Trial · NCT03130738
Dose-Ranging Study for Miconazole Oil for Treatment of Otomycosis
NCT03130738, Phase 2, Completed, Hill Dermaceuticals, Inc.; results first posted 2020-05-08
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Dose-Ranging Study for Miconazole Oil for Treatment of Otomycosis. Trials, record NCT03130738. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03130738
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Dose-Ranging Study for Miconazole Oil for Treatment of Otomycosis
- NCT number
- NCT03130738
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 65 participants, actual
- Lead sponsor
- Hill Dermaceuticals, Inc.
- Conditions
- Otomycosis
- Interventions
- 7-Day Miconazole Oil (Miconazole 2%), 14-Day Miconazole Oil (Miconazole 2%), 14-Day Placebo - Oil Vehicle
- First posted
- 2017-04-26
- Last updated
- 2022-10-05
- Results first posted
- 2020-05-08
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Primary Efficacy Endpoint | At Test of Cure visit (Day 15 for 7 Day Active and Day 22 for 14 Day Active and 14 Day Vehicle) | Percentage of subjects in MITT population, at the "Test of Cure" visit with "Therapeutic cure", defined as a negative fungal culture plus "clinical cure" defined as the absence of all otomycosis signs and symptoms for pruritus, debris, fungal elements, and pain. |
| Secondary | Secondary Efficacy Endpoints | At Test of Cure visit (Day 15 for 7 Day Active and Day 22 for 14 Day Active and 14 Day Vehicle) | 1. Percentage of subjects in MITT population with clinical cure at the Test of Cure Visit 2. Percentage of subjects in MITT population with a negative fungal culture at the Test of Cure Visit 3. Percentage of subjects in MITT population with a negative fungal culture at the Test of Cure visit as well as individual sign or symptom score of 0 or 1 on each of the scales for pruritus and debris and a score of 0 on each of the scales for fungal elements and pain (Secondary therapeutic cure). 4. Percentage of subjects in MITT population with individual signs or symptoms with a score of 0 or 1 on each of the scales for pruritus and debris and a score of 0 on each of the scales for fungal elements and pain (Secondary clinical cure). |
Source ClinicalTrials.gov
Outcomes2
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Primary Efficacy Endpoint | At Test of Cure visit (Day 15 for 7 Day Active and Day 22 for 14 Day Active and 14 Day Vehicle) | Actual number of participants analyzed under Primary efficacy endpoint are MITT population, defined as subjects who had a clinical diagnosis of otomycosis confirmed by positive fungal culture. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Secondary Efficacy Endpoints | At Test of Cure visit (Day 15 for 7 Day Active and Day 22 for 14 Day Active and 14 Day Vehicle) | Percentage of subjects in the MITT population. | 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 | 7-Day Miconazole Oil (Miconazole 2%) | 1 | Participants | ||
| Primary Efficacy Endpoint | 14-Day Miconazole Oil (Miconazole 2%) | 3 | Participants | ||
| Primary Efficacy Endpoint | 14-Day Placebo - Oil Vehicle | 1 | Participants | ||
| Secondary Efficacy Endpoints | 7-Day Miconazole Oil (Miconazole 2%) | Clinical Cure | 2 | Participants | |
| Secondary Efficacy Endpoints | 14-Day Miconazole Oil (Miconazole 2%) | Clinical Cure | 4 | Participants | |
