A Study to Evaluate the Reduction in Sebum (Skin Oil) Induced by Clascoterone Cream 1% in Acne Patients: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for A Study to Evaluate the Reduction in Sebum (Skin Oil) Induced by Clascoterone Cream 1% in Acne Patients (NCT06415279), a na phase 4 study. The primary outcome is The Primary Efficacy Endpoint is the Change in Causal Sebum Measurements From the Forehead Obtained With a Sebumeter During the Study..

2. Clinical Question

3. Trial Design

This is a Phase 4, completed, single-group study sponsored by Sun Pharmaceutical Industries Limited. The registry lists acne vulgaris as the condition and Winlevi (clascoterone) 1% cream as the intervention. Enrollment is recorded as 40. The study began on 2024-02-14, and the primary completion date is 2025-02-12.

The design has no listed control group: allocation is not applicable, the model is single group, and masking is listed as none. The primary endpoint is a change from baseline in forehead sebum measurements, rather than a randomized comparison between treatment groups. A within-group change can describe how measurements differ over time among those measured, but it cannot by itself separate the intervention's contribution from other explanations for change.

The primary outcome is described as the mean change from baseline in casual sebum level, measured using a Sebumeter. Its registered timeframe is Weeks 16. The registry also lists a secondary efficacy endpoint concerning changes in the facial microbiome induced by application at 12 and 52 weeks. The record identifies 2 outcome measures and 3 analyses, but does not report the detailed analysis methods or the numerical results for these outcomes.

The registry status is completed. Completion status does not itself indicate what the outcome values were or whether every enrolled participant contributed data to each analysis. The number included in each analysis and the handling of missing measurements are not reported in the registry record.

4. Participant Flow and Accounting

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

Overall Study

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 The Primary Efficacy Endpoint is the Change in Causal Sebum Measurements From the Forehead Obtained With a Sebumeter During the Study., measured over Weeks 16.

The primary endpoint is the mean change from baseline in casual sebum measurements taken from the forehead. The unit is µg/cm², and the registered timeframe is Weeks 16. A Sebumeter measures the amount of sebum on the skin through grease-spot photometry: a cassette probe brings a mat tape into contact with the forehead, and the device measures the tape's transparency using light transmission. The registry description states that greater sebum absorption makes the tape more transparent and that the measured light transmission corresponds to the amount of sebum on the skin surface.

This measurement is used to quantify a feature of skin oil production rather than to directly measure acne severity. The registry summary explains the study's rationale as testing whether clascoterone cream 1% is associated with sebum reduction. The measurement description gives a range of 0 to 350 µg/cm² and an estimated measurement uncertainty of ±5%. These details describe the instrument and measurement method; they do not tell us what values the participants had or how much their measurements changed.

The reported endpoint would ordinarily be interpreted by considering the mean change alongside its variability and uncertainty. The registry record does not report the numerical mean change, standard deviation, or confidence interval. It therefore does not allow readers to judge the direction, magnitude, or precision of the primary outcome from the record alone.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

What does a mean change describe?

The primary endpoint is a mean change from baseline. In general, a mean change summarizes the average difference between each participant's baseline measurement and a later measurement among the participants included in the analysis. It can provide a concise description of the group pattern, but it does not show how similar or different the individual changes were. The registry record identifies the endpoint as a mean and standard deviation, but does not report the values for either statistic.

A mean change also depends on which observations are included and how the analysis handles participants without a measurement at one of the relevant times. If the set of participants with follow-up measurements differs from the enrolled group, the analyzed mean may not represent everyone enrolled. The registry record does not state the analysis population, the number with paired measurements, or the method used for missing data.

What would a standard deviation tell us?

General statistical explanation: a standard deviation describes the spread of measurements around their mean. For a change endpoint, it helps show whether individual participants' changes tend to cluster near the average or vary more widely. It is not the same as the standard error or a confidence interval, and it does not measure the accuracy of the Sebumeter itself. Although the registry specifies standard deviation as the dispersion measure, no standard deviation is reported for the primary outcome.

