This page provides an independent statistical analysis and educational interpretation of publicly reported results. ClinicalTrials.gov provides the official trial registry record. Numerical trial results on this page are restricted to the results posted in the ClinicalTrials.gov record; calculations added by Clinical Biostats are labelled as such.
1. Trial at a Glance
This page covers the registry results for Laser Treatment for Vulvar Lichen Sclerosus (NCT04134494), a na na study. The primary outcome is Change in Depth of Disease From Baseline to Three Months After the Last Laser Treatment.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT04134494 |
| Phase | NA |
| Condition | Vulvar Lichen Sclerosus |
| Allocation | Not applicable (single group) |
| Design model | Single Group |
| Masking | None (open label) |
| Enrollment | 15 |
| Arms in the primary outcome | n/a |
| Lead sponsor | Beth Israel Deaconess Medical Center |
| Results posted | Yes |
2. Clinical Question
Population
Women with vulvar lichen sclerosus were the intended study population. The intervention description specifies biopsy-proven lichen sclerosus. The primary-outcome population was enrolled participants who had a post-treatment biopsy; the registry record does not report how many participants met that endpoint-population definition.
Intervention
The study assessed ablative fractional 2940 nm laser treatment. Its stated aims included assessing physical and histological changes and evaluating participant satisfaction. The registry record does not provide a complete treatment schedule or full intervention description.
Comparator
There was no concurrent control group. The study is recorded as a non-randomized, single-group study, with allocation listed as NA. Baseline measurements were to be compared with measurements after treatment; that within-participant comparison is not equivalent to a randomized comparison against another treatment or no treatment.
Primary question
The primary question was whether the depth of lichen sclerosus changed from baseline to three months after the last laser treatment, based on biopsy measurements. The registry record specifies a median and inter-quartile range in microns, but does not report the observed change. The description says follow-up biopsy was intended to assess resolution or, if disease persisted, its depth.
The study also listed changes in symptoms and quality of life, symptom change and severity, and treatment satisfaction as secondary outcomes. Those measures broaden the questions beyond histological depth, but their numerical results are not reported in the registry record. The study description presents the work as an assessment of a possible treatment option, including for participants not eligible for high-dose topical steroids or who had failed prior topical steroid treatment. That rationale describes the intended context; it is not evidence that the laser produced a particular outcome.
3. Trial Design
The registry record describes a prospective, non-randomized, single-group study of ablative fractional 2940 nm laser treatment for vulvar lichen sclerosus. It records an enrollment of 15 and lists the study status as terminated. The study start is recorded as 2020-01-01 and the primary completion date as 2022-05-27. The reason for termination is not reported in the registry record.
With no concurrent comparison group, the design focuses on change within participants, using measurements taken before treatment and after treatment. The primary outcome description identifies a clinical biopsy performed before study participation as the basis for baseline disease depth, and a study biopsy at follow-up as the basis for assessing disease depth after treatment. The stated follow-up point is three months after the last treatment. The primary outcome population is enrolled participants who had a post-treatment biopsy, but the number in that population is not reported in the registry record.
The record lists masking as none and allocation as NA. It identifies the intervention as a device and gives the treatment name as ablative fractional 2940 nm laser. The remaining intervention description is incomplete in the registry record, so details such as the full treatment schedule are not reported. The record lists phase as NA and does not report a randomized treatment assignment.
The primary measure was specified as a median with an inter-quartile range, in microns. Four secondary outcomes are listed, covering symptoms, quality of life, symptom severity, and satisfaction; the record lists five outcome measures overall. It does not report numerical outcome results or statistical analyses. The design can describe observed pre-to-post changes among participants with measurements, but without a control group it cannot separate treatment-associated change from other explanations, including natural change over time or effects of measurement and study participation.
