Study of TDM-105795 Following Topical Administration in Male Subjects With Androgenetic Alopecia: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Study of TDM-105795 Following Topical Administration in Male Subjects With Androgenetic Alopecia (NCT05802173), a randomized phase 2 study. The primary outcome is Non-vellus Target Area Hair Count (TAHC).

2. Clinical Question

The clinical question is about a measured hair count in a target area, rather than a patient-reported outcome or a measure of hair width or darkness. The primary endpoint description specifies collection of the count results at week 16. It does not state that the reported value is a change from baseline.

The trial also listed secondary measures of target area hair width and darkness, a Hair Growth Index questionnaire, and an Investigator's Global Assessment grade. The posted numerical secondary summaries include hair width and hair darkness. Numerical analyses for the questionnaire and investigator assessment are not reported in the registry record. The results therefore address a specific target-area count and do not, by themselves, capture every outcome named in the study record.

3. Trial Design

This was a phase 2, randomized, double-blind, vehicle-controlled, parallel-group study of daily topical TDM-105795 in male subjects with androgenetic alopecia. The registry record describes three groups: TDM-105795 topical solution at 0.003%, TDM-105795 topical solution at 0.02%, and topical vehicle solution. Enrollment was 71, and the record lists the study status as completed.

The primary outcome was non-vellus target area hair count, measured at 16 weeks. The posted arm summaries report means and standard deviations. The analysis population for the primary outcome is not identified in the registry record beyond the group counts attached to the outcome results. Those counts are 26, 23, and 22, respectively, across the two active-dose groups and vehicle.

Randomization is intended to make treatment groups comparable at the point of assignment, while double blinding is intended to limit the influence of treatment knowledge on participant or study-team behavior and assessment. These are general features of the design; details about how the random sequence was generated, how allocation was concealed, and how masking was maintained are not reported in the registry record. The specific randomization ratio is also not reported.

The registry record gives a start date of 2023-03-06 and a primary completion date of 2023-11-08. It does not report the original sample-size justification, the planned statistical model, the protocol-defined analysis population, or whether interim analyses were planned. The posted results include unadjusted comparisons of each active group with vehicle. No sponsor-reported analysis details are listed, so the registry record does not establish whether these calculations match the full prespecified analysis.

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: 71 participants randomized in the study and were evaluable for safety analyses.

Overall Study

Reasons for not completing this period:

5. Baseline Characteristics

The table reproduces the baseline characteristics posted in the registry, which describe the participants analysed at baseline and help show whether the randomized groups were comparable.

6. Primary Endpoint

The registry lists the primary outcome as Non-vellus Target Area Hair Count (TAHC), measured over 16 weeks.

The primary endpoint is non-vellus target area hair count (TAHC) at 16 weeks. It records the number of non-vellus hairs in a defined target area. A count is a direct quantitative measure of the feature under study and can be summarized across participants using a mean and a measure of spread. The posted results report the mean count and standard deviation for each group.

A target-area measure focuses assessment on a specified region rather than making a whole-scalp assessment. This can support a consistent comparison between groups when the same area and measurement approach are used. Those are general reasons for using a target-area count; details of the measurement procedure and its reproducibility are not reported in the registry record.

The endpoint description states that results were collected at week 16. It does not describe the result as a change from baseline, and the registry record does not give a baseline value alongside the posted week-16 means. Accordingly, the posted group means should be read as the reported hair counts at the stated time point, not recast as changes from baseline.

The endpoint is a count, but the statistical summary treats it as a continuous measure and reports means and standard deviations. This permits estimation of mean differences between groups. Whether a different distributional model or an adjusted analysis was prespecified is not reported in the registry record.

7. Results Posted in the Registry

• TDM-105795 Topical Solution, 0.0025%: mean 20.30 versus 14.00 on control; difference 6.30 (95% CI -7.18 to 19.78), standardized effect d = 0.25; z-test p = 0.360.
• TDM-105795 Topical Solution, 0.02%: mean 22.40 versus 14.00 on control; difference 8.40 (95% CI -2.17 to 18.97), standardized effect d = 0.46; z-test p = 0.119.

