Study of PK and Safety of the LicartTM Topical System in Pediatric and Adult Participants With Minor Soft Tissue Injury: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Study of PK and Safety of the LicartTM Topical System in Pediatric and Adult Participants With Minor Soft Tissue Injury (NCT05171673), a na phase 3 study. The primary outcome is Plasma Diclofenac Concentration of Licart™ Topical System at V2 and V5/EOS..

2. Clinical Question

The study also describes evaluation of safety and analgesic effects during the treatment course, along with investigator-reported global response to therapy. Listed secondary outcomes include participant-reported pain scores using the Wong-Baker FACES Pain Rating Scale, investigator-reported global response, changes from baseline in systolic and diastolic blood pressure, and change from baseline in heart rate. The posted information identifies these questions but does not give their numerical results. Accordingly, the record allows the study’s intended questions and measurement schedule to be described, but not the magnitude or precision of the observed pharmacokinetic, pain, global-response, or vital-sign findings.

3. Trial Design

This is a Phase 3, multicenter, prospective, open-label study. The registry record identifies the design as single-group, with allocation listed as NA and masking as none. It records enrollment of 151 participants. The brief summary describes 150 male and female participants as the intended enrollment, aged 6-16 and 18-45 years. The status is completed. The recorded study start is 2021-10-31, and primary completion is recorded as 2024-06-30.

The investigational group is described as receiving Licart™ topical system once per day for a maximum of 14 days or until pain resolution, whichever came first. The listed age cohorts are 6 to 11 years, 12 to 16 years, and 18 to 45 years. The safety record reports these same cohorts separately. The primary pharmacokinetic measurement was taken at Visit 2, 24 hours (± 1 hour) after the initial application at Visit 1, and at Day 14 or one day after pain resolution, at the end of study.

Although “controlled” appears in the official title, the posted design does not identify a separate comparison arm or describe random allocation. The record therefore does not establish a randomized treatment contrast. Age-group comparisons are mentioned for the pharmacokinetic endpoint, but these are comparisons among participant groups rather than a comparison of Licart™ against a distinct control treatment. Details about eligibility criteria beyond the stated injury and age descriptions, treatment adherence, and other protocol procedures 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.

Before assignment: The study involved 154 screened participants with minor soft tissue injury. Of these, 102 participants were in the total pediatric group (6-11 years subgroup: 52 participants and 12-16 years subgroup: 50 participants), and 52 participants in the adult group (18-45 years). There were 3 screen failures (1 participant in the 6-11 years subgroup and 2 participants in the adult group). The full analysis set and the safety analysis set included 151 participants.

Overall Study

Reasons for not completing this period:

Analysis population for the primary outcome, as defined in the registry: Pharmacokinetics analysis set was used, which consisted of all participants in the safety analysis that have at least one blood draw to support determination of plasma diclofenac concentration.

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.

Population: Safety analysis set (SAF) was used. The SAF consisted of all participants who provided informed consent, completed all screening procedures (at the Screening visit), and received at least one application of the Investigational Product (IP).

6. Primary Endpoint

The registry lists the primary outcome as Plasma Diclofenac Concentration of Licart™ Topical System at V2 and V5/EOS., measured over 24 hours post-application (day 2 - V2), and Day 14 (V5) or one day after pain resolution (EOS).

The primary endpoint is plasma diclofenac concentration after use of the Licart™ topical system. It is a continuous measure reported in ng/mL, with the planned summary described as a mean and standard deviation. Blood collection is described at Visit 2, 24 hours (± 1 hour) after initial application, and at Day 14 or one day after pain resolution, at the end of study. The primary endpoint title refers to V2 and V5/EOS.

Pharmacokinetic measurements describe the amount of a drug measured in the body at specified times. They can characterize systemic exposure following administration, which is a distinct question from whether participants report pain relief. The registry record says the endpoint was evaluated in a pharmacokinetics analysis set: participants included in the safety analysis who had at least one blood draw suitable for determining plasma diclofenac concentration.

