Study to Evaluate the Safety and Efficacy of a Once-Daily CLS001 Topical Gel Versus Vehicle: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Study to Evaluate the Safety and Efficacy of a Once-Daily CLS001 Topical Gel Versus Vehicle (NCT02547441), a randomized phase 3 study. The primary outcome is Change in Inflammatory Lesion Count From Baseline to Week 12.

2. Clinical Question

The primary endpoint is a continuous measure: change in inflammatory lesion count from baseline to Week 12. The reported group values are least-squares means, so they represent model-based means rather than simple raw averages. The registry also reports the sponsor’s analysis method as ANCOVA and labels its analysis as a superiority analysis. The posted summaries support a separate unadjusted comparison, but that recalculation does not reproduce the sponsor’s analysis.

3. Trial Design

This was a Phase 3, randomized, double-blind, parallel-group, vehicle-controlled study. The official title describes a multicenter study with once-daily treatment for 12 weeks and an open-label safety extension. The registry lists Rosacea as the condition and describes the enrolled population as subjects with severe papulopustular rosacea. Maruho Co., Ltd. is listed as the sponsor.

The treatment group received CLS001 (Omiganan) gel once daily, and the comparator group received vehicle gel once daily. The posted primary outcome is the change in inflammatory lesion count from baseline to Week 12. The primary population is described as all randomized subjects in the intent-to-treat analysis population. The registry lists 235 participants in the treatment group and 228 in the vehicle group for this outcome.

The record lists a study start of 2015-12, primary completion on 2017-07-05, and status as completed. It also lists an open-label period for CLS001 gel, with safety results reported separately from the double-blind period. Because the extension was open-label, its group is not the same kind of randomized comparison as the double-blind treatment and vehicle groups. Details about extension eligibility, timing, treatment duration, and how participants entered the extension are not reported in the registry record.

The registry describes the allocation as randomized and masking as double, but the specific randomization procedure, concealment method, and identities of the masked parties are not reported in the registry record. The original design’s sample-size justification and other design assumptions are also not reported in the registry record.

4. Participant Flow and Accounting

The registry reports how participants moved through each stage of the study. All counts below are exactly as posted; missing counts are not inferred from other stages.

Double-Blind Study Period

Reasons for not completing this period:

Open-Label Study Period

Reasons for not completing this period:

Analysis population for the primary outcome, as defined in the registry: The 'Intent-to-treat' (ITT) analysis population included all randomized 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.

Population: The 'Intent-to-treat' (ITT) analysis population included all randomized subjects.

6. Primary Endpoint

The registry lists the primary outcome as Change in Inflammatory Lesion Count From Baseline to Week 12, measured over 12 weeks.

The primary endpoint measures the change in inflammatory lesion count between baseline and Week 12. A negative change indicates a lower count at follow-up than at baseline. The treatment group’s least-squares mean change was -18.1 lesions, with a standard error of 1.77; the vehicle group’s was -13.5 lesions, with a standard error of 1.85. These are model-based group estimates, not individual participant changes.

Counting inflammatory lesions gives a numerical measure of one aspect of papulopustular rosacea. A continuous outcome can retain information about the amount of change across the measured range, rather than reducing results to whether a participant did or did not meet a single threshold. Comparing changes between groups is intended to separate the pattern observed with the study gel from the pattern observed with vehicle over the same period.

The endpoint’s use does not by itself establish that the observed difference is precise or attributable solely to treatment. Interpretation depends on the between-group analysis, its uncertainty, the analysis population, and the methods used to handle observations and model the outcome. The registry identifies the primary population and reports an ANCOVA analysis, but details of the model specification and missing-data handling are not reported in the registry record.

7. Results Posted in the Registry

• Treatment: mean -18.10 versus -13.50 on control; difference -4.60 (95% CI -9.62 to 0.42), standardized effect d = -0.17; z-test p = 0.072.

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.

