This page provides an independent statistical analysis and educational interpretation of publicly reported results. ClinicalTrials.gov provides the official trial registry record. Numerical trial results on this page are restricted to the results posted in the ClinicalTrials.gov record; calculations added by Clinical Biostats are labelled as such.
1. Trial at a Glance
This page covers the registry results for Multi-Center, Clinical Evaluation of the Cutera Secret RF Device (NCT03424161), a na na study. The primary outcome is Overall Aesthetic Improvement.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT03424161 |
| Phase | NA |
| Condition | Skin Quality |
| Allocation | Not applicable (single group) |
| Design model | Single Group |
| Masking | None (open label) |
| Enrollment | 27 |
| Arms in the primary outcome | n/a |
| Lead sponsor | Cutera Inc. |
| Results posted | Yes |
2. Clinical Question
Population
The registry describes a study for skin quality, with enrollment of 27. It does not report detailed eligibility criteria, participant characteristics, or the clinical setting in the registry record. Availability of the primary outcome varied: 3 subjects had GAIS measurements at both the 4 week and 12 week follow-ups, 5 had measurements only at the 4 week follow-up, and 2 had measurements only at the 12 week follow-up. These availability statements describe the recorded outcome data, not necessarily the full enrolled population or the reasons measurements were unavailable.
Intervention
The intervention was the Secret RF device, described as treatment with Secret RF for skin quality. The registry states that the study objectives were to evaluate the device’s efficacy and safety. Treatment settings, number of treatments, and other procedural details are not reported in the registry record.
Comparator
The registry describes a single-group study and does not identify a separate control group or an allocation method. There is therefore no concurrent comparison in the record against another device, a sham procedure, or no treatment. Changes over follow-up cannot be separated from other influences using a randomized between-group contrast.
Primary question
The primary outcome is Overall Aesthetic Improvement, assessed by the study investigator using the Global Aesthetic Improvement Scale at the 4 week and 12 week follow-ups. The scale runs from 0, meaning no change, through +4, meaning very significant improvement; higher scores indicate better outcomes. The registry identifies the outcome as a mean with standard deviation, but reports no numerical outcome values or analysis results. The record therefore identifies what was intended to be measured, but does not establish the size or precision of any observed change.
3. Trial Design
The registry record describes a multi-center clinical evaluation of the Cutera Secret RF device. The study is marked completed, with enrollment of 27. The recorded start date is 2018-01-10 and the primary completion date is 2018-10-08. The phase and allocation are listed as NA, and masking is listed as none. The design is single-group: the intervention is Secret RF, described as treatment for skin quality, without a separate comparison arm in the record.
The study objectives are described as evaluating efficacy and safety. The primary outcome is Overall Aesthetic Improvement, measured using the investigator-assessed Global Aesthetic Improvement Scale at the 4 week and 12 week follow-ups. The registry classifies the outcome as a continuous measure summarized by a mean and standard deviation. Its description gives the scale categories and states that higher scores indicate better outcomes.
The outcome availability description reports that 3 subjects had measurements at both follow-ups, 5 had measurements only at the 4 week follow-up, and 2 had measurements only at the 12 week follow-up. The record does not explain why measurements were unavailable, whether the outcome population was defined before analysis, or how missing measurements were handled. The reasons for the availability pattern and any participant flow details are not reported in the registry record.
Although the study is marked completed, the registry record reports no analysis results for the primary outcome. It identifies one outcome measure and no analyses. The record does not describe the statistical analysis plan, treatment procedures in detail, recruitment approach, or any interim analyses. As a single-group evaluation, the study can describe recorded outcomes after treatment, but the design does not provide a randomized control comparison for attributing changes specifically to the device.
