Efficacy and Safety of Terbinafine and Itraconazole

Launched by DHAKA MEDICAL COLLEGE · May 20, 2023

Keywords

ClinConnect Summary

This clinical trial is studying the effectiveness and safety of two antifungal medications, terbinafine and itraconazole, to treat skin infections caused by fungi, known as dermatophytosis. The trial aims to find out which doses of these medications work best, whether they can be used together, and how well they help patients with conditions like tinea corporis (ringworm on the body), tinea cruris (jock itch), and tinea faciei (ringworm on the face). If you are between 18 and 60 years old and have a confirmed diagnosis of these skin conditions, you might be eligible to participate.

Participants in the trial will be randomly placed into one of five groups, where they will receive either one of the medications at standard or higher doses, or a combination of both. Throughout the treatment, which lasts for eight weeks, doctors will check how well the participants are responding to the medications and whether there are any side effects. The results will help improve treatment options for these common fungal infections, especially in areas where they are becoming more difficult to treat. It’s important to note that this study is not yet recruiting participants, and there are specific health criteria that must be met to join.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Clinical suspicion of tinea corporis, tinea cruris or tinea faciei or any combination of these conditions
• • Microscopic confirmation of tinea (KOH microscopy showing regularly septate branching hyphae),
• • Age 18- 60 years
• Exclusion Criteria:
• • Children less than 18 years of age
• • Pregnancy and lactation
• • Patients with co-existent tinea unguium, tinea pedis, or tinea manuum,
• • History of recent use of antifungal drugs or steroids in last 4 weeks.
• • Patient with any other disease requiring systemic therapy
• • Patients with co-morbidities like cardiac disorder, liver disorder, renal disorder
• • History of a drug reaction or allergy to any of the two drugs
• • Any significant abnormality in complete blood counts (CBC), liver function test (LFT), renal function test (RFT), and electrocardiogram (ECG),
• • Patients or attendants refused to give informed consent to take part in the study