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 Taclonex Ointment With Hydrogel Patch Occlusion for the Treatment of Psoriasis (NCT00924950), a non-randomized phase 4 study. The primary outcome is Change in Total Modified PASI Score at Week 4 Compared to Baseline.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT00924950 |
| Phase | Phase 4 |
| Condition | Plaque Psoriasis, Psoriasis Vulgaris |
| Allocation | Non-Randomized |
| Design model | Single Group |
| Masking | None (open label) |
| Enrollment | 35 |
| Arms in the primary outcome | n/a |
| Lead sponsor | University of California, San Francisco |
| Results posted | Yes |
2. Clinical Question
Population
People with plaque-type psoriasis were enrolled. The registry lists plaque psoriasis and psoriasis vulgaris as conditions. It reports that 35 patients were enrolled and that 5 were lost to follow-up.
Intervention
Taclonex ointment applied once daily to a psoriatic plaque, together with a hydrogel patch applied once daily. The study description identifies the patch as an adhesive pad containing no medication.
Comparator
Taclonex ointment applied topically once daily without occlusion. The design describes a bilateral comparison, but the registry record does not report the procedure used to assign plaques to the two treatments.
Primary question
At week 4, how did the change from baseline in total Modified PASI score compare between plaques treated with ointment plus patch and plaques treated with ointment alone? A numerical estimate of that comparison is not reported in the registry record.
The study’s stated hypothesis was that plaques treated with ointment under a hydrogel patch would be more effectively treated than plaques treated with ointment alone. The primary endpoint was change in total Modified PASI score at week 4 compared with baseline. This score reflects erythema, induration, and scaling, with each component measured from 0-4 and a maximum summed score of 12. Higher scores indicate greater psoriasis severity; lower scores indicate lower severity.
The comparison is intended to address the added role of occlusion while both treatment conditions involve Taclonex ointment. The registry calls the study bilaterally controlled, but also records nonrandomized allocation and no masking. The record does not describe how plaques were chosen for each condition or whether the comparison was analyzed as paired observations. Those details matter when interpreting how directly the comparison isolates the patch’s contribution.
The registry record does not report a numerical week-4 change, a treatment contrast, or a confidence interval. It therefore does not establish from the posted primary outcome what difference was observed or how precisely that difference was estimated.
3. Trial Design
The registry describes an open-label, bilaterally controlled, single-center study of Taclonex ointment with hydrogel patch occlusion versus Taclonex ointment without occlusion. It is listed as a Phase 4 study, with nonrandomized allocation, no masking, and a single-group model. The sponsor is the University of California, San Francisco. The recorded study status is terminated.
The planned comparison concerns two treatment conditions applied to psoriatic plaques: ointment plus a hydrogel patch, and ointment alone. The intervention description says the combination was used once daily to treat one plaque. The comparator description says ointment was applied topically once daily; its arm description is blank in the registry record. Although the official title calls the study bilaterally controlled, the record does not explain the plaque-selection or treatment-assignment procedure.
The registry reports an enrollment of 35. Its primary outcome description says that 35 patients were enrolled and 5 were lost to follow-up, and that the number of participants was chosen because of budget restrictions. The record does not report a formal sample-size justification. It also does not describe whether all enrolled participants contributed primary-outcome data or how missing observations were handled.
The primary outcome was assessed at 4 weeks: change in total Modified PASI score from baseline. A secondary outcome concerns change in Modified PASI scores between week 4 and week 6 during follow-up, intended to assess whether there was further improvement after occlusion ceased. The record does not provide numerical outcome results for either endpoint.
The study began in 2009-06, and primary completion is recorded as 2009-12. These registry dates and the terminated status do not by themselves explain why the study ended or whether termination affected outcome collection. The reason for termination is not reported in the registry record.
4. Participant Flow and Accounting
The registry reports how participants moved through each stage of the study. All counts below are exactly as posted; missing counts are not inferred from other stages.
