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 Fucidin® Cream in the Treatment of Impetigo (NCT00986856), a randomized phase 4 study. The primary outcome is Number of Patients With Clinical Success (Marked Improvement or Completely Cleared) and Bacteriological Success (Eradication) at End of Treatment (EOT)..
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT00986856 |
| Phase | Phase 4 |
| Condition | Impetigo |
| Allocation | Randomized |
| Design model | Parallel |
| Masking | Double |
| Enrollment | 58 |
| Arms in the primary outcome | n/a |
| Lead sponsor | LEO Pharma |
| Results posted | Yes |
2. Clinical Question
Population
Paediatric patients with impetigo were the population of interest. The primary analysis population was described as the full intention-to-treat analysis set, including patients with confirmed pathogenic bacteria at baseline: S. aureus and/or beta-haemolytic streptococci (group A).
Intervention
The active intervention was Fucidin® cream. The registry record identifies the study as Phase IV and states that it investigated clinical and bacteriological efficacy in paediatric impetigo.
Comparator
The comparator was Fucidin® cream vehicle. Further details about the vehicle or how either cream was applied are not reported in the registry record.
Primary question
At end of treatment, described as the visit at Day 25, how many participants had both clinical success—marked improvement or complete clearance—and bacteriological success, defined as eradication? The registry record names this combined endpoint but does not report the number meeting it in either arm or a comparison between arms.
The study also had stated objectives concerning whether in vitro susceptibility testing of S. aureus to fusidic acid predicted clinical and bacteriological outcomes, and the genetic relationship among S. aureus strains isolated from patients. The record does not report results for those objectives. The central statistical question is therefore identifiable from the endpoint definition, but its answer cannot be established from the posted results described in the registry record.
3. Trial Design
This was a randomized, double-masked, parallel-group Phase IV study comparing Fucidin® cream with Fucidin® cream vehicle in paediatric patients with impetigo. The registry lists enrollment of 58 participants and identifies LEO Pharma as the sponsor. The study started in 2004-05, had a primary completion date of 2005-03, and is listed as terminated. The reason for termination is not reported in the registry record.
Randomized allocation means that treatment assignment was intended to be determined by chance, while a parallel-group design means participants were assigned to one study arm rather than crossing between treatments. In general, masking is intended to limit the influence of knowledge of assignment on care, assessment, or reporting. The record labels the study double-masked, but does not identify which people were masked or describe the masking procedure. The method used to generate the random sequence, allocation concealment, and the planned allocation ratio are not reported in the registry record.
The primary assessment was scheduled at end of treatment, defined as the visit at Day 25. Other listed outcomes included clinical success and bacteriological success at Visit 2, Visit 3, and end of treatment, as well as change in total severity score from baseline to end of treatment using last observation carried forward. The calendar timing of Visit 2 and Visit 3, and details of treatment duration or follow-up beyond the named assessments, are not reported in the registry record.
The enrollment figure should not be read as the number analyzed for the primary endpoint or as the number in either treatment arm. The registry record does not report those primary-endpoint denominators or arm-level outcome counts. Adverse-event risk denominators are listed separately and should be interpreted only for the safety entries.
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 | Fucidin® Cream | Fucidin® Cream Vehicle |
|---|---|---|
| STARTED | 42 | 16 |
| COMPLETED | 42 | 16 |
| NOT COMPLETED | 0 | 0 |
Analysis population for the primary outcome, as defined in the registry: The analysis population was the full (intention-to treat) analysis set including the patients with confirmed presence of pathogenic bacteria (S. aureus and/or betahaemolytic streptococci (group A)) at baseline
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 | Fucidin® Cream | Fucidin® Cream Vehicle | Total |
|---|---|---|---|---|
| Participants analysed | 42 | 16 | 58 | |
| Age, Categorical: <=18 years | Participants | 42 | 16 | 58 |
| Age, Categorical: Between 18 and 65 years | Participants | 0 | 0 | 0 |
| Age, Categorical: >=65 years | Participants | 0 | 0 | 0 |
| Age, Continuous | years | 4.8 (SD 2.7) | 6.3 (SD 2.9) | 5.2 (SD 2.8) |
| Sex: Female, Male: Female | Participants | 18 | 8 | 26 |
| Sex: Female, Male: Male | Participants | 24 | 8 | 32 |
| Region of Enrollment: Sweden | participants | 32 | 15 | 47 |
| Region of Enrollment: Norway | participants | 10 | 1 | 11 |
| S.aureus susceptible to fusidic acid: S. aureus susceptible to fusidic acid | S. aureus | 12 | 4 | 16 |
| S.aureus susceptible to fusidic acid: S. aureus resistant to fusidic acid | S. aureus | 18 | 8 | 26 |
| S.aureus susceptible to fusidic acid: No S. aureus isolated | S. aureus | 12 | 4 | 16 |
6. Primary Endpoint
The registry lists the primary outcome as Number of Patients With Clinical Success (Marked Improvement or Completely Cleared) and Bacteriological Success (Eradication) at End of Treatment (EOT)., measured over EOT: Visit at Day 25.
