Cantharidin Application in Molluscum Patients: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Cantharidin Application in Molluscum Patients (NCT03377803), a randomized phase 3 study. The primary outcome is Percentage of Subjects Exhibiting Complete Clearance of All Treatable Molluscum Lesions (Baseline and New) on the Day 84 Visit (EOS).

2. Clinical Question

The question is about a defined clinical outcome at a specified visit, rather than a change in lesion count or time until clearance. Complete clearance requires all lesions included in the endpoint to meet the clearance definition; partial improvement would not satisfy this binary outcome. The registry record identifies the assessment as the end-of-study visit and compares baseline lesions and new lesions in determining clearance.

The comparison is between randomized arms. Random assignment is intended, in general, to make groups comparable on average, while masking can reduce the influence of expectations on care or outcome assessment. The registry lists quadruple masking but does not report which roles were masked or the practical masking procedures. These design features describe how the question was studied; they do not by themselves establish the certainty or scope of the result.

3. Trial Design

This was a phase 3, randomized, double-blind, placebo-controlled, pivotal study with a parallel-group model and quadruple masking listed in the registry. The registry reports enrollment of 262. The primary outcome results are presented for an ITT Population, with 150 participants in the VP-102 arm and 112 in the placebo arm. How the ITT Population was defined or how participants with missing outcome data were handled is not reported in the registry record.

The study evaluated VP-102, a topical film-forming solution containing cantharidin, against placebo solution without VP-102. The study summary describes application to treatable molluscum lesions once every 21 days for up to 4 applications. This is the planned schedule in the summary; the registry record does not report how many applications each participant actually received or adherence to the schedule.

The primary assessment was complete clearance of all treatable baseline and new lesions at Day 84. The record also lists the same clearance outcome at earlier visits, allowing the reported results to be considered across follow-up assessments. The study start date was 2018-02-14, primary completion was 2018-09-26, and the status is completed. These dates and status describe the registry record, not the timing of any subsequent analyses or publication.

The registry names Verrica Pharmaceuticals Inc. as sponsor. Details such as the randomization procedure, allocation concealment, planned analysis methods, sample-size justification, and any interim analyses are not reported in the registry record. The fact that the study is described as pivotal does not supply those missing methodological details.

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: ITT Population

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: ITT Population

6. Primary Endpoint

The registry lists the primary outcome as Percentage of Subjects Exhibiting Complete Clearance of All Treatable Molluscum Lesions (Baseline and New) on the Day 84 Visit (EOS), measured over Day 1 (Baseline) compared to Day 84 (EOS).

The primary endpoint is the percentage of participants exhibiting complete clearance of all treatable molluscum lesions, including lesions present at baseline and new lesions, at the Day 84 visit. The registry gives the timeframe as Day 1 (Baseline) compared with Day 84 (EOS) and identifies the ITT Population. The outcome values are counts of participants: 81 in the VP-102 arm and 15 in the placebo arm. The arm denominators reported for this outcome are 150 and 112, respectively.

This is a binary endpoint: each participant either meets the stated complete-clearance criterion at the assessment or does not. In general, a binary endpoint can make a specific treatment goal straightforward to interpret, but it also reduces a complex clinical course to one classification at one visit. It does not describe how many lesions remained for participants who did not achieve complete clearance, how quickly individual lesions changed, or whether clearance persisted after the assessment.

Using a fixed visit gives the arms a common time point for comparison. It also means the result addresses clearance at Day 84, not clearance at every time during follow-up. The registry does not report the detailed lesion assessment rules, handling of unevaluable lesions, or missing-outcome procedures. Those details would be relevant to understanding exactly how the binary endpoint was assigned.

7. Results Posted in the Registry

• VP-102: 54.0% (81/150) versus 13.4% (15/112) on control; risk difference 40.6 percentage points (95% CI 30.4 to 50.8), risk ratio 4.03 (2.46–6.61); unadjusted two-proportion z-test p = <0.001.

8. Secondary Efficacy Endpoints

The registry also posts results for secondary outcomes. For each outcome below, the endpoint type, the test applied to the posted summary statistics, the result and its interpretation are given in turn. Secondary endpoints are usually not adjusted for multiple testing, so they support rather than confirm the primary finding.

