Trial · NCT04432376
Efficacy and Safety Study of Miconazole Oil Versus Vehicle on Fungal Infection of the Ear Canal (Otomycosis)
NCT04432376, Phase 2, Phase 3, Completed, Hill Dermaceuticals, Inc.; results first posted 2022-11-04
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Efficacy and Safety Study of Miconazole Oil Versus Vehicle on Fungal Infection of the Ear Canal (Otomycosis). Trials, record NCT04432376. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04432376
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Efficacy and Safety Study of Miconazole Oil Versus Vehicle on Fungal Infection of the Ear Canal (Otomycosis)
- NCT number
- NCT04432376
- Status
- Completed
- Phases
- Phase 2, Phase 3
- Enrollment
- 382 participants, actual
- Lead sponsor
- Hill Dermaceuticals, Inc.
- Conditions
- Otomycosis
- Interventions
- miconazole 2% oil, vehicle oil
- First posted
- 2020-06-16
- Last updated
- 2024-01-19
- Results first posted
- 2022-11-04
- Limitations and caveats
The limited number of patients with otomycosis at any one time, and the lack of standardized FDA-approved clinical studies on otomycosis have proven to be challenging and difficult to assign predetermined analysis endpoints. This is in line with the challenges described in the FDA Accelerating Rare disease Cures Program, such as challenges faced when using well-established trial designs, and complexities in endpoint selection when there is limited information or understanding of the disease.
Source ClinicalTrials.gov
Registered outcomes3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Subjects With Therapeutic Cure | 21 days from first day of drug application | "therapeutic cure" is "mycological cure" plus "clinical cure, in the Modified intent to treat (MITT) only: patients with + fungal culture at baseline. Fungal culture results verified as (+) or (-) after enrollment. Intent to treat (ITT) population were all subjects enrolled and randomized. Active group: ITT=89 (100%), MITT=67 (75.3%); Placebo Group: ITT=90 (100%), MITT=64 (71.1%). Mycological cure is a negative mycological culture (culture is either positive or negative). Score=0 is best. Clinical cure is absence of all otomycosis signs and symptoms (s/s) of Pruritus, Debris, and Aural fullness, graded as (scores) 0=none, 1=mild, 2=moderate, 3=severe; and Presence of fungal elements, score 0=No fungal elements, 1=fungal elements present on visual inspection. Score=0 is best. Efficacy analysis was performed only on MITT (modified intent-to-treat) population, consisting of only those patients that had positive fungal culture at Baseline. |
| Secondary | Percentage of Subjects With Mycological Cure | 21 days from first day of drug application | Mycological cure is a negative mycological culture for the study ear at test of cure visit, in Modified intent to treat (MITT) only: patients with + fungal culture at baseline. Subjects that had negative fungal culture at Baseline were not included in MITT. Fungal culture results verified as (+) or (-) after enrollment. Grading is based on positive or negative mycological (fungal) culture. Negative culture is required. Efficacy analysis was performed only on MITT (modified intent-to-treat) population, consisting of only those patients that had positive fungal culture at Baseline. Intent to treat (ITT) population were all subjects enrolled and randomized. Active group: ITT=89 (100%), MITT=67 (75.3%); Placebo Group: ITT=90 (100%), MITT=64 (71.1%). |
| Secondary | Percentage of Subjects With Clinical Cure | 21 days from first day of drug application | Absence of all otomycosis signs and symptoms according to the scales for each individual sign/symptom. Score=0 is best. Clinical cure is absence of all otomycosis signs and symptoms of Pruritus, Debris, and Aural fullness, graded as (scores) 0=none, 1=mild, 2=moderate, 3=severe; and Presence of fungal elements, score 0=No fungal elements, 1=fungal elements present on visual inspection. Score=0 is best. Efficacy analysis was performed only on MITT (modified intent-to-treat) population, consisting of only those patients that had positive fungal culture at Baseline. Subjects that had negative fungal culture at Baseline were not included in MITT. Fungal culture results verified as (+) or (-) after enrollment. ITT (intent to treat) population were all subjects enrolled and randomized. Active group: ITT=89 (100%), MITT=67 (75.3%); Placebo Group: ITT=90 (100%), MITT=64 (71.1%). |
Source ClinicalTrials.gov
Outcomes3
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Subjects With Therapeutic Cure | 21 days from first day of drug application | MITT (modified intent-to-treat) population - only patients with positive mycological culture at Baseline. ITT (intent-to-treat) population were all subjects enrolled and randomized. Active group: ITT=89 (100%), MITT=67 (75.3%); Placebo Group: ITT=90 (100%), MITT=64 (71.1%). | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Percentage of Subjects With Mycological Cure | 21 days from first day of drug application | MITT (modified intent-to-treat) population - only patients with positive mycological culture at Baseline. ITT population were all subjects enrolled and randomized. Active group: ITT=89 (100%), MITT=67 (75.3%); Placebo Group: ITT=90 (100%), MITT=64 (71.1%). | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Percentage of Subjects With Clinical Cure | 21 days from first day of drug application | MITT (modified intent-to-treat) population - only patients with positive mycological culture at Baseline. ITT population were all subjects enrolled and randomized. Active group: ITT=89 (100%), MITT=67 (75.3%); Placebo Group: ITT=90 (100%), MITT=64 (71.1%). | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group12
