A Phase 1 interventional study of Itraconazole in Onychomychosis, sponsored by Combined Military Hospital Abbottabad. Completed at 1 site in Pakistan. Open to participants aged 20 Years to 60 Years. Per ClinicalTrials.gov, last updated 2022-10-05.
Sponsored by Combined Military Hospital Abbottabad · Phase 1, Interventional, and Treatment
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
Combined Military Hospital Abbottabad is the lead sponsor of 25 studies on the registry; 3 are open to participants now.
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Patients in pulse therapy group received oral itraconazole 100 mg, two capsules twice daily for seven days a month
Drug: 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
Also known as: capsule icon
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
Time frame: 12 weeks
This study is completed, as verified in Oct 2022. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Itraconazole
Combined Military Hospital Abbottabad