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

23:04 EST 20th December 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

Clinical Trials [61 Associated Clinical Trials listed on BioPortfolio]

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

The objective of this study is to compare the relative efficacy and safety of SUBA™-Itraconazole Capsules (HalcyGen Ltd) to an already marketed oral formulation of itraconazole SPORANOX...

A Two-dose Level Clinical Trial of Itraconazole in Patients With Metastatic Prostate Cancer Who Have Had Disease Progression While on Hormonal Therapy

This research is being done to test an investigational drug, called itraconazole, in the treatment of prostate cancer. Itraconazole is approved by the Food and Drug Administration (FDA) fo...

Safety and Efficacy Study of Subjects With Onychomycosis of the Great Toenail

The purpose of the study is to determine the safety and efficacy of 5.0% and 7.5% AN2690 Solution in the treatment of distal, subungual onychomycosis of the great target toenail.

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...

A Study to Evaluate TMI-358 in the Treatment of Distal Subungual Onychomycosis

The purpose of this study is to determine if a local treatment is effective for the treatment of toenail fungus (distal subungual onychomycosis).

PubMed Articles [88 Associated PubMed Articles listed on BioPortfolio]

Placebo Cure Rates in the Treatment of Onychomycosis.

Placebo cure rates vary among randomized clinical trials for onychomycosis, but the factors influencing these cure rates have not been systematically investigated. The PubMed database and reference se...

Efinaconazole Topical Solution, 10% The Development of a New Topical Treatment for Toenail Onychomycosis.

Background : Toenail onychomycosis is a common disease with limited treatment options; treatment failure and relapse are frequently encountered. Many patients experience long-standing disease affectin...

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...

Molecular Determination of Mixed Infections of Dermatophytes and Nondermatophyte Moulds in individuals with Onychomycosis.

Abstract Background: Reports of mixed infections with NDMs and dermatophytes in onychomycosis are rare, possibly due to the inhibition of NDM growth during traditional culture. Objective: To determine...

Therapies for Onychomycosis: A Systematic Review and Network Meta-Analysis of Mycological Cure.

Abstract BACKGROUND:New therapies for onychomycosis continue to be developed, yet treatments are seldom directly compared in randomized controlled trials. The objective of the current study was to com...

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)

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