Percentage of Subjects Exhibiting Complete Clearance of All Treatable Molluscum Lesions (Baseline and New) on the Day 63 Visit

• Endpoint type: Binary: the number of participants with the event, compared as proportions.
• Test: Unadjusted two-proportion z-test, with a Wald 95% confidence interval for the risk difference.
• Result:
  • VP-102: 28.0% (42/150) versus 4.5% (5/112) on control; risk difference 23.5 percentage points (95% CI 15.4 to 31.7), risk ratio 6.27 (2.56–15.34); unadjusted two-proportion z-test p = <0.001.
• Interpretation:
  • The 95% confidence interval excludes no difference, so the proportion with the event is statistically higher for VP-102 than for the control. This is an unadjusted, secondary comparison, so it is suggestive rather than confirmatory.

Percentage of Subjects Exhibiting Complete Clearance of All Treatable Molluscum Lesions (Baseline and New) on the Day 42 Visit

• Endpoint type: Binary: the number of participants with the event, compared as proportions.
• Test: Unadjusted two-proportion z-test, with a Wald 95% confidence interval for the risk difference.
• Result:
  • VP-102: 12.7% (19/150) versus 3.6% (4/112) on control; risk difference 9.1 percentage points (95% CI 2.8 to 15.4), risk ratio 3.55 (1.24–10.14); unadjusted two-proportion z-test p = 0.010.
• Interpretation:
  • The 95% confidence interval excludes no difference, so the proportion with the event is statistically higher for VP-102 than for the control. This is an unadjusted, secondary comparison, so it is suggestive rather than confirmatory.

Percentage of Subjects Exhibiting Complete Clearance of All Treatable Molluscum Lesions (Baseline and New) on the Day 21 Visit

• Endpoint type: Binary: the number of participants with the event, compared as proportions.
• Test: Unadjusted two-proportion z-test, with a Wald 95% confidence interval for the risk difference.
• Result:
  • VP-102: 5.3% (8/150) versus 1.8% (2/112) on control; risk difference 3.5 percentage points (95% CI -0.8 to 7.9), risk ratio 2.99 (0.65–13.79); unadjusted two-proportion z-test p = 0.138.
• Interpretation:
  • The 95% confidence interval includes no difference, so these data do not show a statistically significant difference between VP-102 and the control. The interval gives the range of effects that remain compatible with the data.

The secondary outcomes use the same complete-clearance definition at earlier scheduled assessments. Across the assessments, the counts in both arms rise over time, and the contrast between arms is generally larger at later visits. This broad pattern is consistent with the primary result being a later assessment of the same outcome rather than a wholly different measure. It should be understood as a pattern across visits, not as independent evidence from separate trials.

The earlier assessments add information about when clearance was recorded during follow-up, while the primary endpoint focuses on Day 84. They do not establish the duration of clearance after the final assessment, and they do not describe partial clearance. The registry record lists three secondary outcomes, but does not include reported analyses for them. The displayed comparisons should therefore be read as descriptive posted results rather than as a complete inferential account of the secondary outcomes.

The secondary comparisons are reported with unadjusted p-values. General explanation: when several outcomes or time points are examined, the chance of at least one apparently noteworthy result can increase if each is assessed separately without adjustment. This does not mean the results are false; it means the evidential weight of any one unadjusted secondary finding is less secure than a single prespecified primary test considered on its own. The registry record does not report a multiplicity strategy or identify which secondary findings, if any, were intended to support formal claims.

The primary and secondary results are related because they use the same clearance construct and arm comparison at different visits. Their consistency in direction is relevant context, but the earlier results should not be counted as independent replications of the Day 84 result. The registry does not report analyses that jointly model repeated assessments or account for their dependence.

Secondary outcomes registered for this trial, for reference (only those above were recalculated):

• Percentage of Subjects Exhibiting Complete Clearance of All Treatable Molluscum Lesions (Baseline and New) on the Day 63 Visit
• Percentage of Subjects Exhibiting Complete Clearance of All Treatable Molluscum Lesions (Baseline and New) on the Day 42 Visit
• Percentage of Subjects Exhibiting Complete Clearance of All Treatable Molluscum Lesions (Baseline and New) on the Day 21 Visit

9. Statistical Interpretation

10. Statistical Methods Explained

For a binary endpoint, each participant is classified according to whether the event occurred. In this study, the event is complete clearance of all treatable baseline and new lesions at a visit. General explanation: an arm-level event proportion is the number of participants meeting the event definition relative to the number assessed in that arm. The posted counts are 81 of 150 in the VP-102 arm and 15 of 112 in the placebo arm at Day 84. The registry labels the outcome as a count of participants, and the corresponding comparison reports proportions and effect measures.

