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 The Effects of Aldara as an Adjunct to Laser Treatment (NCT00979550), a randomized phase 2 study. The primary outcome is Effects of Aldera Cream on the Reduction of Port Wine Stain (Vascular Malformation).
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT00979550 |
| Phase | Phase 2 |
| Condition | Port Wine Stains |
| Allocation | Randomized |
| Design model | Parallel |
| Masking | Quadruple |
| Enrollment | 7 |
| Arms in the primary outcome | n/a |
| Lead sponsor | Henry Vasconez |
| Results posted | Yes |
2. Clinical Question
Population
People with port wine stains were the intended population. The registry record lists an enrollment of 7, but it does not provide fuller eligibility criteria or describe the characteristics of participants who enrolled.
Intervention
The intervention was imiquimod, identified as Aldara cream. The arm description says it would be applied nightly for four weeks after standard-of-care laser treatment for a port wine stain.
Comparator
The comparator was non-medicated petroleum cream, also applied nightly for four weeks after standard-of-care laser treatment. The record does not describe further details of the laser treatment or whether it was standardized beyond that description.
Primary question
The primary question was whether adding Aldara to laser treatment affected the cosmetic outcome. The listed outcome concerns reduction in port wine stain, measured as lesion surface area from digital photographs at 3 months. The record does not report a comparative estimate or an analysis of that measure.
3. Trial Design
The registry describes a randomized, parallel-group Phase 2 trial comparing Aldara cream with non-medicated petroleum cream after standard-of-care laser treatment for port wine stains. The enrollment was 7, and the study status is terminated. The record does not report why the study was terminated, how many participants completed follow-up, or whether enrollment reached a planned target.
Both groups were assigned a topical cream to apply nightly for four weeks after laser treatment. This design aims to compare the addition of imiquimod with the use of a non-medicated cream in the same post-laser context. The record does not give further details about the laser procedure, treatment adherence, or how adherence was assessed.
Masking is labeled quadruple. The registry record does not identify which roles were masked or explain how masking was maintained. Randomization can reduce systematic differences between groups at assignment, while masking can limit some forms of bias in treatment delivery or outcome assessment. These features do not, by themselves, establish that groups were balanced or that bias was absent, particularly when the enrollment is small and no outcome analyses are reported.
The registry lists one primary outcome measure, with assessment at 3 months. It describes digital photography and surface-area measurement by blinded observers using image-analysis software. However, the record provides no numerical outcome results, analysis population, or treatment-effect estimate. It also does not report a protocol-level sample-size rationale, allocation procedure, or detailed statistical analysis plan.
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 | Aldara Cream | Non-medicated Petroleum Cream |
|---|---|---|
| STARTED | 4 | 3 |
| COMPLETED | 4 | 3 |
| NOT COMPLETED | 0 | 0 |
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 | Aldara Cream | Non-medicated Petroleum Cream | Total |
|---|---|---|---|---|
| Participants analysed | 4 | 3 | 7 | |
| Age, Categorical: <=18 years | Participants | 4 | 3 | 7 |
| Age, Categorical: Between 18 and 65 years | Participants | 0 | 0 | 0 |
| Age, Categorical: >=65 years | Participants | 0 | 0 | 0 |
| Sex: Female, Male: Female | Participants | 3 | 2 | 5 |
| Sex: Female, Male: Male | Participants | 1 | 1 | 2 |
| Region of Enrollment: United States | participants | 4 | 3 | 7 |
6. Primary Endpoint
The registry lists the primary outcome as Effects of Aldera Cream on the Reduction of Port Wine Stain (Vascular Malformation), measured over 3 months.
| Element | Registry entry |
|---|---|
| Result type | N/A |
| Measure of spread | not applicable |
| Unit | not stated |
| Endpoint classification | not reduced to a single comparison |
The primary endpoint is described as the reduction of a port wine stain, a vascular malformation. Lesions were to be digitally photographed, and blinded observers were to measure lesion surface area using image-analysis software. The planned timeframe was 3 months.