| Element | Registry entry |
|---|---|
| Result type | Number |
| Measure of spread | not applicable |
| Unit | Participants |
| Endpoint classification | Binary Endpoint |
The primary endpoint counted participants who achieved both clinical success and bacteriological success at end of treatment. Clinical success was defined as marked improvement or complete clearance. Bacteriological success was defined as eradication. The assessment time was end of treatment, identified as the visit at Day 25.
Combining the two criteria makes the endpoint more demanding than counting either clinical improvement or bacterial eradication alone: a participant must meet both stated conditions to be counted as a success. In general, a binary endpoint such as this can be summarized by the number of participants meeting the definition and the number assessed in each group. A comparison can then describe how frequently the combined outcome occurred in the two assigned groups, with uncertainty quantified using an appropriate interval or test.
The registry record reports the endpoint definition and the intended analysis population, but not the observed counts, denominators, treatment contrast, confidence interval, or p-value. Consequently, the magnitude and precision of any difference between the cream and vehicle groups are not reported in the registry record. The endpoint definition alone does not establish whether either group had more participants meeting both criteria.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The record identifies a randomized comparison and a clinically and bacteriologically combined primary endpoint, but it does not report the primary outcome results. No arm-level number of participants with success, denominator for that outcome, effect estimate, confidence interval, or p-value is reported in the registry record. Without these results, the direction, size, and precision of the primary comparison cannot be interpreted.
The distinction between endpoint definition and endpoint result is important. The endpoint specifies what would count as success: marked improvement or complete clearance together with eradication, assessed at end of treatment. That definition does not reveal how often success occurred. Nor does the fact that the trial was randomized establish a particular result; randomization describes assignment, not the observed outcome.
The record lists 58 enrolled participants, but enrollment is not a substitute for the primary analysis denominator. Some participants may not have contributed an endpoint observation, and the registry record does not state how many participants in each group had evaluable primary data. It also does not report whether the primary analysis used an imputation method or how missing endpoint observations were handled.
The listed secondary outcomes cover clinical success and bacteriological success at Visit 2, Visit 3, and end of treatment, plus change in total severity score from baseline to end of treatment using last observation carried forward. Their names indicate what was to be assessed, not the outcomes observed. Counts or estimates for these secondary outcomes are not reported in the registry record. The stated additional objectives about susceptibility testing and strain relationships also have no reported results in the record.
Interpretation should therefore remain descriptive: the registry documents the trial question, design, endpoint, and some safety counts, but does not provide the efficacy results needed to estimate the treatment comparison. No conclusion about the comparative efficacy of the cream and vehicle can be drawn from the endpoint description or trial design alone.
9. Statistical Methods Explained
What does a binary endpoint represent?
The primary endpoint is a participant count: each participant either meets the combined success definition or does not. For this trial, meeting the definition required both clinical success—marked improvement or complete clearance—and bacteriological success—eradication—at end of treatment. In general, binary outcomes are commonly summarized with a count and a denominator for each group. A proportion may also be reported, but no primary outcome proportions are reported in the registry record.
When comparing groups, an analysis may express the contrast as a difference in proportions, a ratio of proportions, or another measure suited to the design and analysis plan. These measures answer related but distinct questions. A difference describes an absolute separation; a ratio describes a relative separation. The registry record does not report which comparative measure was used for the primary endpoint, or any numerical estimate.
What would a confidence interval add?
In general, a confidence interval describes the uncertainty around an estimated effect under the assumptions of the analysis. Its range can help readers distinguish a relatively precise estimate from one that remains compatible with a broad range of effects. An interval does not by itself establish clinical importance, and its interpretation depends on the effect measure, analysis, and data. No confidence interval for the primary endpoint is reported in the registry record, so the precision of the comparison cannot be assessed.
How should a p-value be read?
In general, a p-value measures how compatible observed data are with a specified null hypothesis under a statistical model. It is not the probability that the null hypothesis is true, and it does not measure the size or importance of an effect. The primary p-value and the statistical test used are not reported in the registry record. A significance threshold or detailed inferential plan is also not reported in the registry record.
Why does the analysis population matter?
