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 Efficacy and Safety Study of CD2027 Ointment 3 Microgram Per Gram (mcg/g) Twice Daily Treatment for Adults With at Least Moderate Atopic Dermatitis (NCT00919763), a randomized phase 2 study. The primary outcome is Total Severity Score (TSS) of Target Lesion at Baseline and Week 4.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT00919763 |
| Phase | Phase 2 |
| Condition | Atopic Dermatitis |
| Allocation | Randomized |
| Design model | Parallel |
| Masking | Quadruple |
| Enrollment | 102 |
| Arms in the primary outcome | n/a |
| Lead sponsor | Galderma R&D |
| Results posted | Yes |
2. Clinical Question
Population
Adults with at least moderate atopic dermatitis were eligible. The safety objective concerned application to areas involving 5%–20% of body surface area, excluding the Head/Neck. The primary outcome population is described as the Intent To Treat population, including all randomized participants.
Intervention
Participants applied CD2027 ointment 3 mcg/g topically to atopic dermatitis lesions twice daily over 4 weeks. Each application could be up to 10 gram, with applications at least 8 hours apart.
Comparator
The comparison group applied vehicle ointment topically to atopic dermatitis lesions on the same twice-daily, 4-week schedule, with the same stated application limit and interval.
Primary question
The trial aimed to evaluate efficacy by comparing Total Severity Score (TSS) of a target lesion at baseline and Week 4 between CD2027 ointment and vehicle. The registry record does not report the group scores or a treatment-effect estimate, so the posted results do not establish the direction or precision of that comparison.
This is a question about the comparative change in a defined lesion-severity score during treatment, not a direct comparison of every manifestation of atopic dermatitis or of long-term outcomes. TSS combines ratings of erythema, excoriation, exudation, lichenification and pruritus. The registry describes lower scores as indicating improvement and higher scores as indicating worsening. Its stated efficacy objective was to evaluate CD2027 ointment against vehicle in adults with at least moderate disease. The record also lists secondary outcomes involving individual TSS signs, an Investigator's Global Assessment response definition, and percent change in Eczema Area and Severity Index scores at scheduled weeks. Those outcomes broaden the clinical questions, but their results are not reported in the registry record.
3. Trial Design
The registry describes a randomized, parallel-group, vehicle-controlled Phase 2 trial of CD2027 ointment 3 mcg/g in adults with at least moderate atopic dermatitis. Enrollment is recorded as 102, and the trial status is completed. The official title describes a four-week, multicenter study. Participants were assigned to CD2027 ointment or vehicle ointment, both applied topically to atopic dermatitis lesions twice daily. The stated application instructions allowed up to 10 gram per application and required applications to be at least 8 hours apart. The safety objective specifies treatment on 5%–20% involved body surface area, excluding Head/Neck.
The registry's masking field says quadruple, while the brief summary calls the study double-blind. The record does not explain this difference or identify which roles were masked, so the masking procedures should not be inferred from these descriptions alone. Randomization and parallel-group allocation describe the intended comparison structure; they do not, by themselves, establish how the allocation sequence was generated or concealed. Those details are not reported in the registry record.
The primary outcome is TSS of a target lesion at baseline and Week 4, with the population described as the Intent To Treat population including all randomized participants. Secondary outcomes include change from baseline in individual TSS signs at Week 4, a specified Investigator's Global Assessment status and baseline-change criterion over Week 4, and percent change from baseline in Eczema Area and Severity Index total score at Week 1, 2, 3 and 4. The registry lists 4 outcome measures and 0 analyses. The outcome results and a treatment-effect comparison are not reported in the registry record, preventing assessment of the observed efficacy result from this record alone.
The trial began on 2009-05-21, with primary completion recorded as 2009-10-01. The registry record does not report a sample-size justification, details of the randomization procedure, the full statistical analysis plan, or whether any interim analyses were planned or conducted. These omissions limit what can be concluded about the study's design decisions beyond the registered descriptions.
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: A total of 147 participants were screened, of which 102 participants were enrolled and randomized to receive study treatment and 45 participants were reported as screen failure.
