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 Patient-reported Outcomes for Sarecycline Effectiveness and Safety (PROSES) (NCT04820673), a registered phase not stated study. The primary outcome is Change From Baseline in Acne Symptom and Impact Scale Questionnaire (ASIS) Domain Score at Week 12.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT04820673 |
| Phase | Phase not stated |
| Condition | Acne Vulgaris |
| Allocation | Not Stated |
| Design model | Not Stated |
| Masking | Not Stated |
| Enrollment | 300 |
| Arms in the primary outcome | n/a |
| Lead sponsor | Almirall, S.A. |
| Results posted | Yes |
2. Clinical Question
Population
Patients with moderate to severe non-nodular acne vulgaris treated in community practice settings in the United States were eligible. The registry record lists an enrollment of 300. The primary outcome population was defined as participants in the safety population who had answered at least one question relevant to the primary research objective and completed the Week-12 survey; the number meeting that definition is not reported in the registry record.
Intervention
Participants were prescribed commercially available sarecycline. Clinicians made prescribing decisions according to their own clinical judgment and standard practice. Eligible patients were followed for 12 weeks after starting treatment.
Comparator
The registry record describes a single sarecycline cohort and does not identify a control group. It is not a randomized comparison; allocation is not stated. The registry record therefore does not offer a like-for-like control comparison for interpreting changes over time.
Primary question
The primary question was how the Acne Symptom and Impact Scale (ASIS) domain scores changed from baseline to Week 12. ASIS captures participants’ reports about acne signs and its emotional and social impact. The numerical baseline and Week-12 results, including the change in domain scores, are not reported in the registry record.
3. Trial Design
This was a prospective cohort study of patients treated in community practice settings in the United States. The official title describes a real-world study of patients with moderate to severe acne vulgaris treated with sarecycline. The registry record lists 300 participants enrolled and identifies sarecycline as the intervention. It does not describe a randomized allocation or a separate control arm.
Clinicians prescribed sarecycline according to their own clinical judgment and standard practice. Eligible patients prescribed commercially available sarecycline were to be followed for 12 weeks after treatment initiation. The study assessed patient-reported outcomes, the Investigator’s Global Assessment (IGA) of acne vulgaris, and safety measures during the observation period. A secondary outcome was the percentage of participants with facial IGA success at Week 12.
The registry record lists the study as completed. Its start date was 2021-03-09 and its primary completion date was 2022-05-04. These dates describe the study record, not the timing of individual participants’ treatment or follow-up. The registry record does not report a detailed recruitment process, the number of participating clinical sites, or how many enrolled participants completed follow-up.
Because there is no identified control group, the design describes outcomes in people who received sarecycline rather than an estimated treatment contrast against another intervention. Changes between baseline and Week 12 can describe the cohort’s observed course, but they cannot by themselves separate treatment effects from other explanations, such as changes over time or differences among patients. The primary outcome results and the number included in its analysis are not reported in the registry record.
4. Participant Flow and Accounting
The registry reports how participants moved through each stage of the study. All counts below are exactly as posted; missing counts are not inferred from other stages.
Before assignment: A total of 300 Acne Vulgaris (AV) participants were enrolled and received treatment in this study.
Overall Study
| Stage | Sarecycline |
|---|---|
| STARTED | 300 |
| Safety Analysis Set | 300 |
| Full Analysis Set (FAS) | 253 |
| COMPLETED | 262 |
| NOT COMPLETED | 38 |
Reasons for not completing this period:
| Reason | Sarecycline |
|---|---|
| Adverse Event | 6 |
| Due to Lack of Effectiveness | 1 |
| Pregnancy | 1 |
| Voluntary Withdrawal | 20 |
| Lost to Follow-up | 10 |
Analysis population for the primary outcome, as defined in the registry: FAS included all participants within the safety population that had at least one question answered pertaining to study primary research objective and who completed their Week-12 survey.
