A Study to Evaluate the Anti-pruritic Effectiveness of ASN008 in Adults With Mild to Moderate Atopic Dermatitis: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for A Study to Evaluate the Anti-pruritic Effectiveness of ASN008 in Adults With Mild to Moderate Atopic Dermatitis (NCT05870865), a randomized phase 2 study. The primary outcome is Daily Peak Pruritus Numerical Rating Scale (NRS).

2. Clinical Question

The registry describes the trial as randomized, double-blind, vehicle-controlled, and phase 2. It evaluates anti-pruritic efficacy as well as safety, tolerability, and pharmacokinetics. The primary outcome is about participant-reported itch intensity; it is not a direct measure of eczema signs or skin area. Those other aspects were addressed through secondary outcomes, including Eczema Area and Severity Index, total body surface area, and Patient-Oriented Eczema Measure.

3. Trial Design

This was a randomized, parallel-group phase 2 trial with quadruple masking. The registry lists an enrollment of 144 and a completed study status. The recorded start date is 2023-05-03 and the primary completion date is 2023-11-27. The registry does not describe which roles were included in quadruple masking, or provide the method used to generate or conceal the random allocation.

Four groups are described: ASN008 1.25%, ASN008 2.5%, ASN008 5%, and matching vehicle. Each group applied its assigned topical product twice daily for 4 weeks. The stated application was a thin layer, approximately 2 mg/cm^2, on eczema lesions. The available primary outcome results include 30 participants in the 1.25% group, 30 in the 2.5% group, 26 in the 5% group, and 31 in the vehicle group. These outcome-analysis counts need not equal overall enrollment; reasons for the differences are not reported in the registry record.

The primary outcome was analyzed in the Modified Intent to Treat population. The registry names the primary analysis as a mixed models analysis of mean differences in final values. Additional details about the model specification, covariates, handling of repeated measurements, and missing observations are not reported in the registry record. The original sample-size rationale and planned analysis assumptions are also not reported. The numerical planning illustrations associated with the posted results are separate from the trial’s original design 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.

Randomized

Reasons for not completing this period:

Treatment Period

Reasons for not completing this period:

Analysis population for the primary outcome, as defined in the registry: Modified Intent to Treat

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: Modified Intent to Treat Population

6. Primary Endpoint

The registry lists the primary outcome as Daily Peak Pruritus Numerical Rating Scale (NRS), measured over Baseline to Week 4.

The primary endpoint is the percent change from baseline to Week 4 in the 7-day average of daily peak pruritus Numerical Rating Scale scores. It focuses on itch, the symptom that the trial was designed to evaluate, and summarizes daily ratings over a week rather than relying on a single daily report. The registry identifies the measure as a continuous outcome and reports least-squares means with standard errors for the treatment groups.

A change score describes how the measured symptom differs from the participant’s baseline level. In this endpoint, a negative percent change represents a decrease in the recorded score over the assessment period. The group means describe average change, not the experience of every participant. Comparing each dose group with vehicle addresses whether the observed average change differs between assigned groups under the trial conditions.

The endpoint is distinct from clinical signs such as eczema severity or affected body surface area, and from broader patient-reported measures. Those were included among secondary outcomes. The registry record does not give the scale’s response anchors, a threshold for a clinically meaningful change, or a responder definition for the primary endpoint. Those details should not be inferred from the mean changes alone.

7. Results Posted in the Registry

• ASN008 1.25%: mean -45.60 versus -49.90 on control; difference 4.30 (95% CI -9.60 to 18.20), standardized effect d = 0.16; z-test p = 0.544.
• ASN008 2.5%: mean -55.80 versus -49.90 on control; difference -5.90 (95% CI -19.93 to 8.13), standardized effect d = -0.21; z-test p = 0.410.
• ASN008 5%: mean -48.30 versus -49.90 on control; difference 1.60 (95% CI -12.53 to 15.73), standardized effect d = 0.06; z-test p = 0.824.

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.

