This page provides an independent statistical analysis and educational interpretation of publicly reported results. ClinicalTrials.gov provides the official trial registry record. Numerical trial results on this page are restricted to the results posted in the ClinicalTrials.gov record; calculations added by Clinical Biostats are labelled as such.
1. Trial at a Glance
This page covers the registry results for A Study to Evaluate the Effectiveness and Safety of Topical OPA-15406 Ointment to Treat Participants With Atopic Dermatitis (NCT02068352), a randomized phase 2 study. The primary outcome is Percentage of Participants With Success in the Overall Investigator's Global Assessment of Disease Severity (IGA) Score at Week 4 [Using Non-responder Imputation or Last Observation Carried Forward (LOCF)].
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT02068352 |
| Phase | Phase 2 |
| Condition | Atopic Dermatitis |
| Allocation | Randomized |
| Design model | Parallel |
| Masking | Double |
| Enrollment | 121 |
| Arms in the primary outcome | n/a |
| Lead sponsor | Otsuka Pharmaceutical Development & Commercialization, Inc. |
| Results posted | Yes |
2. Clinical Question
Population
Participants with mild or moderate atopic dermatitis were eligible for the study described in its official title. The efficacy sample included randomized participants who received at least one dose of investigational medicinal product. The registry record does not report further eligibility details in the information available for this analysis.
Intervention
One group applied 0.3% OPA-15406 ointment topically twice daily, at approximately 12-hour intervals, to selected treatment areas for 8 weeks. A second group used 1% OPA-15406 ointment on the same schedule.
Comparator
The comparison group applied vehicle ointment, described as a 1%-matching placebo, topically twice daily at approximately 12-hour intervals for 8 weeks. This vehicle-controlled comparison provides a basis for evaluating the active ointments against the ointment vehicle under the trial conditions.
Primary question
The primary endpoint asked what percentage of participants met the overall Investigator's Global Assessment success definition at Week 4. Success required an IGA score of 0 or 1 together with at least a 2-grade reduction from baseline. The registry record does not report the success percentages or a comparison between groups, so the estimated effect and its precision are not available in the record.
3. Trial Design
This was a Phase 2, randomized, double-blind, vehicle-controlled, three-arm, parallel-group study of topical OPA-15406 in participants with mild or moderate atopic dermatitis. Random assignment is intended, in general, to make treatment groups comparable with respect to both measured and unmeasured baseline characteristics. Double masking is intended to limit the influence of treatment knowledge on participant experience and outcome assessment. These design features reduce certain risks of bias, but their presence alone does not establish that groups were balanced or that bias was absent.
The trial enrolled 121 participants. The arms were 0.3% OPA-15406, 1% OPA-15406, and vehicle ointment. Each regimen was applied to selected treatment area or areas twice daily at approximately 12-hour intervals for 8 weeks. The trial began on 2014-06-20, had a primary completion date of 2015-01-28, and is recorded as completed. The sponsor was Otsuka Pharmaceutical Development & Commercialization, Inc.
The primary outcome concerned IGA success at Week 4, with success defined by both a low absolute score and a reduction from baseline. Secondary outcomes included change from baseline in overall IGA score at Week 4 analyzed using mixed model repeated measures and last observation carried forward, and the percentage of participants with adverse events. The registry record lists 9 outcome measures and 27 analyses, but those counts do not identify which results were prespecified as confirmatory or how the analyses were prioritized.
The registry record does not report the allocation ratio, the randomization procedure, the detailed masking procedures, or a sample-size justification. It also does not report a complete statistical analysis plan or interim-analysis details. Those omissions prevent a more specific assessment of how the planned design addressed precision, multiplicity, or operational risks.
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: Participants with mild/moderate atopic dermatitis were randomized in 1:1:1 ratio to receive OPA 15406 (3% w/w, 1% w/w) and matching placebo. Participants had screening evaluations between 30 and 2 days before entering the 8-week treatment phase.