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: Safety population included all participants who received at least one dose of sarecycline during the study observation period, as part of usual care.
| Characteristic | Unit | Sarecycline |
|---|---|---|
| Participants analysed | 300 | |
| Age, Categorical: <=18 years | Participants | 116 |
| Age, Categorical: Between 18 and 65 years | Participants | 184 |
| Age, Categorical: >=65 years | Participants | 0 |
| Sex: Female, Male: Female | Participants | 201 |
| Sex: Female, Male: Male | Participants | 99 |
| Race/Ethnicity, Customized: Ethnicity – Hispanic, Latino, or of Spanish Origin | Participants | 101 |
| Race/Ethnicity, Customized: Ethnicity – Other | Participants | 199 |
| Race/Ethnicity, Customized: Race – White | Participants | 195 |
| Race/Ethnicity, Customized: Race – Black or African American | Participants | 32 |
| Race/Ethnicity, Customized: Race – American Indian or Alaska Native | Participants | 3 |
| Race/Ethnicity, Customized: Race – Asian | Participants | 17 |
| Race/Ethnicity, Customized: Race – Native Hawaiian or Other Pacific Islander | Participants | 3 |
| Race/Ethnicity, Customized: Race – Other | Participants | 41 |
| Race/Ethnicity, Customized: Race – Prefer not to answer | Participants | 9 |
6. Primary Endpoint
The registry lists the primary outcome as Change From Baseline in Acne Symptom and Impact Scale Questionnaire (ASIS) Domain Score at Week 12, measured over Baseline, Week 12.
| Element | Registry entry |
|---|---|
| Result type | Mean |
| Measure of spread | Standard Deviation |
| Unit | Score on a Scale |
| Endpoint classification | Continuous Endpoint |
The primary endpoint was change from baseline in ASIS domain score at Week 12. ASIS is a 17-item patient-reported questionnaire about acne signs and the emotional and social impact of acne vulgaris. Responses are reported on two scales: a Signs domain with 9 items and an Impact domain with 8 items. The Impact domain has Emotional and Social subscales, comprising 6 and 2 items, respectively. Items are scored from 0 (best) to 4 (worst), and domain scores are averages of the scores within their respective scales.
Higher Signs scores indicate more severe symptoms, while higher Impact scores indicate a greater negative impact of acne. The measure is relevant to a study focused on patient-reported outcomes because it captures participants’ reported experience rather than relying only on a clinician’s assessment. A change score can describe how those reports differ between baseline and the scheduled Week-12 assessment. It is important to interpret the direction using the scale definition: a higher score represents a worse experience.
The registry record specifies a mean and standard deviation as the summary approach, but does not report the domain means, standard deviations, or changes. It also does not report a confidence interval or statistical test for the primary endpoint. Consequently, the magnitude and precision of the observed ASIS change cannot be described from the registry record.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry record identifies change in ASIS domain score at Week 12 as the primary outcome, but it does not report the numerical results. Baseline scores, Week-12 scores, mean changes, standard deviations, confidence intervals, and p-values for the primary outcome are not reported in the registry record. Therefore, the direction, size, and precision of any observed change cannot be evaluated from the posted results described in the record.
ASIS scores have a defined direction: higher scores reflect more severe symptoms in the Signs domain and greater negative impact in the Impact domain. If numerical changes were available, their interpretation would depend on the scale and the direction of the change. Without those values, no conclusion about whether scores rose or fell, or how large any change was, is justified. The registry record also does not give a threshold for interpreting a change as clinically important.
The design is an uncontrolled cohort in which clinicians prescribed sarecycline under standard practice. Such a design can describe outcomes among the participants followed, but it does not provide a randomized treatment contrast. A baseline-to-follow-up change alone cannot establish that treatment caused the change, because the registry record does not include a like-for-like control group that could help distinguish treatment-associated change from other influences.
