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

NCT ID: NCT04880980

Last Updated: 2022-04-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-03-15
• Study Completion Date: 2022-03-15

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.

Conditions

Dermatophyte Infection; Terbinafine Adverse Reaction; Itraconazole Adverse Reaction

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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

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

Group Type: ACTIVE_COMPARATOR

Terbinafine Pill

Intervention Type: DRUG

Double than usual dose of oral terbinafine pills will be used for treatment purpose in one group.

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

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

Group Type: ACTIVE_COMPARATOR

Itraconazole capsule

Intervention Type: DRUG

Double than usual dose of oral itraconazole capsules will be used for treatment purpose in second group.

Interventions

Terbinafine Pill

Double than usual dose of oral terbinafine pills will be used for treatment purpose in one group.

Intervention Type: DRUG

Itraconazole capsule

Double than usual dose of oral itraconazole capsules will be used for treatment purpose in second group.

Intervention Type: DRUG

Other Intervention Names

Lamisil; Icon

Eligibility Criteria

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.

• Minimum Eligible Age: 15 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Pak Emirates Military Hospital

OTHER

Sponsor Role: lead

Responsible Party

Dr. Umar Abdul Ali Qureshi

Speciality Registrar Dermatology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Dr. Umar Abdul Ali Qureshi, MBBS

Role: PRINCIPAL_INVESTIGATOR

Pak Emirates Military Hospital

Locations

Pak Emirates Military Hospital

Rawalpindi, Punjab Province, Pakistan

Countries

Pakistan

Other Identifiers

PEMH Rawalpindi

Identifier Type: -

Identifier Source: org_study_id