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
| Stage | Secret RF |
|---|---|
| STARTED | 27 |
| COMPLETED | 10 |
| NOT COMPLETED | 17 |
Analysis population for the primary outcome, as defined in the registry: 3 subjects has GAIS measurements available at both the 4 and 12 week follow ups 5 subjects had GAIS measurements only available at the 4 week follow up 2 subjects had GAIS measurements only available at the 12 week 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.
| Characteristic | Unit | Secret RF |
|---|---|---|
| Participants analysed | 27 | |
| Age, Categorical: <=18 years | Participants | 0 |
| Age, Categorical: Between 18 and 65 years | Participants | 26 |
| Age, Categorical: >=65 years | Participants | 1 |
| Sex: Female, Male: Female | Participants | 22 |
| Sex: Female, Male: Male | Participants | 5 |
| Race (NIH/OMB): American Indian or Alaska Native | Participants | 0 |
| Race (NIH/OMB): Asian | Participants | 9 |
| Race (NIH/OMB): Native Hawaiian or Other Pacific Islander | Participants | 0 |
| Race (NIH/OMB): Black or African American | Participants | 1 |
| Race (NIH/OMB): White | Participants | 17 |
| Race (NIH/OMB): More than one race | Participants | 0 |
| Race (NIH/OMB): Unknown or Not Reported | Participants | 0 |
6. Primary Endpoint
The registry lists the primary outcome as Overall Aesthetic Improvement, measured over at 4 weeks follow-up and 12 weeks follow-up.
| Element | Registry entry |
|---|---|
| Result type | Mean |
| Measure of spread | Standard Deviation |
| Unit | score on a scale |
| Endpoint classification | Continuous Endpoint |
Overall Aesthetic Improvement is the primary outcome. It is intended to describe global skin improvement after treatment with Secret RF, as judged by the study investigator using the Global Aesthetic Improvement Scale. The specified assessment times are the 4 week follow-up and the 12 week follow-up. The scale ranges from 0, no change, to +4, very significant improvement; intermediate categories are +1, mild improvement, +2, moderate improvement, and +3, significant improvement. Higher scores indicate better outcomes.
A global rating can provide a compact assessment of overall appearance rather than a reading of a single skin feature. It is an investigator assessment, however, and the registry record does not describe assessor training, blinding, or procedures intended to support consistency across centers. Those details are not reported in the registry record.
The registry identifies the endpoint as a mean with standard deviation. A mean describes the average recorded score, while a standard deviation describes how spread out scores are around that average. General statistical consideration: the scale categories are ordered, but interpreting their mean assumes that steps between categories can be treated as comparable for averaging. The record supplies no numerical means, standard deviations, confidence intervals, or outcome analyses. The endpoint definition alone therefore does not show what scores were observed or how precisely any estimate was measured.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry specifies a meaningful measurement question: how investigators rated overall aesthetic improvement after treatment, at the 4 week and 12 week follow-ups. It does not, however, report numerical scores for either follow-up. There is no posted mean or standard deviation for the primary outcome in the registry record, and no analysis results are listed. Consequently, the magnitude and variability of the recorded ratings cannot be described from this record.
Outcome availability was not uniform across follow-up. The registry states that 3 subjects had GAIS measurements at both assessments, 5 had measurements only at the 4 week follow-up, and 2 had measurements only at the 12 week follow-up. These figures make clear that the available outcome data were limited and differed by time point. The registry does not explain why observations were unavailable or report how missingness was addressed. Without those details, the available measurements cannot be assumed to represent all enrolled subjects or to be missing for reasons unrelated to outcomes.
The single-group design also affects what can be concluded. Without a concurrent control group, a change in ratings over time cannot be compared with what would have happened over the same period without the device or with another intervention. General statistical consideration: within-group observations can describe the course of measured outcomes, but they do not by themselves isolate the effect of treatment from other explanations, such as changes over time or assessment variation. The registry does not report a control comparison.
The safety record lists 0 serious adverse events among 27 at risk and 0 deaths. It also lists 27 at risk and 27 affected in the other-event category, but does not identify the events or provide further detail in the record. These figures should be read as registry counts, not as a complete description of event type, severity, timing, or relationship to treatment.
