Study To Assess A Radiofrequency Microneedling Device For Dermatologic Conditions: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Study To Assess A Radiofrequency Microneedling Device For Dermatologic Conditions (NCT05097157), a na na study. The primary outcome is Subject Satisfaction.

2. Clinical Question

Statistically, the record supports a description of the study setup and the outcomes that were registered, but not an estimate of the primary satisfaction outcome. Six participants were considered complete but had no satisfaction information from their 30 day follow up. The record does not explain how missing satisfaction information was handled in an analysis. The question that can be framed is whether participants reported satisfaction after treatment; the available record does not supply the response distribution needed to answer it.

3. Trial Design

This was a completed feasibility study of a device for dermatologic conditions. The listed intervention was Potenza, classified as a device, and the study used a single-group model. Allocation is recorded as NA and masking as NONE. Thus, the design did not include a randomized allocation or a masked comparison group. The record identifies one treatment arm, described as treatment with the device.

The arm description states that participants received up to 5 treatments, spaced 4 weeks apart. The study summary says adults aged 18–55 years were to be enrolled and that up to 120 subjects would be enrolled at multiple study centers. The recorded enrollment is 79. The listed conditions cover several skin concerns rather than a single diagnosis, so the population was clinically varied in the conditions motivating treatment. The registry record does not report condition-specific enrollment or outcomes.

The study start date is 2019-09-03, the primary completion date is 2021-04-12, and the status is COMPLETED. The record lists phase as NA. It also identifies Cynosure, Inc. as the sponsor. The official title describes a feasibility study of radiofrequency microneedling for electrocoagulation and hemostasis of soft tissues for dermatologic conditions.

A single-group design can document outcomes observed among treated participants, but it does not by itself distinguish changes associated with treatment from changes that might have occurred for other reasons. Without a control group, comparisons against an untreated course or another intervention are not part of this record. The registry record does not report a detailed protocol, a sample-size justification, an interim-analysis plan, or a statistical analysis plan. Those design details should not be inferred from the feasibility label or from the planned treatment schedule.

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

Analysis population for the primary outcome, as defined in the registry: 6 subjects were considered complete but did not have satisfaction information from their 30 day follow up.

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 Subject Satisfaction, measured over 30 day follow up.

The primary endpoint is titled Subject Satisfaction and is measured in participants. At 30 day follow up, subjects were asked to grade satisfaction with treatment results using six ordered response categories: extremely dissatisfied, dissatisfied, slightly dissatisfied, slightly satisfied, satisfied, or extremely satisfied. The endpoint therefore captures the participant's own appraisal of the treatment result at that follow-up, rather than an independently measured clinical change.

Satisfaction is useful as a patient-reported outcome because it reflects how participants judge their experience and results. The ordered response options distinguish degrees and directions of satisfaction rather than reducing the question to a simple satisfied/not-satisfied choice. However, an interpretation depends on knowing how responses were distributed and how the endpoint was summarized. The registry record does not report those response counts or a summary result, so the degree of satisfaction cannot be characterized from the posted record.

Six participants were considered complete but did not have satisfaction information from their 30 day follow up. The record does not state whether they missed the visit, declined to answer, or had another reason for missing information. Nor does it report an analysis population or a rule for handling these missing responses. The endpoint is identified, but its observed result and the treatment of missing endpoint data are not reported in the registry record.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

What kind of outcome is satisfaction?

General statistical explanation: Satisfaction responses are ordered categories. Their order carries meaning, because extremely dissatisfied is below dissatisfied, and satisfied is below extremely satisfied. But the gaps between adjacent categories are not necessarily equal. An analysis can preserve the categories by reporting a count in each, or it can define a simpler summary, but the choice should be specified and justified. The registry record gives the response choices and identifies the endpoint as a participant count; it does not report the response distribution or a statistical summary.

Counts answer how many participants fall into a category or meet a defined outcome. Interpreting a count requires knowing the denominator and the rule that defines the counted outcome. A category count for an ordered satisfaction scale is not automatically the same as a binary event count. The posted record does not state that the six response options were collapsed into two groups, and no such regrouping should be assumed.

What can a single-group study estimate?

General statistical explanation: A single-group study can describe outcomes observed among participants who received the intervention. If the outcome is summarized with a proportion or a mean, an uncertainty interval can communicate how compatible the estimate is with a range of underlying values under the chosen statistical model. An interval does not correct for design limitations such as missing observations, selection effects, or the lack of a comparison group. It describes sampling uncertainty, not all sources of uncertainty.

Because this study has no randomized comparator, a within-group outcome cannot be interpreted as a randomized treatment contrast. Changes after treatment could reflect the intervention, other influences, or the way participants were selected and followed. This is a general limitation of uncontrolled studies, not evidence for or against a particular explanation in this trial. The registry record does not report a before-and-after primary outcome estimate or a statistical test.

What do the sample-size illustrations represent?

