The purpose of this study is to evaluate the safety and efficacy of G238 for the treatment of otomycosis
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
190
Five drops into the ear canal twice daily for 14 days
Five drops into the ear canal twice daily for 14 days
Laboratorios SALVAT, S.A.
Esplugues de Llobregat, Barcelona, Spain
Proportion of Subjects With a Complete Response to Treatment
Efficacy will be assessed primarily by evaluation of the fungal culture, and the sum of signs and symptom scores (pruritus, otalgia, otorrhea and aural fullness obstruction to be scored as 0=absent; 1= mild; 2=moderate; 3=severe). The primary efficacy variable is the proportion of subjects with a negative culture for fungus, AND a signs and symptom score of 0 on Day 24. Response to the study treatment was classed according to the following definitions: * Complete response: Negative fungal culture or presumed eradication on day 24, and sum score for signs and symptoms = 0 on day 24. * Partial response: Negative culture or presumed eradication on day 24, and sum score for signs and symptoms = 1 or 2 on day 24. * No response: Positive culture on day 24 or negative culture or presumed eradication and sum score for signs and symptoms \> 2 on day 24.
Time frame: Day 24
Changes in Signs/ Symptoms
The secondary efficacy variables include: * Proportion of subjects with signs and symptoms score of "0" at Day 15 * Proportion of subjects with signs and symptoms score of "0" at Day 24 * Proportion of subjects with a negative culture for fungus or presumed eradication (mycological cure) on Day 24.
Time frame: 2 weeks and 4 weeks
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.