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 A Phase 3 Study to Evaluate the Efficacy and Safety of CLS006 Versus Vehicle in Subjects 2 Years of Age or Older With Cutaneous Common Warts (NCT02971891), a randomized phase 3 study. The primary outcome is Difference in the Proportion of Subjects With Complete Clearance of All Treated Warts Between the Active and Vehicle at Week 18/End of Post-treatment Efficacy Evaluation..
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT02971891 |
| Phase | Phase 3 |
| Condition | Cutaneous Common Warts |
| Allocation | Randomized |
| Design model | Parallel |
| Masking | Quadruple |
| Enrollment | 484 |
| Arms in the primary outcome | n/a |
| Lead sponsor | Maruho Co., Ltd. |
| Results posted | Yes |
2. Clinical Question
Population
People 2 years of age or older with nongenital cutaneous common warts, also described as verruca vulgaris. The registry record lists an enrollment of 484.
Intervention
CLS006, identified as furosemide topical gel at 0.125%, applied once daily for six weeks according to the brief summary.
Comparator
Vehicle topical gel. This comparison evaluates the active gel against its vehicle rather than against no treatment or another active medicine.
Primary question
At Week 18, what was the difference between groups in the proportion of participants with complete clearance of all treated warts?
The endpoint is participant-level: the question is whether all treated warts were cleared for each participant, not simply whether wart counts or sizes changed. The registry record also lists secondary measures concerning the proportion of treated warts cleared, complete clearance at Week 12, and change in wart size. Those measures address related but distinct aspects of wart response. The primary question is framed as a between-group difference, which is the relevant contrast for assessing how outcomes differed between CLS006 and vehicle in this trial. However, the registry record does not provide a single primary comparison, its estimate, or its uncertainty. It therefore cannot establish from this record how large or precise any between-group difference was.
3. Trial Design
The registry identifies this as a Phase 3, randomized, double-blind, vehicle-controlled, multicenter study with a parallel-group model. It lists quadruple masking. Random allocation is intended, in general, to make comparison groups less systematically different at the outset; a parallel design assigns participants to a group and evaluates outcomes within that group. Masking is generally used to reduce the influence of expectations on care, reporting, and outcome assessment. The record does not describe which parties were included in the masking designation or how allocation and masking were implemented.
The two interventions were CLS006 (furosemide) topical gel, 0.125%, and vehicle topical gel. The brief summary describes once-daily application for six weeks in people 2 years of age or older with nongenital cutaneous common warts. The primary endpoint is assessed at Week 18, described as the end of the post-treatment efficacy evaluation. The registry also names Week 12 outcomes, including complete clearance and a ratio of cleared to treated warts.
Enrollment is recorded as 484. The trial status is completed; the recorded start is 2017-01, and primary completion is 2018-04-16. Maruho Co., Ltd. is listed as sponsor. The record does not report the recruitment setting beyond identifying the study as multicenter, or explain the details of site selection, allocation procedures, treatment adherence, or follow-up procedures. These omissions limit how fully the conduct of the trial can be reconstructed from the registry entry alone.
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 | CLS006 (Furosemide) | Vehicle |
|---|---|---|
| STARTED | 246 | 238 |
| Subjects Who Had 1 Wart | 118 | 117 |
| Subjects Who Had 2 Warts | 56 | 53 |
| Subjects Who Had 3 Warts | 24 | 24 |
| Subjects Who Had 4 Warts | 21 | 12 |
| Subjects Who Had 5 Warts | 12 | 11 |
| Subjects Who Had 6 Warts | 15 | 21 |
| COMPLETED | 229 | 214 |
| NOT COMPLETED | 17 | 24 |
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.
| Characteristic | Unit | CLS006 (Furosemide) | Vehicle | Total |
|---|---|---|---|---|
| Participants analysed | 246 | 238 | 484 | |
| Age, Continuous | years | 28.6 (SD 16.40) | 29.1 (SD 16.57) | 28.8 (SD 16.47) |
| Age, Customized: >=2 to <12 | Participants | 43 | 37 | 80 |
| Age, Customized: >=12 to <18 | Participants | 41 | 43 | 84 |
| Age, Customized: >=18 to <65 | Participants | 158 | 154 | 312 |
| Age, Customized: >=65 | Participants | 4 | 4 | 8 |
| Sex: Female, Male: Female | Participants | 105 | 101 | 206 |
| Sex: Female, Male: Male | Participants | 141 | 137 | 278 |
| Ethnicity (NIH/OMB): Hispanic or Latino | Participants | 39 | 39 | 78 |
| Ethnicity (NIH/OMB): Not Hispanic or Latino | Participants | 205 | 199 | 404 |
| Ethnicity (NIH/OMB): Unknown or Not Reported | Participants | 2 | 0 | 2 |
| Race (NIH/OMB): American Indian or Alaska Native | Participants | 0 | 0 | 0 |
| Race (NIH/OMB): Asian | Participants | 3 | 1 | 4 |
| Race (NIH/OMB): Native Hawaiian or Other Pacific Islander | Participants | 0 | 3 | 3 |
| Race (NIH/OMB): Black or African American | Participants | 12 | 10 | 22 |
| Race (NIH/OMB): White | Participants | 226 | 221 | 447 |
| Race (NIH/OMB): More than one race | Participants | 0 | 0 | 0 |
| Race (NIH/OMB): Unknown or Not Reported | Participants | 5 | 3 | 8 |
6. Primary Endpoint
The registry lists the primary outcome as Difference in the Proportion of Subjects With Complete Clearance of All Treated Warts Between the Active and Vehicle at Week 18/End of Post-treatment Efficacy Evaluation., measured over Week 18.
