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

NCT05578950 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2022-10-19

No results posted yet for this study

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

Interventions

DRUG

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

DRUG

terbinafine

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

Sponsors & Collaborators

  • Combined Military Hospital Abbottabad

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-03-01
Primary Completion
2022-08-31
Completion
2022-08-31

Countries

  • Pakistan

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05578950 on ClinicalTrials.gov