Overall Study
| Stage | 0.3% OPA-15406 | 1% OPA-15406 | Vehicle Ointment |
|---|---|---|---|
| STARTED | 41 | 43 | 37 |
| COMPLETED | 31 | 35 | 28 |
| NOT COMPLETED | 10 | 8 | 9 |
Reasons for not completing this period:
| Reason | 0.3% OPA-15406 | 1% OPA-15406 | Vehicle Ointment |
|---|---|---|---|
| Lost to Follow-up | 0 | 2 | 0 |
| Adverse Event | 4 | 2 | 7 |
| Participant met (Protocol Specified) Withdrawal Criteria | 0 | 1 | 0 |
| Participant Withdrew Consent to Participate | 6 | 3 | 1 |
| Protocol Deviation | 0 | 0 | 1 |
Analysis population for the primary outcome, as defined in the registry: Efficacy Sample included all participants who were randomized and received at least one dose of IMP. Number analyzed is the number of participants meeting responder criteria defined as an IGA score of 0 or 1 and at least 2-grade reduction from 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.
Population: Efficacy Sample included all participants who were randomized and received at least one dose of investigational medicinal product (IMP).
| Characteristic | Unit | 0.3% OPA-15406 | 1% OPA-15406 | Vehicle Ointment | Total |
|---|---|---|---|---|---|
| Participants analysed | 41 | 43 | 37 | 121 | |
| Age, Continuous | years | 36.4 (SD 15.2) | 34.1 (SD 16.5) | 32.2 (SD 15.6) | 34.3 (SD 15.8) |
| Sex: Female, Male: Female | Participants | 27 | 22 | 23 | 72 |
| Sex: Female, Male: Male | Participants | 14 | 21 | 14 | 49 |
| Ethnicity (NIH/OMB): Hispanic or Latino | Participants | 4 | 7 | 7 | 18 |
| Ethnicity (NIH/OMB): Not Hispanic or Latino | Participants | 37 | 36 | 30 | 103 |
| Ethnicity (NIH/OMB): Unknown or Not Reported | Participants | 0 | 0 | 0 | 0 |
| Race (NIH/OMB): American Indian or Alaska Native | Participants | 0 | 1 | 0 | 1 |
| Race (NIH/OMB): Asian | Participants | 1 | 1 | 2 | 4 |
| Race (NIH/OMB): Native Hawaiian or Other Pacific Islander | Participants | 1 | 0 | 2 | 3 |
| Race (NIH/OMB): Black or African American | Participants | 14 | 11 | 5 | 30 |
| Race (NIH/OMB): White | Participants | 24 | 30 | 28 | 82 |
| Race (NIH/OMB): More than one race | Participants | 0 | 0 | 0 | 0 |
| Race (NIH/OMB): Unknown or Not Reported | Participants | 1 | 0 | 0 | 1 |
6. Primary Endpoint
The registry lists the primary outcome as Percentage of Participants With Success in the Overall Investigator's Global Assessment of Disease Severity (IGA) Score at Week 4 [Using Non-responder Imputation or Last Observation Carried Forward (LOCF)], measured over Week 4.
| Element | Registry entry |
|---|---|
| Result type | Number |
| Measure of spread | not applicable |
| Unit | percentage of participants |
| Endpoint classification | Binary Endpoint |
The primary endpoint was the percentage of participants with success in the overall Investigator's Global Assessment of disease severity at Week 4. A certified rater assessed IGA on a 6-point scale: 0 indicated clear disease, 1 almost clear, 2 mild, 3 moderate, 4 severe, and 5 very severe disease. The assessment used clinical characteristics including erythema, infiltration, papulation, oozing, and crusting to guide the overall severity rating. Assessment covered the overall selected treatment area or areas, including overall percentage body surface area to be treated, and was also performed for the target lesion.
Success was not defined by a low score alone. A participant needed an IGA score of 0 or 1 and at least a 2-grade reduction from baseline. Requiring both conditions makes the endpoint reflect an attained severity category as well as change from the participant's starting score. In general, this type of responder endpoint can be easier to interpret as a proportion meeting a defined clinical criterion than a mean score change, although it also depends on the chosen cutoff and the handling of missing assessments.
