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

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.

Study Overview

• Status: Completed
• Conditions: Terbinafine Adverse Reaction; Dermatophyte Infection; Itraconazole Adverse Reaction
• Intervention / Treatment: Drug: Terbinafine Pill; Drug: Itraconazole capsule

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.

• Study Type: Interventional
• Enrollment (Actual): 120
• Phase: Phase 3

Contacts and Locations

Study Locations

• Pakistan
  • Punjab
    • Rawalpindi, Punjab, Pakistan, 46000
      • Pak Emirates military hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 15 years to 50 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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.	Drug: Terbinafine Pill; Double than usual dose of oral terbinafine pills will be used for treatment purpose in one group.; Other Names: Lamisil
Active Comparator: 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	Drug: Itraconazole capsule; Double than usual dose of oral itraconazole capsules will be used for treatment purpose in second group.; Other Names: Icon

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Duration of treatment required to achieve cure from resistant dermatophyte infections.	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.	2-4 weeks

Collaborators and Investigators

• Sponsor: Pak Emirates Military Hospital
• Investigators: Principal Investigator: Dr. Umar Abdul Ali Qureshi, MBBS, Pak Emirates military hospital

Study record dates

Study Major Dates

• Study Start (Actual): March 15, 2021
• Primary Completion (Actual): March 15, 2022
• Study Completion (Actual): March 15, 2022

Study Registration Dates

• First Submitted: March 16, 2021
• First Submitted That Met QC Criteria: May 5, 2021
• First Posted (Actual): May 11, 2021

Study Record Updates

• Last Update Posted (Actual): April 1, 2022
• Last Update Submitted That Met QC Criteria: March 19, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Keywords: randomized controlled trial; double dose; oral terbinafine; oral itraconazole; dermatophyte skin infection
• Additional Relevant MeSH Terms: Pathologic Processes; Skin Diseases; Disease Attributes; Bacterial Infections and Mycoses; Skin Diseases, Infectious; Mycoses; Infections; Communicable Diseases; Dermatomycoses; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Enzyme Inhibitors; Hormones, Hormone Substitutes, and Hormone Antagonists; Cytochrome P-450 CYP3A Inhibitors; Cytochrome P-450 Enzyme Inhibitors; Hormone Antagonists; Antifungal Agents; Steroid Synthesis Inhibitors; 14-alpha Demethylase Inhibitors; Itraconazole; Terbinafine
• Other Study ID Numbers: PEMH Rawalpindi

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Individual participant's data will be kept confidential.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No