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 Participant Reported Outcomes With Use of Trifarotene 50 μg/g Cream in the Treatment of Moderate Facial and Truncal Acne Vulgaris (NCT03915860), a na phase 3 study. The primary outcome is Change From Baseline in Dermatology Life Quality Index (DLQI) Total Score at Week 12 and 24.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT03915860 |
| Phase | Phase 3 |
| Condition | Acne Vulgaris |
| Allocation | Not applicable (single group) |
| Design model | Single Group |
| Masking | None (open label) |
| Enrollment | 47 |
| Arms in the primary outcome | n/a |
| Lead sponsor | Galderma R&D |
| Results posted | Yes |
2. Clinical Question
Population
Participants with moderate facial and truncal acne vulgaris were enrolled. The study enrolled 47 participants. The registry record does not report further participant characteristics or detailed eligibility criteria.
Intervention
Participants applied trifarotene 50 μg/g cream topically once daily in the evening for 24 weeks.
Comparator
There was no separate comparator group. The study is recorded as a single-group study, with allocation listed as not applicable and masking listed as none.
Primary question
The primary endpoint asks how the Dermatology Life Quality Index (DLQI) total score changed from baseline at Week 12 and Week 24. The registry describes the measure and time points but does not report the numerical changes, their variability, or the numbers of participants contributing to those estimates.
This is a question about change over time within participants receiving the study cream, not a randomized comparison between treatments. A change from baseline can describe how reported quality of life differed at follow-up from the participants’ starting scores. By itself, it does not separate changes that occurred during the study from changes that might also have occurred without the intervention.
The registry also lists secondary outcomes concerning facial and truncal acne assessments and lesion counts at Week 12 and Week 24. These outcomes provide other ways to characterize participants’ condition during follow-up, but their numerical results are not reported in the registry record. The primary question remains focused on a participant-reported measure of the impact of skin disease on daily life.
3. Trial Design
The registry identifies this as a phase 3, multicenter study with a single-group model. Its official title describes evaluation of subject-reported outcomes with trifarotene 50 μg/g cream for moderate facial and truncal acne vulgaris. Allocation is listed as not applicable, and masking is listed as none. There is no separate control or comparison group in the design described by the record.
The study enrolled 47 participants and is marked completed. The recorded start date is 2019-03-27, and the primary completion date is 2019-12-23. Participants applied trifarotene topically once daily in the evening for 24 weeks. The registry identifies Galderma R&D as the sponsor.
The primary outcome is change from baseline in DLQI total score at Week 12 and Week 24, with baseline, Week 12 and Week 24 identified as the measurement time frame. The record lists 11 outcome measures. Secondary outcomes include the proportion achieving an Investigator Global Assessment (IGA) score of 1 (Almost Clear) or 0 (Clear) together with at least a 2-grade improvement, truncal acne assessment success, and changes in facial and trunk inflammatory and non-inflammatory lesion counts. Numerical results for these outcomes are not reported in the registry record.
A single-group follow-up can describe outcome values over time among participants who received the study intervention. It cannot provide a concurrent estimate of how those outcomes would have changed in a separate group receiving another intervention or no intervention. This design feature matters when interpreting change from baseline: any observed change would be a within-group observation, not a controlled treatment contrast.
The registry record does not report a protocol-level sample-size justification, a detailed statistical analysis plan, or planned interim analyses. It also does not report the actual number of participants analyzed at each follow-up time point. Those details should not be inferred from the phase designation, enrollment, or duration of treatment.
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: A total of 47 participants were enrolled in the study. Of which, 46 participants were treated.
Overall Study
| Stage | Trifarotene |
|---|---|
| STARTED | 47 |
| Treated | 46 |
| COMPLETED | 33 |
| NOT COMPLETED | 14 |
Reasons for not completing this period:
| Reason | Trifarotene |
|---|---|
| Adverse Event | 3 |
| Withdrawal by Subject | 6 |
| Lost to Follow-up | 2 |
| Other than specified | 3 |
Analysis population for the primary outcome, as defined in the registry: Analysis was performed on ITT population that included all enrolled participants. Here, overall number of participants analyzed=participants with available data at Week 12 and 24.
