Novel Antiaging Regenerative Skin Care Regimen Containing Human Platelet Extract (HPE): Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Novel Antiaging Regenerative Skin Care Regimen Containing Human Platelet Extract (HPE) (NCT05457491), a na phase 1 study. The primary outcome is Change in Redness Area.

2. Clinical Question

This is a descriptive question about change observed in a treated group, not a comparative estimate of HPE versus an untreated group or another regimen. Without a separate control group, changes over time cannot be separated from other influences by a between-group comparison. The registry record lists cosmetic improvement, satisfaction, recommendation, likelihood of continuing treatment, and self-esteem as secondary outcomes. Numerical results for those outcomes are not reported in the registry record.

3. Trial Design

NCT05457491 is recorded as a Phase 1, single-group study sponsored by Mayo Clinic. Enrollment was 56. The allocation field is NA, and masking is listed as none. The study status is terminated. The registry record gives a start date of 2021-10-01 and a primary completion date of 2022-07-07. It does not report the reason for termination.

The study examined a cosmetic skin-care regimen containing topical human platelet extract. The stated purpose was to investigate safety and tolerability after multiple topical administrations and to assess possible anti-aging or skin-rejuvenation effects. The listed regimen includes HPE, Vanicream Gentle Facial Cleanser, EltaMD UV Daily Broad-Spectrum SPF 40, EltaMD PM Therapy Facial Moisturizer, and Vanicream Lite Lotion. The arm description refers to a standardized morning and evening routine; the evening instructions are not fully reported in the registry record.

Because the design is single group, the participants do not form a randomized comparison between HPE and a control regimen. The other skin-care products named in the intervention record should be understood as components of the described regimen, not as evidence of a separate comparator arm. There is no masked comparison described.

The primary endpoint is a percentage of participants meeting a specified redness-improvement threshold from baseline to 6 weeks. Ten outcome measures are listed, including the primary endpoint and secondary cosmetic and satisfaction outcomes. The registry record lists zero analyses. It does not report an analysis population, a statistical analysis plan, sample-size justification for the trial, interim analyses, or the reason the study was terminated. These omissions limit what can be reconstructed about how the investigators intended to analyze the study.

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 Change in Redness Area, measured over baseline, 6 weeks.

The primary endpoint is the percentage of participants who experienced at least 50% improvement in redness area over baseline, assessed at 6 weeks. Redness was measured by photodocumentation using the VISIA-CR Generation 5 3D PRIMOS with RBX technology. The description says redness pixel variation and the cross-polarized image were transformed into red images correlated with hemoglobin absorption and distribution.

This is a binary participant-level outcome: each participant either meets the stated threshold or does not. The percentage expresses how common that defined response was in the study group. A threshold-based endpoint can make a technical image measure easier to interpret as the proportion reaching a specified degree of change, but it also discards information about how much each participant changed beyond whether the threshold was met. Participants just below and well below the threshold are counted alike for this endpoint.

The comparison is with each participant’s own baseline, not with a concurrent control group. Consequently, the endpoint describes change over time within the treated group; it does not by itself isolate the effect of HPE from other influences. The endpoint’s definition and measurement method are reported, but the observed number or percentage meeting the threshold, and any estimate of uncertainty around it, are not reported in the registry record.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

The registry record describes a binary percentage endpoint and a single-group design, but lists zero analyses and does not report the primary endpoint result. The methods below explain how such outcomes are generally understood; they should not be read as a description of analyses performed in this study unless those analyses are explicitly reported in the registry record.

What does a binary percentage represent?

For a binary endpoint, each participant is classified according to whether a prespecified event occurred. In this study’s primary outcome, the event is reaching at least 50% improvement in redness area from baseline at 6 weeks. The percentage is the count meeting that definition relative to the relevant group of participants with outcome information. This summary answers how often the defined response occurred, not how large the average change in redness was.

A percentage depends on both its numerator and denominator. The numerator is the number meeting the response definition, and the denominator is the number included in the calculation. Enrollment of 56 does not automatically identify the endpoint denominator: some participants might lack a measurement or be excluded from a particular analysis, although the record does not say whether that happened. Because no endpoint count or denominator is reported, the response percentage cannot be interpreted or reconstructed.

How should uncertainty be understood?

A confidence interval is a range of values calculated from the observed data using a statistical method. In general, it communicates the uncertainty around an estimate: a narrower interval indicates greater precision under the assumptions of that method, while a wider interval indicates less precision. A confidence interval does not guarantee that the true value lies within that particular interval, and it does not resolve design limitations such as the absence of a control group.

