Aldena STAR Particles: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Aldena STAR Particles (NCT06004973), a non-randomized na study. The primary outcome is Transepidermal Water Loss (TEWL).

2. Clinical Question

3. Trial Design

This is a completed pilot study with a single-group model and nonrandomized allocation. The registry record lists Emory University as the sponsor, enrollment of 20, healthy participants, and phase as not applicable. The study start is recorded as 2024-02-07 and primary completion as 2024-11-07. These design details describe the study framework; they are not evidence of an application effect.

The study description outlines an eligibility visit followed by a visit in which STAR particles would be applied to different areas of the arm, hand, and face using different pressures. The investigator would administer eight application interventions and a control application. The record explicitly says site and treatment were not randomly assigned on the arm. Thus, differences among application sites or conditions could reflect both the application and the way sites and treatments were assigned. There is no randomized allocation that would make the control a like-for-like comparison.

The control is described as gel without STAR particles. Its placement differs by participant group: participants 1 to 10 received a control application on the volar side of one forearm, while participants 11 to 20 received it on the opposite forearm and the contralateral side of the face. The record does not explain the rationale for these placements or provide a statistical method for accounting for site differences.

The study is intended to inform the application method for STAR particles, not to test an active topical medication. The summary states that no medication with active ingredients would be used. The study also evaluates tolerability through surveys and includes outcomes on sensation, pain, and adverse events. No full statistical analysis plan, allocation rationale, or sample-size justification is reported in the registry record. The enrollment figure alone does not establish whether the study was adequately sized to estimate any particular effect.

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: This was an ADAPTIVE STUDY DESIGN so that after reviewing the data collected from the first 10 participants (Part 1), conditions were altered so that the ideal conditions (cycles and pressure application) discovered from Part 1 (first 10 participants) would be used for the next 10 participants (11 - 20) in Part 2 of the study. In Part 2, each subject had STARs applied to the right head/face and the right forearm, and a control was applied to the left head/face and the left forearm.

Part 1 (Participants 1-10)

Part 2 (Participants 11-20)

Analysis population for the primary outcome, as defined in the registry: Participants 1-10, who had TEWL measurements.

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.

Population: Twenty participants enrolled: Participants 1-10 (9 application sites each) were used to determine ideal pressure \& TEWL. Participants 11-20 had pain and sensation assessed at the forearms and face at the pressure and cycle levels previously chosen from the first 10 enrolled participants.

6. Primary Endpoint

The registry lists the primary outcome as Transepidermal Water Loss (TEWL), measured over Before application, 20 minutes after application, and 30 minutes after application.

The primary endpoint is transepidermal water loss, abbreviated TEWL, measured in g/m^2/hr. The registry record specifies a mean and standard deviation and lists measurements before application, 20 minutes after application, and 30 minutes after application. Its description says TEWL measurements were collected only for the first 10 participants, identified as participants 1–10.

TEWL quantifies water passing through the skin to the surrounding air. As a general measurement concept, it can be used to assess changes in the skin barrier: a change after an application may be consistent with a change in water loss across the skin. The measure does not by itself identify the cause of a change or establish how a topical medication would behave. That distinction matters because the study description says no active medication was used.

Repeated measurements at the listed times can describe how TEWL differs from the pre-application measurement over the specified observation period. Interpretation depends on the actual measurements, variability, and comparison method. Those results and the analysis comparing time points or application conditions are not reported in the registry record. Accordingly, the endpoint’s purpose can be described, but its observed direction, magnitude, and precision cannot be assessed from the record.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

What does a mean describe?

The primary endpoint is specified as a mean, a summary of the measured TEWL values for the relevant observations. A mean gives a concise description of the center of a set of measurements. It does not show how spread out the individual values are, whether there are unusual observations, or whether participant responses differ. The registry record also specifies a standard deviation, which describes the spread of measurements around the mean. Neither statistic is reported numerically for the primary endpoint, so the actual level and variability of TEWL cannot be assessed.

Why does the measurement schedule matter?

The listed TEWL time points are before application, 20 minutes after application, and 30 minutes after application. A pre-application measurement gives a within-participant reference point for describing subsequent measurements. Measurements after application can indicate whether TEWL differs at those particular observation times. They do not, by themselves, establish why any difference occurred, how long it lasted, or whether it would be relevant to a medication effect. The registry record does not report the values or a method for comparing measurements across time.

What can a nonrandomized comparison show?

Random allocation is a general method for balancing measured and unmeasured characteristics across comparison conditions. In this study, allocation is explicitly nonrandomized, and site and treatment were not randomly assigned on the arm. As a result, differences between sites or application conditions may be entangled with the way the investigator assigned them. The control applications also differ in placement across the participant groups described in the record. Without a reported analytic approach addressing these features, a contrast between conditions would not automatically isolate the effect of STAR particles or application pressure.

