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

NCT04880980 | Completed Phase 3

• 1 other identifier: PEMH Rawalpindi
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Dermatophyte Infection; Terbinafine Adverse Reaction; Itraconazole Adverse Reaction

Keywords

double dose; oral terbinafine; oral itraconazole; dermatophyte skin infection; randomized controlled trial

Outcome Measures

Primary Outcomes (2)

• 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 .

  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.

  2-4 weeks

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

  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.

  2-4 weeks

Secondary Outcomes (1)

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

  2-4 weeks

Study Arms (2)

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

ACTIVE COMPARATOR

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

Drug: Terbinafine Pill

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

ACTIVE COMPARATOR

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

Drug: Itraconazole capsule

Interventions

Terbinafine Pill DRUG

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

Also known as: Lamisil

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

Itraconazole capsule DRUG

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

Also known as: Icon

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

Eligibility Criteria

• Age: 15 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Pak Emirates Military Hospital: lead

Study Sites (1)

Pak Emirates Military Hospital

Rawalpindi, Punjab Province, 46000, Pakistan

Location

MeSH Terms

Conditions

Dermatomycoses

Interventions

Terbinafine; Itraconazole; icon infiltrant

Condition Hierarchy (Ancestors)

Mycoses; Bacterial Infections and Mycoses; Infections; Skin Diseases, Infectious; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds; Triazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Piperazines

Study Officials

• Dr. Umar Abdul Ali Qureshi, MBBS

  Pak Emirates Military Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Participants will be randomly assigned to group one or two.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Speciality Registrar Dermatology

Model Details: Randomized controlled trial

Study Record Dates

• First Submitted: March 16, 2021
• First Posted: May 11, 2021
• Study Start: March 15, 2021
• Primary Completion: March 15, 2022
• Study Completion: March 15, 2022
• Last Updated: April 1, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)