Trial Outcomes & Findings for Phase III Efficacy and Safety Study of Miconazole Oil for Otomycosis (NCT NCT05660382)

NCT ID: NCT05660382

Last Updated: 2026-05-12

Results Overview

A score of 0 for fungal elements, pruritus, debris, and aural fullness

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

112 participants

Primary outcome timeframe

7 days after 14 days of Treatment

Results posted on

2026-05-12

Participant Flow

Participant milestones

Participant milestones
Measure	Active Group Miconazole (2%) oil, administered as 5 drops per ear at \~30 mg per drop instilled into the external ear canal of the ear(s) affected by otomycosis, twice daily for 14 days.	Placebo Group Mineral oil, administered as 5 drops per ear instilled into the external ear canal of the ear(s) affected by otomycosis, twice daily for 14 days.
Overall Study STARTED	56	56
Overall Study COMPLETED	49	46
Overall Study NOT COMPLETED	7	10

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Phase III Efficacy and Safety Study of Miconazole Oil for Otomycosis

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Active Group n=56 Participants Miconazole (2%) oil, administered as 5 drops per ear at \~30 mg per drop instilled into the external ear canal of the ear(s) affected by otomycosis, twice daily for 14 days.	Placebo Group n=56 Participants Mineral oil, administered as 5 drops per ear instilled into the external ear canal of the ear(s) affected by otomycosis, twice daily for 14 days.	Total n=112 Participants Total of all reporting groups
Age, Categorical <=18 years	2 Participants n=1512 Participants	3 Participants n=504 Participants	5 Participants n=2016 Participants
Age, Categorical Between 18 and 65 years	27 Participants n=1512 Participants	25 Participants n=504 Participants	52 Participants n=2016 Participants
Age, Categorical >=65 years	27 Participants n=1512 Participants	28 Participants n=504 Participants	55 Participants n=2016 Participants
Sex: Female, Male Female	16 Participants n=1512 Participants	26 Participants n=504 Participants	42 Participants n=2016 Participants
Sex: Female, Male Male	40 Participants n=1512 Participants	30 Participants n=504 Participants	70 Participants n=2016 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=1512 Participants	0 Participants n=504 Participants	0 Participants n=2016 Participants
Race (NIH/OMB) Asian	0 Participants n=1512 Participants	1 Participants n=504 Participants	1 Participants n=2016 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=1512 Participants	0 Participants n=504 Participants	0 Participants n=2016 Participants
Race (NIH/OMB) Black or African American	8 Participants n=1512 Participants	13 Participants n=504 Participants	21 Participants n=2016 Participants
Race (NIH/OMB) White	46 Participants n=1512 Participants	41 Participants n=504 Participants	87 Participants n=2016 Participants
Race (NIH/OMB) More than one race	0 Participants n=1512 Participants	0 Participants n=504 Participants	0 Participants n=2016 Participants
Race (NIH/OMB) Unknown or Not Reported	2 Participants n=1512 Participants	1 Participants n=504 Participants	3 Participants n=2016 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	14 Participants n=1512 Participants	10 Participants n=504 Participants	24 Participants n=2016 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	42 Participants n=1512 Participants	46 Participants n=504 Participants	88 Participants n=2016 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=1512 Participants	0 Participants n=504 Participants	0 Participants n=2016 Participants
Pruritus Mild	0 Participants n=1512 Participants	0 Participants n=504 Participants	0 Participants n=2016 Participants
Pruritus Moderate	46 Participants n=1512 Participants	45 Participants n=504 Participants	91 Participants n=2016 Participants
Pruritus Severe	10 Participants n=1512 Participants	11 Participants n=504 Participants	21 Participants n=2016 Participants
Debris Scant	0 Participants n=1512 Participants	0 Participants n=504 Participants	0 Participants n=2016 Participants
Debris Moderate	26 Participants n=1512 Participants	34 Participants n=504 Participants	60 Participants n=2016 Participants
Debris Heavy	30 Participants n=1512 Participants	22 Participants n=504 Participants	52 Participants n=2016 Participants
Presence of Fungal Elements Absent	0 Participants n=1512 Participants	0 Participants n=504 Participants	0 Participants n=2016 Participants
Presence of Fungal Elements Present	56 Participants n=1512 Participants	56 Participants n=504 Participants	112 Participants n=2016 Participants
Aural Fullness Mild	0 Participants n=1512 Participants	0 Participants n=504 Participants	0 Participants n=2016 Participants
Aural Fullness Moderate	41 Participants n=1512 Participants	39 Participants n=504 Participants	80 Participants n=2016 Participants
Aural Fullness Severe	15 Participants n=1512 Participants	17 Participants n=504 Participants	32 Participants n=2016 Participants

PRIMARY outcome

Timeframe: 7 days after 14 days of Treatment

Population: The primary population for all efficacy analyses will be the ITT population, defined as all subjects who were randomized, dispensed study drug, and with a clinical diagnosis of otomycosis. Note: Reported data based on preliminary outputs and were not quality controlled.