Pruritus Response of ASN008 Topical Gel on Atopic Dermatitis (AD) Assessed by Daily Peak Pruritus NRS

• Endpoint type: Binary: the number of participants with the event, compared as proportions.
• Test: Unadjusted two-proportion z-test, with a Wald 95% confidence interval for the risk difference.
• Result:
  • ASN008 1.25%: 35.3% (12/34) versus 45.5% (15/33) on control; risk difference -10.2 percentage points (95% CI -33.5 to 13.2), risk ratio 0.78 (0.43–1.40); unadjusted two-proportion z-test p = 0.397.
  • ASN008 2.5%: 68.8% (22/32) versus 45.5% (15/33) on control; risk difference 23.3 percentage points (95% CI -0.1 to 46.7), risk ratio 1.51 (0.97–2.35); unadjusted two-proportion z-test p = 0.058.
• Interpretation:
  • The 95% confidence interval includes no difference, so these data do not show a statistically significant difference between ASN008 1.25% and the control. The interval gives the range of effects that remain compatible with the data.
  • The 95% confidence interval includes no difference, so these data do not show a statistically significant difference between ASN008 2.5% and the control. The interval gives the range of effects that remain compatible with the data.

Mean Change From Baseline in Eczema Area and Severity Index (EASI) Score

• 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:
  • ASN008 1.25%: mean -2.70 versus -3.40 on control; difference 0.70 (95% CI -0.42 to 1.82), standardized effect d = 0.31; z-test p = 0.222.
  • ASN008 2.5%: mean -3.50 versus -3.40 on control; difference -0.10 (95% CI -1.26 to 1.06), standardized effect d = -0.04; z-test p = 0.866.
• Interpretation:
  • The 95% confidence interval includes no difference, so these data do not show a statistically significant difference between ASN008 1.25% and the control. The interval gives the range of effects that remain compatible with the data.
  • The 95% confidence interval includes no difference, so these data do not show a statistically significant difference between ASN008 2.5% and the control. The interval gives the range of effects that remain compatible with the data.

Mean Change From Baseline in Total Body Surface Area (BSA)

• 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:
  • ASN008 1.25%: mean -2.60 versus -2.40 on control; difference -0.20 (95% CI -1.75 to 1.35), standardized effect d = -0.06; z-test p = 0.801.
  • ASN008 2.5%: mean -2.90 versus -2.40 on control; difference -0.50 (95% CI -2.09 to 1.09), standardized effect d = -0.16; z-test p = 0.539.
• Interpretation:
  • The 95% confidence interval includes no difference, so these data do not show a statistically significant difference between ASN008 1.25% and the control. The interval gives the range of effects that remain compatible with the data.
  • The 95% confidence interval includes no difference, so these data do not show a statistically significant difference between ASN008 2.5% and the control. The interval gives the range of effects that remain compatible with the data.

The listed secondary outcomes extend the assessment beyond the primary itch score. They include a participant-count pruritus response measure, EASI, total body surface area, and POEM. The posted numerical results cover the response measure, EASI, and body surface area; POEM results are not reported in the registry record. Across the reported secondary measures, estimates vary by outcome and dose rather than presenting a single consistent pattern that independently settles the primary question.

These measures are related to the trial’s broader evaluation but are not interchangeable. A response count depends on a threshold definition, while EASI and body surface area measure aspects of eczema extent or severity. POEM is a patient-oriented measure. An effect on one measure would not necessarily imply an effect of the same size or certainty on another. The secondary results can add context about symptom response and skin outcomes, but they do not replace the primary endpoint.

Unadjusted secondary results carry less weight because several outcomes and comparisons create multiple opportunities for apparently notable findings. Without a prespecified multiplicity procedure, the chance of at least one false-positive result across a set of tests can increase. The registry record lists multiple outcome measures and analyses but does not report whether or how the analyses were adjusted. In addition, responder definitions and full analysis details are not reported for all outcomes. These limitations favor treating secondary findings as exploratory context rather than conclusive confirmation.

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

• Pruritus Response of ASN008 Topical Gel on Atopic Dermatitis (AD) Assessed by Daily Peak Pruritus NRS
• Mean Change From Baseline in Eczema Area and Severity Index (EASI) Score
• Mean Change From Baseline in Total Body Surface Area (BSA)
• Mean Change From Baseline in the Patient-Oriented Eczema Measure (POEM)

9. Statistical Interpretation

10. Statistical Methods Explained

The primary endpoint is continuous, meaning that it is expressed numerically rather than as a count of participants meeting a yes-or-no definition. The registry reports least-squares means for the four groups. In general, a least-squares mean is a model-based group mean; it can account for features included in the model. The exact model specification and any covariates used are not reported in the registry record, so the degree of adjustment cannot be determined from the posted information.

