Comparison · NCT01926496-7dae359e
Ingenol Mebutate vs Imiquimod: Number of Participants With Complete Clearance of AK Lesions at 12 Months
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. Ingenol Mebutate vs Imiquimod: Number of Participants With Complete Clearance of AK Lesions at 12 Months. Trial comparisons, record NCT01926496-7dae359e. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT01926496-7dae359e
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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 | 0.292 | 0.238 | 0.352 | wilson | |
| Risk in group 2 | 0.441 | 0.38 | 0.503 | wilson | |
| Risk difference, group 1 minus group 2 | -0.149 | -0.232 | -0.0634 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.662 | 0.519 | 0.843 | log | |
| Odds ratio, group 1 over group 2 | 0.522 | 0.359 | 0.76 | log | |
| Number needed to treat, for one fewer participant with the outcome on Ingenol Mebutate than on Imiquimod | 6.7 | 4.32 | 15.8 | from the risk difference interval |
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 | Ingenol Mebutate | Arm A: Ingenol mebutate gel 0.015% applied daily for 3 consecutive days to the selected treatment area followed by 8 weeks' rest. Retreatment for another 3 consecutive days if the treatment field is not completely cleared of AKs at Week 8 \>~\> Ingenol Mebutate Gel, 0.015%: Ingenol mebutate gel 0.015 % (Picato®) applied on the selected treatment area. Retreatment if the treatment field is not completely cleared of AKs. | 70 | 240 | OG000 |
| Group 2 | Imiquimod | Arm B: Imiquimod 5% cream applied 3 days per week for 4 weeks to the selected~\> treatment area followed by 4 weeks' rest. Retreatment for another 4 weeks if the treatment field is not completely cleared of AKs at Week 8~\>~\> Imiquimod Cream, 5%: Imiquimod 5% cream applied to the selected treatment area. Retreatment if the treatment field is not completely cleared of AKs | 108 | 245 | OG001 |
Source ClinicalTrials.gov
Outcome
- Type
- SECONDARY
- Title
- Number of Participants With Complete Clearance of AK Lesions at 12 Months
- Description
- To compare the complete clearance of AK lesions at 12 months, defined as no AK lesions in the selected treatment area at any time from the last treatment cycle at Week 8 or 16 through to Month 12.
- Time frame
- 1 year
- Population
- Full analysis set: all randomised subjects.
Source ClinicalTrials.gov
Trial
- Title
- Risk of Squamous Cell Carcinoma on Skin Areas Treated With Ingenol Mebutate Gel, 0.015% and Imiquimod Cream, 5%
- NCT number
- NCT01926496
- Phases
- PHASE4
- Conditions
- Actinic Keratosis (AK)
- Interventions
- Ingenol Mebutate Gel, 0.015%, Imiquimod Cream, 5%
- Lead sponsor
- LEO Pharma
- Results first posted
- 2020-07-29
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT01926496?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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