Effects of Desoximetasone Spray 0.25% in Patients With Moderate to Severe Plaque Psoriasis: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Effects of Desoximetasone Spray 0.25% in Patients With Moderate to Severe Plaque Psoriasis (NCT01206660), a randomized phase 3 study. The primary outcome is Clinical Success ITT.

2. Clinical Question

This is a comparison of the number meeting a categorical threshold, rather than a comparison of average change in a score. The posted primary outcome is labeled “Clinical Success ITT” and measured in participants. The registry record reports the two arm counts and an analysis comparing the spray arm with placebo. It also lists a PGA score at Day 28 as a secondary outcome, offering a different way to describe the same clinical assessment domain. The record does not explain the PGA scale beyond the success threshold used for the primary outcome, nor does it give a separate change-from-baseline definition for the secondary measure.

The question is specific to the registered treatment schedule and 28-day outcome. It does not, on its own, address outcomes after that timeframe or effects in populations not described in the registry record. The posted comparison should therefore be read as evidence about the reported endpoint, population, and follow-up period, not as an answer to broader questions about longer-term outcomes or other treatment settings.

3. Trial Design

The registry describes a randomized, parallel-design phase 3 study with multiple sites, comparing desoximetasone Spray 0.25% with placebo. Enrollment was 120. The primary outcome lists 60 participants in each arm, and the intervention descriptions specify twice-daily application to the affected area for 28 days. The study is marked completed. The registry record gives a start date of 2010-08 and a primary completion date of 2010-12.

The official title calls the study double-blind, while the registry’s masking classification is “TRIPLE.” These are not identical descriptions. The record does not identify which groups of people were masked, or explain the difference between the title wording and the masking classification. It is therefore safest to report both descriptions without inferring who knew treatment assignments. Random allocation and a parallel-group model are recorded, but the method used to generate the allocation sequence, conceal assignments, or maintain masking is not reported in the registry record.

The trial compares two assigned groups over the same treatment period. This structure allows the registry analysis to contrast outcomes in the spray arm with outcomes in the placebo arm. The primary population is labeled ITT, but the record does not provide the operational definition used for that population, such as how participants with missing endpoint assessments were handled. The 60 participants listed for each primary-outcome arm match the arm sizes posted for that outcome; the record does not provide a participant-flow account or explain whether any observations were excluded from particular analyses.

The sponsor is Sun Pharmaceutical Industries, Inc. The registry record does not report the original sample-size justification, detailed protocol methods, allocation ratio rationale, or a schedule of interim analyses. The planning illustrations calculated from the observed results are separate from those original design details and should not be taken as the trial’s prospective planning assumptions.

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

Analysis population for the primary outcome, as defined in the registry: Analysis was conducted using Intent-to-Treat (ITT)

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.

6. Primary Endpoint

The registry lists the primary outcome as Clinical Success ITT, measured over 28 days.

The primary endpoint is “Clinical Success ITT” at 28 days, measured as the number of participants who met the success definition. A participant counted as a success if the Physician’s Global Assessment (PGA) was 0 (clear) or 1 (almost clear). The endpoint therefore converts an assessment into a yes-or-no outcome: each participant either meets the stated threshold or does not.

A threshold outcome can be clinically interpretable because it describes the proportion of participants reaching a prespecified state, rather than only an average score. At the same time, this format discards detail: participants just on either side of the cutoff are classified differently, while distinct scores on the same side are grouped together. The posted result is a count, so the comparison concerns how many participants met the criterion in each arm.

The ITT label indicates the analysis population named in the registry, but does not fully specify how missing assessments, withdrawals, or other post-randomization events were treated. Those handling rules are not reported in the registry record. The endpoint is measured at 28 days; results at other timepoints are not reported in the registry record. The registry’s brief study objective is to assess efficacy and safety in patients with moderate to severe plaque psoriasis, but the primary endpoint alone does not address every aspect of efficacy or safety.

7. Results Posted in the Registry

• Desoximetasone Spray 0.25%: 53.3% (32/60) versus 18.3% (11/60) on control; risk difference 35.0 percentage points (95% CI 19.0 to 51.0), risk ratio 2.91 (1.62–5.22); unadjusted two-proportion z-test p = <0.001.

8. Secondary Efficacy Endpoints

The registry also posts results for secondary outcomes. For each outcome below, the endpoint type, the test applied to the posted summary statistics, the result and its interpretation are given in turn. Secondary endpoints are usually not adjusted for multiple testing, so they support rather than confirm the primary finding.