Overall Study
| Stage | CD2027 Ointment 3 mcg/g, Twice Daily | Vehicle Ointment, Twice Daily |
|---|---|---|
| STARTED | 53 | 49 |
| COMPLETED | 41 | 45 |
| NOT COMPLETED | 12 | 4 |
Reasons for not completing this period:
| Reason | CD2027 Ointment 3 mcg/g, Twice Daily | Vehicle Ointment, Twice Daily |
|---|---|---|
| Adverse Event | 7 | 1 |
| Lost to Follow-up | 1 | 0 |
| Protocol Violation | 1 | 1 |
| Withdrawal by Subject | 3 | 1 |
| Non-compliance | 0 | 1 |
Analysis population for the primary outcome, as defined in the registry: Intent To Treat (ITT) Population included all randomized participants.
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: The analysis was performed on Intent To Treat (ITT) Population that included all randomized participants.
| Characteristic | Unit | CD2027 Ointment 3 mcg/g, Twice Daily | Vehicle Ointment, Twice Daily | Total |
|---|---|---|---|---|
| Participants analysed | 53 | 49 | 102 | |
| Age, Categorical: <=18 years | Participants | 0 | 0 | 0 |
| Age, Categorical: Between 18 and 65 years | Participants | 50 | 48 | 98 |
| Age, Categorical: >=65 years | Participants | 3 | 1 | 4 |
| Age, Continuous | years | 38.3 (SD 14.9) | 40.3 (SD 13.8) | 39.3 (SD 14.3) |
| Sex: Female, Male: Female | Participants | 28 | 20 | 48 |
| Sex: Female, Male: Male | Participants | 25 | 29 | 54 |
| Race/Ethnicity, Customized: Race – Asian | Participants | 4 | 5 | 9 |
| Race/Ethnicity, Customized: Race – Black | Participants | 5 | 10 | 15 |
| Race/Ethnicity, Customized: Race – Caucasian | Participants | 27 | 21 | 48 |
| Race/Ethnicity, Customized: Race – Hispanic | Participants | 15 | 10 | 25 |
| Race/Ethnicity, Customized: Race – OTHER | Participants | 2 | 3 | 5 |
| Region of Enrollment: United States | Participants | 53 | 49 | 102 |
6. Primary Endpoint
The registry lists the primary outcome as Total Severity Score (TSS) of Target Lesion at Baseline and Week 4, measured over Baseline, Week 4.
| Element | Registry entry |
|---|---|
| Result type | Mean |
| Measure of spread | Standard Deviation |
| Unit | score on a scale |
| Endpoint classification | Continuous Endpoint |
The primary endpoint is Total Severity Score (TSS) of a target lesion at baseline and Week 4. TSS adds ratings for erythema, excoriation, exudation, lichenification and pruritus. Each sign is rated on a scale from 0 to 3, giving a total possible range from 0 to 15. The registry defines 0 as best and 3 as worst for each sign, and describes lower total scores as improvement and higher scores as worsening.
A composite such as TSS can provide a concise summary of several clinical features rather than presenting each sign only in isolation. That may make it easier to track overall target-lesion severity across visits, while retaining the individual signs as clinically meaningful components. The endpoint is a score, not a direct measure of disease extent across the whole body or a measure of long-term control. Because the assessment concerns a target lesion, its interpretation should remain tied to that defined scope.
The registry identifies the measure at baseline and Week 4, but it does not report the group means, standard deviations, change values, or a between-group estimate. Although the record names the Intent To Treat population for this outcome, it does not give the number of participants contributing endpoint data or explain how missing measurements were handled. Without the observed values and an analysis, the endpoint definition alone cannot show whether the groups differed or how precisely any difference was estimated.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry establishes the intended comparison: CD2027 ointment 3 mcg/g applied twice daily versus vehicle ointment applied on the same schedule, with TSS assessed at baseline and Week 4. It does not report the primary outcome values or a direct between-group estimate. Consequently, the posted results in this record do not show the magnitude or direction of a difference in TSS, nor do they indicate how uncertain such a difference might be.
