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 CD07805/47 Topical Gel in Subjects With Facial Erythema Associated With Rosacea (NCT01174030), a randomized phase 2 study. The primary outcome is Composite Success.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT01174030 |
| Phase | Phase 2 |
| Condition | Rosacea |
| Allocation | Randomized |
| Design model | Parallel |
| Masking | Double |
| Enrollment | 269 |
| Arms in the primary outcome | n/a |
| Lead sponsor | Galderma R&D |
| Results posted | Yes |
2. Clinical Question
Population
The study enrolled subjects with moderate to severe facial erythema associated with rosacea. The condition listed in the registry is rosacea. The planned analysis population was the Intent-to Treat population, with a stated last-observation-carried-forward approach for missing data at specified timepoints.
Intervention
The active regimens were CD07805/47 gel 0.5% applied once daily, CD07805/47 gel 0.18% applied once daily, and CD07805/47 gel 0.18% applied twice daily. Each regimen was studied over 4 weeks.
Comparator
The comparators were vehicle gel applied once daily or twice daily. The registry says each concentration and regimen was compared with its respective placebo control. The record does not give further detail about how participants were assigned to each arm.
Primary question
At Day 29, how many participants met the definition of composite success, requiring a 2-grade improvement on both the Clinician Erythema Assessment and Patient Self Assessment-5? The registry record does not report the outcome counts or comparative estimates, so it does not establish the size or precision of any difference between a gel regimen and its vehicle control.
The clinical question combines a clinician-assessed measure of erythema with a patient self-assessment. Such a composite can represent improvement from both perspectives, but its interpretation depends on the exact success definition and on results for each component. The registry lists CEA Success and PSA-5 Success among secondary outcomes, which would describe those components separately. Their results are not reported in the registry record. The trial is described as a Phase 2 study; the record does not state a further development objective or provide a statistical rationale for choosing the endpoint.
3. Trial Design
This was a randomized, double-blind, parallel-group, vehicle-controlled, multicenter Phase 2 study. The registry reports enrollment of 269 and a 4-week treatment period. Its title specifies topical administration once daily for the 0.5% gel and once or twice daily for the 0.18% gel. There were five listed arms: three active regimens and vehicle gel once daily and twice daily.
The registry describes the study as double-blind but does not report which people were masked, how masking was maintained, or whether the active and vehicle gels were matched in appearance or use. The allocation method is identified as randomized, but the sequence-generation and allocation-concealment procedures are not reported in the registry record. The arm descriptions contain no additional text about dosing or treatment procedures.
The primary outcome was assessed at Day 29. Each active concentration and regimen was compared with its respective placebo control, as stated in the primary outcome description. The exact mapping of individual active arms to the vehicle arms is not stated beyond that description. The registry does not report the randomization ratio, the number assigned to each arm in the efficacy analysis, or whether the enrollment figure reflects everyone randomized or another enrollment definition.
The registry gives study dates of 2010-08 for start and 2010-12 for primary completion, and lists the overall status as completed. It does not report a sample-size justification, the planned statistical model, the intended confidence level for efficacy estimates, or any interim-analysis plan. These details should not be inferred from the randomized, double-blind, parallel-group design alone.
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% QD | CD07805/47 Gel 0.18% QD | CD07805/47 Gel 0.18% BID | Vehicle Gel QD | Vehicle Gel BID |
|---|---|---|---|---|---|
| STARTED | 53 | 54 | 54 | 55 | 53 |
| COMPLETED | 51 | 52 | 52 | 53 | 52 |
| NOT COMPLETED | 2 | 2 | 2 | 2 | 1 |
Analysis population for the primary outcome, as defined in the registry: Intent-to Treat (ITT) population, LOCF when the data are missing at all four timepoints (i.e. Hours 3, 6, 9, 12) LOCF method will be applied from previous visit.