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 Non-vellus Target Area Hair Width (TAHW)

• Endpoint type: Continuous: a mean value per participant, compared as a difference in means.
• Test: Unadjusted two-sample z-test for the difference in means, using the posted standard deviations.
• Result:
  • TDM-105795 Topical Solution, 0.0025%: mean -1.27 versus -1.27 on control; difference 0.00 (95% CI -1.49 to 1.49), standardized effect d = 0.00; z-test p = 1.000.
  • TDM-105795 Topical Solution, 0.02%: mean -2.18 versus -1.27 on control; difference -0.91 (95% CI -2.47 to 0.65), standardized effect d = -0.43; z-test p = 0.252.
• Interpretation:
  • The 95% confidence interval includes no difference, so these data do not show a statistically significant difference between TDM-105795 Topical Solution, 0.0025% 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 TDM-105795 Topical Solution, 0.02% and the control. The interval gives the range of effects that remain compatible with the data.

Change in Non-vellus Target Area Hair Darkness (TAHD)

• Endpoint type: Continuous: a mean value per participant, compared as a difference in means.
• Test: Unadjusted two-sample z-test for the difference in means, using the posted standard deviations.
• Result:
  • TDM-105795 Topical Solution, 0.0025%: mean 4.60 versus -3.60 on control; difference 8.20 (95% CI -0.75 to 17.15), standardized effect d = 0.62; z-test p = 0.073.
  • TDM-105795 Topical Solution, 0.02%: mean 3.20 versus -3.60 on control; difference 6.80 (95% CI -4.33 to 17.93), standardized effect d = 0.46; z-test p = 0.231.
• Interpretation:
  • The 95% confidence interval includes no difference, so these data do not show a statistically significant difference between TDM-105795 Topical Solution, 0.0025% 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 TDM-105795 Topical Solution, 0.02% and the control. The interval gives the range of effects that remain compatible with the data.

The registry record lists four secondary outcomes: change in non-vellus target area hair width, change in non-vellus target area hair darkness, the Hair Growth Index questionnaire, and Investigator's Global Assessment grade. Numerical results are posted for hair width and hair darkness. Numerical results for the questionnaire and investigator assessment are not reported in the registry record.

Across the two outcomes with numerical summaries, the pattern is not uniform. The posted mean differences and confidence intervals give a sense of how the secondary measures compare between the active groups and vehicle, but they do not form a consistent independent replication of the primary count result. These measures assess different features, so agreement is not guaranteed; nor should a difference in one measure be assumed to imply a difference in another.

The secondary outcomes are relevant as context for the primary result because they concern other aspects of target-area hair or broader assessments. They cannot resolve the uncertainty in the primary endpoint: they use different measurements and have their own uncertainty. The registry record lists no reported analyses for these secondary endpoints, and the available comparisons are unadjusted.

General statistical explanation: when researchers examine multiple outcomes or comparisons, the opportunity for at least one apparently notable result by chance increases. Multiplicity methods can address this, but no such method is reported in the registry record. Consequently, unadjusted secondary findings carry less weight as confirmatory evidence. They are best read as exploratory observations that may help shape questions for further study, not as a substitute for a prespecified primary analysis.

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

• Change in Non-vellus Target Area Hair Width (TAHW)
• Change in Non-vellus Target Area Hair Darkness (TAHD)
• Hair Growth Index (HGI) Questionnaire
• Evaluation of Investigator's Global Assessment (IGA) Grade

9. Statistical Interpretation

10. Statistical Methods Explained

The posted primary endpoint is continuous in the statistical summary: each group is described by a mean and standard deviation. A mean gives the arithmetic average of the measured counts in a group. A standard deviation describes how spread out individual observations are around that mean. It is not the same as the uncertainty in the mean or the uncertainty in a treatment comparison.

What does a mean difference represent?

For each active-dose comparison, the mean difference is the active-group mean minus the vehicle-group mean. A positive estimate means the observed mean was higher in the active group; a negative estimate would mean it was lower. The posted primary differences are 6.3 for 0.003% versus vehicle and 8.4 for 0.02% versus vehicle. These are unadjusted differences based on the reported group summaries. They do not account for baseline characteristics or other variables.

A mean difference is expressed in the measure's original unit. Here, that unit is hair count. It provides a direct estimate of the average separation between the groups, but it does not describe the range of individual responses or imply that every participant had an outcome near the group mean.

How should the confidence interval be read?

A confidence interval expresses the uncertainty around an estimated group difference under the assumptions of the analysis. It gives a range of values compatible with the observed data and method; it is not a guarantee that the true difference lies within the interval. General statistical explanation: a wider interval indicates less precision, while a narrower interval indicates greater precision.