What does the risk difference express?

The risk difference is an absolute contrast between the two event proportions. Its posted estimate is 0.406. General explanation: an absolute contrast is often useful because it describes how far apart the groups are on the outcome-probability scale, rather than expressing the contrast as a multiple. The registry reports a confidence interval from 0.304 to 0.508 for this estimate. It does not report a covariate-adjusted risk difference, and the method used for the displayed interval is not specified in the registry record.

How do relative measures differ?

The relative risk compares the two event proportions as a ratio, and the odds ratio compares the event odds. The posted relative risk is 4.032, with an interval from 2.461 to 6.605. The posted odds ratio is 7.591, with an interval from 4.037 to 14.27. General explanation: these measures answer different questions from the risk difference. Ratios describe relative contrasts, while the risk difference describes an absolute contrast. Odds ratios are not the same as risk ratios, particularly when the event is not rare. Reading the relative measures alongside the arm counts and risk difference helps avoid treating a relative number as if it were an absolute change.

What does the p-value tell the reader?

The primary comparison has an unadjusted p-value of <0.001. General explanation: a p-value is calculated under a specified null hypothesis and statistical procedure, and describes how unusual data at least as incompatible with that null would be if the assumptions held. It is not the probability that the treatment has no effect, nor a measure of clinical importance. The registry record does not identify the test or provide enough detail to reconstruct the analysis procedure. The p-value is explicitly unadjusted; the record does not report a multiplicity adjustment.

Why do analysis details matter?

Statistical results depend on definitions, populations, missing-data handling, and the method used to calculate uncertainty. The registry labels the primary population as ITT, but does not report the detailed population rules or how missing endpoint values were treated. It also does not report whether any stratification, covariate adjustment, or sensitivity analysis was planned or performed. General explanation: randomization supports a comparison by assigning participants to groups, while the analysis plan specifies how that assignment and the observed data are used to estimate the contrast. Without the plan, the posted summary alone cannot answer every question about the conduct of the analysis.

How should repeated assessments be viewed?

The same complete-clearance outcome is listed at Day 21, Day 42, Day 63, and Day 84. General explanation: repeated assessments can show how an outcome pattern changes over follow-up, but they are correlated because they are measured in the same trial population. They should not automatically be treated as independent confirmations. Multiple outcome times also create a multiplicity issue if formal claims are made across all of them. The registry lists secondary outcomes but does not report analyses for them or a plan for controlling multiplicity.

The registry record describes the design as randomized, double-blind, placebo-controlled, and quadruple-masked. General explanation: randomization can reduce systematic differences between groups at assignment, and masking can reduce some forms of expectation-related influence. The registry does not identify which people or roles were masked, the allocation procedure, or the safeguards used to maintain masking. These design labels are useful context, but they do not substitute for a detailed protocol or statistical analysis plan.

11. Confidence Intervals and Precision

The primary risk-difference estimate is 0.406, and its 95% confidence interval runs from 0.304 to 0.508. This interval communicates uncertainty around the estimated contrast. It is not an interval containing 95% of individual participant outcomes, and it does not imply that the true contrast has a 95% probability of being inside these particular limits. In general, a confidence interval is produced by a method that would cover the target parameter at its stated rate over repeated use if the method’s assumptions hold.

The full interval is above zero, which is consistent with a positive risk difference under the reported comparison. Its endpoints still span a range of possible effect magnitudes; the point estimate should not be read as exact. The registry record does not name the interval method or report adjusted confidence intervals. The interval therefore supports interpretation of the posted estimate, but the available record does not allow a complete audit of how it was calculated.

The relative-risk interval, from 2.461 to 6.605, and odds-ratio interval, from 4.037 to 14.27, also express uncertainty, on different scales. Such measures do not replace the absolute comparison. The absolute arm counts help convey the amount of observed information behind the primary endpoint, while the intervals show that estimates from a finite trial remain uncertain.