Change in the Number of Inflammatory Lesions From Baseline at Week 9

• 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 errors.
• Result:
  • Treatment: mean -17.40 versus -15.20 on control; difference -2.20 (95% CI -6.57 to 2.17), standardized effect d = -0.09; z-test p = 0.323.
• Interpretation:
  • The 95% confidence interval includes no difference, so these data do not show a statistically significant difference between Treatment and the control. The interval gives the range of effects that remain compatible with the data.

Change in the Number of Inflammatory Lesions From Baseline at Week 6

• 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 errors.
• Result:
  • Treatment: mean -13.50 versus -11.80 on control; difference -1.70 (95% CI -5.75 to 2.35), standardized effect d = -0.08; z-test p = 0.410.
• Interpretation:
  • The 95% confidence interval includes no difference, so these data do not show a statistically significant difference between Treatment and the control. The interval gives the range of effects that remain compatible with the data.

Percentage of Participants Who Achieved 2 Grade IGA Reduction at Week 9.

• Endpoint type: Binary: the percentage of participants with the event (counts rebuilt from the posted percentages and group sizes).
• Test: Unadjusted two-proportion z-test, with a Wald 95% confidence interval for the risk difference.
• Result:
  • Treatment: 18.3% (43/235) versus 14.5% (33/228) on control; risk difference 3.8 percentage points (95% CI -2.9 to 10.6), risk ratio 1.26 (0.83–1.92); unadjusted two-proportion z-test p = 0.267.
• Interpretation:
  • The 95% confidence interval includes no difference, so these data do not show a statistically significant difference between Treatment and the control. The interval gives the range of effects that remain compatible with the data.

The secondary outcomes add measurements at earlier follow-up times and a responder outcome based on improvement in Investigator Global Assessment grade. Across these outcomes, the posted treatment and vehicle estimates generally point in the same direction as the Week 12 change-score comparison, but their unadjusted comparisons are not a uniform body of confirmatory evidence. The secondary results are best read as supporting context about the pattern over time and across outcome definitions, rather than as replacements for the primary analysis.

The secondary endpoints are related to the primary result but measure different aspects of outcome. Earlier lesion-count changes assess the count at different follow-up points, while the IGA endpoint classifies participants according to a specified grade reduction. Agreement across measures can be informative, but differences in timing, scale, and statistical method mean that results are not interchangeable. Each comparison also has its own uncertainty.

The registry lists four secondary outcomes, but it does not report sponsor analyses for those outcomes in the posted results. The unadjusted recalculations should therefore not be described as the sponsor’s planned or reported tests. Their p-values are unadjusted, and the registry does not report a multiplicity procedure or a prespecified hierarchy for interpreting the family of secondary outcomes.

When several outcomes and time points are examined, the chance of at least one apparently notable result can increase if each is interpreted independently. This is a general multiplicity concern. Without a reported adjustment or prespecified testing sequence, isolated secondary p-values carry less weight than a result supported by a clearly documented confirmatory plan. The pattern across secondary outcomes can still be described, but it should not be used to overstate certainty about the primary comparison.

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

• Change in the Number of Inflammatory Lesions From Baseline at Week 9
• Change in the Number of Inflammatory Lesions From Baseline at Week 6
• Percentage of Participants Who Achieved 2 Grade IGA Reduction at Week 9.
• Percentage of Participants Who Achieved 2 Grade IGA Reduction at Week 6.

9. Statistical Interpretation

10. Statistical Methods Explained

The primary outcome is continuous: change in inflammatory lesion count from baseline to Week 12. The record reports a least-squares mean for each group and a standard error for each mean. It also reports an ANCOVA analysis for the sponsor’s comparison, but does not provide the model specification, covariates, estimated treatment contrast, or confidence interval from that analysis. These omissions constrain what can be independently checked from the registry record.

What does a least-squares mean represent?

