This page provides an independent statistical analysis and educational interpretation of publicly reported results. ClinicalTrials.gov provides the official trial registry record. Numerical trial results on this page are restricted to the results posted in the ClinicalTrials.gov record; calculations added by Clinical Biostats are labelled as such.
1. Trial at a Glance
This page covers the registry results for A Study Evaluating the Efficacy and Safety of SM04554 Topical Solution in Male Subjects With Androgenetic Alopecia (NCT03742518), a randomized phase 2, phase 3 study. The primary outcome is Absolute Non-vellus Hair Count in Target Area.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT03742518 |
| Phase | Phase 2, Phase 3 |
| Condition | Androgenetic Alopecia |
| Allocation | Randomized |
| Design model | Parallel |
| Masking | Triple |
| Enrollment | 675 |
| Arms in the primary outcome | n/a |
| Lead sponsor | Biosplice Therapeutics, Inc. |
| Results posted | Yes |
2. Clinical Question
Population
Male subjects with androgenetic alopecia were enrolled. The study took place in Turkey, and the registry record lists 675 participants enrolled. The primary-outcome description identifies the Full Analysis Set as subjects who were randomized and received study treatment; the further description of that population is incomplete in the registry record.
Intervention
The study compared daily topical SM04554 solution at concentrations of 0.15% and 0.25%. Each treatment was described as being used once daily for up to 48 weeks.
Comparator
The comparator was topical vehicle solution, described as being used once daily for up to 48 weeks. The trial was placebo-controlled; the registry lists the vehicle solution as the placebo arm.
Primary question
The primary endpoint was absolute non-vellus hair count in the target area at Week 48, measured by phototrichogram. The registry record does not report arm-specific Week 48 means, a comparison estimate, or a statistical test result that would answer how the groups differed on this endpoint.
In general, a randomized comparison is designed to assess whether outcome distributions differ between assigned groups while reducing the influence of systematic differences at the start of the study. Masking can also reduce the chance that knowledge of treatment assignment affects care, measurement, or assessment. These are general purposes of the design, not evidence about the size or direction of any treatment effect in this trial.
The available registry entries establish the treatment groups, outcome measure, and assessment time, but they are not enough to judge the primary outcome result. A reader would need the posted arm-level outcome summaries and the prespecified comparison, including its uncertainty, to interpret the result statistically.
3. Trial Design
This was a multicenter, randomized, triple-masked, parallel-group, placebo-controlled study. The registry lists the phases as Phase 2 and Phase 3 and reports enrollment of 675. The study status is completed. The listed start date is 2018-11-01, and the listed primary completion date is 2020-12-31. The registry describes the study as conducted in Turkey and focused on male subjects with androgenetic alopecia.
There were three treatment groups: topical SM04554 0.15%, topical SM04554 0.25%, and topical vehicle solution. Each was described as applied once daily for up to 48 weeks. The registry identifies the vehicle group as placebo. Random allocation assigns participants to treatment groups by chance; a parallel design means participants are assigned to a group rather than crossing between treatments. These are general descriptions of the design terms, not additional details about the conduct of this study.
The registry labels masking as triple but does not report in the registry record which specific roles were masked or how masking was maintained. The allocation ratio, randomization method, and any stratification factors are not reported in the registry record. The protocol’s detailed eligibility criteria and the procedures used to monitor adherence are also not reported in the registry record.
The primary endpoint was absolute non-vellus hair count in the target area at Week 48. The registry also lists secondary measures involving non-vellus, vellus, and total hair counts, as well as average non-vellus hair shaft thickness and density. It reports 11 outcome measures and 96 analyses, but the registry entries available for the primary endpoint do not provide a single primary comparison. Specific secondary-outcome results and their analysis methods are not reported in the registry record.
