Combining Broad Based Light (BBL), Fractionated 1927 (MOXI) and Dual Wavelength 2940/1470 (HALO): Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Combining Broad Based Light (BBL), Fractionated 1927 (MOXI) and Dual Wavelength 2940/1470 (HALO) (NCT06091215), a non-randomized na study. The primary outcome is Change in Brown Spots at 1 Month From Baseline (Single Treatment Group).

2. Clinical Question

3. Trial Design

This was a completed, single-site, non-randomized, non-controlled study at UT Southwestern Medical Center at Dallas in the Department of Plastic Surgery. The registry lists 15 enrolled participants and a parallel-group model. It lists a single-treatment group and a double-treatment group, but does not describe random assignment or masking. The allocation is explicitly non-randomized, and masking is listed as none.

The intervention was the Sciton Joule System. The arm descriptions identify BBL/MOXI/HALO as the treatment: one group received a single treatment, while the other was scheduled to receive two treatments 4-6 weeks apart. The study summary says consenting participants could receive up to 2 treatments. The record does not explain how participants entered one treatment group rather than the other, so the basis for group assignment is not reported in the registry record.

The study started on 2024-01-01, reached primary completion on 2024-06-11, and has status Completed. The phase is listed as NA. The registry describes the study as designed to follow participants after treatment, but does not report a control condition or an untreated comparison. Therefore, differences between the treatment groups cannot be interpreted as randomized treatment effects; group assignment and treatment schedule are entangled with any observed differences.

The primary endpoint is a change in brown-spot count at 1 Month from baseline in the single-treatment group. The record lists 32 outcome measures and 0 analyses. It does not report the study's statistical plan, sample-size justification, interim analyses, or results for the primary endpoint. Those omissions limit what can be concluded about the intended analysis and the observed findings.

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.

Single treatment (4 weeks)

Double treatment (8 weeks)

Analysis population for the primary outcome, as defined in the registry: Analysis was focused on testing whether the effect of the treatment on each parameter differed The per-protocol (PP) population will be the primary population for all statistical analyses. The PP population will include all subjects who received treatment and completed the study in general accordance with the protocol. Only the data of completing subjects will be analyzed.

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 Brown Spots at 1 Month From Baseline (Single Treatment Group), measured over Baseline, 1 Month.

The primary endpoint is the change in brown spots at 1 Month from baseline in the single-treatment group. The registry specifies the measurement as a count of spots and identifies the summary measure as the median with an inter-quartile range. The description says the assessment quantified change in overall UV spots using VISIA 3D analysis on different sides of the face for all subjects. It also states that a lower value signifies improvement.

Spot counts are used to represent visible pigmentation features that can be counted with the specified imaging assessment. In general, a baseline-to-follow-up measure can describe how an observed feature changes over time within a group. It does not, by itself, show what would have happened without treatment. A concurrent control group or another design that supports a comparison would be needed to separate treatment-related change from other influences on measurements over time.

The registry record does not report the baseline or follow-up median, the inter-quartile range, or the calculated change. It also does not give the endpoint's observed sample size. Consequently, the stated endpoint definition and direction can be explained, but the size and precision of the observed change cannot be assessed from the registry record.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

The statistical methods described in the registry are limited. The primary endpoint is designated as a median with an inter-quartile range, and the listed population is per-protocol. However, the record does not provide a full statistical analysis plan, report any analyses, or give the endpoint's observed values. The explanations below describe the general meaning of the methods named in the record, not a claim about analyses that were performed.

What does a median and inter-quartile range describe?

In general, the median is the middle value after observations are ordered. It can be a useful summary when a distribution is skewed or contains unusually high or low values, because it is less affected by extreme observations than the mean. The inter-quartile range describes the span from the lower quarter of the ordered observations to the upper quarter. It gives information about the spread of the middle portion of the data. The registry names these summaries but does not report the median, inter-quartile range, or the number of observations contributing to them.

The endpoint is a change from baseline to 1 Month. In general, a change score represents the follow-up measurement relative to the baseline measurement, but the precise calculation convention is not stated in the registry record. The description states that lower values signify improvement. Without the reported measurements or change value, the direction and magnitude of the observed change cannot be evaluated.

What does a confidence interval mean?

In general, a confidence interval communicates the precision of an estimated effect by giving a range of values compatible with the data and the statistical procedure used. A narrower interval indicates greater precision under that procedure; a wider interval indicates less precision. A confidence interval does not correct for bias from non-random allocation, lack of a control group, missing data, or measurement problems. The registry record does not report confidence intervals for the primary endpoint or identify an interval estimation method.

