Efficacy and Safety of Terbinafine and Itraconazole Monotherapy in Conventional and Increased Doses and in Combination in Dermatophytosis

ERC-DMC/ECC/2023/81

There is a rise in the prevalence in recent years especially in tropical countries along with an increase in the number of treatment failures with chronic and recurrent dermatophytosis. There is a huge gap between the treatment required in the present scenario and the treatment guidelines given in the standard books. The aim of the study is to determine the effectiveness of terbinafine and itraconazole in different doses and in combination in the treatment of dermatophytosis. The study design will be a randomized parallel-group trial. Patients will be randomly divided into five parallel arms in which two of the standard drugs in recommended doses will be compared with their double doses and with a combination of both drugs. The patients will be reevaluated at 2, 4, 6, and 8 weeks of treatment (the end of therapy), using the physician Global Assessment (PGA) Scale. The cure will be considered a complete clinical resolution of the lesions. The patient's response to the treatment will be recorded. Safety and patient compliance will be recorded at each follow-up visit. Findings of observation will be recorded on a pre-prescribed and pre-tested data collection form. After collection, all data will be checked and compiled. Data will be processed and analyzed using computer software with statistical packages for social science SPSS-26. An analysis plan will be developed keeping in view the objectives of the study. The results of the continuous measurement will be presented on mean ± SD (mean-max) and results on categorical measurements will be presented in numbers (%). A p\<0.05 will be considered statistically significant. Results will be disseminated to all Dermatology departments in Bangladesh.

2023-05-01

2023-10-01

2023-11-01

Not yet recruiting

Early phase I

150

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

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2', 'PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 150, 'type': 'ESTIMATED'}}

2023-05-31