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 An Open Label, Safety Study to Assess the Potential for Adrenal Suppression (NCT02932878), a na phase 2 study. The primary outcome is Proportion of Patients in the Study With HPA Axis Suppression.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT02932878 |
| Phase | Phase 2 |
| Condition | Plaque Psoriasis |
| Allocation | Not applicable (single group) |
| Design model | Single Group |
| Masking | None (open label) |
| Enrollment | 16 |
| Arms in the primary outcome | n/a |
| Lead sponsor | Sun Pharmaceutical Industries, Inc. |
| Results posted | Yes |
2. Clinical Question
Population
Patients with plaque psoriasis were enrolled. The registry lists enrollment as 16. The primary endpoint description notes that the 1 patient in Cohort 2 did not qualify for evaluation of HPA-axis suppression, so the endpoint’s evaluable population is not identical to everyone enrolled.
Intervention
The intervention was DSXS topical, administered twice daily for 28 days. The study was open label, and the registry describes a safety assessment following treatment.
Comparator
There was no control arm identified in the registry record. It describes a single-group study, with Cohort 1 and Cohort 2 listings rather than a randomized, like-for-like treatment comparison. Allocation is listed as not applicable.
Primary question
The primary endpoint asks for the proportion of patients in the study with hypothalamic-pituitary-adrenal (HPA) axis suppression, assessed in relation to cosyntropin response at 28 Days. The endpoint result is not reported in the registry record, so the clinical question cannot be answered from the posted endpoint data.
In general, the HPA axis is part of the body’s hormonal system, and a cosyntropin response assessment is used to evaluate adrenal response. The study’s stated safety question concerns whether HPA-axis suppression was observed following the treatment course. That question is distinct from whether treatment changes plaque psoriasis, and the registry’s stated primary endpoint is not a measure of psoriasis improvement.
The record gives no comparator group against which to interpret the endpoint. Even if an endpoint count were available, a single-group result would describe the observed participants under this study’s conditions; it would not by itself establish how the result compares with another treatment or with no treatment. In this record, the primary endpoint result itself is not reported.
3. Trial Design
The registry identifies NCT02932878 as a completed Phase 2, open-label safety study of DSXS topical in patients with plaque psoriasis. Its title and brief description focus on assessing the potential for adrenal suppression following treatment. The listed enrollment is 16. The intervention description states that DSXS topical was administered twice daily for 28 days.
The design is classified as single group, with masking listed as none and allocation listed as not applicable. Cohort 1 and Cohort 2 appear in the safety listings, but the record does not describe them as randomized treatment arms or provide a control group. They should not be interpreted as a like-for-like comparison. The reason for having these cohorts, and any differences in their procedures or characteristics, is not reported in the registry record.
The registry lists the study start as 2016-09-02, primary completion as 2017-04-10, and status as completed. The sponsor is Sun Pharmaceutical Industries, Inc. The planned primary outcome is the proportion of patients with HPA-axis suppression, with a timeframe of 28 Days and a description referring to HPA-axis response to cosyntropin.
The primary endpoint description also states that the 1 patient in Cohort 2 did not qualify for evaluation of HPA-axis suppression. The record does not explain why that patient was ineligible or give a fuller account of the endpoint analysis population. Although the registry lists a primary outcome measure, it reports no analysis for it. The statistical plan, endpoint analysis method, and further details of the study procedures are not reported in the registry record.
Because the study is open label and single group, its design is descriptive rather than a randomized comparison. The registry record does not establish a comparison that would separate a treatment effect from other explanations for any observed outcome.
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 | DSXS Topical Cohort 1 | DSXS Topical Cohort 2 |
|---|---|---|
| STARTED | 15 | 1 |
| COMPLETED | 13 | 0 |
| NOT COMPLETED | 2 | 1 |
Reasons for not completing this period:
| Reason | DSXS Topical Cohort 1 | DSXS Topical Cohort 2 |
|---|---|---|
| Due to Lab Results | 2 | 1 |
Analysis population for the primary outcome, as defined in the registry: The one patient in Cohort 2 did not qualify for evaluation of HPA axis suppression.