A least-squares mean is a model-based estimate of a group mean. In an analysis of covariance, such estimates can account for variables included in the statistical model. The exact interpretation depends on the model terms and the values at which any covariates are evaluated. Those details are not reported in the registry record, so the reported least-squares means should not be treated as simple raw averages or as estimates adjusted for any particular named baseline factor.

What does the standard error describe?

A standard error describes the statistical uncertainty around an estimated mean under the model or calculation used. It is not the spread of individual participant outcomes. The primary group estimates have standard errors of 1.77 and 1.85. Standard errors can help quantify precision, but the registry does not give a confidence interval for either group mean. For the between-group comparison, the sponsor’s ANCOVA estimate and standard error are not reported.

Why are the two p-values different?

The sponsor-reported method is ANCOVA, with p = 0.043. The recalculated comparison uses posted group summaries and is unadjusted, with p = 0.072. The recalculation is not the same analysis as the sponsor’s ANCOVA. ANCOVA may incorporate model terms that are not represented in a simple comparison of posted summaries; the registry record does not identify those terms. Differences in method can lead to different estimates of uncertainty and different p-values. Given the reported discrepancy, the sponsor’s own analysis takes precedence when stating the trial’s reported result.

In general, a p-value is calculated relative to a null hypothesis and the assumptions of a particular analysis. It does not measure the size of a difference, the chance that the null hypothesis is true, or the probability that a result will be repeated. A p-value is most informative when read alongside the estimated effect, its confidence interval, the analysis plan, and the handling of the data. For the sponsor’s result, the estimate and interval are not reported in the registry record.

What does a confidence interval add?

In general, a confidence interval expresses the uncertainty around an estimate using a range of values consistent with the analysis procedure. The recalculated primary mean difference is -4.6 lesions, and its interval crosses zero. That means the interval includes values on either side of no between-group difference. It does not prove that there is no difference, nor does it establish which value within the interval is most plausible. The interval is for the unadjusted recalculation, not the sponsor’s ANCOVA result.

Why can over-dispersion matter?

In general, count outcomes can vary more across participants than a simple statistical model expects. When observed variation exceeds a model’s assumptions, standard errors may be too small if the extra variation is ignored, which can make intervals too narrow and tests too favorable. This is a general concern for count data, not a finding established for this trial. The registry record does not report a dispersion assessment or enough information to determine whether over-dispersion was evaluated in the sponsor’s analysis.

What can be independently reproduced?

The posted group means and standard errors allow an unadjusted comparison to be calculated from summary statistics. Such a recalculation is not an individual-level reanalysis and cannot recover model adjustments or data-handling decisions absent from the record. The resulting estimate and p-value are useful as a check on the posted summaries, but they should remain clearly distinguished from the sponsor-reported ANCOVA analysis. The sponsor’s estimate, confidence interval, covariate specification, and missing-data procedure are not reported in the registry record.

11. Confidence Intervals and Precision

The recalculated primary mean difference is -4.6 lesions, with an interval from -9.618 to a positive upper bound. Because the interval spans zero, it includes values consistent with a larger reduction in the CLS001 group, as well as values consistent with little or no difference and values in the opposite direction. This is an unadjusted interval calculated from the posted group summaries; it is not the confidence interval from the sponsor’s ANCOVA.

In general, a confidence interval communicates uncertainty in an estimate. A wider interval indicates less precision than a narrower interval, while an interval crossing zero for a difference does not rule out potentially meaningful differences in either direction. The interval should be considered alongside the estimated difference and the analysis method. The confidence level for the recalculated interval is not stated in the registry record, so no confidence percentage is assigned.

The sponsor’s reported p-value is 0.043, but the sponsor’s effect estimate and confidence interval are not reported in the registry record. A p-value without an estimate and interval gives limited information about the magnitude and precision of the sponsor’s result. The unadjusted recalculation and the sponsor’s ANCOVA answer related but not identical statistical questions, and the discrepancy prevents treating the recalculated interval as if it described the sponsor’s model.

