Ultherapy™ Treatment Following Sculptra® Treatment: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Ultherapy™ Treatment Following Sculptra® Treatment (NCT01422538), a randomized na study. The primary outcome is Lifting and Tightening of Skin as Determined by Masked Assessment of Pre- and Post-treatment Photographs..

2. Clinical Question

The primary question concerns an assessment of visible change in treated areas, not a direct measurement of tissue or a participant-reported judgment. The outcome description says that three masked assessors reviewed pre- and post-treatment photographs. It does not specify how the assessors’ judgments were combined, how disagreement was resolved, or what threshold counted as improvement. Those details are not reported in the registry record.

The arm-level percentages reported for this endpoint are 40.0% for Group A, 30.0% for Group B, and 33.0% for Group C. These are descriptive results. The registry record does not provide a statistical estimate comparing the combined-treatment group with either treatment-alone group, so the percentages alone do not quantify the uncertainty around any difference.

3. Trial Design

The registry identifies this study as randomized, with a parallel design and no masking listed for the study overall. Participants were assigned to Group A, Group B, or Group C. Group A received the Ulthera® System alone; Group B received Sculptra® only; and Group C received Sculptra® treatment followed by Ultherapy™ treatment. The registry lists the phase as NA and the condition as skin laxity.

Enrollment is recorded as 30. The study status is completed, with a start date of 2011-05 and a primary completion date of 2012-06. Ulthera, Inc is listed as the sponsor. The registry describes the study as evaluating clinical outcomes associated with non-invasive Ultherapy™ treatment following Sculptra® treatment.

Random assignment is intended, in general, to make treatment groups comparable on average with respect to measured and unmeasured factors. It does not guarantee that groups will be alike in a study of this size, and it does not by itself determine how outcomes should be analyzed. The registry record does not report the randomization sequence method, allocation concealment, or whether any stratification was used.

Although masking is listed as none, the primary outcome description specifically says that three masked assessors reviewed the photographs. This indicates masking for that assessment as described, but does not establish that participants, treating personnel, or other study staff were masked. Further masking details are not reported in the registry record.

The primary endpoint is assessed at 90 days post-treatment. Secondary outcomes listed in the record include overall aesthetic improvement and subject satisfaction at 90 days and 180 days post-treatment. The registry record does not describe the full visit schedule, treatment procedures, or rules for follow-up beyond the primary outcome description. It also does not report a protocol-level statistical plan or a sample-size justification.

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: Thirty subjects were enrolled and thirty subjects were treated in the study. The first subject was treated on June 28, 2011; the last subject was treated on March 28, 2012. The last patient follow-up for the trial was September 24, 2012.

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 Lifting and Tightening of Skin as Determined by Masked Assessment of Pre- and Post-treatment Photographs., measured over 90 days post-treatment.

The primary endpoint is the percentage of participants assessed as improved in lifting and tightening of skin at 90 days post-treatment. The registry describes improvement relative to baseline photographs, with the treated areas judged to show lifted and tightened skin. Three masked assessors reviewed pre-treatment and 90-day post-treatment photographs from subjects who returned for follow-up.

This kind of endpoint translates an assessor’s judgment into a proportion: participants judged improved are represented as a percentage of those assessed. In general, a percentage can make the frequency of a defined outcome easier to interpret across groups than a list of individual judgments. It is important, however, to know the definition of improvement and how multiple assessors’ ratings were combined. Those procedures are not reported in the registry record.

The endpoint is based on photographs and assessor judgments rather than a direct measurement described in physical units. Masked assessment can help limit the influence of knowledge about treatment assignment on ratings, but the record does not explain whether the assessors could infer assignment from the photographs or what procedures were used to maintain masking.

The outcome is specific to the 90-day assessment. It does not, by itself, describe durability beyond that visit or participant satisfaction. The registry lists those as separate secondary outcomes at 90 days and 180 days post-treatment. The primary endpoint therefore addresses a particular assessment of visible lifting and tightening at a particular follow-up, not every aspect of clinical outcome.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

The registry labels the study randomized and parallel, with groups assigned to different treatment strategies. In general, randomization is used to reduce systematic differences between groups at the point of assignment. A parallel design means that the assigned groups are considered alongside one another rather than describing a sequence in which all participants receive each strategy. The registry does not report the sequence-generation method, allocation concealment, or the statistical model planned for the primary outcome.

What does the primary percentage represent?

The endpoint is described as the percentage of participants improved, based on masked assessment of photographs at 90 days post-treatment. A percentage expresses an outcome frequency relative to the participants assessed. Here, the record gives the reported percentages by group but does not state the exact improved counts or fully define the denominator used for each arm. It also does not explain how the judgments from the three masked assessors were combined. These omissions make it impossible to reconstruct the outcome from the registry entry.

For an outcome represented as a proportion, a statistical comparison would ordinarily need to specify the effect being estimated, such as a difference in proportions or another measure, and the method used to quantify uncertainty. The record does not report such an estimate for the primary endpoint. It identifies missing or non-estimable values for a two-arm comparison of this count-type outcome. No comparative inference should be substituted for that unavailable analysis.

