A Study of Octave System for Improving Lines and Wrinkles of the Décolleté: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for A Study of Octave System for Improving Lines and Wrinkles of the Décolleté (NCT04681352), a na na study. The primary outcome is Percentage of Treated Subjects With Improvement in Lines and Wrinkles of the Décolleté at Day 90.

2. Clinical Question

This is a before-and-after question within a treated group, not a randomized comparison of treatment against another intervention or no treatment. The primary measure is a percentage of subjects meeting the photograph-based improvement criterion. The endpoint definition makes the evaluators’ judgments central to the outcome, but the number of evaluators and further details of their assessment process are not reported in the registry record. The record also lists a secondary improvement outcome at Day 180 and a secondary measure of treatment-emergent adverse events. These outcomes address later improvement and safety, respectively, but their results are not reported in the registry record. Without a reported primary result, the registry entry does not establish how often improvement was observed or how precisely it was estimated.

3. Trial Design

The registry record describes a prospective, multicenter study of Octave treatment for lines and wrinkles of the décolleté. It is marked completed and lists enrollment of 99. The recorded start date is 2020-12-29, and the primary completion date is 2021-11-24. The phase is listed as NA.

The design is recorded as single group, with allocation listed as NA. The intervention is Octave-Ultherapy treatment, and the arm description specifies a single treatment of décolleté tissue. There is no concurrent control group in the record. Accordingly, the study is not a randomized comparison and its treated-group results should not be read as a treatment-versus-control estimate.

The official title describes the study as evaluator-blind, while the registry masking entry is NONE. The registry record does not explain this difference or provide further details about who was blinded. The primary assessment compares Day 90 photographs with baseline photographs. The record defines improvement as a judgment of improved by at least two evaluators, but does not state the number of evaluators or describe their training, independence, or assessment procedures.

The primary endpoint is the percentage of treated subjects with improvement at Day 90. A secondary outcome concerns improvement at Day 180, and another concerns treatment-emergent adverse events. The registry record lists three outcome measures, but it reports no analyses. No statistical analysis plan, sample-size justification, interim analysis plan, or details of endpoint analysis are reported in the registry record. The recorded completion status describes the study’s status; it does not supply the missing outcome estimates or statistical results.

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: Of the 153 screened subjects, 54 subjects exited as screen failures and 99 subjects were enrolled to receive a single Octave-Ultherapy treatment in this study.

Overall Study

Reasons for not completing this period:

Analysis population for the primary outcome, as defined in the registry: Intent-to-treat (ITT) population included all subjects who were enrolled.

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 (SP) included all subjects who were enrolled and treated with the Octave System.

6. Primary Endpoint

The registry lists the primary outcome as Percentage of Treated Subjects With Improvement in Lines and Wrinkles of the Décolleté at Day 90, measured over Day 90.

The primary endpoint is the percentage of treated subjects whose décolleté lines and wrinkles were judged improved at Day 90 relative to baseline photographs. The registry definition requires at least two evaluators to assess the Day 90 photographs as improved. The endpoint is therefore a binary classification at the subject level: each subject either meets the improvement criterion or does not. The reported measure would express the share meeting that criterion, but the registry record does not report the observed percentage.

A photograph-based endpoint offers a defined way to assess change in appearance over time. Requiring agreement from at least two evaluators is part of the stated endpoint rule; it does not, by itself, show how consistent the judgments were or how disagreements were handled. The number of evaluators and those procedural details are not reported in the registry record.

General statistical explanation: a binary endpoint can be summarized as a proportion, with uncertainty commonly described using a confidence interval. The estimate describes the observed frequency in the defined study population; its precision depends on the outcome data and analysis. Because the registry record does not report the endpoint estimate, denominator used in an analysis, or confidence interval, neither the observed frequency nor its precision can be assessed from the record. A Day 180 improvement outcome is listed separately as a secondary outcome and should not be substituted for the primary Day 90 measure.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

The registry record identifies a binary percentage endpoint: the percentage of treated subjects with improvement in décolleté lines and wrinkles at Day 90. Each subject is classified according to whether the stated photograph-based criterion is met. The criterion compares Day 90 photographs with baseline photographs and requires at least two evaluators to assess the Day 90 photographs as improved.

What does a percentage endpoint describe?

General statistical explanation: a percentage for a binary outcome describes the proportion of the analyzed population that meets a defined condition. It is a summary of observed outcomes, not a measure of how much each subject improved. For this endpoint, the condition is the evaluator-based improvement rule. The registry record does not report the observed percentage, so the frequency of subjects meeting the rule is unknown from this entry.

The record defines the primary population as the intent-to-treat population and states that it includes all subjects who were enrolled. That is the population specified for the endpoint. The record does not say whether all enrolled subjects had Day 90 photographs, whether any were excluded from the analysis, or how missing observations were handled. The stated population definition alone does not resolve those analysis details.

Why does uncertainty matter?