For the primary endpoint, the posted standard errors describe uncertainty in the two least-squares means, not the between-group contrast. Precision for the contrast is best evaluated using an interval from the same analysis that produced the contrast. That interval is available for the recalculation, but not for the sponsor-reported ANCOVA result. The registry record therefore permits a limited precision assessment rather than a complete one.

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 sample-size figures are planning illustrations based on the observed effect, not the trial’s original design justification. For these continuous and binary outcomes, the figures are participants per arm, not total events. The planning assumptions are a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation. Each row considers an effect to detect equal to the stated fraction of the observed effect.

The 80% power column gives the planned number of participants per arm that would, under those assumptions and for the specified effect, yield an 80% chance of detecting that effect using the stated test procedure. The 90% power column gives the corresponding planning number for a 90% chance. Higher planned power generally requires a larger sample. The numbers are planning illustrations and are not observed power.

Rows that plan for a smaller fraction of the observed effect require more participants per arm. This follows because smaller between-group differences are harder to distinguish from random variation at a fixed sample size. The curve expresses this same planning relationship across effect sizes; it is not a forecast of what would happen in a future trial unless the assumptions and target effect are appropriate for that trial.

These calculations use the effect observed in this study as their starting point. Observed effects can be uncertain, and an effect from one trial may not be the effect a future study should target. The original trial’s sample-size justification, target effect, and design assumptions are not reported in the registry record. The planning figures should therefore be read as illustrations under the stated assumptions, not as evidence about the adequacy of the original enrollment.

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, Δ is the difference in means to detect and σ is the common standard deviation.

Worked calculation for this trial

1. Observed difference Δ = -4.600; pooled standard deviation σ = 27.531.
2. n = 2 × (1.96 + 0.842)² × 27.531² / -4.600² = 562.3, rounded up to 563 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
delta <- -4.6                      # observed difference in means
sigma <- 27.5308181093491                     # pooled standard deviation
n_per_arm <- function(power, frac = 1) {
  ceiling(round(2 * (z_a + qnorm(power))^2 * sigma^2 / (delta * frac)^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 (t-based, so very slightly larger)
cat("power.t.test:", round(power.t.test(delta = delta, sd = sigma, power = 0.80)$n, 1), "\n")

# Simulation: exact two-sample t-test using simulated means and variances
set.seed(2547441)
n    <- n_per_arm(0.80)
reps <- 20000
m_diff <- rnorm(reps, delta, sigma * sqrt(2 / n))             # difference in sample means
s2     <- sigma^2 * rchisq(reps, 2 * (n - 1)) / (2 * (n - 1))   # pooled sample variance
tstat  <- m_diff / sqrt(s2 * 2 / n)
cat(sprintf("Simulated power at n = %s per arm: %.3f (%d replicates)\n", format(n, big.mark = ","), mean(abs(tstat) > qt(0.975, 2 * (n - 1))), reps))

Output from running the code

100% of observed effect: n per arm = 563 (80% power), 753 (90% power)
 75% of observed effect: n per arm = 1,000 (80% power), 1,339 (90% power)
 50% of observed effect: n per arm = 2,250 (80% power), 3,011 (90% power)
power.t.test: 563.3 
Simulated power at n = 563 per arm: 0.798 (20000 replicates)

The simulation draws many sets of group means and variances at the planned sample size and counts how often the two-sample t-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 an ANCOVA superiority analysis with p = 0.043. The reported entry does not include the sponsor’s estimated treatment contrast or confidence interval. The group least-squares means are -18.1 for CLS001 and -13.5 for vehicle, but those means alone do not reconstruct every part of an ANCOVA contrast.

The unadjusted recalculation from posted summary statistics estimates a mean difference of -4.6 lesions, with p = 0.072 and an interval that crosses zero. It does not include the sponsor’s model specification or any adjustment terms that may have been used. The p-values are therefore results from different analyses, rather than independent replications of the same calculation.

