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 Ketoconazole Foam 2% for the Treatment of Versicolor (NCT00830388), a na phase 4 study. The primary outcome is The Effect of Ketoconazole 2% Foam for the Treatment of Tinea Versicolor.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT00830388 |
| Phase | Phase 4 |
| Condition | Tinea Versicolor |
| Allocation | Not applicable (single group) |
| Design model | Single Group |
| Masking | None (open label) |
| Enrollment | 11 |
| Arms in the primary outcome | n/a |
| Lead sponsor | Boni Elewski, MD |
| Results posted | Yes |
2. Clinical Question
Population
Adults with a clinical diagnosis of tinea versicolor and a positive potassium hydroxide test using calcofluor were the intended population. The brief summary describes ten adults age 19 and older, while the primary outcome description says eleven participants were tested. The record does not reconcile these counts.
Intervention
The intervention was ketoconazole 2% foam. The study is described as open-label, so participants and study personnel were not masked according to the registry entry.
Comparator
No comparator group is reported. The registry identifies a single-group study and gives allocation as not applicable. There is therefore no concurrent control result for a like-for-like comparison.
Primary question
The primary question concerns the number of participants with yeast still present microscopically at four weeks. The description says participants were tested and retested, with a positive result defined by continued microscopic presence of yeast. The actual number positive at follow-up is not reported in the registry record.
This setup addresses whether a microscopic finding was assessed after use of the foam in the enrolled study group. It does not directly estimate a contrast against no treatment or another intervention, because no comparator is reported. Without the actual follow-up outcome count, the result cannot be characterized as showing how many participants had persistent yeast, nor can a change from the initial assessment be described.
The record lists tinea versicolor as the condition and ketoconazole 2% foam as the drug intervention. The brief summary also names safety and satisfaction as objectives, while the listed secondary outcome concerns safety based on adverse-event occurrence. A satisfaction outcome result is not reported in the registry record. The population description and the discrepancy between ten and eleven participants warrant caution in interpreting any count or denominator.
3. Trial Design
The registry describes a completed phase 4 study with a single-group model and open-label conduct. Allocation is listed as not applicable. These features indicate that the posted record does not describe randomized assignment or a masked comparison. The intervention listed is ketoconazole 2% foam, and the arm description identifies the study as open-label.
The enrollment field reports 11 participants. The brief summary, however, describes ten adult patients age 19 and older, while the primary outcome description says eleven participants were tested and retested. The record does not explain this difference. It is therefore important not to treat the brief summary and enrollment field as a consistent account of the number evaluated.
The recorded start was 2008-11, primary completion was 2010-08, and status is completed. The primary endpoint timeframe is four weeks. The registry does not report additional visit timing or a fuller schedule of assessments. Its primary outcome description says participants were tested for microscopic yeast and retested at four weeks; a continuing microscopic presence counted as positive.
The study design can describe observations in the treated group, but it does not supply a treatment-versus-control contrast. In general, a concurrent comparator helps distinguish an intervention-associated pattern from changes that might also occur over time or under other conditions. That distinction cannot be assessed from a single-group record. The registry record does not report a protocol justification for the design, the planned sample-size rationale, interim analyses, or a statistical analysis plan. The fact that the study is phase 4 does not, by itself, fill in those missing design details.
The listed secondary outcome addresses safety through adverse-event occurrence. The brief summary additionally refers to satisfaction, but the posted outcome information does not give a satisfaction result. There are 2 outcome measures listed and 0 analyses listed in the record. The latter means the registry entry does not provide an analysis record from which a formal treatment estimate or inferential result can be described.