The study has a single-group model, yet includes different application conditions and a gel control. This does not turn it into a randomized controlled comparison. General statistical interpretation should keep the design description distinct from the number of conditions observed: the record does not describe random allocation or a like-for-like control comparison. No covariate adjustment, paired analysis, or other model is reported in the registry record.

How should uncertainty be understood?

An estimate from a study is subject to sampling variability. A confidence interval is a general way to express the precision of an estimate under a specified statistical model and its assumptions. A narrower interval indicates greater precision than a wider interval, but the interval does not account automatically for biases caused by nonrandom allocation, incomplete measurements, or an unsuitable model. The registry record does not report an estimate or confidence interval for TEWL, so precision cannot be judged.

The stated planning assumptions describe a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation, with the effect to detect defined as a stated fraction of the observed effect. These are planning assumptions, not a report of the study’s own design or a substitute for observed results. The study itself is described as single-group and nonrandomized, so the two-arm planning framework does not directly describe its allocation. Numerical planning estimates are not reported in the registry record. Any such sample-size illustrations are planning aids, not observed power. A post hoc power calculation would not recover information missing from the outcome results.

Why can over-dispersion matter?

As a general statistical concept, over-dispersion occurs when observed variability is greater than a model expects. If a model assumes less variability than the data contain, its uncertainty estimates may be too small and its inferential conclusions too confident. The primary endpoint is continuous and has a specified standard deviation, but no numerical distribution or analysis is reported. There is no basis in the registry record to determine whether over-dispersion was relevant or whether any particular model was used.

What do the outcome listings establish?

The record identifies TEWL as the primary outcome and lists secondary outcomes for sensation, pain using the visual analog pain scale, and participants reporting standard adverse events. It records five outcome measures, but outcome listings are not outcome estimates. The registry record reports no analyses and does not give numerical results for these measures. The distinction is important: a measure may be planned or named without its result being available for statistical interpretation.

10. Multiplicity, Missing Data and Analysis Populations

The record identifies TEWL as the primary outcome and lists secondary outcomes covering sensation after application, pain assessed with the visual analog pain scale, and participants reporting standard adverse events. It also records five outcome measures in total. The statistical approach to testing or summarizing multiple outcomes is not reported in the registry record. In particular, the record does not say whether any multiplicity adjustment was planned or how priority among secondary outcomes would be handled.

As a general concept, evaluating multiple outcomes or multiple contrasts can increase the chance of at least one apparently noteworthy result arising by chance when each is assessed separately. Methods for addressing that issue depend on the questions and analysis plan. No such plan or outcome analyses are reported, so the effect of multiplicity on interpretation cannot be assessed.

The TEWL description identifies measurements for participants 1–10 only, but the registry record does not report the number of completed measurements at each time point, whether any were missing, or how missing values were handled. It does not report an analysis population definition, exclusions, or whether all participants who began an application were included in each outcome analysis. The record also does not describe imputation, sensitivity analyses, or reasons for missing measurements.

These omissions matter because missingness can affect both the amount and interpretation of information. As a general principle, an analysis limited to observed measurements may be biased if the availability of measurements is related to participants’ responses or application conditions. Without reported data completeness and handling methods, the direction or importance of any such effect cannot be determined.

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.

The safety record lists STAR Particles Part 1 and STAR Particles Part 2 separately. For each, 10 participants are listed as at risk, with 0 serious adverse events, 0 other adverse events, and 0 deaths. The record therefore documents no events in those categories for either listed part. The safety figures should be read as recorded counts, not as proof that no adverse events could occur.

A zero count does not establish zero risk. With no event counts beyond the recorded values and no additional safety analysis, the precision of an underlying event rate cannot be assessed from the registry record. The record does not report event definitions, observation duration for safety, severity details beyond the serious-versus-other grouping, or whether all events were actively solicited. It lists a secondary outcome concerning participants who reported standard adverse events, but numerical results for that outcome are not otherwise reported.

The two parts are not described as randomized comparison groups, and the listed counts should not be interpreted as a comparative safety test. They do not establish that one application condition is safer than another or support a broader conclusion about safety in populations beyond the healthy participants studied.

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

The record establishes that investigators completed a pilot study of STAR particle application in healthy volunteers and specified TEWL as the primary endpoint. The study was designed around application methods and pressures, skin sites, and assessment of tolerability. The summary states that no medication with active ingredients would be used. Those details define the scope of the study; they do not establish a treatment benefit or lack of benefit.

The primary outcome values and analyses are not reported in the registry record. Consequently, the observed TEWL response, its variability, and the precision of any comparison cannot be described. The record does not support a conclusion that a particular pressure or application method performed better, that TEWL did or did not change, or that the application method has a specific effect on skin.

