A Phase 3 Randomized Parallel Group Study Comparing the Efficacy & Safety of SB206 & Vehicle Gel in the Treatment of MC (B-SIMPLE1): Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for A Phase 3 Randomized Parallel Group Study Comparing the Efficacy & Safety of SB206 & Vehicle Gel in the Treatment of MC (B-SIMPLE1) (NCT03927716), a randomized phase 3 study. The primary outcome is Complete Clearance of All Treatable MC at Week 12.

2. Clinical Question

The primary endpoint is a binary outcome: each participant either had complete clearance of all treatable lesions at the specified assessment or did not. The registry reports participant counts for each group, along with an unadjusted comparison recalculated from the posted summary counts. The primary outcome is designated for the ITT population, which is the population label in the registry record; further details about how that population was defined or analyzed are not reported in the registry record.

The study also assessed complete clearance at Week 8. That earlier assessment is secondary to the Week 12 primary question. The registry record describes the study as a Phase 3, randomized, double-blind, vehicle-controlled, parallel-group study. Its design therefore compares outcomes between two concurrently assigned groups, rather than comparing participants with their own outcomes at different times as the principal treatment contrast.

The central statistical question is about the size and precision of the difference between groups, not only whether one group had more clearances in raw counts. The groups were unequal in size, so raw counts alone are not a fair direct comparison. The posted comparison accounts for the group denominators and expresses the contrast as a risk difference. The point estimate favors SB206, but the interval around that estimate includes no difference, and the unadjusted p value is 0.378. Those features indicate substantial uncertainty about the underlying between-group difference.

3. Trial Design

This was a Phase 3, multicenter, randomized, double-blind, vehicle-controlled, parallel-group study. The registry describes 352 enrolled participants. Its brief summary says the study was to be conducted in up to approximately 340 participants aged at least 6 months; the enrollment figure in the record is 352. The trial status is completed.

Participants or their caregivers applied SB206 12% or Vehicle Gel once daily. The study summary specifies a minimum treatment period of 4 weeks and a maximum of 12 weeks. Treatment was applied to lesions identified at baseline and to new treatable lesions arising during the study. The listed arms identify the active treatment as SB206 12% and the control as placebo, with both applied topically once daily.

Randomization assigns participants to groups by chance, which is intended to support a fair comparison by reducing systematic differences in how participants enter each group. Double masking means the record identifies the study as masked at two levels, although the specific people masked and the procedures used to maintain masking are not reported in the registry record. A parallel-group design means participants were assigned to one group rather than crossing from one treatment to another.

The primary outcome was complete clearance of all treatable molluscum contagiosum at Week 12, measured as the number of participants meeting the clearance definition in each group. The primary outcome population is labeled ITT. Complete clearance at Week 8 was listed as a secondary outcome. The registry record does not report the trial's original sample-size justification, detailed randomization procedures, or the planned statistical analysis method. It also lists no reported analyses. The posted group counts and recalculated comparisons therefore describe the information available in the registry, but do not supply the full statistical analysis plan or sponsor's analysis report.

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.

Before assignment: Subjects receiving current treatment for MC at the time of the Screening Visit will enter a wash out period of up to 14 days prior to randomization.

Overall Study

Analysis population for the primary outcome, as defined in the registry: ITT

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: Males and females, 6 months of age and older, with a minimum of 3 and a maximum of 70 lesions of MC at baseline will be randomized in a 2:1 (active:vehicle) scheme.

6. Primary Endpoint

The registry lists the primary outcome as Complete Clearance of All Treatable MC at Week 12, measured over 12 Weeks.

The primary endpoint is complete clearance of all treatable molluscum contagiosum at Week 12. It is recorded as a participant count within each treatment group and is described in the registry as the proportion of participants with complete clearance, using the number in the treatment group as the denominator. In statistical terms, this is a binary outcome: each participant is classified as meeting or not meeting the clearance criterion at the specified assessment.

A binary clearance endpoint can be straightforward to interpret because it asks whether a defined event occurred by a specified time. It differs from an endpoint that measures a change in lesion count, symptom severity, or time until clearance. The registry record does not give further detail about how treatable lesions were defined, how clearance was adjudicated, or how missing Week 12 assessments were handled.