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 | Ketoconazole 2% Foam |
|---|---|
| STARTED | 11 |
| COMPLETED | 11 |
| NOT COMPLETED | 0 |
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 | Ketoconazole 2% Foam |
|---|---|---|
| Participants analysed | 11 | |
| Age, Categorical: <=18 years | Participants | 0 |
| Age, Categorical: Between 18 and 65 years | Participants | 11 |
| Age, Categorical: >=65 years | Participants | 0 |
| Sex: Female, Male: Female | Participants | 8 |
| Sex: Female, Male: Male | Participants | 3 |
| Region of Enrollment: United States | participants | 11 |
6. Primary Endpoint
The registry lists the primary outcome as The Effect of Ketoconazole 2% Foam for the Treatment of Tinea Versicolor, measured over 4 weeks.
| Element | Registry entry |
|---|---|
| Result type | Number |
| Measure of spread | not applicable |
| Unit | participants |
| Endpoint classification | Binary Endpoint |
The primary endpoint is a participant-level count: participants are classified according to whether yeast remains detectable microscopically at four weeks. The registry defines a positive result as continued microscopic presence of yeast at the follow-up assessment. This is a binary outcome for each participant, even though the reported measure is a number of participants.
A binary endpoint can make a finding straightforward to interpret when the number assessed and the number meeting the definition are both reported. It can distinguish participants with a positive follow-up test from those without one. In this record, the assessment procedure is described, but the count with a positive result is not reported in the registry record. No count of participants without a positive result is reported either. Thus, the outcome definition is available, but the observed endpoint result is not.
Microscopic presence of yeast is the specified measure; the record does not state that this endpoint represents symptom relief, a patient-reported assessment, or satisfaction. Those are distinct kinds of outcomes and should not be substituted for the microscopic endpoint. The brief summary names satisfaction among the study aims, but a satisfaction measure or result is not reported in the registry record.
For a single-group study, the endpoint can describe the status of the participants assessed after treatment. Without a comparison group and the actual outcome count, it cannot establish how the result differs from an alternative. The registry describes eleven participants as tested, but the brief summary says ten; this unresolved discrepancy further limits interpretation of the assessment denominator.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry record establishes that the study was completed and that a microscopic yeast assessment was described at four weeks. It does not report the number of participants who remained positive at that assessment. Consequently, the primary outcome cannot be quantified from the posted record. No treatment effect estimate, confidence interval, or primary-outcome p-value is reported in the registry record, and 0 analyses are listed.
This distinction matters because an endpoint definition is not itself an outcome result. The record explains what counted as positive, but it does not give the observed count meeting that definition. Without that count and a clear denominator, readers cannot describe the frequency of persistent microscopic yeast in the assessed group. The inconsistency between the brief summary's ten patients and the primary description's eleven tested participants adds uncertainty about the population represented by the outcome description.
The study is single-group and open-label, with no comparator reported. A follow-up observation in one treated group does not provide the same information as a contrast between treatment groups. In general, a comparator can help account for the fact that outcomes may change over time for reasons other than the intervention. This record cannot separate such possibilities through a concurrent control comparison. Open-label conduct also means that the record does not describe masking; for a laboratory-defined endpoint, the degree to which that affects measurement depends on procedures not reported in the registry record.
The safety figures report 0 serious adverse events among 11 at risk and 0 other adverse events among 11 at risk. These are the recorded counts and should not be converted into a broader conclusion that no harm was possible or that all safety outcomes were fully captured. The registry does not report deaths in the corresponding field; that absence is not a reported zero. The listed secondary outcome concerns adverse events, but detail about monitoring, event definitions, or completeness of follow-up is not reported in the registry record.
Sample-size figures, if read alongside this record, are planning illustrations rather than evidence about the trial's observed power. The stated illustration assumptions refer to a two-arm design with equal allocation, while the trial itself is described as single-group. Those hypothetical calculations should not be interpreted as a description of the study's design or a substitute for an outcome analysis. The registry does not report the trial's own sample-size justification or a statistical analysis plan.
The defensible interpretation is therefore limited: the record describes a small, open-label, single-group study and specifies a four-week microscopic endpoint, but does not post the primary result. It supports neither a numerical estimate of the endpoint nor a comparative efficacy conclusion. The absence of a posted result should be distinguished from a finding of no effect.