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage of Subjects With Therapeutic Cure | Active Treatment Arm | Achieved Therapeutic cure (Score=0 fungal culture and clinical signs,symptoms) | 14 | Participants | |
| Percentage of Subjects With Therapeutic Cure | Placebo Treatment Arm | Achieved Therapeutic cure (Score=0 fungal culture and clinical signs,symptoms) | 11 | Participants | |
| Percentage of Subjects With Therapeutic Cure | Active Treatment Arm | Not Achieve Therapeutic cure (Positive fungal culture AND/OR clinical score 1 or greater each s/s | 53 | Participants | |
| Percentage of Subjects With Therapeutic Cure | Placebo Treatment Arm | Not Achieve Therapeutic cure (Positive fungal culture AND/OR clinical score 1 or greater each s/s | 53 | Participants | |
| Percentage of Subjects With Mycological Cure | Active Treatment Arm | Achieved mycological cure (negative fungal culture) | 24 | Participants | |
| Percentage of Subjects With Mycological Cure | Placebo Treatment Arm | Achieved mycological cure (negative fungal culture) | 15 | Participants | |
| Percentage of Subjects With Mycological Cure | Active Treatment Arm | Not achieved mycological cure (positive fungal culture) | 43 | Participants | |
| Percentage of Subjects With Mycological Cure | Placebo Treatment Arm | Not achieved mycological cure (positive fungal culture) | 49 | Participants | |
| Percentage of Subjects With Clinical Cure | Active Treatment Arm | Achieved clinical cure (score = 0 for all signs, symptoms) | 22 | Participants | |
| Percentage of Subjects With Clinical Cure | Placebo Treatment Arm | Achieved clinical cure (score = 0 for all signs, symptoms) | 14 | Participants |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 results by groupParticipant flow18
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Double-blind Treatment Period | STARTED | Active Treatment Arm | 89 | |
| Double-blind Treatment Period | STARTED | Placebo Treatment Arm | 90 | |
| Double-blind Treatment Period | STARTED | Open-label Application Group | 0 | |
| Double-blind Treatment Period | COMPLETED | Active Treatment Arm | 84 | |
| Double-blind Treatment Period | COMPLETED | Placebo Treatment Arm | 79 | |
| Double-blind Treatment Period | COMPLETED | Open-label Application Group | 0 | |
| Double-blind Treatment Period | NOT COMPLETED | Active Treatment Arm | 5 | |
| Double-blind Treatment Period | NOT COMPLETED | Placebo Treatment Arm | 11 | |
| Double-blind Treatment Period | NOT COMPLETED | Open-label Application Group | 0 | |
| Enrollment B, Open Label Safety Group. | STARTED | Active Treatment Arm | 0 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 participant flowAdverse events75
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 | ear discomfort | Ear and labyrinth disorders | Active Treatment Arm | 8 | 89 | 8 |
| other | ear discomfort | Ear and labyrinth disorders | Placebo Treatment Arm | 9 | 90 | 9 |
| other | ear discomfort | Ear and labyrinth disorders | Open-label Treatment Arm | 0 | 203 | 0 |
| other | vertigo | Ear and labyrinth disorders | Active Treatment Arm | 2 | 89 | 2 |
| other | vertigo | Ear and labyrinth disorders | Placebo Treatment Arm | 0 | 90 | 0 |
| other | vertigo | Ear and labyrinth disorders | Open-label Treatment Arm | 1 | 203 | 1 |
| other | tinnitus | Ear and labyrinth disorders | Active Treatment Arm | 0 | 89 | 0 |
| other | tinnitus | Ear and labyrinth disorders | Placebo Treatment Arm | 1 | 90 | 1 |
| other | tinnitus | Ear and labyrinth disorders | Open-label Treatment Arm | 0 | 203 | 0 |
| other | tympanic membrane perforation | Ear and labyrinth disorders | Active Treatment Arm | 0 | 89 | 0 |
1 to 10 of 75Source ClinicalTrials.gov
See all 75 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Active Treatment Arm | 0 | 89 |
| Total, all-cause mortality | Placebo Treatment Arm | 0 | 90 |
| Total, all-cause mortality | Open-label Treatment Arm | 0 | 203 |
| Total, other adverse events | Active Treatment Arm | 41 | 89 |
| Total, other adverse events | Placebo Treatment Arm | 51 | 90 |
| Total, other adverse events | Open-label Treatment Arm | 9 | 203 |
| Total, serious adverse events | Active Treatment Arm | 1 | 89 |
| Total, serious adverse events | Placebo Treatment Arm | 0 | 90 |
| Total, serious adverse events | Open-label Treatment Arm | 0 | 203 |
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 comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
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/NCT04432376
GET https://conductscience.org/api/trials/v1/NCT04432376/events?page=2