Itraconazole Tablets Vs. Itraconazole Capsules vs. Placebo in Onychomycosis of the Toenail. - Full Text View

Sponsored by:	Barrier Therapeutics
Information provided by:	Barrier Therapeutics
ClinicalTrials.gov Identifier:	NCT00356915

Purpose

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.

Condition	Intervention	Phase
Onychomycosis of the Toenail	Drug: Itraconazole	Phase III

Drug Information available for: Itraconazole

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Single Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	A Phase III Randomized, Evaluator-Blind, Parallel Group Study of the Safety and Efficacy of Itraconazole Tablets, Itraconazole Capsules and Placebo in the Treatment of Onychomycosis of the Toenail.

Further study details as provided by Barrier Therapeutics:

Primary Outcome Measures:

Investigator's Global Assessment (IGA) score of the target toenail [ Time Frame: 12months ]
Mycology assessments by KOH and culture for dermatophytes of the target toenail [ Time Frame: 12 months ]

Secondary Outcome Measures:

Number of toenails and fingernails affected with onychomycosis [ Time Frame: 12 months ]
Safety and tolerability [ Time Frame: 12 months ]

Enrollment:	1288
Study Start Date:	July 2006

Detailed 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.

Eligibility

Ages Eligible for Study:	16 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Clinical diagnosis of onychomycosis of at least one great toenail
Percent Nail Involvement Score of the more severely affected great toenail (the Target Toenail) must be between 2 and 3 (25-75% of the nail unit).
Length of Unaffected Part of the Target Toenail ≥2mm
Direct microscopic examination with KOH that is positive for the hyphae associated with dermatophytes on the target toenail
Subjects must have signed informed consent
If the subject is woman of childbearing potential, she must have a negative urine pregnancy test and agree to use an effective form of birth control until the first menses after 60 days following the last dose of study medication.

Exclusion Criteria:

Onychomycosis caused by Candida spp. without the presence of a dermatophyte
Participation in a clinical trial for the systemic treatment of onychomycosis of the toenail within 24 weeks prior to Visit 1
Use of systemic antifungals within 12 weeks prior to Visit 1
Use of topical antifungal nail lacquer within 30 days prior to Visit 1
Use of any other topical onychomycosis treatment on any toenail within 7 days prior to Visit 1
Evidence of ventricular dysfunction such as congestive heart failure (CHF) or a history of CHF
Known liver disease or a history of liver toxicity with other drugs
Use of systemic immunosuppressants

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00356915

Show 68 Study Locations

Sponsors and Collaborators

Barrier Therapeutics

Investigators

Study Director:

Lynne Bulger

Barrier Therapeutics

More Information

Study ID Numbers:	BT0300-302-INT
Study First Received:	July 25, 2006
Last Updated:	September 30, 2007
ClinicalTrials.gov Identifier:	NCT00356915
Health Authority:	United States: Food and Drug Administration; Canada: Health Canada

Keywords provided by Barrier Therapeutics:

Onychomycosis
Nail fungus
Itraconazole
Toenail

Study placed in the following topic categories:

Mycoses
Skin Diseases, Infectious
Onychomycosis
Skin Diseases
Clotrimazole
Miconazole

Tioconazole
Hydroxyitraconazole
Itraconazole
Tinea
Dermatomycoses

Additional relevant MeSH terms:

Anti-Infective Agents
Antiparasitic Agents
Antiprotozoal Agents
Nail Diseases

Therapeutic Uses
Antifungal Agents
Infection
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009