Trial · NCT03824912
Clinical Study to Evaluate the Therapeutic Equivalence of Ketoconazole Cream 2% in the Treatment of Tinea Pedis
NCT03824912, Phase 3, Completed, Encube Ethicals Pvt. Ltd.; results first posted 2019-06-13
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Clinical Study to Evaluate the Therapeutic Equivalence of Ketoconazole Cream 2% in the Treatment of Tinea Pedis. Trials, record NCT03824912. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03824912
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Clinical Study to Evaluate the Therapeutic Equivalence of Ketoconazole Cream 2% in the Treatment of Tinea Pedis
- NCT number
- NCT03824912
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 831 participants, actual
- Lead sponsor
- Encube Ethicals Pvt. Ltd.
- Conditions
- Tinea Pedis
- Interventions
- Ketoconazole Cream 2%, Ketoconazole Cream 2% (G&W Laboratories Inc.), Placebo
- First posted
- 2019-01-31
- Last updated
- 2019-06-27
- Results first posted
- 2019-06-13
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Primary Efficacy Endpoint: The Number of Patients in Each Treatment Group With a Therapeutic Cure of Tinea Pedis (Equivalence: Per-Protocol Population) | Two weeks after the end of treatment (Day 56 ± 4) (Equivalence) | Equivalence: Per-Protocol Population Therapeutic Cure: To be considered a Therapeutic Cure, the patient must have both Clinical and Mycological Cure of tinea pedis. Therapeutic Failure: A patient will be considered a Therapeutic Failure if: 1. the patient is a Clinical or Mycological Failure 2. the patient was considered to have an insufficient therapeutic response 3. the patient used topical drug therapy for irritation or pruritus on the feet after the treatment phase of the study |
| Primary | Primary Efficacy Endpoint: The Number of Patients in Each Treatment Group With a Therapeutic Cure of Tinea Pedis (Superiority: Modified Intent-to-Treat Population) | Two weeks after the end of treatment (Day 56 ± 4) (Superiority) | Superiority: modified Intent-to-Treat Population Therapeutic Cure: To be considered a Therapeutic Cure, the patient must have both Clinical and Mycological Cure of tinea pedis. Therapeutic Failure: A patient will be considered a Therapeutic Failure if: 1. the patient is a Clinical or Mycological Failure 2. the patient was considered to have an insufficient therapeutic response 3. the patient used topical drug therapy for irritation or pruritus on the feet after the treatment phase of the study |
| Secondary | Secondary Efficacy Endpoint: The Number of Patients in Each Treatment Group With a Clinical Cure of Tinea Pedis (Equivalence: Per-Protocol Population) | Two weeks after the end of treatment (Day 56 ± 4) (Equivalence) | 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 |
| Secondary | Secondary Efficacy Endpoint:The Number of Patients in Each Treatment Group With a Mycological Cure of Tinea Pedis (Equivalence: Per-Protocol Population) | Two weeks after the end of treatment (Day 56 ± 4) (Equivalence) | 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. |
| Secondary | Secondary Efficacy Endpoint: The Number of Patients in Each Treatment Group With a Clinical Cure of Tinea Pedis (Superiority: Modified Intent-to-Treat Population) | Two weeks after the end of treatment (Day 56 ± 4) (Superiority) | 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 |
| Secondary | Secondary Efficacy Endpoint:The Number of Patients in Each Treatment Group With a Mycological Cure of Tinea Pedis (Superiority: Modified Intent-to-Treat Population) | Two weeks after the end of treatment (Day 56 ± 4) (Superiority) | 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. |
Source ClinicalTrials.gov
Outcomes6
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Primary Efficacy Endpoint: The Number of Patients in Each Treatment Group With a Therapeutic Cure of Tinea Pedis (Equivalence: Per-Protocol Population) | Two weeks after the end of treatment (Day 56 ± 4) (Equivalence) | 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. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Primary Efficacy Endpoint: The Number of Patients in Each Treatment Group With a Therapeutic Cure of Tinea Pedis (Superiority: Modified Intent-to-Treat Population) | Two weeks after the end of treatment (Day 56 ± 4) (Superiority) | The MITT Population was used for analysis. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Secondary Efficacy Endpoint: The Number of Patients in Each Treatment Group With a Clinical Cure of Tinea Pedis (Equivalence: Per-Protocol Population) | Two weeks after the end of treatment (Day 56 ± 4) (Equivalence) | 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. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Secondary Efficacy Endpoint:The Number of Patients in Each Treatment Group With a Mycological Cure of Tinea Pedis (Equivalence: Per-Protocol Population) | Two weeks after the end of treatment (Day 56 ± 4) (Equivalence) | 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. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Secondary Efficacy Endpoint: The Number of Patients in Each Treatment Group With a Clinical Cure of Tinea Pedis (Superiority: Modified Intent-to-Treat Population) | Two weeks after the end of treatment (Day 56 ± 4) (Superiority) | The MITT population was used for analysis. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Secondary Efficacy Endpoint:The Number of Patients in Each Treatment Group With a Mycological Cure of Tinea Pedis (Superiority: Modified Intent-to-Treat Population) | Two weeks after the end of treatment (Day 56 ± 4) (Superiority) | The MITT population was used for the analysis. 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. | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group15