No confidence interval, standard error, or other precision estimate for the primary endpoint is reported in the registry record. Without the underlying event count and analysis denominator, readers cannot assess the sampling uncertainty of the percentage. An estimate and its uncertainty are both important: a point estimate alone can obscure whether the data are compatible with a broad range of values.

What does a single-group comparison allow?

In a single-group study, baseline measurements can be compared with later measurements for participants who have data at both times. This can describe temporal change in the observed group. It does not create the counterfactual comparison that random assignment to another group is designed to support. General influences over time, measurement variation, and other aspects of the care routine may also contribute to observed changes. A within-group change should therefore not be treated as an estimate of the difference caused by HPE relative to a comparator.

Here, the regimen includes several listed skin-care products as well as HPE. The record does not describe a separate group receiving the other products without HPE. Thus, even a reported change would pertain to the regimen and study conditions, rather than isolate the contribution of HPE from the other components.

What can the planning assumptions tell readers?

The registry record describes a planning illustration based on an observed effect, with a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation. It also says that the effect to detect is a stated fraction of the observed effect. Those assumptions describe a planning calculation, not the design actually recorded for this single-group study. They do not establish that participants were assigned to two arms, nor do they demonstrate that a planned analysis was conducted.

Sample-size calculations are planning illustrations: they depend on assumptions about the effect and the statistical method. They are not observed power and cannot substitute for examining the actual estimate and its uncertainty. The registry record does not report a trial-specific sample-size justification or numerical values for a planning calculation. No planning illustration can fill in the missing primary endpoint result.

Why does over-dispersion matter in general?

Over-dispersion occurs when observed variability is greater than a statistical model expects. If a model assumes less variation than the data contain, uncertainty estimates can be too small and inferential conclusions too confident. Appropriate handling depends on the outcome type and analysis model. The registry record does not report a model for the primary endpoint or information that would establish whether over-dispersion was assessed, so no claim can be made about its relevance to an analysis in this study.

What can be inferred from the reported safety counts?

Counts of participants with events are descriptive summaries. Their interpretation depends on the definitions used, the observation period, completeness of follow-up, and how events were attributed and categorized. The record gives serious-event and other-event counts, but does not report detailed event terms, follow-up duration for those counts, or analysis methods. These counts should be read as the posted safety summary, not as a modeled comparison or a measure of cosmetic efficacy.

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("Human Platelet Extract (HPE)")
n      <- c(55)
events <- c(23)
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  Human Platelet Extract (HPE)  55  23  41.8  28.7  55.9  29.7  55.0  29.7  55.0

11. Multiplicity, Missing Data and Analysis Populations

The registry record lists ten outcome measures, including the primary redness endpoint and secondary outcomes concerning cosmetic improvement, satisfaction, recommendation, likelihood of continuing treatment, and self-esteem. It lists zero analyses. No multiplicity strategy is reported in the registry record.

In general, when several outcomes or several statistical comparisons are examined, the chance of at least one apparently notable result can increase. Statistical approaches can address this issue by defining a hierarchy of outcomes, adjusting inference across tests, or clearly distinguishing confirmatory outcomes from exploratory ones. The record identifies a primary endpoint, but does not report a testing hierarchy, adjustment method, or analysis plan. It is not appropriate to assume that any particular approach was used.

Missing-data methods are also not reported in the registry record. The enrollment count of 56 does not establish how many participants had usable baseline and 6-week redness measurements, whether all participants completed follow-up, or how any missing measurements were handled. These details matter for a percentage endpoint because the denominator and the assumptions about participants without endpoint data affect interpretation.

The record does not identify an intention-to-treat, per-protocol, or other analysis population. It also does not explain eligibility for the endpoint analysis or whether the safety and efficacy populations differed. These are not minor bookkeeping details: the population included in an analysis determines which participants the estimate describes. With no analysis results or population definition reported, neither multiplicity nor missing-data handling can be evaluated for this study.

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 reports 0 serious adverse events among 56 participants at risk in the Human Platelet Extract (HPE) group. It reports 0 deaths. For other adverse events, 9 participants are listed as affected among 56 at risk. The record does not list serious adverse-event terms.

These are counts, not comparative estimates. There is no separate control group, and the record does not provide event-level descriptions, timing, severity details for the other events, attribution, or a follow-up period for interpreting the counts. The serious-event count should be read as the reported number in this group, not as proof that serious events are impossible or that all safety concerns have been ruled out. Likewise, the count of participants with other events does not identify what those events were or whether they were considered related to the regimen.

The safety counts should also be kept distinct from the cosmetic endpoint. They do not provide information about the percentage who met the redness-improvement threshold. The registry record’s terminated status does not explain the safety findings or the reason for termination.

