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 Comparing Two Topicals in the Treatment of Acne Vulgaris (NCT03743038), a randomized phase 1 study. The primary outcome is Number of Participants With 0 to 4 Investigator's Global Assessment Score at Week 6.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT03743038 |
| Phase | Phase 1 |
| Condition | Acne Vulgaris |
| Allocation | Randomized |
| Design model | Parallel |
| Masking | Double |
| Enrollment | 12 |
| Arms in the primary outcome | n/a |
| Lead sponsor | Vyne Therapeutics Inc. |
| Results posted | Yes |
2. Clinical Question
Population
The study enrolled participants with acne vulgaris. The registry record reports an enrollment of 12. The outcome description defines the mITT population as randomized participants who met all inclusion and exclusion criteria, applied at least one dose of test article, and returned for at least one post-Baseline evaluation visit. The number analyzed in that population is not reported in the registry record. Further participant characteristics, including age and baseline acne severity, are not reported in the registry record.
Intervention
Test Article A was an FMX101 hydrophobic oil based vehicle, applied topically daily for six weeks to one side of the face. The registry lists FMX101 vehicle as an intervention. The description identifies the product as a vehicle; it does not establish an effect of an active treatment ingredient.
Comparator
Test Article B was a hydro-alcohol solution based vehicle, applied topically daily for six weeks to the contralateral side of the face. This is a within-participant, split-face comparison as described in the intervention text. The registry also classifies the study model as parallel; how that classification relates to the split-face description is not explained in the registry record.
Primary question
The stated primary endpoint concerns the number of participants with an Investigator’s Global Assessment score from 0 to 4 at Week 6. The scale ranges from 0, Clear, to 4, Severe. The registry record does not report the values for either vehicle or an inferential comparison between them. Its outcome listing indicates that several categories or time points were not reduced to a single comparison, so the precise treatment contrast intended by the endpoint wording is not clear from the registry record.
3. Trial Design
This was a randomized, double-masked study recorded as Phase 1, with an enrollment of 12 and a parallel model classification. The registry describes the study as a bilateral comparison and specifies a split-face arrangement: one topical vehicle was applied to one side of each participant’s face and the other vehicle to the contralateral side. Both were applied daily for six weeks. The registry does not explain how its parallel-model classification corresponds to this within-participant arrangement. That distinction matters because a split-face comparison ordinarily compares sides within the same participant, while a parallel-arm comparison ordinarily compares separate groups. The record does not provide further details that resolve the discrepancy.
The registry records randomized allocation and double masking. The official title also describes the study as evaluator-blinded. Details about the randomization sequence, allocation concealment, who was masked, and how masking was maintained are not reported in the registry record. The sponsor is Vyne Therapeutics Inc. The recorded study start was 2018-11-20, and primary completion was 2019-02-11; the status is completed.
The study concerns acne vulgaris and compares two topical vehicles, not two interventions whose active ingredients are described in the record. The intervention descriptions identify an FMX101 hydrophobic oil based vehicle and a hydro-alcohol solution based vehicle. The registry does not report the rationale for choosing these vehicles or describe other aspects of treatment implementation beyond the daily application schedule and six-week duration.
The primary outcome is a Week 6 Investigator’s Global Assessment (IGA) measure. The registry lists 10 outcome measures, but the record does not describe a statistical analysis plan or explain how the primary endpoint was selected among the outcomes. The number of analyses listed is 0. That absence means the registry record does not show an analysis result for the primary endpoint; it does not establish what analyses may have been undertaken outside the posted 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.
Before assignment: The study consisted of a Screening/Baseline Visit, Visits at Weeks 1, 2, and 4, along with a Week 6/End of Treatment (EOT) Visit, and a Week 7/End of Study (EOS) Visit. All participants underwent inclusion and exclusion criteria assessment and all eligible participants signed the informed consent before undergoing any study related procedures. All assessments at screening were done as per the schedule of assessment.
Overall Study
| Stage | Overall |
|---|---|
| STARTED | 12 |
| Test Article A | 12 |
| Test Article B | 12 |
| COMPLETED | 11 |
| NOT COMPLETED | 1 |
Reasons for not completing this period:
| Reason | Overall |
|---|---|
| Physician Decision | 1 |
Analysis population for the primary outcome, as defined in the registry: The mITT population included all randomized participants who met all Inclusion/Exclusion criteria, applied at least one dose of test article, and returned for at least one post-Baseline evaluation visit. Here, overall number of participants analyzed presents only those participants who were analyzed for this particular outcome measure, and number analyzed presents the number of participants that were analyzed at specified week.
