Comparative Study Between Pulse Therapy With Oral Itraconazole Versus Continuous Oral Terbinafine Therapy for Treatment of Onychomycosis

NCT ID: NCT05578950

Last Updated: 2022-10-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-03-01
• Study Completion Date: 2022-08-31

Brief Summary

Nail fungus, often known as onychomycosis (OM), can attack either the toenails or the fingernails. Onychomycosis can affect the matrix, the nail bed, or the nail plate. Though not fatal, onychomycosis is a significant condition that can impede a person's mobility and ability to work. Onychomycosis's wide-ranging emotional and social impacts can have a serious negative impact on patients' well-being.

White superficial onychomycosis (WSO), proximal subungual onychomycosis (PSO), endonyx onychomycosis (EO), and candidal onychomycosis are the most common subtypes of onychomycosis. A patient may exhibit characteristics from more than one of these categories. A severe case of onychomycosis, regardless of its subtype, is called total dystrophic onychomycosis.

Different types of onychomycosis have different pathophysiology. The most frequent type of onychomycosis, known as distal lateral subungual onychomycosis, occurs when a fungus travels from the plantar skin to the nail bed through the hyponychium.

These sections of the nail apparatus become inflamed, leading to the outward manifestations of distal lateral subungual onychomycosis. White superficial onychomycosis, on the other hand, is a less common presentation produced by invasion of the nail plate's surface. Fungi colonise the deep section of the proximal nail plate in the rare condition known as proximal subungual onychomycosis. When the fungi infect the nail through the skin and penetrate the nail plate, the result is known as endonyx onychomycosis, a subtype of distal lateral onychomycosis.

Over and over again, terbinafine has been shown to be more effective than other antifungal medicines in clinical trials. Mycological cure rates for onychomycosis were 76% with terbinafine, 63% with pulse itraconazole, and 48% with fluconazole, according to a meta-analysis of 18 studies.

The aim of this study is to determine the aim of this study is to compare pulse therapy with oral itraconazole versus continuous oral terbinafine for treatment of onychomycosis

Conditions

Onychomycosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

group A pulse therapy of itraconazole

patients with pulse therapy group recieved oral itraconazole 100 mg, two capsules twice daily for 7 days a month

Group Type: ACTIVE_COMPARATOR

itraconazole

Intervention Type: DRUG

100 mg two capsules of itraconazole were givev twice daily to 50 patients in group A for one week per month . baseline LFTs were also monitered

group B continous therapy of terbinafine

patients with continous therapy group , recieved continous oral 250 mg terbinafine once daily for 12 weeks continously

Group Type: ACTIVE_COMPARATOR

terbinafine

Intervention Type: DRUG

one 250 mg tablet of terbinafine were given once daily to 50 patients in group B for 12 weeks continously

Interventions

itraconazole

100 mg two capsules of itraconazole were givev twice daily to 50 patients in group A for one week per month . baseline LFTs were also monitered

Intervention Type: DRUG

terbinafine

one 250 mg tablet of terbinafine were given once daily to 50 patients in group B for 12 weeks continously

Intervention Type: DRUG

Other Intervention Names

capsules icon; tablets terbesil

Eligibility Criteria

Inclusion Criteria

• patients age between 18 and 60 years
• patients positive for fungus via direct microscopy due to identification of hyphae or blastospores on the toe nails
• patients having positive fungal culture
• patients who had not applied any topical agent to the target toe nail for the last one month

Exclusion Criteria

• Pregnant patients
• Lactating women
• Patients with poor adherence
• Patients previously allergic to oral itraconazole or terbinafine
• Patients with elevated baseline LFTs such as ALT ,AST , alkaline phosphatase and total bilirubin twice the upper limit of normal
• History of renal disease
• Patients unresponsive to systemic antifungal therapy with in the past year
• History of using systemic immunosuppressants
• Immunocompromised patients
• Pateints with ventricular dysfunction and history of congestive heart failure

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Combined Military Hospital Abbottabad

OTHER

Sponsor Role: lead

Responsible Party

Dr Mahboob Ali

principal investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Cmh Abbottabad

Abbottābād, Khyber Pakhtunkhwa, Pakistan

Countries

Pakistan

Other Identifiers

cmh abbottabod

Identifier Type: -

Identifier Source: org_study_id