Physician's Global Assessment (PGA) of Psoriasis Score at Day 28.

• Endpoint type: Continuous: a mean value per participant, compared as a difference in means.
• Test: Unadjusted two-sample z-test for the difference in means, using the posted standard deviations.
• Result:
  • Desoximetasone Spray 0.25%: mean 1.73 versus 0.85 on control; difference 0.88 (95% CI 0.52 to 1.24), standardized effect d = 0.88; z-test p = <0.001.
• Interpretation:
  • The 95% confidence interval excludes no difference, so the mean is statistically higher for Desoximetasone Spray 0.25% than for the control. This is an unadjusted, secondary comparison, so it is suggestive rather than confirmatory.

The registry lists the Physician’s Global Assessment score at Day 28 as a secondary outcome. It is a continuous score, complementing the primary endpoint’s classification of participants as clinical successes or not. In general, a continuous measure retains more gradation than a threshold-based outcome, while the threshold can give a more direct count of participants reaching a defined state.

The registry reports a comparison for this secondary measure and a two-sided sponsor analysis. However, the record does not explain which direction of the PGA scale represents a better assessment. The secondary result should therefore be understood as a difference in scores, without assigning clinical direction from the numerical sign alone. The registry’s brief description of the primary threshold does not establish the direction or interpretation of every possible score value.

The secondary measure is related conceptually to the primary endpoint because both use the PGA, but it is not identical to the primary success definition. One summarizes a score; the other counts participants whose score falls within a specified category. Agreement between these forms of summary cannot be assumed simply because they involve the same assessment. The record does not provide individual-level data to examine how the score distribution relates to the success classification.

Only one secondary outcome is listed in the posted secondary outcomes. Any additional secondary measures or their results are not reported in the registry record. The record also does not describe a multiplicity adjustment or a hierarchy of secondary hypotheses. General explanation: when multiple outcomes are tested, the chance of at least one apparently notable result can increase if each is assessed independently. For that reason, unadjusted secondary findings generally carry less confirmatory weight than a clearly prespecified primary result. Here, the registry does not provide enough information about the broader outcome plan to determine how secondary testing was organized.

Secondary outcomes registered for this trial, for reference (only those above were recalculated):

• Physician's Global Assessment (PGA) of Psoriasis Score at Day 28.

9. Statistical Interpretation

10. Statistical Methods Explained

The primary endpoint is binary: clinical success is recorded as either achieved or not achieved for each participant. A natural summary for a binary endpoint is the event count and the number assessed in each arm. The registry lists 32 successes among 60 participants in the spray arm and 11 among 60 in the placebo arm. The recalculated risk difference is 0.35. A risk difference expresses the contrast between the two groups’ event proportions on an absolute scale. It is not a relative measure, and it should not be confused with a ratio.

The recalculation also reports a relative risk of 2.909 and an odds ratio of 5.091. General explanation: the relative risk compares event probabilities as a ratio, while the odds ratio compares event odds as a ratio. These measures answer different questions and can look different in magnitude from an absolute risk difference. The posted values are unadjusted comparisons based on the summary counts; they do not account for covariates or any unreported design features. The registry record does not describe an adjusted model for the primary comparison.

A confidence interval gives a range of values compatible with the data under the calculation’s assumptions. It conveys uncertainty in an estimate and is not a guarantee that the true effect falls within that particular interval. The recalculated interval for the risk difference is 0.190 to 0.510. The registry does not state the confidence level for that recalculated interval, so no confidence percentage should be inferred from the record. The interval is for the risk difference, not the relative risk or odds ratio.

A p-value describes how unusual data at least as discrepant as the observed data would be under a specified null model and its assumptions. It is not the probability that the null hypothesis is true, nor the probability that a result occurred “by chance.” The recalculated primary p-value is p < 0.001. The registry’s sponsor-reported result is from a two-sided t-test and is p < 0.001. General explanation: a two-sided test considers departures in either direction from the null value. The registry does not report the t-test’s detailed implementation or explain its use for the primary count endpoint.

For the secondary PGA outcome, the registry gives a mean and standard deviation in each group and a recalculated mean difference of 0.88. General explanation: a mean difference represents the contrast between the groups’ average scores, while a standard deviation describes variation among individual scores within a group. The posted standard deviations are 1.06 for the spray arm and 0.94 for placebo. The recalculated interval for the mean difference is 0.521 to 1.238. Because the registry does not describe which direction of the PGA scale indicates improvement, the numerical direction of the mean difference should not be assigned a favorable or unfavorable interpretation.

