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 The Pharmacokinetics of 2% TD1414 Cream in Adults With Secondarily Infected Traumatic Lesions (SITL) or Impetigo (NCT00758862), a na phase 2 study. The primary outcome is TD1414 Serum Concentration by Timepoint.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT00758862 |
| Phase | Phase 2 |
| Condition | Secondarily Infected Traumatic Lesions (SITL), Impetigo |
| Allocation | Not applicable (single group) |
| Design model | Single Group |
| Masking | None (open label) |
| Enrollment | 20 |
| Arms in the primary outcome | n/a |
| Lead sponsor | LEO Pharma |
| Results posted | Yes |
2. Clinical Question
Population
Adults with impetigo or secondarily infected traumatic lesions (SITL). The registry record lists an enrollment of 20. It also notes that one participant withdrew at day 3 because the participant was outside the range of an inclusion criterion.
Intervention
2% TD1414 cream, applied 3 times daily for 7 days, as described in the registry summary. The study assessed pharmacokinetics and safety.
Comparator
There was no comparator group. The registry describes a prospective single-group study, with allocation listed as not applicable and masking as none.
Primary question
How does the serum concentration of TD1414 vary across the specified sampling timepoints, and what safety outcomes are recorded during the study? The primary outcome is a mean concentration in pg/mL, with standard deviation specified as the measure of dispersion.
This is a pharmacokinetic and safety question, not a randomized comparison of treatments. The registry does not state a primary clinical efficacy question, such as whether lesions improve relative to another treatment. Its primary outcome focuses on the amount of TD1414 measured in serum over time. That can describe systemic exposure in the study participants, but it does not by itself establish a comparative clinical effect.
The registry gives a detailed sampling schedule spanning 0 hours to 240 hours, with timing dependent in some cases on when the first and last applications occurred. It does not report the measured concentrations at those timepoints. As a result, the record describes what the primary endpoint was intended to measure but does not allow a reader to assess the observed concentration pattern or its precision.
3. Trial Design
The registry identifies this as a completed phase II study sponsored by LEO Pharma. It describes a national, prospective, single-arm investigation in adults with impetigo or secondarily infected traumatic lesions. The intervention was 2% TD1414 cream, applied 3 times daily for 7 days according to the brief summary. The recorded enrollment is 20. The registry lists the study start as 2008-12 and primary completion as 2009-02.
There is no concurrent control group: the study model is single group and allocation is listed as not applicable. Masking is listed as none. Therefore, the design is suited to describing serum concentrations over time and recording safety outcomes under the study conditions, but it does not create a like-for-like comparison between TD1414 and another treatment or control condition. Any changes over time cannot be separated from other time-related influences through a randomized comparison in this record.
The primary outcome is TD1414 serum concentration by timepoint, measured in pg/mL and summarized as a mean with standard deviation. The stated timeframe runs from 0 hours to 240 hours. The protocol description specifies samples before first application, at scheduled intervals after first application, on intervening study days, and around the last application. Some timing depends on the day of the first or final application. The sampling plan therefore aims to capture concentrations across both the early and later parts of treatment and after the final application.
The registry reports one withdrawal at day 3 because the participant was outside the range of an inclusion criterion. It does not give a participant flow account beyond this note, identify an analysis population, or explain how missing samples were handled. The record lists 13 outcome measures and 0 analyses. These listings do not supply the underlying endpoint values or a statistical analysis plan.
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 | TD1414 |
|---|---|
| STARTED | 20 |
| COMPLETED | 19 |
| NOT COMPLETED | 1 |
Analysis population for the primary outcome, as defined in the registry: One participant withdrew at day 3 due to the participant being out of range of the inclusion criterion.
