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 Clobetasol Propionate 0.05% Shampoo in Association With Antifungal Shampoo in Scalp Seborrheic Dermatitis (NCT00862654), a randomized phase 3 study. The primary outcome is Total Severity Score (TSS): Percent Change From Baseline at Week 4.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT00862654 |
| Phase | Phase 3 |
| Condition | Scalp Seborrheic Dermatitis |
| Allocation | Randomized |
| Design model | Parallel |
| Masking | Single |
| Enrollment | 326 |
| Arms in the primary outcome | 4 |
| Lead sponsor | Galderma R&D |
| Results posted | Yes |
2. Clinical Question
Population
The trial concerned people with moderate to severe scalp seborrheic dermatitis. The registry record describes the primary outcome population as Intent To Treat (ITT) with Last Observation Carried Forward (LOCF). Further eligibility details, including specific inclusion or exclusion criteria, are not reported in the registry record.
Intervention
The regimens included clobetasol propionate shampoo 0.05% used four times per week with ketoconazole shampoo 2% twice per week; clobetasol propionate shampoo 0.05% twice per week with ketoconazole shampoo 2% twice per week; and clobetasol propionate shampoo 0.05% twice per week without the listed ketoconazole regimen. The trial assessed these different schedules rather than one single clobetasol regimen.
Comparator
The fourth regimen was ketoconazole shampoo 2% twice per week. Registry-reported comparisons include the clobetasol-twice-weekly combination against this ketoconazole regimen, and clobetasol twice weekly alone against ketoconazole. A reported comparison of the four-times-weekly clobetasol combination against ketoconazole is not included among the two posted analyses.
Primary question
The primary question was how the four regimens differed in median percent change in Total Severity Score (TSS) from baseline to week 4. TSS combines investigator assessments of erythema, scaling and pruritus severity. The registry posts arm-level medians and full ranges, plus p-values for two comparisons. It does not report a comparison effect estimate or confidence interval for those analyses, so the posted inferential results do not describe the size or precision of the between-regimen differences in the same way an estimate with an interval would.
3. Trial Design
The registry identifies this as a randomized, single-masked, parallel-group phase 3 trial. Enrollment was 326, and the record status is completed. The study start is listed as 2009-03 and primary completion as 2010-02. Galderma R&D is the listed sponsor. Randomized allocation means participants were assigned to trial groups, but the method used to generate the allocation sequence and whether allocation was concealed are not reported in the registry record. The identity of the masked party is also not reported.
Four parallel regimens were studied: clobetasol propionate shampoo 0.05% four times per week plus ketoconazole shampoo 2% twice per week; clobetasol propionate shampoo 0.05% twice per week plus ketoconazole shampoo 2% twice per week; clobetasol propionate shampoo 0.05% twice per week; and ketoconazole shampoo 2% twice per week. The arm-level outcome populations are listed as 82, 82, 82 and 80, respectively. The registry does not state why those analysis counts differ from the overall enrollment count, nor does it report a flow of participants through assignment, follow-up and analysis.
The primary outcome was assessed at baseline and week 4. The record identifies its analysis population as ITT with LOCF, but details of the timing and handling of missing assessments beyond that label are not reported. The protocol, planned sample-size justification, intended allocation ratio, and any planned interim analyses are not reported in the registry record. The record gives one primary outcome measure and two posted analyses; it lists no posted secondary outcomes. These details describe what is recorded, not necessarily every procedure that may have been specified or conducted outside the registry entry.