The registry identifies the sponsor’s primary comparisons as mixed models analyses of mean differences in final values. In general, mixed models can represent relationships among repeated or otherwise correlated observations and can use information from more than one measurement occasion. The registry record does not state the repeated-measure structure, covariance assumptions, estimation method, or missing-data assumptions. It is therefore not possible to reconstruct the sponsor’s model from the posted summary alone.

The recalculated comparisons use the reported group means and standard errors to estimate unadjusted differences between each ASN008 dose and vehicle. A mean difference is the estimated separation between two group averages on the outcome scale. A value above or below zero indicates the direction of the numerical difference according to the comparison convention; it does not, by itself, establish a meaningful treatment effect. For the primary endpoint, the recalculated intervals and p-values are not adjusted for other comparisons.

The reported spread alongside each least-squares mean is a standard error. In general, a standard error describes the sampling uncertainty of an estimated mean, rather than the variation among individual participants. It tends to be smaller when an estimate is more precise, while the standard deviation describes spread among observations. The recalculation uses an approximate pooled standard deviation derived from the reported standard errors and group sizes. Because that quantity is estimated from summary information, it may not match the variability used in the original model.

A confidence interval gives a range of values compatible with the estimate under the assumptions of the calculation. In general, a 95% confidence interval describes the performance of the interval-generating method over repeated studies; it is not a probability statement about the fixed true effect in this particular trial. An interval that includes zero means the data do not clearly separate the estimated difference from no difference under that method. It does not show that the groups are identical, and it does not rule out effects elsewhere within the interval.

A p-value measures how unusual the observed data, or more extreme data, would be under a specified null model. It does not measure the probability that the null hypothesis is true, nor the size or importance of an effect. The recalculated p-values are unadjusted. The registry’s primary mixed models p-values are separate sponsor analyses and should be distinguished from the recalculated values. No multiplicity adjustment is described in the registry record.

The secondary pruritus-response outcome is binary in the posted results: participants are counted according to whether they met the response definition. A risk difference compares the proportions in two groups, while an odds ratio compares their odds. Fisher’s exact test is the sponsor’s reported method for the posted response comparisons. In general, exact methods can be useful with small group counts, though any estimate from limited data can remain imprecise. The response threshold and the full definition are not reported in the registry record.

For continuous secondary outcomes, the registry reports least-squares means and standard errors. The posted summaries include EASI and total body surface area changes; the listed secondary outcomes also include POEM. The registry’s reported analyses for the continuous outcomes use mixed models. The specific model details are not reported. The registry lists 10 outcome measures and 15 analyses, but does not explain which analyses formed a prespecified family or how multiplicity was handled.

Over-dispersion is a general concern when count or binary data vary more than a model assumes. If present and ignored, standard errors can be too small and uncertainty can be understated. The posted secondary response analysis uses group counts and Fisher’s exact test rather than a count regression model, so a model-based over-dispersion parameter is not posted. More generally, the available aggregate results cannot diagnose variation patterns or support independent reanalysis at the participant level.

11. Confidence Intervals and Precision

The recalculated primary comparisons have confidence intervals that cross zero. For ASN008 1.25% versus vehicle, the estimated mean difference is 4.3 and the interval runs from -9.601 to 18.2. For ASN008 2.5%, the estimate is -5.9 and the interval runs from -19.93 to 8.127. For ASN008 5%, the estimate is 1.6 and the interval runs from -12.53 to 15.73. Thus, each estimate is uncertain in direction as well as magnitude under the unadjusted calculation.

The widths of these intervals indicate that the posted summaries do not pin down a narrow range of possible differences. In general, a confidence interval conveys precision as well as direction: an interval can include zero while still allowing differences that may matter, or it can be narrow enough to exclude effects of interest. The registry does not define a clinically important difference for this endpoint, so the interval cannot be classified against a stated clinical threshold.

The interval estimates are recalculated from group-level summary statistics and use an approximate pooled standard deviation. They are not the confidence intervals from the sponsor’s mixed models analysis. The registry does not post confidence limits for those sponsor comparisons. The recalculated intervals should therefore be read as simple unadjusted estimates, not as a replacement for the sponsor’s model-based inference. The registry record does not provide participant-level data or sufficient model details to independently reproduce the sponsor’s intervals or assess the impact of missing observations.

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 for 80% power and participants per arm for 90% power. They are not total sample sizes and do not represent observed enrollment or analysis counts. The planning assumptions are a two-sided significance level of 0.05, equal allocation between the two arms, and a normal approximation. Each planning scenario uses the stated fraction of the observed effect: 100%, 75%, or 50%. For these outcomes, the figures are participants per arm, not total events.

