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 Adrenal Suppression and Absorption Study of Halobetasol Propionate Foam in Subjects 12-17 With Plaque Psoriasis (NCT03992261), a na phase 4 study. The primary outcome is Number of Subjects to Exhibit Adrenal Suppression as Measured by a Cosyntropin Stimulation Test.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT03992261 |
| Phase | Phase 4 |
| Condition | Plaque Psoriasis |
| Allocation | Not applicable (single group) |
| Design model | Single Group |
| Masking | None (open label) |
| Enrollment | 24 |
| Arms in the primary outcome | n/a |
| Lead sponsor | Mayne Pharma International Pty Ltd |
| Results posted | Yes |
2. Clinical Question
Population
The study enrolled subjects aged 12 to less than 18 years with plaque psoriasis. The primary outcome description identifies its analysis population as evaluable subjects, but the number meeting that definition is not reported in the registry record.
Intervention
Participants received halobetasol propionate foam, 0.05%, applied twice daily for 2 weeks. The study was open label, so masking was not used.
Comparator
There was no comparator group. The registry record identifies a single-group study and lists allocation as not applicable. Its results therefore do not provide a randomized, between-group estimate of treatment effect.
Primary question
The primary question was how many evaluable subjects met the record’s definition of adrenal suppression based on a cosyntropin stimulation test. Testing was described at Screening and Day 15, with testing approximately 4 weeks post-treatment for subjects whose Day 15 result showed an abnormal HPA axis response. The primary outcome count is not reported in the registry record.
3. Trial Design
This was a Phase 4, open-label, single-group study registered as NCT03992261. It enrolled 24 subjects with plaque psoriasis, aged 12 to less than 18 years. The intervention was halobetasol propionate foam, 0.05%, applied twice daily for 2 weeks. The registry record lists no masking and no allocation to comparison groups.
The study’s stated purpose was to evaluate safety, potential adrenal suppression, and the degree to which the drug is absorbed into the bloodstream. Its official title also describes an evaluation of pharmacokinetic properties. The primary outcome concerned adrenal suppression measured by a cosyntropin stimulation test. The registry record lists 2 outcome measures, but the results and detailed definitions for the other outcome are not reported in the registry record.
The record lists the study as completed, with a start date of 2019-06-14 and a primary completion date of 2019-12-30. Those dates describe the study record; they do not provide information about when individual participants began or finished treatment.
Because there was a single group and no randomized control group, the study can describe observations made among participants receiving the foam, but it cannot directly compare those observations with outcomes under another treatment or no treatment. The open-label design means masking was not used. The registry record does not report whether any additional procedures were used to reduce measurement or reporting bias.
Further design details—including eligibility criteria beyond age and plaque psoriasis, the treatment application area, rules for treatment discontinuation, and the study’s sample-size justification—are not reported in the registry record. The enrollment figure should not be treated as the number included in every outcome analysis: the primary endpoint is described for evaluable subjects, and their number is not reported.
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 | Halobetasol Propionate Foam, 0.05% |
|---|---|
| STARTED | 24 |
| COMPLETED | 24 |
| NOT COMPLETED | 0 |
Analysis population for the primary outcome, as defined in the registry: Evaluable subjects
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 | Halobetasol Propionate Foam |
|---|---|---|
| Participants analysed | 24 | |
| Age, Categorical: <=18 years | Participants | 24 |
| Age, Categorical: Between 18 and 65 years | Participants | 0 |
| Age, Categorical: >=65 years | Participants | 0 |
| Sex: Female, Male: Female | Participants | 11 |
| Sex: Female, Male: Male | Participants | 13 |
| Ethnicity (NIH/OMB): Hispanic or Latino | Participants | 6 |
| Ethnicity (NIH/OMB): Not Hispanic or Latino | Participants | 18 |
| Ethnicity (NIH/OMB): Unknown or Not Reported | Participants | 0 |
| Race (NIH/OMB): American Indian or Alaska Native | Participants | 0 |
| Race (NIH/OMB): Asian | Participants | 0 |
| Race (NIH/OMB): Native Hawaiian or Other Pacific Islander | Participants | 0 |
| Race (NIH/OMB): Black or African American | Participants | 0 |
| Race (NIH/OMB): White | Participants | 24 |
| Race (NIH/OMB): More than one race | Participants | 0 |
| Race (NIH/OMB): Unknown or Not Reported | Participants | 0 |
6. Primary Endpoint
The registry lists the primary outcome as Number of Subjects to Exhibit Adrenal Suppression as Measured by a Cosyntropin Stimulation Test, measured over Screening, Day 15, and approximately 4 weeks post-treatment, an average of 28 days.
| Element | Registry entry |
|---|---|
| Result type | Count Of Participants |
| Measure of spread | not applicable |
| Unit | Participants |
| Endpoint classification | Binary Endpoint |
The primary endpoint counts subjects classified as having evidence of adrenal suppression according to a cosyntropin stimulation test. The record describes the HPA axis response as dichotomized into normal and abnormal. It defines an abnormal response using a post-stimulation serum cortisol threshold: the description gives a result less than or equal to 18.0 mcg/100 mL and also describes a 30-minute post-stimulation serum cortisol level of ≤18 μg/dL at end of study. These are the threshold formulations recorded for the outcome.