General explanation: over-dispersion occurs when observed variation is greater than expected under a model’s assumptions. For binary outcomes, an analysis that assumes a particular variance structure can produce uncertainty estimates that are too narrow if that structure does not fit. The posted recalculation is a simple unadjusted contrast from summary statistics; it is not a model-based analysis of participant-level data and cannot assess covariate balance, clustering by site, or other structure. The registry record identifies multiple sites but does not report whether site was included in the sponsor’s analysis.

The sponsor reports a two-sided t-test for both the primary and secondary comparisons. The registry does not give test statistics, degrees of freedom, model details, or confidence intervals for the sponsor analysis. The recalculated results are useful as transparent checks using the posted summaries, but they do not reproduce an analysis requiring unposted participant-level information. The record marks no discrepancy between the sponsor result and the recalculation. That does not make the methods identical; it means the record does not flag a discrepancy.

The ITT label is the reported population designation for the primary analysis. General explanation: an intention-to-treat approach is commonly intended to preserve the comparison created by randomization, but the label alone does not reveal how missing measurements or deviations from assigned treatment were handled. The registry record does not report those rules. It also does not report the sample-size justification, a detailed statistical analysis plan, or interim-analysis procedures. No assumptions about these features can be recovered from the posted summary statistics.

11. Confidence Intervals and Precision

The primary risk-difference estimate is 0.35, with an interval from 0.190 to 0.510. The interval lies above zero, the value representing no difference in the risk-difference scale. This indicates that the recalculated range is compatible with a positive difference under the calculation’s assumptions. The interval remains a range of plausible values rather than a statement that the effect is known exactly. Its confidence level is not reported in the registry record.

The interval’s width reflects uncertainty in the estimated contrast. Precision depends on factors such as the amount of information in the sample and the variability inherent in the outcome. General explanation: more information can often narrow an interval, whereas sparse outcomes or substantial variability can leave more uncertainty. The primary outcome has 60 participants listed in each arm, and the number of successes differs between groups. These counts form the basis of the unadjusted recalculation; they do not reveal how the estimate would change under a different analysis plan or in another sample.

The recalculated mean difference for the secondary PGA score is 0.88, with an interval from 0.521 to 1.238. This interval concerns a difference in average score, not the primary binary risk difference. The record does not specify the confidence level for the recalculated interval. Nor does it explain the score’s direction, so precision about the numerical mean difference should not be mistaken for clarity about whether a higher score represents improvement.

Intervals do not account for every limitation in the record. The calculations are unadjusted, and the registry does not report participant-level data, missing-data handling, site adjustment, or a multiplicity procedure. Those omissions limit what can be assessed about robustness and the interpretation of several outcomes considered together. The intervals describe sampling uncertainty under the recalculation; they do not resolve uncertainty from unreported analysis choices or generalizability.

12. Planning a Similar Trial: Sample Size

This is a planning illustration, not a re-evaluation of the original trial. It asks: if a new study wanted to detect a difference like the one observed, or a smaller one, how large would it need to be? It is deliberately not “observed power” of the finished trial, which is not a meaningful quantity.

The planning figures are expressed as participants per arm, not total events. The displayed planning illustrations use the observed effect as a reference and consider detecting 100%, 75%, or 50% of that observed effect. For each assumed effect, the results give separate columns for planning at 80% power and 90% power. The binary primary outcome and the continuous secondary PGA outcome are both expressed in participants per arm; there is no time-to-event outcome requiring a total-event count.

The listed planning assumptions are a two-sided significance level of 0.05, equal allocation between the two arms, and a normal approximation. The effect to detect is the stated fraction of the observed effect. The original trial’s own sample-size assumptions and justification are not reported in the registry record. These illustrations are calculated from the observed results and are not a reconstruction of the study’s original design decisions.

General explanation: power is the probability that a planned study will detect an effect of a specified size under the assumptions of its design, if that effect is present. The 80% and 90% columns therefore describe alternative planning targets, not observed properties of this completed trial. The higher target generally requires more participants when other assumptions are held constant. Likewise, planning for a smaller effect requires more participants because a subtler contrast is harder to distinguish from random variation.

