This page provides an independent statistical analysis and educational interpretation of publicly reported results. ClinicalTrials.gov provides the official trial registry record. Numerical trial results on this page are restricted to the results posted in the ClinicalTrials.gov record; calculations added by Clinical Biostats are labelled as such.
1. Trial at a Glance
This page covers the registry results for A Comparative Study to Assess Efficacy of Intralesional MMR Vaccine and Intralesional Vitamin D3 in Treatment of Warts (NCT04428359), a randomized na study. The primary outcome is Efficacy of IL MMR and IL Vitamin D3 in Treatment of Warts.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT04428359 |
| Phase | NA |
| Condition | Verruca Viral |
| Allocation | Randomized |
| Design model | Parallel |
| Masking | Single |
| Enrollment | 66 |
| Arms in the primary outcome | n/a |
| Lead sponsor | B.P. Koirala Institute of Health Sciences |
| Results posted | Yes |
2. Clinical Question
Population
People with warts, listed in the registry under Verruca Viral, were the intended population. The primary outcome describes assessment from treatment initiation through the end of a three-month follow-up after treatment was completed. The registry record does not report further eligibility criteria or a detailed description of the primary-outcome population.
Intervention
Group A was assigned intralesional measles, mumps, and rubella vaccine, abbreviated MMR. The study summary describes an injection of 0.5 ml into a single wart, or a maximum of 5 warts at a time for people with multiple warts. Injections were planned every 3 weeks for a maximum of 5 doses.
Comparator
Group B was assigned intralesional vitamin D3. The summary describes the same stated volume, target-wart approach, injection interval, and maximum number of doses as for MMR. The record does not report whether participants or outcome assessors knew which treatment was assigned; it identifies masking as single without specifying who was masked.
Primary question
The trial aimed to compare complete response to intralesional MMR and intralesional vitamin D3. Complete response was defined as disappearance of warts, including distant ones, with normal skin texture restored at the site. Although the registry lists a primary outcome and response categories, a comparative result is not reported in the registry record.
3. Trial Design
The registry identifies NCT04428359 as a randomized, single-masked, parallel-group study. It lists the phase as NA, the condition as Verruca Viral, and B.P. Koirala Institute of Health Sciences as sponsor. The recorded enrollment is 66. The study summary, by contrast, describes a planned total of 60 patients, with 30 in each group. These figures describe different pieces of registry information; the record does not explain the difference or report the final number analyzed for the primary outcome.
The two groups received intralesional MMR vaccine or intralesional vitamin D3. The summary describes 0.5 ml injections, given every 3 weeks for a maximum of 5 doses. For multiple warts, injections could be given into a maximum of 5 at a time. These are descriptions in the study summary, not confirmation that every participant received the full planned schedule.
The recorded start date is 2020-06-01 and primary completion date is 2021-01-15. The status is COMPLETED. The primary outcome timeframe runs from starting treatment to the end of three months of follow-up after completing treatment. The registry describes the allocation as randomized but does not report the randomization sequence method, allocation concealment, or details of the masking procedure.
The record lists secondary outcomes concerning education level, occupation, duration, and the effect of warts on quality of life as assessed by the Dermatological Life Quality Index. It does not report results for those measures. A sample-size justification, any interim analyses, and a detailed statistical analysis plan are not reported in the registry record.
4. Participant Flow and Accounting
The registry reports how participants moved through each stage of the study. All counts below are exactly as posted; missing counts are not inferred from other stages.
Overall Study
| Stage | Measles, Mumps, Rubella Vaccine | Vitamin D3 |
|---|---|---|
| STARTED | 33 | 33 |
| COMPLETED | 31 | 30 |
| NOT COMPLETED | 2 | 3 |
5. Baseline Characteristics
The table reproduces the baseline characteristics posted in the registry, which describe the participants analysed at baseline and help show whether the randomized groups were comparable.
