Comparison · NCT03154333-eae01485
Diacerein 1% Ointment vs Vehicle Ointment: Proportion of Subjects Who Achieved ≥ 60% Reduction in Body Surface Area (BSA) of EBS Lesions Within Assessment Area
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. Diacerein 1% Ointment vs Vehicle Ointment: Proportion of Subjects Who Achieved ≥ 60% Reduction in Body Surface Area (BSA) of EBS Lesions Within Assessment Area. Trial comparisons, record NCT03154333-eae01485. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT03154333-eae01485
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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 | 0.571 | 0.391 | 0.735 | wilson | |
| Risk in group 2 | 0.538 | 0.355 | 0.712 | wilson | |
| Risk difference, group 1 minus group 2 | 0.033 | -0.218 | 0.279 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.06 | 0.657 | 1.71 | log | |
| Odds ratio, group 1 over group 2 | 1.14 | 0.39 | 3.35 | log | |
| Number needed to treat, for one more participant with the outcome on Diacerein 1% Ointment than on Vehicle Ointment | 30.3 | 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 | Diacerein 1% Ointment | diacerein 1% ointment will be used for 8 weeks~diacerein 1% ointment: diacerein 1% ointment administered topically | 16 | 28 | OG000 |
| Group 2 | Vehicle Ointment | vehicle ointment will be used for 8 weeks~vehicle ointment administered topically | 14 | 26 | OG001 |
Source ClinicalTrials.gov
Outcome
- Type
- PRIMARY
- Title
- Proportion of Subjects Who Achieved ≥ 60% Reduction in Body Surface Area (BSA) of EBS Lesions Within Assessment Area
- Description
- Analysis of the proportion of subjects who achieved a ≥60% reduction in Body Surface Area (BSA) of EBS lesions within Assessment Area from Baseline to Week 8
- Time frame
- Baseline to Week 8
- Population
All efficacy analyses were conducted using the Intent to Treat (ITT) Population that consisted of all randomized subjects who were dispensed study drug. Subjects were included in the treatment group to which they were assigned.
Source ClinicalTrials.gov
Trial
- Title
- Safety and Efficacy of Diacerein 1% Ointment for Subjects With Epidermolysis Bullosa Simplex (EBS)
- NCT number
- NCT03154333
- Phases
- PHASE2
- Conditions
- Epidermolysis Bullosa Simplex
- Interventions
- diacerein 1% ointment, A placebo ointment
- Lead sponsor
- Castle Creek Pharmaceuticals, LLC
- Results first posted
- 2019-11-05
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT03154333?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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