9. Statistical Methods Explained
The outcome is described as a number of participants, with positive status assigned when yeast continued to be present microscopically at four weeks. This is a count of participants meeting a binary definition. The registry specifies the assessment rule, but it does not provide the observed count. No inferential analysis is listed, so there is no reported estimate or test result to interpret.
What does a confidence interval communicate?
As a general statistical concept, a confidence interval expresses uncertainty around an estimated quantity under the assumptions of the method used. A narrow interval indicates greater precision than a wide interval, while a wide interval indicates that the data are compatible with a broader range of values. An interval is not a guarantee that the true value lies within its limits, and it does not by itself establish whether an effect is important. No confidence interval for the primary outcome is reported in the registry record.
What would a comparison add?
In general, a comparison group allows an analysis to estimate a difference between groups under the study design and analysis assumptions. A single-group study instead describes the observed outcome in the group assessed. It cannot directly show how that outcome compares with what would have happened in a control group. This distinction is especially relevant when the only reported endpoint is a follow-up status and no baseline outcome count or comparator result is posted. The registry identifies a single-group model and does not report a control arm.
How should a p-value be read?
In general, a p-value measures how incompatible the observed data are with a specified null model, under the assumptions of the test. It is not the probability that the null hypothesis is true, and it does not measure the size or practical importance of an effect. A p-value also cannot correct design limitations such as the absence of a comparator or missing outcome reporting. No primary-outcome p-value or analysis is reported in this registry record.
The sample-size assumptions describe a planning illustration using a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation. The stated effect to detect is a fraction of the observed effect. These are assumptions for hypothetical planning calculations, not evidence about the trial's own analysis. The record describes the actual study as single-group, so equal allocation between two arms is not a description of its design. The sample-size justification used by the study is not reported in the registry record.
In general, a planning calculation asks how many participants a future study might need under specified assumptions about the target effect, variability, allocation, and error rates. The answer can change when those assumptions change. A planning illustration based on an observed effect is not observed power, and it does not establish that the original study was adequately sized. No numerical planning output is needed to interpret the central limitation: the primary outcome count is not posted, and no primary analysis is listed.
Why does the count and denominator matter?
For a binary participant-level endpoint, interpretation requires knowing how many participants met the positive definition and how many were assessed. The record says eleven participants were tested and retested in the primary description, but the brief summary describes ten patients and the enrollment field reports 11. The discrepancy is unresolved. Missing follow-up data, if any, would also affect the denominator and could bias a descriptive result if the participants without observed outcomes differed from those assessed. Whether any such missingness occurred is not reported in the registry record.
Over-dispersion is a general concern for count outcomes when observed variability exceeds what a chosen probability model assumes. It is not possible to assess that issue for the primary endpoint from this record: the participant-level positive count and an analysis are absent, and the endpoint is described as a count arising from binary status rather than a repeated event total. The registry does not report a model, variance estimate, or diagnostic assessment. No particular statistical test or model should be inferred from the endpoint description alone.
Similarly, the registry record does not report whether the primary analysis was intended to follow an intention-to-treat, per-protocol, or other analysis population. Those labels describe different rules for deciding which participants contribute to an analysis; they cannot be assigned without the study's stated plan and participant-flow information. The record's outcome description and safety counts do not establish which participants were included in a primary efficacy analysis.
Overall, the methods information supports explaining the endpoint and the limits of possible inference, but not reconstructing the sponsor's analysis. The record lists 0 analyses and provides no primary result, confidence interval, or p-value. A statistical method should not be attributed to the study unless it is reported.
10. Multiplicity, Missing Data and Analysis Populations
The registry lists 2 outcome measures and 0 analyses. It does not report how the outcomes were ordered for inferential testing, whether any multiplicity adjustment was planned, or whether a primary analysis hierarchy was used. The primary endpoint is identified by title and timeframe, and a secondary safety outcome is described, but this alone does not establish a statistical testing strategy.
