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 Phase 3 Efficacy and Safety Study of CD07805/47 Topical Gel in Subjects With Facial Erythema Associated With Rosacea (NCT01355458), a randomized phase 3 study. The primary outcome is Composite Success.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT01355458 |
| Phase | Phase 3 |
| Condition | Rosacea |
| Allocation | Randomized |
| Design model | Parallel |
| Masking | Double |
| Enrollment | 260 |
| Arms in the primary outcome | n/a |
| Lead sponsor | Galderma R&D |
| Results posted | Yes |
2. Clinical Question
Population
Subjects with moderate to severe facial erythema associated with rosacea. The primary outcome population is described as the Intent-to-Treat (ITT) population, with the parenthetical “Hours 3,6,9,12.”
Intervention
CD07805/47 gel applied topically once daily, as described in the official study title.
Comparator
Vehicle control, described as placebo in the intervention record.
Primary question
At Day 29, how many participants met the composite success definition, requiring a 2-grade improvement on both the Clinician Erythema Assessment (CEA) and Patient Self Assessment (PSA)?
The registry describes a randomized, double-blind, parallel-group study intended to assess efficacy and safety. Its stated hypothesis is that CD07805/47 gel is more efficacious than vehicle and has an acceptable safety profile. That is the study hypothesis, not a result. The registry record does not provide a single reduced comparison of the primary outcome: it identifies several categories or time points and does not reduce them to one comparison. Therefore, the record as described does not establish how many participants met the composite success definition in either group, or the size and precision of a between-group difference.
The clinical question is specific to facial erythema associated with rosacea and the stated assessment at Day 29. It is not a question about every feature of rosacea or about outcomes beyond the endpoint and timeframe recorded. The posted information identifies CD07805/47 gel and placebo as the interventions, but does not provide detailed descriptions of the arm procedures, dosing beyond the once-daily description, or additional eligibility criteria. Those details are not reported in the registry record.
3. Trial Design
This is a Phase 3 study with randomized allocation, double masking, and a parallel-group model. Its official title describes it as multicenter and vehicle-controlled. The registry lists CD07805/47 gel and placebo as the interventions. The title specifies topical application of the gel once daily. The completed study listed enrollment of 260. The registry dates the study start to 2011-05 and primary completion to 2011-09.
Random allocation is intended, as a general design principle, to make treatment groups comparable on average with respect to characteristics that could affect the outcome. It does not guarantee that every characteristic will be balanced in a particular study. The record does not describe the randomization procedure, sequence generation, allocation concealment, or stratification, so those aspects cannot be assessed from the registry record.
Double masking means that the study is described as blinded for two roles, but the registry record does not identify those roles or explain how masking was maintained. Parallel-group designs assign participants to a group and compare outcomes between groups rather than having each participant receive both interventions in sequence. The record does not provide further procedural details, including visit schedules beyond the primary endpoint timeframe, treatment duration, or handling of treatment discontinuation.
The registry describes the study as completed and gives a planned study hypothesis, but completion alone does not report an efficacy result. The primary endpoint is described as a participant count at Day 29, while the registry record notes that its primary outcome has several categories or time points and is not reduced to one comparison. Detailed outcome estimates, an effect measure, confidence intervals, and a test result are not reported in the registry record. The protocol's sample-size justification, randomization details, and prespecified statistical plan are also 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.
Overall Study
| Stage | CD07805/47 Gel | Placebo |
|---|---|---|
| STARTED | 129 | 131 |
| COMPLETED | 127 | 127 |
| NOT COMPLETED | 2 | 4 |
Analysis population for the primary outcome, as defined in the registry: Intent-to-Treat (ITT) population (i.e. Hours 3,6,9,12)
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 | CD07805/47 Gel | Placebo | Total |
|---|---|---|---|---|
| Participants analysed | 129 | 131 | 260 | |
| Age, Categorical: <=18 years | Participants | 0 | 0 | 0 |
| Age, Categorical: Between 18 and 65 years | Participants | 117 | 117 | 234 |
| Age, Categorical: >=65 years | Participants | 12 | 14 | 26 |
| Age, Continuous | years | 49.5 (SD 11.76) | 48.1 (SD 12.81) | 48.8 (SD 12.30) |
| Sex: Female, Male: Female | Participants | 104 | 102 | 206 |
| Sex: Female, Male: Male | Participants | 25 | 29 | 54 |
| Region of Enrollment: United States | participants | 115 | 116 | 231 |
| Region of Enrollment: Canada | participants | 14 | 15 | 29 |
6. Primary Endpoint
The registry lists the primary outcome as Composite Success, measured over Day 29.