General statistical explanation: an estimate from a study is subject to sampling variability. A confidence interval communicates uncertainty around an estimate under a specified method. Its width depends on the data and the method used; the interval is not a guarantee that the true value lies within its limits. Without the reported endpoint estimate, analysis denominator, and interval, the precision of the primary result cannot be evaluated. No confidence interval or hypothesis test is reported in the registry record.

What can a single-group design establish?

The study is recorded as single group, and allocation is listed as NA. The primary endpoint compares photographs over time within the treated group, rather than comparing outcomes between randomized groups. General statistical explanation: a before-and-after assessment can describe change over time in the observed group. Without a concurrent comparator, it cannot separate treatment-associated change from other influences on change, such as measurement variation or changes that might occur without the intervention. This is a design limitation, not a statement about whether improvement occurred.

The registry record lists a prospective, multicenter study and a single treatment of décolleté tissue. It records enrollment of 99. These design details do not substitute for outcome data or analysis methods. The record does not report a statistical model, a method for constructing an interval, a hypothesis-testing procedure, or a plan for handling evaluator disagreement beyond the criterion that at least two evaluators judge the photographs improved.

How should the safety counts be read?

The adverse-event figures are counts of subjects affected, alongside the number at risk. The registry record lists 0 subjects affected by serious adverse events among 99 at risk, 6 affected by other adverse events among 99 at risk, and 0 deaths. These counts should be read as the recorded descriptive results for the listed group, not as a complete account of event types or individual event histories. The serious-event terms list is empty. The registry record does not describe the other events or provide further information about severity, timing, or relatedness.

What is not available for statistical review?

The record lists three outcome measures and names a Day 180 improvement outcome and a treatment-emergent adverse-event outcome as secondary outcomes. It lists zero analyses. No results for those secondary outcomes are reported. The registry record also does not report a sample-size justification, a statistical analysis plan, interim analyses, or a prespecified approach to multiplicity. Those omissions mean that readers cannot determine from the entry how outcome testing was planned, whether adjustments were intended, or how missing outcomes were to be treated.

A planning illustration, when used, is not an observed trial result or evidence of the study’s achieved power. The assumptions recorded for the planning illustration are a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation, with the effect to detect stated as a fraction of the observed effect. The record characterizes the illustration as planning rather than the trial’s own design. Since the study is single group and the primary endpoint estimate is not reported in the registry record, these assumptions do not provide a treatment-versus-control result or a basis for interpreting observed power.

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("Octave-Ultherapy Treatment")
n      <- c(99)
events <- c(62)
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  Octave-Ultherapy Treatment  99  62  62.6  52.3  72.1  52.8  71.5  52.8  71.5

11. Multiplicity, Missing Data and Analysis Populations

The registry record lists three outcome measures. The primary outcome is the percentage of treated subjects with improvement at Day 90. The secondary outcomes include the percentage with improvement at Day 180 and the number of subjects with treatment-emergent adverse events. No analyses are listed, and no results for these outcomes are reported in the registry record.

Multiplicity refers, in general, to the interpretive issue that arises when several outcomes or statistical tests are considered. If multiple tests are conducted, the chance of obtaining at least one apparently notable result can change, depending on the testing plan. The registry record does not report a multiplicity strategy, a hierarchy among outcomes beyond identifying the primary endpoint, or whether any adjustments were planned. No conclusions about how multiple outcomes were handled can therefore be drawn.

The endpoint population is described as the intent-to-treat population, including all enrolled subjects. However, missing-data methods are not reported in the registry record. It does not say whether Day 90 or Day 180 photographs were missing, how missing assessments were treated, or whether any imputation or sensitivity analyses were planned. The number of evaluators and the handling of incomplete or conflicting evaluations are also not reported.

These omissions matter because the analyzed population and missing-data approach can affect a percentage estimate and its uncertainty. The stated intent-to-treat definition identifies the intended population, but does not establish how unavailable endpoint observations were incorporated into an analysis. With no reported outcome estimate, analysis details, or missing-data account, readers cannot assess the robustness of the primary result or compare results across the listed outcomes.

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 5% reporting threshold.

Most frequent non-serious adverse event terms

The registry record lists the Octave-Ultherapy Treatment group with 99 subjects at risk for serious adverse events and 0 affected. It lists 99 at risk for other adverse events and 6 affected. Deaths are listed as 0. These are counts of subjects affected in the recorded group; they are not a complete description of event episodes or clinical details.

The serious adverse-event terms list is empty. The registry record does not identify the other adverse events or describe their severity, timing, duration, outcome, or possible relationship to treatment. It also does not provide enough detail to determine whether the figures represent all events of interest or how events were collected and classified. The named secondary outcome concerns treatment-emergent adverse events, but no separate analysis of that outcome is reported.

General statistical explanation: a count of zero observed serious events is a description of the data recorded, not proof that the underlying risk is zero. Safety interpretation depends on follow-up, event definitions, ascertainment, and the amount of information available. Those details are not fully reported in the registry record. The counts should therefore be read as descriptive results for the listed group rather than as a complete characterization of safety.

