A Retrospective Review Evaluating the Matrix Pro Applicator for Treatment of Wrinkles: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for A Retrospective Review Evaluating the Matrix Pro Applicator for Treatment of Wrinkles (NCT06219278), a registered phase not stated study. The primary outcome is Improvement in Facial Wrinkles.

2. Clinical Question

The record describes a review of data from a prospective source study, rather than a new prospective treatment assignment for this review. Its stated purpose is to evaluate safety and efficacy of the Matrix Pro applicator for wrinkles. The primary outcome is based on evaluator judgments comparing photographs at Baseline/Pre-treatment with photographs at the 3-month follow-up after the final treatment. The listed primary-outcome timeframe, however, is approximately 6 months following baseline assessment. The record does not explain how that timeframe relates to the photo assessment timepoint.

Subject Global Aesthetic Improvement Scale (GAIS) and Subject Global Aesthetic Improvement Scale (SGAIS) are also listed as secondary outcomes. No results for those outcomes appear in the registry record. Thus the clinical question is defined, but the posted record does not provide the outcome findings needed to describe the observed response.

3. Trial Design

This is a retrospective chart review using data from the multi-site prospective clinical trial “Functional Usability and Feasibility Testing of the Profound Matrix™ System (FUFT2002).” The listed study intervention is the Profound Matrix device, and the treatment arm is identified as Matrix Pro Applicator. The arm description states that source-study subjects received up to three (3) full-face treatments for wrinkles with the Matrix Pro Applicator (27W).

The registry record lists enrollment of 32 and status COMPLETED. The recorded study start is 2023-10-29, and primary completion is 2023-12-29. These record dates do not by themselves establish when each participant received treatment or completed follow-up. The record does not describe the source study’s recruitment process, eligibility criteria, participant characteristics, or the number of participants whose records contributed to each outcome analysis.

This review does not present a randomized comparison. The registry record does not state an allocation method, and its caution notes that the arms are not a like-for-like control comparison. No separate control group for the review is described. Accordingly, the listed intervention arm should be understood as the treatment context for the reviewed records, not as one side of a randomized treatment contrast.

The primary outcome is facial-wrinkle improvement assessed from photographs by three blinded evaluators. The stated photo comparison is between Baseline/Pre-treatment and the 3-month follow-up after the final treatment. The primary-outcome timeframe is separately listed as approximately 6 months following baseline assessment; the record does not reconcile these descriptions. Secondary outcomes are the Subject Global Aesthetic Improvement Scale (GAIS) and Subject Global Aesthetic Improvement Scale (SGAIS). No protocol details on analysis populations, missing observations, or statistical analysis procedures are 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

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 Improvement in Facial Wrinkles, measured over Approximately 6 months following baseline assessment.

The primary endpoint is improvement in facial wrinkles, expressed as a count of participants. It uses a responder definition based on blinded photographic assessment: three evaluators compare Baseline/Pre-treatment photographs with photographs at the 3-month follow-up after the final treatment. A participant is classified as an individual responder if at least two out of three evaluators correctly identify the post-treatment photograph by selecting its corresponding side, left or right.

As a general statistical concept, converting an assessment into a responder count produces a binary outcome for each participant: the definition is either met or not met. A count can communicate how many participants satisfy that rule, but the count alone does not describe the size of any change in wrinkle appearance or the degree of agreement among evaluators. Those details would require additional outcome information, which is not reported in the registry record.

Blinding is relevant because evaluator judgments can be influenced by knowledge of whether an image is pre-treatment or post-treatment. The record says the evaluators were blinded, but does not provide further information about how blinding was maintained or whether evaluator agreement was assessed.

The registry record lists the primary-outcome timeframe as approximately 6 months following baseline assessment, while its description places the photograph comparison at the 3-month follow-up after the final treatment. The relation between these time references is not reported in the registry record. No responder count or other primary-endpoint result is posted, so the endpoint’s definition can be described but its observed outcome cannot.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

The primary endpoint is a binary participant-level outcome reported as a count: each participant either satisfies the responder rule or does not. The rule requires at least two out of three blinded evaluators to correctly identify the post-treatment photograph by choosing its corresponding side. This is a classification procedure, not a direct measurement of the amount of change. The registry record does not report the number classified as responders or the number with evaluable photographs.