| Element | Registry entry |
|---|---|
| Result type | Count Of Participants |
| Measure of spread | not applicable |
| Unit | Participants |
| Endpoint classification | Binary Endpoint |
The primary endpoint asks for the difference between CLS006 and vehicle in the proportion of participants whose treated warts were all completely cleared at Week 18. For each participant, this outcome distinguishes complete clearance of every treated wart from not meeting that complete-clearance condition. The comparison then concerns the proportion meeting that condition in each group.
A complete-clearance endpoint is clinically interpretable because it focuses on an all-or-none state for the treated warts, rather than requiring readers to interpret a change in size or the fraction of warts cleared. That can make the endpoint easier to understand, while also making it a demanding threshold: partial improvement does not meet the stated definition of complete clearance. The separately listed secondary outcomes capture partial clearance and wart-size change, giving different views of response.
The registry record does not report the number or proportion achieving complete clearance in either group, a between-group estimate, or a confidence interval. It also notes that the primary outcome has several categories or time points and is not reduced to one comparison. Consequently, the endpoint definition can be described, but the magnitude and precision of the primary contrast cannot be interpreted from the registry record.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The available record establishes the question the trial was designed to address, but does not provide a single numerical answer to that question. It identifies complete clearance of all treated warts at Week 18 as the primary outcome and frames the comparison as a difference in proportions between CLS006 and vehicle. The record also explicitly indicates that the primary outcome has several categories or time points and was not reduced to one comparison. No group-specific primary outcome counts, proportions, effect estimate, confidence interval, or p-value are reported in the record.
Without those results, it is not possible to judge the direction or size of the primary contrast, how precisely it was estimated, or whether the observed data were compatible with a range of materially different effects. A confidence interval, in general, represents uncertainty around an estimated effect; it is not available for this primary contrast in the registry record. A p-value, in general, measures how inconsistent data are with a specified null hypothesis under the analysis assumptions; no primary p-value is reported. Neither a trial label nor a planned endpoint substitutes for these results.
The named secondary outcomes cover different measures: ratios of cleared to treated warts, complete clearance at Week 12, and change in wart size. Their presence does not supply a result for the Week 18 primary endpoint. Nor should the safety counts be treated as evidence about efficacy. The safety record reports adverse-event counts, while the efficacy outcome concerns wart clearance; these answer different questions.
The record identifies the trial as completed, but completion alone does not establish that a particular efficacy result was favorable, unfavorable, or conclusive. The registry entry is therefore informative about design, population, intervention, comparator, timing, and selected safety counts, but it does not permit an effect estimate or a precision assessment for the primary endpoint. Any interpretation that goes beyond those recorded details would require results not reported in the registry record.
9. Statistical Methods Explained
The registry gives important features of the trial design, but it does not describe the statistical analysis used for the primary endpoint. The distinction matters: knowing that a trial was randomized and parallel-group does not reveal how outcomes were summarized, what model was fitted, how missing observations were handled, or which inferential procedures were used. The primary result is also not reduced to one comparison in the registry record, so there is no single estimate to interpret as the trial's primary effect.
What does a difference in proportions represent?
For a binary participant-level endpoint, each participant either meets the stated outcome definition or does not. The proportion in a group is the number meeting the definition relative to the number evaluated under the applicable analysis. A between-group difference compares those proportions on the absolute scale. It is distinct from a ratio or relative measure. The endpoint is complete clearance of all treated warts at Week 18, but the registry record does not report the group proportions or their difference. No calculation of that contrast can therefore be made from this record.
Why does randomization matter?
In general, random allocation aims to distribute both measured and unmeasured baseline factors across comparison groups, reducing systematic selection differences. Randomization does not guarantee that groups are identical, particularly in any individual trial, and it does not remove the need to report baseline characteristics, outcome data, and an appropriate analysis. The record identifies random allocation but does not provide the allocation sequence method, concealment details, or baseline data needed to assess the achieved balance.
