Safety and Efficacy of ACU-D1 in the Treatment of Acne Rosacea: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Safety and Efficacy of ACU-D1 in the Treatment of Acne Rosacea (NCT03064438), a randomized phase 2 study. The primary outcome is Change From Baseline in Total Lesion Count at Week 12.

2. Clinical Question

The primary outcome combines counts of facial papules, pustules, and nodules. These lesion types are defined in the registry record by their appearance and inflammatory characteristics. Total lesion count offers a numerical measure of disease signs that can be compared across treatment groups and over time. The registry record lists investigator global assessment, individual lesion counts, treatment response, and adverse events among the secondary outcomes, but does not report a complete set of numerical results for those measures.

3. Trial Design

This was a randomized, double-blind, parallel-group, vehicle-controlled phase 2 study of ACU-D1 ointment for acne rosacea. The record identifies Accuitis, Inc. as the sponsor and gives the study status as completed. The study began on 2017-11-28, with primary completion on 2018-06-05. Enrollment was 40. The brief summary describes twice-daily treatment for 12 weeks and says that two-thirds of participants received ACU-D1 while one-third received vehicle control.

The posted primary outcome data list 26 participants in the ACU-D1 arm and 11 in the vehicle arm. The primary analysis population is described as participants in the MITT population with available data at Week 12. Arm counts for the adverse-event results are 27 and 13, respectively. These differing counts relate to different reported data and analysis contexts; the registry record does not explain the relationship in more detail.

Random allocation is intended to reduce systematic differences between groups, while double masking is intended to limit the influence of treatment knowledge on participant experience, study conduct, and outcome assessment. Vehicle control allows the treatment group to be compared with the ointment vehicle under the same stated application schedule. These are general design purposes; the record does not describe how randomization or masking was implemented, or whether masking was assessed.

The registry record does not report the original sample-size justification, the protocol’s detailed statistical plan, interim analyses, or rules for handling missing data. It also does not provide further detail about the study population or the timing of secondary assessments beyond the listed time points. Those omissions limit how fully the design and analysis can be reconstructed from the registry record alone.

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.

Before assignment: Eligible participants will be assigned in a random manner to 1 of the 2 study medications in a 2:1 ratio (ACU-D1 ointment: ACU-D1 ointment vehicle).

Overall Study

Reasons for not completing this period:

Analysis population for the primary outcome, as defined in the registry: Number of participants included participants in the MITT population with available data at Week 12.

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 modified intention-to-treat (MITT) population included all randomized participants who were dispensed study medication and provided any post-baseline efficacy data.

6. Primary Endpoint

The registry lists the primary outcome as Change From Baseline in Total Lesion Count at Week 12, measured over Baseline, Week 12.

The primary endpoint is change from baseline in total lesion count at Week 12, measured as a number of lesions. The total is the sum of facial papules, pustules, and nodules. The registry record describes papules and pustules as raised inflammatory lesions, distinguished by whether visible purulent material is present, and defines nodules as inflammatory masses at least 0.5 cm in diameter.

A count provides a continuous numerical outcome: each participant’s follow-up count can be related to that participant’s baseline count, and group-level changes can then be compared. In general, measuring change from baseline can account for some differences in starting lesion burden, although it does not by itself remove all uncertainty or guarantee that groups were comparable at baseline.

The posted group estimates are least-squares mean changes. Both are negative, indicating decreases in lesion counts from baseline on the reported scale. The estimated change is -10.2 for ACU-D1 and -12.0 for vehicle. The reported between-group difference is 1.8, with the subtraction direction defined by the ACU-D1 group relative to vehicle. A positive difference therefore means the ACU-D1 estimate is numerically less negative. The registry record does not report baseline group means or enough modeling detail to explain precisely how the least-squares means were adjusted.

This endpoint was selected as the primary measure for the posted comparison, but the registry record does not state why it was chosen over other measures. A lesion count describes one aspect of acne rosacea and does not, by itself, capture every dimension of the condition or participants’ experience.

7. Results Posted in the Registry

• ACU-D1 Ointment: mean -10.20 versus -12.00 on control; difference 1.80 (95% CI -2.02 to 5.62), standardized effect d = 0.33; z-test p = 0.355.

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.