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% QD | CD07805/47 Gel 0.18% QD | CD07805/47 Gel 0.18% BID | Vehicle Gel QD | Vehicle Gel BID | Total |
|---|---|---|---|---|---|---|---|
| Participants analysed | 53 | 54 | 54 | 55 | 53 | 269 | |
| Age, Categorical: <=18 years | Participants | 0 | 0 | 0 | 0 | 0 | 0 |
| Age, Categorical: Between 18 and 65 years | Participants | 52 | 50 | 50 | 54 | 51 | 257 |
| Age, Categorical: >=65 years | Participants | 1 | 4 | 4 | 1 | 2 | 12 |
| Age, Continuous | years | 44.9 (SD 11.50) | 46.9 (SD 12.72) | 43.2 (SD 12.28) | 43.4 (SD 12.73) | 43.0 (SD 12.33) | 44.3 (SD 12.32) |
| Sex: Female, Male: Female | Participants | 42 | 44 | 42 | 45 | 44 | 217 |
| Sex: Female, Male: Male | Participants | 11 | 10 | 12 | 10 | 9 | 52 |
| Region of Enrollment: United States | participants | 53 | 54 | 54 | 55 | 53 | 269 |
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 Composite Success at Day 29, expressed as a number of participants. Success is defined in the registry as a 2-grade improvement on the Clinician Erythema Assessment (CEA) and Patient Self Assessment-5 (PSA-5). In other words, the endpoint combines a clinician assessment with a patient self-assessment rather than relying on only one perspective. The registry's wording specifies improvement on both measures.
A composite endpoint can capture whether participants meet a joint criterion across multiple measures. For that reason, its meaning is tied to the threshold and to how each component is assessed. A participant who does not meet the required improvement on either component would not meet the stated composite definition. Separate outcomes can help show whether the overall result is accompanied by improvement on the clinician-rated measure, the patient-rated measure, or both. CEA Success and PSA-5 Success are listed as secondary outcomes, but their results are not reported in the registry record.
The registry identifies the Intent-to Treat population and describes a last-observation-carried-forward rule for data missing at all four timepoints, specified as Hours 3, 6, 9, and 12, with the previous visit carried forward. The record does not clarify how this rule was applied to the Day 29 endpoint or provide further details about the assessment schedule. Most importantly, the registry record does not report the number of participants achieving composite success in any arm or a comparative effect estimate. The endpoint definition is therefore available, but its observed efficacy result cannot be interpreted from this record.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry makes the trial question and endpoint definition clear enough to identify the intended comparison: three topical CD07805/47 gel regimens versus vehicle controls, with composite success assessed at Day 29. It does not provide the primary outcome counts, an effect estimate, a confidence interval, or a p-value. The comparative efficacy result is therefore not reported in the registry record. Enrollment and design details alone cannot establish whether the groups differed, in which direction, or by how much.
For a binary endpoint such as success or failure, a useful report would ordinarily include the number meeting the endpoint and the number analyzed in each arm, along with a between-group estimate and its uncertainty. The counts give context for the estimate, while an interval communicates how precisely the effect is estimated. Without these data, readers cannot assess either the size of an observed difference or the range of effects compatible with the results. No conclusion about statistical significance can be drawn from the record.
The primary outcome description says that each concentration and regimen was compared with its respective placebo control. That matters because the once-daily and twice-daily schedules have different vehicle comparators. Results from one comparison should not be treated as the result of another, and the record does not state a single pooled comparison across active regimens. It also does not report a direct comparison between the active doses or schedules.
Three outcome measures and nine analyses are listed in the record. Those counts indicate that several analysis entries exist, but the registry does not provide their estimates or explain their relationship to one another. It is not possible to determine from the available information which analysis was designated as primary among those entries, whether any estimates were adjusted, or how multiplicity was handled.
The adverse-event information is descriptive and separate from the efficacy endpoint. It gives numbers of participants at risk and affected for serious and other events by arm. Those counts should not be mistaken for a formal comparison of safety between groups. The record does not provide confidence intervals, statistical tests, exposure-adjusted rates, or a full account of event severity and timing. In short, the registry supports a description of the design and selected safety counts, but not a quantitative conclusion about comparative efficacy or a comprehensive assessment of safety.
9. Statistical Methods Explained
Statistical methods should be read in light of what the registry actually specifies. It identifies a randomized, double-blind, parallel-group comparison and a binary primary endpoint: participants either meet the composite success definition or do not. It names the Intent-to Treat population and gives a conditional missing-data rule. It does not report the inferential method used to compare arms, the effect measure, the confidence-interval method, or the adjustment strategy. General statistical explanations below describe how such data are commonly interpreted; they do not assert that a particular method was used in this trial.
What does a binary endpoint represent?
In general, a binary endpoint classifies each participant into one of two outcome categories. For this trial, the category of interest is meeting the stated composite-success criterion at Day 29. A count of successes is meaningful only alongside the number of participants included in that arm's analysis. A comparison can then express how success differs between the active regimen and its vehicle control. The registry record does not report the outcome counts or the comparative estimates, so no such contrast can be described from the record.