The record lists 300 participants enrolled, but the primary outcome population required completion of the Week-12 survey and at least one relevant answered question. The number satisfying those criteria is not reported. That distinction matters because the enrolled population and the group contributing primary outcome data may differ. The record does not describe how missing responses were handled or whether the analysis accounted for differences between participants with and without Week-12 data.
The study also assessed facial IGA success and safety measures, but numerical results for the secondary outcome are not reported in the registry record. For safety, the record lists 1 participant affected by a serious adverse event and 30 affected by other adverse events among 300 at risk, with 0 deaths. These counts describe events recorded during the study and do not, on their own, establish that sarecycline caused them. Overall, the registry record identifies the outcomes and study population but does not report enough outcome statistics to assess the primary result’s magnitude or precision.
9. Statistical Methods Explained
The primary outcome is continuous: an ASIS domain score can take values on a scale rather than representing a simple event count. The registry record says the outcome was summarized using a mean and standard deviation. These statistics describe different features of a distribution. The mean gives its average score, while the standard deviation describes how spread out individual scores are around that average. Neither statistic is reported for the primary outcome in the registry record.
What does a change score represent?
A change-from-baseline outcome compares a participant’s later score with that participant’s baseline score, then summarizes those changes across the analysis population. It is distinct from reporting only the Week-12 average: baseline values provide the starting point for interpreting the follow-up measurement. For ASIS, the scoring direction matters because higher scores mean worse symptoms or greater negative impact. The registry record specifies the assessment at baseline and Week 12 but does not give the average change or the underlying scores. It is therefore not possible to say whether the cohort’s mean score increased or decreased.
How should a confidence interval be read?
General statistical explanation: a confidence interval expresses uncertainty around an estimate under the assumptions of the analysis. A narrower interval indicates greater precision than a wider interval, while the interval’s location indicates which values are compatible with the data and method. A confidence interval is not reported for the primary outcome in the registry record. Without an estimate and its interval, the precision of the mean change cannot be assessed.
What would a significance test add?
General statistical explanation: a significance test evaluates how compatible the data are with a specified null hypothesis, given the model and its assumptions. A p-value does not measure the size or practical importance of an effect, and it does not establish causation. The registry record does not report a p-value or describe a test for the primary outcome. No test result should be inferred from the endpoint description alone.
Why does the cohort design matter?
General statistical explanation: random assignment can support a comparison by balancing prognostic factors across groups on average, whereas an uncontrolled cohort has no randomized control group to serve that purpose. In this study, clinicians prescribed sarecycline under their own judgment and standard practice. This reflects community practice, but treatment was not assigned through a reported randomized comparison. A change over time within the cohort could reflect multiple influences, and the record does not provide a control-group estimate that would isolate a treatment contrast.
What does the planning illustration mean?
The sample-size assumptions describe a planning illustration based on the observed effect, not the study’s own design. They specify a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation, with the effect to detect defined as a stated fraction of the observed effect. For non-time-to-event outcomes, the illustration is expressed as participants per arm for 80% power or other listed power levels; time-to-event illustrations use a total number of events. These are planning quantities, not observed outcomes or observed power. The registry record does not report a trial sample-size justification, and there is no randomized two-arm comparison in the described study. No numerical planning illustration values are reported in the registry record.
General statistical explanation: over-dispersion refers to data varying more than a model’s assumed distribution allows. When present, it can make standard errors too small and confidence intervals too narrow if not addressed. This is a general consideration for statistical modeling; the registry record does not report an over-dispersion assessment or an analysis model for the primary outcome. It also does not report whether the analysis adjusted for covariates or used any other modeling approach.
10. Multiplicity, Missing Data and Analysis Populations
The registry record lists two outcome measures: the primary ASIS domain-score change and a secondary outcome of facial IGA success at Week 12. It lists one analysis. These details do not establish how the analysis handled multiple outcomes or multiple comparisons. A multiplicity adjustment, a hierarchy of hypotheses, or another strategy for controlling the interpretation of multiple tests is not reported in the registry record.