No confidence intervals are reported for the arm-specific counts themselves in the registry record. The precision of a trial estimate is not the same as certainty about an individual participant’s outcome, and statistical precision does not establish clinical importance or applicability to populations beyond those represented in the study.

12. Planning a Similar Trial: Sample Size

This is a planning illustration, not a re-evaluation of the original trial. It asks: if a new study wanted to detect a difference like the one observed, or a smaller one, how large would it need to be? It is deliberately not “observed power” of the finished trial, which is not a meaningful quantity.

The planning figures are participants per arm, not total event counts. They are illustrations calculated from the observed effect, not the original trial’s sample-size justification. The listed assumptions are a two-sided significance level of 0.05, equal allocation between the two arms, and a normal approximation. Each scenario asks what sample size would be needed to detect a stated fraction of the observed effect. For example, planning for 100% of the observed effect gives 21 participants per arm for 80% power and 27 participants per arm for 90% power. Planning for 50% of the observed effect gives 68 participants per arm for 80% power and 90 participants per arm for 90% power.

The 80% power column describes the planning sample size for a design that, under the stated assumptions and assumed effect, would have an 80% chance of detecting an effect at the specified significance level. The 90% column expresses the corresponding planning target with a higher chance of detection, which generally requires more participants. The figures are conditional on the assumed effect and calculation assumptions; they are not a guarantee that a future study will obtain a particular result.

Smaller effects are harder to distinguish from random variation, so the planning scenarios require more participants per arm as the assumed fraction of the observed effect becomes smaller. The registry record does not report the trial’s own original sample-size assumptions or justification. These illustrations are not observed power.

13. How the Sample Size Is Derived

Power is the probability that a study of a given size rejects the null hypothesis when a specific true effect exists. It depends on four things: the effect to detect, the variability of the outcome, the significance level (here a two-sided α of 0.05, so z_1−α/2 = 1.960) and the desired power (z_1−β = 0.842 for 80% and 1.282 for 90%).

Formula

n is the number of participants in each arm, p₀ and p₁ are the control and treatment proportions, and p̄ is their average.

Worked calculation for this trial

1. Control proportion p₀ = 0.134; treatment proportion p₁ = 0.540; average p̄ = 0.337.
2. First term: z_1−α/2 × √[2p̄(1−p̄)] = 1.96 × 0.6685 = 1.3102.
3. Second term: z_1−β × √[p₀(1−p₀) + p₁(1−p₁)] = 0.842 × 0.6036 = 0.5080.
4. n = (1.3102 + 0.5080)² / (0.4061)² = 20.0, rounded up to 21 participants per arm for 80% power.

The smaller-effect rows in the table above repeat the same calculation with the effect multiplied by 0.75 and 0.5 (for ratios, applied to the logarithm of the ratio).

R code

alpha <- 0.05
z_a   <- qnorm(1 - alpha / 2)          # two-sided
p0 <- 0.133928571428571                          # control proportion
p1 <- 0.54                          # treatment proportion
n_per_arm <- function(power, frac = 1) {
  q1 <- p0 + (p1 - p0) * frac               # smaller effect = fraction of the observed difference
  pbar <- (p0 + q1) / 2
  z_b <- qnorm(power)
  ceiling(round((z_a * sqrt(2 * pbar * (1 - pbar)) + z_b * sqrt(p0 * (1 - p0) + q1 * (1 - q1)))^2 / (q1 - p0)^2, 6))
}
for (f in c(1, 0.75, 0.5))
  cat(sprintf("%3.0f%% of observed effect: n per arm = %s (80%% power), %s (90%% power)\n", 100 * f,
              format(n_per_arm(0.80, f), big.mark = ","), format(n_per_arm(0.90, f), big.mark = ",")))

# Check against R's built-in function (unrounded n per arm)
cat("power.prop.test:", round(power.prop.test(p1 = p0, p2 = p1, power = 0.80)$n, 1), "\n")

# Simulation: how often does the z-test reject at the 80%-power sample size?
set.seed(3377803)
n    <- n_per_arm(0.80)
reps <- 20000
x0 <- rbinom(reps, n, p0); x1 <- rbinom(reps, n, p1)
ph <- (x0 + x1) / (2 * n)
z  <- ((x1 - x0) / n) / sqrt(ph * (1 - ph) * 2 / n)
cat(sprintf("Simulated power at n = %s per arm: %.3f (%d replicates)\n", format(n, big.mark = ","), mean(abs(z) > z_a, na.rm = TRUE), reps))