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: Analysis was performed on Intent to treat (ITT) population that included all enrolled participants.
| Characteristic | Unit | Trifarotene |
|---|---|---|
| Participants analysed | 47 | |
| Age, Continuous | years | 15.6 (SD 3.00) |
| Sex: Female, Male: Female | Participants | 13 |
| Sex: Female, Male: Male | Participants | 34 |
| Ethnicity (NIH/OMB): Hispanic or Latino | Participants | 10 |
| Ethnicity (NIH/OMB): Not Hispanic or Latino | Participants | 37 |
| 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 | 5 |
| Race (NIH/OMB): White | Participants | 42 |
| Race (NIH/OMB): More than one race | Participants | 0 |
| Race (NIH/OMB): Unknown or Not Reported | Participants | 0 |
| Dermatology Life Quality Index (DLQI) Score at Baseline | score on a scale | 2.8 (SD 3.00) |
| C-DLQI (Children's Dermatology Life Quality Index) Score at Baseline | score on a scale | 3.2 (SD 4.17) |
| Comprehensive Quality of Life (QOL) Measure for Facial and Truncal Acne at Baseline | score on a scale | 37.8 (SD 17.69) |
| EuroQoL 5-Dimension (EQ-5D-5L) Index Score at Baseline | score on a scale | 0.9416 (SD 0.07334) |
| EuroQoL 5-Dimension (EQ-5D-5L) VAS Score at Baseline | score on a scale | 90.0 (SD 8.99) |
6. Primary Endpoint
The registry lists the primary outcome as Change From Baseline in Dermatology Life Quality Index (DLQI) Total Score at Week 12 and 24, measured over Baseline, Week 12 and Week 24.
| Element | Registry entry |
|---|---|
| Result type | Mean |
| Measure of spread | Standard Deviation |
| Unit | score on a scale |
| Endpoint classification | Continuous Endpoint |
The primary endpoint is change from baseline in the Dermatology Life Quality Index total score at Week 12 and Week 24. The DLQI is described as a validated 10-item questionnaire for participants aged >16 years. It assesses dermatology-related limitations in functional ability and the frequency, severity and impact of inflammatory skin conditions on quality of life.
Each item is scored from 0, meaning “not at all,” to 3, meaning “very much.” Summing responses produces a total score from 0 to 30, with higher scores indicating more impact on quality of life. The endpoint therefore captures participants’ reported experience rather than a clinician’s examination or a lesion count alone. A change score compares the follow-up total with the baseline total; its direction and size would need to be interpreted using the actual reported values.
General: A participant-reported measure can add information about how a condition affects day-to-day functioning and perceived burden. It complements clinical assessments because symptom counts or appearance ratings do not necessarily describe a participant’s own experience. The registry record identifies the measure and its scoring, but does not report the baseline or follow-up means, the changes, standard deviations, or confidence intervals. The magnitude and precision of the primary endpoint result therefore cannot be assessed from the registry information.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry record identifies a meaningful statistical question—whether DLQI scores changed from baseline during follow-up—but does not report the numerical primary outcome results. No mean change, standard deviation, confidence interval, or p-value for Week 12 or Week 24 is reported in the registry record. As a result, the direction, magnitude, and precision of the primary endpoint change cannot be described from these results.
The same limitation applies to the listed secondary outcomes. The registry names acne assessment and lesion-count outcomes, but numerical findings for those measures are not reported in the registry record. A list of planned or registered outcome measures is not itself evidence about the values observed. It also does not establish whether an outcome changed, by how much it changed, or how uncertain an estimate might be.
The study’s single-group structure sets an important boundary on interpretation. If a within-group change were reported, it would describe how scores differed over time among participants in the study. Without a concurrent comparator, that change would not estimate the difference between trifarotene and another treatment or between trifarotene and no treatment. General: In a comparative trial, a treatment effect is usually framed as a contrast between groups. A pre-to-post change in one group is a different quantity and can reflect multiple influences over the follow-up period.
Even a numerical change would need to be read alongside its uncertainty. A mean summarizes the average change, while a standard deviation describes the spread of individual observations around that average. A confidence interval would convey the range of values reasonably compatible with the data under the statistical model used. None of these numerical summaries for the primary endpoint is reported in the registry record, so precision cannot be evaluated.
The record describes an analysis population as including all enrolled participants, while stating that the overall number analyzed was the number with available data at Week 12 and Week 24. The actual analyzed counts and the handling of missing values are not reported in the registry record. Consequently, it is not possible to determine from the record how much follow-up data contributed to the endpoint estimates or whether participants with incomplete follow-up differed from those with observed scores.