| Secondary Efficacy Endpoints | 14-Day Placebo - Oil Vehicle | Clinical Cure | 2 | Participants | |
| Secondary Efficacy Endpoints | 7-Day Miconazole Oil (Miconazole 2%) | Negative Fungal Culture | 4 | Participants | |
| Secondary Efficacy Endpoints | 14-Day Miconazole Oil (Miconazole 2%) | Negative Fungal Culture | 5 | Participants | |
| Secondary Efficacy Endpoints | 14-Day Placebo - Oil Vehicle | Negative Fungal Culture | 3 | Participants | |
| Secondary Efficacy Endpoints | 7-Day Miconazole Oil (Miconazole 2%) | Secondary Therapeutic Cure | 3 | 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 | 7-Day Miconazole Oil (Miconazole 2%) | 23 | |
| Overall Study | STARTED | 14-Day Miconazole Oil (Miconazole 2%) | 22 | |
| Overall Study | STARTED | 14-Day Placebo - Oil Vehicle | 20 | |
| Overall Study | COMPLETED | 7-Day Miconazole Oil (Miconazole 2%) | 20 | |
| Overall Study | COMPLETED | 14-Day Miconazole Oil (Miconazole 2%) | 20 | |
| Overall Study | COMPLETED | 14-Day Placebo - Oil Vehicle | 14 | |
| Overall Study | NOT COMPLETED | 7-Day Miconazole Oil (Miconazole 2%) | 3 | |
| Overall Study | NOT COMPLETED | 14-Day Miconazole Oil (Miconazole 2%) | 2 | |
| Overall Study | NOT COMPLETED | 14-Day Placebo - Oil Vehicle | 6 |
Source ClinicalTrials.gov
Adverse events30
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 pain. Tympanic membrane perforation | Ear and labyrinth disorders | 7-Day Miconazole Oil (Miconazole 2%) | 0 | 23 | 0 |
| other | Ear pain. Tympanic membrane perforation | Ear and labyrinth disorders | 14-Day Miconazole Oil (Miconazole 2%) | 0 | 22 | 0 |
| other | Ear pain. Tympanic membrane perforation | Ear and labyrinth disorders | 14-Day Placebo - Oil Vehicle | 4 | 20 | 4 |
| other | nausea | Gastrointestinal disorders | 7-Day Miconazole Oil (Miconazole 2%) | 0 | 23 | 0 |
| other | nausea | Gastrointestinal disorders | 14-Day Miconazole Oil (Miconazole 2%) | 0 | 22 | 0 |
| other | nausea | Gastrointestinal disorders | 14-Day Placebo - Oil Vehicle | 1 | 20 | 1 |
| other | discharge. discomfort. erosion. pain. pruritus. site pain | General disorders | 7-Day Miconazole Oil (Miconazole 2%) | 4 | 23 | 4 |
| other | discharge. discomfort. erosion. pain. pruritus. site pain | General disorders | 14-Day Miconazole Oil (Miconazole 2%) | 6 | 22 | 8 |
| other | discharge. discomfort. erosion. pain. pruritus. site pain | General disorders | 14-Day Placebo - Oil Vehicle | 9 | 20 | 12 |
| other | Seasonal allergy | Immune system disorders | 7-Day Miconazole Oil (Miconazole 2%) | 0 | 23 | 0 |
1 to 10 of 30Source ClinicalTrials.gov
See all 30 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | 7-Day Miconazole Oil (Miconazole 2%) | 0 | 23 |
| Total, all-cause mortality | 14-Day Miconazole Oil (Miconazole 2%) | 0 | 22 |
| Total, all-cause mortality | 14-Day Placebo - Oil Vehicle | 0 | 20 |
| Total, other adverse events | 7-Day Miconazole Oil (Miconazole 2%) | 9 | 23 |
| Total, other adverse events | 14-Day Miconazole Oil (Miconazole 2%) | 10 | 22 |
| Total, other adverse events | 14-Day Placebo - Oil Vehicle | 15 | 20 |
| Total, serious adverse events | 7-Day Miconazole Oil (Miconazole 2%) | 0 | 23 |
| Total, serious adverse events | 14-Day Miconazole Oil (Miconazole 2%) | 0 | 22 |
| Total, serious adverse events | 14-Day Placebo - Oil Vehicle | 0 | 20 |
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/NCT03130738
GET https://conductscience.org/api/trials/v1/NCT03130738/events?page=2