What does masking contribute?
Masking is generally intended to limit the influence of knowledge about assigned treatment on participant reports, investigator behavior, and outcome assessment. The registry lists quadruple masking, but does not identify the roles covered by that term or describe how the masking was maintained. Therefore, it is appropriate to report the recorded masking designation, but not to infer implementation details or assume that masking could not have been compromised.
How should uncertainty be assessed?
For an estimated difference in proportions, a confidence interval would ordinarily communicate the range of effects compatible with the data under the chosen method and assumptions. A narrower interval generally indicates greater precision, while a wider interval indicates more uncertainty. A p-value addresses a different question and should not be treated as a measure of effect size or precision. The registry record does not report a primary estimate, confidence interval, or p-value, so none of these aspects can be assessed for the primary outcome.
What can be said about the statistical plan?
The registry record does not report the primary analysis model, the estimand, covariate adjustment, the analysis population, or the method for handling missing outcome data. It also does not report a sample-size justification or describe interim analyses. These details should not be inferred from the Phase 3 designation or from the fact that the study was randomized. In general, a complete analysis description would specify how the primary endpoint was coded, which participants contributed to the analysis, how incomplete follow-up was treated, and how estimates and uncertainty were calculated.
How do planning illustrations differ from trial results?
The sample-size assumptions described for planning illustrations are not the trial's own design justification. Those illustrations use a two-sided significance level of 0.05, equal allocation, a normal approximation, and an effect to detect defined as a stated fraction of the observed effect. The record does not give a sample-size justification for the original trial. Planning calculations are hypothetical evaluations of what a future study might require under stated assumptions; they are not observed power and do not establish the reliability of the trial's result. Since a single primary effect is not reported in the registry record, the primary treatment effect and its precision remain unavailable for interpretation.
10. Multiplicity, Missing Data and Analysis Populations
The registry record names a primary endpoint and several secondary outcomes, but does not report a multiplicity strategy. When a study assesses multiple outcomes, time points, or comparisons, the chance of at least one apparently notable result can increase if each is examined without adjustment. In general, an analysis plan may identify a hierarchy of outcomes or specify an adjustment approach. Neither approach is described in the registry record, so it is not possible to determine how multiplicity was addressed or how any secondary findings should be interpreted alongside the primary question.
The record also indicates that the primary outcome has several categories or time points and is not reduced to one comparison. This means the entry does not give a single primary contrast suitable for assessing its estimate and precision. The listed Week 12 measures and the Week 18 primary endpoint should not be treated as interchangeable, because they refer to distinct time points or outcome definitions.
Missing-data methods and analysis populations are not reported in the registry record. It does not state how participants with an unavailable Week 18 assessment were handled, whether outcomes were imputed, or which population was used for the primary analysis. In general, missing outcomes can affect both the estimate and its uncertainty, and the effect depends on why data are missing and on the assumptions used to address them. Without the analysis population, missingness information, and method, those potential effects cannot be evaluated. The registry record likewise does not report protocol deviations or how they were treated in analysis.
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 |
|---|---|---|---|
| CLS006 (Furosemide) | 0 | 246 | 0.0% |
| Vehicle | 0 | 238 | 0.0% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| CLS006 (Furosemide) | 0 of 246 |
| Vehicle | 0 of 238 |
Other (non-serious) adverse events
Participants with at least one non-serious event at or above the registry's 1% reporting threshold.
| Arm | Participants affected of at risk |
|---|---|
| CLS006 (Furosemide) | 9 of 246 |
| Vehicle | 9 of 238 |
Most frequent non-serious adverse event terms
| Event term | Organ system | CLS006 (Furosemide) | Vehicle |
|---|---|---|---|
| Upper respiratory tract infection | Infections and infestations | 5 of 246 | 2 of 238 |
| Headache | Nervous system disorders | 3 of 246 | 3 of 238 |
| Sinusitis | Infections and infestations | 1 of 246 | 4 of 238 |
The registry reports serious adverse events for the recorded safety groups. In the CLS006 group, 0 serious adverse events are listed among 246 participants at risk; in the vehicle group, 0 are listed among 238 participants at risk. The death count is 0 in each group. These are counts in the registry record, not evidence that no events of any kind occurred.
The record also lists 9 other adverse events in the CLS006 group among 246 participants at risk and 9 in the vehicle group among 238 participants at risk. It does not provide event terms for serious adverse events, since no serious terms are listed, or details about the nature, timing, severity, duration, or relatedness of the other adverse events. Counts alone do not establish whether an event was caused by an intervention, and they do not describe the individual experience of participants.
The at-risk counts are the denominators recorded for these safety summaries. No rates or between-group safety comparison are reported, and no additional calculations should be inferred from the counts. The safety figures address recorded adverse events; they do not replace the missing efficacy estimate for complete wart clearance.