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 | C Propionate 4/Week + Ketoconazole 2/Week | C Propionate 2/Week + Ketoconazole 2/Week | C Propionate 2/Week | Ketakonazol 2/Week |
|---|---|---|---|---|
| STARTED | 82 | 82 | 82 | 80 |
| COMPLETED | 76 | 74 | 76 | 74 |
| NOT COMPLETED | 6 | 8 | 6 | 6 |
Reasons for not completing this period:
| Reason | C Propionate 4/Week + Ketoconazole 2/Week | C Propionate 2/Week + Ketoconazole 2/Week | C Propionate 2/Week | Ketakonazol 2/Week |
|---|---|---|---|---|
| Lack of Efficacy | 1 | 0 | 1 | 0 |
| Lost to Follow-up | 1 | 2 | 1 | 3 |
| Adverse Event | 0 | 1 | 1 | 0 |
| Pregnancy | 1 | 1 | 0 | 0 |
| Withdrawal by Subject | 2 | 2 | 2 | 3 |
| Subject mistake | 0 | 1 | 0 | 0 |
| Familly constraint | 0 | 1 | 0 | 0 |
| Never used study drugs | 1 | 0 | 0 | 0 |
| Included after end of inclusions | 0 | 0 | 1 | 0 |
Analysis population for the primary outcome, as defined in the registry: Intent To Treat (ITT) with Last Observation Carried Forward (LOCF)
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 | C Propionate 4/Week + Ketoconazole 2/Week | C Propionate 2/Week + Ketoconazole 2/Week | C Propionate 2/Week | Ketakonazol 2/Week | Total |
|---|---|---|---|---|---|---|
| Participants analysed | 82 | 82 | 82 | 80 | 326 | |
| Age, Categorical: <=18 years | Participants | 2 | 1 | 3 | 1 | 7 |
| Age, Categorical: Between 18 and 65 years | Participants | 65 | 69 | 71 | 66 | 271 |
| Age, Categorical: >=65 years | Participants | 15 | 12 | 8 | 13 | 48 |
| Age, Continuous | years | 46.9 (SD 16.0) | 43.8 (SD 17.2) | 44.9 (SD 15.3) | 44.7 (SD 15.5) | 45.1 (SD 16.0) |
| Sex: Female, Male: Female | Participants | 36 | 39 | 38 | 36 | 149 |
| Sex: Female, Male: Male | Participants | 46 | 43 | 44 | 44 | 177 |
| Region of Enrollment: France | participants | 12 | 11 | 12 | 12 | 47 |
| Region of Enrollment: Mexico | participants | 17 | 18 | 18 | 17 | 70 |
| Region of Enrollment: Belgium | participants | 9 | 7 | 9 | 8 | 33 |
| Region of Enrollment: Germany | participants | 35 | 37 | 34 | 34 | 140 |
| Region of Enrollment: Korea, Republic of | participants | 9 | 9 | 9 | 9 | 36 |
6. Primary Endpoint
The registry lists the primary outcome as Total Severity Score (TSS): Percent Change From Baseline at Week 4, measured over baseline and week 4.
| Element | Registry entry |
|---|---|
| Result type | Median |
| Measure of spread | Full Range |
| Unit | Percent change |
| Endpoint classification | not reduced to a single comparison |
The primary endpoint was median percent change from baseline in TSS at week 4. TSS is the sum of investigator-assessed erythema, scaling and pruritus severity scores for the lesions. Each component is scored on a four-point scale from 0 = None to 3 = Severe, giving TSS a possible range from 0 to 9. The registry specifies the population as ITT with LOCF.
A composite score can summarize several features of disease severity in one outcome. A percent change expresses the week-4 score in relation to the baseline score, while the median describes the middle value in the analyzed group rather than its arithmetic average. A negative percent change indicates a lower follow-up score relative to baseline; the posted arm medians are all negative. This is a general interpretation of change-score direction, not a separate clinical conclusion.
The registry reports the full range for each arm, not a confidence interval for the median. A range describes the observed spread from the smallest to the largest reported value; it does not quantify the precision of an estimated treatment contrast. The record does not report a clinically meaningful threshold for TSS change, or a between-group estimate with a confidence interval. Those omissions limit how much can be inferred about the practical importance and precision of differences between regimens.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The arm-level median percent changes in TSS were -71.4 for clobetasol four times weekly with ketoconazole twice weekly, -66.7 for clobetasol twice weekly with ketoconazole twice weekly, -66.7 for clobetasol twice weekly alone, and -57.1 for ketoconazole twice weekly. The corresponding full ranges were -100.0 to 14.3, -100.0 to 0.0, -100.0 to 0.0, and -100.0 to 33.3. These are descriptive summaries of change within each arm. A contrast between arm medians is not itself the result of the reported pairwise tests.
The registry reports a Cochran-Mantel-Haenszel analysis comparing clobetasol twice weekly with ketoconazole twice weekly, with p < 0.01. It also reports that same method for clobetasol twice weekly alone versus ketoconazole twice weekly, with p = 0.039. The record does not give a comparison effect estimate or confidence interval for either test. It also does not report the outcome coding used for the analyses, the strata used in the method, or whether the p-values were adjusted for multiple comparisons. The p-values therefore convey evidence from the named tests, but do not state the magnitude or precision of the differences.
