OtomycosisPhase 2NCT03130738
Dose-Ranging Study for Miconazole Oil for Treatment of Otomycosis
A Phase 2 study testing 7-Day Miconazole Oil (Miconazole 2%) and 14-Day Miconazole Oil (Miconazole 2%) in people with Otomycosis, run by Hill Dermaceuticals, Inc. at 6 sites in United States.
Trial summary
The purpose of the study is to evaluate the efficacy and safety of active treatment (miconazole oil) for 7 versus 14 days, and to compare 14 days of active treatment (miconazole oil) to inactive treatment (placebo) over a 14-day treatment duration, in subjects with fungal infection (otomycosis) of the external ear. Read more about this study
- Who is it for?
- Ages 25 months and older
- Conditions the study is for
- Otomycosis
- What is being tested?
- 7-Day Miconazole Oil (Miconazole 2%) and 14-Day Miconazole Oil (Miconazole 2%)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 65 participants
- Where
- 6 sitesUnited States
- Study dates
- 20 Apr 2017to 6 Aug 2019
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 months and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Uncomplicated otomycosis of the external ear only, age more than 2 year
Who cannot join
- Pregnancy
- Other dermatoses or conditions of the ear that may interfere with the evaluation of otomycosis, including concomitant otic infections (including bacterial infection) that require antimicrobial treatment, disease that has spread beyond the external ear(s), or pre-existing skin atrophy of the affected ear(s)
- Tympanostomy tube or perforated tympanic membrane in the ear(s) that will be treated
- Previous surgery affecting the ear(s) that will be treated, except for prior tympanostomy tube(s) that had been removed and had completely healed
- Previous use of medicated treatments for otomycosis or participation in another investigational study within 28 days of study entry
- Previous use of any systemic antifungal therapy, warfarin, and immunosuppressive or immune-stimulating drugs within 28 days of study entry, or systemic steroids within 3 months of study entry
- Recurrent otomycosis that had been unresponsive to previous antifungal treatment
- Known hypersensitivity to any of the components in the test formulation
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
Ear Nose and Throat Associates of Southe Florida
Boynton Beach, Florida, 33426
Head and Neck Surgery Specialist
Chula Vista, California, 91910
University of California San Diego
La Jolla, California, 92037-0970
Advanced ENT and Allergy
Louisville, Kentucky, 40207
Silverstein Institute
Sarasota, Florida, 34239
Piedmont ENT Associates
Winston-Salem, North Carolina, 27103
About this study
Official title: Dose-Ranging Study of the Efficacy and Safety of Miconazole Oil Used for 7 or 14 Days Compared With Vehicle in the Treatment of Otomycosis
The purpose of the study is to evaluate the efficacy and safety of active treatment (miconazole oil) for 7 versus 14 days, and to compare 14 days of active treatment (miconazole oil) to inactive treatment (placebo) over a 14-day treatment duration, in subjects with fungal infection (otomycosis) of the external ear.
Read the detailed description
Miconazole, an imidazole antifungal agent, is commonly used for different types of fungal skin infections, such as Candida, ringworm, jock itch, athlete's foot, nail fungus, vaginal yeast infections, and oropharyngeal candidiasis. The 2% formulation of miconazole is commonly used for dermatophytic infections. The mechanisms of action of miconazole against fungi in general appear to be applicable to fungi associated with otomycosis, in that miconazole has been demonstrated to have activity in vitro against some clinical isolates of fungi associated with human otomycosis in the US.
Miconazole targets the cytochrome P450-dependent enzyme 14-α-sterol demethylase, an enzyme that is also involved in mammalian cholesterol synthesis, resulting in inhibition of ergosterol biosynthesis in the cell membrane of the fungal organism. Because ergosterol is an important component of the cell membrane, inhibition of its synthesis inhibits fungal cell growth.
In addition to its activity toward the enzyme 14-α-sterol demethylase, miconazole also leads to increased reactive oxygen species in fungal organisms, which appears to result in fungicidal activity.