The registry identifies the Full Analysis Set as the population for the primary outcome and describes it as including randomized subjects who received study treatment. The analysis population definition is cut off after an incomplete phrase, so further handling of participants and observations cannot be established from 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
| Stage | Placebo | 0.15% SM04554 | 0.25% SM04554 |
|---|---|---|---|
| STARTED | 134 | 272 | 269 |
| COMPLETED | 86 | 174 | 199 |
| NOT COMPLETED | 48 | 98 | 70 |
Reasons for not completing this period:
| Reason | Placebo | 0.15% SM04554 | 0.25% SM04554 |
|---|---|---|---|
| Adverse Event | 3 | 4 | 1 |
| Death | 0 | 0 | 1 |
| Lost to Follow-up | 5 | 8 | 6 |
| Physician Decision | 0 | 1 | 1 |
| Protocol Violation | 8 | 17 | 12 |
| Withdrawal by Subject | 31 | 68 | 49 |
| Military Service Assignment | 1 | 0 | 0 |
Analysis population for the primary outcome, as defined in the registry: The Full Analysis Set (FAS) includes all subjects who are randomized and received study treatment. Full analysis set is used to describe the analysis set which is as complete as possible and as close as possible to the intent-to-treat ideal of including all randomized subjects. Subjects' observed data were analyzed as randomized for the FAS without imputation.
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.
| Characteristic | Unit | Placebo | 0.15% SM04554 | 0.25% SM04554 | Total |
|---|---|---|---|---|---|
| Participants analysed | 134 | 272 | 269 | 675 | |
| Age, Continuous | years | 34.0 (SD 6.8) | 33.1 (SD 6.8) | 33.9 (SD 6.7) | 33.6 (SD 6.8) |
| Sex: Female, Male: Female | Participants | 0 | 0 | 0 | 0 |
| Sex: Female, Male: Male | Participants | 134 | 272 | 269 | 675 |
| Ethnicity (NIH/OMB): Hispanic or Latino | Participants | 1 | 0 | 0 | 1 |
| Ethnicity (NIH/OMB): Not Hispanic or Latino | Participants | 133 | 272 | 269 | 674 |
| Ethnicity (NIH/OMB): Unknown or Not Reported | Participants | 0 | 0 | 0 | 0 |
| Race (NIH/OMB): American Indian or Alaska Native | Participants | 0 | 0 | 0 | 0 |
| Race (NIH/OMB): Asian | Participants | 0 | 0 | 0 | 0 |
| Race (NIH/OMB): Native Hawaiian or Other Pacific Islander | Participants | 0 | 0 | 0 | 0 |
| Race (NIH/OMB): Black or African American | Participants | 0 | 0 | 0 | 0 |
| Race (NIH/OMB): White | Participants | 134 | 272 | 269 | 675 |
| Race (NIH/OMB): More than one race | Participants | 0 | 0 | 0 | 0 |
| Race (NIH/OMB): Unknown or Not Reported | Participants | 0 | 0 | 0 | 0 |
| Region of Enrollment: Turkey | participants | 134 | 272 | 269 | 675 |
| Weight [kg] | kg | 81.3 (SD 11.32) | 81.64 (SD 11.62) | 82.18 (SD 13.03) | 81.79 (SD 12.13) |
| Height [cm] | cm | 175.0 (SD 6.1) | 176.0 (SD 6.8) | 175.5 (SD 6.7) | 175.6 (SD 6.6) |
| Body Mass Index [kg/m²] | kg/m² | 26.54 (SD 3.49) | 26.32 (SD 3.23) | 26.65 (SD 3.64) | 26.49 (SD 3.45) |
| Norwood-Hamilton Classification Score: 3V | Participants | 75 | 160 | 163 | 398 |
| Norwood-Hamilton Classification Score: 4 | Participants | 59 | 112 | 106 | 277 |
6. Primary Endpoint
The registry lists the primary outcome as Absolute Non-vellus Hair Count in Target Area, measured over Week 48.
| Element | Registry entry |
|---|---|
| Result type | Mean |
| Measure of spread | Standard Deviation |
| Unit | Non-vellus hairs |
| Endpoint classification | Continuous Endpoint |
The primary endpoint was absolute non-vellus hair count in the target area at Week 48, with the unit stated as non-vellus hairs. A non-vellus hair count is a continuous measure expressed as a count. The registry specifies that the outcome parameter was a mean and that dispersion was described using a standard deviation. These summaries describe the distribution of measured counts; the mean represents the average, while the standard deviation describes variability among observations around that average.
Hair counts were determined using phototrichogram images. The registry says standardized images of the treatment area were taken before treatment and at visits at Weeks 12, 24, 36, and 48. Before imaging, a rectangular area measuring 20 x 15 mm was clipped to between 0.6 and 0.9 mm in length. Virtual tattoo technology was used to anchor the phototrichogram, and images were uploaded to a blinded vendor for assessment.
In general, a count within a defined target area offers a quantitative way to assess hair growth over time. Measuring a specified area with a standardized imaging procedure can support consistent comparisons, although consistency also depends on image quality and the assessment process. The registry does not report details about measurement reliability or the degree of variability between assessors.