Different effect measures answer related but distinct questions. A difference in proportions describes the absolute separation between groups; a ratio-based measure describes their relative relationship. These are general examples, not reported methods for this study. Any estimate should be accompanied by uncertainty, commonly expressed as a confidence interval. A confidence interval gives a range of values compatible with the observed data under the method's assumptions; it does not guarantee that the true effect lies in that particular interval. No effect measure or interval is reported in the registry record.
Why does randomization matter?
In general, random assignment is intended to make comparison groups similar, on average, with respect to both measured and unmeasured factors at the time of allocation. It supports interpreting an observed between-group contrast as an effect of assignment to the study regimens, provided the analysis and follow-up are appropriate. Randomization does not ensure that groups are identical, and it does not remove uncertainty due to the number of observations or missing outcome data. The registry identifies the allocation as randomized but does not describe sequence generation, concealment, or the analysis model.
Double masking can reduce the influence of expectations on participant reports and clinician assessments, which is relevant when an endpoint includes both a clinician assessment and a patient self-assessment. The registry calls the study double-blind but does not specify which roles were masked or how masking was implemented. The design label alone does not establish that masking remained intact throughout the study.
How should missing data be understood?
The primary outcome population is identified as Intent-to Treat. Generally, this approach aims to analyze participants according to their randomized group, rather than reclassifying them according to treatment received. The registry also states that when data are missing at all four specified timepoints—Hours 3, 6, 9, and 12—the last observation carried forward method is applied from the previous visit. This describes carrying a prior observed value forward to replace a missing value. The record does not explain how this rule relates to the Day 29 composite endpoint, how partial missingness was handled, or how many participants had missing assessments.
As a general statistical matter, carrying a previous observation forward makes an assumption that the carried value is a suitable stand-in for the missing measurement. That assumption may not hold if the outcome changes after the last observed assessment. A method's implications depend on when data are missing, why they are missing, and the outcome's trajectory. The registry's brief description does not provide enough information to evaluate those features or to determine whether alternative missing-data analyses were conducted.
What can be said about multiplicity?
Multiple comparisons can arise when several regimens, outcomes, or analysis timepoints are examined. When many hypotheses are tested, the chance of at least one apparently unusual result can increase if each test is interpreted separately. Statistical plans sometimes address this through a prespecified hierarchy, adjustment, or a clearly limited set of primary comparisons. These are general considerations, not a description of this trial's analysis. The registry lists three outcome measures and nine analyses and says each concentration/regimen was compared with its respective placebo control. It does not report a multiplicity procedure or identify the full testing hierarchy.
A planning calculation is also distinct from an analysis of observed trial results. The assumptions associated with the planning illustration are a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation; the target effect is described as a stated fraction of the observed effect. Such calculations illustrate a hypothetical sample size under assumptions. They are not observed power and do not substitute for the trial's observed effect estimate or its uncertainty. The registry record does not report the trial's own design justification or the statistical plan used to select enrollment.
10. Multiplicity, Missing Data and Analysis Populations
Several analysis and missing-data issues affect how the results should be interpreted, but the registry record does not provide enough detail to resolve them. It lists three outcome measures and nine analyses. The primary endpoint description specifies comparisons of each concentration and regimen with its respective placebo control, while the secondary outcomes are CEA Success and PSA-5 Success. The record does not report a testing hierarchy, a multiplicity adjustment, or which of the nine analyses produced the primary inferential result.
Multiplicity matters when results from several comparisons or outcomes are considered together. In general, interpreting each test without accounting for the broader set can make chance findings more likely. A prespecified approach might control the error rate, prioritize a limited set of comparisons, or treat secondary results as exploratory. Those are general options; none is reported for this trial. Because the efficacy estimates and p-values are absent, the practical consequences of multiplicity cannot be evaluated.
The registry identifies the analysis population as Intent-to Treat and describes last observation carried forward when data are missing at all four timepoints, Hours 3, 6, 9, and 12, using the previous visit. It does not report how many observations were missing, the reasons for missingness, whether all randomized participants were included in each analysis, or whether other missing-data methods were used. It also does not clarify how the stated timepoint rule was applied to the Day 29 composite endpoint.