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 | TD1414 |
|---|---|---|
| Participants analysed | 20 | |
| Age, Continuous | years | 32.1 (SD 11.8) |
| Sex: Female, Male: Female | Participants | 8 |
| Sex: Female, Male: Male | Participants | 12 |
| Region of Enrollment: United States | participants | 20 |
6. Primary Endpoint
The registry lists the primary outcome as TD1414 Serum Concentration by Timepoint, measured over From 0 hours to 240 hours.
| Element | Registry entry |
|---|---|
| Result type | Mean |
| Measure of spread | Standard Deviation |
| Unit | pg/mL |
| Endpoint classification | Continuous Endpoint |
The primary endpoint is TD1414 serum concentration by timepoint. It is a continuous measure, expressed in pg/mL, and the registry specifies a mean and standard deviation. The timeframe is described as 0 hours to 240 hours. The samples are scheduled around the first and last applications and on intervening days, with some collection times depending on application timing.
Serum concentration is used in pharmacokinetic studies to describe how much of a drug is measured in the bloodstream at different times after administration. A series of measurements can characterize the concentration pattern over time and show whether detectable serum exposure is present during and after a dosing period. That is a general description of the purpose of this type of endpoint; it does not establish what pattern occurred in this study.
The mean gives a measure of the group’s average concentration at a timepoint. The standard deviation describes variation among measurements around that average. These summaries answer different questions: the mean describes the central level, while the standard deviation conveys how dispersed participant values are. A mean alone would not show whether concentrations were similar across participants or varied substantially.
The registry record does not report the actual mean concentrations or standard deviations at the scheduled timepoints. It therefore does not permit an assessment of the concentration trajectory, the amount of between-participant variation, or the precision of any estimated mean. The sampling schedule and endpoint definition are reported, but the numerical primary results are not.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The central interpretive point is that the registry describes the primary pharmacokinetic outcome but does not provide its numerical results. It identifies serum concentration as the endpoint, names the unit and summary statistics, and gives the sampling timeframe. Without the mean concentrations and standard deviations at the timepoints, readers cannot determine the observed concentration levels, how they changed over time, or how variable the measurements were.
This study has no comparator group. Accordingly, the registry record does not support a treatment-versus-control contrast. The single-group design can describe measurements collected among participants receiving TD1414 under the study conditions, but it cannot establish how those measurements would compare with another treatment or with no treatment. The same design limitation applies to safety outcomes: recorded events can be described, but the record does not provide a comparative safety estimate.
The safety figures list 0 serious adverse events among 20 participants at risk and 0 other adverse events among 20 participants at risk. These are counts recorded for the listed group, not evidence that an event is impossible or that no event could occur in a broader population. The registry’s deaths field is not reported in the registry record. It also does not list serious adverse event terms. The event counts should therefore be read alongside the missing detail about event types and the short study description, rather than as a complete characterization of possible harms.
The record notes one withdrawal at day 3 because the participant was outside the range of an inclusion criterion. It does not specify whether this participant contributed any endpoint measurements, whether any scheduled samples were missed by other participants, or how missing observations were treated. Those omissions matter for interpreting a timepoint summary: the number of observations contributing to each mean and standard deviation is not reported in the registry record.
The registry lists 0 analyses. It does not report inferential tests, confidence intervals, a statistical analysis plan, or adjusted estimates. Thus there is no basis in the record for judging whether any observed concentration pattern was statistically distinguishable from a reference value, or for assessing the precision of a treatment effect. More fundamentally, no comparative treatment effect is defined by this single-group design.
Any sample-size illustrations should be understood as planning calculations, not evidence about what the study observed. The registry’s stated illustration assumptions use a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation, with an effect defined as a fraction of an observed effect. The trial itself is single group, and the registry record does not report the primary concentration results needed to inspect an observed effect. Such illustrations are not the study’s own design and are not observed power.
9. Statistical Methods Explained
The registry describes a continuous primary measure: TD1414 serum concentration in pg/mL at scheduled timepoints. It specifies the mean as the summary measure and standard deviation as the measure of dispersion. These choices summarize the level and spread of measurements at each timepoint. They do not, on their own, describe the full distribution, and the record does not report the underlying participant-level values.
What does the mean describe?