The registry record does not report a single Week 48 comparison of group means, its confidence interval, or its p-value. As a result, the endpoint definition and measurement approach can be described, but the magnitude and precision of any between-group difference cannot be interpreted from the primary-outcome details reported in the registry record.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry record identifies the primary outcome and its assessment time but does not provide a single comparison suitable for interpreting the primary result. In particular, arm-specific Week 48 means and standard deviations, the between-group estimate, a confidence interval, and a p-value are not reported in the registry record. The skip note states that the primary outcome has several categories or time points and was not reduced to one comparison. No direction or size of the primary treatment effect can therefore be established from the registry entries available for this endpoint.
The listed endpoint is a mean of a continuous measure: absolute non-vellus hair count in the target area. In general, a between-group mean difference describes how far apart the group averages are on the outcome’s measurement scale. A confidence interval describes the range of values for the underlying effect that are compatible with the data and the statistical model. Its width helps convey precision. Neither the difference nor its uncertainty is available for the primary Week 48 comparison in the registry record.
The study randomized participants to two SM04554 concentrations or vehicle, and the listed total enrollment was 675. These design details do not substitute for outcome results. Enrollment alone does not show whether the measured counts differed, how variable they were, or whether any estimated difference was precise. Likewise, the trial’s completed status does not establish an outcome direction.
The registry lists 11 outcome measures and 96 analyses. That indicates multiple outcome and analysis entries, but the registry entries do not identify the full family of confirmatory comparisons, the priority assigned to each, or a multiplicity adjustment. Without those details, an isolated statistical test, if reported elsewhere, could not be evaluated in context. The primary comparison itself is not available as a single result in the registry record.
The adverse-event entries are separate from the efficacy endpoint. The record lists serious and other adverse-event counts by group, as well as deaths, but those counts do not supply evidence about the hair-count outcome. They describe reported safety events in the stated groups and should be read with their group-specific numbers at risk and the limitations of the registry summaries in mind.
In general, statistical interpretation distinguishes the estimated effect, its precision, and the evidence against a statistical null hypothesis. A p-value alone would not express the size or practical importance of an effect, and a confidence interval would be needed to assess uncertainty in the estimate. Here, the primary result elements needed for that interpretation are not reported in the registry record. No recalculated comparison is available, and no conclusion about the primary endpoint should be inferred from the design or enrollment information alone.
9. Statistical Methods Explained
The outcome type and reported summary are important for understanding which statistical methods might be appropriate. The primary outcome is a continuous count, summarized as a mean with a standard deviation. In general, a mean describes the central average of observed values, while a standard deviation describes spread around that average. For a group comparison, an estimate of the difference in means would express the contrast in non-vellus hair counts on the endpoint’s original scale.
What would a confidence interval convey?
In general, a confidence interval expresses statistical uncertainty around an estimated effect. A narrower interval indicates greater precision under the assumptions of the method; a wider interval indicates more uncertainty. The interval is not a range containing every participant’s outcome, and it does not by itself establish whether an effect is important. The registry record does not report a confidence interval for a single primary Week 48 comparison, so its precision cannot be assessed.
What does a p-value address?
In general, a p-value describes how compatible the observed data are with a specified null hypothesis under a statistical model. It is not the probability that the null hypothesis is true, nor a measure of the size of an effect. A p-value is most interpretable alongside the estimate, its uncertainty, the analysis plan, and the number of related comparisons. The primary-outcome p-value and the planned test are not reported in the registry record.
Why can count outcomes need careful modeling?
In general, count data are nonnegative integers, and their variability may not follow the assumptions of a simple normal model. If the spread exceeds what a chosen count model expects, over-dispersion can make standard errors too small and confidence intervals too narrow when it is ignored. Other features, such as many zero counts or differences in observation time, can also affect model choice. These are general considerations. The registry does not report the model used for the primary endpoint, checks of model assumptions, or whether over-dispersion was assessed.
The registry states that the outcome parameter was the mean and dispersion was the standard deviation, but those summary labels do not identify the inferential model. The analysis might use a model-based contrast or another approach, but the specific method is not reported in the registry record and should not be inferred. The available description also does not establish whether the Week 48 value, change from baseline, or repeated measurements were used in the primary comparison; the endpoint is labeled as an absolute count at Week 48.
How should the planning illustration be understood?