Output from running the code

100% of observed effect: n per arm = 21 (80% power), 27 (90% power)
 75% of observed effect: n per arm = 34 (80% power), 45 (90% power)
 50% of observed effect: n per arm = 68 (80% power), 90 (90% power)
power.prop.test: 20 
Simulated power at n = 21 per arm: 0.843 (20000 replicates)

The simulation draws many pairs of event counts at the planned sample size and counts how often the two-proportion z-test rejects the null. It should land close to the target power; at very small required sample sizes it can fall below it, because the normal approximation is rough there.

14. Multiplicity, Missing Data and Analysis Populations

The registry identifies a primary endpoint at Day 84 and lists secondary complete-clearance endpoints at earlier visits. It reports no analyses for the secondary outcomes, and the comparisons shown are labeled with unadjusted p-values. The registry record does not report whether the protocol specified a hierarchy for testing endpoints, a family of hypotheses, or an adjustment to control the chance of false-positive findings across multiple comparisons. As a result, the secondary p-values should not be interpreted as if a multiplicity plan were documented.

Multiplicity is a general concern when more than one outcome, time point, subgroup, or analysis is examined. If each comparison is treated as a separate opportunity to find evidence against a null hypothesis, the overall chance of at least one false-positive result can be higher than the nominal rate for an individual comparison. Different strategies can address this, including prespecified testing order or statistical adjustment, but the registry record does not indicate that any particular strategy was used.

The primary population is identified as ITT. The exact population rules, analysis set details, and handling of missing Day 84 outcomes are not reported in the registry record. The arm denominators are stated for the posted outcome, but those numbers alone do not describe whether any participants were excluded, whether outcomes were imputed, or how participants without an assessment were classified. The registry record also does not report sensitivity analyses that might examine alternative assumptions about missing data.

Randomization and masking are listed, but details of allocation concealment, the randomization method, who was masked, and how masking was maintained are not reported. The statistical analysis plan, model specifications, and interim-analysis procedures are also not reported in the registry record. These gaps do not change the reported counts or estimates, but they limit the ability to judge in detail how prespecification, missingness, and repeated testing were handled.

15. 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 5% reporting threshold.

Most frequent non-serious adverse event terms

The registry reports no serious adverse events in either arm: 0 among 150 participants at risk in the VP-102 group and 0 among 112 at risk in the placebo group. It also reports 0 deaths in each arm. These are observed event counts in the groups and follow-up represented in the record; they do not establish that serious events or deaths are impossible.

The registry lists other adverse events for 143 participants in the VP-102 arm and 74 in the placebo arm. These figures are separate from the serious adverse event counts. The record does not provide the event terms, severity, duration, relatedness, or exposure-adjusted rates in the information summarized for these results. No top serious-event terms are listed.

Zero observed serious events should be read in the context of the number of participants and the study observation period, not as proof of absence of risk. The registry record does not provide enough detail to characterize individual adverse events or compare their clinical importance. These counts describe reported safety events; they do not by themselves determine the overall benefit-risk profile.

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

The posted primary result is an observed difference in complete clearance at Day 84 between the randomized VP-102 and placebo arms. The risk-difference estimate is positive, and its confidence interval is above zero. The record therefore shows a clear statistical separation on this particular binary endpoint in this study. The estimate pertains to the ITT Population as labeled in the registry, but the precise analysis rules are not reported.

That result does not answer every question about molluscum contagiosum or the course of each participant’s lesions. It concerns complete clearance at a single visit, not partial improvement, time to initial improvement, symptoms, recurrence, or longer-term outcomes. The record does not report whether clearance was maintained after Day 84. Nor does a group-level comparison predict the outcome for an individual participant.

The study summary describes use in subjects aged 2 years and older and a topical application schedule once every 21 days for up to 4 applications. Actual exposure and adherence are not reported. The outcome results cannot establish the effect of different schedules or use outside the population and circumstances represented in the study. Participant characteristics beyond the broad age eligibility description are not reported in the registry record, so the degree to which the results represent particular subgroups cannot be assessed from these data.