- Conditions
- Otomycosis
- Being tested
- 7-Day Miconazole Oil (Miconazole 2%), 14-Day Miconazole Oil (Miconazole 2%), 14-Day Placebo - Oil Vehicle
- Medical subject headings
- Otomycosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
7-Day Miconazole Oil (Miconazole 2%)Drug
Also called Miconazole
7 days of 2x per day treatment with Miconazole Oil (Active Drug Product 2% Miconazole)
14-Day Miconazole Oil (Miconazole 2%)Drug
Also called Miconazole
14 days of 2x per day treatment with Miconazole Oil (Active Drug Product 2% Miconazole)
14-Day Placebo - Oil VehicleDrug
Also called (Miconazole) Placebo Oil Vehicle
14 days of 2x per day treatment with Placebo - Oil Vehicle, Study Drug base without active ingredient
| Study group | Role | What they receive |
|---|---|---|
| 7-Day Miconazole Oil (Miconazole 2%) | Active comparator | 7 days of 2x per day of treatment with Miconazole Oil (Active Drug Product 2% Miconazole) Receives: Drug: 7-Day Miconazole Oil (Miconazole 2%) |
| 14-Day Miconazole Oil (Miconazole 2%) | Active comparator | 14 days of 2x per day of treatment with Miconazole Oil (Active Drug Product 2% Miconazole) Receives: Drug: 14-Day Miconazole Oil (Miconazole 2%) |
| 14-Day Placebo - Oil Vehicle | Placebo comparator | 14 days of 2x per day of treatment with Placebo - Oil Vehicle, Study Drug base without active ingredient Receives: Drug: 14-Day Placebo - Oil Vehicle |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Efficacy Endpoint
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.
Measured: At Test of Cure visit (Day 15 for 7 Day Active and Day 22 for 14 Day Active and 14 Day Vehicle)
Secondary outcomes (1)
Secondary Efficacy Endpoints
- Percentage of subjects in MITT population with clinical cure at the Test of Cure Visit
- Percentage of subjects in MITT population with a negative fungal culture at the Test of Cure Visit
- 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).
- 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).
Measured: At Test of Cure visit (Day 15 for 7 Day Active and Day 22 for 14 Day Active and 14 Day Vehicle)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2017
- Study start20 Apr 2017
- Primary completion6 Aug 2019
- Study completion6 Aug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for OtomycosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 65 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hill Dermaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- QST Consultations, Ltd.
- Responsible party
- Sponsor
- Investigators
- Rosario G Ramirez, MD, Study director, Hill Dermaceuticals, Inc.Jack Wazen, MD, Principal investigator, Silverstein InstituteQuyen T Nguyen, MD, Principal investigator, UCSDKenneth Hodge, MD, Principal investigator, Advanced ENT and AllergyKenneth S Maxwell, MD, Principal investigator, Piedmont Ear, Nose and Throat AssociatesWoo Linda, MD, Principal investigator, Head and Neck Surgery Specialists
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03130738
- Sponsor's protocol ID
- HD-MCZ-PHII-DRF062016
- Status last verified
- Sep 2022
- First submitted
- 21 Apr 2017
- Last updated
- 5 Oct 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dose-Ranging Study of the Efficacy and Safety of Miconazole Oil Used for 7 or 14 Days Compared With Vehicle in the Treatment of Otomycosis
- ClinicalTrials.gov ID
- NCT03130738
- Acronym / sponsor ID
- HD-MCZ-PHII-DRF062016
- Conditions
- Otomycosis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 65 participants (actual)
- Lead sponsor
- Hill Dermaceuticals, Inc.Industry (pharma, biotech, devices)
- Collaborators
- QST Consultations, Ltd.
- Study start
- 20 Apr 2017 (actual)
- Primary completion
- 6 Aug 2019 (actual)
- Study completion
- 6 Aug 2019 (actual)
- First posted
- 26 Apr 2017 (actual)
- Results
- Posted 8 May 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of the study is to evaluate the efficacy and safety of active treatment (miconazole oil) for 7 versus 14 days, and to compare 14 days of active treatment (miconazole oil) to inactive treatment (placebo) over a 14-day treatment duration, in subjects with fungal infection (otomycosis) of the external ear.
Detailed description
Miconazole, an imidazole antifungal agent, is commonly used for different types of fungal skin infections, such as Candida, ringworm, jock itch, athlete's foot, nail fungus, vaginal yeast infections, and oropharyngeal candidiasis. The 2% formulation of miconazole is commonly used for dermatophytic infections. The mechanisms of action of miconazole against fungi in general appear to be applicable to fungi associated with otomycosis, in that miconazole has been demonstrated to have activity in vitro against some clinical isolates of fungi associated with human otomycosis in the US.