The posted safety counts are descriptive: 0 serious adverse events among 46 participants at risk, 9 participants with other adverse events among 46 at risk, and 0 deaths. These counts do not provide a comparative safety estimate because the study has no separate control group. The record does not give event details or additional context needed to characterize the other adverse events.
Overall, the registry record supports a description of the study question, design, outcome definitions and selected safety counts. It does not support a numerical conclusion about change in quality of life or the secondary clinical outcomes. Any interpretation should keep the distinction between registered outcome definitions and reported outcome estimates clear.
9. Statistical Methods Explained
The registry describes a continuous primary outcome summarized as a mean with standard deviation. It names change from baseline in DLQI total score at Week 12 and Week 24, but does not report the numerical estimates or analyses for those time points. The explanations below are general statistical context; they do not establish which inferential methods were used for this study.
What does a mean change represent?
General: A mean change is the average of participants’ follow-up scores minus their baseline scores, using a specified convention for the direction of subtraction. It condenses individual changes into one summary. Participants can have different changes, including changes in opposite directions, so the mean does not show the full distribution or the experience of every participant. In this study, the record specifies a mean and standard deviation as the outcome summary, but does not report the mean changes or the number of observations used for them.
For a change-from-baseline endpoint, interpretation depends on knowing the scoring direction and the way change was defined. The DLQI scoring description says that higher total scores indicate more impact on quality of life. The record does not give the observed changes, so it is not possible to state whether the average score rose or fell at either follow-up visit. Nor can a numerical change be judged against a threshold for importance: such a threshold is not reported in the registry record.
What does the standard deviation tell a reader?
General: A standard deviation describes the spread of observations around their mean. It is not the same as a standard error, and it is not a confidence interval. A larger standard deviation generally indicates more variation among participant values, while the mean alone gives only the average. The registry identifies standard deviation as the dispersion measure for the primary outcome but does not report its value at baseline or follow-up. Thus, the degree of variation in DLQI scores cannot be assessed from the registry record.
General: A confidence interval is an interval estimate that communicates uncertainty about a population quantity, subject to the assumptions of the method used. Its width reflects both the variability in the data and the amount of information available, among other aspects of the analysis. A confidence interval is not reported for the primary endpoint in the registry record. Without an interval or other uncertainty measure, precision cannot be described, even if a point estimate were available.
Why does the single-group design matter?
The trial is recorded as single-group, with no allocation to a comparison arm. General: A within-group change and a between-group contrast answer different questions. A within-group change compares participants’ follow-up outcomes with their own baseline outcomes. A between-group contrast compares outcomes across groups assigned to different conditions. Only the first kind of question corresponds to the design described in this record. A change over time in one group cannot, on its own, establish how much of the change is attributable to the intervention rather than to other influences during follow-up.
The registry lists no masking. General: Masking can affect how participants, clinicians, or outcome assessors know about assigned treatment, and this can matter for measurement or reporting. The record does not describe additional procedures for minimizing bias in outcome assessment. It would be inappropriate to infer such procedures from the study title or phase.
How should the planning illustrations be understood?
General: Sample-size planning asks how many participants might be needed under stated assumptions to detect a specified effect with a chosen significance level and power. The planning assumptions described for this study use 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 fraction of the observed effect. For non-time-to-event outcomes, the planning quantities are described as participants per arm for 80% power or another stated power level when applicable; time-to-event planning would instead concern total events.
These assumptions are illustrations and are not the trial’s own design justification. They do not turn the single-group study into a two-arm comparison, and they are not observed power. The registry record does not report the trial’s sample-size justification. In addition, without a numerical observed effect in the record, the basis for numerical planning illustrations cannot be independently evaluated from the reported outcome results. Planning estimates depend on their assumptions and should not be read as evidence that the study did or did not have adequate power.
What can be inferred from the analysis listings?
The record lists 11 outcome measures and 0 analyses. These entries do not supply estimates, uncertainty intervals, or hypothesis-test results. General: A statistical analysis plan would ordinarily clarify which outcomes are primary, how repeated measurements are handled, how missing observations are addressed, and whether or how multiple comparisons are controlled. The registry record does not report those details. The absence of analysis listings is not evidence that a particular statistical method was used or that a particular result was obtained.
