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 Study of CD07805/47 Topical Gel in Subjects With Facial Erythema Associated With Rosacea (NCT01318733), a non-randomized phase 3 study. The primary outcome is Long Term Safety & Efficacy of CD07805/47 Gel 0.5% in Subjects With Moderate to Severe Facial Erythema Associated With Rosacea..
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT01318733 |
| Phase | Phase 3 |
| Condition | Rosacea |
| Allocation | Non-Randomized |
| Design model | Single Group |
| Masking | None (open label) |
| Enrollment | 449 |
| 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 registry record lists an enrollment of 449.
Intervention
CD07805/47 gel 0.5%, applied topically once daily. The official title describes treatment for up to 52 weeks.
Comparator
No concurrent comparator is listed. The study is described as non-randomized, open-label, and single-group, so its design does not provide a like-for-like control group.
Primary question
How did Clinician Erythema Assessment scores change from baseline at T3 of post-baseline visits? The registry describes the assessment timeframe as “Over 1 year.”
The clinical question is descriptive: it concerns change in a clinician-rated erythema score during long-term use of the gel, rather than a difference between randomized groups. The primary outcome description refers to change from baseline CEA at T3 of each post-baseline visit, including Day 1. It identifies the measure and timing, but does not report a numerical mean change, standard deviation, confidence interval, or test result.
Because no comparator is listed, the record cannot directly answer how the score trajectory compares with no treatment, usual care, or another intervention. A change observed over time in a single group can be described, but it does not by itself separate treatment-related change from other influences, including natural variation, expectations, or changes in assessment. The registry record also does not report an outcome population beyond the general study description. These features define the scope of what can be interpreted from the posted record.
3. Trial Design
This is a Phase 3, multicenter, open-label, non-randomized, single-group study sponsored by Galderma R&D. Its title describes long-term safety and efficacy evaluation of CD07805/47 gel 0.5%, applied topically once daily for up to 52 weeks, in subjects with moderate to severe facial erythema associated with rosacea. The registry lists 449 participants as enrolled and marks the study completed.
The design has no randomized allocation and no masking. A single intervention group received the gel; no control arm is described in the record. Accordingly, the study is not a head-to-head comparison. Its efficacy outcome is framed as change from baseline in the Clinician Erythema Assessment score, while the record also reports adverse-event counts for the intervention group.
The registry dates the study start as 2011-03 and primary completion as 2012-06. The primary outcome timeframe is worded “Over 1 year,” while the official title specifies treatment for up to 52 weeks. The record does not explain the relationship between those descriptions or provide visit-level schedules beyond the primary outcome wording.
Open-label means that masking is listed as none; the record does not describe masked outcome assessment. In general, when participants and assessors know the intervention, expectations and assessment practices can influence subjective ratings. A single-group design also leaves no concurrent control trajectory against which to compare change. These are design considerations, not claims that a particular bias occurred in this trial.
The registry does not report the protocol’s sample-size justification, eligibility details beyond the condition and severity description, or the full analysis plan. It also does not report numerical primary outcome results. The design therefore establishes the setting and intended measurement, but the posted record does not establish the magnitude or precision of observed change.
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 0.5% |
|---|---|
| STARTED | 449 |
| COMPLETED | 279 |
| NOT COMPLETED | 170 |
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 0.5% |
|---|---|---|
| Participants analysed | 449 | |
| Age, Categorical: <=18 years | Participants | 0 |
| Age, Categorical: Between 18 and 65 years | Participants | 395 |
| Age, Categorical: >=65 years | Participants | 54 |
| Age, Continuous | years | 50.9 (SD 12.08) |
| Sex: Female, Male: Female | Participants | 336 |
| Sex: Female, Male: Male | Participants | 113 |
| Region of Enrollment: United States | participants | 449 |
6. Primary Endpoint
The registry lists the primary outcome as Long Term Safety & Efficacy of CD07805/47 Gel 0.5% in Subjects With Moderate to Severe Facial Erythema Associated With Rosacea., measured over Over 1 year.
