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

NCT05578950 | Completed Phase 1

• 1 other identifier: cmh abbottabod
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

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

  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

  12 weeks

Study Arms (2)

group A pulse therapy of itraconazole

ACTIVE COMPARATOR

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

Drug: itraconazole

group B continous therapy of terbinafine

ACTIVE COMPARATOR

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

Drug: terbinafine

Interventions

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

Also known as: capsules icon

group A pulse therapy of itraconazole

terbinafine DRUG

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

Also known as: tablets terbesil

group B continous therapy of terbinafine

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Combined Military Hospital Abbottabad: lead

Study Sites (1)

Cmh Abbottabad

Abbottābād, Khyber Pakhtunkhwa, 22020, Pakistan

Location

MeSH Terms

Conditions

Onychomycosis

Interventions

Itraconazole; Terbinafine

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Triazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Piperazines; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principal investigator

Study Record Dates

• First Submitted: October 11, 2022
• First Posted: October 13, 2022
• Study Start: March 1, 2022
• Primary Completion: August 31, 2022
• Study Completion: August 31, 2022
• Last Updated: October 19, 2022

Record last verified: 2022-10

Locations

PA (1)