In general, testing several outcomes can increase the chance of at least one apparently unusual result when each is considered separately. A prespecified hierarchy or adjustment can address that issue, but the approach depends on the study plan. Since no analysis plan or analysis result is reported in the registry record, multiplicity handling cannot be assessed. The brief summary also mentions satisfaction, but the posted outcomes do not provide a satisfaction result or analysis.
Missing-data handling is not reported in the registry record. The primary outcome description says participants were retested at four weeks, yet it does not give a follow-up completion count or describe what was done if a result was unavailable. The mismatch between ten patients in the brief summary and eleven tested participants in the primary description makes a clear accounting especially important, but the record does not provide one.
In general, missing outcomes can affect both the denominator and the interpretation of an observed proportion. Excluding participants without a follow-up result can produce a different description from an analysis that makes explicit assumptions about those missing results. No such approach can be attributed to this study from the posted information.
The analysis population is also not reported in the registry record. There is no stated intention-to-treat, per-protocol, or other analysis set, and no participant flow that resolves how enrollment relates to the outcome description. Accordingly, no population-specific primary estimate can be reconstructed.
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 |
|---|---|---|---|
| Ketoconazole 2% Foam | 0 | 11 | 0.0% |
Other (non-serious) adverse events
Participants with at least one non-serious event at or above the registry's 0% reporting threshold.
| Arm | Participants affected of at risk |
|---|---|
| Ketoconazole 2% Foam | 0 of 11 |
The safety figures report 0 serious adverse events among 11 participants at risk and 0 other adverse events among 11 participants at risk. These are the posted event counts for the ketoconazole 2% foam group. They describe what the registry reports for the recorded safety categories; they do not provide a detailed account of event definitions, monitoring procedures, or the completeness of follow-up.
A count of zero in a study group does not prove that an event is impossible or that a treatment is free of risk. In general, the precision of a safety estimate depends on the amount and quality of follow-up as well as the number of observations. The record does not provide a safety confidence interval or a more detailed analysis. It also does not report deaths in the deaths field, so that item should be read as not reported in the registry record, not as a reported count of zero.
The secondary outcome description says safety was to be assessed based on adverse-event occurrence. The posted figures are therefore relevant to the stated safety objective, but they do not by themselves establish how completely adverse events were ascertained. The registry does not report a comparator group, so these figures cannot support a comparative safety estimate against another intervention or control condition.
12. What the Result Does, and Does Not, Mean
The record documents a completed, open-label, single-group study of ketoconazole 2% foam for tinea versicolor. It describes a microscopic yeast assessment at four weeks and defines a positive result as continued microscopic presence of yeast. It does not report the number positive at follow-up, so the primary endpoint result cannot be stated from the registry record.
This missing outcome count means that the record does not establish the observed frequency of persistent yeast in the group, the precision of that frequency, or a change from an earlier assessment. The description that participants were tested and retested explains the assessment process, not its result. The conflicting participant counts—ten in the brief summary and eleven in the enrollment field and primary outcome description—also prevent a clear account of the assessed population.
The absence of a comparator means the record cannot provide a treatment-versus-control estimate. A single-group observation can describe what was recorded in that group, but it cannot isolate an intervention effect from other possible influences over time. The registry also does not post an analysis plan or primary analysis. Therefore, neither a numerical treatment effect nor a statistical significance conclusion is available.
The safety entry reports zero serious adverse events and zero other adverse events in the group, with 11 participants at risk in each category. These figures are limited to the recorded event categories and do not establish that all possible harms were absent. Deaths are not reported in the registry record. A satisfaction result is also not reported, despite satisfaction being mentioned in the brief summary.
