Efficacy and Safety of Terbinafine and Itraconazole
Status:
Not yet recruiting
Trial end date:
2023-11-01
Target enrollment:
Participant gender:
Summary
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.