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 | DSXS Topical Cohort 1 | DSXS Topical Cohort 2 | Total |
|---|---|---|---|---|
| Participants analysed | 15 | 1 | 16 | |
| Age, Continuous | years | 15.13 (SD 1.88) | 8.00 | 14.69 (SD 2.55) |
| Sex: Female, Male: Female | Participants | 4 | 1 | 5 |
| Sex: Female, Male: Male | Participants | 11 | 0 | 11 |
| Ethnicity (NIH/OMB): Hispanic or Latino | Participants | 11 | 1 | 12 |
| Ethnicity (NIH/OMB): Not Hispanic or Latino | Participants | 4 | 0 | 4 |
| Ethnicity (NIH/OMB): Unknown or Not Reported | Participants | 0 | 0 | 0 |
| Race (NIH/OMB): American Indian or Alaska Native | Participants | 0 | 0 | 0 |
| Race (NIH/OMB): Asian | Participants | 0 | 0 | 0 |
| Race (NIH/OMB): Native Hawaiian or Other Pacific Islander | Participants | 0 | 0 | 0 |
| Race (NIH/OMB): Black or African American | Participants | 2 | 0 | 2 |
| Race (NIH/OMB): White | Participants | 13 | 1 | 14 |
| Race (NIH/OMB): More than one race | Participants | 0 | 0 | 0 |
| Race (NIH/OMB): Unknown or Not Reported | Participants | 0 | 0 | 0 |
| Baseline Total BSA | meters squared | 1.86 (SD 0.35) | 1.31 | 1.83 (SD 0.37) |
| Baseline IGA: Clear | Participants | 0 | 0 | 0 |
| Baseline IGA: Minimal | Participants | 0 | 0 | 0 |
| Baseline IGA: Mild | Participants | 7 | 1 | 8 |
| Baseline IGA: Moderate | Participants | 8 | 0 | 8 |
| Baseline IGA: Severe | Participants | 0 | 0 | 0 |
6. Primary Endpoint
The registry lists the primary outcome as Proportion of Patients in the Study With HPA Axis Suppression, measured over 28 Days.
| Element | Registry entry |
|---|---|
| Result type | Count Of Participants |
| Measure of spread | not applicable |
| Unit | Participants |
| Endpoint classification | Binary Endpoint |
The primary endpoint is the proportion of patients with HPA-axis suppression, measured at 28 Days. Its description identifies HPA-axis response to cosyntropin as the assessment. The registry classifies the outcome as a count of participants, so the underlying observation is whether a participant meets the study’s criterion for suppression. The specific criterion and the procedure used to classify a response are not reported in the registry record.
In general, a binary endpoint records whether an event or condition is present for each participant. A count of participants meeting the endpoint can then be used to describe how often the outcome occurred in the endpoint population. A proportion relates such a count to the participants eligible for that assessment. For this record, however, the endpoint count and reported proportion are not reported in the registry record; no value should be inferred from the safety listings.
The endpoint is relevant to the study’s stated safety question because it focuses on adrenal response following the treatment period. The registry specifically says that the 1 patient in Cohort 2 did not qualify for evaluation of HPA-axis suppression. It does not give the complete analysis denominator or explain the exclusion. That qualification matters when interpreting any proportion: the population assessed must be clear, and enrollment alone does not establish who contributed endpoint data.
The endpoint is not a measure of psoriasis response. No treatment comparison or efficacy outcome is described in the posted primary endpoint information. The result and its precision are not reported in the registry record.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry record identifies the question the study was intended to address, but it does not report the primary endpoint result. The measure is the proportion of patients with HPA-axis suppression at 28 Days, described through HPA-axis response to cosyntropin. No endpoint count, proportion, confidence interval, or inferential analysis is reported in the registry record. Consequently, the posted record does not establish how many eligible participants met the suppression criterion or how precisely that result was estimated.
The endpoint population also requires care. The primary outcome description states that the 1 patient in Cohort 2 did not qualify for evaluation. The record does not give the full analysis population or explain the eligibility decision. Enrollment is listed as 16, but enrollment should not be treated as the endpoint denominator when the record identifies a participant who did not qualify for that assessment. The safety listings use their own at-risk counts; those counts do not supply the missing primary endpoint result.
