Comparison · NCT03824912-da7f26de
Test: Ketoconazole Cream 2% vs Reference: Ketoconazole Cream 2%: Secondary Efficacy Endpoint:The Number of Patients in Each Treatment Group With a Mycological Cure of Tinea Pedis (Equivalence: Per-Protocol Population)
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. Test: Ketoconazole Cream 2% vs Reference: Ketoconazole Cream 2%: Secondary Efficacy Endpoint:The Number of Patients in Each Treatment Group With a Mycological Cure of Tinea Pedis (Equivalence: Per-Protocol Population). Trial comparisons, record NCT03824912-da7f26de. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT03824912-da7f26de
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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 | 0.69 | 0.62 | 0.753 | wilson | |
| Risk in group 2 | 0.621 | 0.55 | 0.687 | wilson | |
| Risk difference, group 1 minus group 2 | 0.0692 | -0.0271 | 0.163 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.11 | 0.959 | 1.29 | log | |
| Odds ratio, group 1 over group 2 | 1.36 | 0.886 | 2.09 | log | |
| Number needed to treat, for one more participant with the outcome on Test: Ketoconazole Cream 2% than on Reference: Ketoconazole Cream 2% | 14.5 | from the risk difference interval | the interval includes no difference |
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 | Test: Ketoconazole Cream 2% | Test: Ketoconazole Cream 2% (Encube Ethicals Pvt Ltd)~Ketoconazole Cream 2%: Patients will be instructed to apply sufficient study product to cover affected and immediate surrounding areas once daily for 42 ± 4 days. Each patient is expected to receive 42 ± 4 doses. | 127 | 184 | OG000 |
| Group 2 | Reference: Ketoconazole Cream 2% | Ketoconazole Cream 2% (G\&W Laboratories Inc.; Registrant: Teva Pharmaceuticals USA Inc.)~Ketoconazole Cream 2% (G\&W Laboratories Inc.): Patients will be instructed to apply sufficient study product to cover affected and immediate surrounding areas once daily for 42 ± 4 days. Each patient is expected to receive 42 ± 4 doses. | 118 | 190 | OG001 |
Source ClinicalTrials.gov
Outcome
- Type
- SECONDARY
- Title
- Secondary Efficacy Endpoint:The Number of Patients in Each Treatment Group With a Mycological Cure of Tinea Pedis (Equivalence: Per-Protocol Population)
- Description
Mycological Cure: To be considered a mycological cure the patient must have a negative Potassium hydroxide (KOH) test and a negative fungal culture.~Mycological Failure: A patient will be considered a Mycological Failure if the patient's KOH test is positive or the patient's fungal culture is positive.
- Time frame
- Two weeks after the end of treatment (Day 56 ± 4) (Equivalence)
- Population
The PP population was used for this analysis to determine equivalence between the Test and Reference groups only. One patient had an inconclusive result for the fungal culture at Visit 3 and was excluded from the analysis of the secondary endpoint for the mycological cure. Patient was a clinical failure and was included in the primary analysis.
Source ClinicalTrials.gov
Trial
- Title
- Clinical Study to Evaluate the Therapeutic Equivalence of Ketoconazole Cream 2% in the Treatment of Tinea Pedis
- NCT number
- NCT03824912
- Phases
- PHASE3
- Conditions
- Tinea Pedis
- Interventions
- Ketoconazole Cream 2%, Ketoconazole Cream 2% (G&W Laboratories Inc.), Placebo
- Lead sponsor
- Encube Ethicals Pvt. Ltd.
- Results first posted
- 2019-06-13
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT03824912?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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