Using the Week 12 assessment as the primary outcome focuses the main comparison on clearance at the end of the stated treatment period. The Week 8 clearance assessment is secondary and provides an earlier assessment of the same broad outcome. The record does not explain why Week 12 was selected as primary or describe the clinical rationale used to select the endpoint. In general, a prespecified primary endpoint helps identify the principal question a trial is intended to address, while secondary endpoints are interpreted as additional evidence and may require more caution when many comparisons are considered.

7. Results Posted in the Registry

• SB206: 25.8% (61/236) versus 21.6% (25/116) on control; risk difference 4.3 percentage points (95% CI -5.0 to 13.6), risk ratio 1.20 (0.80–1.81); unadjusted two-proportion z-test p = 0.378.

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.

Complete Clearance of All Treatable MC at Week 8

• 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:
  • SB206: 15.3% (36/236) versus 10.3% (12/116) on control; risk difference 4.9 percentage points (95% CI -2.3 to 12.1), risk ratio 1.47 (0.80–2.73); unadjusted two-proportion z-test p = 0.207.
• Interpretation:
  • The 95% confidence interval includes no difference, so these data do not show a statistically significant difference between SB206 and the control. The interval gives the range of effects that remain compatible with the data.

The registry lists one secondary endpoint: complete clearance of all treatable molluscum contagiosum at Week 8. Its unadjusted comparison has the same broad direction as the Week 12 primary estimate, with the point estimate favoring SB206. The interval includes no difference, so this earlier assessment does not provide a precise estimate of a between-group effect.

The Week 8 result is related to the primary result because both assess complete clearance, but they refer to different assessment times. The earlier measure can add context about the timing of observed clearance, while the Week 12 measure remains the designated primary outcome. The secondary finding does not independently establish the primary conclusion, nor does consistency in direction resolve the uncertainty in either comparison.

Secondary outcomes generally carry less inferential weight than a prespecified primary outcome. When multiple outcomes are tested, separate unadjusted p values can overstate how much evidence a collection of findings represents. A multiplicity procedure can account for that issue, but the registry record does not report whether one was planned or used. It also lists no sponsor-reported analyses. The posted secondary comparison should therefore be treated as additional, exploratory context rather than as a confirmatory result with a documented error-control strategy.

The registry does not report a broader set of secondary efficacy outcomes or detailed secondary analysis methods. Interpretation is consequently limited to the outcome and summary statistics recorded. The fact that both assessments use clearance does not make them independent replications: they are outcomes measured at different times within the same trial population, and the record does not provide participant-level information about how individual participants' outcomes changed between assessments.

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

• Complete Clearance of All Treatable MC at Week 8

9. Statistical Interpretation

10. Statistical Methods Explained

The registry lists participant counts for a binary primary endpoint and an unadjusted comparison recalculated from those counts. The main effect measure is the risk difference, which subtracts the proportion with the event in one group from the proportion in the other. A risk difference of zero corresponds to equal observed proportions. The posted estimate is 0.043. The registry also reports relative risk and odds ratio measures, but the risk difference is useful for communicating an absolute contrast in the observed proportions.

What does a confidence interval describe?

A confidence interval gives a range of values compatible with the observed data under the method used to calculate it. A narrow interval indicates greater precision than a wide interval, while a wide interval indicates that the data leave more uncertainty about the size and direction of the effect. The Week 12 interval crosses zero. For the risk difference, zero represents no difference between groups. Thus the interval does not rule out no difference, and it also permits values on either side of zero.

A confidence interval is not a guarantee that the true effect lies inside its particular bounds, and it is not a range of outcomes expected for individual participants. It concerns uncertainty in the group-level effect estimate. The confidence level and calculation method for the posted interval are not reported in the registry record, so the interval should be interpreted from its reported bounds and whether it includes the no-difference value, without assigning an unreported confidence level.

What does the p value add?

The unadjusted p value for the primary comparison is 0.378. A p value describes how unusual data at least as discrepant as those observed would be under a specified no-difference model and its assumptions. It is not the probability that the null hypothesis is true, nor is it a measure of the size or clinical importance of an effect. The value should be considered alongside the effect estimate, interval, outcome definition, and analysis population.

The p value is described as unadjusted. That matters because multiple outcomes or comparisons can increase the chance of apparently notable findings when each is assessed separately. The registry lists one secondary outcome and does not report a multiplicity strategy or a sponsor-reported analysis. Consequently, the posted p values should not be treated as if they were part of a documented family-wise testing procedure. The registry record does not specify whether any covariates, stratification factors, or other adjustments were part of the planned analysis.