What does a confidence interval add?

General statistical explanation: a confidence interval expresses uncertainty around an estimated quantity under the assumptions of the analysis. A narrower interval indicates greater precision under those assumptions; a wider interval indicates less precision. The interval is not a range containing every participant's response. No confidence interval for the primary outcome is reported in the registry record. As a result, the precision of the mean change cannot be evaluated.

Why does the single-group structure matter?

In a randomized comparison, a control group can help distinguish changes associated with treatment assignment from changes that occur over time for other reasons. This study has no listed comparator group and no random allocation. General statistical explanation: a before-and-after comparison in one group is more vulnerable to time trends, changes in other care or behavior, and measurement variation than a concurrent controlled comparison. The registry record does not report whether other treatments or exposures were monitored, so their role cannot be assessed.

The lack of masking is another design feature to keep in mind. The registry lists masking as none. General statistical explanation: awareness of treatment or study participation can sometimes affect behavior, measurement procedures, or reporting, depending on the outcome and study conduct. The record does not describe steps used to standardize measurement or reduce such influences.

How should the instrument uncertainty be read?

The description states that the measurement uses grease-spot photometry and has estimated uncertainty of ±5%. This is a property of the measurement method as described in the registry, not a confidence interval for the study's mean change. General statistical explanation: instrument uncertainty and sampling uncertainty answer different questions. Instrument uncertainty concerns the measurement itself; sampling uncertainty concerns how precisely a group statistic estimates a broader quantity. The registry does not report a study-level interval or enough numerical outcome information to assess either the observed change or its statistical precision.

What do the planning assumptions mean?

The planning illustration assumptions specify a two-sided significance level of 0.05, equal allocation between two arms, a normal approximation, and an effect defined as a stated fraction of the observed effect. These are planning assumptions, not reported features of the enrolled study, which is single group. General statistical explanation: sample-size calculations estimate the number of participants needed under specified assumptions about the comparison, variability, and effect to be detected. They do not describe the result actually observed in a completed trial and are not observed power.

The registry record does not state the sample-size justification used to design this study, and the primary outcome result needed to define an observed effect is not reported. The planning assumptions therefore cannot establish what the study was designed to detect or whether the study had adequate precision. Any planning illustration should be treated as hypothetical rather than as evidence about the outcome.

What can be concluded from the analysis information?

The registry lists 3 analyses, but the record does not report their statistical procedures, model specifications, covariates, testing strategy, or analysis populations. It also does not report interim analyses. General statistical explanation: the choice of analysis can affect how an estimate and its uncertainty are calculated, especially when observations are incomplete, measurements are repeated, or multiple endpoints are evaluated. Without the methods and results, readers cannot reproduce or critically evaluate the statistical findings.

The same caution applies to the secondary microbiome endpoint. The record describes the endpoint and the 12- and 52-week timepoints, but does not report the analysis approach or numerical results. The primary and secondary outcome descriptions alone do not establish that any hypothesized change occurred.

10. Confidence Intervals for Each Arm

No two-arm comparison is shown for this trial, but each arm's mean can be given with a t-based 95% confidence interval computed from the posted mean, spread and number of participants.

R code and output

arm <- c("Winlevi (Clascoterone) 1% Cream")
n   <- c(39)
m   <- c(-27.33)
sp  <- c(50.79)
sd  <- sp      # posted standard deviations
for (i in seq_along(n)) {
  se <- sd[i] / sqrt(n[i]); h <- qt(0.975, n[i] - 1) * se
  cat(sprintf("CARM|%s|%d|%.3f|%.3f|%.3f|%.3f\n", arm[i], n[i], m[i], sd[i], m[i] - h, m[i] + h))
}

CARM  Winlevi (Clascoterone) 1% Cream  39  -27.330  50.790  -43.794  -10.866

11. Multiplicity, Missing Data and Analysis Populations

The registry lists 2 outcome measures and 3 analyses. It does not report which analyses correspond to which outcomes, whether all were prespecified, or whether any adjustment was used to account for multiple statistical tests. When several outcomes, timepoints, or analyses are examined, the chance of at least one apparently notable result can rise if each is interpreted without considering the full set. That is a general statistical issue; the registry record does not provide enough detail to determine how it applies to these analyses.