Before assignment: Patients were assessed for psoriasis severity as well as washout from other concomitant medications
Overall Study
| Stage | Ointment + Patch vs. Ointment Alone |
|---|---|
| STARTED | 30 |
| COMPLETED | 28 |
| NOT COMPLETED | 2 |
Reasons for not completing this period:
| Reason | Ointment + Patch vs. Ointment Alone |
|---|---|
| Lost to Follow-up | 2 |
Analysis population for the primary outcome, as defined in the registry: The number of participants was chosen by our budget restrictions. 35 patients were enrolled. 5 patients were lost to follow-up.
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 | Ointment + Patch vs. Ointment Alone |
|---|---|---|
| Participants analysed | 30 | |
| Age, Categorical: <=18 years | Participants | 0 |
| Age, Categorical: Between 18 and 65 years | Participants | 30 |
| Age, Categorical: >=65 years | Participants | 0 |
| Sex: Female, Male: Female | Participants | NA |
| Sex: Female, Male: Male | Participants | NA |
| Region of Enrollment: United States | participants | 30 |
6. Primary Endpoint
The registry lists the primary outcome as Change in Total Modified PASI Score at Week 4 Compared to Baseline, measured over 4 weeks.
| Element | Registry entry |
|---|---|
| Result type | Mean |
| Measure of spread | 95% Confidence Interval |
| Unit | Units on a scale |
| Endpoint classification | Continuous Endpoint |
The primary endpoint is change in total Modified PASI score at week 4 compared with baseline. Modified PASI measures three features of psoriasis: erythema, induration, and scaling. Each is measured from 0-4, and the summed score has a maximum of 12. A higher score represents greater severity, while a lower score represents lower severity.
Change from baseline focuses on how the score changes over the treatment period rather than relying only on the week-4 score. For a comparison of the two treatment conditions, the relevant interpretation would depend on the direction and size of the change in each condition and on the between-condition contrast. The registry record does not provide those numerical results, so the direction or magnitude of any observed difference cannot be described.
In general, a confidence interval expresses the statistical uncertainty around an estimated quantity. The registry identifies the primary outcome’s dispersion as a 95% confidence interval, but does not report its numerical estimate or interval. Without those values, the precision of the primary result cannot be assessed from the registry record.
The endpoint is clinically interpretable as a change in a psoriasis severity score, but the record does not describe a threshold for an important change. It also does not report how component scores were combined beyond the stated summed score, or how the endpoint was analyzed when follow-up measurements were unavailable.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry identifies a primary outcome and its assessment time, but does not report a numerical primary-outcome result. There is no posted mean change, treatment contrast, or confidence interval in the registry record. Consequently, the posted information does not show the size or direction of the week-4 difference between ointment with patch occlusion and ointment alone. It also does not permit an assessment of the precision of that comparison.
The endpoint is a continuous measure, and the registry identifies its summary parameter as a mean. In general, a mean describes the average score change in the analyzed observations. A comparison of means can summarize the difference between conditions, but its interpretation depends on how observations were collected and analyzed. The record describes a bilateral study but does not provide the analysis details needed to determine whether the reported comparison, if any, accounted for paired plaques within participants.
Several design features are relevant to interpretation. Allocation is recorded as nonrandomized, masking as none, and the model as single group. The study is described as open-label and bilaterally controlled. These descriptions do not establish that the two plaque conditions were comparable at baseline, nor do they say whether plaque assignment could have influenced treatment selection. The allocation procedure and baseline balance are not reported in the registry record.
The record states that 35 patients were enrolled and 5 were lost to follow-up. It does not say how many had evaluable primary-outcome data, whether missing outcomes differed by treatment condition, or whether an analysis included all enrolled participants. Missing measurements can affect an estimated mean change, particularly if the likelihood of a measurement being missing is related to the outcome. This is a general statistical concern, not a claim about why these participants were lost.
The reported safety figures list 30 people at risk in each treatment group and 0 serious adverse events affecting people in either group. The registry lists no serious adverse-event terms. These figures describe the posted serious-event counts; they do not supply a numerical primary efficacy result and cannot establish that no other adverse events occurred. Death counts are not reported in the registry record.