| Characteristic | Unit | Measles, Mumps, Rubella Vaccine | Vitamin D3 | Total |
|---|---|---|---|---|
| Participants analysed | 31 | 30 | 61 | |
| Age, Continuous | years | 22.32 (SD 11.167) | 23.93 (SD 8.383) | 23.11 (SD 9.847) |
| Sex: Female, Male: Female | Participants | 16 | 14 | 30 |
| Sex: Female, Male: Male | Participants | 15 | 16 | 31 |
| Race/Ethnicity, Customized: Brahmin/ Chhetri | Participants | 9 | 9 | 18 |
| Race/Ethnicity, Customized: Madhesi | Participants | 2 | 5 | 7 |
| Race/Ethnicity, Customized: Janajati | Participants | 18 | 14 | 32 |
| Race/Ethnicity, Customized: Others | Participants | 2 | 2 | 4 |
| Region of Enrollment: Nepal | participants | 31 | 30 | 31 |
| ITT population | Participants | 31 | 30 | 61 |
6. Primary Endpoint
The registry lists the primary outcome as Efficacy of IL MMR and IL Vitamin D3 in Treatment of Warts, measured over Starting of treatment to end of three months follow-up after completing treatment.
| Element | Registry entry |
|---|---|
| Result type | Count Of Participants |
| Measure of spread | not applicable |
| Unit | Participants |
| Endpoint classification | Binary Endpoint |
The primary outcome is titled Efficacy of IL MMR and IL Vitamin D3 in Treatment of Warts. It concerns the number of participants in response categories, with the description emphasizing the percentage of patients showing complete response. Complete response requires disappearance of warts, including distant warts, and restoration of normal skin texture at the site.
The registry also defines three less complete response categories. Excellent response means a reduction in size and number, including distant warts, with a few residual warts still visible. Good response means some reduction in size, including distant warts, but no decrease in the number of warts. Poor or no response means no significant change in size and number. The record associates these categories with ranges of response, but does not report how many participants fell into each category in either group.
A categorical outcome can preserve distinctions between complete clearance and partial or absent change, rather than compressing all participants into a single continuous measure. That can make the endpoint clinically interpretable, but comparisons need to account for the categories and their ordering. General statistical point: an outcome defined by a participant’s status at follow-up depends on the timing and completeness of assessment. The registry specifies a follow-up timeframe, but the assessment schedule, handling of missing observations, and primary analysis are not reported in the registry record.
Because the outcome includes several categories and the record gives no group-level response counts or analysis, an effect estimate and its precision cannot be described. The primary result is not reported in the registry record.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry describes a randomized comparison of two intralesional treatments and defines a response outcome, but it does not report the group-level primary outcome results or a statistical comparison. Consequently, the relative response observed in the trial, the size of any difference, and the precision of an estimate are not reported in the registry record. No conclusion about comparative efficacy can be drawn from the information recorded for this outcome.
The listed enrollment is 66, while the study summary says 60 patients were planned, 30 in each group. The registry does not explain this difference. The safety entries list 31 participants at risk in the MMR group and 30 in the vitamin D3 group, but those figures alone do not establish the number included in the primary analysis. The primary analysis population and participant flow are not reported in the registry record.
General statistical point: a treatment comparison is more informative when it includes an effect estimate alongside a confidence interval. An estimate describes the observed difference under the chosen analysis, while a confidence interval conveys uncertainty compatible with the data and model. A p-value, if reported, addresses compatibility with a specified null hypothesis; it does not by itself describe effect size or precision. None of these primary comparison statistics is reported in the registry record.
The response definition distinguishes complete, excellent, good, and poor or no response. Reducing a multi-category outcome to a single comparison would require a specified approach, such as comparing the distribution across categories or defining a particular threshold as success. The registry record does not report such an analysis. Its outcome information does not establish which category was used for a statistical comparison or how the category ordering was handled.
There is also no reported adjustment for baseline characteristics, no stated method for handling missing outcomes, and no analysis population definition. Randomized allocation is intended to support a fair comparison, but interpretation still depends on how assignment, follow-up, and analysis were implemented. Details of those procedures are not reported in the registry record. The available entry therefore documents the trial question and outcome definitions more clearly than it documents the evidence needed to assess the comparative result.
9. Statistical Methods Explained
What does randomization contribute?
The registry identifies the study as randomized. General statistical explanation: randomization assigns participants to groups using chance, with the aim of making the groups comparable on average at the start of a study. It can reduce systematic differences in measured and unmeasured characteristics, but it does not guarantee identical groups, particularly in a study of limited size. The method used to generate the assignment sequence and the method used to conceal assignments are not reported in the registry record.