| Element | Registry entry |
|---|---|
| Result type | Number |
| Measure of spread | not applicable |
| Unit | participants |
| Endpoint classification | Binary Endpoint |
The primary endpoint is titled Composite Success and is measured in participants at Day 29. Success is defined as a 2-grade improvement on both the Clinician Erythema Assessment (CEA) and the Patient Self Assessment (PSA). Requiring improvement on both assessments makes this a composite criterion: improvement on either assessment alone does not meet the stated definition. The clinician and participant assessments represent distinct perspectives on facial erythema, combined into a single success rule.
As a general statistical concept, a binary endpoint such as success or not success can make a treatment comparison clinically interpretable when the rule is clearly specified. A participant count can show how many people met the criterion, and a comparison between randomized groups can estimate the difference in the frequency of success. Those interpretations require the outcome counts and a defined analysis; the registry record does not give a single reduced comparison of the primary outcome categories or time points.
The endpoint timeframe is Day 29. The specified primary population is the Intent-to-Treat (ITT) population, with the record's parenthetical “Hours 3,6,9,12.” The registry does not explain that parenthetical further. It also does not report the number meeting the composite criterion in either group, an effect estimate, a confidence interval, or a p-value. Thus the endpoint definition can be described, but the posted primary outcome cannot be used to quantify the treatment-group contrast from the information recorded.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry record gives a well-defined primary success rule and identifies the population and timeframe, but it does not report a single reduced primary-outcome comparison. It notes that the primary outcome has several categories or time points and is not reduced to one comparison. Consequently, there is no posted primary success count by group, no between-group effect estimate, and no confidence interval or p-value to interpret. The hypothesis in the study description is not evidence that the hypothesis was confirmed.
A useful treatment comparison would ordinarily state how often composite success occurred in each randomized group and quantify the contrast between those groups. The counts would describe the observed data; an effect estimate would express the magnitude and direction of the comparison; and a confidence interval would communicate the range of values reasonably compatible with the data under the statistical method used. Without those primary-outcome results, the magnitude and precision of any difference are not reported in the registry record. It is not possible to determine from this record whether the observed data favor either group, or how uncertain a comparison would be.
The registry includes safety figures. For CD07805/47 gel, the serious adverse event count is 1 among 129 at risk; for placebo it is 0 among 131 at risk. Other adverse events are recorded as 0 among 129 at risk for CD07805/47 gel and 0 among 131 at risk for placebo. These are descriptive registry counts, not a substitute for the primary efficacy comparison. The record lists “Accidental drug intake by child” at 0.8% among top serious terms, but does not specify the denominator or link that term to a particular group in the information recorded. Deaths are not reported in the registry record.
The safety counts are small as posted, and a count of zero is not proof that an event cannot occur. As a general statistical principle, estimates based on sparse events are imprecise, and a comparison based on very few events should be interpreted cautiously. No uncertainty interval or inferential comparison for the safety counts is reported in the registry record. The meaning of the at-risk denominators, follow-up completeness, and event-collection procedures are also not described in detail.
The registry lists a planning illustration based on the observed effect and specifies its assumptions: two-sided significance level 0.05, equal allocation, and a normal approximation, with the effect to detect expressed as a fraction of the observed effect. Such values are planning illustrations rather than outcomes observed in the trial. They are not observed power. The record does not provide a protocol-based sample-size justification, and the absence of a reduced primary comparison limits what can be inferred from the posted results about the underlying effect.