Why do denominators and analysis populations matter?

For a binary endpoint, the event count must be read with its denominator. The primary outcome count is 61 among 236 in the SB206 group and 25 among 116 in the placebo group. Those denominators are unequal. The comparison recalculates group proportions before estimating the risk difference, rather than treating the larger raw count as sufficient evidence of a larger event probability.

The primary endpoint is labeled ITT, a term generally used for an analysis based on participants assigned to groups, with the exact handling depending on the protocol and analysis plan. Here, the registry record does not explain which enrolled or randomized participants were included in that population, how deviations from treatment were handled, or how missing outcome data were treated. It would therefore be inappropriate to assume a particular missing-data method or to infer that every participant with no posted event was necessarily assessed and classified as not cleared.

The safety denominators are 235 for SB206 and 116 for placebo, differing from the primary outcome denominators. The record does not explain the population difference. Efficacy and safety counts should therefore be interpreted with their own stated denominators rather than assumed to use identical analysis populations.

What is not documented?

The registry record does not report the original sample-size calculation, the assumptions used to plan the trial, the intended allocation ratio, a detailed statistical analysis plan, interim analyses, or a sponsor-reported analysis. It also does not describe how the confidence intervals were calculated, whether covariate adjustment was planned, or how missing observations were handled. The recalculated comparisons are simple unadjusted comparisons from the posted summary statistics; they are not a substitute for a full trial analysis that could account for prespecified design features or participant-level data.

General statistical considerations still apply: randomization supports comparability at assignment, but chance imbalances can remain, especially in finite samples. A binary outcome can be analyzed with several valid methods, and their properties may differ. The specific method selected by the trial team, its assumptions, and any sensitivity analyses are not reported in the registry record. The posted summaries therefore support a descriptive and unadjusted reading, with the interval and p value conveying uncertainty but not resolving questions about the unreported analysis plan.

11. Confidence Intervals and Precision

The Week 12 risk difference estimate is 0.043. Its confidence interval extends from a value below zero to a value above zero, so it includes the no-difference value. The estimate therefore has limited precision about whether the underlying group difference favors SB206 or placebo. Its interval also indicates that the data remain compatible with a range of possible effects, rather than identifying one precise effect size.

Precision is distinct from the direction of the point estimate. The point estimate favors SB206, but uncertainty around it is substantial enough that the interval includes no difference and values in the opposite direction. The unadjusted p value of 0.378 is consistent with this uncertainty. It should not be read as proof that the groups are equivalent, because equivalence would require a prespecified margin and a suitable analysis; neither is reported in the registry record.

The primary outcome groups contain 236 and 116 participants, respectively. Unequal group sizes affect how much information each group contributes to the comparison, and the smaller group can limit precision. The record does not report a confidence-interval method or a planned precision target, so the interval should be interpreted as posted without assuming additional design details.

The relative risk and odds ratio intervals also include their respective null values. While these measures express the comparison on different scales, they do not remove the fundamental uncertainty. The Week 8 comparison likewise has an interval that includes no difference. Across the posted outcomes, estimates should therefore be understood as uncertain rather than as precise evidence of a stable treatment contrast.

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 sample-size figures are planning illustrations based on the observed effect, not the trial's original design calculation. They are stated as participants per arm, not total participants or total events, because the outcome is a participant count rather than a time-to-event outcome. The assumptions are a two-sided significance level of 0.05, equal allocation between the two arms, and a normal approximation. The effect to detect is specified as a stated fraction of the observed effect.

The 80% power column describes the number of participants per arm that a hypothetical study would require to have an 80% chance of detecting the chosen effect under those planning assumptions, if that effect were the true effect and the assumptions held. The 90% power column applies the same idea with a higher chance of detection, which generally requires more participants. For example, the primary-outcome illustration using 100% of the observed effect gives 1,538 participants per arm for 80% power and 2,058 participants per arm for 90% power.

Other rows consider planning for 75% or 50% of the observed effect. Planning for a smaller effect requires more participants per arm because smaller differences are harder to distinguish from random variation. These figures are hypothetical planning quantities, not the enrollment needed to reproduce the original trial and not a claim about how the trial was designed. The original design assumptions are not reported in the registry record.