Percentage of Participants Who Were Treatment Responders at Week 12

• 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:
  • ACU-D1 Ointment: 19.2% (5/26) versus 18.2% (2/11) on control; risk difference 1.0 percentage points (95% CI -26.3 to 28.4), risk ratio 1.06 (0.24–4.65); unadjusted two-proportion z-test p = 0.941.
• Interpretation:
  • The 95% confidence interval includes no difference, so these data do not show a statistically significant difference between ACU-D1 Ointment and the control. The interval gives the range of effects that remain compatible with the data.

The registry record lists secondary outcome areas covering investigator global assessment, treatment responder status, changes in papules, pustules, nodules, and combined papules plus pustules, as well as adverse events. The posted numerical secondary result available in this record is for treatment responders at Week 12. It reports 19.2% in the ACU-D1 arm and 18.2% in the vehicle arm, with a risk difference of 0.011 and a 95% interval from -0.263 to 0.284. The sponsor’s Fisher Exact test reports p = 1.0.

The numerical secondary result does not provide a clear, precise separation between groups: its interval includes zero and allows differences in either direction. However, a single responder outcome cannot establish the pattern across all secondary measures. Detailed numerical results for the other listed secondary outcomes are not reported in the registry record, so a broader direction or consistency of effects cannot be assessed from this information.

Secondary measures can add context to a primary outcome by examining related aspects of disease signs or response. They do not replace the prespecified primary comparison, and a result on one measure should not be assumed to apply to another. In general, testing many outcomes increases the chance that at least one result may appear notable by chance. The record does not report a multiplicity adjustment or a hierarchy for interpreting the secondary outcomes. Unadjusted secondary results therefore carry less weight as confirmatory evidence, particularly when the full set of results and the analysis plan are unavailable.

The primary outcome and the available responder result should be considered as separate estimates with their own uncertainties, rather than combined into a single conclusion. The registry record does not report enough secondary results to determine whether findings across outcome types align with the primary estimate.

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

• Percent Change From Baseline in Investigator's Global Assessment (IGA) Score at Weeks 2, 4, 8, and 12
• Percentage of Participants Who Were Treatment Responders at Week 12
• Change From Baseline in Papule Lesions at Weeks 2, 4, 8, and 12
• Change From Baseline in Pustule Lesions at Weeks 2, 4, 8, and 12
• Change From Baseline in Nodule Lesions at Weeks 2, 4, 8, and 12
• Change From Baseline in Papules + Pustules Lesions at Weeks 2, 4, 8, and 12
• Number of Participants With Adverse Events

9. Statistical Interpretation

10. Statistical Methods Explained

The primary outcome is continuous: it records change in a count of lesions, rather than a yes-or-no event. The posted analysis summarizes each arm using a least-squares mean and reports the difference between arms. In general, a least-squares mean is a model-based group estimate. Its interpretation can depend on the model and any covariates or assumptions used. Those details are not reported in the registry record, so the model cannot be fully reconstructed from the posted summary.

The sponsor reports a two-sided t-test for the difference of least-squares means. In general, a two-sided test considers departures in either direction rather than only a prespecified increase or decrease. The reported p-value is 0.366. It measures how compatible the observed result is with the test’s null hypothesis under its assumptions; it is not the probability that the null hypothesis is true. The registry record does not report whether additional adjustments or model-based corrections were used.

The confidence interval is a range of values that reflects sampling uncertainty under the analysis method. The sponsor-reported 95% interval for the difference runs from -2.162 to 5.727. Because that range includes zero, it does not isolate a single direction for the between-group difference. This does not demonstrate that the groups are equivalent. Establishing equivalence would require a prespecified margin and a design and analysis directed at that question; such information is not reported in the registry record.

The posted recalculation uses the group summaries to form a simple, unadjusted comparison. The arm means are -10.2 and -12.0, and the reported standard errors are 1.08 and 1.62. The recalculation estimates a difference of 1.8 and uses an approximate pooled standard deviation of 5.469, with an approximate standardized difference of 0.329. These quantities describe a summary-statistic calculation, not the sponsor’s least-squares model. In general, standardizing a difference expresses it relative to a measure of variability, but the result remains dependent on the calculation’s assumptions. The registry record does not report enough information to verify those assumptions at participant level.

Why can the recalculated and reported results differ?

The sponsor’s analysis is based on the reported difference of least-squares means and a two-sided t-test. The recalculation is a simple unadjusted calculation using arm-level summaries; the standard deviations are approximated from the reported standard errors and sample sizes. A model-based analysis and a summary-statistic calculation need not produce identical confidence limits or p-values, particularly when group sizes differ or when the underlying model and analysis population are not fully described. Here, the estimated difference is 1.8 under both approaches, while the reported confidence limits and p-values differ slightly. There is no flagged discrepancy in the record, but the recalculation should still be understood as approximate rather than as a reproduction of the sponsor’s analysis.

