Comparison · NCT04085367-sae
MAL 16.8% Cream vs MAL Vehicle Cream: 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. MAL 16.8% Cream vs MAL Vehicle Cream: serious adverse events. Trial comparisons, record NCT04085367-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT04085367-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 | 0.0137 | 0.00588 | 0.0317 | wilson | |
| Risk in group 2 | 0.00518 | 0.000915 | 0.0288 | wilson | |
| Risk difference, group 1 minus group 2 | 0.00855 | -0.0163 | 0.0271 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 2.65 | 0.312 | 22.5 | log | |
| Odds ratio, group 1 over group 2 | 2.67 | 0.31 | 23.1 | log | |
| Number needed to harm, for one more participant with a serious adverse event on MAL 16.8% Cream than on MAL Vehicle Cream | 117 | 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 | MAL 16.8% Cream | Participants received two treatment session at least 2 weeks apart. Investigator was to apply a thin layer of methyl aminolevulinate (MAL) hydrochloride 16.8% cream to each lesion during treatment. At 30 minutes after cream application, participants were to go outside in daylight for 2 hours. After this time, the cream was to be removed by investigative site personnel by washing the skin with gentle skin cleanser. | 5 | 364 | EG000 |
| Group 2 | MAL Vehicle Cream | Participants received two treatment session at least 2 weeks apart. Investigator was to apply a thin layer of vehicle cream to each lesion during treatment. At 30 minutes after cream application, participants were to go outside in daylight for 2 hours. After this time, the cream was to be removed by investigative site personnel by washing the skin with gentle skin cleanser. | 1 | 193 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- Baseline up to Week 14
Source ClinicalTrials.gov
Trial
- Title
- Multicenter Study to Assess the Efficacy and Safety of Methyl Aminolevulinate Hydrochloride (MAL) 16.8% Cream (CD06809-41) Versus Vehicle Cream for Actinic Keratosis of the Face
- NCT number
- NCT04085367
- Phases
- PHASE3
- Conditions
- Actinic Keratoses
- Interventions
- MAL 16.8% cream, MAL Vehicle Cream
- Lead sponsor
- Galderma R&D
- Results first posted
- 2022-04-01
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT04085367?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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