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 (mITT) population included all randomized participants who met all Inclusion/Exclusion criteria, applied at least one dose of test article, and returned for at least one post-Baseline evaluation visit.
| Characteristic | Unit | Overall |
|---|---|---|
| Participants analysed | 12 | |
| Age, Continuous | Years | 20.1 (SD 5.24) |
| Sex: Female, Male: Female | Participants | 6 |
| Sex: Female, Male: Male | Participants | 6 |
| Ethnicity (NIH/OMB): Hispanic or Latino | Participants | 5 |
| Ethnicity (NIH/OMB): Not Hispanic or Latino | Participants | 7 |
| Ethnicity (NIH/OMB): Unknown or Not Reported | Participants | 0 |
| Race (NIH/OMB): American Indian or Alaska Native | Participants | 0 |
| Race (NIH/OMB): Asian | Participants | 0 |
| Race (NIH/OMB): Native Hawaiian or Other Pacific Islander | Participants | 0 |
| Race (NIH/OMB): Black or African American | Participants | 1 |
| Race (NIH/OMB): White | Participants | 10 |
| Race (NIH/OMB): More than one race | Participants | 1 |
| Race (NIH/OMB): Unknown or Not Reported | Participants | 0 |
6. Primary Endpoint
The registry lists the primary outcome as Number of Participants With 0 to 4 Investigator's Global Assessment Score at Week 6, measured over At Week 6.
| Element | Registry entry |
|---|---|
| Result type | Number |
| Measure of spread | not applicable |
| Unit | Participants |
| Endpoint classification | Binary Endpoint |
The primary endpoint is titled “Number of Participants With 0 to 4 Investigator’s Global Assessment Score at Week 6.” IGA is described as a blinded evaluator’s static assessment of overall facial acne severity on the day of evaluation, taking all facial acne lesions into account. Its five-point scale runs from 0, Clear, through 1, Almost Clear, 2, Mild, and 3, Moderate, to 4, Severe. Lower scores represent a better outcome, while higher scores indicate greater severity.
An IGA assessment can provide a standardized overall description of disease severity at a scheduled evaluation. A participant count based on a defined IGA category or threshold can also be used to express how many participants meet a stated clinical response criterion. However, the registered wording spans the full 0-to-4 scale rather than identifying a single response threshold. The record does not clarify which category or grouping is intended for the primary comparison. It also indicates that several categories or time points were not reduced to one comparison.
No Week 6 outcome counts, group-specific estimates, or treatment comparison are reported in the registry record. Consequently, the endpoint’s definition and scale can be described, but the registered information does not support an interpretation of the observed difference between the vehicles.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry record identifies a randomized comparison and a Week 6 IGA endpoint, but it does not report the outcome counts for either vehicle. No effect estimate, confidence interval, or p-value for the primary endpoint is reported in the registry record. The record also lists 0 analyses. The available information therefore describes the intended outcome and study arrangement, but does not quantify a treatment contrast or its precision.
The endpoint wording creates an additional interpretive limitation. It refers to participants with an IGA score from 0 to 4, which encompasses the full scale described in the record, from Clear to Severe. The registry’s outcome note says the primary outcome has several categories or time points and was not reduced to one comparison. The intended category-specific or threshold-based comparison is therefore not established by the posted record. Without an unambiguous endpoint contrast and observed group counts, no conclusion about a difference in Week 6 IGA can be drawn from this record.
General statistical explanation: an effect estimate describes the size and direction of a comparison, while a confidence interval describes the range of values compatible with the data under the analysis assumptions. A p-value addresses how compatible the observed data are with a specified null model; it is not a measure of clinical importance. None of these inferential quantities for the primary endpoint is reported in the registry record. Even if they were reported, their interpretation would depend on the endpoint definition, analysis population, and comparison method.
The study enrolled 12 participants, but the number analyzed for the primary outcome is not stated. The endpoint description defines an mITT population using eligibility, exposure, and follow-up criteria, and notes that the overall analyzed number includes only those participants analyzed. It does not give that number or state how missing Week 6 assessments were handled. Enrollment alone cannot substitute for the number contributing to a particular comparison.
