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

Condition(s) targeted: Onychomycosis of the Toenail

Intervention: Itraconazole (Drug)

Phase: Phase 3

Status: Active, not recruiting

Sponsored by: Barrier Therapeutics

Official(s) and/or principal investigator(s):
Lynne Bulger, Study Director, Affiliation: Barrier Therapeutics

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.

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.

Study design: Treatment, Randomized, Single Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study

Primary outcome:

Investigator's Global Assessment (IGA) score of the target toenail

Mycology assessments by KOH and culture for dermatophytes of the target toenail

Secondary outcome:

Number of toenails and fingernails affected with onychomycosis

Safety and tolerability

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.

Minimum age: 16 Years. Maximum age: 75 Years. Gender(s): Both.

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

Edifico Professional Guarionex Lopez, Santo Domingo, Dominican Republic

Dr. Manuel Briones, Guayaquil, Ecuador

Clinica Metropolis II, Panama City, Panama

Langeberg Medical Centre, Cape Town, South Africa

Dr. Z. F. Ahmed Vawda, Durban, South Africa

DJW Navorsing, Krugerson, South Africa

University of Cape Town, Cape Town, South Africa

Radiant Research -Birmingham, Birmingham, Alabama 35209, United States

University of Alabama School of Medicine, Birmingham, Alabama 35233, United States

Dr. Kirk Barber, Calgary, Alberta T2S3B3, Canada

Radiant Research - Tucson, Tuscon, Arizona 85710, United States

Burke Pharmaceutical Research, Hot Springs, Arkansas 71913, United States

Dr. Richard Thomas, Vancouver, British Columbia V5Z3Y1, Canada

Radiant Research - Santa Rosa, Santa Rosa, California 95405, United States

East Bay Dermatology Medical Group Inc., Fremont, California 94538, United States

Therapeutics Clinical Research, San Diego, California 92123, United States

University of California, San Francisco, California 94143-0517, United States

Skin Surgey Medical Group, San Diego, California 92117, United States

Meridian Skincare, Englewood, Colorado 80112, United States

The Savin Center, New Haven, Connecticut 06511, United States

Advanced Dermatology and Cosmetic Surgery, Ormond Beach, Florida 32174, United States

FMX Research Corporation, Miami, Florida 33175, United States

Dr. Stephen Horwitz, Aventure, Florida 33180, United States

International Dermatology Research Inc., Miami, Florida 33144, United States

Radiant Research - West Palm Beach, West Palm Beach, Florida 33407, United States

Radiant Research - St. Petersburg, St. Petersburg, Florida 33781, United States

Gwinnett Clinical Research Center Inc., Snellville, Georgia 30078, United States

Radiant Research - Atlanta West, Austell, Georgia 30106, United States

Northwest Clinical Trials, Boise, Idaho 83704, United States

Radiant Research - Chicago, Chicago, Illinois 60610, United States

Radiant Research - Kansas City, Overland Park, Kansas 66215, United States

Dr. David Fivenson, Ann Arbour, Michigan 48103, United States

Skin and Vein Center, Troy, Michigan 48083, United States

Minnesota Clinical Study Center, Fridley, Minnesota 55432, United States

VA Medical Center, Minneapolis, Minnesota 55417, United States

Dr. Marc Bourcier, Moncton, New Brunswick E1C8X3, Canada

Dr. Eduardo Tschen, Albuquerque, New Mexico 87106, United States

Skin Specialty Group, New York, New York 10021, United States

Columbia University Medical Center, New York, New York 10032, United States

Dermatology Consulting Services, High Point, North Carolina 27262, United States

Dermatology Clinical Research Center, Cincinnati, Ohio 45219, United States

Radiant Research - Cincinnati, Cincinnati, Ohio 45249, United States

Dr. Aditja Gupta, London, Ontario N5X2P1, Canada

Dr. Chuck Lynde, Markham, Ontario L3P7N8, Canada

Dr. Jerry Tan, Windsor, Ontario N8W5L7, Canada

EntraLogix, Oakville, Ontario L6K1E1, Canada

Oregon Medical Research Center, Portland, Oregon 97223, United States

Northwest Cutaneous Research, Portland, Oregon 97210, United States

Dr. Robert Bissonnette, Montreal, Quebec H2K4L5, Canada

Rhode Island Hospital, Providence, Rhode Island 02903, United States

Radiant Research - Greenville, Greenville, South Carolina 29617, United States

Dr. J. M. Humeniuk, Greer, South Carolina 29651, United States

Radiant Research - Anderson, Anderson, South Carolina 29621, United States

Centro Orquidea Blanca, San Pedro, Sula, Honduras

Dermatology Associates of Knoxville, Knoxville, Tennessee 37917, United States

Tennessee Clinical Research Center, Nashville, Tennessee 37215, United States

Dermatology East, Germantown, Tennessee 38138, United States

Dr. Terry Jones, Bryan, Texas 77802, United States

Radiant Research - Dallas North, Dallas, Texas 75231, United States

DermResearch Inc., Austin, Texas 78759, United States

Dr. Stephen Miller, San Antoinio, Texas 78229, United States

Endeavor Clinical Trials, San Antonio, Texas 78229, United States

South Valley Dermatology Center, West Jordan, Utah 84088, United States

Dermatology Research Center, Salt Lake City, Utah 84124, United States

Pariser Dermatology Specialists Ltd., Norfolk, Virginia 235507, United States

Radiant Research - Tacoma, Tacoma, Washington 98499, United States

Madison Skin and Research Inc., Madison, Wisconsin 53719, United States

Advanced Healthcare S. C., Milwaukee, Wisconsin 53209, United States

Starting date: July 2006
Last updated: September 30, 2007