The medians indicate that the observed middle percent change was more negative in each clobetasol-containing arm than in the ketoconazole arm. The two twice-weekly clobetasol arms have the same posted median, while their reported comparisons with ketoconazole have different p-values. That is not inherently contradictory: a test can depend on the distribution and analysis structure, not just on the difference between two medians. The registry does not provide enough detail to reconstruct why the p-values differ or to determine the role of stratification, ties, or outcome categorization.
The ranges overlap substantially, and in two arms the maximum observed change was 0.0, while the four-times-weekly combination and ketoconazole arms include positive maxima. Range overlap alone does not establish whether a group comparison is statistically persuasive, and the ranges are not confidence intervals. Similarly, arm sizes describe the analyzed groups but do not by themselves establish precision. No comparison confidence intervals are posted, so the uncertainty around the pairwise differences cannot be read directly from the record.
The four-times-weekly combination has the most negative arm median, but the two reported formal comparisons do not compare that regimen against ketoconazole. No p-value or other formal comparison for that regimen is posted. Nor does the record post a comparison of the two clobetasol-containing combination schedules against one another. The descriptive rankings should therefore not be mistaken for reported statistical tests across all regimens. Overall, the registry presents arm summaries and two pairwise p-values, with limited information about the analysis details and no interval estimates for the treatment contrasts.
9. Statistical Methods Explained
The outcome is reported as a median and full range for each arm. The median is the middle ordered observation: it is less affected than the mean by extreme observations and can be useful when values are skewed or concentrated at boundaries. The full range gives the minimum and maximum observed values, but it does not show how observations are distributed between those endpoints. It is also sensitive to extreme values and should not be read as an uncertainty interval. These are general statistical properties of the summaries used in the registry.
The reported analysis method is the Cochran-Mantel-Haenszel method. In general, this method assesses an association between categorical variables while accounting for strata. A stratified analysis can combine information across defined groups and may be useful when comparisons are intended to account for those groups. The registry names the method but does not report the strata, the category definitions used for the percent-change outcome, or other details needed to reproduce the tests. It is therefore not possible to explain the exact analysis coding from the registry record alone.
A p-value describes how compatible the observed data are with a specified null model under the test assumptions. It is not the probability that the null hypothesis is true, and it does not measure the size or clinical importance of an effect. The two registry p-values are p < 0.01 and p = 0.039. The record does not state whether they are unadjusted or adjusted for multiple testing, and it does not give corresponding estimates or confidence intervals. As a result, those values should be read as reported test results, not as stand-alone summaries of treatment effect.
What does a confidence interval add?
In general, a confidence interval gives a range of values compatible with an estimate under a specified procedure and assumptions. For a between-group contrast, it can show both the direction and the precision of the estimated difference. The registry reports full ranges for individual arms but no confidence intervals for the pairwise comparisons. An arm range cannot substitute for a confidence interval around a treatment contrast: the two quantities answer different questions.
Why can a median and a test tell different parts of the story?
A median compresses an arm's distribution into one central value. A comparison test can use information beyond that single summary, depending on how the outcome is coded and how the test is implemented. Here, the registry reports medians and ranges, alongside Cochran-Mantel-Haenszel p-values, but does not describe the coding and strata. The p-values cannot be derived from the medians alone. General interpretation should therefore keep the descriptive arm summaries distinct from the inferential pairwise analyses.
What does over-dispersion mean in general?
Over-dispersion occurs when observed variability is greater than a statistical model expects. If a model assumes less variability than is present, its standard errors can be too small and uncertainty can be understated. This is a general concept, not a reported finding in this trial. The registry does not identify an over-dispersion assessment or describe a count model for the primary outcome; the endpoint is reported as percent change in a composite severity score. There is no basis in the record to claim that over-dispersion was present or that a particular adjustment was used.
How should the sample-size illustrations be understood?
The planning illustrations use the observed effect as a starting point, a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation. They describe participants per arm for 80% or 90% power, with the effect to detect expressed as a fraction of the observed effect. These are planning illustrations, not the trial's own design justification and not observed power. The protocol's sample-size justification is not reported in the registry record. A calculation based on an observed result is also dependent on that result and the stated assumptions; it should not be treated as evidence that the trial had a particular power before it began.