Participants without a Week 4 IGA score were treated as non-responders in the primary definition. A sensitivity analysis used last observation carried forward to impute missing Week 4 scores before classifying success. The registry record does not report the number or percentage who met the endpoint in any group, nor does it report an effect estimate, confidence interval, or test result. Therefore, the endpoint definition is available, but its observed outcome is not reported in the registry record.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry record describes a trial designed to compare two concentrations of topical OPA-15406 with vehicle ointment. Its primary question was framed around the percentage meeting an IGA responder definition at Week 4. The endpoint requires both an IGA score of 0 or 1 and at least a 2-grade reduction from baseline. This is a defined binary outcome: each participant is classified as a success or not a success under the stated rule.
The record available for this analysis does not report any primary endpoint group results. It therefore does not establish how many participants met the criterion in each arm, how the groups differed, or how precisely any difference was estimated. An effect size, confidence interval, and inferential test result are not reported in the registry record. It is not possible to characterize the observed efficacy result or distinguish a small estimate from a large but imprecise estimate based on these registry entries.
In general, a confidence interval describes a range of effect estimates compatible with the data and the statistical model at a stated confidence level. Its width conveys precision, while its location indicates the direction and scale of the estimated effect. No confidence interval for the primary comparison is reported in the registry record, so precision cannot be assessed. A p-value, if reported, would address compatibility of the data with a specified null model under the chosen analysis; it would not by itself describe the size or clinical importance of an effect. No primary p-value is reported in the record.
The record identifies the efficacy sample as randomized participants who received at least one dose of investigational medicinal product. This is not necessarily identical to every possible analysis population used in clinical trials. The exact number analyzed for the primary outcome and the group-specific denominators are not reported in the information. The definitions state that participants without a Week 4 IGA assessment were classified as non-responders for the primary endpoint, with a LOCF-based sensitivity analysis. The amount and pattern of missing data are not reported, so the influence of missingness on the findings cannot be evaluated.
Safety figures are reported separately from the primary efficacy endpoint. The serious adverse event counts are 2 among 41 at risk in the 0.3% arm, 2 among 43 at risk in the 1% arm, and 0 among 37 at risk in the vehicle arm. Other adverse events are reported for 22 among 41 at risk, 13 among 43 at risk, and 16 among 37 at risk, respectively. These counts describe the posted safety information; they do not supply a comparative statistical analysis. The registry record also reports 0 deaths in each arm. The number of participants affected is not, by itself, a complete account of event timing, recurrence, severity, or causal attribution.
Overall, the available information supports a description of the trial's question, design, endpoint rule, and selected safety counts. It does not support a conclusion about the magnitude, precision, or statistical significance of the primary treatment comparisons. A result cannot be inferred from the trial design or from the fact that the study is marked completed.
9. Statistical Methods Explained
The trial's methods can be understood at two levels: what the registry record explicitly states, and general statistical principles that help explain those choices. The record states that allocation was randomized, masking was double, and the study used a parallel-group model with a vehicle comparator. It also specifies a binary primary endpoint at Week 4 and a missing-data rule. It does not report the full statistical analysis plan, the primary comparison model, or inferential results.
What does randomization contribute?
In general, randomization assigns participants to treatment groups using a chance-based procedure. Its purpose is to reduce systematic differences between groups at the point of assignment, including differences that may not be measured. It does not guarantee exact balance, particularly in a study with a limited enrollment, and it cannot prevent differences arising after assignment. The registry record says the trial was randomized but does not describe the sequence-generation or concealment procedures, so their implementation cannot be assessed from the record.
Why use a double-blind, vehicle-controlled design?
In general, masking can reduce bias when expectations might affect participant-reported experiences, clinical assessments, or decisions about follow-up. A vehicle comparator helps distinguish outcomes observed with active ointment from those observed with the ointment vehicle under study conditions. These features strengthen the design for a treatment comparison, but do not remove every source of bias. The registry record does not give details of how masking was maintained or whether masking was assessed.
How should the responder endpoint be understood?
The primary outcome is a binary responder measure rather than a continuous score. The definition combines an absolute IGA threshold, a score of 0 or 1, with a minimum change from baseline, at least a 2-grade reduction. In general, a binary outcome turns each participant's assessment into a category and reports the proportion in each category. That format can aid interpretation, but it discards information about differences among participants who fall on the same side of the threshold. The endpoint's result would depend on the precise cutoff, baseline status, assessment quality, and missing-data handling. The registry record provides the rule, but not observed response proportions.
What do the named analysis methods mean?