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

The registry record establishes that a prospective, multicenter, single-group study evaluated a single Octave-Ultherapy treatment for décolleté lines and wrinkles. Its primary endpoint was defined as improvement at Day 90 relative to baseline photographs, using a rule requiring at least two evaluators to judge the photographs improved. The record gives the endpoint definition and an intent-to-treat population definition that includes all enrolled subjects.

However, the registry record does not report the primary endpoint result. It therefore does not show the percentage of subjects who met the improvement criterion, nor does it provide an estimate of uncertainty. The Day 180 improvement outcome and treatment-emergent adverse-event outcome are listed, but their results are also not reported. A completed study status is not a substitute for these results.

The safety counts report 0 subjects affected by serious adverse events among 99 at risk, 6 affected by other adverse events among 99 at risk, and 0 deaths. These figures describe the recorded group and do not identify the other events or provide details of their severity or relationship to treatment. They do not, by themselves, give a complete assessment of safety.

The single-group design also limits what any within-group change could mean. General statistical explanation: a comparison of outcomes over time in one treated group cannot isolate the intervention’s contribution in the way a suitable concurrent comparison can. The registry record does not include a control group or a randomized treatment comparison.

Accordingly, the record describes the question the study set out to address and reports limited safety counts, but it does not provide the primary result needed to characterize observed improvement. It cannot establish the magnitude or precision of that result from the information reported, and it does not offer a comparative estimate of treatment effect.

14. Why This Trial Matters Statistically

This study illustrates why an endpoint definition and a numerical result are both necessary for statistical interpretation. The registry record specifies a photograph-based Day 90 improvement criterion, including the requirement that at least two evaluators judge the photographs improved. That definition tells readers what outcome was intended to be counted. It does not reveal how many subjects met the criterion, how uncertain the estimate was, or how assessments were handled in practice.

The record also highlights the distinction between a within-group assessment and a comparative trial. It is a single-group study with allocation listed as NA. A change from baseline can describe what was observed over time among treated subjects, but without a concurrent control group it does not estimate how outcomes would have differed under another condition. This distinction is important when interpreting outcomes that are based on subjective or evaluator-assessed judgments.

Safety reporting is another part of the statistical picture. The record reports counts for serious and other adverse events and deaths, while leaving event details and some assessment procedures unreported. Counts provide a useful descriptive starting point, but interpretation also depends on definitions, follow-up, ascertainment, and the amount of information available.

Finally, the record lists multiple outcomes but no analyses, statistical plan, missing-data methods, or multiplicity approach. These details would help readers understand how endpoint estimates were produced and how uncertainty and multiple outcomes were handled. In their absence, the registry entry is informative about the study’s design and intended questions, but its quantitative evidence is limited. The missing primary result is especially consequential because it prevents readers from assessing the endpoint that was designated primary.

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 main limitation for interpreting this trial from the registry record is the absence of reported outcome analyses. Although the primary endpoint is defined and the study is marked completed, the record does not report the Day 90 improvement percentage. It also does not report a confidence interval, hypothesis test, or other estimate of precision. The record lists zero analyses.

The study is recorded as single group, with allocation listed as NA, and has no like-for-like control comparison. This limits causal interpretation of any change from baseline. The endpoint relies on evaluator judgments from photographs, but the registry record does not state the number of evaluators, describe their assessment process in detail, or report evaluator agreement. The official title describes evaluator-blind conduct, while the masking entry is NONE; the record does not clarify this difference.

Other important methods are not reported in the registry record. These include a statistical analysis plan, sample-size justification, interim analysis plan, missing-data handling, and a multiplicity strategy. Although the primary population is defined as all enrolled subjects, the record does not explain how missing Day 90 photographs or assessments would be handled. The results for the secondary Day 180 improvement outcome and treatment-emergent adverse events are also not reported.

Safety information is limited to group counts. The record does not describe the other adverse events, their severity, timing, or relatedness, and the serious adverse-event terms list is empty. These reporting gaps prevent a detailed assessment of the event profile. Together, the missing efficacy results, limited statistical methods, single-group design, and sparse event descriptions constrain what can be concluded from the registry record.

16. Related Tutorials

17. Related Statistical Calculators

18. Sources

• ClinicalTrials.gov: A Study of Octave System for Improving Lines and Wrinkles of the Décolleté — NCT04681352.
• Registry record last updated 2024-01-18; status last verified 2023-12.
• Results first posted 2023-12-21.
• 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

The registry record describes a completed, prospective, multicenter, single-group study of Octave-Ultherapy treatment for décolleté lines and wrinkles. It lists enrollment of 99 and specifies a single treatment of décolleté tissue. The primary endpoint is improvement at Day 90 compared with baseline photographs, defined by at least two evaluators judging the photographs improved. The primary population is the intent-to-treat population, including all enrolled subjects.

The record lists secondary outcomes for improvement at Day 180 and treatment-emergent adverse events. It reports 0 subjects affected by serious adverse events among 99 at risk, 6 affected by other adverse events among 99 at risk, and 0 deaths. It lists no analyses and does not report the primary endpoint result, secondary outcome results, confidence intervals, or detailed analysis methods. The study has no concurrent control group recorded, limiting comparative interpretation.