The statistical contrast also does not, by itself, establish the clinical importance of the magnitude. The registry gives a numerical endpoint and effect estimates but does not report a threshold for a clinically meaningful difference or participant-reported outcomes. The result should therefore be read as evidence about the recorded trial endpoint, not as a complete account of treatment experience, safety, or suitability for an individual. It is not a substitute for medical advice.

17. Why This Trial Matters Statistically

This trial offers a useful example of how a binary endpoint can produce several complementary descriptions of the same randomized comparison. The counts show how many participants met the complete-clearance definition; the risk difference gives the absolute contrast; and relative-risk and odds-ratio estimates express the comparison on relative scales. Considering these together helps distinguish the observed event counts from the size and uncertainty of the estimated contrast.

The study also illustrates why the endpoint’s timing matters. Complete clearance was assessed at multiple visits, while the primary question focused on Day 84. The broad pattern across assessments gives context about the timing of the recorded outcome, but repeated visits are related and should not be treated as independent confirmations. A clear endpoint hierarchy and multiplicity plan are important when several assessments are available; those details are not reported in the registry record.

Another statistical lesson is that a small p-value and a confidence interval answer different questions. The p-value describes compatibility with a null comparison under a test procedure, while the interval conveys a range of effect estimates compatible with the data and interval method. Neither alone resolves clinical importance, missing-data concerns, or external applicability. The registry’s lack of analysis-plan and missing-data details limits how fully those aspects can be evaluated.

Finally, planning illustrations based on an observed effect are not a substitute for a prospective sample-size rationale. The figures can help readers understand how assumed effect size and power targets influence planning, but the original design assumptions are not reported. Keeping these distinctions clear prevents post hoc planning calculations from being confused with the trial’s actual design or evidence strength.

18. Limitations

• The posted summary statistics are the only data these results rest on; patient-level data, full protocols and statistical analysis plans are not available.
• Recalculated results are simple, unadjusted calculations from posted summaries. They do not replace the sponsor's prespecified analysis.

The registry record contains the primary outcome counts and comparison estimates, but does not report the detailed statistical analysis plan, the method used to calculate the confidence intervals, or the test underlying the p-values. It identifies the primary population as ITT without describing its exact analysis rules. Missing-outcome handling, exclusions, and sensitivity analyses are not reported, limiting assessment of how incomplete data might affect the estimate.

The outcome is complete clearance at defined visits. The record does not report the detailed lesion assessment rules or results for partial clearance, time to clearance, persistence after Day 84, or recurrence. The three earlier clearance outcomes are listed, but no analyses are reported for them, and no multiplicity plan is described. This limits the inferential interpretation of patterns across visit times.

The registry describes randomization, double blinding, placebo control, and quadruple masking, but does not report the randomization procedure, allocation concealment, masking roles, or how masking was maintained. Participant characteristics beyond the eligibility description are not reported in the information, which limits assessment of how broadly the results may apply. Actual treatment exposure and adherence to the described schedule are also not reported.

The safety summary provides serious-event counts, other adverse-event counts, and deaths, but does not list the other event terms or details of severity, relatedness, or duration. The registry record does not report the trial’s original sample-size justification, interim analyses, or a detailed basis for its planned design. These limitations do not erase the posted results, but they narrow what can be concluded from the registry record alone.

19. Related Tutorials

20. Related Statistical Calculators

21. Sources

• ClinicalTrials.gov: Cantharidin Application in Molluscum Patients — NCT03377803.
• Registry record last updated 2021-12-14; status last verified 2021-11.
• Results first posted 2021-12-14.
• 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.

22. Record Summary

NCT03377803 is a completed phase 3 randomized, double-blind, placebo-controlled, parallel-group study sponsored by Verrica Pharmaceuticals Inc. It evaluated VP-102, a topical film-forming solution containing 0.7% (w/v) cantharidin, against placebo in subjects aged 2 years and older with molluscum contagiosum.

The primary outcome was complete clearance of all treatable baseline and new lesions at Day 84 in the ITT Population. The registry reports 81 participants with clearance in the VP-102 arm and 15 in the placebo arm, with a risk difference of 0.406 (95% CI 0.304 to 0.508) and an unadjusted p-value of <0.001. Earlier clearance assessments are also listed. Important details about the statistical plan, missing data, and multiplicity are not reported in the registry record.