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Completed
NCT07816510
Combination of Oral Antifungal Treatment for Refractory Dermatophytosis
Conditions: Dermatophytosis
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: NA
Enrollment: 138
Sponsor: Chittagong Medical College
Location: Chittagong Medical College Chittagong
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.
Eligibility Criteria
Inclusion Criteria:
* Patients with refractory dermatophytosis (patients who did not respond to routine treatment, relapsed soon after stoppage of treatment, or those having persistent dermatophytes infection)
* Patients of both sexes with age 18 years and above.
Exclusion Criteria:
* Refused to participate in the study.
* Pregnancy and lactation.
* Any history of a drug reaction or allergy to any of the four drugs,
* Any significant abnormality in complete blood counts (CBC), liver function test (LFT), renal function test (RFT) and electrocardiogram (ECG)
* Patients with comorbidities like cardiac disorder, liver disorder, renal disorder.
* Patients with an associated bacterial co-infection.
Source: ClinicalTrials.gov (NCT07816510). StuddyBuddy aggregates publicly available trial information.