The endpoint is described as a mean with standard deviation. A mean gives a measure of the group's average score, while a standard deviation describes the spread of individual scores around that average. These summaries answer different questions: an average can characterize a group, whereas the spread indicates how varied its scores are. But the registry record does not give those summaries for either group. It also does not report an adjusted or unadjusted treatment estimate, confidence interval, or p-value for the primary outcome.
The primary outcome is listed at baseline and Week 4, and the record says the endpoint has several categories or time points and was not reduced to one comparison. That matters because a baseline value, a Week 4 value, and a change between visits are not interchangeable descriptions. A comparison of Week 4 scores may account for baseline differently from a comparison of changes. The analysis choice and its numerical result are not reported in the registry record; it would be inappropriate to assume which comparison was used.
The primary population is described as all randomized participants in the Intent To Treat population. This is an important label, but it does not reveal whether all randomized participants had outcome data, how missing values were treated, or whether the posted analysis included every randomized participant. Those details are not reported in the registry record. The record lists 0 analyses, and the primary result values needed to interpret efficacy are absent.
The secondary outcomes identify additional ways of assessing severity and response, including individual TSS signs, an Investigator's Global Assessment criterion and Eczema Area and Severity Index changes over scheduled weeks. Their presence does not establish that they support the primary question, and their results are not reported in the registry record. Nor does the record explain how the chance of false-positive findings across multiple outcomes or time points was handled.
The adverse-event entries report zero serious adverse events in each treatment group, alongside other adverse-event counts of 16 for CD2027 and 8 for vehicle. These are descriptive registry counts, not estimates of treatment effect. The record does not provide a formal comparison or enough detail to assess event types, severity beyond the serious/non-serious distinction, timing, or attribution. No causal conclusion follows from the counts alone.
Overall, the registry conveys the study question, treatment schedules, endpoint definition and some safety counts, but not the numerical primary efficacy analysis. It therefore supports a description of what the trial set out to assess, not a conclusion about the size, precision, or statistical evidence of a TSS treatment difference.
9. Statistical Methods Explained
What does randomization contribute?
In general, randomization assigns participants to treatment groups using a chance-based process. When implemented appropriately, it aims to reduce systematic differences between groups at the start of a trial, including differences that investigators may not have measured. It does not guarantee identical groups, and it does not replace reporting baseline characteristics or the analysis. The registry identifies this study as randomized, but the sequence-generation and allocation-concealment procedures are not reported in the registry record. The presence of randomization should therefore be understood as a design feature, not as proof that every potential source of bias was eliminated.
What does a parallel, vehicle-controlled design mean?
In a parallel-group design, participants are assigned to a treatment group and followed in that group rather than switching between the study treatments. Here, the registered groups were CD2027 ointment and vehicle ointment, each applied to atopic dermatitis lesions twice daily over 4 weeks. A vehicle comparator can help distinguish the experience associated with the active formulation from that associated with applying the vehicle and participating in the trial. The registry does not describe the vehicle's composition, so no further claim about its ingredients or biological effects can be made from this record.
Masking is intended to limit the influence of expectations on treatment delivery, assessment or reporting. The registry's masking field says quadruple, while the brief summary describes the study as double-blind. Because the record does not clarify the discrepancy or specify the masked roles, the exact masking arrangement cannot be determined. In general, masking can reduce some risks of assessment and performance bias, but its effectiveness depends on implementation and cannot be evaluated solely from a label.
How should a mean and standard deviation be read?
The primary measure is a continuous score. In general, a mean summarizes the average score in a group, and the standard deviation describes how much scores vary around that average. A standard deviation is not the same as a confidence interval: it describes participant-level dispersion, whereas a confidence interval describes uncertainty around an estimated quantity. The registry identifies the endpoint parameter as a mean and the dispersion as a standard deviation, but it does not give the actual group summaries. It is therefore not possible to interpret the groups' average TSS levels or score variability from the record.
The TSS ranges from 0 to 15 as defined in the registry, with lower values indicating improvement and higher values indicating worsening. A score is a composite of erythema, excoriation, exudation, lichenification and pruritus. In general, composites can condense information from related features into a single summary, but they can also conceal whether a particular component changed differently from the others. The registry lists a secondary outcome for change in individual signs, but those results are not reported in the registry record.
