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

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

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

Study Overview

• Status: Completed
• Conditions: Onychomychosis
• Intervention / Treatment: Drug: Itraconazole

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Phase 1

Contacts and Locations

Study Locations

• Pakistan
  • Khyber Pakhtunkhwa
    • Abbottabad, Khyber Pakhtunkhwa, Pakistan, 22020
      • CMH Abbottabad

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: group A pulse thearpy of itraconazole; Patients in pulse therapy group received oral itraconazole 100 mg, two capsules twice daily for seven days a month	Drug: Itraconazole; 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; Other Names: capsule icon
Active Comparator: Group B continous thearpy of itraconazole; Patients in continuous therapy group, received continuous oral 100 mg of itraconazole once daily for 12 weeks continuously.	Drug: Itraconazole; 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; Other Names: capsule icon

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Combined Military Hospital Abbottabad

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2021
• Primary Completion (Actual): December 31, 2021
• Study Completion (Actual): December 31, 2021

Study Registration Dates

• First Submitted: September 23, 2022
• First Submitted That Met QC Criteria: October 1, 2022
• First Posted (Actual): October 5, 2022

Study Record Updates

• Last Update Posted (Actual): October 5, 2022
• Last Update Submitted That Met QC Criteria: October 1, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Enzyme Inhibitors; Hormones, Hormone Substitutes, and Hormone Antagonists; Cytochrome P-450 CYP3A Inhibitors; Cytochrome P-450 Enzyme Inhibitors; Hormone Antagonists; Antifungal Agents; Steroid Synthesis Inhibitors; 14-alpha Demethylase Inhibitors; Itraconazole
• Other Study ID Numbers: CMH Abbottabad

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No