These figures are not observed power. They are prospective planning illustrations based on the observed effect and specified assumptions. They do not show the probability that the trial’s result is true, and they do not replace the uncertainty intervals for the observed estimates. Their purpose is to show how required sample size depends on the effect a future study aims to detect and the chosen power target.

13. How the Sample Size Is Derived

Power is the probability that a study of a given size rejects the null hypothesis when a specific true effect exists. It depends on four things: the effect to detect, the variability of the outcome, the significance level (here a two-sided α of 0.05, so z_1−α/2 = 1.960) and the desired power (z_1−β = 0.842 for 80% and 1.282 for 90%).

Formula

n is the number of participants in each arm, p₀ and p₁ are the control and treatment proportions, and p̄ is their average.

Worked calculation for this trial

1. Control proportion p₀ = 0.183; treatment proportion p₁ = 0.533; average p̄ = 0.358.
2. First term: z_1−α/2 × √[2p̄(1−p̄)] = 1.96 × 0.6781 = 1.3291.
3. Second term: z_1−β × √[p₀(1−p₀) + p₁(1−p₁)] = 0.842 × 0.6314 = 0.5314.
4. n = (1.3291 + 0.5314)² / (0.3500)² = 28.3, rounded up to 29 participants per arm for 80% power.

The smaller-effect rows in the table above repeat the same calculation with the effect multiplied by 0.75 and 0.5 (for ratios, applied to the logarithm of the ratio).

R code

alpha <- 0.05
z_a   <- qnorm(1 - alpha / 2)          # two-sided
p0 <- 0.183333333333333                          # control proportion
p1 <- 0.533333333333333                          # treatment proportion
n_per_arm <- function(power, frac = 1) {
  q1 <- p0 + (p1 - p0) * frac               # smaller effect = fraction of the observed difference
  pbar <- (p0 + q1) / 2
  z_b <- qnorm(power)
  ceiling(round((z_a * sqrt(2 * pbar * (1 - pbar)) + z_b * sqrt(p0 * (1 - p0) + q1 * (1 - q1)))^2 / (q1 - p0)^2, 6))
}
for (f in c(1, 0.75, 0.5))
  cat(sprintf("%3.0f%% of observed effect: n per arm = %s (80%% power), %s (90%% power)\n", 100 * f,
              format(n_per_arm(0.80, f), big.mark = ","), format(n_per_arm(0.90, f), big.mark = ",")))

# Check against R's built-in function (unrounded n per arm)
cat("power.prop.test:", round(power.prop.test(p1 = p0, p2 = p1, power = 0.80)$n, 1), "\n")

# Simulation: how often does the z-test reject at the 80%-power sample size?
set.seed(1206660)
n    <- n_per_arm(0.80)
reps <- 20000
x0 <- rbinom(reps, n, p0); x1 <- rbinom(reps, n, p1)
ph <- (x0 + x1) / (2 * n)
z  <- ((x1 - x0) / n) / sqrt(ph * (1 - ph) * 2 / n)
cat(sprintf("Simulated power at n = %s per arm: %.3f (%d replicates)\n", format(n, big.mark = ","), mean(abs(z) > z_a, na.rm = TRUE), reps))

Output from running the code

100% of observed effect: n per arm = 29 (80% power), 38 (90% power)
 75% of observed effect: n per arm = 48 (80% power), 64 (90% power)
 50% of observed effect: n per arm = 101 (80% power), 134 (90% power)
power.prop.test: 28.3 
Simulated power at n = 29 per arm: 0.808 (20000 replicates)

The simulation draws many pairs of event counts at the planned sample size and counts how often the two-proportion z-test rejects the null. It should land close to the target power; at very small required sample sizes it can fall below it, because the normal approximation is rough there.

14. Analyses Reported by the Sponsor

The registry reports the sponsor’s primary comparison as a two-sided t-test with p < 0.001. The recalculation from the posted binary outcome counts gives an unadjusted risk difference of 0.35 and p < 0.001. These results are not the same analysis: the recalculation uses the summary counts to estimate an absolute difference, while the sponsor method is identified as a t-test. The registry record does not give enough detail to reproduce the sponsor’s calculation from participant-level data.

For the secondary PGA score, the sponsor also reports a two-sided t-test with p < 0.001. The simple recalculation gives a mean difference of 0.88 and p < 0.001. Again, the recalculated value is an unadjusted check based on the posted summaries, not a substitute for a fully specified sponsor analysis. The record does not provide the sponsor’s test statistics, degrees of freedom, or confidence intervals.

