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

Pak Emirates Military Hospital

Status and phase: Completed; Phase 3

Conditions: Terbinafine Adverse Reaction; Itraconazole Adverse Reaction; Dermatophyte Infection

Treatments: Drug: Terbinafine Pill; Drug: Itraconazole capsule

Study type: Interventional

Funder types: Other

Identifiers

NCT04880980

PEMH Rawalpindi

Details and patient eligibility

About

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.

Full 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.

Enrollment: 120 patients

Sex: All

Ages: 15 to 50 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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120 participants in 2 patient groups

Efficacy of double dose oral terbinafine in treatment of dermatophytic infections of skin

Active Comparator group

Description:

This group of participants will be given double than usual dose of oral terbinafine for the treatment of dermatophyte skin infections.

Treatment:

Drug: Terbinafine Pill

Efficacy of double dose oral itraconazole in treatment of dermatophytic infections of skin

Active Comparator group

Description:

This group of participants will be given double than usual dose of oral itraconazole for the treatment of dermatophyte skin infections

Treatment:

Drug: Itraconazole capsule