In short, the record documents the study design, endpoint definition, follow-up schedule, outcome availability, and some safety counts, but it does not provide the primary outcome results or inferential analyses. It supports no conclusion about the size or precision of aesthetic improvement. The absence of posted outcome analyses is not evidence that there was no change; it means that the outcome findings are not reported in the registry record.
9. Statistical Methods Explained
The available statistical description is limited. The primary outcome is classified as a continuous measure and is specified to be summarized as a mean with standard deviation. The registry identifies one outcome measure and no analyses. It does not report a model, an inferential test, confidence intervals, a p-value, or an analysis population. These omissions limit the statistical interpretation: an endpoint definition says what was meant to be measured, but does not reveal the observed distribution or the uncertainty around an estimate.
What does a mean describe?
General statistical explanation: the mean is an average of the observed values. For this study, it would summarize the investigator-assigned GAIS ratings at a follow-up time, if numerical results were reported. An average can be useful for condensing a set of ratings, but it does not show whether individual ratings were similar or widely spread. The registry record reports no mean values for either follow-up.
What does a standard deviation describe?
General statistical explanation: a standard deviation describes the dispersion of observations around their mean. A larger standard deviation indicates more spread in the observed values; it is not itself a measure of how precisely the mean has been estimated. Precision also depends on the amount and pattern of available data. Since the registry does not report standard deviations or analysis results, the variability of ratings and precision of any average cannot be assessed from this record.
What is special about this scale?
The GAIS categories are ordered from no change through levels of improvement, and the registry says higher scores indicate better outcomes. The record nevertheless specifies a mean and standard deviation, which treat the score as a continuous measure for summary purposes. General statistical consideration: a mean of an ordered rating scale can be interpreted as an average score, but it implicitly treats differences between adjacent categories as comparable. The registry does not report an alternative ordinal analysis or explain the choice of summary beyond identifying the measure as a mean.
Why does follow-up availability matter?
The availability description distinguishes subjects with measurements at both follow-ups from those measured at only one. General statistical explanation: when outcome measurements are missing, the pattern and reasons for missingness can affect how representative the observed data are. An analysis restricted to recorded measurements may differ from an analysis that makes assumptions about missing values. The registry does not describe a missing-data method, reasons for unavailable measurements, or sensitivity analyses. It is therefore not possible to assess whether missingness was addressed or how it might affect an estimate.
What can a single-group analysis establish?
General statistical explanation: a single-group study can report the observed outcome in its treated group, but a before-and-after or follow-up pattern is not equivalent to a randomized comparison. Without a concurrent control group, differences over time may reflect other factors as well as treatment. The registry does not report a comparator or a statistical method for separating such influences. No adjusted or unadjusted effect estimate is reported, so there is no treatment contrast to interpret.
What do planning assumptions mean?
General statistical explanation: a sample-size planning illustration uses assumptions about a future or hypothetical study to show how design choices relate to a target effect and statistical power. Such an illustration is not an observed result and does not establish that a completed study had adequate power. The planning assumptions associated with this record specify 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. Those are planning assumptions, not a description of the single-group design recorded for this study. The record does not report the trial’s own sample-size justification or design calculations. Any planning illustration should therefore be kept separate from the observed study data and cannot supply the missing primary outcome analysis.
Overall, the statistical information in the registry establishes the intended outcome summary and some availability details, but not the calculations or results needed to estimate improvement or its uncertainty. The registry record does not report an inferential analysis, multiplicity procedure, or model assumptions. General concepts such as standard errors, confidence intervals, and hypothesis tests can explain what an analysis might communicate, but they cannot be applied to this study without the relevant estimates and analysis details.
10. Multiplicity, Missing Data and Analysis Populations
The registry identifies one outcome measure, Overall Aesthetic Improvement, assessed at the 4 week and 12 week follow-ups. It does not state whether one follow-up was designated as the primary time point for inference or whether both assessments were treated as equally important. A multiplicity adjustment or strategy for interpreting repeated assessments is not reported in the registry record. With more than one assessment, general statistical practice distinguishes the number of outcomes from the number of tests or comparisons; the registry supplies no analysis details with which to determine how that issue was handled.
