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

Primary Purpose

Onychomycosis

Status
Completed
Phase
Phase 1
Locations
Pakistan
Study Type
Interventional
Intervention
itraconazole
terbinafine
Sponsored by
Combined Military Hospital Abbottabad
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Onychomycosis

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Cmh Abbottabad

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

group A pulse therapy of itraconazole

group B continous therapy of terbinafine

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
October 11, 2022
Last Updated
October 17, 2022
Sponsor
Combined Military Hospital Abbottabad
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1. Study Identification

Unique Protocol Identification Number
NCT05578950
Brief Title
Comparative Study Between Pulse Therapy With Oral Itraconazole Versus Continuous Oral Terbinafine Therapy for Treatment of Onychomycosis
Official Title
Comparative Study Between Pulse Therapy With Oral Itraconazole Versus Continuous Oral Terbinafine Therapy for Treatment of Onychomycosis
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Completed
Study Start Date
March 1, 2022 (Actual)
Primary Completion Date
August 31, 2022 (Actual)
Study Completion Date
August 31, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Combined Military Hospital Abbottabad

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Onychomycosis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Actual)

8. Arms, Groups, and Interventions

Arm Title
group A pulse therapy of itraconazole
Arm Type
Active Comparator
Arm Description
patients with pulse therapy group recieved oral itraconazole 100 mg, two capsules twice daily for 7 days a month
Arm Title
group B continous therapy of terbinafine
Arm Type
Active Comparator
Arm Description
patients with continous therapy group , recieved continous oral 250 mg terbinafine once daily for 12 weeks continously
Intervention Type
Drug
Intervention Name(s)
itraconazole
Other Intervention Name(s)
capsules icon
Intervention Description
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
Intervention Name(s)
terbinafine
Other Intervention Name(s)
tablets terbesil
Intervention Description
one 250 mg tablet of terbinafine were given once daily to 50 patients in group B for 12 weeks continously
Primary Outcome Measure Information:
Title
effectiveness of pulse therapy of itraconazole and continuous therapy of terbinafine for the treatment of onychomycosis as assessed by ONYCHOMYCOSIS SEVERITY INDEX (OSI)
Description
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
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Cmh Abbottabad
City
Abbottābād
State/Province
Khyber Pakhtunkhwa
ZIP/Postal Code
22020
Country
Pakistan

12. IPD Sharing Statement

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

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