drugset / Trial / NCT07816510

Combination of Oral Antifungal Treatment for Refractory Dermatophytosis

NCT07816510 ↗

Completed 138 enrolled Chittagong Medical College
RandomizedParallel-groupOpen-labelTreatment

Summary

Superficial dermatophytosis is no longer a simple, cutaneous fungal infection that is easily amenable to treatment. It has evolved into a chronic and recurrent, difficult-to-treat condition, which affects the patients' physical and social well-being. In recent years, the number of human diseases caused by this group of fungi has increased considerably. Recently, physicians are facing an overwhelmingly large number of chronic and recurrent dermatophytosis in volumes never encountered previously. This change in the clinical scenario with increasing frequency of treatment failures has given rise to innumerable treatment options mainly based on individual's experience, as the therapeutic regimens given in the standard textbooks have ceased to result in a good clinical response. However, there is a lack of original studies, especially in Bangladesh, depicting dermatophytosis as a huge menace both to the patient and the treating physician. Co-administration of drugs of different mechanisms of action can often be synergist through inhibition of complementary targets inside fungal cells. Terbinafine is a fungicidal drug that inhibits the enzyme squalene epoxidase, which converts squalene to lanosterol. Itraconazole, fluconazole and voriconazole are fungistatic drugs that act through the inhibition of the enzyme 14α-demethylase. Many dermatologists have started using higher doses and combination regimens of antifungals to counter the dermatophytes refractory to the conventional treatment. However, such regimens have not been validated, especially in our context. Hence, this study was designed to evaluate the commonly used systemic antifungal drugs, i.e., terbinafine, itraconazole, fluconazole and voriconazole at various doses and in combinationfor the treatment of refractory dermatophytes.The study results would guide dermatologists in their decision-making process while treating the refractory dermatophytes.

Timeline

Start
2021-03-01
Primary completion
2021-08-31
Completion
2021-08-31

Drugs

EvaluationDrugModalityDoseRoute
Subject Fluconazole Small molecule 100 mg Oral
Subject Itraconazole Small molecule 100 mg Oral
Subject Terbinafine Small molecule 250 mg Oral
Subject Voriconazole Small molecule 100 mg Oral
Subject Voriconazole Small molecule 200 mg Oral

Indications