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Itraconazole Tablets Vs. Itraconazole Capsules vs. Placebo in Onychomycosis of the Toenail.

18:22 EDT 24th April 2014 | BioPortfolio

Summary

Onychomycosis is a common condition accounting for approximately half of all nail disorders. It is most commonly caused by dermatophytes. Itraconazole has been approved for the treatment of onychomycosis in the United States with an approved dosage regimen for the treatment of onychomycosis of the toenail of once daily (QD) treatment with 200mg of itraconazole (two 100mg capsules) for 12 weeks. Barrier Therapeutics has developed a 200mg tablet which could be used in a more convenient one-tablet-per-day dosing regimen. This clinical trial will compare the efficacy and safety of this new tablet formulation with itraconazole capsules and placebo.

Description

Onychomycosis is common and accounts for about half of all nail disorders. Usually the cause is due to dermatophytes, either Trichophyton rubrum (71%) or Trichophyton mentagrophytes (20%) but may also be due to yeast infection, usually Candida albicans.

The prevalence of onychomycosis in the United States population as a whole is 13% and is more prevalent in the elderly (60%). Onychomycosis of the toenail recurs and is thought to have a genetic component.

Onychomycosis can result in permanent nail deformity. This disease has a significant impact on the patient's quality of life (e.g., concern with the appearance of the toenails and fingernails, interference with wearing shoes, walking and sports activities).

Itraconazole has been approved for the treatment of onychomycosis in the United States since the mid-nineteen-nineties. The approved dosage regimen for treatment of onychomycosis of the toenail is once daily (QD) treatment with 200mg of itraconazole (Sporanox®, Janssen Pharmaceutica Products, L.P., Titusville, NJ, USA) for 12 weeks. The approved dosage form is a 100mg capsule. Barrier Therapeutics has developed a 200mg tablet which could be used in a more convenient one-tablet-per-day dosing regimen.

This clinical trial will compare the efficacy and safety of this new tablet formulation with itraconazole capsules and placebo.

Study Design

Allocation: Randomized, Control: Placebo Control, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind, Primary Purpose: Treatment

Conditions

Onychomycosis of the Toenail

Intervention

Itraconazole

Location

Radiant Research -Birmingham
Birmingham
Alabama
United States
35209

Status

Completed

Source

Barrier Therapeutics/ Stiefel, a GSK Company

Results (where available)

View Results

Links

Medical and Biotech [MESH] Definitions

One of the triazole ANTIFUNGAL AGENTS that inhibits cytochrome P-450-dependent enzymes resulting in impairment of ERGOSTEROL synthesis. It has been used against histoplasmosis, blastomycosis, cryptococcal meningitis & aspergillosis.

A fungal infection of the nail plate, usually caused by a DERMATOPHYTES; YEASTS; or nondermatophyte MOLDS.

Separation of nail plate from the underlying nail bed. It can be a sign of skin disease, infection (such as ONYCHOMYCOSIS) or tissue injury.

A general term describing various dermatophytoses. Specific types include TINEA CAPITIS (ringworm of the scalp), TINEA FAVOSA (of scalp and skin), TINEA PEDIS (athlete's foot), and tinea unguium (see ONYCHOMYCOSIS, ringworm of the nails). (Dorland, 27th ed)

A genus of yeast-like mitosporic Saccharomycetales fungi characterized by producing yeast cells, mycelia, pseudomycelia, and blastophores. It is commonly part of the normal flora of the skin, mouth, intestinal tract, and vagina, but can cause a variety of infections, including CANDIDIASIS; ONYCHOMYCOSIS; vulvovaginal candidiasis (CANDIDIASIS, VULVOVAGINAL), and thrush (see CANDIDIASIS, ORAL). (From Dorland, 28th ed)

Clinical Trials [57 Associated Clinical Trials listed on BioPortfolio]

Study Comparing SUBA™-Itraconazole With SPORANOX® (Itraconazole) in the Treatment of Onychomycosis

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SCIO(Scoring Clinical Index for Onychomycosis) in Onychomycosis Treating With ITRACONOZOLE

This clinical study, using SCIO, will assess subjects with toenail onychomycosis confirmed by KOH and culture positive, identify the change of SCIO score after Sporanox capsule administrat...

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PubMed Articles [61 Associated PubMed Articles listed on BioPortfolio]

Longitudinal monitoring of CYP3A activity in patients receiving 3 cycles of itraconazole pulse therapy for onychomycosis.

Itraconazole, a CYP3A inhibitor, is used for the treatment for onychomycosis with a three-cycle pulse therapy over 3 months, but its effects on in vivo CYP3A activity during the entire course remain...

A case of onychomycosis caused by Aspergillus candidus.

Based on epidemiological studies, Aspergillus candidus has been demonstrated as an emerging fungal agent of toenail onychomycosis. Here we report a case of a toenail infection caused by A. candidus in...

Efinaconazole: a new topical treatment for onychomycosis.

Efinaconazole is an emerging antifungal therapy for the topical treatment of onychomycosis. Efinaconazole is an inhibitor of sterol 14α-demethylase and is more effective in vitro than terbinafine, it...

A case report of a mixed Chaetomium globosum/Trichophyton mentagrophytes onychomycosis.

Recently, an increasing prevalence of nondermatophyte mold onychomycosis was observed, in which Chaetomium globosum was rarely involved as primary pathogenic agent. Besides this, reports of mixed infe...

Oral Therapy for Onychomycosis: An Evidence-Based Review.

Onychomycosis is a very common fungal infection of the nail apparatus; however, it is very hard to treat, even when the causative agent is identified, and usually requires prolonged systemic antifunga...

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