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 of Rosacea (NCT01789775), a randomized phase 3 study. The primary outcome is Composite Success Assessment (CEA) and Patient Self Assessment(PSA)..
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT01789775 |
| Phase | Phase 3 |
| Condition | Rosacea |
| Allocation | Randomized |
| Design model | Parallel |
| Masking | Double |
| Enrollment | 114 |
| Arms in the primary outcome | n/a |
| Lead sponsor | Galderma R&D |
| Results posted | Yes |
2. Clinical Question
Population
The study enrolled subjects with facial erythema associated with rosacea. The registry record lists an enrollment of 114 participants. It does not provide further eligibility details or a description of the analyzed population, so the characteristics of participants included in the endpoint analysis are not reported in the registry record.
Intervention
The intervention was CD07805/47 topical gel, described in the study summary as applied once daily. The registry record identifies the gel as the study drug, but it does not report an efficacy result for participants assigned to it.
Comparator
The comparator was CD07805/47 gel placebo, described as placebo. The trial was randomized, double-masked, and parallel. The registry record does not describe the precise procedures used to maintain masking or the allocation process.
Primary question
The primary endpoint was the number of participants with Composite Success Assessment (CEA) and Patient Self Assessment (PSA) success at Day 29. Success required a 1-grade improvement on both the Clinician Erythema Assessment and the Patient Self Assessment. The central efficacy question is whether the proportion meeting that combined criterion differed between the gel and placebo groups. The registry record does not report the group counts, an effect estimate, or an uncertainty interval for this endpoint, so that question cannot be answered from the posted results.
3. Trial Design
This was a Phase 3, randomized, double-masked, parallel study of CD07805/47 topical gel in subjects with facial erythema associated with rosacea. The registry record lists 114 participants enrolled. The study began in 2012-12, reached primary completion in 2013-10, and is marked completed. Galderma R&D is listed as the sponsor.
The intervention was CD07805/47 gel, and the comparator was a gel placebo. The brief study summary describes the active gel as applied topically once daily. A parallel design assigns participants to a study group and compares outcomes between groups rather than comparing each participant under both treatments. Randomization is intended to support a fair comparison by distributing participant characteristics across groups, while masking can reduce the influence of treatment knowledge on care, assessment, and reporting. Those are general features of these design methods; the registry record does not describe the exact randomization or masking procedures used in this trial.
The primary outcome was defined at Day 29 and combined clinician assessment with participant self-assessment. The record lists a secondary outcome as Composite Success Assessment (CEA) and Patient Self Assessment (PSA), but does not provide a distinct secondary result. It lists two outcome measures and no analysis entries. The primary endpoint is described as having several categories or time points and was not reduced to one comparison in the registry record. As a result, the design and endpoint can be described, but the principal between-group efficacy finding cannot be reconstructed from the posted results.
The record does not report the planned sample-size justification, detailed eligibility criteria, treatment duration beyond the endpoint timeframe, or the statistical analysis plan. Those details should not be inferred from the study's phase, allocation, or enrollment.
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 | CD07805/47 Gel |
|---|---|---|
| STARTED | 55 | 57 |
| COMPLETED | 53 | 50 |
| NOT COMPLETED | 2 | 7 |
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 | CD07805/47 Gel | Total |
|---|---|---|---|---|
| Participants analysed | 55 | 57 | 112 | |
| Age, Continuous | years | 44.9 (SD 12.1) | 43.2 (SD 10.8) | 44.0 (SD 11.4) |
| Age, Categorical: <=18 years | Participants | 0 | 0 | 0 |
| Age, Categorical: Between 18 and 65 years | Participants | 51 | 56 | 107 |
| Age, Categorical: >=65 years | Participants | 4 | 1 | 5 |
| Sex: Female, Male: Female | Participants | 40 | 41 | 81 |
| Sex: Female, Male: Male | Participants | 15 | 16 | 31 |
| Region of Enrollment: France | participants | 6 | 8 | 14 |
| Region of Enrollment: Russian Federation | participants | 46 | 46 | 92 |
| Region of Enrollment: Sweden | participants | 3 | 3 | 6 |
6. Primary Endpoint
The registry lists the primary outcome as Composite Success Assessment (CEA) and Patient Self Assessment(PSA)., measured over Day 29.
| Element | Registry entry |
|---|---|
| Result type | Number |
| Measure of spread | not applicable |
| Unit | participants |
| Endpoint classification | Binary Endpoint |
The primary endpoint counts participants who achieved Composite Success Assessment (CEA) and Patient Self Assessment (PSA) success at Day 29. The registry definition requires a 1-grade improvement on both the Clinician Erythema Assessment and the Patient Self Assessment. It is therefore a combined endpoint: participants must satisfy the clinician-based and patient-reported criteria together to count as successes.
