Intralesional Vitamin D Injection for Treatment of Common Warts: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Intralesional Vitamin D Injection for Treatment of Common Warts (NCT04278573), a randomized phase 2 study. The primary outcome is Complete Regression of Wart.

2. Clinical Question

This is a question about a difference between randomized groups in a binary outcome: each participant either had complete wart regression recorded or did not. The posted summary gives group counts and a comparison of the proportions represented by those counts. It does not describe the number or selection of warts assessed per participant, so the endpoint should be understood as the registry’s participant-level count rather than a wart-level analysis. The record’s brief summary says researchers were trying to find out whether injecting Vitamin D into a wart is an effective treatment. The results address the recorded outcome at the stated follow-up, but do not by themselves establish how the intervention performs in other populations or under other treatment procedures.

3. Trial Design

The registry describes a randomized, double-masked, parallel-group phase 2 trial. Participants were assigned to a Vitamin D3 Treatment Group or a Placebo Group, and the arm descriptions state that each group received an injection into a wart. The record lists an enrollment of 77. The posted primary-outcome counts use group sizes of 41 for Vitamin D3 and 36 for placebo.

The study began on 2020-10-20, had a primary completion date of 2023-04-04, and is listed as completed. These dates describe the registry record; they do not give the follow-up duration for each participant. The primary outcome timeframe is stated separately as 24 weeks. The registry also lists regression outcomes at 4 weeks, 8 weeks, and 12 weeks.

Random allocation is relevant because, when implemented and maintained appropriately, it aims to make the groups comparable on average at the start of a trial. Double masking is intended to limit knowledge of assigned treatment from specified parties, but the registry record does not identify which parties were masked or describe how masking was maintained. The record identifies the design as parallel, meaning the group comparison is between participants assigned to the two arms rather than a within-person crossover comparison.

Other design details that would help assess conduct are not reported in the registry record. These include the randomization sequence method, allocation concealment, eligibility criteria, injection dose and schedule, adherence, protocol deviations, and the analysis population. The registry record also does not report the original sample-size justification or trial-specific statistical analysis plan. Those omissions limit what can be concluded about the planned analysis and how closely the posted summary follows it.

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

5. Baseline Characteristics

The table reproduces the baseline characteristics posted in the registry, which describe the participants analysed at baseline and help show whether the randomized groups were comparable.

6. Primary Endpoint

The registry lists the primary outcome as Complete Regression of Wart, measured over 24 weeks.

The primary endpoint is titled Complete Regression of Wart. It measures the number of participants recorded as having a complete resolution of a cutaneous wart, with assessment at 24 weeks. The registry identifies the unit as participants and describes the outcome as a count of participants, making this a binary participant-level endpoint: a participant is counted as having complete regression or is not.

A complete-resolution outcome is useful because it gives a clearly interpretable event for comparing the randomized groups. It distinguishes complete regression from partial change, and its timeframe makes the assessment point explicit. The posted primary results record 12 participants with complete regression in the Vitamin D3 group and 10 in the placebo group. These are event counts, not estimates of the number of warts that resolved.

The endpoint definition available in the registry is brief. It does not explain how complete resolution was assessed, who assessed it, whether assessment was blinded, or how multiple warts in one participant were handled. The record also does not report missing outcome data or the rules used for classifying participants without an assessment. Those details matter because endpoint measurement and missing-data handling can affect the group comparison. The registered outcome therefore supports interpretation of the posted participant counts, while leaving important operational details unreported in the registry record.

7. Results Posted in the Registry

• Vitamin D3 Treatment Group: 29.3% (12/41) versus 27.8% (10/36) on control; risk difference 1.5 percentage points (95% CI -18.7 to 21.7), risk ratio 1.05 (0.52–2.14); unadjusted two-proportion z-test p = 0.885.

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.

Regression of Wart at 4 Weeks

• 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:
  • Vitamin D3 Treatment Group: 4.9% (2/41) versus 5.6% (2/36) on control; risk difference -0.7 percentage points (95% CI -10.7 to 9.3), risk ratio 0.88 (0.13–5.92); unadjusted two-proportion z-test p = 0.894.
• Interpretation:
  • The 95% confidence interval includes no difference, so these data do not show a statistically significant difference between Vitamin D3 Treatment Group and the control. The interval gives the range of effects that remain compatible with the data.