The registry identifies last observation carried forward, or LOCF, for a sensitivity analysis of the primary endpoint. In general, LOCF substitutes a participant's last observed score for a later missing score. This makes a complete analysis dataset possible under that rule, but it assumes that the last score is an appropriate stand-in for the missing assessment. That assumption may not reflect actual change over time, and LOCF does not automatically remove bias caused by missing outcomes. The record says the primary endpoint treated participants without Week 4 IGA scores as non-responders; the sensitivity analysis first imputed missing scores using LOCF and then applied the success definition.
Mixed model repeated measures, or MMRM, is named for a secondary outcome: change from baseline in overall IGA score at Week 4. In general, repeated-measures models use observations across time and account for the association among measurements from the same participant. Their estimates depend on the model specification and assumptions about the observed data and missingness. The record does not provide the model terms, covariance structure, estimation details, or the resulting estimates, so it is not possible to evaluate the particular MMRM implementation.
How should uncertainty and multiplicity be assessed?
In general, effect estimates should be read together with measures of uncertainty, such as confidence intervals. An estimate alone can conceal whether the data support a narrow range of plausible effects or a wide range. The primary effect estimate and its uncertainty are not reported in the registry record. The record lists 9 outcome measures and 27 analyses. Multiple outcomes and analyses can create multiplicity: if many hypotheses are tested, the chance of at least one apparently notable result can rise unless the analysis plan addresses that issue. The registry record does not report whether adjustment, a hierarchy, or another multiplicity strategy was specified.
In general, over-dispersion matters when observed variability in a count or proportion outcome exceeds what a simple statistical model assumes. If ignored, standard errors and uncertainty estimates may be poorly calibrated. The primary endpoint is a participant-level binary response, but the registry record does not state which model or variance approach was used for comparing groups. No conclusion about over-dispersion or model adequacy can be drawn from the endpoint definition alone.
What does a planning calculation represent?
In general, a sample-size calculation is a design-planning exercise, not a summary of what a completed trial observed. The registry describes planning illustrations based on the 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 defined as a stated fraction of the observed effect. Such illustrations depend on their assumptions and should not be interpreted as observed power. They are not evidence that the original trial was designed using those assumptions. The registry record does not report the trial's own sample-size justification, and no planning result is included in the information available for this analysis.
10. Multiplicity, Missing Data and Analysis Populations
The registry record lists 9 outcome measures and 27 analyses. This indicates that multiple outcomes or analytic results are recorded, but the counts do not reveal which comparisons were designated primary, how hypotheses were ordered, or whether a multiplicity adjustment was used. The multiplicity plan is not reported in the registry record. In general, when many outcomes or comparisons are examined, the interpretation of isolated statistical findings depends on whether the analysis plan accounted for the number and relationship of those tests. No adjustment method or confirmatory testing hierarchy can be inferred from the number of listed analyses.
Missing-data handling for the primary outcome is specified in the endpoint definition. Participants without a Week 4 IGA score were treated as non-responders. The sensitivity analysis imputed the missing score using LOCF and then classified success from that imputed score. These approaches produce different assumptions about unobserved outcomes: the non-responder rule assigns no success to missing assessments, while LOCF carries forward a prior score. In general, results under either approach can be affected by why observations are missing and whether missingness differs among groups.
The registry record does not report how many Week 4 assessments were missing, reasons for missingness, or results under either missing-data approach. The efficacy sample is described as randomized participants who received at least one dose of investigational medicinal product; the number analyzed for the endpoint is defined as those meeting the responder criteria. Details of any additional analysis populations are not reported in the registry record. Without outcome counts and missingness details, the sensitivity of the result to analysis-population choices or imputation assumptions cannot be judged.