What does over-dispersion mean in general?

For count outcomes, over-dispersion means that the observed variability is greater than a chosen statistical model expects. In general, failing to account for it can make uncertainty estimates too small and tests too optimistic. The registry record does not identify a count model or report an assessment of over-dispersion. The posted primary analysis is described as a difference of least-squares means with a t-test, so there is not enough information to determine whether or how count-specific modeling was considered.

What can be inferred about missing data?

The record says the primary analysis included participants in the MITT population with available data at Week 12. This indicates that Week 12 availability mattered for inclusion in the reported primary analysis, but it does not explain how missing observations were handled, how many were missing, or why data were unavailable. In general, an analysis restricted to participants with observed outcomes can be biased if missingness is related to outcome or treatment in a way that is not adequately addressed. The extent of that concern cannot be assessed from the registry record.

Overall, the reported test and interval quantify uncertainty under the sponsor’s analysis, while the recalculation offers a transparent but simplified comparison from posted summaries. Neither method supplies information that the record does not contain, such as the full analysis plan, participant-level data, or model diagnostics.

11. Confidence Intervals and Precision

The sponsor-reported 95% confidence interval for the primary difference is -2.162 to 5.727 lesions. It includes zero and spans values in both directions. The point estimate is 1.8 lesions, but the interval indicates that the estimate is not precise enough to isolate a single direction of difference under the reported analysis. The interval’s breadth should be considered alongside the unequal outcome counts of 26 and 11 participants in the two arms.

In general, a confidence interval describes the range of estimates reasonably compatible with the data and analysis procedure at its stated confidence level. It is not a range guaranteed to contain the true effect, and it is not a probability statement about a particular hypothesis. The 95% label refers to the long-run behavior of the interval procedure under its assumptions. Interpretation also depends on how the outcome was measured, how the analysis was conducted, and whether the assumptions are suitable.

The simple unadjusted recalculation gives a 95% interval from -2.016 to 5.616. Its limits differ from the sponsor’s reported interval, although both include zero. This reflects the distinction between an approximate summary-statistic calculation and the sponsor’s least-squares analysis. The recalculation’s interval should not be substituted for the sponsor’s reported result.

The registry record does not state a smallest clinically important difference for lesion count. Without such a threshold, the interval cannot be classified as excluding all clinically meaningful effects. Nor does the interval establish equivalence or prove that the groups had the same outcomes. It shows uncertainty around the estimated comparison, with values on either side of zero remaining compatible with the reported analysis.

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 participants per arm, not total participants, for this continuous primary outcome. The 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 specified as a stated fraction of the observed effect. The original trial’s own sample-size assumptions and justification are not reported in the registry record.

The 80% power column gives the illustrative number of participants per arm for a design with an 80% chance of detecting the stated effect under those planning assumptions, if that effect and the assumptions were correct. The 90% power column makes the same kind of illustration for a 90% chance. These are prospective planning quantities, not guarantees about results in a future study. The figures are not observed power.

The rows for planning for 100% of the observed effect, 75% of the observed effect, and 50% of the observed effect use progressively smaller target effects. Smaller effects are harder to distinguish from random variation, so they require more participants under otherwise comparable assumptions. For example, the figures rise from 145 participants per arm for 80% power at 100% of the observed effect to 258 at 75% and 580 at 50%. For 90% power, the corresponding figures are 194, 345, and 776.

These values use the observed effect as a planning reference, which can be an unstable basis for designing a new study, especially when the estimate is uncertain. They should be treated as illustrations rather than as a recommendation or as evidence about the power of the completed trial. The registry record does not report the trial’s original design calculation.

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 = 1.800; pooled standard deviation σ = 5.469.
2. n = 2 × (1.96 + 0.842)² × 5.469² / 1.800² = 144.9, rounded up to 145 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 <- 1.8                      # observed difference in means
sigma <- 5.46898789278497                     # 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(3064438)
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 = 145 (80% power), 194 (90% power)
 75% of observed effect: n per arm = 258 (80% power), 345 (90% power)
 50% of observed effect: n per arm = 580 (80% power), 776 (90% power)
power.t.test: 145.9 
Simulated power at n = 145 per arm: 0.799 (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 sponsor’s own analysis is the primary reported inferential result: a two-sided t-test of the difference of least-squares means, estimated at 1.8, with a 95% confidence interval from -2.162 to 5.727 and p = 0.366. The record does not flag a discrepancy between the posted analysis and the recalculation.

