Efficacy and Safety Study of 4 Dose Regimens of Oral Albaconazole in Subjects With Distal Subungual Onychomycosis
NCT ID: NCT00730405
Last Updated: 2018-03-12
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
582 participants
INTERVENTIONAL
2008-07-16
2010-02-19
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Albaconazole 100mg
Albaconazole for 36 weeks
Albaconazole 100mg
Albaconazole for 36 weeks
Albaconazole 200mg
Albaconazole for 36 weeks
Albaconazole 200mg
Albaconazole for 36 weeks
Albaconazole 400mg
Albaconazole for 36 weeks
Albaconazole 400mg
Albaconazole for 36 weeks
Albaconazole 400mg 24 weeks, Placebo 12 weeks
Albaconazole for 24 weeks, Placebo for 12 weeks
Albaconazole 400mg
Albaconazole for 24 weeks, Placebo for 12 weeks
Placebo 400 mg
Placebo for 36 weeks
Placebo 400 mg
Placebo for 36 weeks
Placebo 400 mg
Placebo for 36 weeks
Interventions
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Albaconazole 100mg
Albaconazole for 36 weeks
Albaconazole 200mg
Albaconazole for 36 weeks
Albaconazole 400mg
Albaconazole for 36 weeks
Albaconazole 400mg
Albaconazole for 24 weeks, Placebo for 12 weeks
Placebo 400 mg
Placebo for 36 weeks
Eligibility Criteria
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Inclusion Criteria
* Diagnosis with distal subungual onychomycosis of the toenails that affects at least one great toe (target toenail).
* Subject is willing to provide signed and dated written voluntary informed consent (and any local or national authorization requirements) before any protocol-specific procedures are performed.
* Subject is able to complete the study, comply with study instructions, and take study product orally.
* Sexually active non-lactating females of childbearing potential participating in the study must agree to use a medically acceptable method of contraception while receiving protocol-assigned product and up to the first menses 60 days following the last dose of study product.
* Women of childbearing potential must have a negative pregnancy test at enrollment.
* Subject has screening laboratory parameters and ECG within the normal ranges unless considered to be not clinically relevant by the principal investigator.
Exclusion Criteria
* Subject has received an investigational drug within 4 weeks of the first dose of study product, or who are scheduled to receive an investigational drug other than the study product during the study.
* Subject has participated in a clinical trial for the systemic treatment of onychomycosis of the toenails within 6 months prior to the first dose of study product.
* Subject is receiving any drugs that are known substrates of the 3A4 isozyme of cytochrome P450 (CYP3A4) with QT prolongation potential or any of the concomitant medications listed under prohibited medication section.
* Subject has a history of known or suspected intolerance to albaconazole or the formulation excipients, or to azole antifungal drugs in general.
* Subject has previously participated in a clinical study with albaconazole.
* Subject is not prepared to give up use of any nail cosmetic products for the duration of the study.
* Subject has any known immunodeficiency or history of malignancy in the last 4 years, excluding nonmelanoma skin cancer.
* Subject has any known liver disease or a history of liver toxicity with other drugs.
* Subject is currently suffering from any disease or condition, that could include abnormal laboratory tests, and/or who are currently using medication which in the opinion of the investigator may affect the evaluation of the study product or place the subject at undue risk.
* Subject has psoriasis, lichen planus, or other abnormalities that could result in a clinically abnormal toenail.
* Subject has a history of any condition that could possibly affect absorption of drug (eg, gastrectomy), uncontrolled diabetes, clinically significant peripheral vascular disease or peripheral circulatory impairment, or has had any major illness within 30 days prior to the screening examination.
* Subject has a history of drug, prescription medicine, or alcohol abuse within the past 2 years.
* Female subjects who are pregnant, trying to become pregnant, or lactating.
* Employees of Investigator/clinical research organization (CRO) or Stiefel Laboratories, Inc., or an immediate family member (partner, offspring, parents, siblings or sibling's offspring) of an employee.
18 Years
75 Years
ALL
No
Sponsors
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GlaxoSmithKline
INDUSTRY
Stiefel, a GSK Company
INDUSTRY
Responsible Party
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Principal Investigators
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GSK Clinical Trials
Role: STUDY_DIRECTOR
GlaxoSmithKline
Locations
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University of Alabama at Birmingham
Birmingham, Alabama, United States
Genova Clinical Research
Tucson, Arizona, United States
Impact Clinical Trials
Beverly Hills, California, United States
Northern California Research
Carmichael, California, United States
Center for Dermatology Clinical Research
Fremont, California, United States
Therapeutics Clinical Research
San Diego, California, United States
UCSF Dermatology Research
San Francisco, California, United States
Thomas J. Stephens & Associates, Inc. Colorado Research Center
Colorado Springs, Colorado, United States
International Dermatology Research Inc
Miami, Florida, United States
Greater Miami Skin & Laser Center
Miami Beach, Florida, United States
Miami Dermatology Research Institute LLC
North Miami Beach, Florida, United States
MedaPhase, Inc
Newnan, Georgia, United States
Gwinnett Clinical Research Center, Inc.
Snellville, Georgia, United States
Welborn Clinic
Evansville, Indiana, United States
Henry Ford Medical Center
Detroit, Michigan, United States
Minnesota Clinical Study Center
Fridley, Minnesota, United States
Skin Specialists, Inc
Omaha, Nebraska, United States
NYU Medical Center
New York, New York, United States
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, United States
Oregon Dermatology & Research Centre
Portland, Oregon, United States
Oregon Medical
Portland, Oregon, United States
The Skin Wellness Center
Knoxville, Tennessee, United States
Tennessee Clinical Research
Nashville, Tennessee, United States
DermResearch, Inc.
Austin, Texas, United States
J & S Studies, Inc.
College Station, Texas, United States
Research Across America
Dallas, Texas, United States
Center for Clinical Studies
Houston, Texas, United States
DermatologyResearch Center
Salt Lake City, Utah, United States
Education and Research Foundation
Lynchburg, Virginia, United States
Ultranova Skincare
Barrie, Ontario, Canada
North Bay Dermatology Centre Inc.
North Bay, Ontario, Canada
K. Papp Clinical Research Inc.
Waterloo, Ontario, Canada
Dermatology Centre, University of Iceland
Hudlaeknaslodin, Kopavogur, Iceland
Countries
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References
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Sigurgeirsson B, van Rossem K, Malahias S, Raterink K. A phase II, randomized, double-blind, placebo-controlled, parallel group, dose-ranging study to investigate the efficacy and safety of 4 dose regimens of oral albaconazole in patients with distal subungual onychomycosis. J Am Acad Dermatol. 2013 Sep;69(3):416-25. doi: 10.1016/j.jaad.2013.03.021. Epub 2013 May 22.
Other Identifiers
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114554
Identifier Type: -
Identifier Source: org_study_id
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