Regression of Wart at 8 Weeks

• 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:
  • Vitamin D3 Treatment Group: 9.8% (4/41) versus 19.4% (7/36) on control; risk difference -9.7 percentage points (95% CI -25.5 to 6.1), risk ratio 0.50 (0.16–1.58); unadjusted two-proportion z-test p = 0.225.
• Interpretation:
  • The 95% confidence interval includes no difference, so these data do not show a statistically significant difference between Vitamin D3 Treatment Group and the control. The interval gives the range of effects that remain compatible with the data.

Regression of Wart at 12 Weeks

• 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:
  • Vitamin D3 Treatment Group: 17.1% (7/41) versus 22.2% (8/36) on control; risk difference -5.1 percentage points (95% CI -23.0 to 12.7), risk ratio 0.77 (0.31–1.91); unadjusted two-proportion z-test p = 0.569.
• Interpretation:
  • The 95% confidence interval includes no difference, so these data do not show a statistically significant difference between Vitamin D3 Treatment Group and the control. The interval gives the range of effects that remain compatible with the data.

The registry lists regression outcomes at 4 weeks, 8 weeks, and 12 weeks. Across these assessments, the direction of the group comparisons is not uniform: the earliest event counts are equal, while at the later assessments the posted counts are greater in the placebo group. The comparative intervals for these secondary outcomes include zero, so the results do not give a precise account of differences between groups at those timepoints.

This overall pattern does not change the primary finding at 24 weeks. The primary and secondary endpoints measure the same general concept of wart regression at different follow-up times, but they are distinct outcome assessments. The secondary results can provide context about the observed course over follow-up; they cannot substitute for the primary endpoint or resolve its uncertainty. Differences in the timing of assessments also mean the results should not be interpreted as a single repeated-measures trajectory, since such an analysis is not reported in the registry record.

Secondary comparisons generally carry less inferential weight when multiple outcomes are examined without a reported plan for controlling multiplicity. Testing or inspecting several outcomes increases the opportunity for chance patterns to appear. The registry record lists no reported analyses and does not describe a multiplicity adjustment, hierarchy, or confirmatory role for the secondary outcomes. Their unadjusted estimates are therefore best treated as exploratory descriptions. They may motivate further study, but should not be presented as independent confirmation of a treatment effect.

The registry also does not explain how repeated assessments were handled, whether the same participants contributed at every timepoint, or how missing outcome data were managed. Those omissions limit comparison across timepoints. The posted pattern is a description of the recorded summaries, not a basis for inferring individual changes or the timing of regression.

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

• Regression of Wart at 4 Weeks
• Regression of Wart at 8 Weeks
• Regression of Wart at 12 Weeks

9. Statistical Interpretation

10. Statistical Methods Explained

What kind of outcome is being compared?

The primary outcome is a binary participant-level event: complete regression was either recorded or not recorded by the 24-week assessment. For this type of outcome, a group can be described by the number of participants with the event and the number assessed. The posted primary counts are 12 of 41 in the Vitamin D3 group and 10 of 36 in the placebo group. The record does not explain whether every enrolled participant had an observed outcome or how missing assessments were handled, so the denominators should be understood as those attached to the posted results rather than as a documented analysis-population definition.

A risk difference expresses the difference between the groups’ event proportions, with the comparison oriented as Vitamin D3 relative to placebo. A value above zero points toward a larger recorded event proportion in the Vitamin D3 group; a value below zero points toward a larger proportion in the placebo group. The posted estimate is 0.015. This scale is directly tied to the difference between the event proportions, but the estimate is uncertain, as indicated by its confidence interval.

What do relative measures add?

The relative risk compares the event proportion in one group with the event proportion in the other. The odds ratio compares event odds rather than event proportions. These are alternative ways to express a binary-outcome comparison, and their numerical values need not match the risk difference because they use different scales. The posted primary relative risk was 1.054, with a confidence interval from 0.518 to 2.143; the odds ratio was 1.076, with a confidence interval from 0.399 to 2.902. Both intervals include values on either side of the no-difference value for their respective scales. When event counts are limited, relative estimates can be especially imprecise, so they should be read with their intervals rather than as stand-alone point estimates.

How should a confidence interval be understood?

