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Comparative Study Between Pulse Therapy With Oral Itraconazole Versus Continuous Oral Terbinafine Therapy for Treatment of Onychomycosis - Trial NCT05578950

Access comprehensive clinical trial information for NCT05578950 through Pure Global AI's free database. This Phase 1 trial is sponsored by Combined Military Hospital Abbottabad and is currently Completed. The study focuses on Onychomycosis. Target enrollment is 100 participants.

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NCT05578950
Phase 1
Completed
drug
Trial Details
ClinicalTrials.gov โ€ข NCT05578950
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Comparative Study Between Pulse Therapy With Oral Itraconazole Versus Continuous Oral Terbinafine Therapy for Treatment of Onychomycosis

Study Focus

Onychomycosis

itraconazole

Interventional

drug

Sponsor & Location

Combined Military Hospital Abbottabad

Abbottฤbฤd, Pakistan

Timeline & Enrollment

Phase 1

Mar 01, 2022

Aug 31, 2022

100 participants

Primary Outcome

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

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

ICD-10 Classifications

Onychogryphosis
Chromomycosis, unspecified
Onycholysis
Actinomycosis
Blastomycosis

Data Source

ClinicalTrials.gov

NCT05578950

Non-Device Trial