The record states that age-group-based comparisons were performed using ANOVA. However, it does not report group means, standard deviations, an ANOVA result, or confidence intervals for the primary endpoint. Those values are not reported in the registry record, so the direction, size, and precision of any age-group differences cannot be described from the posted information.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

The primary outcome is continuous: plasma diclofenac concentration, measured in ng/mL. A mean describes the arithmetic center of observed values, while a standard deviation describes how spread out individual measurements are around that mean. These summaries answer different questions: the mean gives a typical level under the chosen summary, and the standard deviation describes variability among observations. Neither can be recovered from the study design description alone, and neither is reported for the primary endpoint in the registry record.

What does the stated ANOVA comparison mean?

ANOVA is a general method for comparing mean outcomes across groups. In this study, the record says age-group-based comparisons were performed using ANOVA. That statement identifies the named approach, but does not report the group means, the test statistic, a p-value, a confidence interval, or the specific comparison results. It also does not specify in the posted record whether the model included covariates or other adjustments. Those details are not reported in the registry record.

As a general statistical concept, ANOVA evaluates whether the observed group means are compatible with a common mean under the model. A test result alone would not convey the size or practical importance of any difference; estimates and uncertainty measures are also useful. Since the numerical endpoint results are not reported in the registry record, the analysis cannot be interpreted beyond the fact that an age-group ANOVA was described.

Why does the study design matter?

A single-group, open-label study does not have a separate treatment arm for a direct treatment comparison. The record lists allocation as NA and masking as none. Therefore, the design description does not support a randomized between-treatment estimate. Age-group contrasts may be informative about differences across the listed cohorts, but age groups can differ in other ways as well; the registry record does not describe adjustment for such differences. General statistical interpretation must therefore keep the stated age-group comparison distinct from a treatment-control comparison.

Open-label means that masking is not reported as part of the design; in this record, masking is explicitly listed as none. For outcomes that involve participant reports or investigator ratings, knowledge of treatment can be relevant to measurement and interpretation. That is a general methodological consideration, not evidence that any particular rating in this study was biased.

How should measurement times be read?

The primary endpoint schedule includes blood collection at Visit 2, 24 hours (± 1 hour) after the initial application on Visit 1, and at Day 14 or one day after pain resolution, at the end of study. The treatment schedule allowed application once per day for a maximum of 14 days or until pain resolution, whichever occurred first. Consequently, the endpoint description includes a visit-based measurement and a later measurement tied to either the planned end of study or pain resolution. The registry record does not provide participant-level timing or endpoint values.

The stated pharmacokinetics analysis set consisted of participants in the safety analysis who had at least one blood draw supporting determination of plasma diclofenac concentration. This definition means the analysis population was not simply described as every enrolled participant. The record does not give the number included in that set, the number with measurements at each time, or how incomplete measurements were handled.

What do uncertainty and over-dispersion mean in general?

A confidence interval gives a range of values that are compatible with the data and the specified statistical method, under its assumptions. A narrower interval usually indicates greater precision, while a wider interval indicates more uncertainty. No confidence interval for the primary endpoint is reported in the registry record. Standard deviation describes observed spread; it is not itself a confidence interval and does not directly state the precision of a group mean.

Over-dispersion is a general concern when observed variability is greater than a statistical model expects. If it occurs, model-based standard errors and tests can understate uncertainty unless the analysis accounts for the extra variability. This point is general; the registry record does not report whether over-dispersion was assessed or whether it was relevant to these data. The primary outcome is described as a continuous measure analyzed using mean, standard deviation, and age-group-based ANOVA, and the posted record does not give enough results to evaluate model fit or variance assumptions.

The sample-size assumptions describe planning illustrations based on an observed effect, with a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation; the effect to detect is specified as a fraction of the observed effect. These assumptions are not the same as the study’s own design rationale. The registry record does not report the protocol’s sample-size justification, and an illustration based on an observed effect is not observed power. No planning values are stated in the record’s details, so no participant requirements can be characterized.