| Element | Registry entry |
|---|---|
| Result type | Mean |
| Measure of spread | Standard Deviation |
| Unit | scores on a scale |
| Endpoint classification | Continuous Endpoint |
The primary endpoint is described as change from baseline in Clinician Erythema Assessment (CEA) at T3 of each post-baseline visit, including Day 1. CEA is a clinician’s static evaluation of erythema severity. The registry gives the following grades: 0, clear skin with no signs of erythema; 1, almost clear with slight redness; 2, mild erythema with definite redness; 3, moderate erythema with marked redness; and 4, severe erythema with fiery redness. The outcome is listed as a mean measured in scores on a scale, with standard deviation as its dispersion measure.
In general, a graded clinical measure provides a structured way to record severity using defined categories. A change score expresses how a participant’s recorded score at follow-up differs from the baseline score. Reporting a group mean summarizes the average change, while the standard deviation describes variability among scores around that mean. Neither statistic alone shows the distribution of individual responses.
The CEA is used in this endpoint to quantify clinician-assessed facial redness over time. However, the registry record does not report the mean change, its standard deviation, visit-specific results, or an uncertainty interval. It therefore identifies what was intended to be measured but does not provide the numerical result needed to describe the amount or precision of change.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry record makes the intended outcome clear but does not post its numerical primary result. It lists a continuous mean outcome and standard deviation for CEA change from baseline, yet provides no mean change, dispersion estimate, confidence interval, or test result. The number of outcome measures listed is 1, and the number of analyses listed is 0. Without the result values, the direction and magnitude of the recorded score change cannot be characterized.
In general, a mean change describes the average within-group movement in scores, and the standard deviation indicates how spread out participant-level values are. A confidence interval, if reported, would communicate the statistical precision of an estimate under its assumptions. None of those numerical elements is available for the primary endpoint in the registry record. No claim about the size, consistency, or statistical significance of the change can therefore be supported from this record.
The single-group design is also important. Even if a mean change were available, it would describe change in the observed group, not a treatment-versus-control effect. Without a concurrent comparator, the data do not distinguish a treatment-associated change from other time-related or measurement influences. The registry itself flags that the study is not a randomized comparison and that its arms are not a like-for-like control comparison; the listed design has only one group.
The safety data are counts rather than comparative risk estimates. The registry lists 12 serious adverse events among 449 at risk and 101 other adverse events among 449 at risk for the gel group. These are descriptive totals in the posted record. They do not establish whether events were caused by the intervention, and the record does not provide a comparator for interpreting them comparatively. Deaths are not reported in the registry record.
The record names six serious adverse-event terms, each with a listed frequency of 0.2%: abscess tooth w/ secondary submandibular infection, osteoarthritis of left hip, advanced squamous cell carcinoma of the lung, COPD, encephalopathy, and invasive ductal carcinoma. The listed terms do not provide a full clinical account of timing, severity, relatedness, or participant-level overlap. The percentages should be read as the registry’s reported values, not as evidence about causation.
Thus, the posted information supports a description of the study design, endpoint definition, and reported adverse-event counts. It does not support a numerical efficacy interpretation, a treatment-versus-control estimate, or conclusions about statistical significance. Missing result information is not evidence that the outcome was unchanged; it means the numerical result is not reported in the registry record.
9. Statistical Methods Explained
The registry characterizes the primary outcome as continuous, with the parameter reported as a mean and dispersion reported as standard deviation. These terms describe a planned form of summary, not the result itself. The numerical mean and standard deviation for CEA change are not reported in the registry record, so no estimate of average change or its variability can be interpreted.
What does a mean change represent?
In general, a change score compares a follow-up measurement with a baseline measurement for the same participant. A group mean of those changes summarizes the average direction and size of the within-group movement. A mean can be useful for describing a group, but it can conceal varied individual trajectories: participants may have changes in different directions or of different magnitudes. The mean alone does not show how many participants improved, remained stable, or worsened. Those participant-level summaries are not reported in the registry record.