Combining measures can represent more than one perspective on an outcome. In general, a clinician assessment captures an evaluator's structured judgment, while a patient self-assessment captures the participant's own rating. Requiring improvement on both means the endpoint does not classify improvement on only one measure as composite success. This can make the endpoint stricter than a measure based on either assessment alone, but it also means interpretation depends on how both component scales are defined and administered. Their grading details are not reported in the registry record.
A participant count is useful for communicating how many people met a prespecified success definition. For a comparison between randomized groups, counts are commonly interpreted alongside the numbers assessed in each group and an effect estimate with an uncertainty interval. Here, the endpoint timeframe is reported, but the group-specific success counts and an inferential comparison are not reported in the registry record. The listed endpoint definition alone does not show whether the groups differed.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry record establishes the study question and the endpoint definition, but it does not provide the primary efficacy results needed to evaluate the comparison. The endpoint was composite success at Day 29: a 1-grade improvement on both the Clinician Erythema Assessment and the Patient Self Assessment. However, group-specific counts meeting that definition, an effect estimate, a confidence interval, and a statistical test result are not reported in the registry record.
Without those quantities, the direction and size of the observed difference cannot be described. It is also not possible to assess how precisely the data estimate any between-group difference or whether the posted results support a statistical conclusion. The absence of an analysis entry is not itself evidence that the groups were equivalent, nor does it establish that no analysis was performed outside the registry. It means that such an analysis is not available in the registry record.
The trial enrolled 114 participants. The safety information is separate from the primary efficacy endpoint: the record lists serious adverse event counts of 0 among 55 participants in the placebo group and 1 among 57 participants in the gel group. It also lists other adverse event counts of 0 among 55 placebo participants and 10 among 57 gel participants. These counts describe the posted safety entries; they do not replace the missing efficacy comparison. The registry record does not provide enough detail to infer causes, timing, severity beyond the serious-event designation, or comparative risk.
The listed serious-event term is “Angiodema,” with 1.8% recorded. That term and percentage should be read as registry entries rather than as a complete account of all possible adverse events. Death counts are not reported in the registry record. The lack of a reported death count should not be interpreted as confirmation that no deaths occurred.
In general, an effect estimate describes the observed contrast between groups, while a confidence interval communicates the range of values compatible with the data under the analysis assumptions. Neither is available for this primary outcome in the registry record. Thus, readers can identify what the trial set out to measure and can describe the posted safety counts, but cannot use this record alone to quantify the efficacy result or its precision.
9. Statistical Methods Explained
The trial is described as randomized, double-masked, and parallel. In general, randomization assigns participants to groups using a chance-based process, helping limit systematic differences between groups at enrollment. Double masking is intended to reduce the influence of treatment knowledge on participants and relevant study personnel. A parallel design compares groups followed under separate assignments. The registry record gives these design labels but does not describe the sequence generation, concealment, masking procedures, or any departures from the assigned groups.
What does the endpoint count?
The primary outcome is binary at the participant level: each participant either meets the defined composite success criterion or does not. The criterion requires a 1-grade improvement on both CEA and PSA at Day 29. For a binary endpoint, a group count is often presented with the number of participants assessed, and the groups may then be compared using a difference or ratio of success probabilities. Such estimates need uncertainty measures to show how much precision the observed data support. The registry record does not report the primary outcome counts, effect estimate, confidence interval, or test result, so no such comparison can be explained for this trial.
Why does the combined definition matter?
General interpretation of a composite endpoint depends on its components and on the rule for combining them. Here, success requires improvement on both clinician and patient assessments, not just one. The rule identifies a particular kind of joint response, but it does not reveal which component might account for a result if results were available. The registry record does not provide component-specific counts, scale details, or separate results for CEA and PSA. Consequently, the relative contribution of clinician ratings and self-assessments is not reported in the registry record.
What can a confidence interval tell readers?
In general, a confidence interval expresses the uncertainty around an estimated effect under a specified statistical model and procedure. A narrow interval indicates greater precision than a wide interval, while an interval that includes values representing no difference may be compatible with little or no group separation as well as other effects within its bounds. These concepts require an estimate and interval to interpret. Neither is reported for the primary comparison, so the trial's precision cannot be assessed from the registry record.
What is the role of a significance test?
In general, a statistical test evaluates how compatible the observed data are with a null hypothesis under its assumptions. A p-value is not the probability that the null hypothesis is true and does not describe the magnitude or clinical importance of an effect. The registry record has no analysis entries and does not report a p-value for the primary endpoint. No significance conclusion should therefore be attributed to the registry record.
How should planning illustrations be understood?