Missing outcome data are relevant because the registry reports different availability patterns across follow-up: 3 subjects had measurements at both assessments, 5 only at the 4 week follow-up, and 2 only at the 12 week follow-up. The record does not give reasons for unavailable measurements, describe imputation or other missing-data methods, or report sensitivity analyses. It also does not define an analysis population, such as whether analyses were intended to include all enrolled subjects or only those with an available measurement. These details are not reported in the registry record.
The record lists no analyses for the primary outcome. It therefore does not report whether analyses were adjusted, how repeated measurements were handled, or whether any statistical plan was prespecified. It is not possible to infer the handling of multiplicity, missingness, or analysis populations from the endpoint definition alone. The available data description identifies gaps in follow-up but does not explain their causes or their effect on the results.
11. Safety Results
The registry reports serious adverse events as affected participants divided by participants at risk.
| Arm | Participants with serious adverse events | Participants at risk | Percentage |
|---|---|---|---|
| Secret RF | 0 | 27 | 0.0% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| Secret RF | 0 of 27 |
Other (non-serious) adverse events
Participants with at least one non-serious event at or above the registry's 5% reporting threshold.
| Arm | Participants affected of at risk |
|---|---|
| Secret RF | 27 of 27 |
Most frequent non-serious adverse event terms
| Event term | Organ system | Secret RF |
|---|---|---|
| Edema | Skin and subcutaneous tissue disorders | 27 of 27 |
| Erythema | Skin and subcutaneous tissue disorders | 27 of 27 |
| Pain | Skin and subcutaneous tissue disorders | 20 of 27 |
The registry lists 27 at risk for serious adverse events and 0 affected, and 0 deaths. It also lists 27 at risk and 27 affected in the other adverse-event category. These are the safety counts recorded for the Secret RF group. They do not, on their own, describe what the other events were, when they occurred, how serious they were, or whether investigators considered them related to treatment. The registry record does not provide terms for the most frequent serious events.
A zero count in the serious-event or death fields means that none were recorded in those categories in the posted registry figures; it should not be treated as proof that an event is impossible or that no safety concerns exist. General statistical consideration: event counts are descriptive, and their interpretation depends on how events were defined, collected, followed over time, and attributed. The record does not report a detailed event-collection method or safety follow-up timeframe.
The other-event count should not be substituted for a description of specific harms. Because event names and additional detail are not reported in the registry record, readers cannot determine the nature, duration, or clinical importance of those reports from these counts alone.
12. What the Result Does, and Does Not, Mean
This record establishes that a completed, single-group clinical evaluation of the Secret RF device was registered for skin quality, with an investigator-assessed global improvement outcome planned at the 4 week and 12 week follow-ups. It also records enrollment of 27, some follow-up measurement availability, and the reported safety counts. Those details describe the study and what the registry contains; they do not establish the outcome of the evaluation.
The registry does not report numerical GAIS results, standard deviations, confidence intervals, or analysis results. It is therefore not possible to determine from the record the average rating at either follow-up, how much ratings varied, or how precise an estimated result might be. Missing outcome measurements are noted, but their reasons and statistical handling are not described. The available outcome counts should not be treated as a complete analysis population without further information.
Because no concurrent control group is recorded, the study does not offer a randomized comparison that would distinguish treatment-related change from other influences. General statistical consideration: observing an outcome after treatment can describe what was recorded in that group, but causal conclusions require an appropriate comparison and attention to potential sources of bias. The record does not report such a comparison or an adjusted treatment effect.
The safety counts should also be read narrowly. The record lists no serious events and no deaths, while listing all 27 at risk as affected in the other-event category. It does not report the names or details of those other events, and the counts cannot replace a fuller account of event types and follow-up.