Because outcomes are identified at more than one follow-up time and several secondary measures are listed, readers may wonder whether multiple testing was addressed. The multiplicity procedure, if any, is not reported in the registry record. General: When many outcomes or time points are tested, the chance of at least one apparently notable result can increase if each test is considered independently. Adjustment methods can address that issue, but no adjustment should be assumed without documentation. Here, the lack of numerical analyses and a reported multiplicity approach means statistical significance cannot be assessed.
10. Multiplicity, Missing Data and Analysis Populations
The registry lists a primary DLQI endpoint at Week 12 and Week 24 and several secondary outcome measures, including acne assessments and lesion-count changes at both follow-up visits. It does not report whether the two primary time points were treated as separate tests, how secondary outcomes were ordered or prioritized, or whether any adjustment for multiple comparisons was planned or applied. The multiplicity strategy is not reported in the registry record.
General: Testing multiple outcomes or time points can make isolated results more likely to appear notable by chance when each is interpreted without regard to the others. Statistical plans sometimes address this by defining a testing hierarchy, allocating significance levels, or using an adjustment procedure. No such procedure can be attributed to this study from the registry information. Since numerical test results are also not reported, neither statistical significance nor the effect of any multiplicity handling can be assessed.
The outcome description says the analysis population included all enrolled participants, while also defining the overall number analyzed as participants with available data at Week 12 and Week 24. The actual number analyzed at each visit is not reported in the registry record. The record does not describe why data might be unavailable, how missing observations were handled, whether any imputation was used, or whether sensitivity analyses were conducted.
General: Missing outcome data can affect both the amount of information and the interpretation of an estimate, particularly if the likelihood of missingness is related to participants’ outcomes or study experience. An analysis restricted to available observations can describe those observed data, but its relationship to the full enrolled population depends on assumptions about missingness. No specific missing-data assumption or method should be inferred.
The record’s description of an ITT population does not resolve these questions: it states that all enrolled participants were included in that population while also tying the analyzed number to available follow-up data. Without participant counts, analysis details, and missing-data methods, the extent and handling of incomplete follow-up remain unclear.
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 |
|---|---|---|---|
| Trifarotene | 0 | 46 | 0.0% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| Trifarotene | 0 of 46 |
Other (non-serious) adverse events
Participants with at least one non-serious event at or above the registry's 5% reporting threshold.
| Arm | Participants affected of at risk |
|---|---|
| Trifarotene | 9 of 46 |
Most frequent non-serious adverse event terms
| Event term | Organ system | Trifarotene |
|---|---|---|
| Application site pain | General disorders | 5 of 46 |
| Application site dermatitis | General disorders | 3 of 46 |
| Sunburn | Injury, poisoning and procedural complications | 3 of 46 |
The safety record lists 46 participants at risk for serious adverse events and 0 participants affected by a serious adverse event. For other adverse events, 46 participants were at risk and 9 were affected. The record also lists 0 deaths. No serious adverse event terms are listed.
These are counts, not comparative estimates. The study has a single group and no separate control group, so the counts cannot describe a difference in risk between treatments. The registry record does not give event descriptions for the other adverse events, their severity, timing, duration, relationship to treatment, or the method used to collect them. The absence of listed serious-event terms does not provide further detail about event monitoring or reporting.
The safety population at risk is recorded as 46, while total enrollment is 47. The registry record does not explain this difference. The counts should therefore be read using the stated safety denominator rather than treated as counts for every enrolled participant. They describe the events recorded in this study and do not, on their own, characterize comparative safety or establish whether an event was caused by the intervention.
12. What the Result Does, and Does Not, Mean
The registry record establishes that a phase 3, single-group study enrolled 47 participants with moderate facial and truncal acne vulgaris and evaluated participant-reported outcomes during 24 weeks of once-daily evening application of trifarotene 50 μg/g cream. It identifies change in DLQI total score at Week 12 and Week 24 as the primary outcome. It also defines several secondary outcomes and reports selected adverse-event counts.
The record does not report numerical results for the DLQI endpoint or the secondary outcomes. Therefore, the direction and magnitude of quality-of-life change, the variability among participants, and the precision of any estimate cannot be determined from the registry record. The listed outcome measures should not be mistaken for observed findings.
The single-group design also limits what any reported change over time could establish. General: A within-group change describes what happened to measured outcomes among participants followed in one study group. It does not by itself estimate what would have happened to a comparable group under another condition. A concurrent comparator would be needed to make that kind of direct contrast.