General statistical explanation: The planning illustrations described for the record use a two-sided significance level of 0.05, equal allocation between two hypothetical arms, and a normal approximation. They are based on the observed effect and examine detecting specified fractions of that effect. For non-time-to-event outcomes, the illustrations are expressed as participants per arm; time-to-event calculations use total events. These are planning scenarios, not observed study results and not evidence that the trial had a particular probability of finding a result.

A sample-size illustration depends on its assumptions. The selected effect size, significance threshold, allocation, outcome model, and approximation all influence the planning estimate. An illustration using a fraction of an observed effect asks what planning might look like for a smaller target effect; it does not establish that such an effect is clinically important or that it was the study's intended target. The record does not report the trial's own sample-size justification. The illustrations should therefore be read as hypothetical planning calculations rather than as a reconstruction of the protocol's design rationale.

Power is a design property under specified assumptions, not a measure of whether a result is true. General statistical explanation: observed power calculated from the effect estimate after a study is complete adds little beyond the estimate and its uncertainty. Planning illustrations are not observed power. In this single-group study, the stated hypothetical equal allocation between two arms does not describe the trial's actual design, which has one group and no randomized comparison.

How should event counts be understood?

General statistical explanation: A count records the number of participants meeting a definition within a specified group. It is distinct from the number of episodes, because one participant could experience more than one episode; the registry record's count framing should not be expanded into an event total without information on the counting method. A count also does not by itself express precision or comparative risk. Those require an appropriate denominator, and comparative estimates require suitable groups and analyses.

The primary endpoint is a participant-reported satisfaction assessment, whereas the safety fields separately report serious and other adverse-event counts. They answer different questions and should not be combined into a single measure. The record does not provide confidence intervals, hypothesis tests, adjusted estimates, or a detailed model for either outcome. Any general statistical discussion of intervals, models, or comparisons is explanatory and does not represent an analysis reported for this study.

For count outcomes, variation can be greater than a simple model assumes when observations are more heterogeneous or clustered. General statistical explanation: over-dispersion refers to variability exceeding what a specified count model expects and can make model-based uncertainty too narrow if ignored. The registry record does not report a count model, a dispersion assessment, or a clustered analysis. With multiple study centers described but no center-level details reported, the extent to which outcomes varied by center cannot be assessed from this record.

10. Multiplicity, Missing Data and Analysis Populations

The registry record lists 4 outcome measures and no analyses. It does not report a statistical analysis plan, a prespecified hierarchy among outcomes, or an adjustment for multiple testing. Multiplicity matters when several outcomes or comparisons are tested: considering many tests can increase the chance that at least one appears notable by chance. General statistical explanation: approaches to multiplicity can include defining a primary outcome in advance, adjusting test thresholds, or treating secondary findings as exploratory. The record does not state which approach, if any, was planned, so no multiplicity procedure should be assumed.

For the primary endpoint, 6 participants were considered complete but did not have satisfaction information from their 30 day follow up. The registry record does not explain why the ratings are absent, whether additional satisfaction data were missing, or how missingness was handled. It also does not report an analysis population, such as whether all enrolled participants or only those with observed ratings were included in an endpoint summary. Without those details, the impact of missing satisfaction information cannot be assessed.

The record does not describe an intention-to-treat analysis or a per-protocol analysis. It also does not identify imputation, sensitivity analyses, or rules for excluding observations. These are not interchangeable choices: each can answer a somewhat different question and depends on assumptions about the missing data and study conduct. Their use in this study is not reported in the registry record. Because no primary endpoint result or inferential analysis is listed, neither multiplicity handling nor the consequences of missing endpoint information can be evaluated from the posted results.

11. 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 0% reporting threshold.

Most frequent non-serious adverse event terms

The safety record reports 0 serious adverse events among 79 participants at risk in the treatment group. It separately reports 37 other adverse events among 79 participants at risk, and 0 deaths. The categories are distinct: the serious-event count should not be read as the total of all adverse events, and the other-event count should not be interpreted as a count of serious events.

These figures are descriptive counts in a single treatment group. There is no control group against which to compare them, and the record does not report an adjusted safety analysis or uncertainty interval. The term “other adverse events” is the registry's category; further detail about event types or severity is not reported in the registry record. The record also lists no top serious-event terms.

A recorded count of 0 serious events in this study does not prove that serious events are impossible or that the intervention has no safety risks. It describes the reports captured in this group during the study, whose follow-up and event-collection details are not reported in the registry record. Likewise, the count of other adverse events cannot be interpreted as a comparative risk estimate. These counts should be read as a limited description of reported safety outcomes, not as a basis for medical advice.

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

The posted record establishes that a completed single-group study evaluated the Potenza device in a population with a range of dermatologic conditions. The study enrolled 79 participants, and the treatment arm allowed up to 5 treatments spaced 4 weeks apart. The primary endpoint was participant satisfaction at 30 day follow up, using ordered response options from extremely dissatisfied to extremely satisfied. The registry also reports counts for serious and other adverse events.