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 |
|---|---|---|---|
| 0.3% OPA-15406 | 2 | 41 | 4.9% |
| 1% OPA-15406 | 2 | 43 | 4.7% |
| Vehicle Ointment | 0 | 37 | 0.0% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| 0.3% OPA-15406 | 0 of 41 |
| 1% OPA-15406 | 0 of 43 |
| Vehicle Ointment | 0 of 37 |
Other (non-serious) adverse events
Participants with at least one non-serious event at or above the registry's 5% reporting threshold.
| Arm | Participants affected of at risk |
|---|---|
| 0.3% OPA-15406 | 22 of 41 |
| 1% OPA-15406 | 13 of 43 |
| Vehicle Ointment | 16 of 37 |
Most frequent serious adverse event terms
| Event term | Organ system | 0.3% OPA-15406 | 1% OPA-15406 | Vehicle Ointment |
|---|---|---|---|---|
| Giardiasis | Infections and infestations | 0 of 41 | 1 of 43 | 0 of 37 |
| Liver function test abnormal | Investigations | 1 of 41 | 0 of 43 | 0 of 37 |
| Multiple sclerosis | Nervous system disorders | 1 of 41 | 0 of 43 | 0 of 37 |
| Depression | Psychiatric disorders | 0 of 41 | 1 of 43 | 0 of 37 |
Most frequent non-serious adverse event terms
| Event term | Organ system | 0.3% OPA-15406 | 1% OPA-15406 | Vehicle Ointment |
|---|---|---|---|---|
| Dermatitis atopic | Skin and subcutaneous tissue disorders | 11 of 41 | 7 of 43 | 8 of 37 |
| Nasopharyngitis | Infections and infestations | 3 of 41 | 1 of 43 | 3 of 37 |
| Headache | Nervous system disorders | 2 of 41 | 3 of 43 | 0 of 37 |
| Upper respiratory tract infection | Infections and infestations | 3 of 41 | 1 of 43 | 0 of 37 |
| Pruritus | Skin and subcutaneous tissue disorders | 3 of 41 | 0 of 43 | 1 of 37 |
| Toothache | Gastrointestinal disorders | 0 of 41 | 1 of 43 | 2 of 37 |
| Excoriation | Injury, poisoning and procedural complications | 0 of 41 | 0 of 43 | 2 of 37 |
Serious events with the highest arm-level rate: liver function test abnormal (2.4%), multiple sclerosis (2.4%), giardiasis (2.3%), depression (2.3%).
The posted serious adverse event figures are 2 affected participants among 41 at risk in the 0.3% OPA-15406 arm, 2 among 43 at risk in the 1% OPA-15406 arm, and 0 among 37 at risk in the vehicle arm. The registry record reports 0 deaths in each of the three arms. For other adverse events, the counts affected are 22 among 41 at risk, 13 among 43 at risk, and 16 among 37 at risk, in the same arm order. These are counts as recorded; no additional rates have been calculated.
The record lists liver function test abnormal (2.4%), multiple sclerosis (2.4%), giardiasis (2.3%), and depression (2.3%) among the top serious terms. The information available does not connect those terms to a particular treatment arm or give further context about timing, recurrence, or attribution. Serious adverse events and other adverse events are distinct reporting categories and should not be conflated. The counts alone do not establish causality, comparative risk, or the overall safety profile. The registry record does not report a statistical comparison for these figures.
12. What the Result Does, and Does Not, Mean
The trial addresses a specific statistical question: whether the proportion meeting a defined IGA success criterion at Week 4 differed among participants assigned to 0.3% OPA-15406, 1% OPA-15406, and vehicle ointment. The criterion combines an IGA score of 0 or 1 with at least a 2-grade reduction from baseline. The record also describes a Week 4 change-from-baseline IGA outcome and adverse-event reporting as secondary outcomes.
What the record establishes is the study design, treatment schedules, endpoint definition, and selected adverse-event counts. It does not report the primary outcome results, a comparison estimate, confidence intervals, or p-values. As a result, it cannot show from these registry entries whether one group had a higher response proportion, how large any difference was, or how precise the comparison would be. Completion status does not substitute for those results.
Even when an estimate is available, statistical evidence and clinical importance are different considerations. In general, statistical uncertainty describes how much the estimate may vary under the analysis assumptions, while clinical relevance depends on the meaning of the outcome and the context of the condition and treatment. Neither can be evaluated from a missing primary result. Likewise, a lack of a reported result in the registry record should not be interpreted as evidence of no effect or as evidence of an effect.
The safety counts provide a limited descriptive view. They do not supply event-level narratives, comparative analyses, or enough information to determine whether an event was related to treatment. The listed serious-event terms are not linked to treatment arms in the record. A balanced assessment would require the full posted outcome results and their analysis details, including uncertainty estimates and information about missing observations.