Overall, the registry record describes the intended comparison, endpoint, and some enrollment and safety information, but does not provide the primary outcome estimate. No conclusion about the size, direction, or precision of the week-4 score change comparison can be drawn from the posted results. This is a statement about what the registry record reports, not a conclusion about the treatments themselves.
9. Statistical Methods Explained
The registry describes a continuous primary outcome: change in total Modified PASI score at week 4 compared with baseline. For a continuous outcome, an analysis commonly summarizes observations with means and measures uncertainty around those summaries. The record identifies the parameter as a mean and the dispersion as a 95% confidence interval. However, it does not report numerical estimates for the primary endpoint, so the statistical result cannot be interpreted quantitatively.
What does a confidence interval communicate?
General explanation: a confidence interval gives a range of values compatible with the data and the method used to estimate an effect. Its width reflects precision: a narrower interval indicates a more precise estimate, while a wider interval indicates greater uncertainty. An interval can also help readers distinguish a well-estimated effect from one that remains uncertain. The registry record gives no interval endpoints for the primary outcome, so its width and the values it includes are not reported.
Why does the comparison structure matter?
The official title describes a bilateral comparison, while the registry records nonrandomized allocation and a single-group model. A bilateral design may involve comparing two plaques within the same participant, but the record does not explain whether that was the unit of analysis or how plaques were selected and assigned. General explanation: when observations are paired within a participant, their statistical dependence is important. An analysis that accounts for pairing can use information about within-participant differences; treating paired observations as independent can misstate uncertainty. The registry record does not report whether the analysis accounted for pairing.
Nonrandomized allocation also affects interpretation. In general, random assignment helps balance measured and unmeasured characteristics between treatment conditions, on average. Without random assignment, differences between plaques or their selection may be associated with the treatment condition. The registry does not report an allocation procedure or baseline comparisons that would clarify this issue. This does not establish that a bias occurred; it identifies information needed to judge comparability.
How should the planning assumptions be read?
The record describes planning illustrations based on a stated fraction of an observed effect, using a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation. These assumptions describe a hypothetical planning exercise, not the study’s original design. The record says the enrollment was chosen because of budget restrictions. It does not report a formal sample-size justification, and no numerical primary-effect estimate is reported, so the planning assumptions cannot be used to infer a specific detectable effect from the registry record.
General explanation: a sample-size calculation depends on assumptions about the effect to detect, variability, significance level, allocation, and analysis. Changing those assumptions changes the calculated sample size. A planning illustration is not observed power, and it does not reveal the probability that a completed study detected a real effect. The record’s enrollment information should therefore be read separately from any hypothetical planning calculation.
What role does the outcome scale play?
The Modified PASI score sums erythema, induration, and scaling, each measured from 0-4, with a maximum summed score of 12. The scale’s stated direction is that higher scores mean greater severity and lower scores mean lower severity. For a change score, interpretation requires knowing how the subtraction was defined. The registry names the outcome as change from baseline but does not state the subtraction convention. Without a reported numerical change, direction cannot be resolved from the primary results in any case.
General explanation: continuous score data may vary more than a simple model assumes. Over-dispersion, in general, means the observed variability is greater than a model’s assumed variability; if ignored, uncertainty estimates may be too small. The registry record does not report a distributional assessment or a method addressing over-dispersion. It also does not report the score distribution, variability, or model diagnostics.
The registry lists 2 outcome measures and 1 analysis. It does not describe the statistical model, covariate adjustment, handling of within-participant correlation, missing-data method, or analysis population. The lack of these details limits assessment of how the primary estimate would have been calculated, even apart from the absent numerical result. No interim analysis or multiplicity procedure is reported in the registry record.
10. Multiplicity, Missing Data and Analysis Populations
The registry lists 2 outcome measures: the primary change in total Modified PASI score at week 4 compared with baseline, and a secondary change between week 4 and week 6 during follow-up. It lists 1 analysis. The record does not describe whether both outcomes were tested formally, whether either was designated exploratory, or whether any adjustment was made for multiple comparisons. A multiplicity adjustment is not reported in the registry record.
