Phase 2
N=65
Dose-Ranging Study for Miconazole Oil for Treatment of Otomycosis
Otomycosis
Bottom Line
View on ClinicalTrials.gov: NCT03130738 ↗Enrolled (actual)
65
Serious AEs
0.0%
Results posted
May 2020
Primary outcome: Primary: Primary Efficacy Endpoint — 1; 3; 1 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- 7-Day Miconazole Oil (Miconazole 2%) (Drug); 14-Day Miconazole Oil (Miconazole 2%) (Drug); 14-Day Placebo - Oil Vehicle (Drug)
- Age
- Pediatric, Adult, Older Adult · 0+ yrs
- Sex
- All
- Sponsor
- Hill Dermaceuticals, Inc.
- Primary completion
- Aug 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Primary Efficacy Endpoint |
1; 3; 1 | — |
| SECONDARY Secondary Efficacy Endpoints |
2; 4; 2; 4; 5; 3 | — |
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.
Eligibility Criteria
Inclusion Criteria
- Uncomplicated otomycosis of the external ear only, age more than 2 year
Exclusion Criteria
- 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
Data sourced from ClinicalTrials.gov (NCT03130738). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.