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Antifungal

Active group for Fungal Ear Infection

Phase 3

Recruiting

Research Sponsored by Hill Dermaceuticals, Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Diagnosis of uncomplicated otomycosis of the external ear only, in the ear(s) that will be treated with study drug, with a score for fungal elements of 1 in each ear to be treated with study drug (see Section 7.4 for definitions of the scores for each of the otomycosis signs and symptoms). Subjects must also have the following signs and symptoms of otomycosis in the study ear: pruritus ≥2; debris ≥2; and aural fullness ≥2.

Male or non-pregnant, non-lactating females

Timeline

Screening 3 weeks

Treatment Varies

Follow Up day 22, test of cure

Awards & highlights

Study Summary

This trial is testing whether miconazole oil is effective in treating fungal infections in the ears. Participants will be randomly assigned to receive either the drug or a placebo, and neither the researcher nor the participants

Who is the study for?

This trial is for males and non-pregnant, non-breastfeeding females with a fungal ear infection (otomycosis) in one or both ears. Participants must be generally healthy without significant diseases like uncontrolled diabetes that could affect the study. Women who can have children must test negative for pregnancy and agree to use birth control during the trial.Check my eligibility

What is being tested?

The study tests if Miconazole oil, an antifungal treatment, is effective against ear fungus compared to a placebo (mineral oil). Neither researchers nor participants will know who receives the real drug or placebo. After two weeks of treatment, effectiveness and side effects are assessed.See study design

What are the potential side effects?

Potential side effects from Miconazole oil may include irritation inside the ear, allergic reactions, or discomfort at the site of application. The mineral oil placebo might cause similar local reactions but typically has fewer risks.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have a fungal ear infection with itching, debris, and a feeling of fullness.

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I am a man or a woman not pregnant or breastfeeding.

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I am in good health overall and do not have any major illnesses, including uncontrolled diabetes, that could affect the study.

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I or my caregiver can legally consent to participate.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ day 22, test of cure

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~day 22, test of cure

This trial's timeline: 3 weeks for screening, Varies for treatment, and day 22, test of cure for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

primary efficacy endpoint

Secondary outcome measures

Clinical Cure at the End of Treatment

Modified Clinical Cure at End of Treatment

Modified Clinical Cure at Test of Cure

Trial Design

2Treatment groups

Active Control

Placebo Group

Group I: Active groupActive Control1 Intervention

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.

Group II: Placebo groupPlacebo Group1 Intervention

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.

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

Hill Dermaceuticals, Inc.Lead Sponsor

3 Previous Clinical Trials

455 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the current number of individuals being recruited for participation in this clinical research study?

"To fulfill the requirements of this clinical trial, a total of 100 eligible patients are sought for enrollment. Prospective participants have the opportunity to join from various locations, including Head and Neck Surgery Specialist in Chula Vista, California, as well as Advanced ENT & Allergy in Louisville, Kentucky."

Answered by AI

At how many different venues can this clinical trial be accessed?

"This clinical trial has limited availability in specific locations, such as Head and Neck Surgery Specialist in Chula Vista, California; Advanced ENT & Allergy in Louisville, Kentucky; and Carolina ENT in Orangeburg, South carolina. Additionally, there are 5 other undisclosed sites participating in the study."

Answered by AI

What level of risk does the Active group pose to individuals participating in this study?

"Given that this trial is in Phase 3, indicating previous safety data and evidence of efficacy, the Active group has been assigned a safety rating of 3 by our team at Power."

Answered by AI

Are there ongoing efforts to actively enlist participants for this medical study?

"Indeed, according to the information on clinicaltrials.gov, this ongoing trial is actively seeking eligible participants. The initial posting of the study took place on March 2nd, 2023 and was most recently updated on January 15th, 2024. The research team aims to enroll a total of 100 patients distributed across five different sites."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Phase III Efficacy and Safety Study of Miconazole Oil for Otomycosis

2023. "Phase III Efficacy and Safety Study of Miconazole Oil for Otomycosis". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05660382.