These gaps limit assessment of the robustness of any efficacy result. A complete interpretation would require the arm-level outcome counts, the analysis denominator, the treatment of missing observations, and the prespecified approach to multiple comparisons. These details 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 0.5% QD | 0 | 53 | 0.0% |
| CD07805/47 Gel 0.18% QD | 1 | 54 | 1.9% |
| CD07805/47 Gel 0.18% BID | 0 | 54 | 0.0% |
| Vehicle Gel QD | 1 | 55 | 1.8% |
| Vehicle Gel BID | 0 | 53 | 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 0.5% QD | 18 of 53 |
| CD07805/47 Gel 0.18% QD | 13 of 54 |
| CD07805/47 Gel 0.18% BID | 14 of 54 |
| Vehicle Gel QD | 16 of 55 |
| Vehicle Gel BID | 8 of 53 |
Most frequent serious adverse event terms
| Event term | Organ system | CD07805/47 Gel 0.5% QD | CD07805/47 Gel 0.18% QD | CD07805/47 Gel 0.18% BID | Vehicle Gel QD | Vehicle Gel BID |
|---|---|---|---|---|---|---|
| Gastric Reflux | Gastrointestinal disorders | 0 of 53 | 1 of 54 | 0 of 54 | 0 of 55 | 0 of 53 |
| Deep Vein Thrombosis | Vascular disorders | 0 of 53 | 0 of 54 | 0 of 54 | 1 of 55 | 0 of 53 |
Most frequent non-serious adverse event terms
| Event term | Organ system | CD07805/47 Gel 0.5% QD | CD07805/47 Gel 0.18% QD | CD07805/47 Gel 0.18% BID | Vehicle Gel QD | Vehicle Gel BID |
|---|---|---|---|---|---|---|
| Intraocular pressure increased | Eye disorders | 7 of 53 | 6 of 54 | 8 of 54 | 9 of 55 | 4 of 53 |
| Pruritus | Skin and subcutaneous tissue disorders | 3 of 53 | 3 of 54 | 1 of 54 | 4 of 55 | 0 of 53 |
| Headache | Nervous system disorders | 4 of 53 | 3 of 54 | 3 of 54 | 1 of 55 | 0 of 53 |
| Skin Burning Sensation | Skin and subcutaneous tissue disorders | 3 of 53 | 1 of 54 | 2 of 54 | 1 of 55 | 0 of 53 |
| Nasopharyngitis | Infections and infestations | 2 of 53 | 0 of 54 | 1 of 54 | 3 of 55 | 1 of 53 |
| Sinusitis | Infections and infestations | 0 of 53 | 1 of 54 | 0 of 54 | 2 of 55 | 3 of 53 |
| Flushing | Vascular disorders | 4 of 53 | 1 of 54 | 0 of 54 | 0 of 55 | 0 of 53 |
| Skin Warm | Skin and subcutaneous tissue disorders | 3 of 53 | 0 of 54 | 1 of 54 | 0 of 55 | 0 of 53 |
Serious events with the highest arm-level rate: gastric reflux (1.9%), deep vein thrombosis (1.8%).
The registry reports participants at risk and participants affected for serious adverse events and other adverse events in each arm. For serious adverse events, the listed figures are 0 of 53 for CD07805/47 Gel 0.5% QD, 1 of 54 for CD07805/47 Gel 0.18% QD, 0 of 54 for CD07805/47 Gel 0.18% BID, 1 of 55 for Vehicle Gel QD, and 0 of 53 for Vehicle Gel BID. These are counts, not rates adjusted for time on treatment, and the registry does not provide comparative estimates or uncertainty intervals.
For other adverse events, the listed affected counts are 18 of 53, 13 of 54, 14 of 54, 16 of 55, and 8 of 53 in the same arm order. The record does not provide event definitions or clarify whether these counts refer to participants with at least one event or another counting convention. It lists Gastric Reflux at 1.9% and Deep Vein Thrombosis at 1.8% among the top serious terms, without assigning those terms to specific arms in the information available. Death counts are not reported in the registry record; a null entry should not be read as a reported zero.
These descriptive figures do not establish whether an event was caused by treatment or whether groups differ reliably. The record does not report event timing, severity beyond the serious classification, exposure duration by participant, or statistical comparisons.
12. What the Result Does, and Does Not, Mean
The registry record supports a description of the study's design, treatment regimens, endpoint definition, stated analysis population, and selected adverse-event counts. It does not report the primary outcome results. As a result, it is not possible to say how many participants in any arm achieved composite success, estimate the difference between a gel regimen and its vehicle comparator, or assess the precision of such a difference.
That distinction is important: a clearly defined endpoint does not itself show what happened in the trial. The composite combines clinician and patient assessments, but without component and composite results, readers cannot determine whether success was common or uncommon, whether the components agreed, or whether any observed contrast was large or small. Likewise, the presence of a randomized, double-blind design describes how the study was organized; it does not replace outcome data.
The safety counts allow limited descriptive reading. They report participants affected in each listed arm for serious and other adverse events. They do not establish causality, comparative safety, or the frequency of events over a standardized exposure period. The listed serious-event terms are not attributed to particular groups, and death counts are not reported in the registry record.