A confidence interval communicates uncertainty around an estimated effect under the statistical method used. It is not a guarantee that the true effect lies within the particular interval, and it is not a range of outcomes for individual participants. A narrow interval indicates greater precision on the scale being used; a wide interval indicates less precision. For the primary risk difference, the interval runs from -0.187 to 0.217. Because it spans zero and extends in both directions, the posted estimate does not sharply distinguish a difference favoring one group from a difference favoring the other.

The registry record does not state the confidence-interval construction method or confidence level. In general, intervals can depend on the statistical method, assumptions, and data structure. This matters particularly for binary outcomes when event counts are small, because different methods can yield different interval limits. The posted interval can be interpreted as an uncertainty summary, but its exact construction cannot be reconstructed from the registry record.

What does the p-value say?

A p-value is calculated under a null model and measures how unusual results at least as discrepant as those observed would be under that model and test. It is not the probability that the null hypothesis is true, and it is not the probability that chance alone caused the result. The posted primary unadjusted p-value is 0.885. It should be read with the effect estimate, interval, outcome counts, and limitations of the registry information. The record does not report an adjusted analysis or explain whether this test was the prespecified primary test.

“Unadjusted” indicates that the posted p-value has not been adjusted for the multiple outcomes or comparisons that may have been considered. The registry record does not report a multiplicity procedure. A p-value also does not describe the size or practical importance of an effect; those questions require looking at the estimate, its uncertainty, and a justified threshold for importance. No such threshold is reported in the registry record.

Why can sparse events limit interpretation?

When a binary outcome is recorded for relatively few participants, the estimate can change noticeably with a small change in the event counts. This is a general property of sparse binary data, not a claim about unreported participant-level observations. It can lead to broad intervals and unstable relative measures. The primary outcome has modest event counts in each group, and its posted interval reflects substantial uncertainty. The registry record does not provide individual participant data or additional model-based results that would allow alternative methods to be checked.

For this endpoint, a simple group comparison is understandable because the registry reports counts by randomized group. However, the record does not say whether the comparison was adjusted for baseline characteristics, whether an intention-to-treat population was used, or how protocol deviations and missing outcomes were treated. Such decisions can affect the estimand—the specific treatment contrast the analysis is intended to describe—and therefore affect interpretation. Without those details, the posted summaries are best read as group-level results as recorded, not as a fully documented analysis plan.

Which analysis details remain unknown?

The registry record lists no reported analyses. It does not state the test used for the posted p-value, the confidence-interval method, the handling of missing data, the analysis population, or whether interim analyses were planned or conducted. It also does not report the original sample-size justification. General statistical explanations can clarify what the displayed measures mean, but they cannot fill those gaps. The posted counts and comparisons remain informative descriptions of the registered outcomes, with interpretation bounded by the absence of these methodological details.

11. Confidence Intervals and Precision

The primary risk-difference estimate is 0.015, and the confidence interval extends from -0.187 to 0.217. The interval crosses zero and includes estimates pointing in both directions. It is therefore not precise enough to rule out either a lower or higher event proportion in the Vitamin D3 group relative to placebo. The data are compatible with a range of group differences, rather than establishing that the groups have the same event rate.

The relative measures are also uncertain. The primary relative-risk interval runs from 0.518 to 2.143, and the odds-ratio interval runs from 0.399 to 2.902. Each includes the no-difference value for its measure. Because the risk difference, relative risk, and odds ratio use different scales, their estimates should not be compared as if they represented the same quantity. Each interval describes uncertainty for its own effect measure.

The registry record does not state the confidence level or construction method for these intervals. That limits how specifically their coverage properties can be described. The primary event counts are limited, and the broad ranges are consistent with uncertainty in the group contrast. A confidence interval is not a guarantee about the true effect, and its endpoints should not be treated as the most extreme effects that could occur. Rather, it shows how much uncertainty remains under the calculation used. The record does not report a clinically important difference threshold, so precision cannot be judged against a prespecified clinical margin.

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 illustrations based on the observed effect, not the trial’s original design. The registry record’s stated assumptions are a two-sided significance level of 0.05, equal allocation between the two arms, a normal approximation, and an effect to detect set at the stated fraction of the observed effect. The figures are participants per arm, not total participants or total events.

The 80% power column gives the planned number of participants per arm for a hypothetical study to have an 80% chance of detecting the specified effect under those assumptions, if that effect were the true effect. The 90% power column expresses the corresponding planning target for a 90% chance. These are design calculations, not descriptions of what happened in the completed trial. They are not observed power.