What would a treatment estimate and confidence interval tell a reader?
In general, a treatment estimate quantifies the contrast between groups for a specified endpoint and analysis. A confidence interval expresses the range of values compatible with the data under the method's assumptions; its width gives information about precision. A narrow interval indicates greater precision than a wide interval, while neither the estimate nor the interval alone resolves questions about clinical importance or bias. A p-value, when reported, describes how surprising data at least as incompatible with a specified null hypothesis would be under that hypothesis and the statistical model. It is not the probability that the null hypothesis is true.
For this trial, the registry record does not report a between-group TSS estimate, confidence interval or p-value. It also does not specify a model or adjustment approach for the primary endpoint. The endpoint is recorded at baseline and Week 4, but a reader cannot infer whether the intended contrast used Week 4 scores, change from baseline, or another analysis. Different valid analysis choices can answer related but distinct questions, which is why the analysis specification and result should be reported together.
What is over-dispersion, and why can it matter?
In general, over-dispersion occurs when observed variability in data exceeds what a statistical model assumes. It is especially relevant to count outcomes when the model expects variability to follow a particular count distribution. If over-dispersion is ignored, standard errors and confidence intervals may be too small and tests may appear more decisive than warranted. The primary outcome in this trial is a continuous TSS, not a count endpoint; the registry does not describe an over-dispersion assessment or a model that would require one. The concept is useful when reading statistical methods generally, but it should not be presented as an analysis performed in this trial.
How should the planning assumptions be interpreted?
The record describes sample-size planning illustrations based on a stated fraction of the observed effect, a two-sided significance level of 0.05, equal allocation and a normal approximation. It says that non-time-to-event illustrations are expressed as participants per arm, while time-to-event illustrations use a total number of events. These are planning assumptions, not evidence that the trial had a particular probability of detecting an effect. Sample-size illustrations are not observed power, and they do not substitute for an estimate and its uncertainty. Numerical planning outputs are not reported in the registry record. Since the primary effect estimate is also absent, no planning result or interpretation of its scale can be reconstructed from this record.
The registry does not report the trial's own sample-size justification, nor does it state whether the planning illustration assumptions match the design decisions made before enrollment. That distinction matters: a calculation based on an observed effect is a retrospective planning illustration, whereas a prospective design calculation requires assumptions specified before outcomes are known. The record's description should be read as a general illustration rather than a documented account of the trial's original planning.
10. Multiplicity, Missing Data and Analysis Populations
The registry lists a primary TSS outcome at baseline and Week 4, as well as secondary outcomes covering individual TSS signs, an Investigator's Global Assessment response definition and Eczema Area and Severity Index percent change at Week 1, 2, 3 and 4. Testing or estimating effects across several outcomes, components or time points creates a multiplicity issue: in general, the more comparisons considered, the greater the opportunity for apparently unusual findings to arise by chance. Statistical plans may address this through prespecified outcome hierarchies, adjustment methods or a clear distinction between confirmatory and exploratory analyses. The registry record does not report whether any such approach was planned or used.
The primary outcome is described as having several categories or time points and is not reduced to one comparison. Without a specified primary contrast and its result, a reader cannot determine which comparison was intended to carry the principal inference. The registry lists 0 analyses, and statistical methods for the outcome comparisons are not reported in the registry record.
The primary population is described as the Intent To Treat population, including all randomized participants. However, the registry does not report how many participants contributed baseline and Week 4 TSS observations, whether data were missing, reasons for any missingness, or how missing observations were handled. In general, missing-data methods can affect estimates when the chance of missingness is related to participants' health or outcomes. Simply naming an analysis population does not disclose the actual data available or the assumptions used to address incomplete observations.
Other analysis populations, protocol deviations, sensitivity analyses and handling of intercurrent events are not reported in the registry record. These omissions limit assessment of whether conclusions would be robust to alternative assumptions. No missing-data method or multiplicity adjustment should be inferred from the endpoint list alone.
