Comparison · NCT04608500-sae
FMX103 1.5% vs Vehicle Foam: serious adverse events
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
2 sourcestrial-comparisons-2026-03-23-0.1.0
Cite this record
ConductScience Library. FMX103 1.5% vs Vehicle Foam: serious adverse events. Trial comparisons, record NCT04608500-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT04608500-sae
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Measures6
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
| Measure | Value | 95% interval, lower | 95% interval, upper | Method | Note |
|---|---|---|---|---|---|
| Risk in group 1 | 0.00195 | 0.000344 | 0.0109 | wilson | |
| Risk in group 2 | 0.00778 | 0.00214 | 0.0279 | wilson | |
| Risk difference, group 1 minus group 2 | -0.00584 | -0.026 | 0.00478 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.25 | 0.0228 | 2.74 | log | |
| Odds ratio, group 1 over group 2 | 0.249 | 0.0224 | 2.75 | log | |
| Number needed to treat, for one fewer participant with a serious adverse event on FMX103 1.5% than on Vehicle Foam | 171 | from the risk difference interval | the interval includes no difference |
Source ClinicalTrials.gov
Groups2
Group 2 names the comparator: vehicle.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code |
|---|---|---|---|---|---|
| Group 1 | FMX103 1.5% | Participants applied the assigned FMX103 minocycline foam 1.5% topically once daily for 12 weeks as directed. | 1 | 514 | EG000 |
| Group 2 | Vehicle Foam | Participants applied the assigned vehicle foam topically once daily for 12 weeks as directed. | 2 | 257 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- From Day 0/Baseline until the Safety Follow-up (4 weeks after Week 12 [Final Visit])
Source ClinicalTrials.gov
Trial
- Title
- A Study (Study 2) to Evaluate the Safety and Efficacy of FMX103 1.5% Topical Minocycline Foam in the Treatment of Facial Papulopustular Rosacea
- NCT number
- NCT04608500
- Phases
- PHASE3
- Conditions
- Facial Papulopustular Rosacea
- Interventions
- FMX103 minocycline foam 1.5%, Vehicle foam
- Lead sponsor
- Vyne Therapeutics Inc.
- Results first posted
- 2020-12-16
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT04608500?tab=results
Source ClinicalTrials.gov
Source
- Release
- trial-comparisons-2026-03-23-0.1.0
- Release manifest SHA-256
- f66225897fbf258b57ea10bdacfd0347d3cdfda93f7f5685234b7e06ea36fa57
- AACT copy
- 2026-03-23
- Tables read
- outcome_counts.parquet, outcome_measurements.parquet, outcomes.parquet, reported_event_totals.parquet, reported_events.parquet, result_groups.parquet, studies.parquet, ctgov_trial.parquet
Source ClinicalTrials.gov
Sources 2
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions. The measures are ConductScience's calculation from them.
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