The scenarios use the observed effect and smaller fractions of it. Planning for 75% of the observed effect requires more participants per arm than planning for the full observed effect; planning for 50% requires still more. This follows the general principle that smaller effects are harder to distinguish from random variation, so a study generally needs more information to detect them with the same power. The illustrated values are especially sensitive to the observed estimate: because that estimate is uncertain, it should not be treated as a reliable forecast of the effect a future study would observe.

The trial’s own original sample-size assumptions and justification are not reported in the registry record. These planning calculations therefore should not be read as evidence that the completed trial was designed with these targets, or as a measure of the probability that its result is correct.

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 = 0.278; treatment proportion p₁ = 0.293; average p̄ = 0.285.
2. First term: z_1−α/2 × √[2p̄(1−p̄)] = 1.96 × 0.6386 = 1.2515.
3. Second term: z_1−β × √[p₀(1−p₀) + p₁(1−p₁)] = 0.842 × 0.6385 = 0.5373.
4. n = (1.2515 + 0.5373)² / (0.0149)² = 14,404.3, rounded up to 14,405 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 <- 0.277777777777778                          # control proportion
p1 <- 0.292682926829268                          # 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(4278573)
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 = 14,405 (80% power), 19,283 (90% power)
 75% of observed effect: n per arm = 25,508 (80% power), 34,147 (90% power)
 50% of observed effect: n per arm = 57,165 (80% power), 76,527 (90% power)
power.prop.test: 14404.3 
Simulated power at n = 14,405 per arm: 0.799 (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 record lists one primary outcome and three secondary outcomes, but does not report a statistical analysis plan or a procedure for handling multiplicity. When several outcomes or comparisons are examined, the chance of finding an apparently notable result by chance can increase. Common approaches include designating a single primary comparison, adjusting inference across tests, or explicitly treating additional outcomes as exploratory. Which approach was intended or used is not reported in the registry record.

The posted secondary comparisons are unadjusted. They should not be interpreted as if each had been the sole planned test. The record does not state whether the secondary outcomes were prespecified, whether their order was hierarchical, or whether any adjustment was applied outside the posted summaries. These details matter when deciding how much confirmatory weight to place on individual secondary p-values.

Missing-data handling is also not reported. The registry gives group denominators alongside outcome counts, but does not state whether those denominators represent all randomized participants, participants with available assessments, or another analysis population. It does not report the number of missing assessments, reasons for missingness, imputation methods, or sensitivity analyses. It would therefore be inappropriate to assume that all randomized participants were analyzed or that missing outcomes were handled in a particular way.

The analysis population is not identified as intention-to-treat, per-protocol, or another defined set. The record also does not report treatment adherence, protocol deviations, interim analyses, or a complete trial-specific statistical plan. These are not proof that a particular method was or was not used; they are information gaps in the registry record. As a result, the posted group comparisons can be described, but the exact estimand, multiplicity strategy, and robustness to missing data cannot be fully assessed.

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 0% reporting threshold.

Most frequent non-serious adverse event terms

The serious-adverse-event summary reports zero affected participants in the Vitamin D3 group among 41 at risk and zero in the placebo group among 36 at risk. The death count is 0 in each group. These figures describe the registry’s posted safety counts; they do not establish that no other safety events occurred or that the groups have identical safety profiles.

The record also reports other adverse events affecting 41 participants in the Vitamin D3 group and 36 in the placebo group. It does not list the event terms or explain the severity, timing, duration, or attribution of these other events. The serious adverse-event terms list is empty, so no serious-event descriptions are available in the registry record.

Safety counts depend on how events were defined, collected, and attributed. Those methods are not reported in the registry record. The figures should therefore be read as reported counts, not as a complete account of event types or as evidence of comparative safety. They also do not support medical advice.

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

The posted primary data show 12 participants with complete wart regression in the Vitamin D3 group and 10 in the placebo group at 24 weeks. The risk-difference estimate is 0.015, with a confidence interval from -0.187 to 0.217 and an unadjusted p-value of 0.885. These results describe an estimate close to zero alongside substantial uncertainty. They do not establish a clear direction or a precise size for the difference between the groups.

The results do not prove that there is no difference. The confidence interval includes zero, but also includes effects in either direction. Nor do the results prove that a difference exists. The estimate is one summary of the observed group data, and the interval indicates that the data leave considerable uncertainty. The registry record does not provide a threshold for what size of difference would be important, so the practical importance of the range cannot be determined from the record alone.

