Comparison Of Oral Terbinafine Alone And Oral Terbinafine With Fluconazole in Dermatophytosis Among Children

To compare the efficacy of oral terbinafine alone and oral terbinafine and fluconazole in treating dermatophytes among children under 18 years.

Randomized controlled trail of 200 patients, single centered study

Study would be conducted in Dermatology department, PNS Shifa Hospital, Karachi.

Inclusion criteria: (a) clinical diagnosis of tinea corporis, tinea cruris or tinea faciei, Tinea pedis, tinea capitis (b) microscopic confirmation (potassium hydroxide [KOH] microscopy), (c) age birth to 18 years and (d) no treatment with terbinafine or fluconazole in last one month. Exclusion criteria (a) presence of any other type(s) of tinea, e.g., onychomycosis, b) inability to come for follow-up, c) history of adverse reaction to terbinafine and/or fluconazole, D) history of renal, liver or cardiac disease

Patients would be divided into 2 groups by lottery method based on treatment regimens as follows: 1. Group A: Terbinafine orally at following doses: 62.5 mg/day for <10 kg body weight, 125 mg/day for 10-20 kg body weight, and 250 mg/day for >20kg body weight. 2. Group B: Terbinafine orally at following doses: 62.5 mg/day for <20 kg body weight, 125 mg/day for 20–40 kg body weight, and 250 mg/day for >40 kg body weight. And fluconazole orally at 6mg/kg/every alternate day

Outcome measures and statistical analysis: Patients were labeled as the following at both fourth and eighth weeks. Complete response: Cured (complete clinical resolution of all lesions) Partial response: Partially cured (more than 50% improvement in the total BSA) and No response: Increase in severity of the lesions or no improvement in the lesions after 4 weeks of starting antifungal agents RELAPSE: Reappearance of lesions once they have been cured on follow up visit,

Individuals are randomly divided into two groups on simple method based on sealed envelops. Each participant would be offered a sealed envelop, neither the participant nor the investigator would be aware of the drugs inside the sealed envelop.

The participant, principle investigator, outcome assessors and care givers will all be blinded except for one physician who will open the sealed envelope and give the patient drug A or drug B, as per the group code inside the envelope, without informing the patient if he is being given drug A or drugB

there is no further information

IPD collected for primary outcome

after the study is published

only available for people working in academic institutions.

Not applicable

The investigator

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