More generally, power is a planning probability under assumptions about the effect, variability, design and analysis. It is not a measure of how likely a result is to be true after the trial. Since the registry does not report the original sample-size calculation or its assumptions, the planning illustrations cannot establish whether enrollment was chosen for the primary endpoint or whether the design targeted a particular difference.
What can be reconstructed from the posted summaries?
Simple unadjusted re-calculations from summary statistics are distinct from the sponsor-reported Cochran-Mantel-Haenszel analyses. They may serve as checks under their own assumptions, but cannot reproduce an analysis that depends on unreported outcome categories or strata. The primary outcome's medians and ranges do not contain all participant-level information. The registry does not post comparison effect estimates or confidence intervals for the two formal analyses. Consequently, the summaries and tests should be interpreted as complementary but non-interchangeable evidence: the summaries show arm-level distributions in a limited form, while the p-values report results of the named comparisons.
10. Analyses Reported by the Sponsor
| Method | Estimate | 95% CI | P-value |
|---|---|---|---|
| Cochran-Mantel-Haenszel | not reported | < 0.010 | |
| Cochran-Mantel-Haenszel | not reported | 0.039 |
The registry reports two Cochran-Mantel-Haenszel comparisons: clobetasol twice weekly with ketoconazole twice weekly versus ketoconazole twice weekly, with p < 0.01; and clobetasol twice weekly alone versus ketoconazole twice weekly, with p = 0.039. These are the posted formal comparison results. The registry does not report a comparison effect estimate or confidence interval for either one, and it does not describe the analysis strata or outcome coding.
The arm medians and ranges are descriptive summaries. A simple unadjusted re-calculation from posted summary statistics is a separate analysis and should not be treated as a reproduction of the named Cochran-Mantel-Haenszel tests, which may depend on information not contained in those summaries. No discrepancy is flagged in the registry record. The reported p-values and descriptive summaries answer different questions: the tests provide results for the stated pairwise analyses, while the medians and ranges describe the observed outcome values by arm. Since comparison estimates and intervals are not reported, neither the p-values nor the arm summaries alone provide a direct estimate of the size and precision of the between-arm effects.
11. Multiplicity, Missing Data and Analysis Populations
The registry lists one primary outcome measure and two analyses. It does not report any posted secondary outcomes. The two listed analyses compare each of the clobetasol-twice-weekly regimens with ketoconazole twice weekly. The record does not state whether these were the only planned comparisons, whether other analyses were performed, or whether the reported p-values were adjusted for multiplicity. The number and order of planned hypotheses, and any multiplicity-control strategy, are not reported in the registry record.
Multiplicity matters when several hypotheses are tested: without an appropriate plan, the chance of at least one false-positive result can increase. This is a general statistical consideration, not a claim about how the trial was conducted. The p-values should therefore be interpreted as the registry reports them, without assuming a correction or assuming that no correction was used. A prespecified analysis plan and complete reporting would be needed to clarify that distinction.
The primary outcome population is labeled ITT with LOCF. ITT generally refers to analyzing participants according to their randomized group, while LOCF carries the last observed value forward when a later value is missing; these are general definitions. The registry does not provide participant-level missingness, the amount or pattern of missing data, reasons for missing assessments, or details of how LOCF was applied. It also does not report sensitivity analyses that assess how conclusions might change under different missing-data assumptions. LOCF can make an analysis depend on the assumption that a participant's last recorded score is an appropriate stand-in for the missing assessment; whether that assumption is reasonable cannot be judged from the record.
The analyzed arm counts are 82, 82, 82 and 80, while total enrollment is 326. The registry does not explain the difference between the total and arm-level outcome counts, or give a participant flow diagram in the record. The randomization procedure, analysis-plan deviations and any interim analyses are also not reported in the registry record. These gaps limit assessment of how the analysis was planned and how missing outcomes or multiple comparisons may affect interpretation.
