Comparison · NCT05386030-sae
Saypha® VOLUME Lidocaine vs Juvéderm® Voluma™ XC: 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. Saypha® VOLUME Lidocaine vs Juvéderm® Voluma™ XC: serious adverse events. Trial comparisons, record NCT05386030-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT05386030-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 | 0.0124 | 0.00484 | 0.0315 | wilson | |
| Risk in group 2 | 0.0124 | 0.00341 | 0.0442 | wilson | |
| Risk difference, group 1 minus group 2 | 0 | -0.0326 | 0.0211 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1 | 0.185 | 5.4 | log | |
| Odds ratio, group 1 over group 2 | 1 | 0.181 | 5.52 | log | |
| Number needed to harm | from the risk difference interval | the two groups' risks are equal |
Source ClinicalTrials.gov
Groups2
Neither group, or both, names a comparator, so the groups keep ClinicalTrials.gov's order.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code |
|---|---|---|---|---|---|
| Group 1 | Saypha® VOLUME Lidocaine | For injection, either a needle (27G ½'') or cannula (25G 1½) may be used. Randomization will be stratified by injection equipment in a 1:1 ratio.~The volume administered is at the discretion of the treating investigator and depends on the severity of the midface volume deficit to be corrected. However, the maximum volume (left and right side of the midface together) must not exceed 10 mL in total per treatment (initial and repeat-treatment) or 20 mL per 60 kg (130 lbs) body mass per year.~saypha® VOLUME Lidocaine: Crosslinked hyaluronic acid (HA) 23 mg/mL + 0.3% lidocaine hydrochloride. | 4 | 322 | EG000 |
| Group 2 | Juvéderm® Voluma™ XC | For injection, either a needle (27G ½'') or cannula (25G 1½) may be used. Randomization will be stratified by injection equipment in a 1:1 ratio.~The volume administered is at the discretion of the treating investigator and depends on the severity of the midface volume deficit to be corrected. However, the maximum volume (left and right side of the midface together) must not exceed 10 mL in total per treatment (initial and repeat-treatment) or 20 mL per 60 kg (130 lbs) body mass per year.~Juvéderm® Voluma™ XC: Crosslinked HA 20 mg/mL + 0.3% lidocaine hydrochloride | 2 | 161 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- 48 weeks
Source ClinicalTrials.gov
Trial
- Title
- Saypha® VOLUME Lidocaine for Midface Augmentation
- NCT number
- NCT05386030
- Phases
- PHASE3
- Conditions
- Moderate to Severe Midface Volume Deficit
- Interventions
- saypha® VOLUME Lidocaine, Juvéderm® Voluma™ XC
- Lead sponsor
- Croma-Pharma GmbH
- Results first posted
- 2025-01-16
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT05386030?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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