The stated assessment schedule includes Screening and Day 15. A test approximately 4 weeks post-treatment—described as an average of 28 days—was to be performed if a subject’s Day 15 laboratory result showed an abnormal HPA axis response. This conditional follow-up is important when interpreting the endpoint: the record does not describe the same post-treatment testing schedule for every participant.
In general, a stimulated hormone test assesses a body system’s response to a defined challenge rather than relying only on a single unstimulated measurement. A binary endpoint can make the result straightforward to count, but it also reduces a continuous laboratory value to categories. Values on either side of a cutoff may be close in magnitude while being assigned different classifications.
The registry record does not report the primary endpoint count, the evaluable denominator, or individual cortisol values. Consequently, the endpoint’s observed frequency and the precision of that frequency cannot be assessed from the registry record.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry record describes the intended primary outcome and the study population, but it does not report the primary outcome result. In particular, the number of evaluable subjects meeting the adrenal-suppression definition and the denominator used for that analysis are not reported in the registry record. Without those values, the observed frequency cannot be stated, and no confidence interval or other measure of its precision can be interpreted.
The study enrolled 24 subjects, but that enrollment figure does not establish how many were evaluable for the primary endpoint. The record uses “evaluable subjects” to describe the outcome population without giving its size. It would therefore be inappropriate to treat enrollment as the analysis denominator or to infer that all enrolled subjects completed the relevant testing.
The design also limits what any observed count could establish. This was an open-label, single-group study without a comparator. A count within the treated group would describe the recorded outcome in that group under the study conditions. It would not, on its own, estimate a difference versus another treatment or establish that treatment caused the outcome. Changes over time could not be separated from other influences using a concurrent comparison in this design.
The record’s description of conditional post-treatment testing also matters. Follow-up testing approximately 4 weeks post-treatment was specified for subjects with an abnormal Day 15 response. A reader would need the participant-level assessment pattern, missing-test information, and analysis rules to understand how this schedule affected the final endpoint classification. Those details are not reported in the registry record.
The study’s stated aims include pharmacokinetics and safety, but detailed pharmacokinetic findings are not reported in the registry record. The adverse-event figures indicate 0 participants with a serious adverse event among 24 at risk and 7 with other adverse events among 24 at risk. These are safety counts, not substitutes for the unreported primary endpoint result, and the registry entry does not provide event descriptions for the other adverse events.
In general, confidence intervals communicate the range of values compatible with an estimate under specified assumptions. They are useful for judging precision, but do not remedy missing outcome reporting or the absence of a comparison group. Since the primary count, denominator, and interval are not reported in the registry record, the degree of uncertainty around the primary result cannot be quantified from this record.
9. Statistical Methods Explained
The primary outcome is a count of participants with a binary classification: normal or abnormal HPA axis response. The record defines evidence of adrenal suppression through a cosyntropin stimulation test and a specified cortisol threshold. The study is described as single group, so the endpoint is not a comparison between randomized arms. No inferential statistical method for the primary outcome is reported in the registry record.
What does a binary count tell the reader?
In general, a binary outcome records whether each assessed participant met a defined criterion. The count is interpretable only alongside its denominator: the number of people assessed under the stated outcome rules. A count without a denominator does not indicate how common the event was in the analysis population. In this study, the record identifies evaluable subjects as the population but does not report either the primary count or the number evaluable.
Binary classification also depends on the threshold. A laboratory value at or below the cutoff is placed in a different category from a value above it, even if the values are close. That can be useful when a protocol needs a defined classification, but it discards information about the magnitude and distribution of the original measurements. The registry record does not provide individual cortisol values or a summary of those values.
Why does the study design matter?
In general, a single-group study can describe outcomes observed among participants who receive an intervention. It does not directly estimate a treatment-versus-control contrast. Without a concurrent control group, the observed outcome cannot be distinguished from changes or events that might also occur in the absence of the intervention or under another intervention. The open-label design also means participants and study personnel were not masked, although the record does not describe how that might have affected outcome assessment.
Randomization, when used, helps make groups comparable on average with respect to measured and unmeasured factors. There was no randomized comparison in this study. Thus, methods intended to estimate a randomized between-group difference do not describe the primary design. The registry record does not report a statistical model or adjustment procedure for the endpoint.
How should precision be judged?