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
| Stage | Intervention |
|---|---|
| STARTED | 15 |
| COMPLETED | 13 |
| NOT COMPLETED | 2 |
Reasons for not completing this period:
| Reason | Intervention |
|---|---|
| Lost to Follow-up | 2 |
Analysis population for the primary outcome, as defined in the registry: Enrolled participants who had a post treatment biopsy
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: 2 patients did not have the primary outcome assessed
| Characteristic | Unit | Intervention |
|---|---|---|
| Participants analysed | 13 | |
| Age, Categorical: <=18 years | Participants | 0 |
| Age, Categorical: Between 18 and 65 years | Participants | 9 |
| Age, Categorical: >=65 years | Participants | 4 |
| Sex: Female, Male: Female | Participants | 13 |
| Sex: Female, Male: Male | Participants | 0 |
| Race (NIH/OMB): American Indian or Alaska Native | Participants | 0 |
| Race (NIH/OMB): Asian | Participants | 0 |
| Race (NIH/OMB): Native Hawaiian or Other Pacific Islander | Participants | 0 |
| Race (NIH/OMB): Black or African American | Participants | 1 |
| Race (NIH/OMB): White | Participants | 12 |
| Race (NIH/OMB): More than one race | Participants | 0 |
| Race (NIH/OMB): Unknown or Not Reported | Participants | 0 |
| Region of Enrollment: United States | participants | 13 |
| Baseline depth of lichen penetration | Microns | 600 (400 to 600) |
6. Primary Endpoint
The registry lists the primary outcome as Change in Depth of Disease From Baseline to Three Months After the Last Laser Treatment, measured over From enrollment to 3 months after the last laser treatment.
| Element | Registry entry |
|---|---|
| Result type | Median |
| Measure of spread | Inter-Quartile Range |
| Unit | microns |
| Endpoint classification | not reduced to a single comparison |
The primary endpoint concerns change in the depth of vulvar lichen sclerosus from baseline to three months after the last laser treatment. The registry record specifies that baseline depth was based on a clinical biopsy performed before study participation. A study biopsy at follow-up was intended to assess whether disease had resolved or, if it persisted, how deep it extended. The endpoint is therefore a tissue-based measure rather than a symptom score or participant satisfaction measure. Its unit is microns, and the planned summary is the median and inter-quartile range.
In general, a histological measure can offer an objective way to describe tissue findings, complementing participants’ reports of symptoms and quality of life. The median describes the middle of the observed values, while the inter-quartile range describes the spread of the central portion of those values. This approach can be useful when values are skewed or when a few unusually high or low measurements could pull the mean. That is a general statistical rationale, not evidence about the distribution of measurements in this study.
The endpoint has an important population qualification: it applies to enrolled participants who had a post-treatment biopsy. The number with that biopsy and the resulting endpoint values are not reported in the registry record. The record also does not report an estimate of change, uncertainty interval, or statistical test for this outcome. Thus, the outcome definition explains what investigators intended to measure, but it does not establish whether depth changed or how precisely any change was estimated.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry record supplies the study question and endpoint definition but does not report numerical results for the primary outcome. It specifies a comparison of disease depth at baseline with depth three months after the last laser treatment, summarized by a median and inter-quartile range in microns. No baseline or follow-up median, inter-quartile range, change estimate, confidence interval, or p-value is reported in the registry record. The magnitude, direction, and precision of the primary outcome therefore cannot be described from the recorded results.
The same limitation applies to the listed secondary outcomes. The record names changes in symptoms and quality of life using the Vulvovaginal Symptom Questionnaire, symptom change using the Patient Global Impression Scale of Change, symptom severity using the Patient Global Impression Scale of Severity, and treatment satisfaction using a participant satisfaction questionnaire. Their numerical results are not reported in the registry record. The outcome names indicate what was to be assessed, not what participants experienced.
The study enrolled 15 and is recorded as terminated. Those details do not explain why recruitment or study activity ended, whether the planned enrollment was reached, or whether every participant completed follow-up. The reason for termination and participant flow are not reported in the registry record. Nor does the record report how many participants had the post-treatment biopsy required for the primary-outcome population.
The design also limits causal interpretation. A single-group pre-to-post comparison can describe change among participants with measurements, but it does not include a concurrent control group to represent what might have happened over the same period without the intervention. Any observed change could therefore reflect more than the treatment itself. This is a general limitation of uncontrolled before-and-after comparisons, not a claim that any particular alternative explanation occurred in this study.
With no numerical outcome estimates or analyses, statistical precision cannot be assessed. In general, an estimate describes the observed effect, while a confidence interval communicates the range of values compatible with the data under the analysis assumptions. Neither is reported for the primary endpoint in the registry record. The listed enrollment alone cannot substitute for an outcome estimate or establish how informative the endpoint data would be. The posted record supports a description of the study’s aims and design, not a conclusion about the size or reliability of treatment-associated change.