The primary endpoint is identified as mean change in forehead sebum measurement, and the secondary efficacy endpoint concerns facial microbiome changes at 12 and 52 weeks. Numerical results and inferential statistics for these endpoints are not reported in the registry record. A statistical plan, including any hierarchy of outcomes or multiplicity procedure, is also not reported in the registry record.

Missing-data handling is not reported. The record does not state how many participants contributed measurements at baseline or follow-up, whether analyses used all available observations, or how missing measurements were treated. General statistical explanation: missing data can affect an estimate if the participants with observed outcomes differ systematically from those without them. Without counts, reasons for missingness, and the analysis method, the direction or extent of any effect cannot be assessed.

The enrolled number is not necessarily the number analyzed for each endpoint. The registry record does not report an analysis population or endpoint-specific participant counts. It also does not report a sample-size justification or interim-analysis plan. These omissions limit assessment of the planned and reported statistical procedures.

12. 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 registry lists one group for Winlevi (Clascoterone) 1% Cream. Serious adverse events are recorded for 0 of 40 participants at risk, and deaths are recorded as 0. The registry lists no serious adverse event terms. These are the serious-event figures recorded for this group; they do not describe the primary sebum endpoint.

The other adverse-event category is recorded for 1 of 40 participants at risk. The record does not provide an event term or further detail in the information. These figures should be read as counts recorded in the registry, not as a comparison with an untreated or alternative-treatment group. With no comparator group listed, the figures do not estimate how event counts differ between treatment options.

General statistical explanation: safety counts describe events observed and recorded under the study's reporting definitions and follow-up. A count of zero does not establish that an event is impossible or that no event could occur in a larger or different population. The registry record does not report additional detail about ascertainment, event severity outside the serious category, or the relationship of the other adverse event to treatment.

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

The registry describes a study intended to evaluate change in forehead sebum measurements during use of clascoterone cream 1% in people with acne vulgaris. It identifies the measurement method, a primary endpoint based on mean change from baseline, and a timeframe of Weeks 16. It also describes a secondary facial microbiome endpoint at 12 and 52 weeks. These details establish the questions the study was designed to address, not the answers observed.

The registry record does not report the primary outcome values. It therefore does not show whether mean sebum measurement increased or decreased, how large any change was, or how variable the measurements were. The record also does not report a confidence interval or other inferential result that would describe the precision of an estimate. Numerical results for the secondary microbiome endpoint are likewise not reported.

Even if a within-group change were reported, this single-group design would describe change over time rather than provide a controlled estimate of what would have happened without the intervention. General statistical explanation: a comparison group helps address alternative explanations for changes over time. Because no comparator is listed and masking is none, the design does not support a like-for-like causal comparison. The registry record also does not report information about other treatments or exposures that might help interpret change.

The safety figures record serious adverse events for 0 of 40 participants at risk, deaths of 0, and other adverse events for 1 of 40 participants at risk. These counts are descriptive and are not comparative estimates. They should not be taken as proof that events cannot occur beyond the study observations.

In short, the record supports a description of the study's design, intended measurements, and recorded safety counts. It does not provide the outcome data required to quantify a sebum change, assess its precision, or draw a treatment-effect conclusion. It also does not report enough analysis detail to evaluate missing-data methods or multiplicity handling.

14. Why This Trial Matters Statistically

This study is statistically notable for measuring a biological feature linked in the registry summary to the study's rationale for investigating acne: forehead sebum. Its primary endpoint is a quantitative change from baseline rather than a direct clinical comparison between treatment groups. That focus can be useful for describing a measured biological outcome, but interpretation depends on both the measurement and the design.