General explanation: when several outcomes or statistical tests are considered, the chance of obtaining at least one apparently unusual result can increase. A prespecified testing strategy or adjustment can address that issue, but the registry record does not state whether such a strategy was used. The number of listed outcomes alone does not establish how the analyses were conducted.
The primary outcome description reports that 35 patients were enrolled and 5 were lost to follow-up. It does not state the number with measured week-4 scores, the reasons for loss, or whether missingness occurred before or after the primary assessment. The safety figures list 30 people at risk per treatment group, but those counts do not establish the primary efficacy analysis population.
The method for handling missing primary or secondary outcome data is not reported in the registry record. Nor does the record say whether an analysis included all enrolled participants, only participants with observed measurements, or another defined population. General explanation: missing-data handling can influence estimated changes when the chance of a missing score is related to its value or to treatment condition. Without the analysis population and missing-data method, the impact of the reported losses cannot be evaluated.
The registry does not report an interim analysis, a protocol-defined hierarchy of endpoints, or a statistical analysis plan. These details should be treated as not reported in the registry record, rather than inferred from the outcome listing or study status.
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 |
|---|---|---|---|
| Ointment + Patch vs. Ointment Alone | 0 | 30 | 0.0% |
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 |
|---|---|
| Ointment + Patch vs. Ointment Alone | 0 of 30 |
The registry reports serious adverse-event figures for the group titled “Ointment + Patch vs. Ointment Alone.” It lists 30 people at risk in each treatment group and 0 affected by serious adverse events in each group. No serious adverse-event terms are listed. These are the serious-event counts recorded for the comparison.
These figures should be interpreted as a report of zero recorded serious adverse events among the people listed as at risk, not as proof that serious events were impossible or that no adverse events of any kind occurred. The registry record does not provide counts for non-serious adverse events, event-specific follow-up details, or a description of how safety events were collected. Death counts are not reported in the registry record.
The safety counts do not replace the missing primary efficacy result. They also do not establish that the two treatment conditions had identical safety experience: the record provides only the reported serious-event counts, without further detail on event timing or analysis. The 30 people at risk in each group are safety denominators and should not be assumed to define the primary-outcome analysis population.
In general, a zero count is most informative when the reporting period, event definitions, and completeness of follow-up are clear. Those details are not reported in the registry record, so the serious-event figures are best read narrowly as the posted counts.
12. What the Result Does, and Does Not, Mean
The registry record establishes that the study was designed to compare Taclonex ointment used with a hydrogel patch against ointment alone for plaque-type psoriasis. It identifies change in total Modified PASI score at week 4 as the primary outcome and describes a secondary score change between week 4 and week 6. It also reports enrollment, losses to follow-up, and serious adverse-event counts.
The record does not report a numerical result for the primary endpoint. It therefore does not show whether the mean score change differed between treatment conditions, how large any difference was, or how precisely it was estimated. The absence of a posted estimate is not evidence that the treatments had equal results, and it is not evidence that one condition was better.
The design information also calls for care in interpreting any comparison. The study is described as open-label and bilaterally controlled, with nonrandomized allocation and no masking. The registry does not explain how plaques were assigned to conditions or how the analysis accounted for observations from the same participant. Those details affect how directly the comparison can be interpreted.
The enrollment description states that 35 patients were enrolled and 5 were lost to follow-up. The record does not explain the reasons for loss or the treatment of missing scores. It says enrollment was chosen because of budget restrictions, but does not report a formal sample-size justification. As a result, the registry does not establish how much precision was intended or achieved for the primary comparison.
The serious adverse-event figures report 0 affected in each treatment group among 30 at risk in each group. They are limited to serious events as recorded; other adverse-event counts are not reported. In general, safety and efficacy are distinct questions, and the safety figures do not fill the gap in the primary efficacy results.