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 |
|---|---|---|---|
| CD2027 Ointment 3 mcg/g, Twice Daily | 0 | 53 | 0.0% |
| Vehicle Ointment, Twice Daily | 0 | 49 | 0.0% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| CD2027 Ointment 3 mcg/g, Twice Daily | 0 of 53 |
| Vehicle Ointment, Twice Daily | 0 of 49 |
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 |
|---|---|
| CD2027 Ointment 3 mcg/g, Twice Daily | 16 of 53 |
| Vehicle Ointment, Twice Daily | 8 of 49 |
Most frequent non-serious adverse event terms
| Event term | Organ system | CD2027 Ointment 3 mcg/g, Twice Daily | Vehicle Ointment, Twice Daily |
|---|---|---|---|
| Dermatitis atopic | Skin and subcutaneous tissue disorders | 6 of 53 | 3 of 49 |
| Blood 1,25-dihydroxycholecalciferol increased | Investigations | 5 of 53 | 0 of 49 |
| Skin irritation | Skin and subcutaneous tissue disorders | 1 of 53 | 1 of 49 |
| Application site pruritis | General disorders | 1 of 53 | 0 of 49 |
| Hyperbilirubinaemia | Hepatobiliary disorders | 1 of 53 | 0 of 49 |
| Gastroenteritis | Infections and infestations | 1 of 53 | 0 of 49 |
| Influenza | Infections and infestations | 0 of 53 | 1 of 49 |
| Nasopharyngitis | Infections and infestations | 0 of 53 | 1 of 49 |
| Prostate infection | Infections and infestations | 0 of 53 | 1 of 49 |
| Vaginal infection | Infections and infestations | 0 of 53 | 1 of 49 |
The registry separates serious adverse events from other adverse events. In the CD2027 ointment group, 0 serious adverse events were recorded among 53 participants at risk; 16 participants were recorded with other adverse events among 53 at risk. In the vehicle group, 0 serious adverse events were recorded among 49 participants at risk; 8 participants were recorded with other adverse events among 49 at risk. No deaths were recorded in either group.
These are counts reported for the groups, not a formal comparison of treatment-related risk. They do not establish whether an event was caused by the assigned ointment, how severe the other events were, when they occurred, or whether participants experienced more than one event. The registry record does not provide event descriptions for the other adverse events, and it does not report a statistical comparison or uncertainty interval for these safety counts. A zero serious-event count in the record should be read as no serious events recorded in this trial data, not as evidence that serious events are impossible or that risk is absent.
The at-risk counts describe the denominators used for the adverse-event entries. They should not be treated as proof of complete follow-up or as a substitute for details about exposure time and adverse-event ascertainment, which are not reported in the registry record. These figures are descriptive and should be interpreted alongside the limited follow-up and study context.
12. What the Result Does, and Does Not, Mean
This trial record is useful for identifying the question investigators set out to study: whether CD2027 ointment 3 mcg/g, applied twice daily over 4 weeks, would differ from vehicle on target-lesion TSS in adults with at least moderate atopic dermatitis. It also documents the registered treatment schedules, the score's components, the stated analysis population and several secondary outcome definitions. These details help clarify the intended clinical comparison and the measurement framework.
However, the registry record does not report the primary outcome group values or a comparative estimate. It therefore does not show whether TSS was higher or lower in either group at Week 4, how much scores changed, or how precise a group difference might be. No conclusion about statistical significance or clinical importance can be drawn from the endpoint definition, trial design or enrollment figure alone. The secondary outcome definitions also do not establish any result because their findings are not reported in the registry record.
The safety entries record no serious adverse events and give counts for other adverse events, but they do not provide event descriptions, attribution, uncertainty or a comparative analysis. Those counts are not sufficient to establish a safety difference between treatments. The short 4-week treatment schedule also defines the period covered by the trial objective; the record does not establish outcomes beyond that timeframe.
More broadly, the registry record is not a complete statistical report. The analysis methods, handling of missing observations, multiplicity approach and primary contrast are not reported. A completed status indicates that the trial is recorded as completed, not that its results are available in this record. The appropriate interpretation is therefore limited: the record describes a randomized, vehicle-controlled study and its planned measures, but does not provide the efficacy analysis needed to characterize the observed treatment effect.