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Primary Efficacy Endpoint: The Number of Patients in Each Treatment Group With a Therapeutic Cure of Tinea Pedis (Equivalence: Per-Protocol Population) | Test: Ketoconazole Cream 2% | 89 | Participants | ||
| Primary Efficacy Endpoint: The Number of Patients in Each Treatment Group With a Therapeutic Cure of Tinea Pedis (Equivalence: Per-Protocol Population) | Reference: Ketoconazole Cream 2% | 90 | Participants | ||
| Primary Efficacy Endpoint: The Number of Patients in Each Treatment Group With a Therapeutic Cure of Tinea Pedis (Superiority: Modified Intent-to-Treat Population) | Test: Ketoconazole Cream 2% | 92 | Participants | ||
| Primary Efficacy Endpoint: The Number of Patients in Each Treatment Group With a Therapeutic Cure of Tinea Pedis (Superiority: Modified Intent-to-Treat Population) | Reference: Ketoconazole Cream 2% | 94 | Participants | ||
| Primary Efficacy Endpoint: The Number of Patients in Each Treatment Group With a Therapeutic Cure of Tinea Pedis (Superiority: Modified Intent-to-Treat Population) | Placebo: Cream (Test Vehicle) | 26 | Participants | ||
| Secondary Efficacy Endpoint: The Number of Patients in Each Treatment Group With a Clinical Cure of Tinea Pedis (Equivalence: Per-Protocol Population) | Test: Ketoconazole Cream 2% | 97 | Participants | ||
| Secondary Efficacy Endpoint: The Number of Patients in Each Treatment Group With a Clinical Cure of Tinea Pedis (Equivalence: Per-Protocol Population) | Reference: Ketoconazole Cream 2% | 110 | Participants | ||
| Secondary Efficacy Endpoint:The Number of Patients in Each Treatment Group With a Mycological Cure of Tinea Pedis (Equivalence: Per-Protocol Population) | Test: Ketoconazole Cream 2% | 127 | Participants | ||
| Secondary Efficacy Endpoint:The Number of Patients in Each Treatment Group With a Mycological Cure of Tinea Pedis (Equivalence: Per-Protocol Population) | Reference: Ketoconazole Cream 2% | 118 | Participants | ||
| Secondary Efficacy Endpoint: The Number of Patients in Each Treatment Group With a Clinical Cure of Tinea Pedis (Superiority: Modified Intent-to-Treat Population) | Test: Ketoconazole Cream 2% | 100 | Participants |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 results by groupParticipant flow9
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Test: Ketoconazole Cream 2% | 332 | |
| Overall Study | STARTED | Reference: Ketoconazole Cream 2% | 335 | |
| Overall Study | STARTED | Placebo: Cream (Test Vehicle) | 164 | |
| Overall Study | COMPLETED | Test: Ketoconazole Cream 2% | 192 | |
| Overall Study | COMPLETED | Reference: Ketoconazole Cream 2% | 201 | |
| Overall Study | COMPLETED | Placebo: Cream (Test Vehicle) | 96 | |
| Overall Study | NOT COMPLETED | Test: Ketoconazole Cream 2% | 140 | |
| Overall Study | NOT COMPLETED | Reference: Ketoconazole Cream 2% | 134 | |
| Overall Study | NOT COMPLETED | Placebo: Cream (Test Vehicle) | 68 |
Source ClinicalTrials.gov
Adverse events54
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Diarrhoea | Gastrointestinal disorders | Test: Ketoconazole Cream 2% | 1 | 314 | 1 |
| other | Diarrhoea | Gastrointestinal disorders | Reference: Ketoconazole Cream 2% | 1 | 319 | 1 |
| other | Diarrhoea | Gastrointestinal disorders | Placebo: Cream (Test Vehicle) | 0 | 156 | 0 |
| other | Dyspepsia | Gastrointestinal disorders | Test: Ketoconazole Cream 2% | 0 | 314 | 0 |
| other | Dyspepsia | Gastrointestinal disorders | Reference: Ketoconazole Cream 2% | 1 | 319 | 1 |
| other | Dyspepsia | Gastrointestinal disorders | Placebo: Cream (Test Vehicle) | 0 | 156 | 0 |
| other | Gastritis | Gastrointestinal disorders | Test: Ketoconazole Cream 2% | 0 | 314 | 0 |
| other | Gastritis | Gastrointestinal disorders | Reference: Ketoconazole Cream 2% | 0 | 319 | 0 |
| other | Gastritis | Gastrointestinal disorders | Placebo: Cream (Test Vehicle) | 1 | 156 | 1 |
| other | Toothache | Gastrointestinal disorders | Test: Ketoconazole Cream 2% | 0 | 314 | 0 |
1 to 10 of 54Source ClinicalTrials.gov
See all 54 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Test: Ketoconazole Cream 2% | 0 | 314 |
| Total, all-cause mortality | Reference: Ketoconazole Cream 2% | 0 | 319 |
| Total, all-cause mortality | Placebo: Cream (Test Vehicle) | 0 | 156 |
| Total, other adverse events | Test: Ketoconazole Cream 2% | 12 | 314 |
| Total, other adverse events | Reference: Ketoconazole Cream 2% | 15 | 319 |
| Total, other adverse events | Placebo: Cream (Test Vehicle) | 6 | 156 |
| Total, serious adverse events | Test: Ketoconazole Cream 2% | 0 | 314 |
| Total, serious adverse events | Reference: Ketoconazole Cream 2% | 0 | 319 |
| Total, serious adverse events | Placebo: Cream (Test Vehicle) | 0 | 156 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons3
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
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 |
Test: Ketoconazole Cream 2% vs Reference: Ketoconazole Cream 2%: Primary Efficacy Endpoint: The Number of Patients in Each Treatment Group With a Therapeutic Cure of Tinea Pedis (Equivalence: Per-Protocol Population) | Trial comparisons |
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 |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
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
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT03824912
GET https://conductscience.org/api/trials/v1/NCT03824912/events?page=2