Treatment of the Face and Neck With Lower Ulthera System Energy Settings: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Treatment of the Face and Neck With Lower Ulthera System Energy Settings (NCT01713998), a randomized na study. The primary outcome is Subjects' Assessment of Pain During Treatment With Lower Energy Settings.

2. Clinical Question

The study therefore asks about treatment-session experience, rather than a reported change in skin laxity. The listed secondary outcomes concern quantitative brow lift and participants’ assessments of improvement at follow-up. Those outcomes do not replace the primary pain question, and their numerical results are not reported in the registry record. Without posted estimates, it is not possible to describe the size, direction, or precision of any differences in pain ratings among settings.

3. Trial Design

This was a randomized, double-masked, parallel-design study of the Ulthera System for lifting and tightening the face and neck with lower energy settings. The registry lists the phase as NA and the status as completed. The sponsor is Ulthera, Inc. Enrollment was 47; the brief summary had described enrollment of up to 60 subjects. The registry record lists a start of 2011-09 and primary completion of 2012-06.

The summary describes one treatment on the face and neck, with follow-up visits at 90 and 180 days after treatment. Images were to be obtained before treatment, immediately after treatment, and at each follow-up. Those details describe the planned study procedures; the registry record does not report how many participants completed each visit or had images available.

Group A’s description specifies increased-density treatment over the full face, with energy turned down to the second highest of four possible settings on one side. Group B’s description specifies increased-density guideline treatment over the full face, with energy at the lowest of four possible settings on one side. Group C’s description specifies increased-density guideline treatment, a 4 MHz transducer on the upper face in place of a 7 MHz transducer, and the lowest energy setting. These descriptions do not establish how many participants were in each group or how treatment settings were allocated.

The primary outcome description says research staff blinded to the energy settings completed split-face comparisons of pain scores. Although the overall study is described as double-masked, the identity of both masked parties and the masking procedures are not reported in the registry record. Allocation procedures and group sizes are also 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.

Overall Study

Reasons for not completing this period:

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.

6. Primary Endpoint

The registry lists the primary outcome as Subjects' Assessment of Pain During Treatment With Lower Energy Settings, measured over Participants were assessed for the duration of study treatment, an average of 75 minutes.

The primary outcome was participants’ assessment of pain during treatment with lower energy settings. Participants rated their sensory response using a validated Numeric Rating Scale from 0 to 10, where 0 represented no pain and 10 represented the worst pain possible. The registry specifies a mean as the summary measure and the full range as the dispersion measure. The stated timeframe was the duration of study treatment, averaging 75 minutes.

Ratings were collected after treatment of sections on both sides of the face and neck: submental, submandibular, cheek, periorbital, infraorbital, and forehead. Ratings were also collected for each transducer used. Thus, the endpoint description covers multiple anatomical regions, sides, and treatment settings rather than a single pain rating for each participant. The registry record does not report numerical means, ranges, participant counts contributing to each rating, or a specific single contrast.

As a general statistical rationale, a participant-reported pain scale captures the experience of treatment in the person receiving it. A mean gives a measure of the average rating, while a range conveys the span of recorded values. These summaries answer different questions: the average does not show how ratings were distributed, and the range does not show how common ratings near either end were. The endpoint is relevant to treatment-session tolerability, but the posted record does not provide results with which to characterize the ratings.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

The registry record identifies randomization, double masking, and a parallel design, but it does not report a detailed statistical analysis plan. The methods below explain general statistical considerations relevant to the described endpoint; they should not be read as methods confirmed to have been used in this study.

What does randomization contribute?

In general, randomization assigns participants to study groups using a chance-based procedure. It is intended to reduce systematic differences between groups at the start of a trial, including differences that may not be measured. Its value depends on how the sequence is generated, how assignments are concealed, and whether the assigned interventions are delivered as planned. The registry record does not describe the randomization sequence, concealment, or assignment process. It therefore supports identifying the study as randomized, but not evaluating those implementation details.

The registry describes three groups and also says the pain analysis included split-face comparisons. A parallel design usually refers to participants being assigned to groups that proceed alongside one another, while a split-face comparison refers to ratings from different sides of a participant’s face. These are distinct design features that can coexist in a study description. The record does not clarify the precise relationship between group assignment and the paired side-level comparisons, so the analysis structure cannot be reconstructed from the description alone.

Why does masking matter?

In general, masking can reduce the influence of expectations on treatment delivery, participant reports, or outcome assessment. This is particularly relevant to a subjective pain rating, because the rating is reported by the participant and may be affected by awareness of the setting. The registry calls the trial double-masked and states that research staff making split-face comparisons were blinded to the energy settings. It does not identify all masked parties or explain how masking was maintained. The degree to which masking was successful is not reported in the registry record.

How should repeated pain ratings be analyzed?

The primary outcome description calls for ratings after treatment of multiple facial and neck regions, on both sides, and for each transducer used. Ratings from the same participant are generally correlated: they share characteristics of that participant and are gathered during the same treatment experience. As a general principle, an analysis of repeated or paired observations should reflect this dependence. Treating related ratings as independent can make uncertainty estimates misleading. Methods for paired data or repeated measurements can account for within-participant correlation, but the particular method used in this study is not reported in the registry record.