Miconazole targets the cytochrome P450-dependent enzyme 14-α-sterol demethylase, an enzyme that is also involved in mammalian cholesterol synthesis, resulting in inhibition of ergosterol biosynthesis in the cell membrane of the fungal organism. Because ergosterol is an important component of the cell membrane, inhibition of its synthesis inhibits fungal cell growth.
In addition to its activity toward the enzyme 14-α-sterol demethylase, miconazole also leads to increased reactive oxygen species in fungal organisms, which appears to result in fungicidal activity.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 7-Day Miconazole Oil (Miconazole 2%) | Active comparator | Drug: 7-Day Miconazole Oil (Miconazole 2%)7 days of 2x per day of treatment with Miconazole Oil (Active Drug Product 2% Miconazole) |
| 14-Day Miconazole Oil (Miconazole 2%) | Active comparator | Drug: 14-Day Miconazole Oil (Miconazole 2%)14 days of 2x per day of treatment with Miconazole Oil (Active Drug Product 2% Miconazole) |
| 14-Day Placebo - Oil Vehicle | Placebo comparator | Drug: 14-Day Placebo - Oil Vehicle14 days of 2x per day of treatment with Placebo - Oil Vehicle, Study Drug base without active ingredient |
Who may qualify
- Ages
- 25 months and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Uncomplicated otomycosis of the external ear only, age more than 2 year
Key exclusion criteria (8 listed)
- Pregnancy
- Other dermatoses or conditions of the ear that may interfere with the evaluation of otomycosis, including concomitant otic infections (including bacterial infection) that require antimicrobial treatment, disease that has spread beyond the external ear(s), or pre-existing skin atrophy of the affected ear(s)
- Tympanostomy tube or perforated tympanic membrane in the ear(s) that will be treated
- Previous surgery affecting the ear(s) that will be treated, except for prior tympanostomy tube(s) that had been removed and had completely healed
- Previous use of medicated treatments for otomycosis or participation in another investigational study within 28 days of study entry
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 7-Day Miconazole Oil (Miconazole 2%)Also: Miconazole7 days of 2x per day treatment with Miconazole Oil (Active Drug Product 2% Miconazole) | Drug | 7-Day Miconazole Oil (Miconazole 2%) |
| 14-Day Miconazole Oil (Miconazole 2%)Also: Miconazole14 days of 2x per day treatment with Miconazole Oil (Active Drug Product 2% Miconazole) | Drug | 14-Day Miconazole Oil (Miconazole 2%) |
| 14-Day Placebo - Oil VehicleAlso: (Miconazole) Placebo Oil Vehicle14 days of 2x per day treatment with Placebo - Oil Vehicle, Study Drug base without active ingredient | Drug | 14-Day Placebo - Oil Vehicle |
Primary outcome
Primary Efficacy Endpoint
Time frame: 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.
1 secondary outcome
Secondary Efficacy Endpoints
Time frame: At Test of Cure visit (Day 15 for 7 Day Active and Day 22 for 14 Day Active and 14 Day Vehicle)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
Related trials for Otomycosis
Recruiting
Nanoparticle-Based Prunus Salicina Extract vs. Clotrimazole for Otomycosis
Otomycosis, Antifungal Agents
Not yet recruiting
Terbinafine Hydrochloride for the Treatment of Otomycosis
Otomycosis, Fungal Ear Infection
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rosario G Ramirez, MD study director
Hill Dermaceuticals, Inc.
Jack Wazen, MD principal investigator
Silverstein Institute
Quyen T Nguyen, MD principal investigator
UCSD
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing 7-Day Miconazole Oil (Miconazole 2%) and 14-Day Miconazole Oil (Miconazole 2%) in people with Otomycosis, run by Hill Dermaceuticals, Inc. at 6 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 8 May 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary Efficacy Endpoint (time frame: At Test of Cure visit (Day 15 for 7 Day Active and Day 22 for 14 Day Active and 14 Day Vehicle)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Oct 2022.