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IRCT20230531058353N1 IRCT 2023-08-07 PNS Shifa Efficacy of oral itraconazole with sertaconazole cream versus oral itraconazole with clotrimazole cream in dermatophytosis - a randomized controlled trial in a tertiary care hospital in Pakistan Efficacy of oral itraconazole with sertaconazole cream versus oral itraconazole with clotrimazole cream in dermatophytosis - a randomized controlled trial in a tertiary care hospital in Pakistan 2023-06-26 anticipated 118 Complete https://irct.ir/trial/70492 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Randomization done by lottery method, in which small chits of paper are kept in a jar and the patients will be asked to pick one deciding their treatment regimen. Half of the chits will be Group A and half of the chits will be Group B. Chits will be folded uniformly to conceal their identity, Blinding description: In this study, the participant, the investigator and outcome assessor were all blinded except for one physician who was supposed to recruit the patients in the group. As explained above, the participants will be asked to pick up a chit of paper from a jar that will be decide in which group they will fall into. Half of the chits will be Group A and half of the chits will be Group B. The chits will be folded uniformly to conceal identity. The participants will not open the chit themselves, but will hand it over to the non-blinded accessor, who will give them the medicine without any label showing the brand or generic name. 3 Dermatophyte infection. Intervention 1: Intervention group: In group "A", patients were treated with Tab Itraconazole 100mg twice a day and sertaconazole cream applied topically twice a day for 4 weeks or less in patients in which clinical response is achieved. Intervention 2: Intervention group: In group "B", patients were treated with Tab Itraconazole 100 mg twice a day and clotrimazole cream applied twice a day for 4 weeks or less in which clinical response is achieved. Yes - There is a plan to make this available What will be shared: Primary outcome When: 1 month after the trial and for lifetime To whom: People working in academic institutions Conditions: Many Where to obtain: abshaabbasi5@gmail.com How to obtain: Request Comments:
public Dr Absha Abbasi
Dr Absha Abbasi, 5th floor, OPD Tower, PNS Shifa Hospital
Karachi Pakistan 74900 +92 21 48506592 abshaabbasi5@gmail.com PNS Shifa scientific Dr Absha Abbasi
Dr Absha Abbasi, 5th Floor, OPD Tower, PNS Shifa Hospital
Karachi Pakistan 74900 +92 21 48506592 abshaabbasi5@gmail.com PNS Shifa Pakistan Patients of both, male and female genders, in age group 12-75 years with clinical manifestations of cutaneous dermatophyte infections (tinea corporis/tinea cruris/tinea faciei) and confirmation done with skin scraping positive for potassium hydroxide (KOH) mount. 12 years 75 years Both Patients with age less than 12 years and greater than 75 years. Hyperlipidemia Abnormal liver function tests Pregnant and breast feeding females. solitary lesion which is less than 3 cm in diameter hypersensitivity to antifungals if patients are on any systemic medications known to have interactions with itraconazole superadded bacterial infections patients on immunosuppressive drugs patients who are known case of liver or renal disease Tinea capitis and onychomycosis B35 Dermatophytosis Treatment - Drugs Treatment - Drugs Intervention group: In group "A", patients were treated with Tab Itraconazole 100mg twice a day and sertaconazole cream applied topically twice a day for 4 weeks or less in patients in which clinical response is achieved. Intervention group: In group "B", patients were treated with Tab Itraconazole 100 mg twice a day and clotrimazole cream applied twice a day for 4 weeks or less in which clinical response is achieved. Clinical evaluation and absence of fungal hyphae on KOH microscopy. Timepoint: Patients were evaluated clinically on 2 weeks of treatment then 4 weeks of treatment (end point) and then further followed up after 4 weeks. Method of measurement: Clinical evaluation. PNS Shifa Approved 2023-06-27 Ethical review committee, PNS Shifa PNS Shifa Hospital, DHA Phase 2, Karachi, Pakistan Karachi Sindh Pakistan