A score of 0 for fungal elements, pruritus, debris, and aural fullness

Outcome measures

Outcome measures
Measure	Active Group n=56 Participants Miconazole (2%) oil, administered as 5 drops per ear at \~30 mg per drop instilled into the external ear canal of the ear(s) affected by otomycosis, twice daily for 14 days.	Placebo Group n=56 Participants Mineral oil, administered as 5 drops per ear instilled into the external ear canal of the ear(s) affected by otomycosis, twice daily for 14 days.
Number of Participants With Clinical Cure	19 Participants	18 Participants

Adverse Events

Active Group

Serious events: 0 serious events

Other events: 13 other events

Deaths: 0 deaths

Placebo Group

Serious events: 0 serious events

Other events: 12 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Additional Information

Gerardo Mendez

Hill Dermaceuticals, Inc.

Phone: 407-323-1887

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: OTHER

Measure	Active Group n=56 participants at risk Miconazole (2%) oil, administered as 5 drops per ear at \~30 mg per drop instilled into the external ear canal of the ear(s) affected by otomycosis, twice daily for 14 days.	Placebo Group n=56 participants at risk Mineral oil, administered as 5 drops per ear instilled into the external ear canal of the ear(s) affected by otomycosis, twice daily for 14 days.
Ear and labyrinth disorders Tympanic membrane perforation	0.00% 0/56 • From Enrollment (Day 1) through Safety Follow Up Call, which occurred 14 days after the last day of treatment, which for subjects that complete the full 14-day treatment, the phone call should occur on Day 29 (+ 3 days). However, for subjects that do not complete the full treatment (less than 14 days), the follow-up call should occur 14 days from the last dosage.	1.8% 1/56 • From Enrollment (Day 1) through Safety Follow Up Call, which occurred 14 days after the last day of treatment, which for subjects that complete the full 14-day treatment, the phone call should occur on Day 29 (+ 3 days). However, for subjects that do not complete the full treatment (less than 14 days), the follow-up call should occur 14 days from the last dosage.
Ear and labyrinth disorders Tympanic membrane disorder	1.8% 1/56 • From Enrollment (Day 1) through Safety Follow Up Call, which occurred 14 days after the last day of treatment, which for subjects that complete the full 14-day treatment, the phone call should occur on Day 29 (+ 3 days). However, for subjects that do not complete the full treatment (less than 14 days), the follow-up call should occur 14 days from the last dosage.	0.00% 0/56 • From Enrollment (Day 1) through Safety Follow Up Call, which occurred 14 days after the last day of treatment, which for subjects that complete the full 14-day treatment, the phone call should occur on Day 29 (+ 3 days). However, for subjects that do not complete the full treatment (less than 14 days), the follow-up call should occur 14 days from the last dosage.
Ear and labyrinth disorders Ear discomfort	3.6% 2/56 • From Enrollment (Day 1) through Safety Follow Up Call, which occurred 14 days after the last day of treatment, which for subjects that complete the full 14-day treatment, the phone call should occur on Day 29 (+ 3 days). However, for subjects that do not complete the full treatment (less than 14 days), the follow-up call should occur 14 days from the last dosage.	1.8% 1/56 • From Enrollment (Day 1) through Safety Follow Up Call, which occurred 14 days after the last day of treatment, which for subjects that complete the full 14-day treatment, the phone call should occur on Day 29 (+ 3 days). However, for subjects that do not complete the full treatment (less than 14 days), the follow-up call should occur 14 days from the last dosage.
Ear and labyrinth disorders Ear pain	0.00% 0/56 • From Enrollment (Day 1) through Safety Follow Up Call, which occurred 14 days after the last day of treatment, which for subjects that complete the full 14-day treatment, the phone call should occur on Day 29 (+ 3 days). However, for subjects that do not complete the full treatment (less than 14 days), the follow-up call should occur 14 days from the last dosage.	1.8% 1/56 • From Enrollment (Day 1) through Safety Follow Up Call, which occurred 14 days after the last day of treatment, which for subjects that complete the full 14-day treatment, the phone call should occur on Day 29 (+ 3 days). However, for subjects that do not complete the full treatment (less than 14 days), the follow-up call should occur 14 days from the last dosage.