Why does the design matter for statistical interpretation?

Random allocation, when used, helps balance known and unknown participant characteristics between groups on average. This study is listed as non-randomized. In general, that means group differences may reflect both the treatment schedule and other differences between participants. The record does not explain group assignment or report baseline comparisons. With no control group, before-and-after changes also lack a contemporaneous untreated comparison. Statistical adjustment can sometimes address measured differences, but the registry record does not report whether adjustment was planned or performed.

The parallel-group model means the record describes distinct treatment groups. It does not make those groups equivalent. The single-treatment and double-treatment schedules are not randomized control conditions, and the primary endpoint is specifically defined for the single-treatment group. The record does not report a direct inferential comparison between the groups.

What can be said about planning calculations?

The registry describes a sample-size planning illustration based on the observed effect, with a two-sided significance level of 0.05, equal allocation between arms, and a normal approximation. The illustration defines its target effect as a stated fraction of the observed effect. These are planning assumptions for an illustration, not evidence of the study's original design or a report of observed power. The registry record does not report the trial's own sample-size justification. Any sample-size values associated with such an illustration should be understood as hypothetical planning quantities, not as participants actually enrolled or as proof that the study had a particular probability of detecting an effect.

In general, a sample-size calculation depends on assumptions about the effect to detect, variability, significance level, allocation, and analysis. If an illustration uses an observed effect, its output is conditional on that effect estimate and does not independently validate it. The record does not report enough details to determine whether the illustration's assumptions match the actual study or the endpoint's data structure.

Why can over-dispersion matter?

In general, count outcomes may vary more across participants than a simple model assumes. This extra variability is called over-dispersion. If it is ignored, standard errors and confidence intervals can be too small, making estimates look more precise than they are. A model that allows for over-dispersion may be appropriate for some count data, but the registry does not report a model, dispersion assessment, or model-based analysis. Since the endpoint is reported as a median and inter-quartile range, no count-model method should be inferred from the endpoint description alone.

Overall, the record identifies a descriptive summary for the primary measure but not the inferential procedures used to analyze it. It supplies no analysis results, uncertainty estimates, or full protocol-level statistical details. The statistical interpretation must therefore remain limited to the endpoint definition, design, and explicitly reported registry information.

10. Multiplicity, Missing Data and Analysis Populations

The registry lists 32 outcome measures and 0 analyses. It does not report how the primary endpoint was distinguished from other outcomes in the statistical analysis plan, whether a hierarchy of outcomes was used, or whether any adjustment for multiple testing was planned. In general, testing many outcomes can increase the chance of finding an apparently notable result by chance. Methods to address that issue depend on the analysis plan and the inferential goal. Since no analyses are reported, the registry record does not support an assessment of multiplicity handling or its consequences.

Missing-data procedures are not reported in the registry record. The primary population description says that the per-protocol population includes subjects who received treatment and completed the study in general accordance with the protocol, but the text ends before the full criteria are given. The record does not specify how incomplete follow-up, missing measurements, protocol deviations, or participants excluded from the per-protocol population were handled. It also does not report the number of participants with endpoint data.

In general, excluding participants with missing outcomes or protocol deviations can affect the interpretation of a per-protocol analysis, especially when the reasons for missingness relate to outcomes or treatment. That is a general methodological concern, not a finding about this study. Without participant flow, endpoint-specific counts, and analysis details, the extent or direction of any such effect cannot be assessed.

The study's sample-size justification and interim-analysis procedures are not reported in the registry record. The registry's planning illustration is not a substitute for the trial's own design justification. No assumptions about interim review, early stopping, or multiplicity control should be inferred.

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 registry reports 0 serious adverse events among 7 participants at risk in the single-treatment group and 0 among 8 participants at risk in the double-treatment group. It also reports 0 other adverse events in each group and 0 deaths in each group. No serious adverse-event terms are listed.

These figures describe the entries in the registry record, not a guarantee that an event was impossible or that every potential harm was captured. In general, a study with a limited number of participants may provide limited information about uncommon events. The record does not give detailed adverse-event definitions, collection procedures, severity criteria, or a fuller account of follow-up for safety. It also does not report whether any events were judged related to treatment.

Accordingly, the figures should be read as the recorded counts for the groups, not as proof that the treatments are free from risk. They are descriptive safety information and do not establish comparative safety between schedules, particularly because allocation was non-randomized and there was no control group.

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

The registry record establishes that a completed study evaluated BBL/MOXI/HALO treatment in a non-randomized, non-controlled setting and defined a primary measure of brown-spot count in the single-treatment group. It also states that a lower value signifies improvement. However, it does not report the actual endpoint result. No conclusion about the amount, direction, or precision of change can be drawn from the endpoint description alone.