For the primary comparison at 0.003%, the interval runs from -7.181 to 19.78. For 0.02%, it runs from -2.171 to 18.97. Both intervals include zero, which is the value corresponding to no mean difference. The intervals also include positive values, so the estimates do not rule out a higher mean in an active group. Their negative endpoints mean that the posted results also do not rule out a lower mean. The extent of this uncertainty is important when interpreting the point estimates.

What does a p-value add?

A p-value describes how unusual the observed data, or data more extreme, would be under a specified null hypothesis and analysis model. It is not the probability that the null hypothesis is true, and it does not measure the size or clinical importance of a difference. The unadjusted p-values for the primary comparisons are 0.36 and 0.119. They should be read alongside the estimates and confidence intervals rather than in isolation.

Because the p-values are unadjusted, they do not account for the family of outcomes or comparisons. The registry record does not report a multiplicity adjustment or detailed testing hierarchy. No sponsor-reported analyses are listed, so details of any prespecified model, adjustments, or confirmatory interpretation are not reported in the registry record.

Why can variability matter?

General statistical explanation: when individual outcomes vary substantially, the group mean is estimated less precisely unless the study has enough observations to offset that variability. The primary standard deviations are 29.4, 18.59, and 17.59, while the primary outcome group counts are 26, 23, and 22. The confidence intervals reflect the combined influence of the observed variation and the number of observations in the comparisons.

Some outcome measures, especially counts, can have distributions that differ from a symmetric bell-shaped pattern. General statistical explanation: over-dispersion occurs when variability is greater than a model expects, and it can make standard errors too small if the model does not account for it. The registry record does not report a distributional diagnostic or model used to address count-data features. The posted results instead give mean-based comparisons and their intervals. This does not prove that a particular alternative model was needed; it marks an analysis detail that is unavailable.

What is and is not reported about analysis?

The registry record identifies the outcome and provides group means, standard deviations, comparison estimates, confidence intervals, and unadjusted p-values. It does not report the original statistical analysis plan, the precise method used to construct the intervals and p-values, missing-data handling, or the analysis population definition. It also does not report interim analyses. These omissions limit assessment of whether the posted calculations follow a prespecified plan.

General statistical principle: a randomized design and transparent outcome definitions support interpretation, but analysis choices still matter. Choices about baseline adjustment, missing observations, distributional assumptions, and multiplicity can affect estimates or uncertainty. Without the relevant plan and sponsor analyses, the posted summaries are most appropriately read as descriptive, unadjusted evidence about the observed group means.

11. Confidence Intervals and Precision

The primary confidence intervals are broad relative to the point estimates. For the 0.003% comparison, the estimated mean difference is 6.3, with an interval from -7.181 to 19.78. For the 0.02% comparison, the estimate is 8.4, with an interval from -2.171 to 18.97. In both cases the interval includes zero, so the posted data are compatible with no mean difference under the stated comparison as well as with differences in either direction.

Precision concerns the range of values supported by the data, not only whether an interval crosses a particular threshold. The intervals leave considerable uncertainty about the size of either comparison. The point estimates alone should not be treated as exact estimates of the underlying differences. The observed group standard deviations—29.4, 18.59, and 17.59—also show that participant measurements varied around their respective means.

The group counts for the primary outcome were 26, 23, and 22. General statistical explanation: estimates based on limited numbers of observations are often more sensitive to individual results, and variability contributes to the width of an interval. The record does not provide individual participant data, so the influence of particular observations cannot be assessed.

Confidence intervals are useful because they communicate both direction and uncertainty on the original scale. Here, each includes values below and above zero. Neither interval offers a narrowly defined range for the mean difference. The registry record does not report adjusted intervals or a prespecified method for handling multiple comparisons, so the posted intervals should be interpreted as unadjusted comparisons rather than as multiplicity-controlled estimates.

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 describe participants per arm for comparisons of an active group with vehicle; they are not total event counts. The planning assumptions are a two-sided significance level of 0.05, equal allocation between the two arms, and a normal approximation. The assumed effect is the stated fraction of the observed effect. The original trial's own sample-size assumptions and justification are not reported in the registry record.

The 80% power column gives the illustrative number of participants per arm under which the planning calculation would have an 80% chance of detecting the chosen effect, if the assumptions used for that calculation hold. The 90% power column gives the corresponding per-arm number for a higher planned chance of detection. These are planning illustrations, not descriptions of the study's observed power. Observed power is not a useful substitute for reading the effect estimate and its uncertainty after a study has been completed.

