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NCT Number: NCT05567484

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

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

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Key information

Conditions

Age range

20 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

cmh Abbottabad

Abbottabad, Khyber Pakhtunkhwa, 22020, Pakistan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Other names: capsule icon

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)

    Time frame: 12 weeks

    Onychomycosis severity index was used to measure the effectiveness of drug

Sponsors and collaborators

Lead sponsor

Combined Military Hospital Abbottabad

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Oct 5, 2022
Registry last updated
Oct 5, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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