The record describes sample-size assumptions as a planning illustration based on the observed effect, not the trial’s own design. It specifies a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation, with the effect to detect expressed as a stated fraction of the observed effect. For time-to-event tables, the record says the total number of events is used; for other outcomes, it says participants per arm are used. Those assumptions describe an illustrative calculation, not the actual design rationale or an observed-power analysis. The numerical planning results are not reported in the registry entries, and the trial’s own sample-size justification is not reported in the registry record.
In general, a planning calculation estimates the sample size needed under chosen assumptions about the effect, variability, significance level, and desired power. Changing the assumed effect changes the planning result. Such calculations are scenarios, not evidence that a completed trial had a particular probability of detecting its observed result. No sample-size justification or power target for this study is reported in the registry record.
What cannot be inferred from the analysis count?
The registry lists 96 analyses and 11 outcome measures. In general, multiple comparisons increase the chance of at least one apparently unusual result if many tests are interpreted without accounting for multiplicity. Methods such as hierarchical testing or adjusted significance thresholds can address some multiplicity concerns, but the use of any such approach in this trial is not reported in the registry record. The counts of analyses and outcomes alone do not reveal which results were primary, exploratory, or adjusted.
The record’s Full Analysis Set description includes randomized participants who received study treatment and says that this set is intended to be as complete as possible and as close as possible to the intent-to-treat ideal. The remaining population description is incomplete. In general, analysis-population definitions matter because exclusions after randomization can affect how closely a comparison preserves the benefits of random assignment. The handling of participants who discontinued, missed visits, or lacked an endpoint measurement is not reported in the registry record.
These methods explanations are general. They clarify what the stated outcome type and planning assumptions mean, but they do not establish which inferential procedures were actually used. The statistical analysis plan, the detailed missing-data approach, and the assumptions underlying the primary comparison are not reported in the registry record.
10. Multiplicity, Missing Data and Analysis Populations
The registry lists 11 outcome measures and 96 analyses, so the record contains multiple outcome and analysis entries. In general, when many comparisons are made, the chance of at least one result appearing statistically unusual can increase if the comparisons are treated as independent confirmatory tests without adjustment. A prespecified hierarchy, adjusted testing procedure, or clear distinction between confirmatory and exploratory analyses can help readers interpret multiple results. The registry record does not report whether any such strategy was used, which comparisons were designated primary, or how multiplicity was handled.
The primary endpoint is named as absolute non-vellus hair count in the target area at Week 48, but the record notes that the primary outcome has several categories or time points and was not reduced to one comparison. A single primary estimate and inferential result are therefore not reported in the registry record. The protocol’s complete statistical analysis plan and any interim analyses are not reported in the registry record.
The Full Analysis Set is described as including subjects who were randomized and received study treatment, and as being as complete as possible and as close as possible to the intent-to-treat ideal. The description is truncated, so further rules for inclusion cannot be determined. The registry record does not report how missing Week 48 measurements were handled, whether participants with partial follow-up contributed to other analyses, or whether sensitivity analyses were conducted.
In general, missing data can affect interpretation when the likelihood of missingness is related to treatment or outcome. Different methods make different assumptions about the unobserved values, so the approach and sensitivity of results to those assumptions are relevant. No particular missing-data mechanism or method can be attributed to this trial from the registry record. The number of participants with observed Week 48 data by group and reasons for missing observations are not reported in the registry record.
11. Safety Results
The registry reports serious adverse events as affected participants divided by participants at risk.
| Arm | Participants with serious adverse events | Participants at risk | Percentage |
|---|---|---|---|
| Placebo | 2 | 134 | 1.5% |
| 0.15% SM04554 | 1 | 272 | 0.4% |
| 0.25% SM04554 | 3 | 269 | 1.1% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| Placebo | 0 of 134 |
| 0.15% SM04554 | 0 of 272 |
| 0.25% SM04554 | 2 of 269 |
Other (non-serious) adverse events
Participants with at least one non-serious event at or above the registry's 0% reporting threshold.