The nonrandomized design also limits causal interpretation. Treatment and site were not randomly assigned on the arm, and the control placement differs across the participant groups described. Even if outcome values were available, an observed difference could not automatically be attributed to the STAR particles or pressure without considering these design features and an appropriate analysis.

General interpretation should separate the measurement question from the intended future use. TEWL can describe water loss across the skin at specified times, but these measurements alone would not demonstrate that an active topical medication is absorbed more effectively or produces a clinical effect. The registry summary presents that possibility as motivation for future work, not as a result tested by this study.

The safety record reports zero serious events, zero other events, and zero deaths in each listed part. Those are descriptive counts in the registry record. They do not demonstrate absence of risk, establish comparative safety, or guarantee similar findings in other groups or settings. In short, the record describes a pilot design and records limited safety counts, but lacks the outcome analyses needed to characterize the primary endpoint or establish an application effect.

13. Why This Trial Matters Statistically

This study raises a useful statistical distinction between evaluating a measurement procedure and demonstrating a clinical effect. Its stated focus is finding an application method for STAR particles, while the primary endpoint is TEWL and the summary says no active medication is used. Statistical interpretation must therefore stay close to the measured question: skin water loss after application, not effectiveness of a medication or a clinical outcome.

The design also illustrates why assignment matters. A comparison between conditions is most informative when differences in participant characteristics and measurement sites do not systematically track with the condition being compared. Here, allocation is nonrandomized, and the record says site and treatment were not randomly assigned on the arm. The control applications also differ in location between the participant groups. These features complicate attribution of any observed differences to the application itself.

Repeated measurement over time can be valuable because a pre-application measure supplies a reference for post-application observations. Yet repeated measurements require clear reporting of completeness, analysis methods, and uncertainty. The registry record specifies the measurement times and population for TEWL but does not report the values, variability, or analyses. Statistical transparency is necessary to tell whether the data show a consistent pattern or are too variable for a precise estimate.

The study is described as a pilot, but the registry record does not report a sample-size justification or a statistical analysis plan. Enrollment alone cannot show what effect the study could estimate precisely. The record’s planning assumptions concern a two-arm illustration, while the study is described as single-group and nonrandomized; this difference underscores why planning calculations must be interpreted in relation to the actual design.

Finally, named outcomes and recorded safety counts are not substitutes for complete outcome reporting. Results, uncertainty, missing-data handling, and analysis populations are needed to judge what the observations mean and how far they can be generalized.

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 registry record does not report the primary TEWL results, including means, standard deviations, comparisons, or uncertainty estimates. It also records zero analyses. This prevents assessment of the direction, size, variability, and precision of the primary outcome.

TEWL measurements are described for participants 1–10 only, whereas enrollment is listed as 20. The record does not explain why TEWL was limited to that group, whether measurements were complete at all specified times, or how the measured participants were selected. No further participant characteristics are reported, limiting assessment of how well the group represents other populations.

Allocation was nonrandomized, and the record explicitly says treatment and site were not randomly assigned on the arm. The control application locations differ between participant groups. This makes direct attribution of differences to STAR particles or pressure difficult and limits any causal comparison. The registry record does not report a statistical approach addressing site, repeated measurements, or other potential sources of variation.

The study summary states that no active medication with active ingredients was used. Consequently, the record does not report evidence on medication delivery, medication effectiveness, or clinical benefit. It is a study of application and associated measurements, not a test of a topical drug.

The record does not report a full analysis plan, sample-size justification, missing-data methods, or multiplicity approach. Numerical results for the listed sensation and pain outcomes are also not reported. The adverse-event entries show zero events in the recorded categories, but event definitions and safety observation details are not reported. These limitations restrict both statistical interpretation and generalization.

15. Related Tutorials

16. Related Statistical Calculators

17. Sources

• ClinicalTrials.gov: Aldena STAR Particles — NCT06004973.
• Registry record last updated 2026-02-04; status last verified 2026-01.
• Results first posted 2026-02-04.
• 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.

18. Record Summary

The registry record describes Aldena STAR Particles, a completed pilot study sponsored by Emory University. It lists a single-group model, nonrandomized allocation, healthy participants, enrollment of 20, and phase as not applicable. The recorded study start is 2024-02-07, with primary completion on 2024-11-07.

The study examines application of STAR particles at different pressures and includes a gel control without STAR particles. The summary states that no active medication would be used. The primary endpoint is mean TEWL, measured before application and at 20 minutes and 30 minutes after application, with the endpoint description limited to participants 1–10.

The registry record lists secondary outcomes for sensation, pain, and standard adverse events. It records zero serious adverse events, zero other adverse events, and zero deaths in each of the two listed parts. Primary outcome values and analyses are not reported in the registry record, so the study’s TEWL findings and statistical precision cannot be assessed from the posted information.