How should uncertainty be understood?

In general, a confidence interval communicates the precision of an estimate by showing a range of values compatible with the observed data and the assumptions of the method. A p-value, when used, addresses how compatible data are with a specified null hypothesis under a statistical model; it does not state the probability that a treatment effect is real. Neither confidence intervals nor p-values are reported for the primary outcome in the registry entries. The percentages alone do not show the uncertainty around the observed group results or any comparison.

In general, statistical methods for proportions must account for the limited number of possible outcomes within each participant and the variability of the observed counts. The appropriate method depends on the analysis question and design. The registry does not report enough detail to identify a fitted model or determine whether any adjustment was used. No model assumptions, diagnostics, or sensitivity analyses are reported in the registry record.

What do the planning illustrations mean?

Planning sample sizes, when calculated from an observed effect, are hypothetical illustrations rather than results from the randomized comparison. The stated illustration assumptions use a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation; the effect to detect is defined as a stated fraction of the observed effect. Such calculations depend on those assumptions and on the observed effect used as their starting point. They do not measure the power actually achieved by this trial, and they do not replace a protocol-based sample-size justification. The registry record does not report the trial’s own sample-size justification.

In general, power is a design property describing the chance that a specified statistical procedure will detect a defined effect under assumptions. It cannot be inferred simply from whether a result is statistically significant, and it is not an observed outcome. Any planning illustration based on an observed result is especially dependent on that result and should not be presented as observed power. The registry entries do not include numerical planning estimates to interpret.

What is not described about the analysis?

The registry records zero analyses for the reported outcomes in this fact set and does not provide an analysis plan for the primary endpoint. Details not reported include the precise estimand, the approach to missing outcome data, any adjustment for baseline characteristics, and whether the primary analysis followed assigned treatment. The record also does not report interim analyses or stopping rules. These points should be treated as unknown rather than inferred from the randomized design or from the reported percentages.

The listed secondary outcomes concern overall aesthetic improvement and subject satisfaction at 90 days and 180 days post-treatment. A multiplicity strategy for interpreting several outcomes or follow-up times is not reported. In general, considering multiple outcomes can increase the chance of a false-positive finding if each is tested separately without an appropriate plan. That general concern cannot be translated into a specific adjustment for this study because no testing strategy or secondary outcome analyses are reported.

10. Multiplicity, Missing Data and Analysis Populations

The registry lists four secondary outcomes: overall aesthetic improvement at 90 days post-treatment, overall aesthetic improvement at 180 days post-treatment, subject satisfaction at 90 days post-treatment, and subject satisfaction at 180 days post-treatment. The primary outcome is lifting and tightening of skin at 90 days post-treatment. A prespecified hierarchy, multiplicity adjustment, or other plan for interpreting findings across outcomes and time points is not reported in the registry record. The record does not include results for those secondary outcomes in the registry record for this analysis.

The primary endpoint description refers to photographs from 29 subjects who returned for the 90-day follow-up visit, while enrollment is recorded as 30. The arm-level entries for the primary endpoint list 10 for Group A, 10 for Group B, and 9 for Group C. These figures identify the participants described for the endpoint, but the record does not explain the full flow from enrollment to analysis or why follow-up photographs were unavailable for participants not included in that description. No imputation method, missing-data sensitivity analysis, or reason for missingness is reported.

The analysis population is not reported in the registry record. In particular, the record does not say whether the primary outcome analysis included all randomized participants, only those with follow-up photographs, or another defined population. It also does not describe how participants were handled if they did not complete assigned treatment or had incomplete outcome assessments. These omissions limit assessment of the risk that missing outcome information could influence the observed percentages.

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 adverse-event figures list 10 participants at risk in each group for serious adverse events, with 0 affected in Group A, 0 in Group B, and 0 in Group C. For other adverse events, the figures likewise list 10 participants at risk in each group and 0 affected in each group. These are the event figures recorded for the groups; they do not provide detail about event types, timing, severity beyond the serious-event classification, or duration of observation.

The registry’s death entries are not populated with a number. A missing death value should not be read as a reported zero; the death count is not reported in the registry record. The primary outcome arm entries list 10, 10, and 9, whereas the safety entries list 10 at risk in each group. These refer to different registry fields and should not be treated as interchangeable denominators.

In general, zero reported events does not establish that an event is impossible or that the risk is absent. Safety interpretation depends on the participants observed, the length and completeness of follow-up, and how events were collected and classified. Those details are not reported in the registry record, so the recorded zero counts should be interpreted narrowly.

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

The registry records arm-level percentages for the primary assessment of lifting and tightening of skin at 90 days post-treatment: 40.0% in Group A, 30.0% in Group B, and 33.0% in Group C. These values describe the reported assessment results. They do not provide a direct estimate of the effect of adding Ultherapy™ after Sculptra® compared with Sculptra® alone, because no comparative estimate or uncertainty measure is reported.

The results do not establish whether the differences between the percentages are statistically distinguishable from chance. The registry does not report a p-value, confidence interval, or a formal test for the primary comparison. Nor does it explain how assessors’ ratings were combined to determine whether a participant was improved. Without those details, the reported values are best treated as descriptive group outcomes.

