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NCT Number: NCT04880980

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

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.

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Key information

Conditions

Dermatophyte Infection Bacterial Infections and Mycoses Dermatomycoses Infections Itraconazole Adverse Reaction Mycoses Skin Diseases Skin Diseases, Infectious Skin and Connective Tissue Diseases Terbinafine Adverse Reaction

Age range

15 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Pak Emirates Military Hospital

Rawalpindi, Punjab Province, 46000, Pakistan

About this study

  • 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Terbinafine Pill

Drug

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

Other names: Lamisil

Itraconazole capsule

Drug

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

Other names: Icon

Primary outcomes

  1. 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 .

    Time frame: 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.

  2. Adverse effects including effects on liver function tests of double dose oral terbinafine Vs itraconazole in the treatment of resistant dermatophyte skin infections.

    Time frame: 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 outcomes

  1. Duration of treatment required to achieve cure from resistant dermatophyte infections.

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Pak Emirates Military Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
May 11, 2021
Registry last updated
Apr 1, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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