12. What the Result Does, and Does Not, Mean
The registry record supports a description of the clinical question and trial structure: CLS006 topical gel was compared with vehicle in a randomized, masked, parallel-group Phase 3 study of people 2 years of age or older with cutaneous common warts. The primary endpoint was complete clearance of all treated warts at Week 18. The study is recorded as completed, and selected adverse-event counts are available.
What the record does not establish is the size or direction of the primary efficacy difference. It gives no group-specific clearance counts or proportions, no single effect estimate, and no confidence interval or primary p-value. Since the registry notes that the primary outcome was not reduced to one comparison, it is not possible to judge from this entry how precisely the endpoint was estimated or what range of effects remains compatible with the results. The absence of a reported estimate is not evidence of no difference, and it is not evidence of benefit.
The endpoint definition also sets limits on what a result would mean. Complete clearance requires all treated warts to be clear; partial clearance or a size change is not equivalent to meeting that definition. The listed secondary outcomes address some of those other dimensions, but the record does not supply results for them. A result for one endpoint or time point would not automatically answer questions about another outcome or time point.
The safety counts are likewise limited. They show the counts recorded for serious and other adverse events, but do not provide event descriptions or establish causation. Overall, the registry record describes the design and selected safety information, but leaves the central primary efficacy comparison and its uncertainty unreported.
13. Why This Trial Matters Statistically
This trial is statistically notable as a randomized, vehicle-controlled, masked comparison built around a participant-level endpoint. The primary question is framed as a difference in the proportion achieving complete clearance, a direct comparison of the two assigned groups rather than a within-group change alone. The parallel design and vehicle control provide a structure for evaluating that contrast, while the recorded masking designation indicates an effort to limit knowledge of assignment during the study.
The endpoint also illustrates an important distinction in outcome measurement. Complete clearance is a threshold outcome, whereas the secondary measures include the fraction of treated warts cleared and change in wart size. These measures can tell different statistical and clinical stories: an all-or-none endpoint can remain unmet even when partial improvement occurs. Reporting more than one outcome can therefore add context, but it also makes a clear analysis plan and transparent reporting of multiplicity important.
For interpretation, the central statistical contribution would be the estimated between-group difference together with uncertainty. The registry record does not report a single primary comparison or its precision, so the trial's design cannot be converted into a conclusion about the size of an efficacy effect. This is a useful reminder that design characteristics, completion status, enrollment, and safety counts do not substitute for an outcome estimate. Statistical interpretation depends not only on what was planned and measured, but also on transparent reporting of the analysis and its results.
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 main trial-specific limitation of the registry entry is that it does not provide a single reduced primary comparison. Although it identifies Week 18 complete clearance of all treated warts as the primary endpoint, it notes that the primary outcome has several categories or time points and is not reduced to one comparison. The registry record does not report group-specific outcome counts, proportions, an effect estimate, a confidence interval, or a p-value for that endpoint. Therefore, neither the direction nor precision of the primary contrast can be assessed.
Details needed to evaluate the analysis are also not reported in the registry record. These include the primary statistical method, analysis population, handling of missing outcomes, protocol deviations, and any adjustment for multiple outcomes or time points. The entry does not describe the sample-size justification or interim analyses. The recorded masking designation is not accompanied by an explanation of which parties were masked or how masking was maintained.
Safety reporting is limited to selected counts. The record does not give descriptions of the other adverse events, their severity or timing, or assessments of relatedness. Consequently, the counts cannot be used to characterize particular event patterns or attribute events to an intervention. These limitations apply to what can be concluded from the registry record; they do not establish that the unreported analyses or details were absent from other trial materials.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: A Phase 3 Study to Evaluate the Efficacy and Safety of CLS006 Versus Vehicle in Subjects 2 Years of Age or Older With Cutaneous Common Warts — NCT02971891.
- Registry record last updated 2023-09-14; status last verified 2023-08.
- Results first posted 2023-09-14.
- 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 NCT02971891, a Phase 3 randomized, quadruple-masked, parallel, vehicle-controlled, multicenter study sponsored by Maruho Co., Ltd. It evaluated CLS006 (furosemide) topical gel, 0.125%, against vehicle in people 2 years of age or older with cutaneous common warts. The brief summary describes once-daily use for six weeks. Enrollment is recorded as 484; the study is marked completed, with start recorded as 2017-01 and primary completion as 2018-04-16.
The primary endpoint is the difference in the proportion of participants with complete clearance of all treated warts at Week 18. The record does not provide a single primary comparison or its estimate and uncertainty. Safety counts list 0 serious adverse events in each group, 9 other adverse events in each group, and 0 deaths in each group. Further details on the analysis, missing data, and event descriptions are not reported in the registry record.