The registry’s discrepancy indicator is false. The results can therefore be read alongside one another without a flagged discrepancy, while recognizing that their methods and reported p-values differ. The registry does not explain the exact statistical procedures behind the sponsor’s analyses, so the recalculations should be understood as straightforward checks rather than exact replications.

15. Multiplicity, Missing Data and Analysis Populations

The registry identifies an ITT analysis population for the primary outcome, but it does not describe how that population was operationalized. The record does not say how participants without a Day 28 assessment were handled, whether any values were imputed, or whether analyses were repeated using another population definition. Although 60 participants are listed in each arm for the primary outcome, the record does not include a detailed accounting of withdrawals, exclusions, or missing endpoint values. The handling of missing data is therefore not reported in the registry record.

The record lists a primary endpoint and a secondary PGA outcome, but does not report a multiplicity strategy. It does not say whether the secondary outcome was tested within a hierarchy, whether p-values were adjusted across outcomes, or whether any other planned comparisons were included. The absence of this information matters because interpreting several statistical tests as separate confirmatory claims can overstate the strength of evidence. The reported p-values should be read as the results for their respective analyses, without assuming a correction that is not described.

The registry reports a two-sided t-test for both posted comparisons. It does not provide a detailed statistical analysis plan, test statistics, or a full description of covariate adjustment. Whether the sponsor used site, baseline characteristics, or other factors in the analyses is not reported in the registry record. The randomized, multiple-site design is recorded, but the statistical handling of site variation is not described.

The record also does not report interim analyses, stopping rules, or the original sample-size justification. These omissions do not establish that such procedures were absent; they mean the registry record does not report them. The planning illustrations based on the observed effect do not fill that gap, because they are not the trial’s original prospective design assumptions. Together, the missing details limit independent assessment of the full analysis plan, missing-data sensitivity, and the control of false-positive findings across outcomes.

16. Safety Results

The registry reports serious adverse events as affected participants divided by participants at risk.

Other (non-serious) adverse events

Participants with at least one non-serious event at or above the registry's 2% reporting threshold.

Most frequent non-serious adverse event terms

The registry reports 0 serious adverse events among 60 participants in the desoximetasone spray arm and 0 among 60 participants in the placebo arm. These figures describe the serious-event counts recorded for the groups during the registry’s safety reporting. They do not establish that no serious events could occur, and they do not by themselves quantify risk outside this study or beyond its recorded period.

The record also lists other adverse events affecting 4 participants in the spray arm and 5 in the placebo arm. These are distinct from the serious adverse event counts. The registry does not provide the event terms, severity breakdown, timing, or causal assessment in the posted summary. The serious-event terms list is empty. Death counts are not reported in the registry record; a blank value should not be interpreted as a reported count of zero.

Safety counts are descriptive and should be considered alongside the study’s size and follow-up duration. The registry lists the treatment period as 28 days, and the record does not provide longer-term safety results. These figures cannot establish comparative safety for uncommon events or outcomes not included in the posted data.

17. What the Result Does, and Does Not, Mean

The posted primary counts show more participants meeting the stated clinical-success threshold in the desoximetasone spray arm than in the placebo arm at 28 days. The unadjusted risk-difference estimate and its interval describe the size and uncertainty of that group contrast. The registry also reports a statistically significant sponsor analysis for the primary comparison. These are statements about the registered endpoint and analysis, not a general judgment about treatment or an individual’s likely outcome.

The result does not establish that every participant experienced the same outcome, nor does a group-level difference predict what will happen to a particular person. The primary endpoint reduces PGA assessments to a success threshold, so it does not describe the full distribution of scores. The secondary score comparison adds a continuous summary, but the record does not report the scale direction needed to characterize the numerical change as favorable or unfavorable.

The findings concern a 28-day treatment schedule in a randomized, parallel-group phase 3 trial enrolling patients with moderate to severe plaque psoriasis. They do not establish persistence of an outcome after treatment, effects at later timepoints, or results in other populations. Those outcomes are not reported in the registry record. The trial’s multiple-site setting is noted, but the registry does not report whether the analysis accounted for site differences.

Statistical significance does not by itself indicate whether an effect is large enough to matter clinically. The registry does not give a threshold for clinical importance or a detailed interpretation of the PGA scale. The uncertainty intervals also do not resolve missing information about analysis choices, missing-data handling, or multiplicity. The safety summary is limited to the reported counts and does not establish the absence of unobserved or uncommon events.