What does a responder count tell the reader?

As a general statistical concept, a count describes the number of observed participants meeting a defined criterion. To interpret a count as a rate or proportion, the relevant analysis denominator must also be known. Enrollment is reported as 32, but the registry record does not say whether all enrolled participants had the required photographs or were included in the primary analysis. It would therefore be inappropriate to assume that enrollment is the endpoint denominator.

A binary definition can make an outcome easier to summarize, but it discards gradations within each category. Participants just meeting the criterion and those with a more apparent change are both classified as responders under this rule. Conversely, evaluator judgments that do not satisfy the rule fall outside the responder category, even if there may be other kinds of change. The record does not provide a continuous measure of wrinkle change alongside the responder classification.

Why does blinding matter?

General: blinding can reduce the possibility that an evaluator’s expectations influence an assessment. Here, the registry description states that three blinded evaluators compared photographs. It does not describe the blinding procedure, whether image order or presentation was standardized, or how disagreement among evaluators was recorded. The responder rule specifies how many evaluator identifications are required, but does not provide individual evaluator results or an agreement statistic.

What can be said about statistical testing?

The registry record reports no analyses and posts no primary endpoint estimate, confidence interval, or p-value. No statistical analysis plan, model, or hypothesis-testing procedure is reported in the registry record. General: an estimate describes the outcome under a chosen analysis, while an uncertainty interval indicates how much statistical uncertainty accompanies that estimate under its assumptions. Without a reported estimate and uncertainty measure, neither the magnitude nor precision of the primary outcome can be assessed.

The registry record includes planning assumptions for a separate sample-size illustration: two-sided significance level 0.05, equal allocation between two arms, and a normal approximation, with the target effect expressed as a stated fraction of the observed effect. These are planning assumptions, not a description of the retrospective review’s analysis. The record cautions that sample sizes are planning illustrations, not observed power. A planning calculation does not establish what was observed, and it cannot replace an outcome estimate or uncertainty interval. The registry record does not report the trial’s own sample-size justification.

The planning description also refers to two-arm allocation, while the review is not a randomized comparison and no like-for-like control comparison is identified. Thus those assumptions should not be read as evidence that this review assigned participants equally between treatment arms. The planning values and assumptions cannot resolve the absence of a reported outcome analysis.

How should the timeframe be read?

The primary outcome is described using photographs at the 3-month follow-up after the final treatment, while its listed timeframe is approximately 6 months following baseline assessment. These are distinct time references in the registry record, and their relationship is not explained. The record does not provide participant-level treatment dates or follow-up timing that would clarify the interval for each person. Interpretation should retain both descriptions rather than treating them as interchangeable.

The secondary outcomes, Subject Global Aesthetic Improvement Scale (GAIS) and Subject Global Aesthetic Improvement Scale (SGAIS), reflect additional assessments named in the record. Their scoring definitions, assessment timepoints, results, and analysis methods are not reported in the registry record. No conclusion about those outcomes can be drawn from their listing alone.

10. Exact Estimates for Each Arm

No two-arm comparison is shown for this trial, but each arm's result can still be summarized with exact interval estimates computed from the posted counts. The Clopper-Pearson interval is exact and conservative; the Wilson interval is a common closer-to-nominal alternative; the Bayesian credible interval uses a uniform Beta(1, 1) prior. For small groups the three can differ noticeably.

R code and output

arm    <- c("Matrix Pro Applicator")
n      <- c(32)
events <- c(24)
for (i in seq_along(n)) {
  ci <- binom.test(events[i], n[i])$conf.int          # Clopper-Pearson exact interval
  cr <- qbeta(c(0.025, 0.975), 1 + events[i], 1 + n[i] - events[i])   # Bayesian, uniform Beta(1,1) prior
  wi <- (function(x, n) { p <- x / n; z <- qnorm(0.975); d <- 1 + z^2 / n
    c((p + z^2 / (2 * n) - z * sqrt(p * (1 - p) / n + z^2 / (4 * n^2))) / d, (p + z^2 / (2 * n) + z * sqrt(p * (1 - p) / n + z^2 / (4 * n^2))) / d) })(events[i], n[i])
  cat(sprintf("ARM|%s|%d|%d|%.1f|%.1f|%.1f|%.1f|%.1f|%.1f|%.1f\n", arm[i], n[i], events[i], 100 * events[i] / n[i],
              100 * ci[1], 100 * ci[2], 100 * wi[1], 100 * wi[2], 100 * cr[1], 100 * cr[2]))
}