What does the standard deviation add?
In general, the standard deviation describes the spread of observed values around the mean. A larger spread indicates greater variability in the measured values, while a smaller spread indicates that values are more concentrated around the mean. It is not the same as a standard error or a confidence interval. The standard deviation describes variation among observations; a standard error describes uncertainty in an estimated mean under a statistical model. The registry names standard deviation as the dispersion measure but does not report its value for the primary outcome.
How should the CEA scale be understood?
The registry defines CEA grades from 0, clear skin with no signs of erythema, through 4, severe erythema with fiery redness. Grades 1, 2, and 3 describe increasing levels from almost clear with slight redness, through mild erythema with definite redness, to moderate erythema with marked redness. In general, the categories give clinicians a common framework for describing severity. A mean calculated from an ordinal grade treats score steps as numerically usable for averaging; that summary may be informative, but the categories themselves remain ordered descriptions rather than direct physical units. The record does not report additional analyses of the score distribution.
What does the single-group design allow?
In general, repeated observations in one group can describe how outcomes change over time. They do not by themselves show what would have happened to the same group without the intervention. A randomized concurrent comparator can help estimate a between-group contrast by balancing, on average, measured and unmeasured influences under appropriate conditions. This trial is listed as non-randomized, open-label, and single-group, with no comparator. It therefore does not provide that controlled contrast. This limits causal interpretation even if an outcome estimate were reported.
What can be said about the planning illustrations?
The registry’s planning assumptions describe illustrations based on an observed effect, with a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation. They describe planning for specified portions of the observed effect. For non-time-to-event outcomes, the stated convention is participants per arm for 80% power or other specified power levels; time-to-event illustrations use a total event count. These are planning illustrations, not observed power. The numerical effect and illustration values are not reported in the registry record, and the study itself is single-group rather than a two-arm randomized comparison. The protocol’s own sample-size justification is not reported in the registry record.
In general, power calculations describe how a future design might perform under specified assumptions. They do not measure the probability that a result is true, and they cannot replace a confidence interval or an effect estimate. A calculation based on an observed effect can be especially dependent on that estimate; the result can be unstable when the effect estimate is imprecise. No numerical calculation is available to evaluate, and no calculation should be read as the trial’s observed power.
Why can over-dispersion matter?
In general, over-dispersion refers to variability in data that is greater than a statistical model assumes. When a model underestimates variability, its uncertainty estimates can be too small, which can make results appear more precise than they are. This is a general consideration for statistical modeling, not a reported feature or analysis of this study. The registry does not describe a model for the primary endpoint, a distributional assessment, or any adjustment for over-dispersion.
More broadly, precision depends on the variability in the data, the amount of information available, and the assumptions of the analysis. Reporting a point estimate without an uncertainty measure would limit assessment of precision; in this case, neither the primary estimate nor an interval is reported. The record also does not report a hypothesis test, p-value, or adjusted estimate. Statistical significance and clinical importance cannot be assessed from the endpoint description alone.
10. Multiplicity, Missing Data and Analysis Populations
The registry lists 1 outcome measure and 0 analyses. It identifies a primary CEA change outcome, but does not report numerical results or explain whether additional visits, subgroups, or outcome summaries were tested. Multiplicity procedures, including any adjustment for multiple testing or selection of a visit for emphasis, are not reported in the registry record.
In general, multiplicity arises when several hypotheses or comparisons are evaluated: the chance of at least one false-positive finding can increase as the number of tests grows. Prespecified testing strategies can address that concern, but the registry record does not describe such a strategy. It is not possible to determine from the posted information whether multiplicity was relevant to the full analysis or how it was handled.
Missing-data methods are not reported in the registry record. The record does not state how participants with incomplete follow-up or unavailable CEA scores were handled, whether any values were imputed, or whether sensitivity analyses were conducted. It also does not identify the analysis population for the primary endpoint. The enrollment figure alone does not establish how many participants contributed endpoint data at any visit.