In general, sample-size planning asks how many participants may be needed to detect a chosen effect under stated assumptions, including a significance level, allocation, and statistical model. The registry record's planning description specifies a two-sided significance level of 0.05, equal allocation, and a normal approximation, with the effect set as a stated fraction of the observed effect. These are planning assumptions, not evidence about the observed endpoint result. The description explicitly characterizes such calculations as planning illustrations based on the observed effect, not as the trial's own design. They are not observed power, and they do not substitute for reporting the actual group outcomes and their uncertainty. The registry record does not provide the trial's sample-size justification.
Why can over-dispersion matter?
In general, over-dispersion arises when observed variability is greater than a statistical model assumes. If a model underestimates variability, uncertainty intervals can be too narrow and tests can appear more decisive than the data warrant. This consideration is relevant when a chosen model relies on restrictive assumptions about variability. The registry record does not report a model for the primary endpoint or information that would establish whether over-dispersion was assessed. No model-specific conclusion can be drawn for this study.
Overall, the design labels and endpoint definition identify the intended comparison, while the missing outcome analysis prevents a statistical interpretation of efficacy. The registry record does not report enough detail to assess covariate adjustment, the analysis population, handling of incomplete observations, or the statistical procedure used for the endpoint.
10. Multiplicity, Missing Data and Analysis Populations
Multiplicity arises when a study evaluates multiple outcomes, comparisons, time points, or analyses. In general, making many statistical tests can increase the chance of obtaining an apparently unusual result by chance. A prespecified plan may identify a primary comparison and describe whether and how testing across outcomes is controlled. The registry record lists two outcome measures and identifies the primary endpoint at Day 29, but does not report a multiplicity strategy or a statistical analysis plan.
The primary outcome description is identified as having several categories or time points and was not reduced to one comparison in the registry record. This means the posted record does not supply a single primary estimate to interpret. The record also does not provide a hierarchy of endpoints, adjustment procedure, or results across the listed measures. These details are not reported in the registry record and should not be inferred.
Missing-data handling is also not reported in the registry record. It does not state how participants with absent Day 29 assessments, incomplete CEA or PSA measurements, or other unavailable data were handled. Nor does it describe whether analyses used all randomized participants, participants who received treatment, or another analysis population. The enrollment count alone does not establish how many participants contributed to the primary endpoint.
In general, missing outcome data can affect both the estimated group contrast and its precision, especially if the likelihood of missingness differs across groups or relates to the outcome. Assessing that possibility requires information about completeness, reasons for missingness, and analysis choices. Those details are not reported in the registry record. Therefore, the primary efficacy result, its multiplicity context, and the effect of missing data cannot be assessed from the posted registry information.
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 Placebo | 0 | 55 | 0.0% |
| CD07805/47 Gel | 1 | 57 | 1.8% |
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 Placebo | 0 of 55 |
| CD07805/47 Gel | 10 of 57 |
Most frequent serious adverse event terms
| Event term | Organ system | CD07805/47 Gel Placebo | CD07805/47 Gel |
|---|---|---|---|
| Angiodema | Skin and subcutaneous tissue disorders | 0 of 55 | 1 of 57 |
Most frequent non-serious adverse event terms
| Event term | Organ system | CD07805/47 Gel Placebo | CD07805/47 Gel |
|---|---|---|---|
| Rosacea | Skin and subcutaneous tissue disorders | 0 of 55 | 7 of 57 |
| Erythema | Skin and subcutaneous tissue disorders | 0 of 55 | 3 of 57 |
Serious events with the highest arm-level rate: angiodema (1.8%).
The registry record lists serious adverse events for 0 of 55 participants in the CD07805/47 gel placebo group and 1 of 57 participants in the CD07805/47 gel group. It lists other adverse events for 0 of 55 placebo participants and 10 of 57 gel participants. These are counts as recorded, not a complete comparative safety analysis. The record does not describe event definitions, follow-up duration for safety, severity grading beyond the serious designation, or the method used to determine whether an event was related to study treatment.
“Angiodema” is listed as the leading serious-event term, with 1.8% recorded. This spelling is retained from the registry record. A listed term and percentage do not provide information about the clinical circumstances or establish causation. Death counts are not reported in the registry record; an unreported count should not be read as zero.
In general, sparse event counts can yield imprecise comparisons, and simple counts do not account for differences in exposure time or participant characteristics. No adjusted safety estimate or uncertainty interval is reported. The posted counts should therefore be described as registry entries, not as proof for or against a safety difference.