Accordingly, the record permits an appraisal of how the clinical question was framed and how the primary endpoint was defined, but not a conclusion about treatment efficacy or comparative safety. The distinctions matter: a trial can be well described methodologically while its outcome estimates remain unavailable in the registry record. No medical recommendation follows from the design information or the counts alone.
13. Why This Trial Matters Statistically
This study is statistically informative as an example of a multi-arm randomized design in which two active concentrations are compared with a vehicle control. The parallel-group structure separates the treatment assignments, while randomization and double masking are design features intended in general to support fair comparisons and reduce assessment bias. The treatment schedule is specified, and the primary assessment is anchored at Week 4 within an 8-week regimen.
The endpoint also illustrates a common analytic choice: defining response using both a threshold score and change from baseline. Such a rule gives the responder category a specific meaning, but interpretation depends on its components and on how missing assessments are classified. Here, the stated primary rule treats a missing Week 4 assessment as a non-response, while a LOCF sensitivity analysis uses a different procedure. Comparing results under those assumptions would help readers understand whether missing-data handling materially affects the findings, but those results are not reported in the registry record.
The study also demonstrates why design descriptions and outcome reporting must be considered separately. The registry reports enrollment of 121 participants and lists 9 outcome measures and 27 analyses, yet the primary result and its uncertainty are not reported in the information available for this analysis. Without group-specific outcome results, readers cannot evaluate the size or precision of the treatment comparisons, and cannot assess how multiple analyses were addressed.
The posted safety counts offer a descriptive starting point but not a full comparative safety analysis. Event counts require context about event definitions, follow-up, attribution, and uncertainty. The distinction between serious and other adverse events is important, as is avoiding conclusions based on isolated counts. Overall, the record highlights the statistical value of prespecified endpoint definitions, transparent missing-data reporting, and complete estimates with uncertainty alongside design details.
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 important limitation for interpreting this trial from the registry record is that the primary endpoint results are not reported in the information available for this analysis. There are no group-specific success percentages, comparison estimates, confidence intervals, or p-values to assess. The study's completed status and its detailed endpoint definition do not fill that gap.
Further details needed to evaluate the analysis are not reported in the registry record. These include the sample-size justification, the full statistical analysis plan, the primary comparison method, any multiplicity strategy, and interim-analysis details. The record lists multiple outcomes and analyses, but does not establish how they were prioritized or whether results were adjusted for multiple testing. The randomization procedure and detailed masking methods are also not described in the information.
Missing-data information is limited to the stated endpoint rules. The record does not report the amount or reasons for missing Week 4 IGA assessments, nor the results under the non-responder and LOCF approaches. The details of the model used for the secondary MMRM outcome are likewise not reported. Those omissions restrict assessment of robustness to assumptions about missingness and model specification.
The safety information is also limited. Arm-level counts are available for serious and other adverse events and deaths, but detailed event narratives, timing, attribution, and comparative statistical analyses are not reported. The listed serious-event terms are not connected to individual arms in the record. These limitations mean that the available information supports a design-focused account, but not a complete evaluation of efficacy, precision, or comparative safety.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: A Study to Evaluate the Effectiveness and Safety of Topical OPA-15406 Ointment to Treat Participants With Atopic Dermatitis — NCT02068352.
- Registry record last updated 2021-11-23; status last verified 2021-10.
- Results first posted 2021-11-23.
- 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
This completed Phase 2 study was randomized, double-blind, vehicle-controlled, and parallel-group, with enrollment of 121 participants with atopic dermatitis. It compared topical 0.3% OPA-15406 and 1% OPA-15406 with vehicle ointment, applied twice daily for 8 weeks. The primary endpoint was IGA success at Week 4, defined as a score of 0 or 1 with at least a 2-grade reduction from baseline.
The registry record specifies non-responder handling for missing primary assessments and a LOCF sensitivity analysis. It also lists secondary IGA and adverse-event outcomes. However, primary endpoint results and treatment-effect estimates are not reported in the record. Safety counts are available by arm, but do not constitute a comparative analysis. The record therefore supports a description of the design and analysis definitions, not a conclusion about efficacy or comparative safety.