What does a parallel-group design mean?
The record describes a parallel design: participants are assigned to one group and receive that group’s intervention rather than crossing over between treatments. A comparison in such a design generally uses outcomes from the two groups over the defined follow-up period. The registry identifies single masking but does not specify whether participants, clinicians, outcome assessors, or another group were masked. Masking details matter because knowledge of assignment can influence treatment delivery or outcome assessment, especially when response categories involve clinical judgment.
How should a categorical endpoint be analyzed?
The response outcome has four ordered descriptions: complete, excellent, good, and poor or no response. General statistical explanation: categorical data are counts of participants in distinct groups. For an ordered outcome, an analysis might compare the full distribution or use a prespecified threshold to distinguish response levels. Different choices answer different questions. A complete-response comparison focuses on the strictest category; a comparison across all categories uses more of the outcome information but relies on a method suited to the category structure. The statistical method selected for this trial is not reported in the registry record, and the primary outcome is not reduced to a single comparison.
What do estimates and confidence intervals communicate?
General statistical explanation: an effect estimate describes the size and direction of a contrast between groups. A confidence interval gives a range of values compatible with the observed data under the statistical model and its assumptions. A narrow interval indicates greater precision than a wide interval, but precision does not establish that an effect is important. A p-value is another summary, conventionally assessed against a prespecified significance level, but it is not a measure of the probability that a treatment works. The registry record does not report a primary effect estimate, confidence interval, or p-value.
Why do missing outcomes matter?
General statistical explanation: if outcome status is unavailable for some randomized participants, the analysis can depend on why those outcomes are missing and how missingness is handled. Excluding participants with missing data can lead to a biased comparison if their outcomes differ systematically from those observed. Other approaches require assumptions that should be described. The numbers with primary outcome data, reasons for missingness, and analysis method are not reported in the registry record.
What can be said about sample-size planning?
The registry includes a planning illustration based on the observed effect, with two-sided significance level 0.05, equal allocation, and a normal approximation; the stated effect to detect is a fraction of the observed effect. The record does not provide the calculated participant counts in the information available for this analysis. The trial’s own sample-size justification is not reported in the registry record. General statistical explanation: such planning figures are conditional on assumptions about the target effect, variability or event frequency, significance level, and desired power. They are planning illustrations, not observed power and not evidence that a study has detected an effect.
The registry record does not state whether any interim analysis was planned or conducted. It also does not report a full statistical analysis plan, including the model, test, handling of the ordered categories, or adjustment for baseline variables. Without these details and the primary outcome data, the analysis methods and their assumptions cannot be evaluated from the registry entry.
10. Multiplicity, Missing Data and Analysis Populations
The record lists a primary outcome with multiple response categories and several secondary outcomes. It does not report a single primary contrast across the categories or an analysis that compares the full distribution. The primary outcome is not reduced to one comparison in the registry record. Therefore, the precise hypothesis test, if any, used for the primary outcome is not reported in the registry record.
General statistical explanation: testing several outcomes or several contrasts increases the chance of finding at least one apparently unusual result by chance if each test is assessed separately. A statistical plan can address this by identifying a primary hypothesis in advance and specifying whether and how other tests will be adjusted or treated as exploratory. A multiplicity strategy is not reported in the registry record. The number of analyses listed is zero, so no analysis-specific comparison is available to interpret.
The entry does not report the number of participants with observed primary outcomes, losses to follow-up, reasons for missingness, or a method for handling missing data. It also does not define whether the primary analysis included everyone according to randomized assignment, only participants who completed treatment, or another population. These analysis-population details are not reported in the registry record.
General statistical explanation: an intention-to-treat analysis typically retains participants in their randomized groups, while a per-protocol analysis applies specified criteria concerning treatment or follow-up. Neither label alone resolves missing-outcome problems; the analysis population and assumptions need to be stated. The registry does not identify which approach was used. With no reported primary outcome counts or analysis description, the effects of missing data, analysis choices, and multiple comparisons cannot be assessed.