A split-face comparison can control for participant-level characteristics because both sides belong to the same person. A paired analysis would focus on the within-person contrast between sides or settings. However, the registry does not provide the side-specific ratings, pairwise contrasts, or a precise specification of which conditions were compared. It is therefore not possible to identify an estimand—the exact treatment contrast the analysis was intended to estimate—from the posted description.

What do mean and full range convey?

The registry specifies the mean and full range for the pain outcome. In general, the mean summarizes the arithmetic average of recorded ratings. It can be easy to compare, but may not describe the shape of the data or the experience of participants whose ratings differ from the average. The full range reports the lowest and highest values observed; it does not indicate how many participants gave ratings near either endpoint. A distribution or additional summaries could provide complementary information, but those are not reported in the registry record.

A confidence interval, in general, expresses the statistical uncertainty around an estimate under the assumptions of the analysis. A narrow interval indicates greater precision than a wide interval, though precision alone does not establish clinical importance. No confidence interval or other measure of uncertainty for the primary outcome is reported in the registry record. No p-value or primary outcome comparison estimate is reported either.

What can the planning assumptions tell us?

The record describes a planning illustration using a two-sided significance level of 0.05, equal allocation between two arms, a normal approximation, and an effect defined as a stated fraction of the observed effect. This is a generic planning framework, not a statement of the trial’s original sample-size justification. The record does not report the original sample-size rationale, the effect size used in planning, or numerical planning outputs. The illustration’s two-arm assumption should not be mistaken for evidence about the allocation across the three described groups.

As a general explanation, sample-size planning estimates how many participants may be needed to detect a specified effect under stated assumptions. A calculation based on an observed effect is retrospective and depends on that effect estimate; it does not show the probability that the completed study detected a true effect. Such planning figures are not observed power. The registry record does not report an interim analysis or explain whether the sample size was changed during the study.

Why can variability affect uncertainty?

As a general statistical concept, over-dispersion means that observed data vary more than a model assumes. When that happens, a model that understates variability may produce uncertainty estimates that are too small. For the described ratings, variability could arise across participants, facial regions, sides, or transducers. The registry does not report a distributional assessment or model, so it is not possible to say whether over-dispersion was present or how it was handled.

10. Multiplicity, Missing Data and Analysis Populations

The primary outcome is not a single uncomplicated observation in the registry description. Ratings were collected across multiple anatomical regions, both sides, and each transducer used, while the analysis description refers to split-face comparisons. The registry record does not state which comparisons were prespecified as primary, how multiple comparisons were prioritized, or whether any adjustment for multiplicity was planned or applied. It also does not report a single primary contrast or corresponding estimate.

The record lists 5 outcome measures. Named secondary outcomes include quantitative assessment of brow lift at 90 days, participants’ assessment of improvement at 90 days, and participants’ assessment of improvement at 180 days. The registry does not report whether statistical tests across these outcomes were adjusted for multiplicity, nor does it provide results for them. Without a stated analysis plan and estimates, the likelihood of selective emphasis among multiple outcomes cannot be assessed from the registry entry.

Missing-data methods and the number of participants contributing data at each assessment are not reported in the registry record. Although the summary describes follow-up at 90 and 180 days and image collection at several visits, it does not give completion counts or reasons for missing observations. The analysis population—such as whether analyses included all randomized participants or only participants with available outcome data—is also not reported. The registry record does not describe imputation, sensitivity analyses, or handling of incomplete paired ratings.

11. Safety Results

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

Other (non-serious) adverse events

Participants with at least one non-serious event at or above the registry's 5% reporting threshold.

The registry lists a study population of 47 participants at risk, with zero serious adverse events and zero other adverse events recorded. These are counts in the posted adverse-event summary. The record does not provide event terms, event descriptions, timing, severity details, or information about how adverse events were collected. The absence of listed events should therefore be read as the registry’s reported count, not as proof that no symptoms or other experiences occurred.

Deaths are not reported in the adverse-event listing. A missing death count is not the same as a reported count of zero. The registry record also does not state how many participants completed follow-up or the duration for which each participant was monitored for safety. These figures alone do not permit an assessment of event rates over time or comparison of safety among the treatment settings.

As a general statistical point, safety counts are most informative when the event definition, observation period, and number of people actually assessed are clear. Here, the record gives the at-risk count and event counts but not those additional details. The figures describe what is listed in the registry and should not be interpreted as a comprehensive account of all treatment experiences.

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

The registry record establishes that this completed study evaluated Ulthera System treatment of the face and neck using lower energy settings, with pain during treatment as the primary outcome. It describes randomized allocation, double masking, a parallel design, several treatment-setting descriptions, and split-face pain comparisons. It also lists 47 enrolled participants and secondary outcomes concerning brow lift and perceived improvement.