The record describes the primary analysis population as the full intention-to-treat analysis set, including patients with confirmed presence of pathogenic bacteria at baseline: S. aureus and/or beta-haemolytic streptococci (group A). In general, an intention-to-treat approach analyzes participants according to their randomized group, helping preserve the benefits of randomized assignment. The wording in the record does not provide the arm-specific population counts or clarify how participants without confirmed baseline bacteria were handled in the analysis. The numbers analyzed for the primary endpoint are not reported in the registry record.
What is the role of the other outcomes?
The listed secondary outcomes include clinical and bacteriological success at Visit 2, Visit 3, and end of treatment, and change in total severity score from baseline to end of treatment using last observation carried forward. These outcomes describe additional time points or measures. In general, repeated assessments can offer information about how outcomes vary over time, while also raising questions about which assessment is primary and how multiple comparisons are interpreted. The registry record does not report results for these secondary outcomes or a plan for adjusting for multiple testing.
The last observation carried forward wording applies to the named severity-score outcome. In general, this method substitutes a participant’s last observed value for a later missing measurement. It can be problematic if the outcome changes after the last observation, because the carried-forward value may not represent the unobserved measurement. The registry record does not describe how missing data were handled for the primary endpoint.
What can sample-size planning illustrations tell readers?
In general, a sample-size calculation is a planning exercise based on assumptions about the effect to detect, variability or event frequency, significance level, power, and allocation. It is not an observed result and does not establish the precision of the completed trial. The planning description associated with this record states that illustrations use the observed effect, a two-sided significance level of 0.05, equal allocation, and a normal approximation, with the target effect expressed as a fraction of the observed effect. It also distinguishes total events for time-to-event outcomes from participants per arm for other outcomes. These are planning assumptions, not evidence that the trial was designed using them. The record does not report the trial’s own sample-size justification, and the primary endpoint has multiple categories or time points and is not reduced to one comparison in the analysis description. No specific planning result or observed primary effect is reported in the registry record.
10. Multiplicity, Missing Data and Analysis Populations
The registry lists a combined primary endpoint and several secondary outcomes: clinical success and bacteriological success at Visit 2, Visit 3, and end of treatment, together with change in total severity score from baseline to end of treatment using last observation carried forward. The record also states objectives concerning susceptibility testing and genetic relationships among S. aureus strains. Considering several outcomes or time points can create a multiplicity issue: in general, the more comparisons examined, the greater the chance that an apparently notable result arises by chance when no adjustment or prespecified interpretation strategy is used.
The registry record does not report a multiplicity-control procedure, a hierarchy of secondary outcomes, or how secondary analyses were intended to support interpretation. It also does not report whether any interim analyses were planned or conducted. These details should not be inferred from the outcome list or from the trial’s terminated status.
The primary population is described as the full intention-to-treat analysis set including participants with confirmed pathogenic bacteria at baseline. The primary endpoint denominator, arm-level analysis populations, participant flow, and numbers with missing endpoint measurements are not reported in the registry record. The record names last observation carried forward for the severity-score change outcome, but does not describe missing-data handling for the primary endpoint or other binary outcomes.
Without those details, readers cannot determine how complete the endpoint data were, whether exclusions affected the primary comparison, or how robust results might be to alternative missing-data assumptions. No primary results are reported against which these methodological questions could 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 |
|---|---|---|---|
| Fucidin® Cream | 0 | 40 | 0.0% |
| Fucidin® Cream Vehicle | 0 | 16 | 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 |
|---|---|
| Fucidin® Cream | 5 of 40 |
| Fucidin® Cream Vehicle | 4 of 16 |
Most frequent non-serious adverse event terms
| Event term | Organ system | Fucidin® Cream | Fucidin® Cream Vehicle |
|---|---|---|---|
| Infections and infestations | Infections and infestations | 3 of 40 | 4 of 16 |
| Gastrointestinal disorders | Gastrointestinal disorders | 1 of 40 | 0 of 16 |
| Infections and | Skin and subcutaneous tissue disorders | 1 of 40 | 0 of 16 |
The safety entries list zero participants affected by serious adverse events in the Fucidin® Cream group, with 40 participants at risk, and zero in the Fucidin® Cream Vehicle group, with 16 participants at risk. These figures describe the recorded serious-event counts and listed denominators; they do not establish that no serious event occurred outside the period or reporting scope represented by these entries.
The record also lists other adverse events affecting 5 participants in the Fucidin® Cream group and 4 in the Fucidin® Cream Vehicle group, using the same group-specific risk denominators. The registry record does not provide event descriptions, severity details, timing, or a comparative analysis for these entries. The deaths field is not reported in the registry record, so it should not be interpreted as a reported zero.
In general, safety counts need to be read with their denominators and with information about event definitions and observation periods. The counts alone do not establish whether an event was caused by treatment, and the registry record does not report a causal assessment for these events.
