Pilot Evaluation of Platelet Rich Fibrin Matrix (PRFM) for the Correction of Nasolabial Folds: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Pilot Evaluation of Platelet Rich Fibrin Matrix (PRFM) for the Correction of Nasolabial Folds (NCT00874094), a na phase 1, phase 2 study. The primary outcome is Difference in Wrinkle Assessment Score, Between Pre-treatment and 12 Weeks Post-treatment..

2. Clinical Question

3. Trial Design

This completed pilot study evaluated platelet rich fibrin matrix for nasolabial folds. It is listed as Phase 1 and Phase 2, with a single-group model, allocation recorded as NA, and no masking. The registry lists enrollment of 15 and identifies The New York Eye & Ear Infirmary as sponsor. The recorded start was 2008-04 and primary completion was 2009-06.

The arm description says both nasolabial folds were treated with 0-2 cc of autologous platelet rich fibrin matrix, sufficient to efface the fold. Because there was no separate control group, the design cannot distinguish a treatment-associated change from changes that could occur over time or from measurement variation. Treating both folds does not create a like-for-like comparison between treated and untreated folds.

The study summary describes facial photographs collected serially over a 12 week period. It also describes injections into or under the skin of the arm near the elbows and serial biopsies over that period. The registry lists a primary score comparison at 12 weeks and secondary score comparisons at 1, 2, and 6 weeks. Further details of the procedures, visit schedule, eligibility criteria, or conduct are not reported in the registry record.

The registry lists four outcome measures and no analysis entries. That does not establish which analyses were conducted outside the registry. The protocol’s statistical plan, sample-size justification, and any interim analyses are not reported in the registry record. The study is marked completed, but completion alone does not supply evidence about the primary outcome.

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: Any patient who refused to attend all scheduled follow up visits were to be excluded.

Overall Study

Analysis population for the primary outcome, as defined in the registry: Number of participants were calculated based on need to achieve 1 unit improvement of Wrinkle Assessment score over baseline (pre-treatment) to be clinically relevant.

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 Difference in Wrinkle Assessment Score, Between Pre-treatment and 12 Weeks Post-treatment., measured over Difference in Measurements taken Pre-treatment and 12 weeks after treatment..

The primary endpoint is the difference in wrinkle assessment score between pretreatment and 12 weeks after treatment. The score ranges from 0, least noticeable, to 5, most noticeable. The registry describes the endpoint as a mean and specifies standard deviation as its measure of dispersion. It states that a 1 unit improvement over baseline was considered clinically relevant for the population calculation.

A repeated score can describe how the recorded appearance of the folds changes over time. The scale gives an ordered numeric description of wrinkle prominence, with lower values corresponding to folds that are less noticeable. However, the registry does not state the sign convention used to calculate the difference, nor does it report the baseline or follow-up score, the mean change, or its standard deviation. The degree of change and its precision therefore cannot be assessed from the registry record.

In general, a change score is interpreted alongside its variability and the number of participants contributing measurements. The endpoint’s intended timing gives a specific follow-up point, but does not by itself establish whether data were collected for every participant or how incomplete measurements were handled. Those details are not reported in the registry record.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

For a continuous endpoint such as a wrinkle assessment score, a mean describes the average score or average change across participants. Standard deviation describes how widely individual scores or changes vary around that mean. These statistics answer different questions: the mean locates the group average, while the standard deviation describes variability among observations. The registry identifies the primary parameter as a mean and the dispersion measure as standard deviation, but does not report their values.

What a confidence interval would add

In general, a confidence interval gives a range of values compatible with the data under the statistical method used. It communicates estimation uncertainty rather than guaranteeing that the true value lies in a particular interval. For a mean change, a narrow interval would indicate greater precision than a wide interval, though interpretation would still depend on the scale and study design. No confidence interval for the primary endpoint is reported in the registry record.

What a p-value can and cannot say

In general, a p-value measures how unusual data at least as incompatible with a specified null hypothesis would be if that hypothesis and the model assumptions held. It is not the probability that the null hypothesis is true, nor does it measure the size or practical importance of an effect. A p-value would not resolve the lack of a control group in this study. No primary-endpoint p-value or test is reported in the registry record.

Within-group change is not a controlled effect

A pretreatment-to-follow-up comparison can describe whether scores changed within the observed group. In general, that comparison is not equivalent to comparing outcomes under treatment with outcomes under a control condition. The latter would require an appropriate comparator and a design and analysis that support that contrast. Here, allocation is recorded as NA and the model is single-group; the registry does not describe a control arm. Thus, even if within-group measurements were available, they would not alone establish what would have happened without treatment.