9. Statistical Methods Explained
The record identifies a non-randomized, single-group design and a primary endpoint summarized using the median and inter-quartile range. It does not report the statistical analysis plan, model, hypothesis test, confidence interval method, or any completed outcome analysis. The explanations below describe general statistical concepts and distinguish them from the methods documented for this study.
What does a single-group design estimate?
In general, a before-and-after design compares measurements from participants at different times. When the same participants contribute both measurements, the analysis can focus on within-participant change. Such a comparison describes change over the observed period, subject to having the needed measurements, but does not by itself show what would have occurred over that period without treatment. A concurrent control group can help address that counterfactual question; this registry record does not describe one.
The primary endpoint is phrased as change in depth from baseline to follow-up, but the registry record does not state exactly how that change was calculated or summarized. For example, a median of individual participant changes and a difference between two group medians are distinct summaries. The specific approach is not reported in the registry record, so the reader should not infer which was used.
Why report a median and inter-quartile range?
In general, the median is the central value after measurements are ordered. The inter-quartile range describes the span between the lower and upper quartiles and conveys variability among observations without relying on the most extreme values. These summaries are often considered when data are skewed or when extreme observations may strongly affect a mean. The registry record names these summaries but does not report the observed distribution or explain why they were chosen for this endpoint.
A summary of the distribution is not the same as an estimate of the uncertainty in a treatment-associated change. A confidence interval, when calculated, can show the range of estimates compatible with the data under a specified method and assumptions. No confidence interval for the primary outcome is reported in the registry record. The absence of a reported interval means precision cannot be judged from this record.
What can biopsy measurements contribute?
The endpoint description treats biopsy as an objective assessment of tissue findings: the baseline clinical biopsy establishes the starting depth, while the study biopsy at follow-up assesses resolution or persistent disease depth. In general, an objective measurement can complement reports of symptoms and satisfaction. It does not remove all measurement uncertainty: biopsy findings depend on what tissue is sampled and how measurements are assessed. The registry record does not describe sampling procedures, assessor procedures, or reliability checks, so those details are not reported in the registry record.
How should the planning illustration be read?
The record describes a planning illustration based on a stated fraction of the observed effect, with a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation. It states that such figures are planning illustrations, not observed power. The actual study is recorded as single-group, so a hypothetical equal-allocation, two-arm calculation does not describe the trial’s design. The numerical planning outputs and the observed effect used for those calculations are not reported in the registry record summarized by the outcome information. These illustrations should not be read as participant outcomes, proof of adequate sample size, or evidence that a treatment effect was detected.
In general, power calculations depend on assumptions about the effect to detect, variability, significance level, and design. They are prospective planning tools, not a measure of how likely a completed study’s finding is to be true. A calculation based on an observed effect can be especially difficult to interpret as planning information, because the observed effect itself may be uncertain. No trial-specific sample-size justification or design calculation is reported in the registry record.
What is not documented?
The registry record lists zero analyses and does not report an inferential procedure for the primary or secondary outcomes. It does not report how missing measurements were handled, whether analyses adjusted for any covariates, or whether an analysis population was prespecified beyond the primary endpoint description that refers to participants with a post-treatment biopsy. It also does not report interim analyses or a multiplicity strategy. Those details cannot be inferred from the endpoint names or the fact that multiple measures were registered.
Without the analysis method and numerical estimates, it is not possible to verify the relationship between the planned endpoint and a reported result, judge model assumptions, or assess statistical precision. These are general considerations for interpreting clinical trial analyses; the registry record does not establish that a particular analysis was performed.
10. Multiplicity, Missing Data and Analysis Populations
The registry record lists a primary outcome and four secondary outcomes. The secondary measures cover symptoms and quality of life, symptom change, symptom severity, and satisfaction. It does not report a multiplicity plan, such as whether one outcome was designated as confirmatory or how statistical testing across outcomes would be interpreted. In general, testing multiple outcomes can increase the chance of finding an apparently notable result by chance if each is treated as a separate test. Whether that concern applies to a particular analysis depends on the analysis plan and the intended interpretation; no such plan is reported in the registry record.