The safety information reports zero serious adverse events for the listed DSXS Topical Cohort 1 group and zero for the listed DSXS Topical Cohort 2 group. It also reports zero deaths in each listing. These are descriptive counts in the registry’s safety categories. They do not substitute for the HPA-axis endpoint, and they do not establish the absence of every possible adverse event or outcome. The record also gives no serious adverse event terms.
As a single-group, open-label study with no control arm, the design does not support a randomized comparison. Any outcome recorded in such a study would describe participants observed under the study conditions, without a control group to help distinguish the intervention’s contribution from other influences. Here, even that descriptive interpretation is constrained because the primary endpoint result is not reported.
In general, a confidence interval communicates the uncertainty around an estimate; narrower intervals indicate greater precision, while wider intervals indicate less precision. No confidence interval for the primary endpoint is reported in the registry record. A p-value, adjusted or otherwise, is also not reported. The posted information therefore does not allow a reader to assess statistical uncertainty or draw an inferential conclusion about the endpoint.
The registry’s completion status indicates that the study is marked completed, not that all planned outcome results are available in the record. The absence of an endpoint analysis limits what can be concluded from the posted data. It does not demonstrate that suppression occurred, nor that it did not occur.
9. Statistical Methods Explained
The registry describes a binary primary outcome: the proportion of patients with HPA-axis suppression. It also characterizes the measure as a count of participants. In general, a binary outcome has two possible classifications for each assessed participant, such as meeting or not meeting a prespecified condition. A count records how many participants meet the condition; a proportion relates that count to the number of participants assessed. For this study, the registry does not report the endpoint count or proportion, and the specific classification rule is not reported in the registry record.
What does the endpoint population mean?
The population included in an endpoint analysis can differ from the enrolled population when some participants are not eligible for an assessment or lack an interpretable measurement. The primary outcome description explicitly says the 1 patient in Cohort 2 did not qualify for evaluation of HPA-axis suppression. It does not explain the reason, give a complete accounting of endpoint eligibility, or state the final analysis denominator. In general, a proportion is interpretable only when its denominator and inclusion rules are clear. Here those details are not reported in the registry record, and no endpoint value is posted.
The safety listings report participants at risk for the adverse-event categories, but these counts describe the safety information rather than the primary endpoint population. A safety denominator should not be substituted for the endpoint denominator without an explicit link in the record. The record does not provide that link.
What can a single-group design estimate?
In general, a single-group study can describe outcomes observed among the participants assessed under its study conditions. It does not include a concurrent control arm for estimating how outcomes might differ under another treatment or no treatment. This registry classifies the model as single group, allocation as not applicable, and masking as none. It identifies Cohort 1 and Cohort 2 in safety listings, but provides no basis for treating them as randomized comparison arms. The design therefore does not support a randomized between-group treatment contrast.
Open-label means the record does not describe masking. In general, lack of masking can affect how outcomes are assessed or reported, depending on the outcome and procedures. The registry does not describe any safeguards or assessment procedures beyond the endpoint’s reference to cosyntropin response. Further detail is not reported in the registry record.
How should uncertainty be understood?
In general, an estimate is a summary of the observed data, while a confidence interval expresses uncertainty around that estimate under a statistical model. A wider interval indicates less precision than a narrower interval. A p-value, when reported, summarizes how compatible the observed data are with a specified statistical null model; it does not measure the size or clinical importance of an effect. These general interpretations do not imply that such analyses were performed for this endpoint. The registry reports no endpoint estimate, confidence interval, or p-value, and the analysis method is not reported in the registry record.
For a binary outcome, the number of participants meeting the endpoint and the number assessed are central to interpreting the estimate. Without both, the reader cannot verify a reported proportion or determine how much information supports it. No recalculation from posted summary statistics is available for the primary endpoint because the necessary endpoint result is absent. No sponsor analysis of this outcome is reported in the registry record.
What does over-dispersion mean in general?
Over-dispersion occurs when observed variation is greater than a statistical model expects. In general, accounting for over-dispersion can prevent uncertainty from being understated when the model’s assumptions do not match the data. This concept is not identified as an issue in the registry record, and no analysis of over-dispersion is reported. The primary endpoint is a binary participant count; the record does not describe a model or analysis that would justify further claims about its variance assumptions.