Accordingly, the registry record documents the intended measurement and selected descriptive information, but does not provide enough outcome or analysis detail to quantify improvement or its uncertainty. This is a limitation of what is reported in the record, not evidence that a particular clinical outcome occurred or did not occur.
13. Why This Trial Matters Statistically
This trial is statistically notable for the gap between a clearly named outcome and the absence of its numerical results in the registry record. The endpoint specifies an investigator-rated global assessment at two follow-up times, and the record identifies the intended summary as a mean and standard deviation. Yet no outcome values or analyses are reported. Without them, readers cannot assess the level of ratings, variability, or precision.
The pattern of outcome availability also matters for interpretation. The record distinguishes subjects assessed at both follow-ups from those assessed at only one. This signals that the follow-up data are not uniformly available, while leaving the reasons and handling of missing measurements unreported. A transparent account of missing data is important because conclusions based only on observed measurements may depend on who has available follow-up and why other measurements are absent.
The design makes the comparator question especially important. This is a single-group evaluation, not a randomized comparison. General statistical explanation: a control group can help distinguish changes associated with an intervention from changes that could occur for other reasons. Without that contrast, an outcome observed after treatment cannot by itself establish what would have happened otherwise.
Finally, the record illustrates why registry completion status and analysis reporting are separate considerations. The study is marked completed, but no primary outcome analyses are listed. The safety fields contain counts, but not event descriptions sufficient for a detailed account. For biostatisticians and clinical researchers, these features underscore the value of complete reporting: estimates, uncertainty, missing-data methods, analysis populations, and event details are needed to interpret a study beyond its design and endpoint definitions.
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 main trial-specific limitation in the registry record is the absence of numerical primary outcome results. Although the endpoint and summary type are identified, no means, standard deviations, confidence intervals, or analyses are reported. The magnitude and precision of investigator-rated improvement therefore cannot be evaluated from the record.
Outcome availability is described as 3 subjects with measurements at both follow-ups, 5 with measurements only at the 4 week follow-up, and 2 with measurements only at the 12 week follow-up. The registry does not state why measurements were unavailable, how missingness was handled, or which analysis population was used. These omissions prevent assessment of whether the available outcome data may differ systematically from the unavailable data.
The single-group design has no recorded concurrent control arm. Consequently, the registry contains no randomized between-group comparison to help distinguish treatment-associated change from other influences. Allocation is listed as NA and masking as none; further details about assessment procedures or protections against observer variation are not reported in the registry record.
The endpoint is an investigator assessment using ordered GAIS categories, while the planned summary is a mean with standard deviation. The record does not explain how the mean was interpreted for this scale or report any alternative analysis. It also does not describe assessor training, treatment procedures in detail, or the timing and conduct of safety surveillance beyond the stated outcome follow-ups.
Safety reporting is limited to counts. The record lists no serious events or deaths and lists 27 affected in the other-event category, but does not provide event names or detail. The registry also does not report a statistical analysis plan, multiplicity approach, interim analysis information, or the trial’s sample-size justification. These limitations concern what is reported and do not establish what occurred outside the registry record.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Multi-Center, Clinical Evaluation of the Cutera Secret RF Device — NCT03424161.
- Registry record last updated 2023-09-15; status last verified 2023-09.
- Results first posted 2023-09-15.
- 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.
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18. Record Summary
NCT03424161 is a completed, single-group, multi-center clinical evaluation of the Cutera Secret RF device for skin quality. The registry records enrollment of 27, a start date of 2018-01-10, and a primary completion date of 2018-10-08. Masking is listed as none, and phase and allocation are listed as NA.
The primary outcome is Overall Aesthetic Improvement, assessed by an investigator using GAIS at the 4 week and 12 week follow-ups. The registry describes a mean and standard deviation as the outcome summary and reports differing measurement availability across follow-up. It lists one outcome measure and no analyses; numerical primary outcome results are not reported in the registry record.
Safety fields list 0 serious adverse events and 0 deaths, along with 27 affected in the other-event category. Further event details are not reported in the registry record.