The primary outcome population was defined as participants in the safety population who answered at least one question pertaining to the primary research objective and completed the Week-12 survey. The record does not report the number who met this definition. It also does not report the number who lacked a baseline score, missed Week 12, or had incomplete questionnaire responses.
How missing outcome data were handled is not reported in the registry record. There is no description of imputation, exclusion rules beyond the stated population definition, or sensitivity analyses. General statistical explanation: missing data can affect an estimate when participants with observed outcomes differ systematically from those without them. The direction and extent of any such effect depend on the missingness pattern and the analysis assumptions; neither can be assessed from the record.
The registry record does not report a detailed statistical analysis plan, the planned handling of multiple tests, or interim analyses. These omissions do not establish that a particular method was or was not used; they mean those details 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 |
|---|---|---|---|
| Sarecycline | 1 | 300 | 0.3% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| Sarecycline | 0 of 300 |
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 |
|---|---|
| Sarecycline | 30 of 300 |
Most frequent serious adverse event terms
| Event term | Organ system | Sarecycline |
|---|---|---|
| Idiopathic intracranial hypertension | Nervous system disorders | 1 of 300 |
Most frequent non-serious adverse event terms
| Event term | Organ system | Sarecycline |
|---|---|---|
| Nausea | Gastrointestinal disorders | 4 of 300 |
| Dizziness | Nervous system disorders | 3 of 300 |
| Headache | Nervous system disorders | 3 of 300 |
| Pruritus | Skin and subcutaneous tissue disorders | 3 of 300 |
| Rash | Skin and subcutaneous tissue disorders | 3 of 300 |
| Abdominal discomfort | Gastrointestinal disorders | 2 of 300 |
| Diarrhea | Gastrointestinal disorders | 2 of 300 |
| COVID-19 | Infections and infestations | 2 of 300 |
| Vulvovaginal mycotic infection | Infections and infestations | 2 of 300 |
| Migraine | Nervous system disorders | 2 of 300 |
Serious events with the highest arm-level rate: idiopathic intracranial hypertension (0.3%).
The registry record lists 300 participants at risk in the sarecycline group. It records 1 participant affected by a serious adverse event and 30 affected by other adverse events. It lists 0 deaths. The most frequent serious adverse-event term shown is idiopathic intracranial hypertension, reported as 0.3%.
These figures should be read as registry-recorded safety counts and a listed term, not as a comparison with an untreated or alternative-treatment group. No control group is identified, so the record does not provide a comparative safety estimate. The figures also do not establish that sarecycline caused an event. The record does not report further detail about event timing, duration, severity beyond the serious-event classification, or the outcome of individual events.
The number of participants affected is not necessarily the same as the total number of events if an individual experienced more than one event; the registry record does not provide event-level detail. The reported 0 deaths is a count for the study record, not evidence about risks outside the observed cohort or observation period. These safety figures should be interpreted within the study’s 12-week follow-up context and its lack of a control comparison.
12. What the Result Does, and Does Not, Mean
This registry record describes a prospective, real-world cohort in which clinicians prescribed sarecycline to patients with moderate to severe non-nodular acne vulgaris in U.S. community practice. It identifies a patient-reported primary outcome, a 12-week follow-up period, a secondary facial IGA outcome, and safety measures. It also records an enrollment of 300 and defines the population intended for the primary outcome analysis.
The primary outcome values are not reported in the registry record. As a result, the posted information does not establish the direction or magnitude of the mean ASIS change, its variability, or its statistical precision. No primary-outcome confidence interval or p-value is reported. The registry record also does not provide numerical results for the listed secondary IGA outcome.
The design does not identify a randomized control group. A change in scores among participants followed over time would describe their reported experience, but would not by itself show that sarecycline caused the change. Other influences cannot be separated from treatment-associated change using a single uncontrolled cohort alone.
The safety record lists 1 participant affected by a serious adverse event, 30 affected by other adverse events, and 0 deaths among 300 at risk. Those figures describe the recorded study experience; without a control group, they do not give a comparative estimate or establish causality. The record’s safety detail is limited, and the follow-up period was 12 weeks.