Because the registry-reported result differs from the recalculation, the sponsor’s own analysis takes precedence in describing the trial’s reported statistical conclusion. That does not make the recalculation equivalent to the sponsor’s model, nor does the sponsor’s p-value disclose the magnitude or precision of the sponsor’s estimated contrast. The covariates, model details, and sponsor’s contrast interval are not reported in the registry record.

15. Multiplicity, Missing Data and Analysis Populations

The registry identifies the primary population as the intent-to-treat population, including all randomized subjects. That definition supports an intention-to-treat framing, but it does not explain how each outcome was analyzed when a measurement was missing. The method for handling missing baseline or follow-up data, the assumptions used, and any sensitivity analyses are not reported in the registry record.

The registry reports one primary outcome and lists secondary outcomes at additional time points and on a responder scale. It does not report whether the sponsor adjusted for multiple comparisons, used a prespecified testing hierarchy, or treated the secondary analyses as exploratory. Without that information, unadjusted secondary p-values should not be interpreted as though they each had a separately protected confirmatory error rate.

The sponsor’s primary analysis is identified as ANCOVA, but the model terms, covariates, and treatment of missing observations are not reported. The registry also does not report the original statistical analysis plan or interim analyses. No particular method for missing data, multiplicity control, or interim monitoring can be inferred from the available record.

These omissions do not establish that the analyses were inappropriate; they mean the record does not provide enough information to assess those decisions. They also limit independent reproduction of the sponsor’s result. A complete interpretation would ordinarily consider the prespecified analysis, the population included, missing-data rules, and how primary and secondary hypotheses were handled. Those details are not reported in the registry record.

16. Safety Results

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

Deaths

Other (non-serious) adverse events

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

Most frequent serious adverse event terms

Most frequent non-serious adverse event terms

Serious events with the highest arm-level rate: presyncope (0.4%), costochondritis (0.4%), intervertebral disc protrusion (0.4%), salivary gland neoplasm (0.4%), cholecystitis acute (0.4%).

During the double-blind period, the registry lists 4 participants affected by serious adverse events in the CLS001 group and 4 in the vehicle group. It lists 83 participants affected by other adverse events in each of those groups. Deaths are listed as 0 in both groups. These are participant counts in the record, not estimates of comparative risk calculated.

For the open-label CLS001 period, the record lists 8 participants affected by serious adverse events, 116 affected by other adverse events, and 0 deaths among 363 participants at risk. This is an open-label period and should not be treated as a randomized comparison with the vehicle group. The record also lists six serious adverse event terms at 0.4% each: presyncope, costochondritis, intervertebral disc protrusion, salivary gland neoplasm, acute cholecystitis, and seizures. The record does not identify an arm for those terms in the information.

Safety counts do not establish whether an event was caused by treatment, and they do not describe event severity or duration beyond the categories recorded. Further detail about event timing, relatedness, and participant-level overlap is not reported in the registry record.

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

The posted primary results show a negative mean change in inflammatory lesion count in both groups from baseline to Week 12. The CLS001 group’s least-squares mean change was more negative than the vehicle group’s, and the unadjusted recalculation estimates a difference of -4.6 lesions. The sponsor-reported ANCOVA analysis is labeled as a superiority analysis and has p = 0.043. These are descriptions of the statistical record, not medical advice.

The result does not, by itself, establish the clinical importance of the difference. The registry does not report the sponsor’s estimated contrast or its confidence interval, and the unadjusted recalculation has an interval crossing zero. Neither the p-value nor the direction of the group estimates alone determines whether a difference matters to patients or how it compares with a clinically meaningful threshold. Such a threshold is not reported in the registry record.

The posted figures also do not establish that every participant experienced the group-average change. Least-squares means describe group-level estimates, and the standard errors describe uncertainty in those estimates rather than the range of individual responses. The record does not provide individual-level outcome distributions in the information.