The Sebumeter description makes clear that the outcome is an instrument-based measure, reported in µg/cm², using transparency changes in a tape that contacts the forehead. The registry gives the measurement method and its estimated uncertainty of ±5%. This makes it important to distinguish uncertainty in an individual measurement from uncertainty in a group mean change. The record does not report the outcome estimates needed to examine either the observed pattern or its precision in this study.

The single-group structure also matters. It can describe a before-and-after pattern, but does not supply a concurrent control for separating treatment-associated change from other changes over time. Masking is listed as none. These features make transparent reporting of the outcome values, analysis population, missing measurements, and analysis methods particularly important for interpretation.

The registry record identifies 3 analyses and 2 outcome measures, but does not provide the statistical methods or numerical outcome results. Without those details, readers cannot assess whether estimates are robust to analysis choices, how multiple outcomes were handled, or how complete the follow-up data were. The study is a useful example of why endpoint descriptions and a completed status are not substitutes for reported results.

15. Limitations

• The posted summary statistics are the only data these results rest on; patient-level data, full protocols and statistical analysis plans are not available.
• Recalculated results are simple, unadjusted calculations from posted summaries. They do not replace the sponsor's prespecified analysis.

The registry record does not report the numerical primary outcome, including baseline and follow-up summaries, mean change, standard deviation, or confidence interval. This prevents assessment of the direction, size, and precision of the outcome. Numerical results for the secondary microbiome endpoint are also not reported.

The study has a single-group design, with allocation recorded as not applicable and no masking. No comparator group is listed. Consequently, the design does not provide a concurrent control comparison. The registry record does not report whether other acne treatments, changes in skin care, or other relevant exposures were monitored, so their potential contribution to any change cannot be assessed.

The registry lists enrollment of 40, but does not report how many participants contributed to each endpoint or analysis. The analysis population, completeness of follow-up, reasons for missing measurements, and missing-data methods are not reported. These omissions make it difficult to understand who the results would represent even if outcome values were available.

The record describes the Sebumeter method and its estimated uncertainty of ±5%, but does not report study-level reliability information or results that would show how the measurement behaved in this sample. The analysis methods, model details, statistical testing strategy, multiplicity handling, and any interim analyses are also not reported in the registry record.

Finally, the listed planning assumptions concern a two-arm illustration, while the registered study is single group. The record does not report its own sample-size justification. Planning assumptions cannot substitute for an outcome estimate, and the absence of reported results prevents evaluation of the study's precision or the statistical evidence for change.

16. Related Tutorials

17. Related Statistical Calculators

18. Sources

• ClinicalTrials.gov: A Study to Evaluate the Reduction in Sebum (Skin Oil) Induced by Clascoterone Cream 1% in Acne Patients — NCT06415279.
• Registry record last updated 2026-06-15; status last verified 2026-05.
• Results first posted 2026-06-15.
• 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.

19. Record Summary

NCT06415279 is a completed Phase 4, single-group study sponsored by Sun Pharmaceutical Industries Limited. It enrolled 40 participants with acne vulgaris and evaluated Winlevi (clascoterone) 1% cream. The study began on 2024-02-14, with primary completion on 2025-02-12. Allocation is recorded as not applicable, and masking as none.

The primary efficacy endpoint is mean change from baseline in forehead casual sebum measurement using a Sebumeter, with the registered timeframe listed as Weeks 16. The secondary efficacy endpoint concerns facial microbiome changes at 12 and 52 weeks. The registry identifies 2 outcome measures and 3 analyses.

The primary and secondary numerical results, analysis methods, analysis populations, and missing-data handling are not reported in the registry record. Serious adverse events are recorded for 0 of 40 participants at risk, deaths are 0, and other adverse events are recorded for 1 of 40 participants at risk. The single-group design does not provide a like-for-like control comparison.