Measurement and masking

The endpoint depends on a score ranging from 0, least noticeable, to 5, most noticeable. In general, score-based outcomes can be affected by how assessors apply the scale, and consistent measurement procedures matter when changes are compared over time. The registry records masking as none. It does not report who assigned the scores, whether the same assessor evaluated each time point, or how disagreements or measurement variability were handled. These missing details limit assessment of measurement reliability.

Planning calculations and observed power

The stated sample-size assumptions describe a planning illustration using a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation. The effect to detect is described as a stated fraction of the observed effect. Those assumptions do not describe the actual single-group design, and the registry does not report the trial’s own sample-size justification. Any resulting sample-size figures are planning illustrations, not observed power and not evidence that the study had a particular probability of detecting an effect. In general, post hoc calculations based on an observed effect should not be treated as a substitute for an adequately justified design.

The planning assumptions refer to equal allocation between two arms, whereas this registry record classifies the study as single-group. This mismatch means such planning figures should not be read as a description of the trial’s enrollment plan or as a direct assessment of its design. The registry does not report a protocol-based target enrollment rationale or the assumptions used by investigators when planning the pilot.

What cannot be reconstructed

Reproducing an endpoint analysis would require the outcome values or sufficient summary statistics, along with details such as the analysis population and handling of missing measurements. Those are not reported in the registry record. No recalculated estimate can therefore be interpreted from the available endpoint information. In general, a recalculation from summary statistics would be an unadjusted analysis and would not replace a sponsor’s own analysis if the two differed; no sponsor analysis is reported.

10. Confidence Intervals for Each Arm

No two-arm comparison is shown for this trial, but each arm's mean can be given with a t-based 95% confidence interval computed from the posted mean, spread and number of participants.

R code and output

arm <- c("Treatment With Platelet Rich Fibrin Matrix")
n   <- c(15)
m   <- c(1.13)
sp  <- c(0.76)
sd  <- sp      # posted standard deviations
for (i in seq_along(n)) {
  se <- sd[i] / sqrt(n[i]); h <- qt(0.975, n[i] - 1) * se
  cat(sprintf("CARM|%s|%d|%.3f|%.3f|%.3f|%.3f\n", arm[i], n[i], m[i], sd[i], m[i] - h, m[i] + h))
}

CARM  Treatment With Platelet Rich Fibrin Matrix  15  1.130  0.760  0.709  1.551

11. Multiplicity, Missing Data and Analysis Populations

The registry lists a primary score comparison at 12 weeks and secondary score comparisons at 1, 2, and 6 weeks. Considering several outcomes or follow-up times raises a general multiplicity issue: if many statistical tests are conducted, the chance of at least one apparently noteworthy result can increase. Methods such as prespecifying a primary comparison or adjusting inference can address this issue, but the registry record does not report a multiplicity strategy or identify which secondary comparisons, if any, were tested.

The registry lists four outcome measures but no analysis entries. The relationship between all listed outcomes and those four measures is not further explained. No analysis population, statistical test, covariate adjustment, or prespecified hierarchy is reported in the registry record. It is therefore not possible to determine from the record how the primary endpoint would have been distinguished from exploratory analyses.

Missing-data handling is also not reported. The record does not state how many participants had measurements at each time point, whether anyone withdrew, or how incomplete scores were treated. In general, missing measurements can affect both the estimate and its uncertainty, especially if participants with missing outcomes differ from those with observed outcomes. No assumption or method for addressing this issue is reported.

The registry does not describe an intention-to-treat population, a per-protocol population, or another analysis set. Enrollment of 15 does not establish how many were included in an endpoint analysis. The protocol’s statistical analysis plan, interim analyses, and sample-size justification are not reported in the registry record.

12. 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 1% reporting threshold.

For the treatment group, the registry records 15 participants at risk for serious adverse events and zero affected. It also records 15 at risk for other adverse events and zero affected. These entries mean that no events are recorded in those categories in the registry result fields; they should not be expanded into a claim that no adverse events occurred under any broader definition or outside the reporting represented in the record.

The registry does not list serious-event terms. Deaths are not reported in the registry record. The record also does not provide event timing, severity details beyond the serious-versus-other categories, or a narrative description of how events were collected. These details should not be inferred from the zero counts.

In general, safety counts describe what was recorded in the observed group. With no comparator group, they cannot provide a comparative estimate of event frequency. The small enrollment also means the listed counts should be interpreted as descriptive registry data, not as a precise estimate of risk. No additional safety conclusion is supported by these entries alone.