The trial compared once-daily CLS001 gel with vehicle gel under a randomized, double-blind design during the 12-week treatment period. Its primary finding should be read in that context and alongside the sponsor’s analysis method, the unadjusted recalculation, the uncertainty, and the unreported details about missing data and model specification. The open-label safety extension is not a randomized vehicle comparison. The available record supports a cautious statistical description, not a claim that a treatment works or does not work.

18. Why This Trial Matters Statistically

This trial illustrates why statistical reporting should include both an estimated effect and its uncertainty, as well as the method used to obtain them. The sponsor reports an ANCOVA superiority analysis with p = 0.043, while an unadjusted recalculation from the posted summaries gives p = 0.072 and an interval crossing zero. Since these analyses are not identical, readers need to keep the sponsor’s result distinct from the recalculation rather than treating one as a correction of the other.

The distinction is important because a p-value is not a measure of effect size. The sponsor-reported p-value is not accompanied by the sponsor’s treatment contrast or confidence interval in the registry record. That leaves the magnitude and precision of the sponsor’s estimated difference less transparent than the reported test result alone might suggest.

The record also illustrates the value of reporting analysis populations, missing-data procedures, model terms, and multiplicity plans. It identifies the intent-to-treat population and ANCOVA method, but does not describe the model specification or missing-data handling. The secondary outcomes span different times and outcome types, yet the record does not report a multiplicity procedure. These details affect how a reader should weigh statistical evidence.

Finally, sample-size planning illustrations based on observed effects should not be confused with the original trial’s design rationale or with observed power. They can show how sample size changes under explicit assumptions, but do not establish the adequacy of the original study or guarantee the results of a future one.

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 does not report the sponsor’s primary treatment contrast or confidence interval, even though it reports an ANCOVA p-value. This limits direct assessment of the magnitude and precision of the sponsor’s result. The separate recalculation is based on posted summaries and is unadjusted, so it cannot reproduce the sponsor’s analysis.

The ANCOVA model specification, including any covariates, is not reported. The record also does not describe missing-data handling, sensitivity analyses, the original statistical analysis plan, or interim analyses. It is therefore not possible from the registry record to determine how those choices affected the reported result.

Multiplicity methods for the secondary outcomes are not reported. The secondary outcomes include multiple follow-up times and a responder definition, so their unadjusted comparisons should be treated cautiously. The registry record does not provide enough information to determine whether a testing hierarchy or another prespecified approach was used.

The open-label safety extension lacks a concurrent randomized vehicle comparison in the posted information. Its safety counts should not be directly interpreted as a randomized treatment contrast. The record also does not report detailed event relatedness, duration, or participant-level overlap. Finally, the sample-size illustrations use observed effects and stated planning assumptions, not the study’s original design justification.

20. Related Tutorials

21. Related Statistical Calculators

22. Sources

• ClinicalTrials.gov: Study to Evaluate the Safety and Efficacy of a Once-Daily CLS001 Topical Gel Versus Vehicle — NCT02547441.
• Registry record last updated 2022-08-02; status last verified 2022-07.
• Results first posted 2022-08-02.
• 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

NCT02547441 is a completed Phase 3, randomized, double-blind, parallel-group, vehicle-controlled study sponsored by Maruho Co., Ltd. It compared once-daily CLS001 (Omiganan) topical gel with once-daily vehicle gel in participants with severe papulopustular rosacea. The official title describes a 12-week treatment period followed by an open-label safety extension.

The primary outcome was change in inflammatory lesion count from baseline to Week 12 in the intent-to-treat population, defined as all randomized subjects. The sponsor-reported ANCOVA analysis is labeled as a superiority analysis and reports p = 0.043. An unadjusted recalculation from posted summaries estimates a mean difference of -4.6 lesions, with p = 0.072 and an interval crossing zero. Given this discrepancy, the sponsor’s own analysis takes precedence when describing the reported trial result.

The registry does not report the sponsor’s estimated contrast and confidence interval, the ANCOVA model specification, missing-data methods, or a multiplicity procedure for secondary outcomes. Safety results are listed separately for the double-blind and open-label periods.