In general, an estimate of an event frequency is more informative when accompanied by a confidence interval. The interval reflects sampling uncertainty under the analysis method; it does not account automatically for bias, incomplete outcome measurement, or differences between the study population and other populations. A narrow interval is not proof of causal effect, and a wide interval signals limited precision rather than proof that there is no effect.
Here, neither the primary count nor its analysis denominator is reported in the registry record, so a frequency and its interval cannot be interpreted from the available outcome information. No primary endpoint confidence interval or p-value is reported in the registry record. It would be inappropriate to invent or reconstruct one without the required analysis data and methods.
What does the assessment schedule imply?
The record describes testing at Screening and Day 15, with an additional assessment approximately 4 weeks post-treatment for subjects whose Day 15 result was abnormal. In general, conditional follow-up can mean that participants have different numbers of measurements, and the endpoint’s handling of those patterns should be specified. The registry record does not report the final classification rule for a participant with a missing test, the number of tests completed, or how missing measurements were handled.
What is and is not known about planning?
The registry record does not report the protocol’s sample-size justification, target event frequency, or statistical plan. Any sample-size illustrations based on an observed effect are planning exercises, not evidence of the study’s observed power. In general, such calculations depend on assumptions about the effect to detect, variability or event frequency, significance level, allocation, and analysis method. They cannot replace reporting the actual endpoint count, denominator, and uncertainty. The assumptions underlying the study’s own design are not reported in the registry record.
The record lists 2 outcome measures and 1 analysis. Those counts alone do not explain which analyses were prespecified, whether analyses were changed, or how multiple outcomes were handled. The statistical analysis plan and any interim analyses are not reported in the registry record.
10. Multiplicity, Missing Data and Analysis Populations
The registry record lists 2 outcome measures and 1 analysis, but does not explain the analysis mapping, identify a multiplicity procedure, or report whether any outcomes were designated as secondary or exploratory. The statistical plan for controlling error across multiple outcomes or analyses is not reported in the registry record. In general, when several hypotheses are tested, the chance of at least one apparently notable result can increase; a prespecified strategy can clarify how such findings should be interpreted. No such strategy can be inferred from the number of listed outcomes alone.
The record identifies the primary endpoint population as evaluable subjects, but does not state how many subjects were evaluable. The number with missing or incomplete cosyntropin assessments, reasons for missing assessments, and rules for classifying incomplete data are not reported in the registry record. These details matter because the analyzed group may differ from the enrolled group, and missing measurements can affect both the estimate and its interpretation.
The assessment schedule includes conditional follow-up at approximately 4 weeks post-treatment for subjects with an abnormal Day 15 response. The record does not report how subjects with missing Day 15 results or missing conditional follow-up were handled, nor whether any sensitivity analyses were conducted. The statistical analysis plan, interim analysis plan, and prespecified analysis population definitions beyond “evaluable subjects” 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 |
|---|---|---|---|
| Halobetasol Propionate Foam, 0.05% | 0 | 24 | 0.0% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| Halobetasol Propionate Foam, 0.05% | 0 of 24 |
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 |
|---|---|
| Halobetasol Propionate Foam, 0.05% | 7 of 24 |
Most frequent non-serious adverse event terms
| Event term | Organ system | Halobetasol Propionate Foam, 0.05% |
|---|---|---|
| ACTH Stimulation Test Abnormal | Endocrine disorders | 7 of 24 |
| Local skin reactions | Skin and subcutaneous tissue disorders | 6 of 24 |
The registry record lists 24 participants at risk for serious adverse events and 0 participants affected. It lists 24 participants at risk for other adverse events and 7 participants affected. These are participant counts in the record, not event rates calculated. No serious adverse event terms are listed.
The distinction between serious and other adverse events is important: the serious-event count does not describe all adverse events, and the other-event count should not be read as a count of serious events. The record does not provide the terms, severity, timing, duration, relatedness assessment, or participant-level detail for the 7 participants with other adverse events. It also does not state whether any individual experienced more than one event, so participant counts should not be interpreted as total event counts.
In general, a zero recorded count in a study does not establish that an event cannot occur. Interpretation depends on the population observed, the duration and completeness of follow-up, and the event definitions and reporting procedures. Those additional details are not reported in the registry record. These safety figures do not supply the missing primary adrenal-suppression result.
12. What the Result Does, and Does Not, Mean
This study addresses an important measurement question in adolescents with plaque psoriasis: how many evaluable subjects meet a defined adrenal-suppression criterion during the stated treatment and assessment schedule. It also states aims concerning safety and drug absorption. The registry record gives the design, intervention, population, and endpoint definition, but does not report the primary endpoint count or denominator. The central result therefore cannot be described from the registry record.