The trial is identified as Phase 2 and enrolled 269. Neither fact indicates the magnitude or reliability of an efficacy result. The registry does not report a sample-size justification, full statistical analysis plan, confidence intervals, p-values, or missing-data sensitivity analyses. A planning illustration based on an observed effect, if considered, is a hypothetical design calculation rather than observed power or evidence of a treatment effect.
Accordingly, the record is informative about the question the study was designed to ask, but insufficient to answer it statistically. No clinical recommendation or conclusion about benefit can be drawn from the information reported.
13. Why This Trial Matters Statistically
This study raises several statistical issues that are common in clinical trials. First, its primary endpoint is composite: success requires a 2-grade improvement on both a clinician assessment and a patient self-assessment. Combining measures can make an endpoint reflect more than one perspective, but it also means the interpretation depends on the component definitions and on whether both components contribute similarly to the final classification. Separate CEA Success and PSA-5 Success outcomes are listed, though their results are not reported in the registry record.
Second, the study evaluates multiple regimens and uses regimen-specific vehicle comparisons. A once-daily regimen and a twice-daily regimen should be interpreted against the comparator specified for that schedule, not treated as interchangeable comparisons. Multiple outcomes and nine analyses also make the testing strategy relevant. Without the hierarchy or multiplicity procedure, readers cannot tell how the investigators intended to distinguish confirmatory findings from other analyses.
Third, the stated missing-data method warrants attention. The record describes carrying the previous visit's observation forward when data are missing at all four specified timepoints. In general, any imputation method relies on assumptions about the unobserved outcome. How many measurements were missing and why they were missing would help determine whether those assumptions are plausible, but those details are not reported in the registry record.
Finally, the difference between a design description and an outcome report is central. Randomization, masking, and a defined endpoint describe the intended framework for a comparison. They do not supply its effect estimate, uncertainty, or robustness. Because the primary results are not reported, the statistical importance of the trial is chiefly methodological: its structure illustrates questions about composite outcomes, several treatment comparisons, and incomplete data that require transparent analysis reporting.
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 interpretation is that the registry record does not report primary efficacy counts or estimates. It gives no group-level composite-success results, comparative effect, confidence interval, or p-value. The listed endpoint and study design therefore cannot support an assessment of efficacy magnitude or precision.
The record also provides limited information about the analysis. It identifies an Intent-to Treat population and describes a last-observation-carried-forward rule for missing data at Hours 3, 6, 9, and 12. It does not report missingness by arm, reasons for missingness, the analysis denominators, or sensitivity analyses. The application of the stated timepoint rule to the Day 29 composite outcome is not explained.
Although three outcome measures and nine analyses are listed, the registry does not describe their hierarchy or report a multiplicity adjustment. The full statistical analysis plan, sample-size justification, and interim-analysis information are not reported in the registry record. Randomization and double masking are stated, but the methods used to generate and conceal allocation and maintain masking are not described.
Safety information is also limited. The record presents counts of participants at risk and affected, but does not provide comparative statistical estimates, exposure-adjusted rates, event timing, or a complete account of severity and relatedness. The serious-event terms are not assigned to particular arms in the reported information, and death counts are not reported in the registry record. These limitations make the safety figures descriptive rather than a basis for a comparative assessment.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Efficacy and Safety Study of CD07805/47 Topical Gel in Subjects With Facial Erythema Associated With Rosacea — NCT01174030.
- Registry record last updated 2021-02-26; status last verified 2014-01.
- Results first posted 2014-03-11.
- 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
NCT01174030 is a completed, randomized, double-blind, parallel-group, vehicle-controlled, multicenter Phase 2 study sponsored by Galderma R&D. It enrolled 269 subjects with moderate to severe facial erythema associated with rosacea and evaluated CD07805/47 gel over 4 weeks. The active regimens were 0.5% once daily and 0.18% once daily or twice daily; vehicle gel once daily and twice daily served as controls.
The primary endpoint was Composite Success at Day 29, defined as a 2-grade improvement on CEA and PSA-5 in the Intent-to Treat population. The registry describes a missing-data rule using last observation carried forward under the stated condition. CEA Success and PSA-5 Success are listed as secondary outcomes.
The registry reports selected adverse-event counts, but does not report the primary efficacy results, comparative estimates, confidence intervals, or p-values. It also does not report the statistical plan, multiplicity approach, or sample-size justification. The record therefore describes the study framework but does not allow a quantitative interpretation of its primary efficacy comparison.