The safety record lists 12 participants at risk for serious adverse events and 0 affected, and 12 at risk for other adverse events and 5 affected. It also lists 0 deaths. These are descriptive safety counts, not estimates of the comparative safety of the two vehicles. The registry gives an overall group only, and does not provide arm-specific counts or an attribution of events to either vehicle.
The sample-size planning description specifies a two-sided significance level of 0.05, equal allocation between arms, and a normal approximation, with the effect to detect expressed as a fraction of the observed effect. Such planning illustrations are not observed results or observed power. The registry record does not report the trial’s own sample-size justification. The planning assumptions cannot fill in the absent Week 6 results or establish the precision of a treatment comparison.
9. Statistical Methods Explained
Statistical methods are interpretable only in relation to a clearly defined outcome, comparison, and analysis population. The registry record identifies randomization, masking, the IGA scale, and an intended Week 6 endpoint, but does not report an analysis plan or primary outcome results. The notes below explain general statistical concepts relevant to the recorded design; they do not establish which methods the investigators used.
What does a participant count measure?
General explanation: a count records how many participants meet a defined event or category. To compare groups, the event needs a reproducible definition, and the count needs a denominator: the number of participants assessed in each group or condition. Counts alone do not show how common an event is unless the corresponding number assessed is known. Comparisons may then use a difference in proportions, a relative measure, or another prespecified statistic, with uncertainty described using an appropriate interval estimate.
The registry classifies the primary outcome as a binary count of participants with an event. Yet its title refers to scores from 0 to 4 on the IGA scale, and its outcome note indicates that multiple categories or time points were not reduced to one comparison. This leaves uncertainty about what event the count represents. The record does not report category-level counts, denominators by vehicle, or a chosen threshold. It is therefore not possible to reconstruct a binary comparison from the registry record.
How does the split-face arrangement affect analysis?
General explanation: in a split-face study, both conditions are applied to different sides of the same participant. The two side-specific measurements are paired, because they share participant-level characteristics. A paired analysis accounts for that dependence; treating the sides as if they came from unrelated participants can misstate uncertainty. By contrast, a conventional parallel-group analysis compares outcomes from separate participant groups. The registry classifies this study as parallel while describing application to opposite sides of each participant’s face. The record does not report the analysis method or explain how the design classification was reconciled with the split-face description.
The precise unit of analysis also matters. A participant-level outcome, such as whether a participant meets a response criterion, is different from a side-level outcome. The primary endpoint is worded as a number of participants, while treatment is described as applied to separate sides. The record does not explain how each participant’s two side-specific assessments would contribute to the participant count or comparison. Without that detail, a reader cannot determine whether the proposed analysis preserved the paired structure.
What does masking contribute?
General explanation: masking can reduce the influence of expectations on treatment delivery, outcome assessment, or reporting. The registry records double masking, and the official title describes evaluator blinding. The record does not state which roles were masked, how the vehicles were made indistinguishable, or whether masking was assessed. Those details are not reported in the registry record, so the practical protection against measurement or performance bias cannot be assessed from the record alone.
How should uncertainty be read?
General explanation: a confidence interval expresses uncertainty around an estimate under the assumptions of the analysis. A narrow interval indicates more precise estimation than a wide interval, while an interval that includes values compatible with different directions or magnitudes may leave the comparison uncertain. Precision depends on factors including the amount of information in the data and the analysis model. The registry record reports no effect estimate or confidence interval for the primary endpoint. No statement about the degree of statistical uncertainty in the treatment comparison is therefore available.
General explanation: a significance test evaluates data against a stated null hypothesis under a chosen model. A p-value does not establish that a treatment effect is important, nor does it directly give the probability that the null hypothesis is true. The registry does not report a primary endpoint p-value, test statistic, or analysis method. The planning description uses a two-sided significance level of 0.05, but that planning assumption is not an observed test result and does not establish that a corresponding test was performed.
What is the role of sample-size planning?
General explanation: sample-size planning considers a target effect, variability, allocation, a significance level, and a desired power before a study begins. A planning illustration based on an observed effect is a hypothetical design calculation: it asks how many participants per arm for 80% power might be required under specified assumptions. It does not measure the power actually achieved by a completed trial. The record describes illustrations using a two-sided significance level of 0.05, equal allocation, a normal approximation, and target effects expressed as fractions of the observed effect. It does not report the study’s own sample-size justification. Any planning illustration should therefore be kept separate from interpretation of the observed study, especially because the primary outcome results are not reported.