12. What the Result Does, and Does Not, Mean
The registry record establishes that a randomized, double-masked, parallel-group Phase IV study compared Fucidin® cream with Fucidin® cream vehicle in paediatric patients with impetigo. It also specifies a primary outcome that required both clinical success and bacteriological success at end of treatment. These details clarify the question the study was designed to address.
They do not reveal the answer to that question. Primary outcome counts, denominators, comparative estimates, confidence intervals, and p-values are not reported in the registry record. The listed secondary outcomes and additional objectives likewise do not have results reported in the record. Thus, the comparative efficacy and its statistical precision cannot be determined from the information recorded.
The registry lists 58 enrolled participants, but this does not show how many participants were analyzed for the primary endpoint or how many were assigned to each arm. The trial is listed as terminated, but the reason is not reported in the registry record. Neither fact should be used to infer the direction or reliability of the missing efficacy results.
The safety entries report zero serious adverse events in each group, as well as counts for other adverse events. Those entries should be interpreted within their listed denominators and without assuming unreported details about event definitions, follow-up, or causality.
In general, a treatment comparison is best understood by considering the estimated effect, its uncertainty, the analysis population, missing data, and the prespecified plan together. Since key efficacy estimates and analysis details are not reported in the registry record, the posted information supports a description of the study question and design, not a conclusion about the comparative effects of the two creams.
13. Why This Trial Matters Statistically
This trial is statistically notable for using a combined endpoint: participants had to meet both a clinical criterion and a bacteriological criterion at end of treatment. Such endpoints can be informative because they join two dimensions of outcome, but they also require careful definition and clear reporting. Here, clinical success is specified as marked improvement or complete clearance, while bacteriological success is eradication.
The design also illustrates why a stated endpoint is not enough for interpretation. To assess a randomized comparison, readers need the number of successes and the analysis denominator in each group, followed by an effect estimate and its uncertainty. Those primary results are not reported in the registry record. Without them, the study question can be described, but the treatment contrast cannot be quantified.
The listed assessments at Visit 2, Visit 3, and end of treatment also highlight the importance of prespecifying how multiple outcomes and time points will be interpreted. The record names several secondary outcomes but does not report a multiplicity strategy or their results. It additionally identifies a severity-score analysis using last observation carried forward, bringing missing-data assumptions into view for that outcome.
Finally, the registry’s terminated status, enrollment figure, and safety counts each answer different questions. None can substitute for the missing primary comparison. The record is therefore a useful example of the distinction between trial design information and evidence needed to interpret an observed treatment effect.
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 main limitation for statistical interpretation is that primary efficacy results are not reported in the registry record. There are no arm-level success counts or denominators, comparative effect estimate, confidence interval, or p-value. The reason the study was terminated is also not reported, so the status alone cannot explain the absence of a reported primary result.
Other design and analysis details are not reported in the registry record, including the random-sequence method, allocation concealment, masking procedures, group-specific primary analysis counts, and handling of missing primary endpoint observations. Although the record identifies a full intention-to-treat analysis set with confirmed pathogenic bacteria at baseline, it does not provide participant flow or clarify exclusions and endpoint evaluability.
The record lists multiple secondary outcomes and additional objectives, but does not report their results or a multiplicity strategy. The severity-score outcome names last observation carried forward, but the record does not give enough information to evaluate its implementation or assumptions. Details about the timing of Visit 2 and Visit 3, the vehicle, treatment application, and the follow-up period beyond the named assessments are not reported in the registry record.
Safety interpretation is also limited by the absence of event descriptions and details about timing, severity, and causality. Deaths are not reported in the registry record. These gaps limit what can be concluded from the posted information; they do not establish what unreported results or procedures would have shown.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Fucidin® Cream in the Treatment of Impetigo — NCT00986856.
- Registry record last updated 2025-03-06; status last verified 2015-03.
- Results first posted 2010-09-29.
- 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
NCT00986856 is a Phase IV randomized, double-masked, parallel-group study of Fucidin® cream versus Fucidin® cream vehicle for impetigo in paediatric patients. The sponsor is LEO Pharma. The record lists enrollment of 58, a start date of 2004-05, a primary completion date of 2005-03, and a status of terminated; the reason for termination is not reported in the registry record.
The primary endpoint was the number of participants with both clinical success—marked improvement or complete clearance—and bacteriological success—eradication—at end of treatment, identified as the visit at Day 25. The analysis population was described as the full intention-to-treat analysis set including participants with confirmed pathogenic bacteria at baseline. Primary outcome counts and comparative estimates are not reported in the registry record.
The safety entries list zero serious adverse events in each group and other adverse events affecting 5 participants in the cream group and 4 in the vehicle group. Further event details and deaths are not reported in the registry record.