12. What the Result Does, and Does Not, Mean
The record shows that a randomized, double-masked, parallel Phase 3 study evaluated CD07805/47 topical gel against gel placebo in subjects with facial erythema associated with rosacea. It defines primary success as a 1-grade improvement on both the Clinician Erythema Assessment and Patient Self Assessment at Day 29. It also records adverse-event counts for the two groups.
Those details do not establish the primary efficacy result. The group-specific number of participants achieving composite success is not reported in the registry record, and neither an effect estimate nor an uncertainty interval or test result is available. It is therefore not possible to say from this record whether the groups differed, how large any difference was, or how precise an estimate might have been. This absence of a reported comparison is not evidence of no difference.
The safety counts also have limits. They do not by themselves identify event causes, account for time at risk, describe all aspects of event severity, or establish a comparative safety profile. The serious adverse event term and percentage are registry entries, while deaths are not reported in the registry record. Neither the missing efficacy results nor the limited safety information should be filled in by assumptions.
In general, conclusions from a clinical trial depend on its analysis population, methods, completeness of follow-up, estimates, and uncertainty. The registry information available for this study is sufficient to describe its design, intended endpoint, and some safety counts, but not to judge the magnitude or precision of its efficacy result. Readers should distinguish an endpoint definition from a reported outcome: knowing what the trial intended to measure does not reveal what the measured results were.
13. Why This Trial Matters Statistically
This study illustrates a basic distinction in clinical-trial interpretation: a clearly defined endpoint is not the same as a reported endpoint result. The registry record specifies a combined success criterion at Day 29, requiring improvement on both clinician and participant assessments. That definition tells readers what would count as success, but without group counts and a comparison estimate it does not answer whether success differed between the randomized groups.
The design labels also matter, but they cannot replace outcome data. Randomization and masking are intended to support fair comparisons and reduce certain sources of bias. Their presence does not guarantee that the results are precise or that all potential biases have been removed. Assessing those issues requires details about implementation, analysis populations, missing observations, and outcome reporting, much of which is not reported in the registry record.
The record is also a useful reminder that safety counts and efficacy outcomes answer different questions. The listed adverse-event counts describe recorded events in the groups, while the primary endpoint concerns a combined assessment of facial erythema. Neither type of information can stand in for the other. Sparse safety counts also require careful description without overinterpreting causality or comparative risk.
Finally, planning calculations and observed evidence serve different purposes. General planning illustrations describe what assumptions might imply for a future or planned study; they are not observed power and cannot substitute for the study's endpoint estimates. Here, the registry record does not provide the primary comparison needed to interpret efficacy. The statistical lesson is to separate what was planned, what was defined, and what was actually reported.
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 main trial-specific limitation in the registry record is that it defines the primary endpoint but does not report the endpoint counts or a comparison between groups. Because the record lists no analysis entries, the efficacy effect and its precision cannot be assessed. The endpoint description also refers to several categories or time points and was not reduced to one comparison, leaving no single primary estimate to interpret.
Other details needed for a full statistical appraisal are not reported in the registry record. These include the planned sample-size justification, analysis populations, handling of missing assessments, the statistical model and test, any adjustment for multiplicity, and component-specific CEA and PSA results. Eligibility criteria and details of randomization and masking procedures are also not provided in the record.
The safety entries are limited to the reported counts and the listed serious-event term. The registry record does not provide event timing, exposure-adjusted rates, attribution, fuller severity information, or death counts. These omissions limit interpretation of the safety information and prevent a complete comparison across groups.
These limitations concern what can be concluded from the registry record; they do not establish that analyses or additional study documentation do not exist elsewhere. They do mean that the posted information alone cannot support a quantitative conclusion about the primary efficacy comparison or a detailed assessment of the trial's statistical conduct.
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 of Rosacea — NCT01789775.
- Registry record last updated 2014-10-20; status last verified 2014-10.
- Results first posted 2014-10-20.
- Data retrieved from ClinicalTrials.gov on 2026-11-09.
- Group sizes, means, event counts and sponsor-reported p-values are reproduced as posted. Effect estimates, confidence intervals and p-values not attributed to the sponsor are independently calculated from the posted summary statistics.
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18. Record Summary
The registry record describes a completed Phase 3 randomized, double-masked, parallel study sponsored by Galderma R&D. It enrolled 114 subjects with facial erythema associated with rosacea and compared CD07805/47 topical gel with gel placebo. The study began in 2012-12 and reached primary completion in 2013-10.
The primary endpoint was composite success at Day 29, defined as a 1-grade improvement on both the Clinician Erythema Assessment and Patient Self Assessment. Primary endpoint group counts and a statistical comparison are not reported in the registry record. The record lists serious adverse event counts of 0 among 55 placebo participants and 1 among 57 gel participants, and other adverse event counts of 0 and 10, respectively. Death counts are not reported in the registry record.