10. Multiplicity, Missing Data and Analysis Populations

The registry record lists 8 outcome measures and 56 analyses. The outcomes include the primary plasma diclofenac concentration endpoint and secondary measures of participant-reported pain, investigator-reported global response, systolic and diastolic blood pressure changes, and heart rate change. When several outcomes, time points, or group comparisons are examined, the chance of obtaining at least one apparently notable result can increase. This is a general multiplicity concern.

The record does not report whether a multiplicity adjustment was planned or applied, how the 56 analyses were grouped, or which analyses were designated confirmatory. An adjustment method or testing hierarchy is not reported in the registry record. Without those details and the analysis results, the statistical meaning of any individual test cannot be fully assessed.

The primary analysis population is described as the pharmacokinetics analysis set, consisting of participants in the safety analysis with at least one blood draw supporting plasma diclofenac concentration determination. The number of participants in that set and the number with data at each measurement time are not reported in the registry record. The record also does not describe an intention-to-treat population for the primary endpoint.

Missing-data methods are not reported in the registry record. It does not state how absent blood draws, incomplete concentration measurements, or missing secondary-outcome responses were handled. The reasons for missing observations and any assumptions used in analyses are also not reported. These omissions limit assessment of whether the analyzed participants and available observations fully represent the enrolled study population.

11. Safety Results

The registry reports serious adverse events as affected participants divided by participants at risk.

Deaths

Other (non-serious) adverse events

Participants with at least one non-serious event at or above the registry's 0% reporting threshold.

Most frequent non-serious adverse event terms

The registry record lists safety counts separately for the Licart™ Patch groups aged 6 to 11 years, 12 to 16 years, and 18 to 45 years. For serious adverse events, the affected count is 0 in each group. The listed numbers at risk are 51, 50, and 50, respectively. Deaths are recorded as 0 for each group.

For other adverse events, the affected counts are 0 among 51 participants at risk in the 6 to 11 years group, 2 among 50 in the 12 to 16 years group, and 3 among 50 in the 18 to 45 years group. These counts indicate how many participants were recorded as affected in each category; they are not counts of every event episode. The record does not give the terms or descriptions of the other adverse events in the registry record for this analysis.

Zero serious adverse events in these groups is a statement about the posted counts, not proof that an event is impossible or that risk is absent. The registry record lists no serious adverse-event terms. It does not provide a separate treatment comparator, so the counts cannot establish comparative safety between interventions. The reported group counts also do not describe timing, severity beyond the serious/other classification, or duration of follow-up for each participant.

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

The record describes a prospective, open-label study of Licart™ topical system in pediatric and adult participants with minor soft tissue injuries. It identifies plasma diclofenac concentration as the primary endpoint and states when blood was collected. It also describes age-group comparisons using ANOVA and reports safety counts by age group. These design and reporting details clarify what was intended to be measured.

The record does not report the numerical primary-endpoint results. It therefore does not show the concentration means, their standard deviations, or the estimated age-group differences and their uncertainty. The listed secondary outcomes are also not accompanied by numerical findings in the registry information used for this analysis. No conclusion about the magnitude of pain-score changes, investigator global response, blood-pressure changes, or heart-rate changes can be drawn from the available results.

The safety counts show no participants affected by serious adverse events and no deaths in the listed age groups. Other adverse events are recorded for 2 participants in the 12 to 16 years group and 3 participants in the 18 to 45 years group, with none recorded in the 6 to 11 years group. These counts should be read as descriptive observations, not as estimates comparing Licart™ with another treatment.

The registry record does not describe a randomized control group, despite the use of “controlled” in the official title. Its posted design is single-group, open-label, with allocation listed as NA. The record therefore does not provide a randomized treatment contrast from which to isolate a treatment effect. It also does not report the sample-size rationale, missing-data approach, multiplicity adjustment, or detailed statistical results. The information supports an account of study design and posted safety counts, but not a full assessment of outcome effect size or precision.