ARM  Matrix Pro Applicator  32  24  75.0  56.6  88.5  57.9  86.7  57.7  86.7

11. Multiplicity, Missing Data and Analysis Populations

The registry record lists a primary outcome and two secondary outcomes: Subject Global Aesthetic Improvement Scale (GAIS) and Subject Global Aesthetic Improvement Scale (SGAIS). It does not report whether the outcomes were tested using a formal hierarchy, whether any adjustment for multiple testing was planned, or how findings across outcomes were intended to be interpreted. General: when several outcomes are examined, the chance of at least one apparently unusual result can increase if each is assessed independently. A prespecified strategy can help define how such results are interpreted, but no strategy is reported in the registry record.

Missing-data handling is also not described. The record gives enrollment of 32, but does not state how many participants had complete baseline and follow-up photographs, whether any records were excluded, or how unavailable assessments were treated. The analysis population is not reported in the registry record. It is therefore not possible to establish whether the endpoint count, had it been posted, would include all enrolled participants or a subset with evaluable data.

The primary outcome description gives an assessment timepoint of 3-month follow-up after the final treatment, whereas the timeframe field says approximately 6 months following baseline assessment. The record does not explain how participants with follow-up at other times would be handled, or whether the listed timeframe corresponds to the photograph comparison. These details matter because outcome availability and timing can affect which observations contribute to an analysis.

No analysis results are posted for the primary or secondary outcomes, so there is no reported basis for evaluating the influence of missing observations or multiplicity on the findings. Such decisions should not be inferred from the endpoint list alone.

12. Safety Results

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

Deaths

Other (non-serious) adverse events

Participants with at least one non-serious event at or above the registry's 0% reporting threshold.

Most frequent non-serious adverse event terms

The registry record lists 32 participants at risk for serious adverse events and 0 affected in the Matrix Pro Applicator group. It separately lists 32 at risk and 5 affected under other adverse events. Deaths are listed as 0. These figures are counts in the record; they do not identify the event types or describe when events occurred.

The serious adverse-event count and the other adverse-event count are distinct entries and should not be combined. The record does not clarify whether the other adverse events were non-serious, provide their terms, or report severity, duration, outcome, or possible relation to the device. It also does not give an adverse-event analysis method or explain whether all participants were followed for the same period.

As a general statistical point, a count is descriptive and does not establish comparative risk. This review does not report a like-for-like control group, and the registry record does not state an allocation method. The counts therefore should not be interpreted as a comparison against another treatment or as proof that events were or were not caused by treatment. The listed at-risk counts are useful context, but do not supply details about the completeness of event collection or the number contributing to other study outcomes.

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

The registry record identifies a retrospective review of records from a multi-site prospective study, focused on the Matrix Pro applicator for wrinkles. It specifies a photographic responder definition based on three blinded evaluators and lists subject global aesthetic assessments as secondary outcomes. It also reports enrollment of 32 and adverse-event counts for the Matrix Pro Applicator group.

Those details describe the study question and the intended outcome assessment, but the record does not report the primary responder count or results for either secondary outcome. There is no posted estimate of response, measure of uncertainty, or inferential analysis. The available record therefore cannot show how often the responder criterion was met, how consistent the assessments were, or how precisely any outcome was estimated. Enrollment is not interchangeable with the number analyzed.

The safety entries show 0 participants affected by serious adverse events among 32 at risk, 5 affected under other adverse events among 32 at risk, and 0 deaths. These are descriptive registry counts. They do not establish causes, comparative risks, or whether all events were captured over a common follow-up period.

General: a study result is most informative when its outcome definition, analysis population, estimate, and uncertainty are considered together. Here, the definition is available, but the outcome estimate and analysis details are not reported in the registry record. The record also gives different time descriptions for the primary assessment: the endpoint description references the 3-month follow-up after the final treatment, while the listed timeframe is approximately 6 months following baseline assessment. Their relationship is not clarified.

The record does not support a conclusion about whether treatment was effective or ineffective. It supports a narrower statement: the review was designed to assess photographic wrinkle improvement and safety, but the posted registry results do not provide the efficacy findings needed to quantify the primary or secondary outcomes.