Overall, the registry record supports a description of the study’s purpose, design, outcome definitions, and selected safety counts. It does not support a quantitative judgment about the primary outcome’s size or precision, nor a causal treatment comparison. Those limits follow from the outcome results and analysis details not being reported in the registry record and from the uncontrolled cohort design.
13. Why This Trial Matters Statistically
This study is statistically relevant because it uses patient-reported outcomes alongside clinician assessment and safety measures in a real-world cohort. ASIS captures both acne signs and the emotional and social impact of acne. Its two domains have different interpretations: higher Signs scores reflect more severe symptoms, while higher Impact scores reflect greater negative impact. Understanding what each scale measures is necessary before interpreting any reported change.
The cohort design also illustrates a distinction between describing change and estimating a comparative effect. Following participants from baseline to Week 12 can characterize outcomes over time, but without a randomized control group it cannot provide the same treatment contrast as a controlled trial. Clinician prescribing according to standard practice makes the setting observational, and the record does not identify a like-for-like comparator.
Completeness of follow-up matters for patient-reported outcomes. The primary outcome population required a completed Week-12 survey and at least one relevant answer, while the enrolled total was 300. Because the number included in that analysis and the handling of missing responses are not reported in the registry record, readers cannot judge how closely the analyzed group represents everyone enrolled.
Finally, interpretation depends on the results and uncertainty estimates, not only on the endpoint definition. The registry record identifies the primary measure and its scoring, but does not report the mean change, variability, or confidence interval. This makes the record useful for understanding what the study set out to assess, while limiting what can be concluded statistically about the observed primary outcome.
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 report numerical results for the primary ASIS outcome. It provides no baseline or Week-12 domain means, mean changes, standard deviations, confidence intervals, or p-values. The magnitude and precision of the primary outcome therefore cannot be assessed from the record. Numerical results for the secondary facial IGA success outcome are also not reported.
The study is described as a cohort in which clinicians prescribed sarecycline according to their own judgment and standard practice. No randomized control group is identified, so the study does not provide a like-for-like treatment comparison. This limits causal interpretation of any within-cohort change.
Although the record lists 300 enrolled participants, it does not report how many completed follow-up or met the primary outcome population definition. The handling of missing questionnaire data, the number of incomplete assessments, and any sensitivity analyses are not reported in the registry record. The representativeness of the primary outcome analysis population therefore cannot be assessed.
The record also does not report a detailed statistical analysis plan, multiplicity strategy, interim analyses, or sample-size justification. The listed sample-size assumptions refer to a planning illustration based on the observed effect rather than the study’s own design. Safety detail is limited to the listed affected-participant counts, deaths, and top serious-event term; event-level detail and a comparator are not reported. The follow-up period was 12 weeks, which bounds the observation described by this study.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Patient-reported Outcomes for Sarecycline Effectiveness and Safety (PROSES) — NCT04820673.
- Registry record last updated 2024-10-10; status last verified 2024-10.
- Results first posted 2024-10-10.
- 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
NCT04820673, titled Patient-reported Outcomes for Sarecycline Effectiveness and Safety (PROSES), was a completed prospective real-world cohort study sponsored by Almirall, S.A. It enrolled 300 participants with moderate to severe non-nodular acne vulgaris in U.S. community practice settings. Clinicians prescribed sarecycline according to their own judgment and standard practice, and eligible patients were followed for 12 weeks.
The primary outcome was change from baseline to Week 12 in ASIS domain score. The study also listed facial IGA success at Week 12 as a secondary outcome and assessed safety. The record lists 1 participant affected by a serious adverse event, 30 affected by other adverse events, and 0 deaths among 300 at risk. Numerical primary and secondary outcome results are not reported in the registry record. A randomized control group, detailed missing-data methods, and a detailed statistical analysis plan are not reported.