Efficacy and Safety Study of Miconazole Oil Versus Vehicle on Fungal Infection of the Ear Canal (Otomycosis)
Status:
Recruiting
Trial end date:
2021-12-01
Target enrollment:
Participant gender:
Summary
This study involves two portions, a randomized, double-blind portion and an open-label
portion, to evaluate the efficacy and safety of Miconazole oil 2% versus its Vehicle in the
treatment of fungal infection of the outer ear canal (Otomycosis). The subjects randomized in
the first portion of the study will have active fungal infection of the ear(s) and will be
treated with either Miconazole Oil or the Vehicle for 14 days twice daily, 5 drops into the
ear(s) per dose. The subjects enrolled in the open-label portion of the study may or may not
have active fungal infection of the ear(s), and will be given the Miconazole Oil active drug
following the same application of 5 drops into the ear(s) twice daily for 14 days.
The intention of the study is to evaluate the efficacy of Miconazol Oil on fungal infection
of the ears when applied using 5 drops into the ear(s) twice daily for 14 days continuously.
This study also intends to show safety of Miconazole Oil 5 drops into each ear twice a day
for 14 consecutive days.