Surface area is a quantitative way to assess the visible extent of a lesion. Digital images and software-based measurement can make an assessment more structured than an unaided visual judgment, while blinded observers are intended to reduce the influence of knowing which cream a participant received. These are general reasons such measures may be used; the registry does not report whether measurement reliability was evaluated or how images were standardized.
The record does not state the unit of measurement, the exact calculation used to define reduction, or the summary statistic planned for the comparison. It also does not give baseline or follow-up values. Although the endpoint description states that surface area would be measured, no numerical result or treatment comparison is reported. The endpoint therefore identifies what the study intended to measure, not what the study found.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry record reports a study design and an intended outcome assessment, but it does not report an analyzed comparison of Aldara cream with non-medicated petroleum cream. There is no numerical estimate of the difference between groups, no confidence interval, and no p-value for the primary endpoint. Consequently, the record does not show the magnitude or precision of any treatment contrast in lesion surface area at 3 months.
The record lists an enrollment of 7 and a terminated status. These details give context for the trial but do not explain the status or establish how many participants contributed data to the primary outcome. The reason for termination, participant flow, and number assessed at the planned endpoint are not reported in the registry record. Without those details, the extent and completeness of outcome follow-up cannot be determined from the posted information.
A confidence interval, in general, describes a range of values compatible with the data and statistical model. A narrow interval indicates greater precision than a wide interval, while an interval spanning values on both sides of no difference may leave the direction and size of an effect uncertain. No confidence interval is reported for this trial, so its precision cannot be assessed. Likewise, a p-value would address compatibility with a specified null hypothesis under a model; no primary-outcome p-value is reported.
The record identifies the primary outcome as lesion surface area, but the registry marks the outcome as not reduced to one comparison because it has several categories or time points. No single comparison should therefore be treated as the trial's reported result. The record reports zero analyses. It does not provide the values needed to describe a treatment effect or its uncertainty.
Randomization and blinded outcome measurement are relevant design features, but they cannot substitute for results. The information supports a description of the planned comparison and measurement approach only. It does not establish whether the groups differed in outcome, how large any difference might have been, or whether the observed data were consistent with a meaningful effect.
9. Statistical Methods Explained
The trial is described as randomized and parallel. In general, randomization assigns participants to groups using a chance-based process, aiming to reduce systematic differences in prognostic factors at the point of assignment. A parallel design means participants are assigned to one group rather than receiving each intervention in sequence. The registry identifies these design features but does not report the randomization sequence method, allocation concealment, or the assignment procedure.
The two groups differed in the cream used after standard-of-care laser treatment: Aldara cream, identified as imiquimod, or non-medicated petroleum cream. Both arm descriptions specify nightly application for four weeks. A comparison of these groups would address the contrast between the two post-laser cream strategies as described. The record does not report additional details that would clarify whether other aspects of care were held constant.
Masking is recorded as quadruple. Masking generally means that one or more people involved in a trial are kept unaware of treatment assignment, which can reduce the risk that expectations affect care, assessment, or reporting. The registry does not identify the roles covered by this label or describe the masking procedures. The primary outcome description separately says that observers measuring surface area from photographs would be blinded. This indicates intended blinding of outcome measurement, but the record does not report whether masking was successful.
The planned endpoint uses image-based measurement. In general, quantitative measurements can be analyzed by comparing group summaries or by modeling individual observations, with the method depending on the endpoint scale and distribution. A treatment estimate would describe the size and direction of the between-group contrast; a confidence interval would communicate its precision. The registry gives no endpoint unit, group-level values, individual-level data, estimate, or confidence interval. It is therefore not possible to identify or evaluate the statistical model used for the primary outcome.
The registry lists one outcome measure but zero analyses. It also states that the primary outcome has several categories or time points and was not reduced to one comparison. This means that the record does not offer a single primary-outcome contrast for statistical interpretation. The precise categories or time points are not described in the available outcome entry, and a planned analysis model is not reported in the registry record.