In general, a mean is the arithmetic average of the measurements included in a summary. For a concentration endpoint, a separate mean at each scheduled timepoint can describe the average measured serum level at that time. Interpreting that average depends on knowing which observations contributed to it. The registry record does not report the number of measurements available at each timepoint or how missing measurements were handled, so the composition of each reported mean cannot be checked from the record.
What does the standard deviation add?
In general, the standard deviation describes how widely measurements are spread around their mean. A smaller standard deviation indicates measurements closer to the mean, while a larger standard deviation indicates more dispersion. It is not the same as a confidence interval: a standard deviation describes variation among observations, whereas a confidence interval describes uncertainty about an estimated quantity. The registry specifies standard deviation but does not report numerical values for it, and it does not report confidence intervals for the primary endpoint.
How does the sampling schedule shape interpretation?
The record describes repeated serum sampling from 0 hours to 240 hours. It includes a sample before the first application and samples at specified intervals afterward, along with collections on intervening days and around the last application. Some collection timing depends on when the first application occurred or whether the final application fell on a particular study day. This schedule is intended to characterize concentrations across multiple phases of exposure rather than at just one measurement time.
Repeated measurements can be informative because values from the same participant are related: they are not equivalent to measurements from entirely separate participants. In general, an analysis of repeated observations may need to account for that within-participant dependence. The registry record does not describe an analysis model for repeated measurements, report a fitted concentration-time model, or give a statistical plan. It is therefore not possible to say how the study’s analyses handled the repeated sampling structure.
What does a single-group design permit?
In general, a single-group study can describe outcomes observed during exposure to an intervention. It does not provide a randomized between-group contrast. With no concurrent comparator, differences over time cannot be attributed uniquely to the intervention through this design alone. The study’s stated pharmacokinetic aim is descriptive of serum concentrations, while the safety outcomes are event counts in the intervention group. Neither should be read as a randomized estimate of relative benefit or harm.
The registry lists allocation as not applicable, masking as none, and the model as single group. These design details reinforce that there is no control arm for comparison. They do not establish whether other procedures were used to reduce measurement or operational bias; such details are not reported in the registry record.
How should precision be assessed?
A confidence interval is a general statistical tool for expressing uncertainty around an estimate. Its width depends on factors such as sample size and observed variability, as well as the method used to calculate it. A confidence interval around a mean would help communicate uncertainty in the estimated average concentration, but no such interval is reported for the primary outcome. The standard deviation, even if reported, would not substitute for that interval because it describes participant-level spread rather than uncertainty in the mean.
The registry reports an enrollment of 20, but does not report how many participants contributed data to each endpoint timepoint. It notes one withdrawal at day 3 due to an inclusion-criterion issue. Without timepoint-specific observation counts and missing-data details, the amount of information supporting each summary cannot be evaluated from the record.
What do the planning assumptions mean?
General sample-size calculations estimate how many participants might be needed under stated assumptions to detect a specified effect with a chosen statistical procedure. The registry describes a planning illustration using a two-sided significance level of 0.05, equal allocation between two arms, a normal approximation, and an effect defined as a stated fraction of an observed effect. It says non-time-to-event illustrations refer to participants per arm. Those assumptions do not describe the design of this single-group study, which has no pair of allocated arms.
Such calculations are planning illustrations, not observed power and not evidence that a study had a particular probability of detecting an effect after the data were collected. The registry record does not provide the observed primary concentration results or specific illustration outputs, so those outputs cannot be interpreted from the record alone. They should not be treated as a substitute for estimates, uncertainty intervals, or a comparison that the study design did not make.
Finally, the registry lists 0 analyses. It does not report hypothesis tests, model estimates, confidence intervals, multiplicity adjustments, or a prespecified analysis plan. In the absence of those details and the endpoint values, the statistical interpretation is necessarily limited to describing the intended endpoint, design, and reported event counts.
