Study for the RevLite Laser System for Facial Solar Lentigines: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Study for the RevLite Laser System for Facial Solar Lentigines (NCT02110108), a randomized na study. The primary outcome is Photographic Evaluation Using the Blinded Global Aesthetic Improvement Scale.

2. Clinical Question

The study concerns whether photographic assessments of facial solar lentigines differ after treatment with the RevLite Laser System using a single wavelength or two wavelengths. Its primary outcome is a blinded comparison of photographs taken at baseline with photographs taken 1 month post last treatment, rated on the Global Aesthetic Improvement Scale. The registry record does not report the ratings or a comparison between the treatment approaches, so the clinical question cannot be answered from the posted primary outcome results.

3. Trial Design

The registry identifies this as a randomized, parallel study with no masking. Enrollment was 10. The listed phase is NA. The study status is completed; the registry gives a start of 2014-03 and a primary completion of 2015-02. Cynosure, Inc. is the sponsor.

The intervention is the RevLite Laser System, recorded as a device. The arm descriptions distinguish a single-wavelength approach, using 1064nm on half of the face, and a dual-wavelength approach, using 1064 nm and 532 nm on half of the face. Although the registry labels the model parallel, the half-face wording raises a design detail that cannot be resolved from the record alone. It does not explain how the parallel allocation relates to the two halves of each face, or provide further procedural details.

The registry describes the primary outcome as a blinded photographic evaluation, while the trial-level masking entry is none. These statements concern different aspects of the record, but who performed the blinded assessment and how the blinding was maintained are not reported in the registry record. The schedule is tied to each subject’s final treatment: the stated primary outcome timeframe is 1 month post last treatment.

A Physician Satisfaction Questionnaire is listed as a secondary outcome. The record lists 2 outcome measures and 0 analyses. No arm-specific enrollment counts, allocation ratio, or fuller treatment schedule are reported in the registry record. The record also does not report a sample-size justification or explain how the enrollment target was chosen.

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

Analysis population for the primary outcome, as defined in the registry: Since all subjects who enrolled received at least 1 treatment and had a 30 day follow up to this treatment, all subject information is included. The time frame is based off of the follow up to each subject's final treatment.

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 Photographic Evaluation Using the Blinded Global Aesthetic Improvement Scale, measured over 1 month post last treatment.

The primary endpoint is titled “Photographic Evaluation Using the Blinded Global Aesthetic Improvement Scale.” It uses photographs taken at baseline and photographs taken 1 month post last treatment to assess improvement. The record describes the scale as ranging from -1 to 3: -1 means worsened, 0 means no change, 1 means improved, 2 means much improved, and 3 means very much improved. The outcome unit is participants, and its parameter is described as a count of participants.

In general, before interpreting a clinical endpoint it is important to know what is being measured, when it is assessed, and how its values are defined. A photographic rating can organize visual assessments into categories, while a blinded evaluation is intended to limit the influence of knowledge about treatment on the assessment. The registry says this evaluation is blinded, but does not identify the assessor or provide details of the blinding process.

The endpoint description does not include the number of participants in each scale category, a summary of the ratings, or a comparison between the treatment approaches. The registry’s note about the primary outcome indicates that it has several categories or time points and was not reduced to one comparison. The exact outcome breakdown and any prespecified method for summarizing the scale are not reported in the registry record. Consequently, the scale’s definition can be described, but the observed level of improvement cannot be characterized.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

Statistical methods are the rules used to turn observations into an estimate and describe its uncertainty. The registry record gives an outcome definition and some design information, but does not report an analysis method for the primary endpoint. The explanations below are general: they describe concepts relevant to interpreting this kind of outcome and do not assert that a particular method was used in this study.

What does the scale represent?

The Global Aesthetic Improvement Scale is described using ordered categories from -1 to 3. In general, an ordinal scale preserves the order of categories but does not necessarily imply that the step between every pair of adjacent categories has the same meaning or size. A statistical summary should therefore make clear whether it describes counts in each category, a distribution across categories, or a reduced summary. The registry provides the category labels but not the observed category counts or a method for combining them.

The outcome parameter is described as a count of participants. A count can be informative when the event or category being counted is defined clearly. With a multi-category scale, an interpretation also depends on which categories are counted together, if any, and how missing assessments are treated. Those details are not reported in the registry record. The fact that the outcome has several categories or time points, as noted in the registry, is a reason to avoid treating it as one simple binary outcome without an explicit rule.

What does randomization contribute?

In general, random allocation can help balance prognostic characteristics across assigned groups, on average, and supports a causal comparison when the study is conducted and analyzed according to a suitable plan. Randomization does not guarantee that groups will be similar in every characteristic, especially in a small study. The registry identifies the allocation as randomized but does not report the allocation procedure, concealment details, or arm-specific enrollment. The parallel model is listed, while the arm descriptions refer to treatment on half of the face. How these features were implemented together is not explained in the registry record, so the precise comparison structure should not be inferred.