The record lists no analyses and does not report numerical results for the outcomes. It also does not report whether there were interim analyses or how any missing outcome measurements were handled. Those omissions do not establish that missing observations or interim looks occurred; they mean these details are not reported in the registry record.
The primary endpoint population is described as enrolled participants who had a post-treatment biopsy. The number in that population is not reported, and the record does not give a participant-flow account or explain how participants without a follow-up biopsy would be treated in an analysis. The recorded enrollment is 15, but enrollment alone does not identify how many contributed primary endpoint data. A complete-case summary, an analysis using imputation, and other approaches can lead to different interpretations when outcome data are unavailable; which, if any, was used is not reported.
In general, missingness matters because participants with observed follow-up measurements may differ from those without them. Statistical methods cannot fully resolve that concern without information about the reasons for missingness and assumptions used to address it. The registry record does not provide those details, so the completeness and representativeness of the outcome data cannot be assessed.
11. Safety Results
The registry reports serious adverse events as affected participants divided by participants at risk.
| Arm | Participants with serious adverse events | Participants at risk | Percentage |
|---|---|---|---|
| Intervention | 0 | 13 | 0.0% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| Intervention | 0 of 13 |
Other (non-serious) adverse events
Participants with at least one non-serious event at or above the registry's 0% reporting threshold.
| Arm | Participants affected of at risk |
|---|---|
| Intervention | 0 of 13 |
Most frequent non-serious adverse event terms
| Event term | Organ system | Intervention |
|---|---|---|
| Light spotting | Reproductive system and breast disorders | 0 of 13 |
| Allergic reaction to topical anesthetic | Skin and subcutaneous tissue disorders | 0 of 13 |
| Infection from the biopsy or the laser treatment | Infections and infestations | 0 of 13 |
The registry record lists 13 participants at risk in the intervention group. It reports zero serious adverse events, zero other adverse events, and zero deaths for that group. These are the posted safety counts; they do not describe the primary outcome or establish the size of any treatment effect.
In general, a count of zero means that no events of the specified type were recorded among the participants included in that safety listing. It does not prove that an event cannot occur, and it does not establish that the intervention is free of risk. The information is limited to the participants counted and the event definitions and observation period used. The registry record does not provide further detail about event definitions, surveillance, duration of safety follow-up, or whether all enrolled participants contributed to this safety group.
The safety count is 13, while the recorded enrollment is 15. The registry record does not explain that difference, so it should not be attributed to a particular reason. Counts without additional context also do not allow assessment of event timing, severity beyond the serious-event classification, or comparisons with another treatment. No concurrent control group is recorded. These figures should therefore be read narrowly as the safety events reported for the listed intervention group, not as evidence of comparative safety.
12. What the Result Does, and Does Not, Mean
The record documents an investigation of ablative fractional 2940 nm laser treatment in a prospective, non-randomized, single-group study of vulvar lichen sclerosus. Its primary question concerned change in biopsy-assessed disease depth from baseline to three months after the last treatment. It also lists symptom, quality-of-life, symptom-severity, and satisfaction outcomes. These details establish what investigators intended to assess; they do not establish what the measurements showed.
The registry record does not report numerical primary or secondary outcome results, and it lists no analyses. Consequently, the direction and magnitude of any change, the variability of measurements, and the precision of an estimate are not reported. The endpoint’s median and inter-quartile-range format is specified, but the actual summaries are not. A reader cannot determine from the registry record whether disease depth changed, whether symptoms changed, or how participants rated satisfaction.
Even if within-participant change estimates were available, a single-group design would describe change over time rather than isolate the effect of treatment from other possible causes. In general, an uncontrolled comparison cannot establish how outcomes would have differed under a concurrent alternative. The lack of randomization and a comparison group should therefore shape interpretation of any observed pre-to-post findings.
The study is recorded as terminated, with enrollment of 15. The reason for termination, participant flow, and number contributing post-treatment biopsies are not reported in the registry record. These gaps limit assessment of how complete the endpoint data were and why the study ended. They do not, on their own, demonstrate that a specific problem occurred.
The safety record lists zero serious adverse events, zero other adverse events, and zero deaths among 13 participants at risk. Those counts describe the posted safety information, but a zero count in this group cannot rule out uncommon events or establish comparative safety. Overall, the registry record permits a careful description of the study question, design, and limited safety counts. It does not support a conclusion about treatment efficacy or the certainty of an outcome effect.