12. 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 |
|---|---|---|---|
| C Propionate 4/Week + Ketoconazole 2/Week | 1 | 82 | 1.2% |
| C Propionate 2/Week + Ketoconazole 2/Week | 0 | 82 | 0.0% |
| C Propionate 2/Week | 1 | 82 | 1.2% |
| Ketakonazol 2/Week | 0 | 80 | 0.0% |
Other (non-serious) adverse events
Participants with at least one non-serious event at or above the registry's 2% reporting threshold.
| Arm | Participants affected of at risk |
|---|---|
| C Propionate 4/Week + Ketoconazole 2/Week | 15 of 82 |
| C Propionate 2/Week + Ketoconazole 2/Week | 18 of 82 |
| C Propionate 2/Week | 17 of 82 |
| Ketakonazol 2/Week | 16 of 80 |
Most frequent serious adverse event terms
| Event term | Organ system | C Propionate 4/Week + Ketoconazole 2/Week | C Propionate 2/Week + Ketoconazole 2/Week | C Propionate 2/Week | Ketakonazol 2/Week |
|---|---|---|---|---|---|
| UPPER LIMB FRACTURE | Injury, poisoning and procedural complications | 0 of 82 | 0 of 82 | 1 of 82 | 0 of 80 |
| ANGINA PECTORIS | Cardiac disorders | 1 of 82 | 0 of 82 | 0 of 82 | 0 of 80 |
Most frequent non-serious adverse event terms
| Event term | Organ system | C Propionate 4/Week + Ketoconazole 2/Week | C Propionate 2/Week + Ketoconazole 2/Week | C Propionate 2/Week | Ketakonazol 2/Week |
|---|---|---|---|---|---|
| Nasopharyngitis | Infections and infestations | 5 of 82 | 4 of 82 | 7 of 82 | 5 of 80 |
| Influenza | Infections and infestations | 3 of 82 | 4 of 82 | 2 of 82 | 1 of 80 |
| Pharyngitis | Infections and infestations | 2 of 82 | 1 of 82 | 2 of 82 | 2 of 80 |
| Dermatitis Acneiform | Skin and subcutaneous tissue disorders | 1 of 82 | 1 of 82 | 2 of 82 | 1 of 80 |
| Headache | Nervous system disorders | 0 of 82 | 2 of 82 | 0 of 82 | 2 of 80 |
| Pruritus | Skin and subcutaneous tissue disorders | 0 of 82 | 3 of 82 | 1 of 82 | 0 of 80 |
| Respiratory Tract Infection | Infections and infestations | 1 of 82 | 2 of 82 | 0 of 82 | 1 of 80 |
| Rhinitis | Infections and infestations | 0 of 82 | 1 of 82 | 1 of 82 | 2 of 80 |
| Sinusitis | Infections and infestations | 1 of 82 | 0 of 82 | 0 of 82 | 2 of 80 |
| Dengue fever | Infections and infestations | 0 of 82 | 0 of 82 | 2 of 82 | 0 of 80 |
Serious events with the highest arm-level rate: upper limb fracture (1.2%), angina pectoris (1.2%).
The serious adverse-event counts are reported as 1 among 82 participants in the four-times-weekly clobetasol plus ketoconazole group, 0 among 82 in the twice-weekly clobetasol plus ketoconazole group, 1 among 82 in the clobetasol-only group, and 0 among 80 in the ketoconazole group. The record also lists upper limb fracture and angina pectoris as serious adverse-event terms, each with a reported 1.2%. It does not specify in that listing which treatment group or groups those terms correspond to, so they should not be assigned to a particular arm based on the record.
These figures describe reported events within the registry's safety reporting, not a complete account of every possible harm. The record does not provide event onset, duration, outcome, causal assessment, or a comparative safety analysis. Death counts are not reported in the registry record. The counts are small, and the registry does not post uncertainty intervals for between-arm safety differences. General interpretation therefore requires caution: event counts alone do not establish that one regimen caused an event or that the groups' safety profiles differ.
13. What the Result Does, and Does Not, Mean
The posted results describe change in investigator-assessed TSS from baseline to week 4 in four randomized groups. All four arm medians are negative, and the median change is more negative in each clobetasol-containing arm than in the ketoconazole-only arm. The registry also reports p-values for two comparisons involving the twice-weekly clobetasol regimens and ketoconazole. Those results are relevant to the stated analyses, but the registry does not provide comparison estimates or confidence intervals that would quantify their magnitude and precision.
The results do not provide a formal test for every possible pair of regimens. In particular, a comparison involving the four-times-weekly combination is not among the two posted analyses, and no direct test between the two clobetasol-containing combination schedules is reported. Descriptive differences between arm medians do not replace those missing tests. Nor does a p-value establish the clinical importance of a difference: the registry does not state a threshold for meaningful TSS change.
The endpoint is a composite investigator score, and the reported analysis uses ITT with LOCF. The registry does not provide enough detail to evaluate the impact of missing values, the outcome coding used in the categorical comparison method, or potential multiplicity. The arm ranges describe observed extremes, not uncertainty around the treatment comparisons. These considerations leave important questions about robustness and precision unresolved.