11. Safety Results
The registry reports serious adverse events as affected participants divided by participants at risk.
| Arm | Participants with serious adverse events | Participants at risk | Percentage |
|---|---|---|---|
| Measles, Mumps, Rubella Vaccine | 0 | 31 | 0.0% |
| Vitamin D3 | 6 | 30 | 20.0% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| Measles, Mumps, Rubella Vaccine | 0 of 31 |
| Vitamin D3 | 0 of 30 |
Other (non-serious) adverse events
Participants with at least one non-serious event at or above the registry's 5% reporting threshold.
| Arm | Participants affected of at risk |
|---|---|
| Measles, Mumps, Rubella Vaccine | 31 of 31 |
| Vitamin D3 | 30 of 30 |
Most frequent serious adverse event terms
| Event term | Organ system | Measles, Mumps, Rubella Vaccine | Vitamin D3 |
|---|---|---|---|
| Hypervitaminosis D | Renal and urinary disorders | 0 of 31 | 6 of 30 |
Most frequent non-serious adverse event terms
| Event term | Organ system | Measles, Mumps, Rubella Vaccine | Vitamin D3 |
|---|---|---|---|
| Pain | Skin and subcutaneous tissue disorders | 31 of 31 | 30 of 30 |
| Swelling | Skin and subcutaneous tissue disorders | 0 of 31 | 18 of 30 |
| Hyperpigmentation | Skin and subcutaneous tissue disorders | 1 of 31 | 9 of 30 |
| Pruritus | Skin and subcutaneous tissue disorders | 1 of 31 | 5 of 30 |
| Hypopigmentation | Skin and subcutaneous tissue disorders | 2 of 31 | 2 of 30 |
Serious events with the highest arm-level rate: hypervitaminosis d (20.0%).
The safety entries list 31 participants at risk in the MMR group and 30 in the vitamin D3 group. Serious adverse events affected 0 participants in the MMR group and 6 in the vitamin D3 group. Deaths are recorded as 0 in each group. The registry also lists 31 participants with other events in the MMR group and 30 in the vitamin D3 group.
The record does not define the distinction between the serious-event and other-event counts in enough detail to interpret the latter as a particular type of event, nor does it describe event ascertainment, severity grading beyond the serious-event designation, or causal attribution. These details are not reported in the registry record. The entry lists Hypervitaminosis D at 20.0% among the top serious terms. That listing does not, on its own, establish how many participants experienced that term or whether an event was judged related to treatment.
General statistical explanation: event counts are descriptive and should be read with their denominators, definitions, follow-up period, and ascertainment methods in mind. A count alone does not establish a comparative risk or explain whether an event was caused by an intervention. No adjusted safety comparison or uncertainty estimate is reported in the registry record. These figures describe the registry’s recorded safety entries and do not replace the missing details about event definitions and analysis.
12. What the Result Does, and Does Not, Mean
The registry record establishes that a randomized, single-masked, parallel-group study compared intralesional MMR vaccine with intralesional vitamin D3 for warts. It gives a planned treatment schedule and defines complete, excellent, good, and poor or no response. It also records enrollment of 66 and provides some safety counts. These details describe the intended comparison and parts of the recorded study information.
The primary outcome results are not reported in the registry record. There are no response counts by group, no reported contrast between groups, and no confidence interval or p-value for that outcome. The available information therefore does not show the direction or size of a primary-outcome difference, or how precisely such a difference was estimated. It cannot establish that either treatment was better than the other on the primary endpoint.
The safety entries show the recorded serious-event counts and deaths, but they do not provide the definitions, attribution, or analysis needed to explain those counts fully. The other-event counts and the listed serious term should not be treated as a complete account of safety without those details. A recorded count is not by itself evidence of causation.
General statistical point: a trial’s design can support a fair comparison, but the interpretation of results also depends on complete outcome reporting, a prespecified analysis, participant follow-up, and the precision of estimates. Those elements are not fully documented in the registry record. The difference between planned enrollment in the summary and recorded enrollment is not explained, and the primary analysis population is not reported.
Accordingly, the record is informative about the study question, interventions, and response definitions, but does not provide enough primary outcome evidence to quantify or interpret a comparative treatment effect. No medical recommendation follows from these registry entries.
