Comparison of Efficacy of Double Dose Oral Terbinafine Vs Itraconazole in Treatment of Dermatophyte Infections of Skin.

Phase 3

Completed

• Conditions: Terbinafine Adverse Reaction; Dermatophyte Infection; Itraconazole Adverse Reaction
• Interventions: Drug: Terbinafine Pill; Drug: Itraconazole capsule

• Registration Number: NCT04880980
• Lead Sponsor: Pak Emirates Military Hospital

Brief Summary

Study would be conducted to compare the efficacy and safety of double than usual dose oral terbinafine versus itraconazole in treatment of dermatophyte infections of skin in patient presenting at dermatology department of Pak Emirates Military Hospital, Rawalpindi, Pakistan.

Detailed Description

* Study would be a randomized controlled trial, in which 120 subjects would be randomly divided into two equal groups of 60 each.

* Each group would be prescribed double than usual dose of terbinafine(250 mg twice daily) or itraconazole(100mg twice daily) for 2 weeks initially. Treatment may be extended to 4 weeks if cure has not been achieved.

Patients will be diagnosed and followed on the basis of classical clinical features of dermatophyte infections and microscopic potassium hydro-oxide slide preparation for fungal hyphae and spores.

Liver function tests will be checked on day 0, 14 and 28. Individuals aged 15-50 years with one or no co-morbidity will be included in the study.

Study will be conducted over a period of 6-8 months.

Study Timeline

• Study Start: 2021-03-15
• Study First Submitted: 2021-03-16
• Study First Submitted QC: 2021-05-05
• Study First Posted: 2021-05-11
• Status Verified: 2022-03
• Primary Completion: 2022-03-15
• Study Completion: 2022-03-15
• Last Update Submitted: 2022-03-19
• Last Update Posted: 2022-04-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

• individuals with dermatophyte skin infection, aged 15-50 years with one or no co-morbidities.

Exclusion Criteria

• individuals with two or more co-morbidities or known cases of chronic liver disease.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Efficacy of double dose oral terbinafine in treatment of dermatophytic infections of skin	Terbinafine Pill	This group of participants will be given double than usual dose of oral terbinafine for the treatment of dermatophyte skin infections.
Efficacy of double dose oral itraconazole in treatment of dermatophytic infections of skin	Itraconazole capsule	This group of participants will be given double than usual dose of oral itraconazole for the treatment of dermatophyte skin infections

Primary Outcome Measures

Name	Time	Method
Percentage of patients cured by using double dose of oral terbinafine Vs itraconazole in the treatment of resistant dermatophyte skin infections as assessed by measuring pruritis, erythema and scaling .	2-4 weeks	Classical clinical features of dermatophyte skin infections (pruritis, erythema and scaling, all will be graded on a scale 0-3 i. e 0=none to 3=severe) would be noted at start of treatment after 2 weeks and then if required after 4 weeks of treatment.
Adverse effects including effects on liver function tests of double dose oral terbinafine Vs itraconazole in the treatment of resistant dermatophyte skin infections.	2-4 weeks	Objective Assessment of adverse effects (nausea, vomiting, jaundice) as well as laboratory evaluation of liver function tests (Bilirubin umol/L, ALT U/L, ALP U/L) would be performed at start of treatment after 2 weeks and if required than after 4 weeks.

Secondary Outcome Measures

Name	Time	Method
Duration of treatment required to achieve cure from resistant dermatophyte infections.	2-4 weeks	Treatment response in form of clinical features (changes in erythema. Pruritis and scaling) and KOH fungal slide smear testing would be done after 2 weeks of treatment and if required than after 4 weeks.

Trial Locations

Locations (1)

Pak Emirates Military Hospital; 🇵🇰 Rawalpindi, Punjab, Pakistan