13. Why This Trial Matters Statistically
This study is statistically notable for the contrast between a tissue-based primary endpoint and a single-group design. The endpoint was intended to use biopsy findings to assess disease depth before and after treatment, while the design did not include a concurrent control group. In general, objective measurement and causal comparison answer different questions: biopsy can provide a defined measurement, but it does not by itself distinguish treatment-associated change from change that might have occurred for other reasons.
The study also illustrates why a registered outcome definition is not a result. The record names the measurement, unit, summary method, and follow-up point, but does not report the numerical primary outcome or any analyses. Without an estimate and a measure of its uncertainty, statistical interpretation cannot progress from describing the planned endpoint to judging the size or precision of a finding.
Enrollment and analysis populations also need to be distinguished. The record reports enrollment of 15, but describes the primary endpoint population as enrolled participants who had a post-treatment biopsy. The number with that biopsy is not reported. In general, the number enrolled does not necessarily equal the number contributing data to a particular outcome. Participant flow and missing-data handling are needed to understand which observations inform a result.
The record’s safety counts offer a separate example of careful interpretation. It reports zero events in categories for 13 participants at risk, but these counts have no concurrent comparison and do not establish that risk is absent. Counts should be read with their denominators and reporting context, rather than as definitive evidence about comparative safety.
Finally, the record describes planning illustrations based on a hypothetical two-arm allocation even though the study design is single-group. Such calculations are not observed power and do not change the design that was conducted. Keeping the distinction between planning assumptions, study design, registered endpoints, and reported results clear is essential for interpreting clinical research without claiming more than the record supports.
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 most direct limitation for interpreting this study is that the registry record does not report numerical outcome results or statistical analyses. Although the primary endpoint and secondary measures are named, there are no reported estimates, confidence intervals, or p-values. As a result, the registered objectives cannot be compared with observed outcomes using the information in the record.
The study is recorded as a single-group, non-randomized design with no masking. There is no concurrent control group for comparison, and the record does not describe randomized allocation. In general, this limits causal interpretation of pre-to-post change because other influences over time cannot be separated from the intervention using a within-group comparison alone.
The primary outcome depends on a post-treatment biopsy, and its population is defined as enrolled participants who had that biopsy. The number with post-treatment biopsy data is not reported. The record also does not report participant flow, reasons for missing measurements, or missing-data methods. Therefore, the completeness of the primary endpoint and the extent to which its observed population represents all enrolled participants cannot be assessed.
The study is listed as terminated, but the reason for termination is not reported in the registry record. The intervention description is incomplete, and details about treatment schedule, biopsy procedures, and assessment procedures are not reported. The record also does not report the statistical analysis plan, multiplicity approach, interim analyses, or sample-size justification.
Finally, the safety data list 13 participants at risk, while enrollment is 15, and the record does not explain the difference. The event counts are informative only for the reported group and do not provide a comparative safety assessment. These limitations describe gaps in the registry record; they do not establish that any particular protocol deviation, missing-data mechanism, or safety concern occurred.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Laser Treatment for Vulvar Lichen Sclerosus — NCT04134494.
- Registry record last updated 2024-06-05; status last verified 2024-05.
- Results first posted 2024-06-05.
- 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.
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18. Record Summary
The registry record describes a prospective, non-randomized, single-group study of ablative fractional 2940 nm laser treatment for vulvar lichen sclerosus. It records enrollment of 15, no masking, and a terminated status. The recorded start date is 2020-01-01, and the primary completion date is 2022-05-27. The reason for termination is not reported in the registry record.
The primary outcome was change in disease depth from baseline to three months after the last treatment, assessed by biopsy and summarized as a median and inter-quartile range in microns. Four secondary outcomes addressed symptoms, quality of life, symptom severity, and satisfaction. Numerical outcome results and statistical analyses are not reported in the registry record.
The intervention safety group lists 13 participants at risk, with zero serious adverse events, zero other adverse events, and zero deaths. The record does not report the reason for the difference between enrollment and the safety denominator. Without numerical efficacy results, participant-flow details, or a control group, the record supports description of the study’s question and design but not a conclusion about treatment effects.