| Arm | Participants affected of at risk |
|---|---|
| Placebo | 16 of 134 |
| 0.15% SM04554 | 36 of 272 |
| 0.25% SM04554 | 19 of 269 |
Most frequent serious adverse event terms
| Event term | Organ system | Placebo | 0.15% SM04554 | 0.25% SM04554 |
|---|---|---|---|---|
| COVID-19 | Infections and infestations | 0 of 134 | 1 of 272 | 1 of 269 |
| Acute myeloid leukaemia | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 0 of 134 | 0 of 272 | 1 of 269 |
| COVID-19 pneumonia | Infections and infestations | 0 of 134 | 0 of 272 | 1 of 269 |
| Papillary thyroid cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 1 of 134 | 0 of 272 | 0 of 269 |
| Vocal cord neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 1 of 134 | 0 of 272 | 0 of 269 |
Most frequent non-serious adverse event terms
| Event term | Organ system | Placebo | 0.15% SM04554 | 0.25% SM04554 |
|---|---|---|---|---|
| Application site pruritus | General disorders and administration site conditions | 1 of 134 | 10 of 272 | 6 of 269 |
| COVID-19 | Infections and infestations | 0 of 134 | 3 of 272 | 5 of 269 |
| Headache | Nervous system disorders | 2 of 134 | 6 of 272 | 0 of 269 |
| Nasopharyngitis | Infections and infestations | 3 of 134 | 1 of 272 | 1 of 269 |
| Application site pain | General disorders and administration site conditions | 0 of 134 | 4 of 272 | 0 of 269 |
| Upper respiratory tract infection | Infections and infestations | 1 of 134 | 2 of 272 | 0 of 269 |
| Alanine aminotransferase increased | Investigations | 1 of 134 | 2 of 272 | 0 of 269 |
| Aspartate aminotransferase increased | Investigations | 0 of 134 | 3 of 272 | 0 of 269 |
| Pruritus | Skin and subcutaneous tissue disorders | 0 of 134 | 3 of 272 | 0 of 269 |
| Lip dry | Gastrointestinal disorders | 0 of 134 | 0 of 272 | 2 of 269 |
Serious events with the highest arm-level rate: papillary thyroid cancer (0.7%), vocal cord neoplasm (0.7%), covid-19 (0.4%), acute myeloid leukaemia (0.4%), covid-19 pneumonia (0.4%).
The registry reports serious adverse events and other adverse events by group, with a number at risk and a number affected for each category. For serious adverse events, the listed figures are 2 affected among 134 at risk for Placebo, 1 among 272 at risk for 0.15% SM04554, and 3 among 269 at risk for 0.25% SM04554. For other adverse events, the figures are 16 among 134 at risk for Placebo, 36 among 272 at risk for 0.15% SM04554, and 19 among 269 at risk for 0.25% SM04554. The registry lists deaths as 0, 0, and 2, respectively.
These are descriptive counts, not adjusted comparisons. In general, counts should be read with their denominators and with attention to how long participants were observed. The registry describes treatment for up to 48 weeks, but the safety figures alone do not establish individual exposure duration, event timing, causality, or whether participants experienced more than one event. Those details are not reported in the registry record.
The registry lists serious-event terms and percentages including Papillary thyroid cancer at 0.7%, Vocal cord neoplasm at 0.7%, COVID-19 at 0.4%, Acute myeloid leukaemia at 0.4%, and COVID-19 pneumonia at 0.4%. The listed terms are not assigned to particular treatment groups in the available record. They should not be interpreted as comparative risks by arm without group-specific event details.
12. What the Result Does, and Does Not, Mean
The registry record establishes that NCT03742518 was a completed, randomized, triple-masked, parallel, placebo-controlled study of two topical SM04554 concentrations and topical vehicle in male subjects with androgenetic alopecia. It identifies a Week 48 primary endpoint based on absolute non-vellus hair count in a defined target area and describes a phototrichogram measurement procedure. It also lists serious and other adverse-event counts by treatment group.
Those details do not establish the size or direction of a treatment effect. Arm-specific Week 48 means and standard deviations, a primary between-group estimate, its confidence interval, and a p-value are not reported as a single comparison in the registry record. Without those results, it is not possible to assess the magnitude, precision, or statistical evidence for a difference in the primary endpoint from the available details. Enrollment and completion status do not fill that gap.
In general, a treatment comparison and a claim about clinical importance are distinct. A statistical estimate describes the observed contrast under an analysis method; its uncertainty indicates how imprecisely that contrast is known. Clinical importance requires additional context about what outcome changes matter, which is not reported in the registry record. No medical conclusion follows from the design description alone.
The safety counts provide a descriptive account of events as listed, but they do not identify whether events were caused by treatment or establish a comparative safety profile. The group counts, follow-up details, event timing, and attribution methods would be needed to interpret safety contrasts more fully. The registry also lists deaths in the groups, but the available entries do not provide their causes or circumstances.