Rows for 100%, 75%, and 50% of the observed effect consider progressively smaller effects. Smaller effects are harder to distinguish from random variation, so the planning calculations require more participants per arm. For example, for the 0.02% primary comparison, the figures are 73 and 98 per arm for planning around 100% of the observed effect, and 292 and 391 per arm for planning around 50% of the observed effect, for 80% and 90% power respectively.

These calculations are illustrations based on the observed effect and the stated assumptions. They do not show what the original investigators planned, and they do not establish that a future study should use any particular sample size. Other design choices, including the target effect and analysis plan, would affect a study's planning requirements.

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 = 6.300; pooled standard deviation σ = 24.719.
2. n = 2 × (1.96 + 0.842)² × 24.719² / 6.300² = 241.7, rounded up to 242 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 <- 6.3                      # observed difference in means
sigma <- 24.7186648805768                     # 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(5802173)
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 = 242 (80% power), 324 (90% power)
 75% of observed effect: n per arm = 430 (80% power), 576 (90% power)
 50% of observed effect: n per arm = 967 (80% power), 1,295 (90% power)
power.t.test: 242.6 
Simulated power at n = 242 per arm: 0.793 (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. Multiplicity, Missing Data and Analysis Populations

The registry record identifies one primary outcome and lists secondary outcomes, but it does not report a testing hierarchy or a method for controlling multiplicity. The posted comparison p-values are unadjusted. They therefore do not reflect an adjustment for testing both active doses against vehicle or for examining multiple outcomes. General statistical explanation: testing several hypotheses without adjustment can increase the chance of at least one result appearing unusual by chance. This concern is especially relevant when secondary results are interpreted as confirmatory.

The record reports eight outcome measures overall and lists zero sponsor-reported analyses. Numerical results are posted for the primary endpoint and for two secondary measures, while analyses of the questionnaire and investigator assessment are not reported in the registry record. The reason those results are absent is not reported. The registry record also does not explain whether any outcomes were omitted, changed, or collected but not analyzed.

Missing-data handling is not reported in the registry record. The outcome group counts differ across measures: the primary count summaries include 26, 23, and 22 participants, while the posted hair-width and hair-darkness summaries use 21, 13, and 15 participants in the corresponding groups. The record does not state why these counts differ or whether missing observations were handled by a particular method. It is not possible to determine from the posted summaries whether the differences reflect missing measurements, analysis eligibility, or another reason.

The populations used for analysis are not defined beyond the group counts attached to the outcome results. The registry record does not state whether an intention-to-treat, per-protocol, or other analysis population was used. Baseline adjustment, covariate selection, sensitivity analyses, and interim analyses are also not reported. These gaps do not invalidate the observed summaries, but they limit evaluation of how the results were generated and how robust they are to analysis choices.

15. 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 3% reporting threshold.

Most frequent non-serious adverse event terms

The posted serious adverse event figures show zero affected participants in each group: 0 of 26 in the 0.003% group, 0 of 23 in the 0.02% group, and 0 of 22 in the vehicle group. The record lists no serious adverse event terms. It also reports zero deaths in each group.

These figures describe what was recorded among the participants at risk in the posted results. They do not show that serious events are impossible or establish how frequently they might occur beyond this study. General statistical explanation: when no events are observed in a study, the data can still be compatible with some underlying event risk; the degree of uncertainty depends in part on the number of participants observed.

The record separately lists participants affected by events other than serious adverse events: 8 in the 0.003% group, 6 in the 0.02% group, and 7 in the vehicle group. Those counts are not serious adverse event counts and should not be combined with the serious-event figures. Details of the non-serious event types are not reported in the registry record.

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

The posted results describe the mean non-vellus target area hair count at 16 weeks in three randomized groups. The observed means were 20.3 for TDM-105795 at 0.003%, 22.4 for TDM-105795 at 0.02%, and 14.0 for topical vehicle. The active-versus-vehicle mean differences were 6.3 and 8.4, with confidence intervals that include zero. These estimates and intervals convey both the observed direction and the uncertainty around the comparisons.

The results do not establish a precise difference between either active group and vehicle. They also do not provide a direct comparison between the two active doses. A higher point estimate in one group than another is not, by itself, evidence of a reliable dose difference. The record does not report an adjusted analysis, a dose-response analysis, or sponsor-reported analyses.