Over-dispersion is a general concern when count data vary more than a statistical model expects. If a model assumes less variability than the data contain, estimated uncertainty can be too small. That concept is not a finding about this study: the registered primary endpoint is a participant count, and the registry record does not report a count model, dispersion estimate, or analysis capable of assessing over-dispersion.
10. Multiplicity, Missing Data and Analysis Populations
The registry lists 10 outcome measures and indicates that the primary outcome has several categories or time points that were not reduced to one comparison. When a study evaluates multiple outcomes, categories, or time points, there can be multiple opportunities to identify an apparently notable result. General explanation: multiplicity procedures or a prespecified hierarchy can help define how such results are interpreted and can control the chance of false-positive findings across a family of tests. The registry record does not report a multiplicity strategy, an outcome hierarchy beyond labeling the primary outcome, or a statistical analysis plan. It is therefore not possible to establish how multiple comparisons were handled.
The primary outcome description defines the mITT population as randomized participants who met all inclusion and exclusion criteria, applied at least one dose, and returned for at least one post-Baseline evaluation visit. It also says the overall analyzed number presents only participants who were analyzed. The number meeting this definition is not reported in the registry record. Neither the number randomized to each condition nor the number with an evaluable Week 6 assessment is stated.
Missing-data methods are not reported in the registry record. The record does not say whether unavailable assessments were excluded, imputed, or handled through another approach, nor does it describe sensitivity analyses. These omissions matter because the analyzed population and missing-outcome handling can affect both the estimate and its uncertainty. No analysis results are listed, so the effect of these choices cannot be assessed from the posted 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 |
|---|---|---|---|
| Overall | 0 | 12 | 0.0% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| Overall | 0 of 12 |
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 |
|---|---|
| Overall | 5 of 12 |
Most frequent non-serious adverse event terms
| Event term | Organ system | Overall |
|---|---|---|
| Upper Respiratory Tract Infection | Infections and infestations | 3 of 12 |
| Gastroenteritis Viral | Gastrointestinal disorders | 1 of 12 |
| Influenza | Infections and infestations | 1 of 12 |
| Sinusitis | Infections and infestations | 1 of 12 |
The registry reports an overall safety group. For serious adverse events, 12 participants were at risk and 0 were affected. For other adverse events, 12 participants were at risk and 5 were affected. The deaths count is 0. No serious adverse event terms are listed.
These figures are descriptive counts in the overall group. They do not provide a comparison between the two vehicles: the registry does not report arm-specific safety counts or identify which vehicle was associated with an event. The record also does not describe event severity beyond the serious-versus-other classification, the timing of events, or an attribution assessment. The count of participants affected should not be read as the number of individual events, because the record does not provide that event-level detail.
General explanation: an absence of recorded serious adverse events in a study does not demonstrate that a treatment has no risk. Safety interpretation depends on the number observed, follow-up, event definitions, and completeness of reporting. Here, the study’s safety figures are limited to the counts in the registry record; they do not establish a comparative safety profile or rule out events that were not reported.
12. What the Result Does, and Does Not, Mean
The registry record establishes that a randomized, double-masked Phase 1 study compared two topical vehicles in participants with acne vulgaris. It describes daily use over six weeks, application to opposite sides of the face, and a Week 6 IGA outcome. It also provides limited overall adverse-event counts. These registry entries characterize the study’s intended comparison and posted safety information.
The record does not report the primary outcome values, arm-specific participant counts, an effect estimate, a confidence interval, or a p-value. It therefore does not show the direction or size of an IGA difference between the vehicles, or how precisely such a difference was estimated. The endpoint wording also spans the full IGA scale and is not reduced to a single comparison in the outcome listing. No treatment effect should be inferred from the design description alone.
The findings cannot be described as evidence that either vehicle is superior, equivalent, or ineffective. Those conclusions require observed data and a defined comparison. Nor can a lack of posted results be interpreted as a null result: the registry’s absence of a reported estimate is not evidence that the comparison found no difference.
The overall safety counts report 0 participants affected by serious adverse events, 5 affected by other adverse events, and 0 deaths among the stated at-risk groups. They do not identify events by vehicle and should not be treated as a direct comparison of harms. The record’s small enrollment and unavailable analysis details further limit what can be inferred from these counts.