What the record does not establish is the numerical result of the primary pain assessment. Means, ranges, between-setting contrasts, confidence intervals, and test results are not reported. The secondary outcome results are also not reported. Consequently, no conclusion about the direction, magnitude, or precision of differences in pain or follow-up assessments can be drawn from the registry record.

In general, a study design indicates how evidence was intended to be collected; it is not itself an outcome. Randomization and masking can support a credible comparison when implemented well, but the registry does not give enough detail to evaluate implementation or analysis. Nor does the number of enrolled participants, by itself, reveal the precision of an outcome estimate. Precision depends on the data and the analysis, neither of which is posted for the primary outcome.

The adverse-event summary lists zero serious and zero other adverse events among 47 participants at risk. This describes the posted counts but does not document event ascertainment or follow-up completeness. Deaths are not reported. These safety entries do not show that all participants had no symptoms or that all possible events were captured.

The appropriate reading is therefore bounded: the registry describes the study question and design, but it does not provide the findings needed to quantify the primary endpoint. It cannot establish whether ratings differed across settings, how large any difference was, or how uncertain an estimate might be.

13. Why This Trial Matters Statistically

This study is statistically notable for the structure of its primary outcome. Pain ratings were collected across several regions, both sides, and transducers, while the analysis description refers to split-face comparisons. That creates a repeated-measure setting in which observations from the same participant are related. In general, recognizing that dependence is essential for estimating uncertainty appropriately.

The registry also illustrates why a clear estimand matters. A treatment question should specify the exact comparison, outcome summary, and assessment period of interest. Here, the primary endpoint is described as a mean with a full range over the treatment session, but the record does not identify one comparison or post numerical results. The listed analysis count is zero, and the registry does not describe the method used to combine or compare the multiple ratings.

Masking is relevant because the main outcome is participant-reported pain. The record states that the study was double-masked and that research staff conducting split-face comparisons were blinded to energy settings. It does not document masking procedures or success, so the role of masking can be recognized without assuming its effectiveness.

The study also separates a treatment-session outcome from later outcomes. Pain was assessed during treatment, whereas the named secondary outcomes concern brow lift and participant assessments at follow-up. These outcomes address different questions and should not be treated as interchangeable. Since numerical findings for either primary or secondary outcomes are not reported, the record mainly supports examination of outcome definition and design structure, rather than effect estimation.

Finally, the sample-size assumptions are described as a planning illustration based on an observed effect, not as the trial’s original design justification. This distinction matters: retrospective planning calculations are not observed power and cannot substitute for reported estimates and uncertainty. The trial record makes visible how important it is to report the analysis population, missing-data handling, comparison definition, and results alongside the design.

14. Limitations

• The posted summary statistics are the only data these results rest on; patient-level data, full protocols and statistical analysis plans are not available.
• Recalculated results are simple, unadjusted calculations from posted summaries. They do not replace the sponsor's prespecified analysis.

The registry record leaves important design and reporting details unresolved. It gives three group descriptions but does not report group sizes, allocation procedures, or how assignment to those descriptions relates to the split-face comparisons. It does not identify which side received which setting or explain whether side assignment was randomized. The specific treatment contrast intended for the primary analysis is therefore unclear.

The primary endpoint description includes ratings across anatomical regions, sides, and transducers, but no numerical results or participant counts for the individual ratings are posted. It is not possible to assess the mean, range, distribution, or precision of the pain ratings. The record lists no analyses and does not report an analysis plan, a prespecified primary contrast, or multiplicity handling.

Although follow-up visits and image collection are described, attendance, completion, and missing-data details are not reported. The analysis population and any methods for incomplete observations are also not reported. The registry does not provide participant baseline characteristics, detailed eligibility criteria, or information on treatment delivery beyond the arm descriptions.

The sample-size information is characterized as a planning illustration rather than the trial’s original justification, and no numerical planning outputs are included in the registry record. The posted adverse-event summary gives counts but not event definitions, ascertainment procedures, or follow-up completeness; deaths are not reported. These limitations restrict interpretation of both outcome evidence and safety reporting.

15. Related Tutorials

16. Related Statistical Calculators

17. Sources

• ClinicalTrials.gov: Treatment of the Face and Neck With Lower Ulthera System Energy Settings — NCT01713998.
• Registry record last updated 2017-12-11; status last verified 2017-11.
• Results first posted 2014-02-21.
• 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.

18. Record Summary

NCT01713998 is a completed randomized, double-masked, parallel-design study sponsored by Ulthera, Inc. It enrolled 47 participants with skin laxity and evaluated Ulthera System treatment of the face and neck using lower energy settings. The registry lists a start of 2011-09 and primary completion of 2012-06.

The primary outcome was participants’ pain assessment during treatment, using a Numeric Rating Scale from 0 to 10. Ratings were collected across facial and neck regions, sides, and transducers; the stated summary measures were the mean and full range. The registry also lists follow-up outcomes concerning brow lift and participants’ assessments of improvement.

Numerical outcome results, statistical analyses, missing-data methods, and analysis populations are not reported in the registry record. The adverse-event summary lists zero serious and zero other adverse events among 47 participants at risk; deaths are not reported.