Comparative Study Between Pulsed and Continuous Itraconazole for the Treatment of Onychomycosis

NCT05567484 | Completed Phase 1

• 1 other identifier: CMH Abbottabad
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

The term onychomycosis is used for a chronic fungal infection of the nail which when caused by dermatophytes, becomes tinea unguium. It not only includes the dermatophytes but also saprophytic molds infections and yeasts. Thorough literature research has revealed that 90% toenail and 75% fingernail onychomycosis are a result of dermatophytes arguably by Trichophyton mentagrophytes and Trichophyton rubrum. Comorbid conditions such as diabetes mellitus and peripheral arterial disease and immunosuppression due to HIV plays a catalytic role in its prognosis. In a study, upon comparison of placebo with continuous terbinafine 250 mg daily for 24 weeks and continuous terbinafine 250 mg daily for 16 weeks, no significant differences were observed by the researchers between the two methods i.e continuous and pulse regimens of terbinafine, itraconazole, and fluconazole respectively. Moreover, in one another research study, the researchers also did not find significant superiority of continuous itraconazole 200 mg daily for 12 weeks over pulsed itraconazole 400 mg in the treatment of terms onychomycosis of mycological cure that is the reason why continuous daily itraconazole 200 mg for 24 weeks has so far performed best in rank probabilities over other therapies, but its clinical significance is still debated. The purpose of carrying out this study was to carry out comparison between pulsed and continuous itraconazole for the treatment of onychomycosis as previous literature shows ambiguous results, therefore, this study will cement the rare evidence pertaining to the efficacy of pulsed and continuous itraconazole in the treatment of onychomycosis in our local population

Conditions

Onychomychosis

Outcome Measures

Primary Outcomes (1)

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

  Onychomycosis severity index was used to measure the effectiveness of drug

  12 weeks

Study Arms (2)

group A pulse thearpy of itraconazole

ACTIVE COMPARATOR

Patients in pulse therapy group received oral itraconazole 100 mg, two capsules twice daily for seven days a month

Drug: Itraconazole

Group B continous thearpy of itraconazole

ACTIVE COMPARATOR

Patients in continuous therapy group, received continuous oral 100 mg of itraconazole once daily for 12 weeks continuously.

Drug: Itraconazole

Interventions

Itraconazole DRUG

100 mg two capsules of itraconazole were given twice daily to 30 patient group A for one week per month.baseline LFTs were also monitered

Also known as: capsule icon

Group B continous thearpy of itraconazole; group A pulse thearpy of itraconazole

Eligibility Criteria

• Age: 20 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Patients age between 20-60 years
• Patients positive for fungus via direct microscopy due to the identification of hyphae or blastospores on the target toenail
• Patients positive fungal culture. Patients who had not applied any topical agent to the target toenail for the last 1 month

You may not qualify if:

• Pregnant patients
• Patients with poor adherence
• Lactating women.
• Patients previously allergic to oral itraconazole.
• Patients with elevated baseline liver function tests 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 within the past year
• History of using systemic immunosuppressants.
• Patients exhibiting evidence of ventricular dysfunction and history of congestive heart disease
• Immunocompromised patients

Sponsors & Collaborators

• Combined Military Hospital Abbottabad: lead

Study Sites (1)

cmh Abbottabad

Abbottabad, Khyber Pakhtunkhwa, 22020, Pakistan

Location

MeSH Terms

Interventions

Itraconazole

Intervention Hierarchy (Ancestors)

Triazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Piperazines

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: principle investigator

Study Record Dates

• First Submitted: September 23, 2022
• First Posted: October 5, 2022
• Study Start: May 1, 2021
• Primary Completion: December 31, 2021
• Study Completion: December 31, 2021
• Last Updated: October 5, 2022

Record last verified: 2022-10

Locations

PA (1)