10. Multiplicity, Missing Data and Analysis Populations
The registry lists 13 outcome measures, but it does not report a statistical analysis plan or explain how the outcomes were prioritized or analyzed together. It also lists 0 analyses. The record therefore does not say whether formal hypothesis tests were conducted, whether any multiplicity adjustment was planned, or how any such adjustment would have been applied. With multiple outcomes or timepoints, multiplicity can matter when many statistical tests are performed, because the chance of at least one apparently unusual result can increase. That is a general statistical concern, not evidence that this study conducted multiple tests.
The primary endpoint is described as mean TD1414 serum concentration by timepoint, with standard deviation. The record does not report numerical values at the timepoints, confidence intervals, test results, or a model for the repeated measurements. It is also not reported in the registry record whether the timepoints were analyzed separately or jointly.
One participant withdrew at day 3 because the participant was outside the range of an inclusion criterion. The record does not describe the analysis population, state whether that participant’s existing measurements were retained, explain how missing samples were handled, or report the number of available observations at each timepoint. It also does not state whether other data were missing. Consequently, the potential influence of incomplete sampling on the endpoint summaries cannot be assessed from the registry record.
These gaps are distinct from the study’s enrollment figure. Knowing the recorded enrollment does not establish how many participants contributed to a particular endpoint analysis. The registry does not report an intention-to-treat, per-protocol, or other analysis population, so none should be assumed.
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 |
|---|---|---|---|
| TD1414 | 0 | 20 | 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 |
|---|---|
| TD1414 | 0 of 20 |
The safety record lists 0 serious adverse events among 20 participants at risk in the TD1414 group. It also lists 0 other adverse events among 20 participants at risk. These figures describe the counts recorded for this study group during the registry’s stated reporting period; they do not establish that risk is absent in other settings or populations.
The deaths field is not reported in the registry record, so the record does not support describing the death count as zero. No serious adverse event terms are listed. The registry record also does not provide event timing, duration, severity details beyond the serious-event classification, or information about how events were assessed. The figures should therefore be read as limited event-count information rather than a comprehensive safety profile.
In general, an observed count of zero in a study does not prove that an event cannot occur. The ability to characterize uncommon events depends on the amount and duration of observation, among other considerations. The registry summary describes treatment for 7 days, but it does not provide sufficient follow-up detail to establish a broader safety observation period.
There is no comparator group, so the event counts cannot be used to estimate a relative difference in adverse-event risk versus another treatment. They are descriptive counts for the listed group, not a comparative safety result.
12. What the Result Does, and Does Not, Mean
This study is relevant as a prospective, single-group investigation of the pharmacokinetics and safety of 2% TD1414 cream in adults with impetigo or secondarily infected traumatic lesions. Its stated primary outcome is serum concentration measured at scheduled timepoints. The registry provides the endpoint definition, measurement unit, summary statistics, sampling schedule, and a note about one withdrawal.
The record does not report the actual primary endpoint values. It therefore does not show the mean serum concentrations, the standard deviations, or how concentration measurements changed across the specified timeframe. It also provides no confidence intervals or inferential analyses for the primary endpoint. Readers cannot determine the precision of the mean concentrations or judge the observed amount of variability from this record.
The design does not include a control group. The study can describe the measurements and event counts recorded among participants receiving the intervention, but it cannot establish a comparative effect against another treatment. The registry does not report a clinical efficacy result, and serum concentration alone is not a direct comparison of clinical outcomes.
The safety figures report 0 serious adverse events and 0 other adverse events among 20 participants at risk. The deaths field and serious-event terms are not reported in the registry record. These event counts are descriptive and should not be interpreted as proof that adverse events cannot occur or as a comparison with another intervention.
In general, pharmacokinetic measurements can help characterize exposure and inform further research questions. That general role does not fill in the absent numerical findings or establish a clinical benefit. The registry record supports an account of what was studied and how the primary endpoint was defined, but not a conclusion about the observed concentration profile, comparative effectiveness, or a complete safety profile.