9. Statistical Methods Explained
The registry identifies a randomized, double-blind, parallel-group design and a binary primary endpoint measured as participants meeting a composite success rule. The endpoint requires a 2-grade improvement on both CEA and PSA at Day 29. These features describe the intended comparison and outcome definition, but they do not by themselves specify the statistical analysis used for the trial. A detailed statistical plan is not reported in the registry record.
What does randomization contribute?
As a general principle, randomization assigns participants to treatment groups by chance. It is used to reduce systematic differences between groups at the start of a study, including differences in factors that may not be measured. Randomization supports a fair comparison, but it does not ensure perfect balance in every characteristic, particularly in a finite study. The registry states that allocation was randomized but does not report the sequence-generation method, concealment process, or any stratification factors. Those features therefore cannot be evaluated from the registry record.
How should a binary endpoint be compared?
For a binary endpoint, each participant is classified according to whether the stated success criterion was met. A treatment comparison can then describe the number meeting the criterion in each group and use a suitable effect measure to express the difference between groups. Common effect measures have different interpretations, so the measure should be named and defined alongside the estimate. The registry record does not report the group-specific primary success counts or a single comparison, and it does not identify an effect measure or statistical test for that comparison.
A confidence interval is, in general, a way to show the precision of an estimated effect. A narrower interval indicates greater precision under the model and method used, while a wider interval indicates greater uncertainty. It does not guarantee that the true effect lies within the particular interval, nor does it by itself determine whether a result is important. No primary-outcome confidence interval is reported in the registry record. A p-value, also not reported for the primary outcome, would address compatibility of data with a specified null model under the test assumptions; it would not measure the size or clinical importance of an effect.
What is the role of the composite criterion?
The endpoint combines assessments from a clinician and a participant by requiring improvement on both. As a general matter, this type of rule can represent success across more than one perspective, but it also means that a participant who meets only part of the rule is not counted as a composite success under the stated definition. The interpretation depends on the exact grading scales, how assessments were conducted, and how missing or discordant assessments were treated. Those operational details are not reported in the registry record. The record also does not describe whether the threshold or composite definition was prespecified in a protocol.
What can the planning assumptions tell the reader?
The registry describes a planning illustration based on the observed effect, with a two-sided significance level of 0.05, equal allocation, and a normal approximation. It states that the effect to detect is a stated fraction of the observed effect. In general, a planning calculation asks what sample size would be needed under specified assumptions to detect a target effect at a chosen significance level and power. It is not a calculation of the probability that the completed trial's findings are true, and it is not observed power. The record's illustration is not a substitute for a design justification documented in the protocol. The protocol-based sample-size rationale and the trial's prespecified power target are not reported in the registry record.
The posted record does not show the numeric planning values in the registry record described for this analysis, so no planning sample size can be interpreted. In particular, a planning value should not be confused with the actual enrollment of 260, which is the enrollment recorded for the completed study. The illustration's assumptions also do not establish that the same assumptions were used in the trial's own design or analysis.
Why do distributional assumptions matter?
As a general concept, a normal approximation is a mathematical method that can be used for some planning calculations. Its adequacy depends on the outcome and the assumptions behind the calculation. For binary outcomes, the distribution of counts and the method used to estimate uncertainty matter; the record does not describe the analysis method for the primary endpoint. Over-dispersion is relevant in settings where observed variability exceeds what a chosen model expects. When present, a model that assumes less variability than the data contain can understate uncertainty and make intervals too narrow. The registry record does not report an over-dispersion assessment or indicate that such a model was used, so this is a general consideration rather than a claim about this study.
For safety outcomes, sparse counts require particular care. A zero count in a group is an observed count, not proof that the underlying risk is zero. A formal comparison would need a defined outcome window, denominators, an appropriate method, and an uncertainty estimate. These are not reported for the safety figures in the registry record. Accordingly, the posted counts support a descriptive reading only.
10. Multiplicity, Missing Data and Analysis Populations
The primary outcome is explicitly described as having several categories or time points and not being reduced to one comparison. That leaves an important interpretation gap: the registry record does not identify a single primary contrast to which an effect estimate and uncertainty interval can be attached. It also does not report whether categories or time points were prespecified as separate analyses, whether one was designated as primary for inference, or how multiple comparisons were handled. Those details are not reported in the registry record.