This is not observed power. It is a forward-looking illustration that depends on the selected effect and assumptions, and it does not measure whether the completed study had a particular probability of success after its results were known. The record's actual enrollment was 352, while the planning figures illustrate how sample size changes with the assumed detectable effect and desired 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 = 0.216; treatment proportion p₁ = 0.258; average p̄ = 0.237.
2. First term: z_1−α/2 × √[2p̄(1−p̄)] = 1.96 × 0.6014 = 1.1787.
3. Second term: z_1−β × √[p₀(1−p₀) + p₁(1−p₁)] = 0.842 × 0.6006 = 0.5055.
4. n = (1.1787 + 0.5055)² / (0.0430)² = 1,537.1, rounded up to 1,538 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 <- 0.21551724137931                          # control proportion
p1 <- 0.258474576271186                          # 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(3927716)
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 = 1,538 (80% power), 2,058 (90% power)
 75% of observed effect: n per arm = 2,691 (80% power), 3,602 (90% power)
 50% of observed effect: n per arm = 5,956 (80% power), 7,973 (90% power)
power.prop.test: 1537.1 
Simulated power at n = 1,538 per arm: 0.798 (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

Multiplicity arises when a study evaluates more than one outcome, time point, comparison, or subgroup. If each is tested separately, the chance of at least one apparently strong finding can increase. Statistical plans often address this by designating a primary endpoint, ordering tests, adjusting significance thresholds, or using another prespecified procedure. The registry identifies complete clearance at Week 12 as primary and clearance at Week 8 as secondary, but a multiplicity strategy is not reported in the registry record.

The record lists no reported analyses. The posted recalculated comparisons are unadjusted, so they should not be interpreted as results from a documented multiplicity-controlled analysis. The registry record does not report whether there were additional prespecified outcomes, subgroups, interim looks, or analytic choices beyond those listed. Without that information, the complete family of tests and the intended inferential hierarchy cannot be reconstructed.

The primary outcome is labeled ITT, but the registry does not define the analysis population or explain how participants with missing Week 12 assessments were handled. For a binary endpoint, missing observations can affect estimated proportions depending on whether they are excluded, imputed, or classified under a specified rule. No such method should be assumed from the posted counts. The record also does not state how treatment discontinuations, protocol deviations, or participants without an assessment were handled.

These omissions matter because the validity and interpretation of a comparison depend not only on the endpoint and group counts but also on who was included and how unobserved outcomes were treated. A complete analysis plan would help clarify whether the posted summaries follow the intended analysis, how uncertainty was calculated, and how multiple questions were handled. Those details are not reported in the registry record, so the available results support an unadjusted reading of the posted summaries rather than a reconstruction of the full planned analysis.

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 serious adverse events among participants at risk: 0 of 235 in the SB206 group and 0 of 116 in the placebo group. It also reports 0 deaths in each group. No serious adverse-event terms are listed. These figures indicate that no serious adverse events or deaths were recorded in the stated safety groups in the registry summary.

Zero recorded events in a trial does not establish that the true risk is zero. It also does not demonstrate that the groups have identical safety profiles. The number of participants and the observation period limit how much can be concluded about uncommon or delayed events, and the registry summary does not give event timing or detailed follow-up information.

The record separately lists other adverse event counts, but those should not be confused with serious adverse events. The serious-event figures are counts with their own at-risk denominators; they do not summarize all tolerability outcomes. Event definitions, severity breakdowns, collection procedures, and statistical comparisons are not reported in the registry record. These numbers are therefore a concise accounting of posted serious events, not a complete assessment of safety.

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

The posted Week 12 counts show complete clearance in 61 participants assigned to SB206 and 25 assigned to placebo. After accounting for the different group sizes, the recalculated risk difference is 0.043 in the direction favoring SB206. However, the confidence interval includes zero and the unadjusted p value is 0.378. The results therefore do not provide a precise estimate that rules out no difference between groups.

This does not mean the groups have been shown to be equivalent. Equivalence or non-inferiority requires a prespecified margin and an analysis designed for that question; such information is not reported in the registry record. Nor does the result prove that a difference exists simply because the point estimate is positive. The data are compatible with a range of possible differences, including no difference.

The findings also do not establish what would happen in a different population, with a different treatment schedule, or outside the study setting. The registry describes topical once-daily use and the studied population, but it does not provide all participant characteristics, the full analysis plan, or detailed follow-up information. Generalization beyond the recorded trial context requires evidence beyond these summary counts.

The safety summary reports no serious adverse events and no deaths in either group during the recorded trial, but this does not establish an absence of risk. It cannot address uncommon events with certainty, nor does it provide a complete account of non-serious events or longer-term outcomes. The statistical interpretation is limited to what the registry record reports and should not be turned into medical advice.

