NCT04880980

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

Comparison of Efficacy of Double Dose Oral Terbinafine Versus Itraconazole in Treatment of Dermatophyte Infections of Skin - A Prospective, Randomized Controlled Trial

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 120 (actual)
• Sponsor: Pak Emirates Military Hospital · Academic / Other
• Sex: All
• Age: 15 Years – 50 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
DRUG	Terbinafine Pill	Double than usual dose of oral terbinafine pills will be used for treatment purpose in one group.
DRUG	Itraconazole capsule	Double than usual dose of oral itraconazole capsules will be used for treatment purpose in second group.

Timeline

• Start date: 2021-03-15
• Primary completion: 2022-03-15
• Completion: 2022-03-15
• First posted: 2021-05-11
• Last updated: 2022-04-01

Locations

1 site across 1 country: Pakistan