As a general statistical principle, evaluating several outcomes, time points, or comparisons can increase the chance of a seemingly notable result arising by chance if each is interpreted separately without a plan. Multiplicity procedures may control that risk, but the appropriate approach depends on the hypotheses and analysis plan. No multiplicity adjustment or hierarchy is reported in the registry record. The available description is therefore insufficient to assess how confirmatory claims would have been protected against multiple testing.
The stated primary population is the Intent-to-Treat (ITT) population, with the parenthetical “Hours 3,6,9,12.” The registry does not explain how participants with missing endpoint assessments, protocol deviations, or treatment discontinuation were handled. It does not report the number analyzed for the primary outcome, missing outcome counts, imputation methods, or sensitivity analyses. These matters are not reported in the registry record.
In general, missing outcome data can affect a treatment comparison if the likelihood of missingness differs between groups or relates to the outcome. An ITT label alone does not explain the analysis rules or resolve missing-data concerns. The registry record identifies the population label but does not provide enough detail to evaluate the implementation of that analysis population. The statistical analysis plan and the procedures used for missing data are not reported in the registry record.
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 |
|---|---|---|---|
| CD07805/47 Gel | 1 | 129 | 0.8% |
| Placebo | 0 | 131 | 0.0% |
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 |
|---|---|
| CD07805/47 Gel | 0 of 129 |
| Placebo | 0 of 131 |
Most frequent serious adverse event terms
| Event term | Organ system | CD07805/47 Gel | Placebo |
|---|---|---|---|
| Accidental drug intake by child | Injury, poisoning and procedural complications | 1 of 129 | 0 of 131 |
Serious events with the highest arm-level rate: accidental drug intake by child (0.8%).
The registry reports serious adverse events for each group using counts and at-risk denominators. In the CD07805/47 gel group, 1 serious adverse event is recorded among 129 at risk. In the placebo group, 0 serious adverse events are recorded among 131 at risk. Other adverse events are recorded as 0 among 129 at risk for CD07805/47 gel and 0 among 131 at risk for placebo. These are the counts as recorded, and they should be read separately for each group.
The registry lists “Accidental drug intake by child” at 0.8% among the top serious terms. The information recorded does not identify the denominator for that percentage or specify the group associated with the term, so it should not be assigned to an arm or treated as a group-specific rate. Deaths are not reported in the registry record.
As a general statistical principle, a small count or a zero count does not establish that an event is absent from the broader population. The denominators and event counts are descriptive; without uncertainty estimates, follow-up details, or a defined comparative analysis, they do not quantify the precision of a safety difference. The registry record does not provide those details for these figures. The counts also do not by themselves establish causation or explain the clinical context of an event.
12. What the Result Does, and Does Not, Mean
The posted information establishes the design and the definition of the planned primary endpoint: a Day 29 composite success required a 2-grade improvement on both CEA and PSA. It also records a completed, randomized, double-blind, parallel-group Phase 3 study of CD07805/47 gel against placebo, with enrollment of 260. These are details about the study design and endpoint, not proof of an efficacy result.
The record does not provide a single reduced primary-outcome comparison, and it does not give group-specific composite success counts, an effect estimate, a confidence interval, or a p-value. As a result, the magnitude, direction, and precision of the primary treatment contrast are not reported in the registry record. The study hypothesis that the gel would be more efficacious than vehicle is not a finding and should not be read as one. No conclusion about whether the primary endpoint favored either group can be drawn from the posted primary-outcome information.
The safety figures are descriptive counts: 1 serious adverse event among 129 at risk in the gel group and 0 among 131 at risk in the placebo group; other adverse event counts are 0 among 129 and 0 among 131, respectively. The top serious term is reported as “Accidental drug intake by child” at 0.8%, without a specified denominator or group association in the information recorded. These figures do not provide a full account of safety, a precise comparison, or evidence of causation. Deaths are not reported in the registry record.