These limits do not mean the study found no effect; they mean that the necessary primary result and comparative evidence are not posted. The study record supplies information about the design, assessment definition, and recorded safety counts, but it is insufficient for a quantitative efficacy interpretation. Conclusions should remain confined to those details.
13. Why This Trial Matters Statistically
This record illustrates why an endpoint definition and an endpoint result must be distinguished. The registry explains that persistent microscopic yeast at four weeks counted as positive, but does not give the number meeting that definition. Without the result count, readers cannot calculate or interpret an observed endpoint frequency from the posted record.
It also shows why participant accounting matters. The brief summary describes ten patients, while the enrollment field and primary outcome description refer to 11 participants. The record does not explain the difference. Such a mismatch can complicate even a simple descriptive interpretation because readers need to know which participants were assessed and which denominator applies.
The single-group, open-label design is another important statistical feature. It provides no concurrent control comparison, so an outcome description in the treated group would not by itself identify what would have happened under another condition. Recognizing this boundary helps prevent a within-group observation from being read as a controlled treatment effect.
Finally, the registry lists 0 analyses and does not report a statistical analysis plan, primary result, or satisfaction result. This makes clear that registration details, outcome definitions, and analysis results are different kinds of information. A completed status does not ensure that every result is available in the registry. The safety counts offer a limited descriptive record, but not a full comparative safety analysis. Statistically, the main lesson is to separate what the design specifies from what the posted results actually quantify.
14. Limitations
- The posted summary statistics are the only data these results rest on; patient-level data, full protocols and statistical analysis plans are not available.
- Recalculated results are simple, unadjusted calculations from posted summaries. They do not replace the sponsor's prespecified analysis.
The primary limitation is that the registry describes the endpoint but does not report its observed result. The number of participants positive for microscopic yeast at four weeks is not reported in the registry record, and 0 analyses are listed. A numerical primary estimate or inferential conclusion therefore cannot be recovered.
The participant counts are inconsistent: the brief summary describes ten adults, the enrollment field reports 11, and the primary outcome description says eleven participants were tested and retested. The record does not reconcile the difference or give a participant-flow account. This leaves uncertainty about the population represented by the outcome description.
The study is single-group and open-label, with allocation listed as not applicable and no comparator reported. It therefore cannot provide a randomized or concurrent-control contrast. The registry does not report the analysis population, missing-data handling, masking procedures beyond the open-label designation, statistical plan, or sample-size justification. The endpoint timeframe is stated as four weeks, but other assessment details are not reported.
Safety information is limited to counts of 0 serious adverse events and 0 other adverse events among 11 at risk in each category. Definitions and completeness of event ascertainment are not reported, and deaths are not reported in the corresponding field. Satisfaction is mentioned in the brief summary but no result is posted. These limitations constrain interpretation of efficacy, safety, and the consistency of the reported study population.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Ketoconazole Foam 2% for the Treatment of Versicolor — NCT00830388.
- Registry record last updated 2012-08-22; status last verified 2012-07.
- Results first posted 2012-08-22.
- Data retrieved from ClinicalTrials.gov on 2026-11-09.
- Group sizes, means, event counts and sponsor-reported p-values are reproduced as posted. Effect estimates, confidence intervals and p-values not attributed to the sponsor are independently calculated from the posted summary statistics.
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18. Record Summary
The record describes a completed phase 4, open-label, single-group study of ketoconazole 2% foam for tinea versicolor. Allocation is listed as not applicable. The recorded start was 2008-11 and primary completion was 2010-08.
The primary outcome concerns participants with microscopic yeast still present at four weeks. The endpoint definition is described, but the number positive at follow-up is not reported in the registry record. The brief summary says ten patients, while the enrollment field and primary outcome description refer to 11 participants; this difference is not explained.
The safety figures report 0 serious and 0 other adverse events among 11 at risk in each category. Deaths are not reported. The registry lists 2 outcome measures and 0 analyses; it does not report a primary analysis, statistical analysis plan, or satisfaction result.