Accordingly, the posted record supports a description of the study question and its reported design, but not a conclusion about the primary treatment comparison. It also does not support an inference that the absence of numerical efficacy results means there was no effect. The key statistical limitation is that the estimate and its uncertainty are not reported.
13. Why This Trial Matters Statistically
This study raises a useful design question: how should a comparison be analyzed when two treatment conditions are applied to plaques in a bilateral, nonrandomized study? The registry’s description identifies the intended contrast, while the allocation and analysis details needed to assess comparability and dependence are not reported. These issues are important because the analysis should reflect how observations are linked to participants and how treatment conditions were assigned.
The endpoint also illustrates the value of distinguishing a score’s definition from its result. The registry explains that Modified PASI combines erythema, induration, and scaling, with each component measured from 0-4 and a maximum total of 12. It specifies the week-4 change from baseline as primary. But without the mean change, treatment contrast, or confidence interval, readers cannot judge either the observed difference or its precision.
Missing follow-up is another important statistical consideration. The registry says 5 of 35 enrolled patients were lost to follow-up, but does not report how missing scores were addressed or define the primary analysis population. A transparent account of participant flow and missing-data handling helps readers understand which observations contribute to an estimate and how robust it may be.
Finally, the record distinguishes an enrollment constrained by budget from a formal sample-size justification. General statistical practice treats sample-size calculations as planning tools tied to explicit assumptions, not as evidence that a study was sufficiently informative after completion. The registry’s stated planning assumptions are hypothetical and do not substitute for a reported primary estimate and interval.
The statistical significance of this trial record lies in the questions it leaves open: the paired or unpaired nature of the comparison, the handling of missing data, and the absence of numerical outcome results. Those limitations shape what can be learned from the posted information without implying a treatment conclusion.
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 does not report a numerical primary outcome estimate, a between-condition contrast, or the 95% confidence interval identified for the primary outcome. This prevents assessment of the observed direction, size, and precision of the main comparison. Numerical results for the secondary outcome are also not reported in the registry record.
The design is described as bilateral and nonrandomized, but the record does not explain the procedure for choosing plaques or assigning treatment conditions. It does not report whether the analysis treated plaques as paired within participants or otherwise accounted for their relationship. No baseline plaque characteristics or comparison of baseline scores are reported.
The registry states that 5 of 35 patients were lost to follow-up, but does not give reasons, timing, or treatment-specific missingness. It does not identify the primary analysis population or explain how missing outcome measurements were handled. The safety denominators do not clarify the efficacy population.
The record says enrollment was chosen because of budget restrictions and does not report a formal sample-size justification. It does not provide the statistical model, covariate adjustment, assumptions for the primary analysis, or a plan for multiplicity. Interim analyses and a statistical analysis plan are not reported in the registry record.
The study is listed as terminated, but the reason for termination is not reported. The record also does not provide numerical non-serious adverse-event results or death counts. These omissions limit interpretation of both the efficacy and safety information; they do not, by themselves, establish what the missing results would have shown.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Taclonex Ointment With Hydrogel Patch Occlusion for the Treatment of Psoriasis — NCT00924950.
- Registry record last updated 2019-04-18; status last verified 2019-04.
- Results first posted 2012-12-05.
- 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
NCT00924950 is a Phase 4, open-label, single-center study described as a bilateral comparison of Taclonex ointment with hydrogel patch occlusion against ointment alone for plaque-type psoriasis. Allocation is recorded as nonrandomized, masking as none, and the model as single group. The sponsor is the University of California, San Francisco.
The registry reports 35 enrolled patients and 5 lost to follow-up. The primary outcome is change in total Modified PASI score at week 4 compared with baseline; the secondary outcome concerns change between week 4 and week 6. Enrollment was chosen because of budget restrictions. The record does not report numerical outcome results or a formal sample-size justification.
The recorded status is terminated. Serious adverse-event figures list 30 at risk and 0 affected in each treatment group; no serious-event terms are listed. The reason for termination, death counts, and non-serious adverse-event results are not reported in the registry record.