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

The record’s clearest contribution is a description of a Phase 1, single-group evaluation of a topical HPE-containing skin-care regimen, including its stated safety and tolerability purpose and a prespecified redness endpoint. It also records enrollment of 56 and a limited summary of adverse events. This information can help readers understand what was planned and what safety counts were posted.

It does not establish how many participants met the primary redness-improvement threshold. The primary endpoint result is not reported in the registry record, and the record lists zero analyses. Numerical results for the listed secondary outcomes are also not reported. There is no endpoint estimate or precision measure on which to base a conclusion about the observed degree of change.

Even if a within-group change were available, the absence of a comparator would limit causal interpretation. A baseline-to-follow-up comparison describes what happened in the observed group over time. It cannot, by itself, show how that change compares with no HPE or with a different skin-care regimen. The combination of listed products also means that a regimen-level observation would not isolate the effect of HPE.

The posted safety counts should be interpreted descriptively and within the limitations of the information recorded. Zero serious adverse events and zero deaths are the counts reported, while 9 participants are listed with other adverse events. Without event details and fuller follow-up information, those summaries do not answer every safety question.

Overall, the registry record supports an account of study design and reporting status, but not a conclusion about the magnitude, precision, or comparative effect of the primary outcome. The reason for termination, the analysis populations, missing-data procedures, and statistical analysis plan are not reported in the registry record.

14. Why This Trial Matters Statistically

This study is statistically informative as an example of why a clearly defined endpoint is only one part of interpreting clinical research. The redness outcome specifies a measurement approach, a follow-up time, and a threshold for classifying participant response. Those details define what the study intended to summarize. But without the observed count, denominator, or estimate, readers cannot judge the frequency or precision of that response.

The single-group design also illustrates the difference between describing change and estimating a comparative effect. A within-group change may be useful for describing the observed participants, but it does not provide a concurrent contrast. This distinction is especially relevant when an intervention is a regimen with several named skin-care products: a change associated with the regimen cannot automatically be assigned to one component.

The record further shows why enrollment is not the same as an endpoint analysis population. Although enrollment is 56, no primary endpoint denominator or missing-data handling is reported. Without those details, readers cannot know how much of the enrolled group contributes to the endpoint summary.

Finally, registry reporting is part of statistical transparency. The record identifies ten outcome measures and a terminated status, yet gives zero analyses and no primary outcome result. The reason for termination and the analysis plan are also not reported. These absences do not prove that analyses were never conducted, but they mean that the posted record does not allow readers to assess them. Careful interpretation distinguishes what the record defines, what it reports numerically, and what remains unknown.

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 interpreting efficacy is that the primary endpoint result is not reported in the registry record. Although the endpoint is defined as a percentage meeting a threshold, the record does not provide the response count, percentage, denominator, or uncertainty estimate. The listed secondary outcomes likewise have no numerical results in the registry record, and zero analyses are listed.

The design is single group, with allocation recorded as NA and no masking. There is no separate comparator arm for estimating a between-group difference. Any change from baseline, if reported elsewhere, would not by itself distinguish regimen-related change from other influences over time. Because HPE is included alongside several skin-care products, this design also would not isolate HPE’s contribution from the regimen as a whole.

Enrollment was 56, but participant flow and the analysis population are not reported. The record does not state how many participants had evaluable measurements at baseline and 6 weeks, or how missing observations were handled. It does not report a statistical analysis plan, multiplicity approach, trial-specific sample-size justification, or interim analyses.

The registry status is terminated, but the reason for termination is not reported in the registry record. The evening regimen description is incomplete in the record. Safety information is limited to aggregate counts and does not include detailed terms or other context needed to characterize the events. These limitations constrain interpretation of both the efficacy question and the safety summary.

16. Related Tutorials

17. Related Statistical Calculators

18. Sources

• ClinicalTrials.gov: Novel Antiaging Regenerative Skin Care Regimen Containing Human Platelet Extract (HPE) — NCT05457491.
• Registry record last updated 2024-10-04; status last verified 2024-09.
• Results first posted 2024-10-04.
• 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

NCT05457491 is a Phase 1, single-group study sponsored by Mayo Clinic, with enrollment of 56 and status recorded as terminated. The listed intervention is a topical HPE-containing skin-care regimen. Allocation is NA, and masking is none.

The primary endpoint is the percentage of participants with at least 50% improvement in redness area from baseline to 6 weeks, measured using photodocumentation. The endpoint result is not reported in the registry record. Ten outcome measures are listed, and zero analyses are listed.

The safety record lists 0 serious adverse events and 0 deaths among 56 at risk, and 9 participants with other adverse events among 56 at risk. The reason for termination, analysis populations, missing-data handling, and statistical analysis plan are not reported in the registry record.