Comparison · NCT03824912-2d02cd43
Test: Ketoconazole Cream 2% vs Reference: Ketoconazole Cream 2%: Secondary Efficacy Endpoint: The Number of Patients in Each Treatment Group With a Clinical 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 Clinical Cure of Tinea Pedis (Equivalence: Per-Protocol Population). Trial comparisons, record NCT03824912-2d02cd43. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT03824912-2d02cd43
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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 | 0.527 | 0.455 | 0.598 | wilson | |
| Risk in group 2 | 0.576 | 0.505 | 0.644 | wilson | |
| Risk difference, group 1 minus group 2 | -0.0487 | -0.148 | 0.0515 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.915 | 0.762 | 1.1 | log | |
| Odds ratio, group 1 over group 2 | 0.821 | 0.546 | 1.23 | log | |
| Number needed to treat, for one fewer participant with the outcome on Test: Ketoconazole Cream 2% than on Reference: Ketoconazole Cream 2% | 20.5 | 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. | 97 | 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. | 110 | 191 | OG001 |
Source ClinicalTrials.gov
Outcome
- Type
- SECONDARY
- Title
- Secondary Efficacy Endpoint: The Number of Patients in Each Treatment Group With a Clinical Cure of Tinea Pedis (Equivalence: Per-Protocol Population)
- Description
Clinical Cure: To be considered a clinical cure the patient's total severity score must be ≤ 2 with no individual severity score \> 1.~Clinical Failure: A patient will be considered a Clinical Failure if the patient's total severity score is \> 2 or any individual score is \> 1.~Local Signs and Symptoms The most severely affected area will be identified as the target lesion at the baseline visit and will be used for the assessments at Day 42 and Day 56 visits.~The Clinical Signs and Symptoms of tinea pedis will be rated by the Investigator as none, mild, moderate or severe using the following standardized rating scale.~0 = None (complete absence of any sign or symptom)~1. = Mild (Slight)~2. = Moderate (Definitely Present)~3. = Severe (Marked, Intense)~The following signs and symptoms will be rated at each visit:~* Signs: Fissuring/cracking, erythema, maceration, and scaling~* Symptoms: Pruritus and burning/stinging
- Time frame
- Two weeks after the end of treatment (Day 56 ± 4) (Equivalence)
- Population
The Per-Protocol population was used for this analysis to determine equivalence between the Test and Reference groups only. To determine equivalence, only the test and reference treatment arms are analyzed.
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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