Accordingly, the most defensible reading is narrow: the posted data show a difference in the number meeting the primary threshold at the reported timepoint, with an unadjusted estimate and interval quantifying that contrast. The record leaves important questions about longer-term outcomes and full analysis procedures unanswered.

18. Why This Trial Matters Statistically

This trial illustrates why an endpoint’s scale matters. The primary outcome is a binary success classification, defined by PGA categories 0 or 1. The resulting count comparison is directly tied to how many participants cross that threshold. A risk difference expresses the contrast in absolute terms, while relative risk and odds ratio express it on ratio scales. Those summaries are related but not interchangeable, and each emphasizes a different aspect of the comparison.

The posted summary also shows the distinction between a sponsor-reported test and a recalculation from arm-level statistics. The registry identifies a two-sided t-test, while the simple recalculation reports an unadjusted risk difference for the binary outcome. The results need not be numerically identical because they are not described as the same procedure. That difference is a useful reminder that a p-value alone does not disclose the estimand, analysis population, assumptions, or handling of missing data.

Precision is another essential part of interpretation. The risk-difference interval provides a range of uncertainty around the point estimate, rather than a guarantee or a clinical-importance threshold. The mean-difference interval for the secondary score likewise quantifies uncertainty in a different type of measure. Interpreting either result requires attention to both the estimate and the scale on which it is expressed.

Finally, the planning illustrations show how assumed effect size and desired power affect future sample-size planning. They are not evidence of the completed trial’s observed power or its original design rationale. The registry does not report the original sample-size justification, missing-data procedures, or multiplicity strategy. These gaps illustrate why registry results are most informative when estimates, uncertainty, endpoint definitions, analysis methods, and limitations are considered together.

19. 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 offers limited detail about trial conduct and analysis. Although it records randomization and a parallel design, the sequence-generation and allocation-concealment methods are not reported. The official title describes the study as double-blind, while the masking classification is triple; the record does not explain this difference or identify masked roles. This limits assessment of how masking was implemented.

The primary analysis is labeled ITT, but the record does not specify the exact analysis population or how missing Day 28 assessments were handled. It lists 60 participants per arm for the primary endpoint but does not provide participant flow, withdrawals, or missing-data sensitivity analyses. The posted result is consequently difficult to assess for sensitivity to missing observations or exclusions.

The registry reports a two-sided t-test, but does not provide its detailed implementation, test statistic, degrees of freedom, or any covariate adjustments. It does not say whether site was considered in the analysis. The unadjusted recalculations use arm-level summaries and cannot account for participant-level characteristics or reconstruct a more detailed model. The record also does not report a multiplicity plan, interim analyses, stopping rules, or the original sample-size justification.

Interpretation of the secondary PGA score is constrained because the scale direction is not stated. Only one secondary outcome is listed, and other secondary measures or results are not reported in the registry record. Safety reporting is also brief: the posted summary lacks adverse-event terms and details, while death counts are not reported in the registry record. Finally, the posted outcomes are tied to the stated 28-day timeframe; longer follow-up results are not reported.

20. Related Tutorials

21. Related Statistical Calculators

22. Sources

• ClinicalTrials.gov: Effects of Desoximetasone Spray 0.25% in Patients With Moderate to Severe Plaque Psoriasis — NCT01206660.
• Registry record last updated 2014-07-03; status last verified 2014-06.
• Results first posted 2014-07-03.
• 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.

23. Record Summary

NCT01206660 is a completed, randomized, parallel-group phase 3 study of desoximetasone topical spray 0.25% versus placebo in patients with moderate to severe plaque psoriasis. Enrollment was 120, with 60 participants listed in each arm for the primary outcome. Both treatments were described as applied to the affected area twice a day for 28 days.

The primary outcome was clinical success at 28 days, defined as a PGA score of 0 (clear) or 1 (almost clear), analyzed in an ITT population. The registry reports 32 successes in the spray group and 11 in the placebo group. The unadjusted recalculated risk difference is 0.35, with an interval from 0.190 to 0.510 and p < 0.001. The sponsor-reported two-sided t-test result is p < 0.001.

The posted secondary outcome is PGA score at Day 28. Serious adverse event counts are 0 in both groups. Details about missing-data handling, multiplicity, and the original sample-size rationale are not reported in the registry record.