Are the sample-size assumptions the trial’s analysis plan?
The registry record includes planning-illustration assumptions based on an observed effect: a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation. It states that the effect to detect is a stated fraction of the observed effect and distinguishes participant-per-arm illustrations from total event counts for time-to-event outcomes. These are planning assumptions, not evidence that the trial itself was designed as a two-arm comparison. The recorded design is single group, and the assumptions do not establish the original protocol’s sample-size justification, statistical plan, or observed power. Those details are not reported in the registry record.
A sample-size illustration is a planning tool, not a result from participants. It cannot replace an endpoint estimate or show whether a study found an effect. The registry record provides no sample-size justification for the original study and no endpoint analysis from which precision could be assessed. In general, inferential methods should be interpreted in light of the design, endpoint definition, population analyzed, and missing-data handling. Those elements are not fully documented for this primary endpoint.
10. Multiplicity, Missing Data and Analysis Populations
The registry lists one primary outcome measure and no analyses. It does not report a multiplicity adjustment, testing hierarchy, or plan for handling multiple statistical tests. The statistical plan is not reported in the registry record. Without those details, it is not possible to determine whether any multiplicity issue was anticipated or how it would have been addressed.
The primary endpoint description says that the 1 patient in Cohort 2 did not qualify for evaluation of HPA-axis suppression. The reason is not reported in the registry record. The record does not provide a complete participant flow for the endpoint, the number with evaluable results, a missing-data method, or an analysis population definition beyond that note. It therefore does not show how eligibility, unavailable assessments, or other missing endpoint information were handled.
In general, missing-data handling matters because estimates can depend on which participants contribute outcome data and on why other data are absent. A complete-case result, an imputed result, and a result based on a different analysis population can have different interpretations. These are general possibilities, not methods identified for this trial. No imputation or sensitivity analysis is reported in the registry record.
The listed enrollment and safety at-risk counts do not resolve the missing endpoint denominator. Nor does the completed status establish that the primary endpoint was analyzed or posted. The registry reports no primary endpoint analysis, so the endpoint estimate and its uncertainty cannot be assessed.
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 |
|---|---|---|---|
| DSXS Topical Cohort 1 | 0 | 15 | 0.0% |
| DSXS Topical Cohort 2 | 0 | 1 | 0.0% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| DSXS Topical Cohort 1 | 0 of 15 |
| DSXS Topical Cohort 2 | 0 of 1 |
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 |
|---|---|
| DSXS Topical Cohort 1 | 0 of 15 |
| DSXS Topical Cohort 2 | 0 of 1 |
The registry’s safety listings show zero serious adverse events in DSXS Topical Cohort 1 and zero in DSXS Topical Cohort 2. The corresponding at-risk counts are 15 for Cohort 1 and 1 for Cohort 2. The listings also report zero deaths in each cohort. These are cohort-specific safety counts, not a randomized comparison.
In general, an at-risk count identifies the participants covered by a particular safety listing, while an affected count records participants with the specified event category. The serious-event counts describe only the category named in the listing. They should not be read as proof that no non-serious events occurred, or that no other safety outcome was possible. The registry lists no serious adverse event terms.
These safety figures do not report the primary HPA-axis suppression endpoint. They also do not establish a treatment effect, because the study is single group and has no control arm. The safety data are descriptive of the posted listings and should be interpreted within that scope.
12. What the Result Does, and Does Not, Mean
The posted record identifies a completed, open-label, single-group safety study of DSXS topical in patients with plaque psoriasis. It specifies twice-daily administration for 28 days and names HPA-axis suppression assessed through cosyntropin response as the primary endpoint. It also reports zero serious adverse events and zero deaths in each of the two cohort safety listings.
The central limitation for interpretation is that the primary endpoint result is not reported in the registry record. There is no posted count or proportion of participants meeting the HPA-axis suppression criterion, no reported uncertainty interval, and no primary endpoint analysis. The registry notes that the 1 patient in Cohort 2 did not qualify for evaluation but does not explain the exclusion or give the complete endpoint population. Accordingly, the record does not show whether the endpoint was observed or how precisely it could be estimated.