General explanation: statistical significance and clinical importance are distinct. A result may be estimated imprecisely even when a test is reported, and a statistically detectable difference need not be important to patients. In this case, neither an estimate nor a test result for the primary endpoint is reported. The appropriate interpretation is therefore restricted to what the registry documents about design, outcome definition, and safety counts.
13. Why This Trial Matters Statistically
This study raises a useful statistical issue: design labels and treatment descriptions need to align with the analysis. The registry records a parallel model but describes applying the two vehicles to opposite sides of the same participant’s face. Those descriptions imply different structures for the data. A split-face comparison involves paired observations, whereas a conventional parallel comparison involves separate groups. The analysis should reflect the actual allocation and unit of observation, but the registry record does not report the analysis method or resolve the difference between its design label and intervention description.
The endpoint wording illustrates a second important issue. The IGA scale is ordinal, with five stated severity categories, while the primary endpoint is presented as a binary participant count covering scores from 0 to 4. The record notes that categories or time points were not reduced to one comparison. A reader needs a clearly stated threshold or category definition to understand what event is counted and what treatment contrast is being estimated. Without that specification and the observed counts, interpretation is not possible.
The record also shows why a completed study status is not a substitute for posted outcome estimates. Enrollment and safety counts provide context, but they do not establish the primary endpoint’s effect or precision. A clear analysis population, missing-data approach, and multiplicity plan would help readers evaluate the strength of an estimate, but those details are not reported in the registry record.
General explanation: transparent reporting links the clinical question to the endpoint, analysis population, statistical method, and uncertainty estimate. When any of those links is absent, readers should distinguish documented design features from conclusions that require results. This study’s registry record supports a description of the comparison but not a statistical conclusion about its primary endpoint.
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 central limitation for statistical interpretation is that no primary endpoint results or analyses are reported in the registry record. There are no counts by vehicle, estimate of a treatment contrast, or uncertainty interval. The registry’s outcome note also says that multiple categories or time points were not reduced to one comparison, leaving the intended endpoint contrast unclear.
The reported design information is not fully aligned: the registry classifies the model as parallel, while the intervention descriptions specify application to opposite sides of each participant’s face. The record does not clarify the allocation or analysis structure, the unit of analysis, or how within-participant pairing was addressed. Randomization sequence details, allocation concealment, masking roles, and the statistical analysis plan are not reported in the registry record.
The mITT definition is stated, but the number analyzed is not reported. The registry does not provide the number with an evaluable Week 6 assessment, the handling of missing outcome data, or sensitivity analyses. The endpoint is described as a participant count spanning IGA scores from 0 to 4, without a specific response threshold or category-level results.
The safety figures are overall rather than vehicle-specific, and the record does not report attribution, event timing, or event-level detail. The registry does not report the trial’s own sample-size justification. The enrollment of 12 and the absence of a reported analysis limit assessment of precision; the planning assumptions described in the record do not replace observed outcome data. These limitations prevent a comparative efficacy or safety conclusion from being drawn from the posted information.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: A Study Comparing Two Topicals in the Treatment of Acne Vulgaris — NCT03743038.
- Registry record last updated 2021-04-06; status last verified 2021-03.
- Results first posted 2021-02-23.
- Data retrieved from ClinicalTrials.gov on 2026-11-09.
- Group sizes, means, event counts and sponsor-reported p-values are reproduced as posted. Effect estimates, confidence intervals and p-values not attributed to the sponsor are independently calculated from the posted summary statistics.
Continue through the Clinical Biostats statistical pathway
Use this trial's endpoint as a starting point for deeper study of effect measures, confidence intervals, and sample-size planning.
18. Record Summary
NCT03743038 is a completed randomized, double-masked Phase 1 study of two topical vehicles for acne vulgaris. The registry describes a split-face comparison using daily application for six weeks, while also classifying the study model as parallel. Enrollment was 12; the recorded start was 2018-11-20 and primary completion was 2019-02-11.
The primary endpoint is the number of participants with an IGA score from 0 to 4 at Week 6. The scale ranges from 0, Clear, to 4, Severe. The registry record does not report primary outcome counts, a treatment effect, or an analysis result, and notes that the categories or time points were not reduced to one comparison. Overall safety counts are 0 affected by serious adverse events, 5 affected by other adverse events, and 0 deaths. The record does not provide vehicle-specific safety comparisons or the number analyzed for the primary endpoint.