The 80% power column describes a planning scenario in which a study of the stated size would have an 80% chance of detecting the assumed effect under the calculation’s assumptions, if that effect and model assumptions held. The 90% power column uses a higher target chance of detection and therefore generally requires more participants. These are design illustrations, not a guarantee that a future study will produce a particular result.

Smaller effects require more participants to detect under the same assumptions. This is why planning for 75% or 50% of the observed effect yields larger required group sizes than planning for the full observed effect. The calculations use effects estimated from this trial, which may be unstable, especially when the observed difference is small. They are not the original sample-size justification; that justification is not reported in the registry record. This is not observed power.

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 = 4.300; pooled standard deviation σ = 27.696.
2. n = 2 × (1.96 + 0.842)² × 27.696² / 4.300² = 651.2, rounded up to 652 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 <- 4.3                      # observed difference in means
sigma <- 27.6958312349821                     # 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(5870865)
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 = 652 (80% power), 872 (90% power)
 75% of observed effect: n per arm = 1,158 (80% power), 1,550 (90% power)
 50% of observed effect: n per arm = 2,605 (80% power), 3,488 (90% power)
power.t.test: 652.2 
Simulated power at n = 652 per arm: 0.794 (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 primary analyses are reported as mixed models analyses of mean differences in final values. The reported estimates are 4.28 for ASN008 1.25% versus vehicle, -5.89 for ASN008 2.5% versus vehicle, and 1.66 for ASN008 5% versus vehicle. The sponsor’s corresponding p-values are 0.548, 0.412, and 0.818. These are the registry’s own analyses and should take precedence over the simple recalculations for interpretation of the sponsor’s planned comparisons.

The recalculated estimates are close to the sponsor’s reported mean differences, but the methods are not identical. The recalculation is unadjusted and based on posted group summaries, using an approximate pooled standard deviation for the intervals. The sponsor used mixed models. Because details of the model and its assumptions are not reported in the registry record, exact agreement is not expected, and the recalculated confidence intervals should not be attributed to the sponsor.

The sponsor analyses do not include confidence intervals in the posted results. The p-values alone do not describe the range of effect sizes compatible with the data. The registry does not report a multiplicity strategy for the multiple comparisons, so the sponsor p-values should not be treated as adjusted for the full set of trial analyses.

15. Multiplicity, Missing Data and Analysis Populations

The registry lists 10 outcome measures and 15 analyses, including comparisons across treatment groups and multiple outcomes. It does not report a multiplicity procedure, such as a hierarchy for testing outcomes or an adjustment to control the overall false-positive rate. The primary comparisons and secondary comparisons therefore should not automatically be interpreted as a single protected family of tests. The recalculated p-values are explicitly unadjusted, and the adjustment status of the sponsor’s analyses is not reported in the registry record.

Missing-data handling is also not reported. The primary population is identified as Modified Intent to Treat, but the registry does not describe how participants with incomplete Week 4 measurements were handled, whether imputation was used, or what assumptions were made about missingness. The outcome-analysis group sizes differ among endpoints, and reasons for those differences are not reported. Without those details, it is not possible to assess whether missing observations could have affected the estimates.

The registry names mixed models for the primary and continuous secondary analyses, but does not give enough specification to evaluate model assumptions or reproduce the analysis. Randomization and masking are described, but allocation procedures, protocol deviations, analysis-population rules, and sensitivity analyses are not detailed in the posted record. Interim analyses and a fuller statistical analysis plan are not reported in the registry record. These gaps limit assessment of whether all analytical choices followed prespecified plans and how robust the findings are to alternative assumptions.

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 1% reporting threshold.

Most frequent non-serious adverse event terms

The registry reports zero serious adverse events in each group among those listed as at risk: 34 participants for ASN008 1.25%, 32 for ASN008 2.5%, 32 for ASN008 5%, and 33 for matching vehicle. Deaths are reported as zero in all four groups. These figures describe the posted safety counts; they do not establish that no serious events occurred outside the recorded analysis or observation period.

The registry also lists other adverse events affecting 12 participants in the 1.25% group, 14 in the 2.5% group, 13 in the 5% group, and 9 in the vehicle group. The serious-event figures should be kept distinct from these other adverse-event counts. The record does not provide the serious-event terms because none are listed, and it does not give enough detail to assess event type, timing, severity beyond seriousness classification, or attribution. Counts from a trial of this size and duration describe observed events; they do not establish comparative safety for less common or longer-term outcomes.

