Clotrimazole

ArticlesLactation Safety InformationNew Medicines ·
5797005

Articles

Lactation Safety Information

For vaginal infections

For vaginal infections
30 July 2020

For use in the ear

For use in the ear
30 July 2020

For topical use

For topical use
30 July 2020

New Medicines

Fungal infections of the ear (otomycosis) in adults

Information

New formulation
Laboratorios SALVAT
Laboratorios SALVAT

Development and Regulatory status

None
None
Phase III Clinical Trials

Category

SVT-15652 is an otic solution of clotrimazole. SVT-15652 is a broad spectrum antimycotic or antifungal agent. Clotrimazole acts primarily by damaging the permeability barrier in the cell membrane of fungi.
The incidence of otomycosis is not known but it is more common in hot climates and in those who partake in aquatic sports. About 1 in 8 of otitis external infections is fungal in origin. 90% of fungal infections involve Aspergillus spp. and the rest Candida spp. The prevalence rate has been quoted as 10% of patients presenting with signs and symptoms of otitis externa [1].
Fungal infections of the ear (otomycosis) in adults
Topical

Trial or other data

Feb 20PIII study to compare the efficacy and safety of SVT-15652 otic solution to that of Placebo, when administering one vial twice daily during 14 days starts (NCT03686384). 191 adults will be recruited in the US. Primary outcome is therapeutic cure; collection of these data is due to complete Mar 21 [2].