13. Why This Trial Matters Statistically
Pharmacokinetic studies address a different statistical question from trials designed primarily to compare clinical outcomes. By measuring serum concentration at multiple timepoints, this study was structured to describe exposure over time after application of 2% TD1414 cream. That focus can be useful when planning or interpreting subsequent research, because concentration measurements characterize an aspect of how an intervention is present in the body.
The design also illustrates why the estimand matters. A single-group study can summarize concentrations and safety events in the participants studied, but it does not estimate a randomized contrast with a control group. Statistical summaries should be interpreted in line with that design, rather than treated as comparative evidence. The registry explicitly lists allocation as not applicable, masking as none, and the model as single group.
The repeated sampling schedule raises general questions about within-participant dependence, available measurements at each timepoint, and how incomplete observations are handled. Those issues are important for precise estimation, but the registry does not report the relevant analysis methods or timepoint-specific data counts. The record also lacks the numerical concentration summaries themselves, so readers cannot assess how the planned measurements turned out.
The safety entries offer a further statistical lesson: zero recorded events in a study group are counts, not proof of zero underlying risk. The record’s missing death status and absence of serious-event terms also show why event counts need accompanying definitions and follow-up detail for interpretation.
Finally, planning calculations need to match the design and question they are intended to address. The registry’s described sample-size illustration assumes equal allocation between two arms, whereas this study is single group. Those calculations are planning illustrations, not observed power or a description of the trial’s own design. Distinguishing study design, endpoint measurement, and planning assumptions helps keep statistical claims aligned with what the record actually documents.
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 most consequential limitation for interpreting the registry record is that it does not report the numerical results for the primary endpoint. Although the record specifies mean serum concentration, standard deviation, units, and a 0 hours to 240 hours timeframe, it gives no concentration estimates or timepoint-specific dispersion values. The observed pharmacokinetic pattern therefore cannot be assessed.
The study is single group, with no comparator. As a result, it does not provide a randomized treatment contrast. Masking is listed as none. The registry does not report further procedures for limiting measurement or assessment bias, so those details cannot be evaluated.
The record notes one withdrawal at day 3 because the participant was outside the range of an inclusion criterion, but it does not provide a full participant-flow description. It does not report the number of participants or samples contributing at each timepoint, how missing observations were handled, or which analysis population was used. Those omissions limit assessment of the endpoint summaries’ completeness.
The registry lists 13 outcome measures and 0 analyses, but does not report a statistical analysis plan, model for repeated measurements, confidence intervals, or multiplicity approach. It also does not provide numerical outputs for the described planning illustrations. The stated illustration assumptions involve two arms, whereas the study itself is single group.
Safety reporting is limited to event counts. The deaths field is not reported in the registry record, and no serious adverse event terms are listed. The record does not include enough detail to assess event timing or the completeness of safety follow-up. These limitations constrain interpretation to the study’s recorded design and event-count fields.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: The Pharmacokinetics of 2% TD1414 Cream in Adults With Secondarily Infected Traumatic Lesions (SITL) or Impetigo — NCT00758862.
- Registry record last updated 2025-03-13; status last verified 2018-06.
- Results first posted 2018-07-23.
- 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 registry identifies NCT00758862 as a completed phase II study sponsored by LEO Pharma. It describes a prospective, single-group investigation of 2% TD1414 cream in adults with impetigo or secondarily infected traumatic lesions. Recorded enrollment is 20, and the summary describes application 3 times daily for 7 days.
The primary outcome is TD1414 serum concentration by timepoint, in pg/mL, summarized as a mean with standard deviation over a stated timeframe from 0 hours to 240 hours. The registry describes a detailed sampling schedule but does not report numerical concentration results. It notes one withdrawal at day 3 due to an inclusion-criterion issue.
The safety entries list 0 serious adverse events and 0 other adverse events among 20 participants at risk. Deaths are not reported in the registry record. The design has no comparator group, and the record lists 0 analyses. It does not report an analysis plan, timepoint-specific observation counts, or missing-data methods.