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

The results show substantial average decreases in the recorded itch score in all four groups from baseline to Week 4, including the matching-vehicle group. The primary statistical question is whether the dose groups differed from vehicle, not whether scores changed within each group. The recalculated between-group intervals include zero for all three dose comparisons, and the sponsor’s reported p-values do not indicate clear separation in those comparisons. These findings describe the posted data and analyses; they do not prove that the groups are equivalent.

The estimates are not precise enough to rule out a range of possible differences, and the registry does not define a threshold for clinical importance. A numerical difference or a p-value should not be read as a complete judgment of treatment value. The study also assessed secondary outcomes and safety, but those measures answer different questions and have their own uncertainty and multiplicity considerations.

The record describes a randomized, masked, vehicle-controlled design, which is useful for comparing assigned groups under the study conditions. However, the available registry information does not include the full statistical plan, detailed eligibility criteria, missing-data methods, or confidence intervals from the sponsor’s models. The results should therefore be interpreted as estimates from a phase 2 trial with limited posted analytical detail, rather than as a universal conclusion about ASN008 or atopic dermatitis.

18. Why This Trial Matters Statistically

This trial illustrates why an observed change within each group is not the same as evidence of a difference between groups. The vehicle group also had a negative average change in the primary itch measure. The relevant comparison is the difference in average change between each dose and vehicle, with its uncertainty, rather than the direction of change in a dose group alone.

It also shows how estimates and uncertainty work together. The three recalculated mean differences vary in direction, while all three confidence intervals include zero and extend across a range of possible effects. Reporting only a point estimate or a p-value would omit important information about precision. The registry’s sponsor analyses and the simple recalculations are close in estimate but arise from different methods, underscoring the need to distinguish model-based reported analyses from aggregate-summary recalculations.

Finally, the trial includes multiple outcomes and comparisons. Secondary measures can help describe different dimensions of itch and eczema, but unadjusted findings across many tests need cautious interpretation. The case highlights why a statistical analysis plan, clear handling of missing observations, and transparent multiplicity procedures matter when assessing a complex set of results.

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 analysis counts are smaller than the overall enrollment, and the registry does not explain the differences or report missing-data handling. The primary endpoint results are model-based means, but the model specification and assumptions are not given. The sponsor’s primary comparisons have no posted confidence intervals, while the recalculated intervals use approximate pooled variability from summary statistics rather than the original model.

The registry record does not report the original sample-size justification, analysis plan details, multiplicity handling, interim analyses, or clinically meaningful thresholds for the primary endpoint. It also does not provide full responder criteria for the secondary pruritus outcome. POEM is listed as a secondary outcome, but its numerical results are not reported in the registry record.

The primary endpoint is limited to the recorded period from baseline to Week 4. Longer-term outcomes are not reported in these results. The trial’s parallel-group comparison and vehicle control address the stated short-term question, but the posted summaries alone cannot establish how results might vary by participant characteristics or clinical setting. Safety counts are descriptive and do not provide detailed event narratives or establish the frequency of uncommon harms.

20. Related Tutorials

21. Related Statistical Calculators

22. Sources

• ClinicalTrials.gov: A Study to Evaluate the Anti-pruritic Effectiveness of ASN008 in Adults With Mild to Moderate Atopic Dermatitis — NCT05870865.
• Registry record last updated 2025-05-16; status last verified 2025-05.
• Results first posted 2024-12-27.
• 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

NCT05870865 is a completed randomized, quadruple-masked, parallel-group phase 2 trial evaluating topical ASN008 in adults with mild to moderate atopic dermatitis. Participants were assigned to ASN008 1.25%, 2.5%, 5%, or matching vehicle, applied twice daily for 4 weeks. The primary outcome was percent change from baseline to Week 4 in the 7-day average daily peak pruritus NRS.

In the posted primary results, all three recalculated dose-versus-vehicle confidence intervals include zero. The sponsor’s mixed models analyses report corresponding mean differences and p-values, without confidence intervals. Secondary results cover selected itch and eczema outcomes, while POEM results are not reported in the registry record. No serious adverse events or deaths are listed in any group. Key details about multiplicity, missing-data handling, model specification, and the original sample-size rationale are not reported in the registry record.