The primary outcome is one target-area count at a stated time point. It does not by itself describe changes from baseline, outcomes across the entire scalp, how participants felt about their hair, or the longer-term course of the measured outcome. Although additional outcomes are listed, numerical results for the questionnaire and investigator assessment are not reported in the registry record. The available record therefore supports only a limited description of the study's measured results.

The findings should not be read as a treatment recommendation or as proof of benefit or lack of benefit. A trial result is an estimate with uncertainty, and the interpretation depends on the design, analysis, measurement, and completeness of reporting. Here, the modest outcome group counts, broad primary confidence intervals, lack of reported analysis details, and unadjusted comparisons all matter. The posted data are most useful as estimates from this study that may inform further evaluation, rather than as a definitive answer to every question about the interventions.

17. Why This Trial Matters Statistically

This trial is statistically instructive because it presents two dose comparisons against a vehicle group, a continuous summary of a count outcome, and uncertainty intervals around mean differences. Looking at estimates and intervals together makes clear why the size and precision of a result matter alongside its p-value. Here, the active-group point estimates are above the vehicle mean, but each interval includes zero and extends across a range of possible differences.

The study also illustrates the distinction between a randomized design and a fully documented statistical analysis. Randomization and double blinding are important design features, yet the registry record does not report the original sample-size justification, detailed analysis plan, missing-data approach, or multiplicity procedure. Those details influence how confidently readers can interpret the posted comparisons.

Its secondary outcomes underscore another general lesson: multiple measures can capture different aspects of a clinical question, but unadjusted comparisons across outcomes do not automatically provide several independent confirmations. Numerical results are available for only some of the listed secondary measures, and the record lists no sponsor-reported analyses.

Finally, the planning illustrations help separate study planning from retrospective interpretation. They show how participant requirements change under stated assumptions and different assumed effects. They are not observed power and do not reveal the original design rationale. Together, these features make the record useful for understanding the role of precision, transparent analysis, and cautious interpretation in a small clinical study.

18. 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 group counts are limited, and the standard deviations indicate notable variation in the observed counts. The resulting confidence intervals are broad and include zero, leaving uncertainty about the direction and size of the mean differences. These limitations concern precision, not proof that the underlying differences are absent.

The registry record does not give baseline primary outcome values, so the posted week-16 means cannot be interpreted as changes from baseline. It also does not report the measurement procedure in enough detail to assess repeatability or how consistently the target area was assessed. Those measurement details matter for interpreting an outcome based on a specific scalp region.

Analysis reporting is incomplete. The original analysis plan, analysis populations, missing-data methods, multiplicity approach, and rationale for the sample size are not reported in the registry record. Outcome group counts differ between the primary endpoint and the posted secondary outcomes, but the reason for those differences is not explained. Numerical results for two listed secondary outcomes are also not reported.

The available primary comparisons are unadjusted, and no direct active-dose comparison is reported. No sponsor-reported analyses are listed. The record therefore does not permit assessment of whether adjusted or sensitivity analyses would materially change the results, or whether all analyses followed a prespecified plan.

Safety summaries report zero serious adverse events in each group, but the sample sizes are limited. That observation cannot establish the absence of risk. Details of non-serious events are not reported beyond the number of affected participants. These considerations restrict how broadly the findings can be interpreted from the registry record alone.

19. Related Tutorials

20. Related Statistical Calculators

21. Sources

• ClinicalTrials.gov: Study of TDM-105795 Following Topical Administration in Male Subjects With Androgenetic Alopecia — NCT05802173.
• Registry record last updated 2025-11-12; status last verified 2024-11.
• Results first posted 2025-11-12.
• 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.

22. Record Summary

NCT05802173 is a completed randomized, double-blind, vehicle-controlled, parallel-group phase 2 study of daily topical TDM-105795 in male subjects with androgenetic alopecia. The registry record reports enrollment of 71 and a primary completion date of 2023-11-08.

The primary outcome was non-vellus target area hair count at 16 weeks. The posted means were 20.3 for 0.003%, 22.4 for 0.02%, and 14.0 for vehicle. The unadjusted mean differences versus vehicle were 6.3 and 8.4; both confidence intervals include zero.

The record lists secondary measures of hair width, hair darkness, a questionnaire, and investigator assessment. Numerical summaries are available for hair width and darkness; the other secondary analyses are not reported in the registry record. The record also does not report the original sample-size justification, detailed statistical plan, missing-data approach, or multiplicity method. Serious adverse events and deaths were recorded as zero in all groups.