13. Why This Trial Matters Statistically
This trial is statistically relevant because it poses a direct comparison between two interventions and uses random allocation, which is intended to support a fair group comparison. Its endpoint also illustrates an important analysis issue: response is described through several ordered categories rather than a single reported binary result. The choice to compare complete response alone or use the full category distribution changes the question being answered.
The registry’s distinction between planned enrollment and recorded enrollment is another practical point. The summary describes a planned total of 60 patients, with 30 in each group, while recorded enrollment is 66. The record does not explain the difference, and the safety entries do not establish the primary analysis population. Clear participant flow and group-specific outcome counts are needed to connect enrollment to the analysis.
For statistical interpretation, a result is more useful when it includes an effect estimate and uncertainty, along with an explanation of the analysis population and missing-data approach. Those primary comparison details are not reported in the registry record. Without them, a reader cannot judge either the magnitude or precision of the endpoint comparison, nor assess whether the analysis matched the defined response categories.
The entry also lists multiple secondary outcomes and safety information, but does not report an analysis plan addressing multiplicity or details of event definitions and attribution. These omissions matter because interpreting several outcomes and adverse-event counts requires knowing how they were collected and analyzed. The study therefore highlights that a clear research question and outcome definition are important, but do not by themselves provide the evidence needed to assess a comparative result.
14. Limitations
- The posted summary statistics are the only data these results rest on; patient-level data, full protocols and statistical analysis plans are not available.
- Recalculated results are simple, unadjusted calculations from posted summaries. They do not replace the sponsor's prespecified analysis.
Several trial-specific details needed to evaluate the primary comparison are not reported in the registry record. These include response counts by group, the primary effect estimate, its uncertainty, the statistical test or model, and the analysis population. The record defines response categories but does not say how they were combined or compared analytically.
The summary’s planned enrollment is 60, with 30 in each group, while the recorded enrollment is 66. The reason for this difference is not reported in the registry record. The safety entries list 31 participants at risk in the MMR group and 30 in the vitamin D3 group, but participant flow and the number with primary outcome data are not given. The record does not explain whether all randomized participants completed follow-up or how missing assessments were handled.
Masking is identified as single, but the people who were masked and the procedures used to maintain masking are not reported in the registry record. Randomization is recorded, but sequence generation and allocation concealment details are also not reported. The registry does not provide a full statistical analysis plan, a multiplicity approach, or a sample-size justification for the trial itself. Whether interim analyses occurred is not reported in the registry record.
Safety interpretation is limited by the absence of detailed event definitions, ascertainment methods, follow-up information for safety, and causal assessments. The listed serious term does not provide enough context to interpret its frequency or relationship to treatment. These reporting gaps limit assessment of both the primary comparison and the safety entries; they do not establish that the trial procedures were absent, only that their details are not reported in the registry record.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: A Comparative Study to Assess Efficacy of Intralesional MMR Vaccine and Intralesional Vitamin D3 in Treatment of Warts — NCT04428359.
- Registry record last updated 2021-04-09; status last verified 2021-04.
- Results first posted 2021-04-09.
- Data retrieved from ClinicalTrials.gov on 2026-11-09.
- Group sizes, means, event counts and sponsor-reported p-values are reproduced as posted. Effect estimates, confidence intervals and p-values not attributed to the sponsor are independently calculated from the posted summary statistics.
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18. Record Summary
NCT04428359 is a completed randomized, single-masked, parallel-group study sponsored by B.P. Koirala Institute of Health Sciences. It compares intralesional MMR vaccine with intralesional vitamin D3 for warts. The recorded enrollment is 66; the study summary describes 60 planned participants, 30 per group. The recorded study start is 2020-06-01, and primary completion is 2021-01-15.
The primary outcome concerns response from treatment initiation through the end of three months of follow-up after treatment. Response categories range from complete response to poor or no response. The registry record does not report group-level primary outcome results or a statistical comparison. It lists secondary outcomes concerning education, occupation, duration, and quality of life, but their results are not reported in the registry record.
Safety entries record serious adverse events affecting 0 participants in the MMR group and 6 in the vitamin D3 group, with 0 deaths in each group. Further detail needed to interpret those event counts is not reported in the registry record.