The safety counts describe 0 serious adverse events and 0 deaths among the recorded safety population of 46 participants, and other adverse events affecting 9 of 46. They do not establish comparative risks, and the record lacks descriptions needed to characterize the other adverse events in detail.
These limitations do not make the study question unimportant; they define what can be concluded from the registry information. The record identifies a participant-reported endpoint and follow-up schedule, but not the numerical outcome results, detailed analysis methods, or missing-data handling. Claims about the size, precision, clinical importance, or comparative effect of outcome changes are not supported by the information reported.
13. Why This Trial Matters Statistically
This study is statistically notable for centering a participant-reported quality-of-life measure in a study of moderate facial and truncal acne vulgaris. The DLQI is designed to capture how a skin condition affects functional ability and quality of life, complementing clinician assessments and lesion counts. Its use makes the endpoint relevant to participants’ reported experience, rather than limiting assessment to clinical signs.
The repeated measurement schedule—baseline, Week 12 and Week 24—also makes the question one of change over time. Such measurements can describe the trajectory of an outcome during follow-up. Yet the design is single-group, so the central statistical contrast is within participants over time, not between treatment groups. This distinction is essential for keeping descriptive change separate from a controlled estimate of treatment effect.
The registry record also illustrates why outcome definitions and outcome results must be distinguished. It lists 11 outcome measures and provides descriptions of the primary and secondary measures, but reports 0 analyses. As a result, readers can understand what was intended to be measured without being able to assess the observed effect or its uncertainty from the registry record.
Finally, the record highlights the importance of transparent reporting about analysis populations and missing data. It describes an ITT population that includes enrolled participants while defining the analyzed number by availability of follow-up data, but does not report the actual counts or missing-data methods. Those details affect how readers judge the representativeness and precision of an estimate. In this record, they are additional reasons to avoid drawing numerical conclusions beyond the safety counts that are reported.
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 most direct limitation for interpreting outcomes is that the registry record does not report numerical results for the primary DLQI endpoint or the listed secondary outcomes. Without estimates and measures of uncertainty, the magnitude, direction, and precision of outcome changes cannot be assessed. The record lists 0 analyses, so it does not provide statistical test results or analysis estimates.
The single-group design has no concurrent comparator. Any change from baseline, if numerical results were available, would describe change over time in the treated group rather than a controlled difference between treatment conditions. Masking is listed as none. The registry record does not describe additional safeguards for outcome assessment or participant reporting.
The record describes enrollment of 47 participants, but the analyzed numbers at Week 12 and Week 24 are not reported. It states that the ITT population included all enrolled participants and that the overall number analyzed was based on participants with available data at both follow-up time points. Missing-data handling, reasons for missingness, and sensitivity analyses are not reported. These omissions leave uncertainty about the contribution of incomplete follow-up to the primary analysis.
The registry does not report a detailed statistical analysis plan, multiplicity procedures, interim analyses, or the trial’s sample-size justification. The listed outcome measures include multiple outcomes and follow-up times, but the handling of those multiple measurements is not described. The planning assumptions are illustrative and do not establish the study’s original design rationale.
For safety, the record gives counts for 46 participants at risk but does not explain why this differs from total enrollment. It provides no descriptions or further characterization of the 9 other adverse events. These limitations constrain interpretation of the safety counts as well as the efficacy-related outcomes.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Participant Reported Outcomes With Use of Trifarotene 50 μg/g Cream in the Treatment of Moderate Facial and Truncal Acne Vulgaris — NCT03915860.
- Registry record last updated 2021-12-15; status last verified 2019-04.
- Results first posted 2021-12-15.
- 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.
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18. Record Summary
NCT03915860 is a completed phase 3, multicenter, single-group study sponsored by Galderma R&D. It enrolled 47 participants with moderate facial and truncal acne vulgaris. Participants applied trifarotene 50 μg/g cream topically once daily in the evening for 24 weeks. The recorded start date is 2019-03-27, and the primary completion date is 2019-12-23.
The primary outcome was change from baseline in DLQI total score at Week 12 and Week 24. The record lists 11 outcome measures and 0 analyses, and does not report numerical results for the primary or secondary outcomes. The analysis population description refers to all enrolled participants and available data at the follow-up visits, but actual analyzed counts and missing-data methods are not reported.
The safety record lists 0 serious adverse events among 46 at risk, 9 participants with other adverse events among 46 at risk, and 0 deaths. The study has no separate comparator group, so the record describes a single-group evaluation rather than a randomized treatment comparison.