14. Why This Trial Matters Statistically

This record illustrates why an endpoint definition and an outcome result are different kinds of information. A detailed rule explains how a responder was to be classified: at least two out of three blinded evaluators had to correctly identify the post-treatment photograph side. That rule helps a reader understand what the intended count represents, but without the observed count and its analysis denominator, it does not tell how many participants met the rule.

The distinction is important in retrospective chart reviews, where the records available for analysis may not necessarily match the total enrollment. The registry lists enrollment of 32, but does not report the number with evaluable photographs or the analysis population. General: clear reporting of participant flow and missing assessments helps readers judge how well an analysis reflects the enrolled group. Those details are not reported in the registry record.

The record also demonstrates the value of precise timepoint descriptions. The endpoint narrative places the photo comparison at the 3-month follow-up after the final treatment; the listed timeframe is approximately 6 months after baseline assessment. Without an explanation linking these descriptions, readers cannot determine the exact intended timing from the record alone.

Finally, the entries for serious and other adverse events show that safety counts require context. The record reports the number at risk and the number affected, but not event terms, timing, or attribution. These limits matter especially when there is no like-for-like control comparison. More complete outcome and safety reporting would be needed to assess the observed findings and their precision. As posted, the record is informative about the question and measurement approach, but not about the quantitative efficacy result.

15. Limitations

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

The principal limitation for interpretation is that the registry record does not report the primary responder count or results for the secondary outcomes. Without those outcomes, there is no effect estimate or measure of precision to interpret. Although enrollment of 32 is listed, the record does not state how many participants contributed evaluable photographs, whether any records were excluded, or which analysis population was used.

The review draws on data from a multi-site prospective source study, but this record describes a retrospective chart review and does not report a randomized comparison. The allocation method is not stated, and the registry record cautions that arms are not a like-for-like control comparison. A causal treatment contrast cannot be inferred from the presence of a treatment arm alone.

The primary outcome timing is not fully clear. The description refers to photographs at the 3-month follow-up after the final treatment, while the listed timeframe is approximately 6 months following baseline assessment. The record does not explain the relationship between those time references. It also does not report evaluator-level results or an agreement measure, so the consistency of the blinded assessments cannot be evaluated.

Important protocol and analysis details are not reported in the registry record, including eligibility criteria, participant characteristics, missing-data handling, outcome analysis methods, and multiplicity procedures. The record lists serious and other adverse-event counts but not event terms, timing, severity detail for other events, or attribution. These limitations restrict what can be concluded from the posted information and should be distinguished from findings that might be available in other records, which are not described.

16. Related Tutorials

17. Related Statistical Calculators

18. Sources

• ClinicalTrials.gov: A Retrospective Review Evaluating the Matrix Pro Applicator for Treatment of Wrinkles — NCT06219278.
• Registry record last updated 2024-10-08; status last verified 2024-09.
• Results first posted 2024-09-19.
• Data retrieved from ClinicalTrials.gov on 2026-11-09.
• Group sizes, means, event counts and sponsor-reported p-values are reproduced as posted. Effect estimates, confidence intervals and p-values not attributed to the sponsor are independently calculated from the posted summary statistics.

19. Record Summary

The COMPLETED record describes a retrospective chart review of data from the multi-site prospective clinical trial FUFT2002, evaluating the Profound Matrix System Matrix Pro applicator for wrinkles. Enrollment is listed as 32. The recorded study start is 2023-10-29, and primary completion is 2023-12-29. The arm description states that source-study subjects received up to three (3) full-face treatments with the Matrix Pro Applicator (27W).

The primary endpoint is a participant count based on blinded photographic assessment. A responder is defined as a participant for whom at least two out of three evaluators correctly identify the post-treatment photograph side. The description refers to a 3-month follow-up after the final treatment, while the listed timeframe is approximately 6 months following baseline assessment. The registry record does not explain the difference.

Secondary outcomes are Subject Global Aesthetic Improvement Scale (GAIS) and Subject Global Aesthetic Improvement Scale (SGAIS). Primary and secondary outcome results are not reported in the registry record. For safety, the record lists 32 at risk and 0 affected for serious adverse events, 32 at risk and 5 affected for other adverse events, and 0 deaths. Further event details and analysis methods are not reported.