The record also reports serious adverse-event counts, but does not provide the detail needed to assess event timing, attribution, or comparative uncertainty. It should not be read as a complete assessment of all benefits and harms. More broadly, the registry record is a report of posted trial outcomes and analyses; it does not by itself establish that a particular regimen is appropriate for an individual or answer questions beyond the studied population, regimens and follow-up period.
14. Why This Trial Matters Statistically
This trial illustrates why an arm-level summary and a treatment comparison are not interchangeable. The medians offer a compact description of change in each group, while the reported Cochran-Mantel-Haenszel tests address two specified pairwise comparisons. Because the test coding and strata are not reported, and because the registry does not provide comparison estimates or confidence intervals, the reader cannot fully connect the p-values to the size and precision of the contrasts.
The record also demonstrates the distinction between an endpoint's observed spread and uncertainty about an estimate. Full ranges show the minimum and maximum reported change in each arm; they do not show the precision of a between-group effect. Treating a range as an interval estimate would confuse two different statistical quantities. Confidence intervals for the comparisons would have helped communicate uncertainty around the contrasts, but none are reported.
Analysis populations and missing-data methods matter as well. The ITT with LOCF label gives a broad description of the primary analysis, but the registry does not detail missingness or the implementation of LOCF. Those omissions constrain assessment of how much the reported results depend on incomplete follow-up and the assumptions used to handle it.
Finally, a four-arm randomized design raises questions about which comparisons were planned and how multiplicity was handled. The record reports two analyses but does not state whether they exhaust the planned comparisons or whether the p-values were adjusted. This is a useful example of how registry results can convey meaningful descriptive and inferential information while leaving key details about precision, analysis structure and reporting completeness unresolved.
15. 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 the detailed eligibility criteria, recruitment setting, randomization sequence method, allocation concealment, or the identity of the party masked. It gives the trial as single-masked but does not specify who was masked. These omissions limit assessment of how allocation and masking may have affected conduct or outcome assessment.
The primary outcome uses investigator-assessed erythema, scaling and pruritus scores. The record describes the score scales but does not report assessor training, measurement reliability, or whether the investigators remained masked to group assignment. These details are not reported in the registry record. The registry also does not define a clinically meaningful TSS change, limiting interpretation of whether the observed changes would be considered important beyond their statistical description.
Only two pairwise analyses are posted, with no comparison effect estimates or confidence intervals. The record does not describe outcome coding or the strata used for the Cochran-Mantel-Haenszel method, and it does not state whether multiplicity adjustment was applied. The posted ranges do not resolve these gaps because they are arm-level observed ranges, not intervals for treatment contrasts.
The ITT with LOCF label is not accompanied by counts or reasons for missing outcome data, details of LOCF implementation, or sensitivity analyses. The registry does not explain the difference between overall enrollment and the arm-level analysis counts. It also does not report the protocol's sample-size justification, interim analyses, or whether all planned outcomes and comparisons are posted. Follow-up beyond the week-4 primary assessment and additional clinical outcomes are not reported in the registry record. These limitations concern what can be evaluated from the registry entry; they do not establish that unreported procedures were absent.
16. Related Tutorials
17. Related Statistical Calculators
18. Sources
- ClinicalTrials.gov: Clobetasol Propionate 0.05% Shampoo in Association With Antifungal Shampoo in Scalp Seborrheic Dermatitis — NCT00862654.
- Registry record last updated 2021-02-18; status last verified 2011-08.
- Results first posted 2011-08-12.
- 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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19. Record Summary
This completed, randomized, single-masked, parallel-group phase 3 trial enrolled 326 participants with scalp seborrheic dermatitis. It assessed three clobetasol propionate shampoo 0.05% schedules, including two used with ketoconazole shampoo 2%, and a ketoconazole-only regimen. The primary outcome was median percent change in TSS from baseline to week 4, analyzed in an ITT population with LOCF.
The registry posts arm medians and full ranges, along with two Cochran-Mantel-Haenszel p-values: p < 0.01 and p = 0.039. It does not report comparison effect estimates or confidence intervals, analysis strata, or multiplicity handling. Serious adverse-event counts are also posted, but the record gives limited detail about the events and does not report death counts. Important design, missing-data and analysis-plan details are not reported in the registry record.