Even if an endpoint count were available, a single-group, open-label design would support a description of outcomes observed in the enrolled study group, not a randomized comparison with another treatment or with no treatment. A count alone would not establish a causal relationship. The record does not report an alternative comparator, and no treatment-effect contrast is available from this design as described.
The endpoint is based on a dichotomized stimulated cortisol result. As a general statistical point, a cutoff makes a classification operational and countable, but does not show the full range of laboratory responses. The record does not provide individual measurements, distributions, or a confidence interval for the primary endpoint. Therefore, readers cannot assess the observed frequency, its precision, or how results might vary across the study population from the primary outcome information in this record.
The safety figures are limited to counts: 0 participants with serious adverse events among 24 at risk and 7 with other adverse events among 24 at risk. Descriptions and other details of the non-serious events are not reported in the registry record. The study’s stated pharmacokinetic aim is also not accompanied by detailed results in the registry record.
In general, interpretation of a clinical study depends on its methods, outcome definitions, completeness of follow-up, and the availability of results. Here, key details about missing assessments and the analysis plan are not reported in the registry record. The record supports a description of the study’s intended question and design, but not a conclusion about the frequency of adrenal suppression or a comparative treatment effect.
13. Why This Trial Matters Statistically
This study is statistically notable because its primary outcome turns a laboratory response into a participant-level binary classification. Such an endpoint is easy to express as a count, but its interpretation depends on a clearly defined cutoff, complete assessment, and a reported denominator. The registry record describes the cutoff and testing schedule, while the primary count and evaluable population size are not reported in the registry record.
The conditional follow-up schedule adds an interpretive consideration: an assessment approximately 4 weeks post-treatment was specified for subjects with an abnormal Day 15 result. In general, when testing depends on an earlier result, transparent reporting of who was tested, who was not, and how incomplete data were handled helps readers understand the final endpoint. Those details are not reported in the registry record.
The single-group, open-label design is also central to statistical interpretation. It can describe outcomes in the study group, but it does not offer a randomized comparison that estimates how outcomes differ between treatment strategies. Readers should distinguish descriptive safety counts from causal evidence or comparative efficacy claims.
Finally, the record’s stated aims extend beyond the primary adrenal-suppression endpoint to safety and drug absorption. A useful assessment of those aims requires the outcome results and analysis details, not only the study description. Detailed pharmacokinetic findings are not reported in the registry record. Taken together, the record illustrates why complete reporting of analysis populations, outcome counts, uncertainty, and missing-data handling is essential for interpreting a clinical study.
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 primary limitation for interpreting the study’s principal question is that the primary outcome count and denominator are not reported in the registry record. Although enrollment was 24, the outcome population is described as evaluable subjects, and its size is not stated. The primary result’s frequency and precision therefore cannot be assessed.
The design is single group and open label, with no comparator. Consequently, the record does not support a randomized between-group estimate, and any within-group observation would not by itself establish a causal effect. The record does not report whether outcome assessment used procedures intended to reduce the influence of the unmasked design.
The primary assessment includes scheduled and conditional testing: follow-up approximately 4 weeks post-treatment is specified for subjects with an abnormal Day 15 response. The number completing each assessment, reasons for missing tests, and rules for handling incomplete results are not reported in the registry record. These omissions limit assessment of possible selection or missing-data effects.
The endpoint uses a threshold-based binary classification. Individual cortisol results and their distribution are not reported in the registry record, so the degree to which values clustered near the threshold cannot be assessed. The registry record also does not report the statistical analysis plan, multiplicity approach, sample-size justification, or any sensitivity analyses.
Although the stated aims include pharmacokinetics and safety, detailed pharmacokinetic results and descriptions of other adverse events are not reported in the registry record. The serious adverse event count is listed as 0 among 24 at risk, but broader follow-up and event-detail information is not reported. These limitations mean the record supports an account of design and selected safety counts, not a complete evaluation of all stated aims.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Adrenal Suppression and Absorption Study of Halobetasol Propionate Foam in Subjects 12-17 With Plaque Psoriasis — NCT03992261.
- Registry record last updated 2023-07-06; status last verified 2023-03.
- Results first posted 2023-07-06.
- 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
NCT03992261 is a completed Phase 4, open-label, single-group study of halobetasol propionate foam, 0.05%, in subjects aged 12 to less than 18 years with plaque psoriasis. The record lists enrollment of 24 and a regimen of twice-daily application for 2 weeks. The primary outcome was the number of evaluable subjects meeting a defined adrenal-suppression criterion on cosyntropin stimulation testing.
The primary outcome count and evaluable denominator are not reported in the registry record. The record lists 0 participants with serious adverse events among 24 at risk and 7 participants with other adverse events among 24 at risk. Detailed pharmacokinetic findings, analysis-plan details, and missing-data handling are not reported in the registry record. With no comparator group, the study description does not provide a randomized treatment contrast.