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

The registry establishes that this was a completed, single-group pilot of platelet rich fibrin matrix for nasolabial folds, with a planned primary comparison of wrinkle assessment scores from pretreatment to 12 weeks. It also states that a 1 unit improvement over baseline was considered clinically relevant for the population calculation. These details describe the study question and intended endpoint, not the result.

The primary outcome values are not reported in the registry record. There is therefore no basis in the record to state the direction or size of the observed score change, how variable participants’ changes were, or how precisely any estimate was measured. The listed secondary time points likewise have no reported score results. The study summary’s description of serial photographs and arm biopsies does not substitute for numerical outcome findings.

Even if a change from baseline were available, the design would support a description of change within the treated group rather than a controlled estimate of treatment effect. No untreated or alternative-treatment comparator is described. The absence of masking also matters for a score-based outcome, although the registry does not provide enough detail to determine how scores were assessed.

The safety entries record zero serious and zero other adverse events among 15 at risk in each category. They are descriptive counts for the registry’s treatment group; they do not establish comparative safety or rule out events that were not captured in the record.

Accordingly, the record documents a pilot study’s design, measurement schedule, and selected safety counts, while leaving the main efficacy result and key analytical details unavailable. It cannot establish the amount of change, its precision, or whether change was attributable to treatment.

14. Why This Trial Matters Statistically

This trial illustrates why a clearly specified endpoint and a reported result are both necessary for statistical interpretation. The registry defines a wrinkle assessment scale, a comparison with pretreatment, and a 12-week primary time point. Those features tell readers what the investigators intended to measure. Without the endpoint values and their variability, however, the size and precision of the change cannot be assessed.

The single-group design also demonstrates the distinction between observing change and estimating a treatment effect. In general, a before-and-after pattern can be informative as a description of participants’ measurements, but it does not supply the counterfactual comparison needed to attribute change to an intervention. A treated group with both folds treated does not offer an untreated fold as a control.

The record also makes visible the limits of registry reporting. It lists outcome measures but no analysis entries, gives limited information about scoring and missing measurements, and does not report the statistical plan. Readers cannot infer these methods from the endpoint label or from the fact that the study is complete. Reporting planned outcomes, analysis populations, handling of incomplete data, and estimates with uncertainty would make the results more interpretable.

Finally, the safety counts show why event totals need context. The recorded zeros are useful descriptive information, but the absence of a comparator and the limited enrollment restrict what can be concluded. These distinctions are important in pilot research: design, measurement, statistical estimation, and causal interpretation are related but are not interchangeable.

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 most consequential limitation of the registry record is that it does not report the primary outcome results. There is no mean change, standard deviation, confidence interval, or p-value for the 12-week wrinkle assessment. Results for the listed secondary time points are also not reported. The amount and precision of any observed change therefore remain unknown.

The single-group design has no control comparison, and both nasolabial folds were treated. Any within-group change, if available, could not by itself separate treatment-associated change from time trends, measurement variability, or other explanations. Masking is listed as none, while the identity of score assessors and scoring procedures are not reported.

The registry does not report participant flow, the number with complete measurements at each time point, missing-data methods, or the analysis population. It also does not report the protocol’s statistical analysis plan, multiplicity approach, interim analyses, or sample-size justification. These omissions prevent assessment of whether reported analyses, if any, followed prespecified methods.

The study summary mentions arm injections and serial biopsies, but the listed outcome information does not provide biopsy findings. Safety information is limited to the recorded event counts; deaths are not reported in the registry record, and further event details are absent. These limitations concern what can be interpreted from this record and should not be mistaken for evidence that unreported procedures or analyses did not occur.

16. Related Tutorials

17. Related Statistical Calculators

18. Sources

• ClinicalTrials.gov: Pilot Evaluation of Platelet Rich Fibrin Matrix (PRFM) for the Correction of Nasolabial Folds — NCT00874094.
• Registry record last updated 2013-07-12; status last verified 2013-07.
• Results first posted 2013-07-12.
• 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

NCT00874094 is a completed Phase 1 and Phase 2, single-group pilot sponsored by The New York Eye & Ear Infirmary. The registry lists enrollment of 15, no masking, and study dates from 2008-04 to primary completion in 2009-06. The intervention was platelet rich fibrin matrix for nasolabial folds.

The primary endpoint was the difference in wrinkle assessment score between pretreatment and 12 weeks after treatment. The scale ranges from 0, least noticeable, to 5, most noticeable. The registry does not report primary or secondary score results, analysis methods, or missing-data handling. It records zero serious and zero other adverse events among 15 at risk in each category; deaths are not reported in the registry record.