which parts of assessment were masked and how. More broadly, a completed trial record can state design and safety counts without reporting efficacy estimates, uncertainty, or analysis methods. Recognizing that distinction is central to careful reading.

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 central limitation for statistical interpretation is that the registry record does not report the primary effectiveness result. There is no observed responder count or rate, confidence interval, or test result with which to assess the stated comparison against 60%. The record also lists no analyses, so it does not document the inferential methods used to evaluate the endpoint.

The single-group design has no listed concurrent control. As a result, the design cannot make a randomized comparison with another treatment, and changes from baseline cannot be separated from other influences using a control group. The target response rate is a benchmark, but its rationale is not reported in the registry record.

The primary analysis is limited to the Per Protocol Set, defined by completion of the six-month assessment and absence of major protocol deviations. The number in that set, participant flow, and handling of missing assessments are not reported. The record does not provide enough information to assess the effect of exclusions or incomplete follow-up.

There is a reporting inconsistency about masking: the official title describes a blinded study and the endpoint specifies blinded evaluators, while the masking field is NONE. The registry record does not resolve this difference. Details of outcome-rating procedures and evaluator agreement are also not reported.

For safety, the record gives participant counts but not detailed event types, timing, severity for the other adverse events, or attribution. The study has no control group for comparative safety interpretation. The summary describes follow-up over a 12-month period, but detailed follow-up completeness is not reported. The number of sites actually involved, the detailed handling of run-in participants, and a prospective sample-size justification are also not reported in the registry record.

16. Related Tutorials

17. Related Statistical Calculators

18. Sources

• ClinicalTrials.gov: To Show the Safety and Effectiveness of the Demetech Barbed Polydioxanone (PDO) Suture — NCT06404372.
• Registry record last updated 2026-08-11; status last verified 2026-06.
• Results first posted 2026-08-11.
• 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.

19. Record Summary

NCT06404372 is listed as a completed, single-group, multi-center study of the Demetech Barbed PDO Suture for temporary treatment of midface wrinkles. Enrollment is 57; the summary describes follow-up over 12 months and up to four sites. The primary effectiveness endpoint is the percentage of participants in the Per Protocol Set with at least a 1-point improvement on the Lemperle Classification Facial Wrinkle Scale at 6 months, based on ratings by a panel of three blinded evaluators. The stated benchmark is a target response rate of 60%.

The record lists 0 participants with serious adverse events, 0 deaths, and 26 participants with other adverse events among 57 at risk. It does not report the observed primary response result, its precision, or the analysis used. The allocation field is NA and the design is single group, so no concurrent control comparison is listed. The masking field is NONE, although the endpoint description refers to blinded evaluators; the discrepancy is not explained.