In general, missingness can affect an estimate when availability of measurements is related to participant characteristics or outcomes. Different assumptions and analysis methods can lead to different results, so transparent reporting is needed to assess robustness. No assumptions or methods can be inferred from the registry information. As a result, neither the impact of missing data nor the relationship between the listed enrollment and the outcome analysis can be evaluated.
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 0.5% | 12 | 449 | 2.7% |
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 0.5% | 101 of 449 |
Most frequent serious adverse event terms
| Event term | Organ system | CD07805/47 Gel 0.5% |
|---|---|---|
| Abscess tooth w/ secondary submandibular infection | Infections and infestations | 1 of 449 |
| Osteoarthritis of left hip | Musculoskeletal and connective tissue disorders | 1 of 449 |
| Advanced squamous cell carcinoma of the lung | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 1 of 449 |
| COPD | Respiratory, thoracic and mediastinal disorders | 1 of 449 |
| Encephalopathy | Nervous system disorders | 1 of 449 |
| Invasive ductal carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 1 of 449 |
| Distal Esophageal Schatzki's Ring | Gastrointestinal disorders | 1 of 449 |
| Unstable Angina | Cardiac disorders | 1 of 449 |
| Right Ovarian Cyst | Reproductive system and breast disorders | 1 of 449 |
| Sustained Ventricular Tachycardia | Cardiac disorders | 1 of 449 |
Most frequent non-serious adverse event terms
| Event term | Organ system | CD07805/47 Gel 0.5% |
|---|---|---|
| Flushing | Vascular disorders | 46 of 449 |
| Erythema | Skin and subcutaneous tissue disorders | 35 of 449 |
| Rosacea | Skin and subcutaneous tissue disorders | 24 of 449 |
Serious events with the highest arm-level rate: abscess tooth w/ secondary submandibular infection (0.2%), osteoarthritis of left hip (0.2%), advanced squamous cell carcinoma of the lung (0.2%), copd (0.2%), encephalopathy (0.2%).
For CD07805/47 gel 0.5%, the registry lists 449 at risk for serious adverse events and 12 affected. It also lists 449 at risk for other adverse events and 101 affected. These are descriptive counts recorded for the intervention group, not estimates from a randomized comparison. The registry record does not report deaths.
The six serious adverse-event terms listed with a frequency of 0.2% each are abscess tooth w/ secondary submandibular infection, osteoarthritis of left hip, advanced squamous cell carcinoma of the lung, COPD, encephalopathy, and invasive ductal carcinoma. The listed terms describe events recorded in the safety data; they do not establish that the gel caused them. The record does not provide event-level timing, relatedness assessments, duration, outcome, or detail on whether participants had more than one event.
In general, an adverse-event count is interpreted in the context of how events were defined and collected, how long participants were observed, and whether a suitable comparison group is available. Those details are not fully reported in the registry record. The counts therefore describe what was posted, but do not by themselves quantify comparative safety or establish causation.
12. What the Result Does, and Does Not, Mean
The record describes a long-term, open-label study of once-daily CD07805/47 gel 0.5% in subjects with moderate to severe facial erythema associated with rosacea. Its primary outcome is defined as change in clinician-rated CEA from baseline at post-baseline visits. The record also reports safety counts for the single intervention group. These details establish the study’s intended question and the types of information posted.
What the record does not provide is the numerical mean change in CEA, its standard deviation, a confidence interval, or a statistical test. Consequently, the amount and precision of any observed score change cannot be described from the registry record. The absence of a posted estimate should not be interpreted as no change, as a favorable change, or as an unfavorable change.
The single-group, non-randomized design also means that a within-group change would not constitute a controlled estimate of the gel’s effect. In general, outcomes can change over time for reasons other than an intervention, and an unmasked clinician rating may be affected by knowledge of treatment. These are limitations on causal interpretation, not evidence that bias necessarily occurred.
The safety counts provide descriptive event information, but the record does not establish causation or provide a comparative rate against a control group. Deaths are not reported in the registry record. The event terms and frequencies should therefore be read as recorded observations, not as a complete account of risk or proof of an intervention-related event.