What the record does not establish is the primary satisfaction result. It gives no response counts, summary measure, confidence interval, or statistical test for that endpoint. Six participants were considered complete but lacked satisfaction information at the follow-up, and no missing-data method is reported. Consequently, the registry entry does not show how participants rated their results or how precisely satisfaction could be estimated.

The study's single-group design also limits interpretation. Without a randomized control group, an outcome observed after device treatment would not isolate the treatment's effect from other possible influences. The record does not report a comparative treatment estimate. The absence of a reported satisfaction result is not evidence of either benefit or lack of benefit; it means that the primary endpoint cannot be evaluated from the registry results.

The safety counts describe recorded outcomes among the treated group, not comparative safety. The 0 serious adverse events and 37 other adverse events are reported with 79 participants at risk; the registry lists 0 deaths. These figures do not establish the absence of risks or provide a comparison with another treatment. Their interpretation is constrained by the lack of further event detail and analysis information.

Statistically, this record is most informative as a description of design and registered outcome definitions. The endpoint result, statistical analysis plan, missing-data approach, and comparison needed for stronger causal interpretation are not reported in the registry record. The appropriate scope of interpretation is therefore limited to the study setup and the counts that are explicitly posted.

13. Why This Trial Matters Statistically

This study illustrates a common distinction between registering an endpoint and reporting an interpretable endpoint result. The registry identifies a participant-satisfaction measure and describes its response categories and follow-up time. Without the corresponding response distribution or a summary estimate, however, readers cannot see whether ratings tended toward satisfaction, dissatisfaction, or another pattern. Clear outcome definitions are valuable, but they do not substitute for outcome results.

The entry also illustrates the limits of a single-group design. A study can document what was observed among treated participants, but without a comparator it cannot estimate a randomized contrast. That matters especially when the endpoint is a subjective assessment, because participant expectations and other influences may shape responses. This is a general design consideration, not a claim about what happened in this study.

Missing primary outcome information adds a further interpretive challenge. Six participants were considered complete but had no satisfaction information at 30 day follow up. Reporting how missing outcomes were handled helps readers judge which participants contributed to an estimate and how robust it may be. That handling is not reported in the registry record.

Finally, the safety entries distinguish serious events from other adverse events and give the number at risk. This supports a basic descriptive reading but not a comparative risk assessment. Taken together, these features make the record useful for understanding study structure and endpoint definitions, while also showing why complete results and transparent analysis methods are essential to statistical interpretation.

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.

Several limitations specific to this record constrain interpretation. The single-group model has no control arm, and allocation is recorded as NA. There is therefore no like-for-like randomized comparison. The study was also unmasked. These design features limit what can be inferred about comparative effects and leave participant satisfaction open to influences beyond the device itself.

The participant population includes multiple dermatologic conditions, from wrinkles and fine lines to acne scars and stretch marks. The record does not report how enrollment or outcomes were distributed across these conditions, so condition-specific findings cannot be assessed. Although the summary describes multiple study centers, center-level enrollment and outcome information are not reported in the registry record.

The primary outcome is not accompanied by its response counts or a summary result. Six participants were considered complete but lacked satisfaction information at 30 day follow up. The record does not describe reasons for missingness, missing-data handling, or the analysis population. The absence of these details prevents evaluation of the potential influence of missing endpoint information.

The registry record lists 4 outcome measures but no analyses. A statistical analysis plan, sample-size justification, multiplicity approach, interim-analysis plan, and detailed protocol are not reported in the registry record. Safety reporting is also limited to the listed counts; further detail about other adverse events and their collection is not reported. These limitations do not establish that unreported procedures or information did not exist, but they cannot be evaluated from the registry record.

15. Related Tutorials

16. Related Statistical Calculators

17. Sources

• ClinicalTrials.gov: Study To Assess A Radiofrequency Microneedling Device For Dermatologic Conditions — NCT05097157.
• Registry record last updated 2022-06-09; status last verified 2022-05.
• Results first posted 2022-06-09.
• 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

NCT05097157 is a completed, single-group feasibility study sponsored by Cynosure, Inc., of the Potenza radiofrequency microneedling device for dermatologic conditions. Enrollment was 79. The study summary describes adults aged 18–55 years, multiple study centers, and up to 120 planned participants. The treatment arm allowed up to 5 treatments spaced 4 weeks apart. The study started on 2019-09-03, with primary completion on 2021-04-12.

The primary endpoint was Subject Satisfaction at 30 day follow up, assessed with six ordered response options. Six participants were considered complete but lacked satisfaction information. The registry record does not report the satisfaction result or an analysis. Safety counts are 0 serious adverse events, 37 other adverse events, and 0 deaths among 79 participants at risk. The record lists no analyses and does not report a control group, analysis plan, or missing-data method.