Even if a baseline-to-follow-up change were available, a change within the treated group would not by itself demonstrate that treatment caused the change. In general, before-and-after observations can also reflect natural fluctuation, measurement variability, or other changes over time. A control group can help interpret such changes, but none is reported for this study. The two treatment groups are not randomized control and intervention groups; they received different treatment schedules and were assigned non-randomly.

The record also does not support a comparison of treatment schedules. It does not report group-specific outcome results, baseline characteristics, adjusted estimates, or an inferential analysis. The fact that 32 outcome measures are listed does not reveal which results were analyzed or how multiplicity was addressed, particularly because the registry reports 0 analyses.

The adverse-event entries record no serious events, other events, or deaths in either group. These counts describe what is recorded, but do not establish the absence of all possible harms or compare safety reliably between schedules. In short, the registry identifies the study question and the type of measurement, while leaving the principal outcome and analysis results unavailable. The findings, if any, cannot be quantified or independently interpreted from the registry record.

13. Why This Trial Matters Statistically

This study is statistically informative as an example of how a clinical question and an outcome measure can be specified without enough posted results to evaluate the outcome. The registry identifies a quantitative measure, its follow-up time, the summary statistic, and the direction considered favorable. Yet it does not report the observed median change, its inter-quartile range, or an analysis result. Without those elements, readers cannot assess the magnitude or precision of the primary endpoint.

The design also illustrates why treatment groups are not automatically valid comparators. The single-treatment and double-treatment groups differ in schedule, and allocation was non-randomized. Those features limit causal interpretation of any between-group difference. The absence of a control group also means that a within-group change cannot be separated from other changes over time on the basis of this design alone.

The registry lists multiple outcome measures but no analyses. That makes clarity about outcome selection, missing data, and multiplicity especially relevant. A transparent analysis plan and complete reporting of estimates and uncertainty would help readers distinguish descriptive change from a treatment comparison. Those details are not reported in the registry record.

For biostatisticians and clinical researchers, the record underscores the importance of reporting both the measurement definition and the results needed to interpret it: the analyzed population, participant counts, estimates, uncertainty, and analysis methods. Here, the record supports a careful account of the study structure and reporting gaps, but not a numerical assessment of treatment effects.

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.

Several limitations specific to this study constrain interpretation. The design was non-randomized and non-controlled, and masking was listed as none. The single-treatment and double-treatment groups therefore do not provide a randomized comparison, and the record does not describe how participants were assigned. The registry also does not report baseline characteristics that could show whether the groups were similar before treatment.

The primary endpoint is defined for the single-treatment group, but the registry record does not report its observed value, median, inter-quartile range, or endpoint-specific participant count. It therefore provides no basis for judging the size or precision of the measured change. The record lists 32 outcome measures and 0 analyses, and it does not explain how the primary endpoint was selected or how multiple outcomes were addressed.

The per-protocol population description is incomplete: it says participants must have received treatment and completed the study in general accordance with the protocol, but does not provide the rest of the definition. The record does not describe participant flow, missing measurements, exclusions, or methods for handling missing data. It also does not report the statistical analysis plan, the trial's sample-size justification, or interim analyses.

Safety reporting is limited to the listed counts and does not include detailed definitions, event narratives, or attribution. Finally, the study was conducted at a single site and enrolled 15 participants. These features limit how broadly the study's observations could be generalized, even if outcome results were available.

15. Related Tutorials

16. Related Statistical Calculators

17. Sources

• ClinicalTrials.gov: Combining Broad Based Light (BBL), Fractionated 1927 (MOXI) and Dual Wavelength 2940/1470 (HALO) — NCT06091215.
• Registry record last updated 2026-01-27; status last verified 2025-11.
• Results first posted 2026-01-27.
• 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

NCT06091215 is a completed, single-site, non-randomized, non-controlled study sponsored by the University of Texas Southwestern Medical Center. It enrolled 15 participants with the condition listed as Pigment Skin and evaluated the Sciton Joule System for BBL/MOXI/HALO treatment. One group received a single treatment; another was scheduled for two treatments 4-6 weeks apart.

The primary endpoint was change in brown-spot count at 1 Month from baseline in the single-treatment group, summarized as a median with an inter-quartile range. The registry says a lower value signifies improvement, but does not report the endpoint result. It lists 32 outcome measures and 0 analyses. Adverse-event entries report 0 serious adverse events, 0 other adverse events, and 0 deaths in each group. The record does not report a full statistical analysis plan, missing-data methods, or the trial's sample-size justification.