The recalculation uses the posted arm summaries and is unadjusted. It returns the same estimated difference, 1.8, but a 95% confidence interval from -2.016 to 5.616 and p = 0.355. Its standard deviation is approximate, and it does not reproduce the sponsor’s least-squares analysis. Differences in the interval and p-value are therefore consistent with the methods and assumptions not being identical.

The recalculation can serve as a check on the arithmetic implied by the posted summary statistics, but it cannot replace the sponsor’s analysis or resolve questions about the model, analysis population, or missing-data handling. The registry record does not give the details needed to reconstruct those aspects. The sponsor’s result should consequently be used as the trial’s reported analysis, with the recalculation treated as a supplementary, unadjusted view.

15. Multiplicity, Missing Data and Analysis Populations

The registry record lists 10 outcome measures and 22 analyses, as well as multiple secondary outcome families and repeated assessment times. When several outcomes, comparisons, or time points are tested, the chance of obtaining at least one apparently unusual result by chance can increase. In general, multiplicity procedures or a prespecified testing hierarchy can help control how a collection of tests is interpreted. The registry record does not report whether such procedures were planned or used.

The primary outcome is identified as change in total lesion count at Week 12, and the sponsor reports a two-sided test for that comparison. The record does not provide the full statistical analysis plan, identify any multiplicity adjustment, or explain how the other tests relate to the primary test. Secondary results should therefore be treated as exploratory unless additional protocol or analysis documentation establishes otherwise. The available record does not support a claim that all reported analyses were confirmatory or controlled for multiple testing.

For the primary outcome, the analysis population is described as participants in the MITT population with available Week 12 data. The meaning of MITT is not expanded in the record, and the number excluded for unavailable data is not stated. The record does not describe imputation, sensitivity analyses, or other missing-data methods. It also does not report reasons for missing outcomes or whether missingness differed between groups.

In general, missing-data methods matter because the analysis can be distorted if the probability of having an observed outcome is related to treatment or the outcome itself. Without information on missingness and the planned handling method, it is not possible to evaluate how robust the reported comparison is to those issues. The different arm counts reported for the primary outcome and adverse events are visible in the record, but an explanation for that difference is not reported.

These documentation gaps do not show that a particular bias occurred. They do limit the ability to assess multiplicity, reproduce the analysis, and understand how missing observations may affect the estimates.

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 0% reporting threshold.

Most frequent non-serious adverse event terms

The serious adverse-event figures report zero participants with serious adverse events in the ACU-D1 arm and zero in the vehicle arm. The corresponding at-risk counts are 27 and 13. The record also reports zero deaths in each arm. These are the posted counts for the registry’s adverse-event data.

A zero count means no serious adverse event was recorded in the reported data for that group; it does not establish that serious events are impossible or that the treatments have equivalent safety. In general, uncommon events may not appear in a study of limited size, and the absence of a recorded event is not evidence that risk is absent. The registry record does not provide event definitions, exposure-adjusted rates, or additional details about safety surveillance.

The adverse-event counts should be read separately from the primary efficacy analysis, which uses a Week 12 MITT population with available outcome data. The registry record does not explain the difference between the adverse-event at-risk counts and the outcome counts. Other adverse events are also reported, but serious adverse events and deaths are the focus of these figures. No treatment recommendation or broad safety conclusion follows from the serious-event counts alone.

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

The primary result describes the estimated difference between groups in change in total facial lesion count at Week 12. The sponsor’s estimate is 1.8 lesions, with a 95% confidence interval from -2.162 to 5.727 and p = 0.366. The observed arm means were -10.2 for ACU-D1 and -12.0 for vehicle. These values describe the recorded outcome and its statistical uncertainty; they do not, by themselves, establish a treatment effect or its clinical importance.

Because the confidence interval includes zero, the reported analysis does not distinguish the estimate from no between-group difference at the stated confidence level. That is not the same as proving there is no difference. The interval also extends in both directions, so the data do not pin down a single direction of the comparison. The registry record does not specify a threshold for a clinically meaningful lesion-count change, which prevents judging the interval against such a threshold.