The registry says the photographic evaluation is blinded, and separately lists masking as none. In general, blinding an outcome assessor can reduce the risk that knowledge of treatment assignment influences a subjective rating. It does not by itself describe whether participants or treatment providers were masked, or whether photographic features could reveal treatment. The identity of the assessor and the practical blinding procedures are not reported in the registry record.

How should uncertainty be assessed?

In general, an estimate is more informative when accompanied by an uncertainty interval. A confidence interval expresses the precision of an estimate under the assumptions of the method; a wide interval indicates that the observed data are compatible with a broader range of values than a narrow interval. For categorical outcomes, methods can estimate category probabilities or contrasts between groups. Their appropriateness depends on the outcome definition, allocation structure, sample size, and analysis plan. No primary outcome estimate, confidence interval, p-value, or model specification is reported in the registry record.

Over-dispersion is a general issue for count data: it means observed variation is greater than a particular model assumes. If present, a model that assumes less variability than the data contain can understate uncertainty. This is a general consideration rather than a finding about this study; the registry record does not report a model or enough outcome data to assess over-dispersion. Likewise, a binary analysis would require a clear definition of what counts as an event, and the record does not specify a binary threshold for the multi-category scale.

What do the planning assumptions mean?

The record’s sample-size assumptions describe a planning illustration based on the observed effect, not the trial’s own design. They state a two-sided significance level of 0.05, equal allocation between the two arms, and a normal approximation; the effect to detect is a stated fraction of the observed effect. For non-time-to-event outcomes, the illustration is expressed as participants per arm; time-to-event illustrations use total events. These are planning assumptions, not evidence that the trial was planned that way or that a target was met. Sample-size illustrations are not observed power, and no sample-size justification for the study itself is reported in the registry record.

In general, the uncertainty of a comparison depends on the amount and pattern of data, not only on the nominal number enrolled. A planning calculation also depends on assumptions about the outcome and the effect considered meaningful. Since the registry does not report the primary outcome distribution or its analysis, the planning assumptions cannot be used to infer the study’s observed result or its precision.

10. Multiplicity, Missing Data and Analysis Populations

The registry lists 2 outcome measures and identifies the Physician Satisfaction Questionnaire as a secondary outcome. It does not report a multiplicity strategy, such as how interpretation would account for assessing more than one outcome or comparing multiple categories. In general, examining multiple outcomes or contrasts can increase the chance of a nominally notable result arising by chance. Whether and how that issue was addressed in this study is not reported in the registry record.

The primary outcome is described using a scale with several categories, and the registry notes that the outcome has several categories or time points and was not reduced to one comparison. No analysis is listed. The record therefore does not specify which contrast, summary, or time point would serve as the principal inferential test, or whether any adjustment was planned.

The primary outcome population description states that all subjects who enrolled received at least 1 treatment and had a 30 day follow-up to that treatment, and that all subject information is included. It also ties the timeframe to follow-up after each subject’s final treatment. This is useful context, but it does not report the number of evaluable photographs, the handling of any missing or unusable assessments, or whether participants were analyzed according to randomized assignment. Those analysis-population and missing-data details are not reported in the registry record.

In general, missing outcome data can affect interpretation if the likelihood of missingness is related to treatment or outcome. Statistical approaches depend on why data are missing and on the analysis target. The registry’s population statement does not provide enough detail to determine whether any missing-data method was necessary or used. No imputation approach or sensitivity analysis is reported in the registry record.

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.

Most frequent non-serious adverse event terms

The registry reports serious adverse event counts separately for two groups. For Revlite Laser System Single, 0 of 10 participants at risk had a serious adverse event; for Revlite Laser System Combo, 0 of 10 participants at risk had a serious adverse event. Deaths are listed as 0 in both groups. The record also reports other adverse events in 9 of 10 participants at risk in each group.

These are counts of participants, not descriptions of the events. The registry does not list serious adverse event terms, and it does not provide the types, severity, timing, or duration of the other adverse events in the information recorded. A count of 0 observed serious events does not establish that serious events are impossible or that the groups have equivalent safety; the counts describe only the reported observations and their recorded denominators.

In general, safety comparisons require attention to how events were defined, how long participants were observed, whether events were collected consistently, and the uncertainty around group estimates. The registry provides the stated at-risk counts but not a statistical comparison or uncertainty interval. These descriptive counts should therefore be read separately from the unreported primary photographic outcome and should not be treated as a formal comparison of safety.

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

The record documents a completed randomized study of the RevLite Laser System for facial solar lentigines, with descriptions of single-wavelength and dual-wavelength treatment. It specifies a photographic primary outcome, the scale categories, and an assessment timeframe of 1 month post last treatment. It also records a Physician Satisfaction Questionnaire as a secondary outcome and reports adverse event counts.