13. Why This Trial Matters Statistically
This trial is statistically informative as an example of why a clearly defined endpoint and a reported result are both necessary for interpreting a clinical study. The registry describes TSS in considerable measurement detail: it names the target-lesion focus, the component signs, the scoring range and the direction of interpretation. It also identifies the assessment times and the Intent To Treat population. Those elements help readers understand what the outcome was intended to represent.
At the same time, endpoint definitions cannot replace comparative estimates. Without group summaries, a treatment-effect estimate and a measure of precision, a reader cannot distinguish a substantial difference from a small or uncertain one. The record's lack of a single reduced comparison also highlights the importance of specifying which outcome contrast is primary when measurements are collected at multiple times or across multiple outcome components.
The design further illustrates the need for transparent reporting of analysis choices. Randomization and masking are registered, but the record does not detail the allocation procedure, clarify the different masking descriptions, or report the statistical analysis plan. The population label does not explain missing-data handling, and the list of secondary outcomes does not establish how multiplicity was addressed. Each detail can affect how confidently a result is interpreted.
Finally, the posted safety counts show why descriptive data should not be overread. Counts without event detail, comparative uncertainty or attribution cannot answer all safety questions. The record supports a careful account of the trial's design and measures, while its absent efficacy analysis underscores a basic statistical principle: conclusions depend on transparent estimates and their uncertainty, not on the study question alone.
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 the absence of the primary outcome values and comparative analysis. The record gives the TSS definition and assessment times but not group means, standard deviations, changes, a treatment estimate, confidence interval or p-value. As a result, the observed efficacy finding and its precision cannot be evaluated.
The record also does not specify the exact primary contrast or statistical model. The endpoint is listed at baseline and Week 4, and the registry notes that it has several categories or time points and is not reduced to one comparison. It is therefore not possible to tell which comparison was intended to anchor the main inference. The statistical analysis plan, any covariate adjustment, and any sensitivity analyses are not reported in the registry record.
Information needed to assess missing data is absent. The Intent To Treat population is defined as all randomized participants, but the record does not say how many had endpoint measurements, whether any observations were missing, why they were missing, or how missingness was handled. The multiplicity approach for the primary and secondary outcomes is also not reported.
Masking is described differently in the registry fields: the masking designation is quadruple, while the brief summary calls the study double-blind. The roles covered by masking and the reason for the difference are not reported. The allocation procedure and concealment details are not reported either.
For safety, serious adverse-event counts and other adverse-event counts are available, but the record does not describe the other events, their severity, timing, attribution or comparative uncertainty. The treatment period was 4 weeks, so the registered objectives do not provide evidence about longer-term outcomes. These limitations arise from the information recorded and should not be resolved by assumptions about the trial.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Efficacy and Safety Study of CD2027 Ointment 3 Microgram Per Gram (mcg/g) Twice Daily Treatment for Adults With at Least Moderate Atopic Dermatitis — NCT00919763.
- Registry record last updated 2022-07-19; status last verified 2022-05.
- Results first posted 2012-05-01.
- 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.
Continue through the Clinical Biostats statistical pathway
Use this trial's endpoint as a starting point for deeper study of effect measures, confidence intervals, and sample-size planning.
18. Record Summary
The registry describes a completed Phase 2 randomized, parallel-group, vehicle-controlled study of CD2027 ointment 3 mcg/g in adults with at least moderate atopic dermatitis. Enrollment is recorded as 102. Participants applied CD2027 ointment or vehicle ointment twice daily to lesions over 4 weeks. The primary endpoint was target-lesion TSS at baseline and Week 4, with the population defined as all randomized participants in the Intent To Treat population.
The record lists secondary outcomes involving individual TSS signs, an Investigator's Global Assessment criterion and Eczema Area and Severity Index changes across scheduled weeks. It records 0 serious adverse events in either group, with other adverse-event counts of 16 for CD2027 and 8 for vehicle. The primary efficacy values and comparative analysis are not reported in the registry record. Details of missing-data handling, multiplicity, the statistical analysis plan and the masking-description discrepancy are also not reported.