In short, the primary estimate points toward more observed clearance in the SB206 group after accounting for group size, but uncertainty remains substantial. The secondary outcome has a similar broad direction but is also uncertain and lacks a reported multiplicity plan. The record supports a cautious description of the observed data, not a definitive claim that one treatment is better, worse, or equivalent.

17. Why This Trial Matters Statistically

This trial illustrates why event counts should be read alongside denominators and uncertainty measures. The SB206 group had a larger raw number of Week 12 clearances, but it also had more participants. The risk difference gives a group-size-aware contrast, while its confidence interval communicates that the estimate is uncertain. A point estimate alone would conceal that uncertainty.

It also demonstrates the distinction between an endpoint estimate and an inferential conclusion. The primary estimate favors SB206, yet the interval includes no difference and the unadjusted p value is 0.378. A statistical reading must account for both the estimated direction and the amount of information in the data. Neither the positive direction nor the p value alone answers every question about clinical importance or reproducibility.

The registry identifies a primary and a secondary clearance assessment, making it possible to distinguish the main question from an additional time point. At the same time, the lack of a reported multiplicity strategy and sponsor analysis limits the strength of conclusions that can be drawn from the secondary comparison and from the registry summaries overall. The absence of details about missing observations and the planned analysis also limits evaluation of robustness.

Finally, the planning illustrations show how hypothetical sample-size needs change when the detectable effect is smaller or a higher power target is chosen. They are not evidence about the study's original design and should not be confused with observed power. Taken together, the record is a useful example of interpreting a binary endpoint with unequal group sizes, a confidence interval spanning the null value, and incomplete reporting of analysis methods.

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 gives summary counts and unadjusted recalculations, but no sponsor-reported analyses. It does not report the original sample-size justification, the prespecified statistical analysis plan, or the method used to calculate confidence intervals. As a result, the posted summaries cannot establish whether the recalculations match all planned design features or analytical choices.

Although the primary endpoint is labeled ITT, the record does not define the analysis population or explain how missing Week 12 outcomes were treated. The efficacy denominators differ from the safety denominators, and the reason is not reported. Without further details, it is not possible to assess how participant exclusions, treatment discontinuations, or incomplete assessments may have affected the reported counts.

The record does not report a multiplicity adjustment, interim analyses, covariate adjustments, subgroup methods, or sensitivity analyses. It lists one secondary outcome, but does not state how the trial controlled the interpretation of multiple outcomes. These gaps limit assessment of confirmatory evidence and robustness.

The registry summary also does not provide detailed participant characteristics, lesion-level data, outcome adjudication procedures, or the full adverse-event profile. The serious-event summary is not a substitute for complete safety reporting. Finally, the sample-size illustrations are based on the observed effect rather than the trial's own design assumptions, which are not reported in the registry record. These limitations do not invalidate the posted counts, but they narrow the conclusions that can be drawn from them.

19. Related Tutorials

20. Related Statistical Calculators

21. Sources

• ClinicalTrials.gov: A Phase 3 Randomized Parallel Group Study Comparing the Efficacy & Safety of SB206 & Vehicle Gel in the Treatment of MC (B-SIMPLE1) — NCT03927716.
• Registry record last updated 2022-12-27; status last verified 2022-12.
• Results first posted 2022-12-27.
• Data retrieved from ClinicalTrials.gov on 2026-11-09.
• Group sizes, means, event counts and sponsor-reported p-values are reproduced as posted. Effect estimates, confidence intervals and p-values not attributed to the sponsor are independently calculated from the posted summary statistics.

22. Record Summary

NCT03927716 is a completed Phase 3, randomized, double-blind, parallel-group study of SB206 12% and placebo, described as Vehicle Gel, for molluscum contagiosum. The registry reports enrollment of 352 participants and topical once-daily treatment. The primary outcome was complete clearance of all treatable lesions at Week 12 in the ITT population; complete clearance at Week 8 was listed as secondary.

At Week 12, the posted counts were 61 of 236 for SB206 and 25 of 116 for placebo. The unadjusted risk difference estimate was 0.043, with an interval that includes zero and an unadjusted p value of 0.378. Serious adverse events and deaths were reported as zero in both groups. The registry record does not list sponsor-reported analyses or the trial's original statistical design assumptions.