The outcome is limited to photographic assessment at 90 days post-treatment. It is not the same as participant satisfaction, overall aesthetic improvement, or a longer-term assessment. The registry lists satisfaction and overall aesthetic improvement at 90 days and 180 days as secondary outcomes, but results for them are not reported in the registry record for this analysis.

The randomized design provides a framework for comparing assigned groups, but it does not remove the importance of complete follow-up, a prespecified analysis, and appropriate uncertainty estimates. The record does not report the analysis population or the handling of missing photographs. The primary endpoint description states that photographs were available from subjects who returned for the 90-day visit, leaving the completeness and consequences of missing follow-up insufficiently characterized.

These findings should not be extended beyond the outcomes and groups recorded in the registry. They do not establish what would happen in other populations or settings, and they do not address unreported outcomes. They are a limited description of the study’s recorded 90-day photographic assessment, not a complete account of comparative benefit or risk.

13. Why This Trial Matters Statistically

This trial is statistically notable because it places a combined treatment strategy alongside each treatment-alone strategy in a randomized, parallel design. That structure makes comparative questions relevant: the combined-treatment group can be considered in relation to the Ulthera® System-alone group and the Sculptra®-only group. However, the registry does not report formal comparisons for the primary outcome, so the design’s comparative potential is not matched by a reported inferential result in this record.

The primary outcome also illustrates why a clearly defined endpoint matters. The result is a percentage judged improved from photographs, rather than a measurement whose meaning is determined solely by a fixed physical scale. The record names masked assessors and a follow-up time, but does not explain the rating rule or how assessor judgments were combined. Such details affect how reproducible and interpretable an outcome can be.

The record also makes the distinction between an observed percentage and a treatment-effect estimate important. The arm-level values are descriptive. A comparative estimate with an interval would communicate both the direction and precision of a contrast; neither is reported. The entry’s note that a two-arm comparison was not estimable further cautions against treating the ordering of group percentages as a tested result.

Finally, the follow-up description and analysis details matter to interpretation. Photographs are described for subjects returning at 90 days, while the registry does not state the analysis population or missing-data approach. These are not minor reporting details: they determine which observations contribute to an endpoint and how confidently readers can interpret the resulting group summaries. The case therefore highlights how design features, endpoint definitions, analysis reporting, and follow-up completeness jointly shape what a clinical trial result can support.

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 primary outcome is based on masked assessment of photographs, but the registry does not report the operational definition of improvement, assessor training, agreement between assessors, or the method used to combine their judgments. The outcome description therefore leaves important measurement details unclear. Although the primary endpoint includes a 90-day assessment, the record does not describe the photographic standardization or procedures used to keep assessors masked.

The primary outcome is reported as a percentage by arm, but exact numbers judged improved are not reported. The registry also does not provide confidence intervals, p-values, or comparative effect estimates. It notes that values were missing or not estimable for a two-arm comparison of this count-type endpoint. Consequently, the precision and statistical evidence for any group contrast cannot be evaluated from the recorded primary results.

The outcome description refers to photographs from 29 subjects who returned for the 90-day visit, and the arm-level primary outcome entries list 10 for Group A, 10 for Group B, and 9 for Group C. The record does not explain the follow-up flow, reasons for missing photographs, or how missing data were handled. The analysis population is not reported, limiting assessment of whether the reported results reflect all randomized participants or a subset defined by available follow-up.

The record lists four secondary outcomes but does not report their results or a multiplicity plan. It also does not give details of the randomization process, allocation concealment, statistical model, baseline comparability, or prespecified sample-size justification. These limitations concern reporting in the registry record; they should not be taken as proof that a particular procedure was or was not used outside what the record describes.

15. Related Tutorials

16. Related Statistical Calculators

17. Sources

• ClinicalTrials.gov: Ultherapy™ Treatment Following Sculptra® Treatment — NCT01422538.
• Registry record last updated 2017-12-13; status last verified 2017-11.
• Results first posted 2013-08-27.
• 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

The registry record for NCT01422538 describes a completed randomized, parallel-group study of treatments for skin laxity. Group A received the Ulthera® System alone, Group B received Sculptra® only, and Group C received Sculptra® followed by Ultherapy™. Enrollment is recorded as 30. The study start date is 2011-05, and the primary completion date is 2012-06. Ulthera, Inc is listed as the sponsor.

The primary endpoint was the percentage assessed as improved in lifting and tightening of skin at 90 days post-treatment, based on masked review of photographs. Reported values are 40.0% for Group A, 30.0% for Group B, and 33.0% for Group C. The registry record does not report a formal comparative estimate, confidence interval, or p-value for this endpoint. Secondary outcomes listed include aesthetic improvement and subject satisfaction at 90 days and 180 days post-treatment; their results are not reported in the registry record for this analysis.

Safety entries report 0 serious adverse events and 0 other adverse events in each group. Death counts are not reported in the registry record. Important details about missing outcome data, analysis populations, and statistical methods are also not reported.