The sample-size assumptions describe planning illustrations based on an observed effect, with a two-sided significance level of 0.05, equal allocation, and a normal approximation. The stated effect to detect is a fraction of the observed effect. These are planning assumptions, not evidence about the study's actual power or its observed outcome. Any sample-size illustration should be read as a hypothetical design calculation under its assumptions, not as observed power. The record does not report a protocol-based sample-size justification or explain how a target enrollment was selected. Because no single primary comparison is reported, the illustrations do not establish a definitive analysis of the trial endpoint.
Over-dispersion is a general concern when outcome variability is greater than a statistical model assumes; if ignored, standard errors and uncertainty estimates can be misleading. Whether over-dispersion is relevant depends on the outcome and model. The registry record does not report a fitted model, dispersion estimate, or diagnostic assessment, so no conclusion about this issue is possible for this trial.
In general, an intention-to-treat analysis compares participants according to randomized assignment, while a per-protocol analysis restricts or classifies participants according to adherence or protocol completion. The record does not identify an analysis population or say whether either approach was used. It also does not describe missing-data methods, adjustment for baseline measurements, or sensitivity analyses. With no reported analyses, these methodological choices cannot be evaluated.
10. Multiplicity, Missing Data and Analysis Populations
The registry record lists one primary outcome measure, but notes that it includes several categories or time points and is not reduced to one comparison. When multiple outcomes, categories, or time points are tested, the chance of at least one apparently notable result can increase. General approaches to multiplicity include identifying a primary contrast in advance, adjusting inferential thresholds, or treating analyses as exploratory. The registry does not report a multiplicity strategy or identify a single primary contrast for interpretation.
There are zero analyses listed. The record does not report which participants were included in any outcome analysis, whether participants were analyzed according to randomized assignment, or how deviations from the planned treatment were handled. These analysis-population details are not reported in the registry record.
The record also does not give participant flow, the number with outcome measurements at 3 months, or reasons for missing measurements. Missing-data methods, if any, are not reported. In general, missing outcomes can affect interpretation when the availability of measurements is related to treatment assignment or to the outcome itself. Without information about missingness and the analysis approach, its potential effect cannot be assessed.
The terminated status adds context, but the reason for termination and its relationship to recruitment or follow-up are not reported. No conclusions about the source or extent of missing data, or about the effect of multiplicity, can be drawn from the registry information alone.
11. Safety Results
The registry reports serious adverse events as affected participants divided by participants at risk.
| Arm | Participants with serious adverse events | Participants at risk | Percentage |
|---|---|---|---|
| Aldara Cream | 0 | 4 | 0.0% |
| Non-medicated Petroleum Cream | 0 | 3 | 0.0% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| Aldara Cream | 0 of 4 |
| Non-medicated Petroleum Cream | 0 of 3 |
Other (non-serious) adverse events
Participants with at least one non-serious event at or above the registry's 0% reporting threshold.
| Arm | Participants affected of at risk |
|---|---|
| Aldara Cream | 0 of 4 |
| Non-medicated Petroleum Cream | 0 of 3 |
The registry lists serious adverse events, other adverse events, and deaths for the two cream groups. In the Aldara Cream group, 4 participants were listed as at risk; 0 were affected by serious adverse events, 0 by other adverse events, and 0 deaths were reported. In the non-medicated petroleum cream group, 3 participants were listed as at risk; the corresponding counts were 0, 0, and 0.
These are event counts in the groups and risk sets recorded in the registry. They do not provide a detailed description of event types, duration of monitoring, or the completeness of safety reporting. The record lists no serious-event terms. Zero reported events in a small trial does not establish that an event cannot occur, nor does it permit a reliable comparison of safety between groups. It is a limited summary of what was recorded, not a comprehensive assessment of risk.
12. What the Result Does, and Does Not, Mean
The registry record establishes that a randomized, parallel Phase 2 study was intended to compare Aldara cream with non-medicated petroleum cream after laser treatment for port wine stains. It identifies a planned 3-month assessment of lesion surface area using digital photographs and blinded observers. It also records an enrollment of 7 and a terminated status.
