Inclusion Criteria:

•Subject aged 18 to 75 years.
•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:


Subjects with any of the following conditions or characteristics will be excluded from study enrollment (ie, will not receive study product):

•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.

• Canada (click to view all sites in Canada)
• North Bay Dermatology Centre Inc.
  North Bay, Ontario, P1B 3Z7; Completed;
  
• K. Papp Clinical Research Inc.
  Waterloo, Ontario, N2J 1C4; Completed;
  
• Ultranova Skincare
  Barrie, Ontario, L4M 6L2; Completed;
  
• Iceland (click to view all sites in Iceland)
• Dermatology Centre, University of Iceland
  Hudlaeknaslodin, Kopavogur, 201; Completed;
  
• USA (click to view all sites in USA)
• University of Alabama at Birmingham
  Birmingham, Al, 35233; Completed;
  
• Genova Clinical Research
  Tucson, AZ, 85791; Completed;
  
• Northern California Research
  Carmichael, CA, 95608; Completed;
  
• Impact Clinical Trials
  Beverly Hills, CA, 90211; Completed;
  
• UCSF Dermatology Research
  San Francisco, CA, 94115; Completed;
  
• Therapeutics Clinical Research
  San Diego, CA, 92123; Completed;
  
• Center for Dermatology Clinical Research
  Fremont, CA, 94538; Completed;
  
• Thomas J. Stephens & Associates, Inc. Colorado Research Center
  Colorado Springs, CO, 80915; Completed;
  
• Miami Dermatology Research Institute LLC
  North Miami Beach, FL, 33169; Completed;
  
• International Dermatology Research Inc
  Miami, FL, 33144; Completed;
  
• Greater Miami Skin & Laser Center
  Miami Beach, FL, 33140; Completed;
  
• Gwinnett Clinical Research Center, Inc.
  Snellville, GA, 30078; Completed;
  
• MedaPhase, Inc
  Newnan, GA, 30263; Completed;
  
• Welborn Clinic
  Evansville, IN, 47713; Completed;
  
• Henry Ford Medical Center
  Detroit, MI, 48202; Completed;
  
• Minnesota Clinical Study Center
  Fridley, MN, 55432; Completed;
  
• University of North Carolina at Chapel Hill
  Chapel Hill, NC, 27599; Completed;
  
• Skin Specialists, Inc
  Omaha, NE, 68144; Completed;
  
• NYU Medical Center
  New York, NY, 10016; Completed;
  
• Oregon Medical
  Portland, OR, 97223; Completed;
  
• Oregon Dermatology & Research Centre
  Portland, OR, 97210; Completed;
  
• Tennessee Clinical Research
  Nashville, TN, 37215; Completed;
  
• The Skin Wellness Center
  Knoxville, TN, 37922; Completed;
  
• DermResearch, Inc.
  Austin, TX, 78759; Completed;
  
• J & S Studies, Inc.
  College Station, TX, 77845; Completed;
  
• Center for Clinical Studies
  Houston, TX, 77058; Completed;
  
• Research Across America
  Dallas, TX, 75234; Completed;
  
• DermatologyResearch Center
  Salt Lake City, UT, 84124; Completed;
  
• Education and Research Foundation
  Lynchburg, VA, 24501; Completed;