Those details do not reveal the primary outcome result. No participant ratings or category counts, treatment comparison, confidence interval, or primary-outcome analysis are reported in the registry record. As a result, the direction, size, and precision of any difference between treatment approaches cannot be assessed from the posted primary outcome information. The absence of a reported analysis is not evidence that there was no effect; it means the registry record does not provide an analyzed result to interpret.

The safety entries show that the registry recorded 0 serious adverse events and 0 deaths in each group, and other adverse events in 9 of 10 participants at risk in each group. These descriptive figures do not establish equivalence between groups or describe the nature of the other events. They also do not substitute for the missing primary outcome results.

In general, a clinical result is best interpreted in light of its estimate, uncertainty, design, and analysis population. Here, important details such as the primary outcome distribution, the statistical plan, multiplicity handling, and detailed missing-data procedures are not reported in the registry record. The study’s enrollment of 10 is not, by itself, a measure of precision or proof that a comparison could reliably detect a particular effect. No conclusion about comparative clinical effects should be drawn from the information recorded without the missing outcome and analysis details.

13. Why This Trial Matters Statistically

This study is statistically notable because its central endpoint is a multi-category photographic assessment, while the registry does not report the distribution of ratings or an analysis. The scale distinguishes worsening, no change, and different degrees of improvement. Those categories preserve more detail than a simple yes-or-no outcome, but interpreting them requires a clear summary or comparison rule. The record indicates that the outcome has several categories or time points and was not reduced to one comparison, leaving the intended statistical contrast unclear.

The design description also illustrates why allocation and measurement details matter. The registry lists a randomized, parallel model and no masking, while the two arm descriptions refer to treatment on half of the face and the primary photographic evaluation is described as blinded. These entries provide useful labels but do not explain the operational design or the assessor’s role. Without those details, readers should avoid assuming a specific within-person comparison or a particular blinding procedure.

The small enrollment and the absence of primary outcome results make precision especially difficult to judge. In general, an estimate without an uncertainty measure cannot show how compatible the data are with a range of possible effects. A planning illustration based on an observed effect does not establish the study’s original design adequacy and is not observed power. The registry does not report its sample-size justification.

These limitations matter because a well-defined endpoint and transparent analysis are needed to distinguish what the study measured from what can be concluded. The record describes the measurement framework and some safety counts, but not the primary result or its uncertainty. That distinction is central to careful statistical interpretation.

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 primary limitation for interpretation is that the registry record does not report the primary photographic outcome values or an analysis. The scale is defined, but there are no participant counts by rating category and no estimate of a contrast between treatment approaches. The record lists 0 analyses, so neither the direction nor precision of the primary result can be assessed.

The registry identifies the study as randomized and parallel, but the arm descriptions specify treatment on half of the face. It does not explain how those descriptions relate to participant allocation or whether observations from the two halves were analyzed as paired or independent. The record also does not give arm-specific enrollment counts, allocation details, or the procedure used to generate and conceal randomization.

The outcome assessment is described as blinded, whereas masking is listed as none. The record does not identify who was blinded, how photographs were presented, or whether treatment assignment could be inferred. The primary outcome’s timeframe is based on follow-up after each subject’s final treatment, but the number or timing of treatments is not reported in the registry record.

The registry does not report the sample-size justification, analysis plan, multiplicity handling, or detailed approach to missing data. Its population description says all enrolled subjects received at least 1 treatment and had a 30 day follow-up to that treatment, but it does not provide an evaluable-photo count or details of any unavailable assessments. Safety information is limited to group counts; event terms and further details about other adverse events are not reported in the registry record.

15. Related Tutorials

16. Related Statistical Calculators

17. Sources

• ClinicalTrials.gov: Study for the RevLite Laser System for Facial Solar Lentigines — NCT02110108.
• Registry record last updated 2021-11-30; status last verified 2021-11.
• Results first posted 2021-02-04.
• 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 NCT02110108, a completed randomized, parallel study sponsored by Cynosure, Inc., evaluating the RevLite Laser System for facial solar lentigines. Enrollment was 10. The record gives a start of 2014-03 and primary completion of 2015-02, lists the phase as NA, and records masking as none.

The intervention descriptions distinguish single-wavelength 1064nm treatment on half of the face from dual-wavelength 1064 nm and 532 nm treatment on half of the face. The primary outcome is a blinded photographic evaluation using the Global Aesthetic Improvement Scale at 1 month post last treatment. A Physician Satisfaction Questionnaire is listed as a secondary outcome. The record lists 2 outcome measures and 0 analyses.

For each of the two adverse-event groups, 0 of 10 participants at risk had a serious adverse event, 9 of 10 had an other adverse event, and deaths were 0. Primary outcome ratings and a comparative analysis are not reported in the registry record.