As a general statistical principle, findings from a randomized study are interpreted through the results actually reported, the analysis methods, and the uncertainty around estimates. The available description does not report the analysis details needed to evaluate those elements for the primary endpoint. It also does not establish how missing data were handled or how multiple categories and time points were addressed. The appropriate interpretation is therefore bounded: the registry gives the study framework and some safety counts, but does not report a single primary efficacy comparison from which an effect or its precision can be assessed.
13. Why This Trial Matters Statistically
This trial is statistically notable because its registry record combines a clearly named composite endpoint with an outcome description that is not reduced to one comparison. A composite endpoint can be useful when success is intended to capture more than one assessment; here, the rule requires improvement on both clinician and patient assessments. That clarity in the definition helps explain what success would mean, but it does not replace the group-level outcome data needed to interpret an effect.
The design is described as randomized, double-blind, parallel-group, and vehicle-controlled. In general, randomization and masking can support a credible treatment comparison by limiting some forms of bias, while a parallel-group structure makes the groups the basis for comparison. Their value to interpretation depends on implementation and analysis details, which are not reported in the registry record. The design labels alone cannot show whether the endpoint result was precise or whether the analysis followed a prespecified plan.
The registry also illustrates why readers should separate outcome definitions, observed results, and planning calculations. An endpoint definition explains how success is classified. A result reports what was observed. A planning illustration describes assumptions for a hypothetical design calculation and is not an observed treatment effect or observed power. The record gives planning assumptions but does not provide a single reduced primary-outcome result to interpret alongside them.
Finally, the safety counts show why context and uncertainty matter. Sparse counts can be described accurately, but without analytic details or uncertainty estimates they do not support a precise comparative conclusion. Taken together, the record is useful for understanding the trial's design, endpoint, and recorded safety counts, while leaving important questions about the primary effect and analysis unresolved.
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 direct limitation is that the registry record does not reduce the primary outcome's several categories or time points to one comparison. It therefore does not provide a single primary success count by group or an effect estimate with uncertainty. The endpoint definition and Day 29 timeframe are recorded, but the outcome data needed to assess the treatment contrast are not reported in the registry record.
Further limitations concern analysis transparency. The statistical plan, primary comparison method, multiplicity approach, missing-data procedures, and sensitivity analyses are not reported in the registry record. The primary population is labeled ITT, but the record does not explain the handling of missing assessments, treatment discontinuation, or protocol deviations. The parenthetical “Hours 3,6,9,12” accompanying the population description is not explained.
The endpoint requires improvement on both CEA and PSA, but details of the scales, assessment procedures, and rules for incomplete or discordant assessments are not reported in the registry record. The randomization and masking labels are present, but the methods used to generate and conceal allocation and maintain masking are not described. The number of centers and additional eligibility criteria are not reported in the registry record.
Safety information is also limited. The record provides serious and other adverse event counts with at-risk denominators, but does not give uncertainty estimates, event follow-up details, or a comparative safety analysis. The top serious term is associated with a percentage whose denominator and group are not specified in the recorded information. Deaths are not reported in the registry record. These limitations constrain interpretation of the posted safety data and should not be filled by assumptions.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Phase 3 Efficacy and Safety Study of CD07805/47 Topical Gel in Subjects With Facial Erythema Associated With Rosacea — NCT01355458.
- Registry record last updated 2021-02-18; status last verified 2013-09.
- Results first posted 2013-11-21.
- 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
NCT01355458 is a completed Phase 3 randomized, double-blind, parallel-group study of topical CD07805/47 gel versus vehicle/placebo for facial erythema associated with rosacea. The official title describes multicenter conduct and once-daily application. Enrollment was 260; the recorded start was 2011-05 and primary completion was 2011-09.
The primary endpoint is Composite Success at Day 29, defined as a 2-grade improvement on both CEA and PSA in the stated ITT population. The registry record notes that the primary outcome has several categories or time points and is not reduced to one comparison, and does not report group-specific primary success counts or an effect estimate. Serious adverse events are recorded as 1 among 129 at risk for CD07805/47 gel and 0 among 131 at risk for placebo. Other adverse events are recorded as 0 among 129 and 0 among 131, respectively. The top serious term is listed at 0.8%; its denominator and group association are not specified in the recorded information.