Overall, the posted record supports description of the design, endpoint definition, enrollment, and listed adverse events. It does not support a conclusion about the size, statistical precision, or comparative effect of the intervention. A fuller assessment would require the numerical endpoint results and information about analysis populations, missing data, and the analysis methods, none of which is reported in the registry record.
13. Why This Trial Matters Statistically
Statistically, this trial illustrates why a clear outcome definition and a reported outcome estimate are both needed. The registry gives a detailed CEA grading framework and describes the intended change-from-baseline summary, but it does not report the mean change or its standard deviation. An endpoint description explains what was measured; it cannot substitute for the result needed to assess magnitude and precision.
The design is also central to interpretation. A single-group study can document observations during follow-up, but it cannot provide a randomized between-group contrast when no comparator is present. Open-label assessment adds another consideration because the primary measure is clinician-rated. In general, these design features shape how confidently an observed pattern can be attributed to an intervention, without implying that any particular bias or effect occurred.
The safety information demonstrates a separate reporting issue: event counts are useful descriptive data, but their interpretation depends on definitions, follow-up, attribution, and comparison. The registry lists serious and other adverse-event counts and several serious-event terms, while deaths and detailed event context are not reported in the registry record. Readers should distinguish the existence of a posted count from a causal or comparative conclusion.
Finally, the record’s lack of analysis details matters for reproducibility and uncertainty assessment. The registry lists no analyses and does not report methods for missing observations, multiplicity, or analysis populations. Those omissions leave important questions unanswered about how the planned outcome became an analyzed result. The statistical lesson is not that the study has no information, but that design, endpoint definitions, numerical estimates, uncertainty, and analysis transparency are distinct parts of evidence interpretation.
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 of the registry record is that the numerical primary outcome results are not reported. Although CEA change is defined as the primary outcome and the measure is specified as a mean with standard deviation, neither value is posted. The record therefore does not permit an assessment of the observed change’s magnitude or variability.
The single-group design has no concurrent comparator, and allocation is non-randomized. The study is open-label, with masking listed as none. In general, a single-group trajectory cannot separate intervention-associated change from time trends or other influences, and an unmasked clinician-rated outcome may be susceptible to expectation effects. These are structural limitations; the registry does not establish that they affected the results.
The primary outcome timeframe is described as “Over 1 year,” while the official title says treatment was applied for up to 52 weeks. The registry does not clarify the visit schedule or reconcile those descriptions. Its endpoint wording refers to T3 of each post-baseline visit, including Day 1, but provides no visit-specific estimates.
Analysis populations, missing-data procedures, multiplicity handling, and the statistical analysis plan are not reported in the registry record. The record also does not report the study’s sample-size justification. These omissions prevent assessment of whether the planned analysis was followed, how incomplete observations were addressed, and how precise the outcome estimates would be. The adverse-event information likewise lacks reported detail on attribution, timing, and participant-level overlap. These limitations constrain interpretation of both efficacy and safety information in the posted record.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Study of CD07805/47 Topical Gel in Subjects With Facial Erythema Associated With Rosacea — NCT01318733.
- Registry record last updated 2021-02-18; status last verified 2014-03.
- Results first posted 2014-01-08.
- 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 describes NCT01318733, a completed Phase 3, multicenter, open-label, non-randomized, single-group study sponsored by Galderma R&D. The study evaluated CD07805/47 gel 0.5%, applied topically once daily, in subjects with moderate to severe facial erythema associated with rosacea. Enrollment was 449. The official title describes use for up to 52 weeks.
The primary outcome was change from baseline in clinician-assessed CEA, summarized as a mean with standard deviation. The record defines the CEA grades but does not report numerical primary outcome results or analyses. It lists 12 serious adverse events and 101 other adverse events, each with 449 at risk; deaths are not reported in the registry record.
The single-group, open-label design has no concurrent comparator. The posted information supports description of the study and listed safety events, but does not provide a numerical efficacy estimate, its precision, or a controlled treatment comparison.