The zero serious adverse event and death counts are limited to those listed categories and groups. They cannot be taken as a report of every possible adverse event or as a replacement for the primary endpoint. They also do not demonstrate that the intervention caused any particular outcome.
In general, a single-group study can describe outcomes observed among its participants, but it cannot provide the same comparative evidence as a randomized controlled design. This registry identifies no control arm, so it does not support a like-for-like comparison with another treatment or with no treatment. The cohort labels do not create such a comparison.
Thus, the record documents the study question, design, treatment schedule, and selected safety counts, but leaves the primary result and its precision unavailable. It does not establish either the presence or absence of HPA-axis suppression in the assessed population. It also does not provide a basis for claims about psoriasis efficacy.
13. Why This Trial Matters Statistically
This study illustrates why a clearly stated endpoint and an available endpoint result are both needed for statistical interpretation. The registry names a focused safety outcome—HPA-axis suppression assessed through cosyntropin response at 28 Days—but does not report the outcome count or proportion. Without that result, readers cannot assess the observed frequency or its precision, even though the study is marked completed.
The endpoint population is also important. The record explicitly states that the 1 patient in Cohort 2 did not qualify for the primary endpoint assessment, while giving no full account of eligibility or the analysis denominator. This highlights a general statistical principle: enrollment, safety follow-up, and endpoint evaluation need not involve the same participants, and the relevant population must be clear for an estimate to be interpretable.
The design matters as well. The registry classifies the study as single group and open label, with allocation not applicable. Cohort listings for safety do not constitute a randomized comparison. Any descriptive result would need to be read in that context, and the absent endpoint analysis prevents even that endpoint-specific description.
Finally, the safety listings and primary outcome answer different questions. Zero serious adverse events and zero deaths in the listed cohorts are specific descriptive counts; they do not answer the HPA-axis endpoint question. Keeping these outcomes separate avoids treating one type of evidence as a substitute for another. The record is useful for identifying the study’s intended safety focus and design, while also showing how missing outcome reporting limits what can be concluded statistically.
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 endpoint result is not reported in the registry record. The posted information therefore does not include the endpoint count or proportion, an estimate of precision, or an analysis that could be interpreted statistically. This is the most direct limitation for assessing the study’s stated question.
The registry states that the 1 patient in Cohort 2 did not qualify for endpoint evaluation, but does not report why. It also does not give the complete endpoint analysis population, a participant-flow account, or a method for handling missing assessments. These omissions make it difficult to determine exactly which participants would contribute to a primary endpoint estimate.
The design is single group and open label, and no control arm is identified. Cohort 1 and Cohort 2 are listed for safety, but the record does not describe them as comparable randomized arms or explain their relationship. As a result, they should not be used to infer a treatment contrast. The study’s statistical analysis plan, endpoint definition details, sample-size justification, and any interim analyses are not reported in the registry record.
The safety figures are limited to the event categories and groups listed. The record gives zero serious adverse events and zero deaths for each cohort but no serious adverse event terms. These counts do not describe every safety outcome and do not fill the gap in primary endpoint reporting. The completion status alone does not clarify whether missing results were never collected, not analyzed, or not posted; the reason is not reported in the registry record.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: An Open Label, Safety Study to Assess the Potential for Adrenal Suppression — NCT02932878.
- Registry record last updated 2018-12-06; status last verified 2018-11.
- Results first posted 2018-12-06.
- 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
NCT02932878 is listed as a completed Phase 2, open-label, single-group safety study sponsored by Sun Pharmaceutical Industries, Inc. It enrolled 16 patients with plaque psoriasis and evaluated DSXS topical, administered twice daily for 28 days. The registry lists the study start as 2016-09-02 and primary completion as 2017-04-10.
The primary outcome was the proportion of patients with HPA-axis suppression at 28 Days, described as HPA-axis response to cosyntropin. The record notes that the 1 patient in Cohort 2 did not qualify for endpoint evaluation, but does not report the primary outcome result or a statistical analysis.
Safety listings report zero serious adverse events and zero deaths in both DSXS Topical Cohort 1 and DSXS Topical Cohort 2. The record does not identify a control group, and the cohort listings do not establish a randomized comparison.