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

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

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Key information

Conditions

Onychomycosis Bacterial Infections and Mycoses Dermatomycoses Infections Mycoses Nail Diseases Skin Diseases Skin Diseases, Infectious Skin and Connective Tissue Diseases Tinea

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Cmh Abbottabad

Abbottābād, Khyber Pakhtunkhwa, 22020, Pakistan

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Itraconazole

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

Other names: capsules icon

Terbinafine

Drug

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

Other names: tablets terbesil

Primary outcomes

effectiveness of pulse therapy of itraconazole and continuous therapy of terbinafine for the treatment of onychomycosis as assessed by ONYCHOMYCOSIS SEVERITY INDEX (OSI)

Time frame: 12 weeks

OSI is calculated as follows:score of area involvement multiplied by score for proximity of disease to the matrix and10 points are added for the presence of dermatophytoma or subungal hyperkeratosis of greater than 2 mm.

A cumulative score of 0 indicates cured; 1 through 5, mild onychomycosis; 6 through 15, moderate onychomycosis; and 16 through 35 , severe onychomycosis.

Area of involvement score 0 to 5, proximity of disease to matrix score 1 to 5 , presence of subungal dermatophytoma or subungal hyperkeratosis score 0 or 10

Sponsors and collaborators

Lead sponsor

Combined Military Hospital Abbottabad

Other

Registry information

Important dates

Study start: 2022
Primary completion: 2022
Study completion: 2022
First posted: Oct 13, 2022
Registry last updated: Oct 19, 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.

Published trials that share one or more normalized conditions with this study.

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