drugset / Trial / NCT02582177

Effectiveness Study of Ketoconazole and Betamethasone to Treat Fungal Infection and Dermatophytosis

NCT02582177

Phase 3 Completed 125 enrolled Ache Laboratorios Farmaceuticos S.A.
RandomizedParallel-groupTriple-blindTreatment

Summary

To evaluate the no-inferiority of the ketoconazole20mg/g and betamethasone dipropionate 0.64 mg/g association (Candicort®) cream versus clotrimazole 10mg and dexamethasone acetate 0.443 mg/g association (Baycuten N®) cream, general relief of signs and symptoms (erythema, maceration, peeling, blistering / papules / pustules, itching and burning / stinging) 06 (± 1) days after onset treatment.

Timeline

Start
2019-06-11
Primary completion
2020-01-20
Completion
2020-03-24

Drugs

EvaluationDrugModalityDoseRoute
Subject Clotrimazole Unknown 10 mg Topical
Subject Dexamethasone Small molecule 0.443 unknown Topical
Subject Ketoconazole Small molecule 20 unknown Topical
Subject betamethasone dipropionate Small molecule 0.64 unknown Topical

Indications