What the record does not establish is whether the groups differed in lesion surface area. No numerical primary-outcome result, treatment-effect estimate, confidence interval, or p-value is reported, and zero analyses are listed. The absence of a reported estimate is not evidence that the treatments had the same effect; it means that the posted record does not provide the analysis needed to assess the comparison.
The event counts report no serious adverse events, other adverse events, or deaths in the listed groups. These counts should not be interpreted as proof of safety or as a precise comparison of risks. The registry does not report the reason the study was terminated, participant flow, the number assessed at follow-up, or detailed safety-monitoring information.
In general, conclusions from a trial depend on the outcomes observed, the analysis methods, and the precision of the estimates, as well as the design. Here, design features can be described, but outcome effects and their uncertainty cannot. The appropriate statistical reading is therefore limited: the registry documents the planned clinical question and measurement approach, while leaving the primary comparative result unreported.
13. Why This Trial Matters Statistically
This trial illustrates why registry entries should be distinguished from analyzed trial results. A record can describe randomization, treatment arms, masking, and a planned endpoint without providing an estimate of the outcome comparison. Those design details help identify the question the trial was intended to address, but they do not answer it statistically.
The outcome description also shows why an endpoint needs a clearly defined analysis target. Lesion surface area is identified as the measurement, and the planned assessment is at 3 months, but the registry notes that the primary outcome has several categories or time points and is not reduced to one comparison. Without a defined contrast and reported analysis, readers cannot interpret a single effect estimate or its uncertainty.
The enrollment of 7 and terminated status are important context for the limits of the record, but neither explains the absence of analyses. The reason for termination and the extent of follow-up are not reported. The safety counts are similarly descriptive: event counts without detailed follow-up or comparative uncertainty do not establish relative safety.
Statistically, the central lesson is that trial design and trial findings are different kinds of evidence. Randomization and blinded measurement can support a credible comparison when results are collected and analyzed appropriately; they cannot replace the estimate, precision, and participant-flow information needed to judge that comparison. This registry entry supports a careful account of what was planned and recorded, not a conclusion about the effect of either cream.
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 registry record has important gaps for interpreting this specific trial. It is marked terminated, but the reason for termination is not reported in the registry record. Although enrollment is listed as 7, participant flow, completion of follow-up, and the number contributing to the primary endpoint are not stated.
The primary outcome description identifies photographic surface-area measurement by blinded observers at 3 months, but it does not specify the unit, the exact definition of reduction, or the summary measure intended for analysis. The record notes several categories or time points and does not reduce the outcome to one comparison. No primary-outcome result or analysis is listed.
Further details about eligibility criteria, baseline characteristics, the randomization procedure, masking roles, laser treatment, adherence, and protocol deviations are not reported. The registry also does not provide a sample-size justification, analysis population, missing-data approach, multiplicity strategy, or sensitivity analyses. These omissions limit assessment of trial conduct and analysis; they do not establish that the underlying study lacked such procedures.
The adverse-event summary records zero events in the listed groups, but does not provide event terms, monitoring duration, or fuller safety context. Taken together, the available information is insufficient to quantify treatment effects, assess precision, or draw comparative conclusions about efficacy or safety.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: The Effects of Aldara as an Adjunct to Laser Treatment — NCT00979550.
- Registry record last updated 2018-03-22; status last verified 2018-03.
- Results first posted 2018-03-22.
- 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 a randomized, quadruple-masked, parallel Phase 2 trial of imiquimod (Aldara cream) versus non-medicated petroleum cream after laser treatment for port wine stains. Both creams were described as being applied nightly for four weeks. Enrollment was 7, and the study status is terminated.
The primary outcome was described as lesion surface area measured from digital photographs by blinded observers at 3 months. The registry lists one outcome measure and zero analyses; it does not report a numerical treatment comparison. The reason for termination, participant flow, and analysis methods are not reported. The listed adverse-event counts are zero in both groups, but do not establish comparative safety.