The record lists many outcomes and analyses, while the multiplicity strategy, missing-data methods, full analysis populations, and detailed statistical plan are not reported in the registry record. Consequently, the posted details support a description of the trial and its recorded measures, but not a complete assessment of the primary efficacy result or all potential sources of uncertainty.
13. Why This Trial Matters Statistically
This study is statistically notable because it compares two concentrations of a topical intervention with a vehicle control in a randomized, masked, parallel design. Such a design can support direct group comparisons when allocation is maintained and outcomes are measured consistently. Here, the primary measure was an objectively defined hair count in a target area assessed with standardized phototrichogram imaging. The registry also describes a procedure for anchoring images and using a blinded vendor for assessment.
The endpoint is a continuous count, and the record identifies means and standard deviations as its summary measures. That makes the distinction between the group averages and the spread of individual measurements important. A mean contrast without an uncertainty interval would be incomplete; a test result without the size of the contrast would also leave important information out. The primary result is not reported as a single comparison in the registry record, so these statistical elements cannot be evaluated.
The record also lists 11 outcome measures and 96 analyses. This makes prespecification and multiplicity handling especially relevant statistical questions. Without information on which analyses were confirmatory, how the outcomes were prioritized, and whether testing was adjusted, readers cannot determine how the analysis count was reflected in interpretation. These details are not reported in the registry record.
Finally, a nearly complete analysis population and a clear approach to missing observations are important in randomized studies. The Full Analysis Set description is incomplete, and the missing-data approach is not reported in the registry record. These gaps limit assessment of how closely the analyzed groups may reflect the randomized comparison. The trial’s design and measurement details are informative, but a transparent analysis plan and complete results are needed for a fuller statistical interpretation.
14. 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 provide a single primary Week 48 comparison for absolute non-vellus hair count. Arm-specific means and standard deviations, the between-group estimate, its confidence interval, and the p-value are not reported in the registry record. The available skip note says that the primary outcome has several categories or time points and was not reduced to one comparison. This prevents interpretation of the primary endpoint’s direction, magnitude, and precision.
The Full Analysis Set description is incomplete. Although it states that the set includes randomized participants who received study treatment and is intended to be close to the intent-to-treat ideal, the remaining definition is cut off. The handling of participants who discontinued treatment, missed assessments, or had incomplete follow-up is not reported in the registry record. Nor are the numbers with observed Week 48 outcomes by group or sensitivity analyses for missing data.
The registry lists 11 outcome measures and 96 analyses, but does not report which comparisons were confirmatory or how multiplicity was addressed. The statistical model for the primary outcome, model assumptions, and any diagnostic checks are not reported in the registry record. The allocation ratio and randomization details are also not reported in the registry record.
The adverse-event summaries are counts by group, but the record does not provide enough detail to assess event timing, duration of exposure, causality, or recurrence. The listed serious-event terms and percentages are not assigned to treatment groups in the available record. The reasons for the reported deaths are not reported in the registry record.
The registry describes a planning illustration based on the observed effect and specified assumptions, but the trial’s own sample-size justification is not reported in the registry record. These limitations concern the information available in the registry record; they do not establish that corresponding details were absent from the study’s other documents.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: A Study Evaluating the Efficacy and Safety of SM04554 Topical Solution in Male Subjects With Androgenetic Alopecia — NCT03742518.
- Registry record last updated 2026-10-01; status last verified 2026-09.
- Results first posted 2026-10-01.
- 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.
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18. Record Summary
NCT03742518 is listed as a completed Phase 2 and Phase 3 randomized, triple-masked, parallel, placebo-controlled study of topical SM04554 in male subjects with androgenetic alopecia. The registry reports enrollment of 675 and describes daily treatment with SM04554 0.15%, SM04554 0.25%, or topical vehicle solution for up to 48 weeks. The study was conducted in Turkey.
The primary endpoint was absolute non-vellus hair count in the target area at Week 48, assessed by phototrichogram. The registry lists 11 outcome measures and 96 analyses. It does not report a single primary-outcome comparison with arm means, an effect estimate, a confidence interval, or a p-value. Serious and other adverse-event counts are listed by group, along with deaths and several serious-event terms.
The full analysis-population definition, missing-data approach, multiplicity strategy, and detailed statistical analysis plan are not reported in the registry record.