Gastrointestinal disorders Abdominal discomfort	1.8% 1/56 • From Enrollment (Day 1) through Safety Follow Up Call, which occurred 14 days after the last day of treatment, which for subjects that complete the full 14-day treatment, the phone call should occur on Day 29 (+ 3 days). However, for subjects that do not complete the full treatment (less than 14 days), the follow-up call should occur 14 days from the last dosage.	0.00% 0/56 • From Enrollment (Day 1) through Safety Follow Up Call, which occurred 14 days after the last day of treatment, which for subjects that complete the full 14-day treatment, the phone call should occur on Day 29 (+ 3 days). However, for subjects that do not complete the full treatment (less than 14 days), the follow-up call should occur 14 days from the last dosage.
Gastrointestinal disorders Cheilitis	1.8% 1/56 • From Enrollment (Day 1) through Safety Follow Up Call, which occurred 14 days after the last day of treatment, which for subjects that complete the full 14-day treatment, the phone call should occur on Day 29 (+ 3 days). However, for subjects that do not complete the full treatment (less than 14 days), the follow-up call should occur 14 days from the last dosage.	0.00% 0/56 • From Enrollment (Day 1) through Safety Follow Up Call, which occurred 14 days after the last day of treatment, which for subjects that complete the full 14-day treatment, the phone call should occur on Day 29 (+ 3 days). However, for subjects that do not complete the full treatment (less than 14 days), the follow-up call should occur 14 days from the last dosage.
Gastrointestinal disorders Constipation	1.8% 1/56 • From Enrollment (Day 1) through Safety Follow Up Call, which occurred 14 days after the last day of treatment, which for subjects that complete the full 14-day treatment, the phone call should occur on Day 29 (+ 3 days). However, for subjects that do not complete the full treatment (less than 14 days), the follow-up call should occur 14 days from the last dosage.	0.00% 0/56 • From Enrollment (Day 1) through Safety Follow Up Call, which occurred 14 days after the last day of treatment, which for subjects that complete the full 14-day treatment, the phone call should occur on Day 29 (+ 3 days). However, for subjects that do not complete the full treatment (less than 14 days), the follow-up call should occur 14 days from the last dosage.
Gastrointestinal disorders Nausea	0.00% 0/56 • From Enrollment (Day 1) through Safety Follow Up Call, which occurred 14 days after the last day of treatment, which for subjects that complete the full 14-day treatment, the phone call should occur on Day 29 (+ 3 days). However, for subjects that do not complete the full treatment (less than 14 days), the follow-up call should occur 14 days from the last dosage.	1.8% 1/56 • From Enrollment (Day 1) through Safety Follow Up Call, which occurred 14 days after the last day of treatment, which for subjects that complete the full 14-day treatment, the phone call should occur on Day 29 (+ 3 days). However, for subjects that do not complete the full treatment (less than 14 days), the follow-up call should occur 14 days from the last dosage.
General disorders Disease progression	14.3% 8/56 • From Enrollment (Day 1) through Safety Follow Up Call, which occurred 14 days after the last day of treatment, which for subjects that complete the full 14-day treatment, the phone call should occur on Day 29 (+ 3 days). However, for subjects that do not complete the full treatment (less than 14 days), the follow-up call should occur 14 days from the last dosage.	10.7% 6/56 • From Enrollment (Day 1) through Safety Follow Up Call, which occurred 14 days after the last day of treatment, which for subjects that complete the full 14-day treatment, the phone call should occur on Day 29 (+ 3 days). However, for subjects that do not complete the full treatment (less than 14 days), the follow-up call should occur 14 days from the last dosage.
Infections and infestations COVID-19	0.00% 0/56 • From Enrollment (Day 1) through Safety Follow Up Call, which occurred 14 days after the last day of treatment, which for subjects that complete the full 14-day treatment, the phone call should occur on Day 29 (+ 3 days). However, for subjects that do not complete the full treatment (less than 14 days), the follow-up call should occur 14 days from the last dosage.	1.8% 1/56 • From Enrollment (Day 1) through Safety Follow Up Call, which occurred 14 days after the last day of treatment, which for subjects that complete the full 14-day treatment, the phone call should occur on Day 29 (+ 3 days). However, for subjects that do not complete the full treatment (less than 14 days), the follow-up call should occur 14 days from the last dosage.