13. Why This Trial Matters Statistically

This study raises statistical questions that are important in pharmacokinetic research: how concentrations are measured over time, how age groups are compared, and which participants contribute to each analysis. The endpoint is defined at specified visits, and the analysis population is described in terms of safety-analysis participants with at least one supporting blood draw. Those definitions matter because the population and timing determine what a reported mean would represent.

The age-group structure also makes the estimand important. An age-group ANOVA can address differences in mean concentrations across cohorts, but it does not by itself estimate a treatment effect against a control intervention. The registry record’s single-group design and absence of a separately listed comparator should guide interpretation of the analyses and prevent age-group comparisons from being mistaken for randomized treatment comparisons.

Reporting uncertainty is equally important. Mean and standard deviation are named as the endpoint summary, but the numerical results and confidence intervals are not reported in the registry record. Without estimates and uncertainty, readers cannot judge the size or precision of any concentration differences. The record’s safety counts are available as descriptive group-level information, while event details and comparative safety estimates are not.

The record also illustrates why analysis planning matters when multiple outcomes and analyses are reported. It lists 8 outcome measures and 56 analyses, but does not report a multiplicity strategy or missing-data methods. These details help readers understand how to interpret statistical evidence and how robust conclusions may be. Their absence does not determine what the study found; it limits what can be evaluated from the registry record.

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 principal limitation for interpreting the posted results is that numerical values for the primary plasma diclofenac concentration endpoint are not reported in the registry record. The means, standard deviations, age-group comparison estimates, confidence intervals, and ANOVA test results are unavailable. Numerical results for the listed secondary outcomes are also not reported in the registry information used.

The design is identified as single-group and open-label, with allocation listed as NA and masking as none. Although the official title calls the study controlled, no separate control intervention is described in the posted design. This prevents interpretation as a randomized comparison with another treatment. The age-group analyses, as described, do not substitute for such a control comparison.

The registry record does not report the sample-size justification, the number included in the pharmacokinetics analysis set, or the number with observations at each time point. It also does not report the missing-data approach, multiplicity adjustment, model details beyond the stated ANOVA, or assessments of statistical assumptions. The specific eligibility criteria and further participant-flow information are not reported in the registry record.

The safety information is limited to participant counts by group and the serious-versus-other distinction. It does not describe the other adverse-event terms, timing, or event-level context. Without a separate comparator, these counts are descriptive and do not support a between-treatment safety contrast. The treatment schedule allowed use until pain resolution or a maximum of 14 days; the record does not provide individual exposure durations.

15. Related Tutorials

16. Related Statistical Calculators

17. Sources

• ClinicalTrials.gov: Study of PK and Safety of the LicartTM Topical System in Pediatric and Adult Participants With Minor Soft Tissue Injury — NCT05171673.
• Registry record last updated 2026-09-30; status last verified 2026-09.
• Results first posted 2026-09-30.
• Data retrieved from ClinicalTrials.gov on 2026-11-09.
• Group sizes, means, event counts and sponsor-reported p-values are reproduced as posted. Effect estimates, confidence intervals and p-values not attributed to the sponsor are independently calculated from the posted summary statistics.

18. Record Summary

NCT05171673 is a completed Phase 3, multicenter, prospective, open-label, single-group study of Licart™ (diclofenac epolamine) topical system in participants with minor soft tissue injuries. Enrollment is recorded as 151. The brief summary describes planned enrollment of 150 male and female participants aged 6-16 and 18-45. Treatment was once daily for a maximum of 14 days or until pain resolution, whichever occurred first.

The primary endpoint was plasma diclofenac concentration at V2 and V5/EOS, summarized as a mean and standard deviation. Age-group-based ANOVA is described. Numerical primary and secondary outcome results are not reported in the registry record. Safety counts list no serious adverse events or deaths in the three age groups, and other adverse-event counts of 0, 2, and 3 participants, respectively.