The comparison is specific to the registered intervention, placebo procedure, participant population, outcome definition, and follow-up. The registry does not report enough detail to determine how the injection was delivered, how complete regression was assessed, or which analysis population was used. These limitations make it difficult to extend the result beyond the posted trial summary.

The secondary outcomes provide additional timepoint descriptions, but they are unadjusted and do not offer precise evidence of group differences. Safety figures report no serious adverse events or deaths in either group, while the other adverse-event summaries do not provide event terms. These registry data do not constitute a complete safety evaluation. Overall, statistical interpretation should distinguish what was recorded from what remains uncertain. No treatment recommendation follows from this trial summary.

17. Why This Trial Matters Statistically

This trial is statistically informative because it illustrates the difference between a point estimate and the precision of that estimate. The primary risk difference is close to zero, but its confidence interval spans a wide range and includes both directions. Looking only at the point estimate or the unadjusted p-value would miss how much uncertainty remains.

The outcome is binary and the event counts are limited. In that setting, the group-level counts are easy to understand, while relative measures can be sensitive to sparse data. Reporting the event counts alongside risk difference, relative risk, odds ratio, confidence intervals, and a p-value gives readers different views of the comparison. The measures should be interpreted together rather than as competing verdicts.

The registry also illustrates why secondary outcomes and sample-size illustrations require context. Outcomes at multiple timepoints can add descriptive information, but unadjusted results across several assessments are not equivalent to a single confirmatory test. Similarly, planning figures based on an observed effect are hypothetical design aids; they are not evidence about the original design or the completed trial’s observed power.

Finally, statistical interpretation depends on design and analysis details as well as numerical results. The registry identifies randomization, masking, and a parallel design, but leaves the analysis population, missing-data strategy, multiplicity plan, and endpoint assessment procedures unreported. Recognizing these gaps helps separate a useful summary of posted results from claims that the available record cannot support.

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.

Important trial-specific details are absent from the registry record. It does not give eligibility criteria, participant characteristics, wart location or number, Vitamin D3 dose, injection schedule, placebo composition, or procedural details. These omissions limit assessment of how the intervention and comparison were implemented and to whom the results may apply.

The primary endpoint is described as complete resolution of a cutaneous wart, but the assessment method, assessor, and handling of multiple warts per participant are not specified. Missing outcome counts and rules for classifying participants without an assessment are also not reported. Although the trial is described as double-masked, the record does not identify who was masked or how masking was maintained.

The registry lists no reported analyses and does not provide the trial-specific statistical analysis plan. The test behind the posted p-value, confidence-interval method, analysis population, adjustment strategy, and missing-data approach are not described. No original sample-size justification is reported; the displayed planning illustrations use the observed effect and are not the trial’s own design assumptions.

These limitations do not invalidate the posted counts, but they constrain their interpretation. In particular, the data do not allow a full assessment of outcome ascertainment, departures from random assignment, or robustness to missingness and analysis choices. The safety summaries also lack event terms for other adverse events and details of collection or attribution. Conclusions should remain tied to the registry’s reported results and the information gaps in that record.

19. Related Tutorials

20. Related Statistical Calculators

21. Sources

• ClinicalTrials.gov: Intralesional Vitamin D Injection for Treatment of Common Warts — NCT04278573.
• Registry record last updated 2024-04-30; status last verified 2024-04.
• Results first posted 2024-04-30.
• 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

NCT04278573 is listed as a completed, randomized, double-masked, parallel phase 2 trial of intralesional Vitamin D3 versus placebo for common warts. The registry reports enrollment of 77, a start date of 2020-10-20, and a primary completion date of 2023-04-04.

The primary outcome was the number of participants with complete wart regression at 24 weeks. The registry reports 12 events in the Vitamin D3 group and 10 in the placebo group, with a risk difference of 0.015, confidence interval from -0.187 to 0.217, and unadjusted p-value of 0.885. Secondary regression outcomes are listed at 4 weeks, 8 weeks, and 12 weeks.

The serious-adverse-event summary reports zero affected participants and zero deaths in both groups. The record does not report analyses or the trial-specific statistical plan, and it omits details needed to assess missing data, analysis populations, multiplicity, and endpoint procedures. The posted findings therefore describe the registered summaries, with uncertainty and important methodological details unresolved.