Infections and infestations Otitis externa fungal	1.8% 1/56 • From Enrollment (Day 1) through Safety Follow Up Call, which occurred 14 days after the last day of treatment, which for subjects that complete the full 14-day treatment, the phone call should occur on Day 29 (+ 3 days). However, for subjects that do not complete the full treatment (less than 14 days), the follow-up call should occur 14 days from the last dosage.	1.8% 1/56 • From Enrollment (Day 1) through Safety Follow Up Call, which occurred 14 days after the last day of treatment, which for subjects that complete the full 14-day treatment, the phone call should occur on Day 29 (+ 3 days). However, for subjects that do not complete the full treatment (less than 14 days), the follow-up call should occur 14 days from the last dosage.
Infections and infestations Otitis media	1.8% 1/56 • From Enrollment (Day 1) through Safety Follow Up Call, which occurred 14 days after the last day of treatment, which for subjects that complete the full 14-day treatment, the phone call should occur on Day 29 (+ 3 days). However, for subjects that do not complete the full treatment (less than 14 days), the follow-up call should occur 14 days from the last dosage.	0.00% 0/56 • From Enrollment (Day 1) through Safety Follow Up Call, which occurred 14 days after the last day of treatment, which for subjects that complete the full 14-day treatment, the phone call should occur on Day 29 (+ 3 days). However, for subjects that do not complete the full treatment (less than 14 days), the follow-up call should occur 14 days from the last dosage.
Musculoskeletal and connective tissue disorders Pain in jaw	0.00% 0/56 • From Enrollment (Day 1) through Safety Follow Up Call, which occurred 14 days after the last day of treatment, which for subjects that complete the full 14-day treatment, the phone call should occur on Day 29 (+ 3 days). However, for subjects that do not complete the full treatment (less than 14 days), the follow-up call should occur 14 days from the last dosage.	1.8% 1/56 • From Enrollment (Day 1) through Safety Follow Up Call, which occurred 14 days after the last day of treatment, which for subjects that complete the full 14-day treatment, the phone call should occur on Day 29 (+ 3 days). However, for subjects that do not complete the full treatment (less than 14 days), the follow-up call should occur 14 days from the last dosage.
Nervous system disorders Dizziness	0.00% 0/56 • From Enrollment (Day 1) through Safety Follow Up Call, which occurred 14 days after the last day of treatment, which for subjects that complete the full 14-day treatment, the phone call should occur on Day 29 (+ 3 days). However, for subjects that do not complete the full treatment (less than 14 days), the follow-up call should occur 14 days from the last dosage.	1.8% 1/56 • From Enrollment (Day 1) through Safety Follow Up Call, which occurred 14 days after the last day of treatment, which for subjects that complete the full 14-day treatment, the phone call should occur on Day 29 (+ 3 days). However, for subjects that do not complete the full treatment (less than 14 days), the follow-up call should occur 14 days from the last dosage.
Nervous system disorders Headache	1.8% 1/56 • From Enrollment (Day 1) through Safety Follow Up Call, which occurred 14 days after the last day of treatment, which for subjects that complete the full 14-day treatment, the phone call should occur on Day 29 (+ 3 days). However, for subjects that do not complete the full treatment (less than 14 days), the follow-up call should occur 14 days from the last dosage.	1.8% 1/56 • From Enrollment (Day 1) through Safety Follow Up Call, which occurred 14 days after the last day of treatment, which for subjects that complete the full 14-day treatment, the phone call should occur on Day 29 (+ 3 days). However, for subjects that do not complete the full treatment (less than 14 days), the follow-up call should occur 14 days from the last dosage.
Skin and subcutaneous tissue disorders Pruritus	1.8% 1/56 • From Enrollment (Day 1) through Safety Follow Up Call, which occurred 14 days after the last day of treatment, which for subjects that complete the full 14-day treatment, the phone call should occur on Day 29 (+ 3 days). However, for subjects that do not complete the full treatment (less than 14 days), the follow-up call should occur 14 days from the last dosage.	0.00% 0/56 • From Enrollment (Day 1) through Safety Follow Up Call, which occurred 14 days after the last day of treatment, which for subjects that complete the full 14-day treatment, the phone call should occur on Day 29 (+ 3 days). However, for subjects that do not complete the full treatment (less than 14 days), the follow-up call should occur 14 days from the last dosage.