The trial was randomized, double-blind, and vehicle controlled, features intended in general to support a fair comparison. Yet the registry record lacks details about implementation, missing data, and the full statistical plan. The primary analysis included participants with available Week 12 data, and the record does not explain how unavailable data were handled. Those limitations constrain interpretation of the estimate.

The available secondary responder result is also uncertain, and numerical results for the other listed secondary outcomes are not reported in the registry record. Serious adverse events and deaths were recorded as zero in both arms, but those counts do not rule out uncommon harms. Neither efficacy nor safety conclusions should be generalized beyond the study population and recorded outcomes without further evidence.

In short, the registry record reports a numerical comparison with substantial uncertainty, not a definitive answer about clinical benefit, lack of benefit, equivalence, or overall safety. The result is best understood as a limited estimate from a completed phase 2 study, with important analysis details not reported.

18. Why This Trial Matters Statistically

This trial illustrates why an observed difference should not be read without its uncertainty. The primary estimate of 1.8 lesions is accompanied by a 95% confidence interval that includes zero and extends in both directions. A point estimate alone would conceal how much uncertainty remains about the comparison.

It also demonstrates the value of distinguishing a sponsor-reported model-based analysis from a simple recalculation. Both produce an estimated difference of 1.8, while the confidence limits and p-values vary slightly. The recalculation is useful for understanding what the arm summaries imply under a simplified approach, but the sponsor’s analysis remains the trial’s reported result. Model details matter when moving from group summaries to formal inference.

The study’s outcome structure raises broader interpretation issues. Total lesion count is a continuous measure built from several lesion types, while listed secondary outcomes include assessments of individual lesion categories and responder status. In general, multiple measures can offer complementary views, but selective emphasis on whichever result appears most favorable risks overstating evidence. The record does not report a multiplicity strategy or a complete numerical set of secondary findings.

Finally, the difference between the outcome and adverse-event counts, and the limited description of missing-data handling, show why analysis populations and data availability need clear documentation. These details affect how readers judge precision, reproducibility, and potential bias. The result is statistically informative, but its interpretation depends on recognizing both what is reported and what remains undocumented.

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 primary outcome comparison is based on the Week 12 MITT population with available data, but the registry record does not explain the MITT definition, report the number with missing outcome data, or describe how missingness was handled. The reported primary outcome counts are 26 for ACU-D1 and 11 for vehicle, while the adverse-event at-risk counts are 27 and 13. The reason for these differences is not reported in the registry record.

The sponsor’s least-squares analysis cannot be reproduced from the available information. The registry record does not report the model specification, any covariates, diagnostics, or the full statistical analysis plan. The unadjusted recalculation is approximate and should not be treated as a substitute. The record does not state the original sample-size justification or whether interim analyses were planned.

Although multiple secondary outcomes are listed, the numerical information available does not provide results across all of them. The record does not report a multiplicity strategy, which limits interpretation of any secondary tests as confirmatory. It also does not state a clinically meaningful threshold for the primary lesion-count change.

The record identifies the study as randomized and double-blind but does not explain the procedures used to implement allocation or masking. Further participant characteristics and eligibility details are not reported. These limitations restrict assessment of generalizability, potential bias, and the clinical context of the estimates. They identify uncertainties in the available record; they do not establish that a particular design or analysis problem occurred.

20. Related Tutorials

21. Related Statistical Calculators

22. Sources

• ClinicalTrials.gov: Safety and Efficacy of ACU-D1 in the Treatment of Acne Rosacea — NCT03064438.
• Registry record last updated 2021-08-23; status last verified 2021-08.
• Results first posted 2021-08-23.
• 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

NCT03064438 is a completed randomized, double-blind, vehicle-controlled phase 2 study of ACU-D1 ointment for moderate to severe acne rosacea. Treatment was applied to the face twice daily for 12 weeks. The primary outcome was change from baseline in total lesion count at Week 12.

The sponsor reported a difference of least-squares means of 1.8 lesions, with a 95% confidence interval from -2.162 to 5.727 and a two-sided p-value of 0.366. The interval includes zero and leaves uncertainty about the direction and size of the between-group difference. The record also reports zero serious adverse events and zero deaths in both arms.

Detailed numerical results for most listed secondary outcomes, the original sample-size justification, and important analysis details are not reported in the registry record. The posted findings should therefore be interpreted as a limited statistical account of the trial, rather than a complete basis for conclusions about clinical effect or overall safety.