Comparison · NCT03573401-sae
BF-200 ALA vs Vehicle: serious adverse events
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
2 sourcestrial-comparisons-2026-03-23-0.1.0
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ConductScience Library. BF-200 ALA vs Vehicle: serious adverse events. Trial comparisons, record NCT03573401-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT03573401-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 | 0.0207 | 0.00706 | 0.0591 | wilson | |
| Risk in group 2 | 0.0476 | 0.0132 | 0.158 | wilson | |
| Risk difference, group 1 minus group 2 | -0.0269 | -0.138 | 0.0246 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.434 | 0.0751 | 2.52 | log | |
| Odds ratio, group 1 over group 2 | 0.423 | 0.0682 | 2.62 | log | |
| Number needed to treat, for one fewer participant with a serious adverse event on BF-200 ALA than on Vehicle | 37.1 | 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 | BF-200 ALA | Topical Photodynamic therapy (PDT) using the red light device BF-RhodoLED® after 3h incubation of BF-200 ALA containing 7.8% 5-ALA (5-aminolevulinic acid). | 3 | 145 | EG000 |
| Group 2 | Vehicle | Topical Photodynamic therapy (PDT) using the red light device BF-RhodoLED® after 3h incubation of vehicle to BF-200 ALA. | 2 | 42 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
The collection of adverse events (AEs) started with the subjects' informed consent (≤ 4 weeks prior to the first PDT) until the end of the clinical observation period (12 weeks after start of last PDT cycle).
Source ClinicalTrials.gov
Trial
- Title
- Study to Evaluate the Safety and Efficacy of BF-200 ALA (Ameluz®) and BF-RhodoLED® in the Treatment of Superficial Basal Cell Carcinoma (sBCC) With Photodynamic Therapy (PDT).
- NCT number
- NCT03573401
- Phases
- PHASE3
- Conditions
- Superficial Basal Cell Carcinoma
- Interventions
- Photodynamic therapy (PDT) (ALA-PDT, Ameluz®-PDT), Placebo Photodynamic therapy (PDT) (vehicle to BF-200 ALA containing no active ingredient)
- Lead sponsor
- Biofrontera Inc.
- Results first posted
- 2025-04-29
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT03573401?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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